ONC Seeks Comment on the Federal Health IT Strategic Plan 2011-2015

Providing strategic leadership to public and private sector efforts to improve health and health care through the use of information and technology is a key responsibility of the Office of the National Coordinator for Health Information Technology (ONC). The Federal Health IT Strategic Plan (“the Plan”) [PDF - 1 MB] is an important tool for guiding national efforts and investments in health IT over the next several years. 

The Health Information Technology for Economic and Clinical Health (HITECH) Act, part of the American Recovery and Reinvestment Act of 2009, requires ONC to update the Plan. The Plan was last published in 2008 and is being updated to take into account the rapidly changing landscape of health IT and health IT policy that has been drastically altered over the past years by two major pieces of legislation that have established an agenda and committed significant resources to health IT—the HITECH Act and the Affordable Care Act.

Over the past year, ONC has worked closely with our federal partners and the private sector (through the HIT Policy Committee) to update the Plan. The Plan reflects ONC’s strategy, developed in collaboration with other federal partners, for realizing Congress and the Administration’s health IT agenda over the next five years.

The Plan starts in 2011, the year when medical care entered a new era—the age of meaningful use. This new era creates opportunities to transform the health care system by improving the flow of information through health IT. Meaningful use is currently aimed at widespread adoption and information exchange, and ultimately at improving health care outcomes. The Plan demonstrates how we will build off the foundation of meaningful use to unlock the power of information to:

  • Enhance our ability to study care delivery and payment systems
  • Empower individuals to improve and participate more in their care
  • Improve care, efficiency, and population health outcomes, through tools such as clinical decision support, real- time feedback of performance to clinicians, and targeted public health campaigns

Some components of the Plan may already be familiar, including the Medicare and Medicaid Electronic Health Record Incentive Programs and the grant programs created by the HITECH Act, which are creating an infrastructure to support meaningful use. However, the Plan also charts new ground for the federal health IT agenda:

  • In Goal I, the health information exchange strategy focuses on first fostering business models that create health information exchange, supporting exchange where it is not taking place, and ensuring that information exchange takes place across different business models.
  • In Goal II, we discuss how integral health IT is to the National Health Care Quality Strategy and Plan that is required by the Affordable Care Act.
  • In Goal III, we highlight efforts to step up protections to improve privacy and security of health information, and discuss a major investment in an education and outreach strategy to increase the provider community and the public’s understanding of electronic health information, how their information can be used, and their privacy and security rights under the HIPAA Privacy and Security rules.
  • In Goal IV, we recognize the importance of empowering individuals with access to their electronic health information through useful tools that can be a powerful driver in moving toward more patient-centered care.
  • In Goal V, we have developed a path forward for building a “learning health system,” that can aggregate, analyze, and leverage health information to improve knowledge about health care across populations.

We are only beginning to unlock the vast promise of electronic health information to improve decision making, help individuals better manage their health, and improve the health system’s capacity for rapid learning. We hope you will join us in this effort by providing comments on the Plan.

The Federal Health IT Strategic Plan: 2011 – 2015 [PDF - 1 MB] public comment period is now closed.

Following the analysis of the comments received during the public comment period, ONC intends to publish a summary of the major themes that emerged from the public, as well as a final version of the Plan on its website.

For more information:

  • Read more about the Plan, including an overview and goals, on the ONC website.
  • Read the HHS press release on the Federal Health IT Strategic Plan.
  • Check out the blog post from Todd Park, Chief Technology Officer, HHS.

241 Comments

  1. James Aita says:

    One concern is that ONC may not have done an extensive enough review of available standards for vocabularies used in for data exchange. For example, SNOMED, while comprehensive, is often convoluted and difficult to map to, particularly for use at the point of care. To date, it has also been difficult to determine how to consult or give input to ONC on available standards for vocabularies for data exchange, specifically those that are in widely adopted by EMR systems (both in the public and commercial arenas) already but not “accepted” for exchange by ONC.

  2. David Hager, M.D. says:

    Don’t know if the Strategic Plan goals are in any hierarchy. If so, I suggest that “designing health IT policies and programs to meet individual needs and expectations” in Goal IV should be part of, or a prelude to “Achieve Adoption” in Goal I.

    As a life-time geek, avocational web designer, code writer and daily physician EHR user, I do not see how current EHR technologies are mature enough for prime time. Perhaps there’s a hope that pushing this thing off the cliff will force it to fly. Maybe.

    I’ve also come to conclude that the best way to catalyze the EHR industry to create products that “meet individual needs and expectations” is standardization of data.

    Example: the world wide web. Data constructs are standardized sufficiently that users can change browsers at will. The WWW doesn’t have to change it’s data configuration because I changed from Internet Explorer to Opera.

    Unfortunately, when clinicians buy EHR products now, they marry a database structure, for better and for worse. Divorce is too expensive.

    Don’t like your current EHR? Too bad.

    New product cost + data migration cost = prohibitive cost.

    Might as well just dump it all back to paper and move on. After all, a doc can see more patients with a paper chart than an EHR, and paper is cheaper to buy/maintain. It’s also more reliable and easier to use.

    When a clinician can change EHR products as easily as any computer user can change browsers, market competition will unleash the innovation needed to drive quality up and cost down.

    When docs are finally presented with irresistible EHR technologies that make them faster, smarter, safer and more profitable, no federal programs will be needed to carrot/stick them into lining up at the door to buy them.

    • Troy Seagondollar, MSN (Informatics), RN-BC says:

      I agree with Dr Hager and add that while adoption is an advantageous ideal it can not be achieved by forcing clinicians to adapt. Currently many of the certified EHR’s, and other technologies available today, force the clinician to spend exhaustive amounts of time doing system analysis in comparison and contrast to their clinical workflow only to find out that the system does not match their processes. Since changing and/or modifying systems is cost restrictive, this, in turn, forces them to change their way of practice while forcing them to learn a new system of documentation, coding, and billing.
      Adoption is something that ones accepts into their life willingly “by choice.” Adaption forces one to change their life based on something being thrust upon them without recourse. Regardless of incentives, if the system does not follow the “flow” of the clinical work, it will likely not be adopted and will not be utilized to achieve “Meaning Use” criteria.

      • Adoption of new technology is usually not driven by choice, but out of necessity. Even if one does not believe in the notion of “innovative disruption” (see Clayton Christensen’s et al book – “The Innovator’s Prescription”), it is hard to argue that many businesses were placed at a competitive disadvantage when the PC-based word processor replaced the typewriter. It will be the same for EHRs, every other industry has replaced paper files with electronic ones.

        • David Hager, M.D. says:

          Competitive advantage. Important point.

          Ironically, docs can still see more patients per day and at less cost by using paper.

          Also, paper charts don’t go down when the power goes out, or a driver goes bad, or the router goes out, or malware gets in, or software conflicts break something in the EHR, or a hard drive dies, or a power supply croaks, or coffee spills, or … (There could be generated a very, very long list of trivial factors that can bring down computer systems.)

          You speak of competitive advantage. This is true now in most business sectors. It makes sense that they have made the move. Prodigious overhead (technology and payroll) is offset by the resulting profit.

          I’m not yet convinced an EHR improves competitive advantage in the mainstream of clinical, one patient-at-a-time service provision. You cannot yet convince a clinical end-user that take home pay in a couple of years will be higher because an EHR system was installed at the clinic. The math isn’t there yet.

          The key word is “yet.” The job the feds have invited upon themselves should focus mightily upon removing that “yet,” rather than forcing the immature mess into our laps now.

          When the industry has removed the “yet,” no federal carrots/sticks will be needed to cause EHR adoption. Carrots/sticks certainly weren’t needed for the business sectors you mentioned that have already gone electronic! Sadly, proof of the EHR industry’s immaturity is the very existence of the federal carrots/sticks in the first place.

        • Eric S. Lichtenstein, MD says:

          The analogy just doesn’t work. Think about it… The data entry is the same for computer word processing and typing on a typewriter. The advantage is in the post data entry processing with the computer system. The electronic health record systems may or may not be good at data processing (GIGO), but the problem is that data entry is not ready for prime time… neither efficient, nor reliably accurate, depending upon the skill and knowledge of the user. The cost effectiveness ratio is inversely proportional to the user’s level of knowledge and responsibility, because of the data entry inefficiency.

        • Cory Cook says:

          Yea I see your point about having a competitive disadvantage, yet I do not think competition is the sole benefit of new technologies either. Especially relating to the use of electronic files instead of paper filing systems. There are many people that are against technology, however I am not one of them. I just feel that we need to focus on using our technological advances in the correct way to do good for every living thing that is involved, instead of just to out perform the competition. Electronic files can save the amount of paper getting wasted, which in turn can help minimize the amount of trees getting destroyed, which in result can help minimize the reduction of oxygen being released from these trees.
          I feel new technologies can either set us free, or destroy us, but the choice is up to us.

    • All good points.

      I particularly agree with the need for vendors to separate data layers from presentation layers, though that may be difficult to reflect in the strategic plan. It would also be nice if every vendor was required to conform to basic user design principles as outlined in the recent NIST report on EHR usability.

      Perhaps the design process, in addition to checking off feature functions, could become a part of EHR certification. Normally, I would consider that micromanagement and prefer market forces, but after 20+ years of EHR development, the poor penetration into the provider market suggests that the EHR vendors (as a group) have not responded to market needs or they already would be widely adopted. In the absence of that response and in the presence of government hammers on providers, there may need to be similar government hammers on vendors to forward the interest in and ability of providers to more easily incorporate EHRs into their practices.

    • Tom Albro says:

      EXCELLENT!!!

    • Tory says:

      Very good point about the benefits of paper. ‘you can’t push a rope’ (sounds like you have knowledge about lean systems???) There are some innovative ways being developed that address the issue of transitioning incrementally (in a lean ‘pull’ fashion) that show great promise. It doesn’t have to be either/or and, in fact, I lean on the side of Toyota Production System(TPS) ‘pull’ approach.
      Like you, keep it simple, keep it effective… but with an eye on the future.
      We want to help providers like you meet the systems halfway, and use your experience to make the systems better.

      • David Hager, M.D. says:

        Pushing rope refers to motivational psychology. Try to force me to buy a widget, and I’m more likely respond with passive inaction. Put a delicious widget out there that makes me salivate, and I’m more likely to go after it with an open wallet. Easier to pull a rope than to push it.

        Simply, EHR products should sell themselves. The feds shouldn’t be involved in pushing them in their current form. They aren’t the ones suffering through the awkwardness of poor design during in-the-trenches work. Let the customer decide when a product is ready to be purchased.

        The present, premature push of problematic software wouldn’t be so onerous, though, were it simple to change products. However, the reality is that when I say “ughhh” to Product A … there’s no simple way to get to Product B. Product A has me locked in to its data structure, leaving me with three choices:

        1. Suck it up and pay someone a bunch of $$ to migrate my patient data to Product B, while also paying $$ to buy Product B.
        2. Stick with Product A in persistent, unhappy frustration
        3. Dump Product A data to paper and return to paper charting.

        • Bill says:

          Dr. Hager,

          I feel your sentiments and passion about quality EHR products and service. I have a BS in Information Technology, worked within computer services for 29 years, and currently teach IT courses for a living.

          My perspective about technology is purely how useful it is to help me be productive. Although, I am amazed about the entertaining progresses that have been made ( my concern is the obsessive nature of using the technology to a person’s harm).

          I was in the computer industry before MS Winodws 3.0 revolutionalized the business world. My mother sweared by her IBM type writer never being replaced. The EHR reminds me of this era of destined change and conformity. MS later developed the Word processor which added to the business tool arsenal of efficiency for high prodcutivity in the work place , in additon to improved processes in manufacturing products by using specialized operating systems.

          I agree that many of the certified EHR systems have managed to slip pass the quality managment needed to reduce cost in the clinics. I look at software development maybe a little different than most and for good reasons. I had to install IBM and MS original LAN manager products with 32 corrective diskettes ( yes diskettes !) which in some cases failed after the 31st diskette was inserted and the process had to be started over.

          EHR systems need to be evaluated from a complinace and conformity perspective. Conformity is meeting the customers specific needs.Complinance is just meeting enough of the goverment standards to to play ball and entertain the customer with meaningless incentives and long term cost increases.

          My greater concern is that the government not put blinders on regarding the high rate of unsuccessful IT projects. If there is oversite with the intent to serve the customer with a proven and demonstrated solution before purchasing, then I believe the end result owuld be an hugh increase in EHR purchures because their is a try- before-buy incentive.

          I am currently one of the IT professional who decide to learn about the EHR systems and train clinicians. I am currently in school in a 6 month intense grant program. When I am finished this program ” EHR Specialist/IT”, I hope to evangilze your concerns.

          Bill

    • Will Melson says:

      Well said. Having been a part of other industries that have gone through this cycle of “innovation”, I hope we can use those valuable lessons learned and reach the points others have.

    • Carol Frew says:

      As a patient I am angry that the government is insinuating itself into Health-care including giving orders as to how the medical profession handles their business. I am sure that medical records can be handled by the private sector better than the government can.

      I will fight against Obama-care and will let my doctors know that we don’t want our private records getting into the hands of the government! I hope the doctors that are for this kind of socialistic intrusion will fight against the government too. As a patient I would like to know if the majority of doctors are for government health-care. I am 66 years old and am very upset that this government has become so corrupt that they will do as they want not what the people want.

      Apathy is the most dangerous disease and is an epidemic…we need our doctors to stand and take a very important role in fighting against this system that has been engineered by socialist or worse.

      We are a free country last time I looked!

      • Tammy says:

        Carol,

        If you are 66 years old and are on Medicare, or soon to be, the government already has your private health records because the government is paying your health care bills!

    • Janet Messcher says:

      I agree. My husband can see many more patients and take care of them – which is his job – instead of doing the administrator’s work on a hand-held tablet.

    • I agree with Dr. Hager that standards are still in their infancy. Innovation in other areas of IT happens because any small shop can develop an application that is compatible with a myriad of devices and programs. While standards are being developed for EHRs they are still proprietary and development is compromised by the inability to integrate with the various EHRs without their acquiescence which can be in conflict with their own competitive objectives. If we want to accelerate populating the space we need to make the door easier to walk through.

  3. Tory says:

    As a Lean/Agile enthusiast and recent grad from the first cohort group through the Community College HIT program, I/we (students) have experienced the thrill of perpetual evolution! I embrace the foundational principals that I see increasingly arise… e.g. the Open Government Initiative •Transparency • Participation * Collaboration. We’re not there yet but we are moving closer… and in the interim, as we continue to open up bi-directional channels of communication for mutual development, we, as students/grads are doing ‘what it takes’ to contribute to this very important and vital endeavor!

    • David Hager, M.D. says:

      Nice enthusiasm. Hope you won’t turn into one of the IT people who forgets who the customer is. I run into too many IT people who seem to believe IT is the customer, and I (an end-user) am an irritating inconvenience.

      In the case of EHR technologies, the people who buy them and use them daily (clinicians) are the primary customers. (Patients are beneficiaries, not the primary customers.)

      Please remember that IT is a means to an end, and not the end unto itself. If EHR technologies don’t make clinicians faster, smarter, safer AND help the actual bottom line, they will not be durably welcome in our world. This whole project will turn into a temporary, failed, well-intentioned experiment.

      You can’t push a rope.

      • Robert Wolfe says:

        Unfortunately, Dr. Hagar has it backwards: The patient is the Client, not the physician. The physician who views Health IT as merely an engine for making more money and a pain in the exam room represents the system that has prevented the introduction of computers into health care for decades. True, we need to convince the physicians who need to use technology that they should do so to attain the very efficiency that will permit them more time to deal with patients and to do the primary service of health care, curing disease. Rather than suggest means of making systems better, some physicians are happy just to proclaim “not ready for prime time”. We are going to need some short term success stories to convince these diehards. Dr. Hagar discloses his desire for the same old slow moving, high cost methods of the past by urging we all return to paper. Covered Wagons any one?

        • David Hager, M.D. says:

          Reps for EHR companies are not marketing to the patients – because patients don’t buy EHR systems.

          Reps are showing up at practices to find the financial decision makers – still usually clinical staff. Those are the ones buying the EHR technologies. They fork out the money. They are the primary customers for EHR technologies.

          (Analogy: A floor cleaner company seeks out a contract with Wal-Mart, not me, the store’s customer on aisle 5. However, I benefit from the clean floors, and am more likely to patronize the store if the floors are kept clean.)

          The patient is the customer of the clinician, not the EHR company. The patient benefits (hopefully) from the EHR technology … and is thus a beneficiary.

          However, a difficult disconnect occurs when the EHR customers and end-users are separate parties, as happens in large service delivery systems. For example, a state agency (the EHR customer) will decide re: EHR technologies with separate authority from the clinical end-users. The results can be rather unfortunate (speaking from significant experience.)

        • Morgan says:

          Don’t you think that the real goal should be better communication between doctors and patients? I don’t believe anyone can argue that innovations in IT aren’t good for both parties. The digital world we live in now allows us to relay critical information almost instantly, something the “paper world” could never do. The more relevant data in a doctor’s hands, the more precise his opinion can be. I’m not saying that paper can, or should, be eliminated entirely. Hard copies for backup is probably a good idea. We can’t deny that the digital world is here to stay, and if we responsibly utilize it, we all win in the long run.

          • Mich Flani, MPH says:

            Unfortunately the desire of the Fed and of vendors won’t make this technology be accepted any more or less IF the intermediary organizations are not ready or willing to play. One can see the disparity between capability and meaningful use. In AR, there is no HIE for its $140M grant and the plan to get one is pretty weak (their plan is online). Today, one cannot readily directly exchange records unless the parties are on the same shared system (SAAS). One cannot readily exchange immunization data with the health department because they are not enabled (as of 4/14/11). So making the investment won’t get docs the whole benefit of the incentives available. As a large group practice said to me just yesterday, “it does not seem like the State supports this initiative. Why make the investment for EMR and meaningful use without local governance support?

            A quick check shows that not many states are ready for meaningful use. So it just seems like this effort, no matter how noble or beneficial, is not going to be wildly successful without local government support.

        • Janet Messcher says:

          Are you kidding me? You’d rather have a doctor examine you and then turn his/her back on you to type into the computer and finish up? Talk about ‘you’re dismissed!’ And you go to the doctor for expert medical advice, not to update your medical database. Who would you rather see for medical advice and treatment? A really good clinician or a really good data entry clerk?

      • james says:

        Hello 1990. The blast from the past is the feeling I get reading many of these posts. Not to be too harsh because everyone seems like they are trying to be constructive but this is exactly the same discussion I remember having with administrative personnel during my 1st job out of school. The arguments all the same. It doesn’t work – Too Hard – Too Expensive – Paper will always be better… It is amazing how similar this discussion always is. Let’s go to the root cause of the issue which is Change is Difficult! That doesn’t mean that current EHR systems are lacking…. It does mean that we don’t want it bad enough yet.

        Another experience in this area from the past – somebody with power and authority will have to force the change. Otherwise the there will never be enough momentum to sustain the initiative long enough to get folks to do things differently. All we really need to do is replace paper and pen and we will be well on our way – who’s got that covered?

        • David Hager, M.D. says:

          EHR technology can work. Eventually.

          Docs are extensive technogy users – where it makes sense. They haven’t been buying EHR products because the products haven’t been ready for integration into busy clinical work.

          The government shouldn’t be mandating implementation of premature technology.

          It remains my opinion that the government’s most useful role here is standards development. Homogeneity of data is more useful to patient care than carrots and sticks for the doctors. It would also catalyze the market place/product development by giving docs greater freedom to change products.

  4. J. Garner says:

    I have a second profession, education. As you may well know, educators throughout the country have had to contend with high stakes testing for a number of years now. While this is not exactly the same, there are similarities.

    The attempt to tack empirical accountability measures to healthcare is fraught with all sorts of statistical application difficulties. Establishing a benchmark is very difficult when regional differences, cultural differences, educational level differences exist in the consumer database. Furthermore, differences exist in these proposed measurments between teacing and non-teaching medical care providers. How do we see to it that organizations do not abandon teaching in favor of higher reimbursments or perhaps take up teaching to secure higher reimbursements?

    Every hospital has policies and procedures in place that accomplish the same tasks, but the results of the efficiencies of a given process can skew the results of any healthcare organization. Furthermore the software used in hospitals varies greatly from place to place.

    There are differences in the results of satisfaction surveys that differ by hospital bed capacity that are built into the system. The larger hospitals that receive the more serious cases are at a direct disadvantage when it come to patient outcomes, and therefore they are also at a disadvantage when it comes to the satisfaction of patients and their families.

    Rather than to create a new bureaucracy, the government would do well to pilot this program for at least 5 years to get a viable database before it starts penalizing healthcare organizations with financial penalties that may be based upon false realities.

    This is being pushed into place too rapidly and we need to make sure that it does not have a detrimental effect upon healthcare.

  5. Cyndy Nayer says:

    EMR must be able to download into Personal Health Record in order to build accountable consumers. Patient should not have to download each record, simply give access. This is a part of the accountable care continuum that will drive Health Value rapidly and put the power of health improvement into the hands of consumers–there will be fractured care, fractured responsibility until we build the culture of health within and around the individual.
    Cyndy Nayer, co-founder and CEO, Center for Health Value Innovation

  6. Lee Hauser says:

    I have to agree with Dr. Hager on this. Like Tory, I am a recent graduate of a community college HIT certificate program. The possibilities and problems are dizzying, and as individuals we can only do our small parts to helping things get better.

    I spent many years in IT learning that, as cool and fun as technology is, it is only a tool, a means to help people accomplish things. I’ve also learned, though, that people are often resistant to technology. There are sometimes good reasons for this, and sometimes irrational reasons. Technological advancement — I won’t call it “progress,” because it isn’t, always — is inevitable. But eventually those who refuse to participate will be left behind.

    I’m not advocating blind acquiescence. Instead, doctors and nurses should be active in the process. Without input from those who will use the technology, the vendors and the government will force you to take what they think is best. Will you ride the wave, let it roll over you, or just hope your raft keeps you afloat?

    Times of disruption are always difficult. Fortunes are won and lost, sacred cows are slaughtered, and everyone wishes such events hadn’t occurred in their lifetimes. In the end, things always settle down…for awhile.

    • “doctors and nurses should be active in the process. Without input from those who will use the technology, the vendors and the government will force you to take what they think is best.”

      All fine and good, but if there is one thing that will upend this whole process, it is the lack of primary care providers — current providers are overworked, and nobody wants to jump into their lives. They are too busy seeing patients to play technology. I say this as one who it tasked with meeting MU, and the hoops I have to jump through with those who have used EMR for 7 years and believe in it are challenging.

  7. Neelam Khanna says:

    I agree with Dr Hager, that standardization is key – only when EHR programs are inter-changeable will there be good value for the client i.e. health care providers and only then can there be good accurate flow of data. This may be a very simple example by like cell phone provider know – if they do not provide the needed service after the contract is over one will jump to another provider who meets my needs – the client keeps their number so it is quite seamless transitions for the client.
    This example may be a very simple example but the idea is clear, especially when the federal programs are providing incentive they should mandate that vendors/industry come up with standards that are compatible and inter-changeable with no major issues.

    I worked for a enterprise systems implementation team and can tell you that HIT vendor are salivating at the opportunity to sell you their programs and then squeeze you and squeeze you when converting, providing enhancements and maintenance. Bad conversion data, mistakes and inefficiencies are blamed on and uncooperative legacy system. Required minimum is done to understand the source material and context. Lots of loop holes are built into the contracts to charge more for fixing bad data or to force clients to accept it as is and them move forward with their new product.
    The clients after having gone thru that pain full, expensive, and long process is will not go thru it again even if it does not work as they though it should.

  8. Randy Robinson, M.D. says:

    I feel a bit like I am entering the lions den here as I am much less excited than Dr. Blumenthal about all this, I feel rather like I am about to be told to eat my spinach whether I like it or not. The push for EMR is laudable and there are many advantages that it offers, but the bottom line is that for the majority of small offices the software just isn’t there. I have looked at several EMR programs including the highest rated for my office size and they are consistently expensive, feature a huge learning curve, questionable support and in the end will slow me down. I am being asked to assume both a financial and productivity cost for very questionable gains.

    Is it the position of the ONC that productivity and affordability be sacrificed for the greater good? The push for technology is being mandated before the technology exists, and the practicing physicians and providers on the front lines are woefully under-represented in its implementation.

  9. Dr. Khalid Iqbal Arain says:

    Now a days the Health Information Technology is playing very important role to improve health and health care all over the world. Being global village it is your responsibility to expend it to poor ocuntries of the world. .

  10. mark casey says:

    A great start, but the key is missing:

    process management software and techniques

    They are critical to any Healthcare IT system. Just having a nice common database structure or I/O protocol is nice, but will do no good if process management and orchestration is also used. I am primarily speaking about management processes, not clinical ones.

    This is a critical error of this effort. Please do not reply, “one thing at a time”, as both what you are proposing now and process management can and should be done at the same time. Don’t just blow this one off, folks, it is critical to meaningful healthcare optimization.

    Thanks for all you folks do, I’ve been there and know how hard it is.

  11. Fred Smith says:

    The effectiveness of the strategy will depend on execution and supporting efforts. I do not see the these efforts actively addressing issues such as data ownership, identity, liability for use of incorrect data, to be progressing in a manner that enables execution of Goals II through V. Today, little beyond relatively simple bi-lateral exchanges of information is commercially viable. As closed bilateral exchanges it is easy to address these contentious issues. It is far more difficult to address them in multi-lateral multi-party environment s. The time it took for the Defense Department and Veterans Administration to agree interoperability is one example of this complexity.
    For me, Goal III is the hardest to attain as well as measure. A person’s medical information is private and if made public, it cannot be made private again. For the payment world, people can be refunded with no permanent loss. Therefore, to generate confidence in the system, the HIT security standards have to be demonstrably better that used by FTC/OCC for electronic commerce and payments. I am not seeing this in the HIT security specifications or in practice by medical exchanges as well as hospital patient portals in my state (Virginia).
    Without a unique patent identifier that is used across a multi-lateral exchange environment it will be hard to validate the relationship between the electronic information and the actual patient will be problematic. My daughter has three different records at the local hospital for this very reason. Unfortunately issuing a medical ID number (like the UK NHS ID) will be viewed by many as a national ID card.
    Goal V and parts of Goal IV depend on the collection of patient data and using it aggregate for research and follow-on improvements to the ‘system’. The achievement of these reasonable goals will require clear ownership of the underlying data. Ownership is not clear today and will get even more complex should the data be utilized in ‘for profit’ activities. Also, I have some concern that HIPPA rules may not provide sufficient privacy to patient data. Currently the UK NHS is wrestling with this issue with the inclusion of post code (zip code) information in the research data base.
    In closing, I approve of the goals and overall strategy but I question their viability without significant changes to federal and state laws and aggressively addressing sensitive issues like identity and privacy.

    • Renee Tweneboah-Koduah says:

      The effectiveness of the strategy will depend on execution and supporting efforts. I do not see the these efforts actively addressing issues such as data ownership, identity, liability for use of incorrect data, to be progressing in a manner that enables execution of Goals II through V. Today, little beyond relatively simple bi-lateral exchanges of information is commercially viable. As closed bilateral exchanges it is easy to address these contentious issues. It is far more difficult to address them in multi-lateral multi-party environment s. The time it took for the Defense Department and Veterans Administration to agree interoperability is one example of this complexity.
      For me, Goal III is the hardest to attain as well as measure. A person’s medical information is private and if made public, it cannot be made private again. For the payment world, people can be refunded with no permanent loss. Therefore, to generate confidence in the system, the HIT security standards have to be demonstrably better that used by FTC/OCC for electronic commerce and payments. I am not seeing this in the HIT security specifications or in practice by medical exchanges as well as hospital patient portals in my state (Virginia).
      Without a unique patent identifier that is used across a multi-lateral exchange environment it will be hard to validate the relationship between the electronic information and the actual patient will be problematic. My daughter has three different records at the local hospital for this very reason. Unfortunately issuing a medical ID number (like the UK NHS ID) will be viewed by many as a national ID card.
      Goal V and parts of Goal IV depend on the collection of patient data and using it aggregate for research and follow-on improvements to the ‘system’. The achievement of these reasonable goals will require clear ownership of the underlying data. Ownership is not clear today and will get even more complex should the data be utilized in ‘for profit’ activities. Also, I have some concern that HIPPA rules may not provide sufficient privacy to patient data. Currently the UK NHS is wrestling with this issue with the inclusion of post code (zip code) information in the research data base.
      In closing, I approve of the goals and overall strategy but I question their viability without significant changes to federal and state laws and aggressively addressing sensitive issues like identity and privacy

  12. Phil Church says:

    So, here’s the reality…I have been in the “Automotive” industry for over 40 years. I got in 10 years before “Electronics” were introduced. We only had Mechanical and Electrical. (A Transistor Radio was state of the art). Early 70′s introduced “Little Black Boxes” that ran different systems and we (Mechanics) weren’t allowed inside any more. Around 1980 we got Computers that monitored and adjusted Engine Electronics. Now, we (Technicians), were allowed to hook up Scanners to read the information coming to and through the Computer. We got Analogl information by which to DIAGNOSE failures, even before they completely failed. In the 90′s the Computers were becoming sophisticated and each Manufacturer had gone in their individual directions with Strategy and Operation systems (much like Apple vs. PC). Now, each Technician had to have a Specific Monitor to plug into each specific Manufacturer, that included Software and Updates that were marginally successful and Generic Monitors did not work any better than guessing. By then, the Federal Government had entered the fray with REQUIRING Manufacturers to ALLOW technicians access to those Computers’ information. (Keeping us out was labeled Discrimination under Consumer Protection and it was considered a Monopoly for a Manufacturer to HIDE their data from the Public). The point of this analogy is this: When the Feds designed the LAW that regulated the Manufacturers, they (lawyers, not Technicians),required a short list (11) points of information that MUST be provided to the Public, from the Operating System of the Vehicle. Thus, a “Generic” information system was designed for (only most), Vehicles sold in the US, starting in 1996. That GENERIC information was marginally accurate as it had a slower baud rate of data update (speed), and didn’t include dozens of other live stream data that a Technician would routinely use for Diagnosis and Repair. The war was on. One vehicle spoke English, another German, Japanese, Korean, etc. etc. Imagine the quality of the “Language” that simplified the Operating data to 11 words that every language would use for common understanding?.Today, the automotive systems are still produced in different countries, with different Operating Systems, that still DON’T allow ME to interface with them. If you have a Toyota, you can’t take it to a Chevy Dealership to have it diagnosed. Now, here we are in the Medical arena. A similar effort to create a Language by which all Health Care Givers can communicate effectively. There are similar quantities of data and information needed to efficiently and thoroughly diagnose and treat Patients. The Feds are mandating that the Industry create a Language that the English, German, Japanese, etc. etc. can all understand and that will only happen if Medical Information is limited to 11 points of common language. That won’t work. All this considered (and conceivably addressed), we also have to create a System that keeps ALL information SECURE from theft and error during storage and transmission over OPEN avenues of communication. Who is overseeing this strategy? I hope it’s not the same Government Agency that has failed to get the Automobile System into a functional state? When you figure out how to make the Health IT work, please send a copy to the US EPA so they can forward it to the Auto Regulators. Thanks, Phil Church

    • Sunny Stokes, RN says:

      Phil,
      I was fully prepared to go head to head with you on your analogy…until I realized where you were going with this argument. I’ve been an RN for over 10 years and I thought I’d never witness an environment that could rival that of medicine in the sheer number of differing protocols and standards. Communication errors, or the lack of of any communication at all, was fingered as the source of more catastrophic outcomes than I care to remember. One year ago, I traded my stethoscope for a mouse and keyboard and entered the world of Health IT as a clinical analyst programmer. I’d seen too many useless systems in my day and I wanted to be on the front lines making sure that we used technology to our advantage. Too many times I’ve seen tools built to mimic our habits, rather than change them for the better. I had (and still have) a great deal of excitement about all the potential this move to technology brings. So far, I’ve seen a few obstacles, but none of them compare to the fly in the ointment that you outlined above. Bottom line: If there isn’t some consensus on the language standards necessary for the kind of integration we’re aiming for…..we’re in for an uphill battle the size of Waterloo.

      • David Hager, M.D. says:

        Personally, I like this quote:

        “The real danger is not that computers will begin to think like men, but that men will begin to think like computers.” ~Sydney J. Harris

        http://www.quotegarden.com/computers.html

        I prefer that clinicians, rather that IT personnel, choose how clinicians should think and behave.

        • Tory says:

          Dr. Hager and others, it’s very nice to get honest opinions. We can work together with a solid foundation of truth ‘what we really think’. What do you think might be the reason(s) that IT personnel have, at least in part, earned a reputation of ‘thinking like a computer’? Is it that they really aren’t taking time to empathetically understand what we, as a team (IT and the provider), need to do in order to best serve the patients/customers? (and hence trust that you, as the provider, know what needs to be done)
          In our Workforce Curriculum, the developers have done an EXCELLENT job addressing many of these areas. (culture, communication skills, respecting the ‘pecking order’ and cultural norms’). My classmates and I have worked very hard to try to improve any such weaknesses that we may have. I think/hope you will be pleasantly surprised if you give us a chance. After all, I think we are all after the same thing… serving the patient and the greater good. We have a group of over 30 grads and growing in a discussion group that WE created. I would love to meet you or any other clinicians for tea. I would like to learn. I know my fellow grads would be willing to go the extra mile for you as well.
          Most of us are in the Los Angeles area but we have friends in other states as well.

        • frustrated patient says:

          Really? You prefer that physicians choose how they think and behave?

          As a patient I prefer that the physician do what’s going to keep me alive. And given that studies show physicians are wrong in their diagnosis and or do not follow best practice an unacceptably high percentage of the time (to the tune of more than 100,000 dead patients a year), I prefer that physicians use every tool at their disposal to provide me with the best care possible.

          Physicians don’t intentionlly kill anyone. They do it because they are tired, or they have 15 patients yet to see, or their handwriting can’t be read. They do it because they are human. They make mistakes. And because they are human I want them to have a little backup. An alert here. Some decision support there. Because my life, and the lives of my family are more important than your ego.

          As a patient that what I prefer.

          • David Hager, M.D. says:

            Frustration with imperfect human docs is very understandable. And techology such as computer-aided support can prove very valuable in compensating for our faults.

            My problem, from daily experience with a very frustrating EHR system, is this – I know I do a better job of thinking clinically than a programmer does.

            Thus, I want programmers to generate product that works for clinicians … not what works for programmers.

  13. Use the StratML (Strategy MarkUp Language) to distribute the final version in machine readable format and be compliant with the Government Performance and Results Act Modernization Act of 2010.

  14. Create a goal to baseline the human health data model for a 100 yr lifespan starting with embryonic detection through postmortem disposition of all fluids, tissues and organs. I have been surprised for the last three years to find no government, academic or industry office, official or group with an human health data model baseline spanning 100 years of life and death for a male and female’s wellness validation based on some base year’s medical device technologies and medical protocols.

    The baseline I refer to is more than a normalization of medical vocabularies, terms and concepts; it is an instance of digital values from the execution of medical observations and measurements based on human factors for dental, mental, vision and plain old medical (everything but the former shredouts) conditions. The baseline data structure will reveal the trivial facts such as total data volume in Bytes as a function of time period, fastest data creation rate and events, mesured data versus derived data as a function of age or any time period, etc. These data are medical images (fMRI, PET, CAT, etc), audiograms, UTF-8 from practioners’ notes (speech to text or just typed), point clouds from 3D body scans, etc.

    I believe there is a correlation between cost and data volume, data at rest and data in motion. It would helpful to create an interactive health finance simulation for the public to learn the cost per Byte of healthcare.

  15. Donald W. Simborg, MD says:

    This plan continues to ignore healthcare fraud as a legitimate responsibility of healthcare IT in general and ONC in particular. It represents a neutral position on the issue of fraud that will undermine the laudable goals outlined in this plan.

    In 2005, Dr. David Brailer, the first coordinator of the newly formed Office of the National Coordinator for Health Information Technology (ONC) asked an interesting question. Should the emerging Nationwide Health Information Network (NHIN), which he was responsible for building be neutral with respect to fraud or proactive in combatting fraud? The question was to an expert panel that he had convened to study this question. Although no one (except fraudsters) condones fraud, it was a legitimate question since combatting fraud is the responsibility of the Centers for Medicare and Medicaid Services (CMS), the Office of the Inspector General (OIG) and the Department of Justice (DOJ) at the federal level. ONC, it could be argued, with its then limited budget and overwhelming task should focus on its primary goal, which is to promote the use of IT technology in healthcare and build the infrastructure for its support. The expert panel concluded, however, that it must be proactive or healthcare IT would become a vehicle for fraud. That is, there is no neutral position with regard to fraud. Either safeguards are built in from the beginning or else fraud will increase in an electronic environment.

    It is now six years later and ONC is pursuing a neutral or near neutral position with regard to fraud and this new five-year plan illustrates this position. In the intervening years since Dr. Brailer first raised the question regarding fraud, ONC has done an excellent job in creating the infrastructure for healthcare IT. However, throughout this period, combatting fraud has not been on the agenda for ONC or any of its related organizations including CCHIT, HITSP and the current IT policy and standards committees. In 2007, ONC did convene another expert panel to make recommendations to CCHIT and HITSP regarding fraud management functions for EHRs, which was certainly a non-neutral activity. However, the recommendations from this panel have been ignored and the report was issued under a completely obfuscating title, “Recommended Requirements for Enhancing Data Quality in Electronic Health Record Systems.” There are now multiple organizations, which can certify EHRs. All of them take their guidance ultimately from ONC. Although there are some security requirements for EHRs, there is nothing in the certification requirements specifically aimed at reducing fraud. It should be pointed out that there is a difference between fraud management functions and security and privacy functions, which are a part of this plan.

    What should ONC be doing that it is not? First it needs to focus on fraud prevention in its EHR certification rules. Right now, to be certified, there is a list of functions that a vendor’s product must perform. There is no list of functions that it should NOT perform. For example, the 2007 report mentioned above recommended that “decision support” aimed solely at increasing the billing code should not be allowed. This goes on today in many vendor products. There are a number of “tools” provided by vendors that are legitimate and serve to speed up the entry of encounter notes. These include templates, “cloning”, copy forward, “make me and author”, single-click multiple entries, and others. But some uses of these tools are abusive or fraudulent. For example, the “cloning” of vital signs and other quantitative data from a previous visit into a current visit has little efficiency value but is very useful when creating a fabricated encounter note. ONC needs to clearly set the guidelines for the use of these tools and set certification criteria to proscribe abusive uses. Further, there needs to be a credible threat of decertification for vendors that are discovered providing these functions. Another area needing ONC focus is the generation of audit data and its availability to fraud detection programs. The so-called “metadata” regarding the “who, what, when, and how” of data entry would greatly enhance the ability to detect suspicious claims. This data is in part routinely collected now in audit trails of most EHRs, but it is not standardized, complete, consistent from one vendor to another, protected from “tools” to disable it, nor made easily available. Finally, the function of provider and patient authentication at the point of care requires major revision.

    Why doesn’t ONC focus on fraud? The potentially legitimate excuse from 2005 regarding limited resources is hardly true today. It is simply not a part of its mandate. The previous 5-year plan published by ONC for healthcare IT makes no mention of fraud and the current draft has only an insignificant single reference to it in one sentence. A more politically charged reason is that a focus on fraud conflicts with its goal of IT adoption. The fear by physicians of false positive claims of fraud from OIG or DOJ has led some to lobby against such a focus by ONC. As one prominent adviser to physician organizations has said, “Physicians will not purchase the gun that shoots them.” However, the increased risk of fraud in an electronic environment is too great. Theft of legitimate electronic encounter notes, the ability to create legitimate-looking bogus notes in mass quantities using various “tools”, the increasing access to multiple encounters of the same patient through HIEs and the availability of stolen IDs all create a rich environment for the creation of credible fraudulent episodes of care. Adding fraud management to EHRs can be done in a manner that protects rather than threatens honest physicians and greatly raises the bar for fraudsters.

    At a recent meeting a spokesperson for Bank of America stated that they knew their fraud losses in every category almost down to the penny. At the same meeting, a spokesperson for CMS admitted that they don’t know their fraud losses to the nearest $10B, but it is probably in the range of $80B/yr. That is 100 times the rate of fraud at Bank of America. Yet ONC is providing $billions to proliferate technologies for which OIG and DOJ are spending $billions to combat this unintended consequence of the same technologies. A little bit of help from ONC will produce far greater returns that any equivalent amounts spent by OIG and DOJ. However, the two must work together on this problem. To design the correct solutions, ONC needs access to people and data at OIG and DOJ to better characterize the problems. On the other hand, OIG and DOJ need ONC to implement the solutions at the point of care. This will be a continuing process that must evolve. There must be a plan for this process that is totally lacking from the current draft. There is no neutral position for ONC. Doing nothing promotes fraud.

    • The DOJ has done a good job fighting fraud but that’s closing the barn door after the horses have left. We have to have a proactive architecture.

    • Marion Ball says:

      Don, You are right on target to down play this most crucial aspect is just plain irresponsible!! You have articulated the issue most eloquently and I hope you will be heard. Thank you.

    • David States says:

      Many patients feel a sense of ownership in their insurance, particular with the Medicare system and deeply resent the fact that some parties are abusing the system through fraud and wasteful spending. If electronic medical records present a clear linkage of billing to medical issues, it will increase confidence and an acceptance of EMR by both patients and providers. On the other hand, if electronic records overwhelm users with reams of obtuse data and obfuscate the relationship between payments and health care, it will be both an open invitation to fraudulent activity and a detriment to acceptance of the system by legitimate patients and providers.

    • David States says:

      As a component of the Federal Government, ONC does not have the option of being “neutral” on fraud, Medicare or otherwise. Obeying the law and safeguarding government property are basic and fundamental responsibility of public service. Federal employees are duty bound to report fraud under the Code of Federal Regulations (CFR): “Employees Shall Disclose Waste, Fraud, Abuse, and Corruption to Appropriate Authorities.” 5 CFR 2635.101(b)(11).

      Fighting fraud may not be the primary mission of ONC, but putting in place policies that minimize the risk of fraud occurring and facilitate the detection and prosecution of fraud should it occur are responsibilities of any Federal agency.

  16. Azman Sabet RN says:

    I wonder if French system of “Vital Card” designed and made in the Silicon Valley (USA) is something we can use in the US!
    This system allows each individual to be responsible for his or her own healthcare information just as we are responsible for protecting our own financial information. It allows for perfect continuity of care; and it is a great tool to assess poly-pharmacy or provider quality measurements for national regulatory bodies as well as third-party payers and most importantly the consumers (patients). There are numerous benefits in their system including the fact that it is a tested system which allows us to learn from their mistake and achieve our goals faster!

    • David Hager, M.D. says:

      Carte Vitale appears to be primarily a financial/benefits instrument, not an clinical EHR modality.
      http://www.readyforfrance.com/health/carte_vitale.php

      Also, folks don’t carry their financial transaction information around with them on cards. That information is maintained on banking servers.

      • will ross says:

        Regarding the Carte Vitale (and similar smart card approaches in other countries) — to me the physical card is a side issue. Besides, the physical card is subordinate to the authoritative patient account data on the cloud. I am more impressed that the price list for health care services is fully known and the billing transaction is completed when the physician hands the card back to the patient at the end of the visit. Imagine closing the visit note as the moment the service is billed, instead of as the start of a cumbersome financial coding process that can take months to settle. Imagine instead getting paid in two weeks. Also, note the inherent synchronization of the current patient encounter with all recent encounters. Imagine the impact on medication reconciliation, or on drug shopping patients scamming in the pharmacy or the ER, or the opportunity for collegial coordination of care for patients with multiple chronic conditions, or the implication for a patient centered medical home. For me the card is not the point, the simplified and unified care system is the point.

  17. As a healthcare clinician (psychologist), researcher and health IT inventor/developer who has been focused on such issues for 30 years, the ONC goals, in general, are acceptable to me. Assuming, however, that providing ever more cost-effective (i.e., high-value) care to the patient/consumer is—or at least it should be—the overarching objective of the ONC strategy, then the following issues ought to be clearly addressed, imo.

    One issue is the need for clinicians to collaborate with researchers and IT technicians via loosely coupled social networks (that cross professional, regional and organizational boundaries). The clinicians should primary care physicians and specialists across all settings, from in solo practice to large hospitals and integrated care organizations. They should deliver all types of healthcare, including conventional and CAM “sick care,” as well as “well care” (focused on prevention, health optimization and self-maintenance). These diverse groups of professionals would represent a “whole-person integrated care” approach that addresses biomedical, psychological and mind-body (biopsychosocial) factors/problems/conditions.

    The clinicians in these collaborative networks would do two important things:

    1) They would use health IT tools that build a research data warehouse with process and outcomes data, as well as lessons learned. This information exchange must be done securely and protect patient privacy.

    2) They would also share and discuss ideas to guide the evolution of health IT by, for example, defining:
    (a) Information models that depict what need to know and how they need the information presented;
    (b) Where the information comes from (e.g., input by the clinician/office staff or received directly from the patient via a PHR);
    (c) Ways to use the IT tools so they fit it into clinical workflows; and
    (d) The kind of decision support they would want to receive (such as “patient-centered cognitive support,” [ref 1].

    The researchers, in turn, would generate evidence-based results by performing aggregate analyses on the patient and treatment data in the data warehouse, along with any relevant data from controlled clinical trials and lessons learned shared from everyday clinical practice.

    The researchers and clinicians would then collaborate to transform the results into patient-specific recommendation in the form of preferred practice guidelines, protocols and clinical pathways. These recommendations ought to go beyond comparative effectiveness and focus on cost effectiveness [ref 2].

    The IT technicians would incorporate these recommendations into clinical decision support systems (CDSSs).When clinicians vary from these evidence-based recommendations, a CDSS should (a) enable clinicians to justify why they was such variance, (b) track what was done instead and (c) determine how varying from particular recommendations affects outcomes and costs.

    A second issue is the need for lifetime whole-person health records that use of different models to adapt clinical terminologies, data sets, analytics/rules, data input forms, reports/views and user interface to a clinician’s particular requirements. There should also be a way for patients to input data to, and receive relevant data from, their providers’ EHRs.

    Finally, a third issue is the need for tools and policies that support “new models of care, such as patient centered medical homes and accountable care organizations, [which] must emphasize value-driving elements of advanced primary care — enhanced access, better care coordination, use of health information technology to support care transformation, and payment models that reward coordinated care” [ref 3]. This means, in part, changing the payment model to one that incentivizes clinicians who focus on delivering high value (cost-effective) care to their patients by paying more to clinicians who take the time to use EHRs, CDDS, participate in the social networks discussed above, and focus on demonstrating continuous improvement in both quality and efficiency.

    References:
    [1] http://curinghealthcare.blogspot.com/2009/06/meaningful-use-clinical-decision.html
    [2] http://healthaffairs.org/blog/2011/03/28/medicares-embedded-ethics-the-challenge-of-cost-control-in-an-aging-society/
    [3] http://www.prnewswire.com/news-releases/patient-centered-primary-care-collaborative-commonwealth-fund-dartmouth-institute-release-landmark-consensus-document-on-acos-medical-homes-118892059.html

  18. Securing private health information and containing fraud is a huge challenge within the new electronic framework. When the Department of Health and Human Services published the technologies/methodologies to render PHI secure in April 2009, it rejected electronic redaction. Perhaps HHS was influenced by the sensational news stories where organizations improperly redacted sensitive content using word processing software. However, dedicated redaction software is completely secure, highly automated and it’s been securing citizens’ private information within public records for several years. ID Shield customers have redacted over one billion pages with zero failures of the software to completely remove sensitive content. Gartner analysts have cited the reliability of dedicated electronic redaction software. If we’re serious about securing PHI in every environment, it would be advantageous if all proven technologies, including dedicated electronic redaction, were sanctioned.

  19. The issue of enhancing and ensuring healthcare IT safety seems to be missing from the plan.

    It’s as if reports such as the FDA’s “Health Information Technology Safety Issues” of Feb. 23, 2010 (obtained by the Huffington Post Investigative Fund, now archived at http://tinyurl.com/FDAreport ) doesn’t exist.

  20. Korey Stephens, HITECH Graduate says:

    I have enjoyed reading all of the comments and agree with many of them. I am going to offer a few solutions because I remember the Mars Rover and the Space shuttle for those who said, “It couldn’t be done”.
    Vision: A health system that uses information to empower individuals and to improve the health of the population.

    1. In Goal I, Boots on the ground: Every graduate of the HITECH should have the same opportunities as the VA internship has offered.
    a. Adoption as a result of necessity or simple desire will result in a transition phase that many physicians are not willingly to participate due to time or disruptions. I recommend that your strategy utilize what is available – HITECH graduates to facilitate the bridge by learning the workflow in various medical facilities on location. ONC should have them report on a monthly basis their observations to formulate a number of generic workflows structures to assist in the design phase amongst all vendors for better collaboration and CCHIT certification requirements.
    b. The win/win is the HITECH grads (like me) who are currently sitting on the sidelines in limbo could be subsidized by the ONC with no money out of the physicians pocket, add additional on location staffing reducing time loss or disruptions to support facilities in the process.

    2. Public announcements: Social Networks Broadcast: Get the public involved with PA of empowerment of the people/ individual to improve and participate more in their care. Social networks are changing countries.
    3. Create a mock portal that will allow those interested in viewing the wave of the future with video and informational trailers in the senior communities, Generation X and Millennials. Note: Kaiser is up and running with a high degree of success and several countries already functional in some degree.
    4. In Goal III, hire security professionals and convert those HITECH graduates that have an interest to support awareness. A real security professional knows that most breaches is due to internal human error onsite. Make medical data breach/hacks carry a penalty as serious as child abduction with life sentences. Many people would consider their medical records priceless and no amount of money is going to make them feel better when it is the wrong place publicly.
    Increase the standards of what is meant by “certified” EMR/EHR amongst the vendors.
    5. I fully understand “meaningful use” but my mailman did not until we had a chat about the benefits to him. Explain it to the public…. Again public announcements will increase interest, participation and demand amongst their local physicians when their clients are asking for it. This will open more doors than monetary incentives to choose mediocre EMR applications. In similar fashion to the pharmaceutical industry mass markets get first priority and better quality products.
    6. On a professional level of IT remove the “hold harmless” clause to EHR/EMR vendors to improve usability concerns which would improve the service of the applications. Once the real stakeholders are now required to standardize basic core platforms for greater interoperability than you can move forward with greater velocity in HIE.
    7. I agree with David Hagar, MD the customer is the physician and IT is a service which allows the physician to provide better care to their clients. This falls back in alignment of how we/IT can help the industry be more efficient and provide value.
    8.
    I really think the strategy should not be aimed at the physician but at the vendors. The EHR/EMR market is a “gold rush” and vendors are looking at volume. We are “pushing incentives” toward physicians to adopt what is available within a certain time frame is really one-sided.

    Thinking positive….. “There are always growing pains as we get taller”

    Thanks,

    Korey S.
    HITECH Alumni

  21. Kathy Ficco says:

    Dear Dr. Blumenthal,
    Thank you for providing the opportunity to provide feedback and to make a request to address an oversight in Federal HIT Funding that impacts non FQHC non RHC clinics who furnish uncompensated care to very needy patient populations. Our clinic does not reach the 30% MediCaid or Medicare threshold to be elgible for funding because we serve so many uninsured low income patients. We are not eligible to apply for the % “needy patient” as we are not FQHC or RHC clinics. More about our clinic:
    St. Joseph Health System-Sonoma County operates the St. Joseph Mobile Health Clinic, a licensed mobile community health clinic providing primary healthcare, prevention and education services to more than 1,600 low-income families annually who are without a regular physician and who have difficulty obtaining affordable healthcare in their community. The mobile clinic has a unique capacity to transcend language, culture and access to care barriers by bringing healthcare directly to those who need it most.
    As reported to OSHPD for Calendar Year 2010, the St. Joseph Mobile Health Clinic provided 3,574 patient encounters for 1607 individual patients. Of these patients 70% are under 100% FPL and 15% are at 100 to 200% FPL; 79% of these patients are uninsured and are offered a minimal sliding fee or free care, most are not eligible for entitlement funding due to their immigration status. In addition, 80% of the mobile clinic’s patient population considers it their “medical home” or regular source of healthcare in the region. The mobile clinic offers preventive and primary healthcare and education to disadvantaged areas throughout Sonoma County. Services include evaluation and management of acute and chronic illness, health screenings, testing, and education in areas such as hypertension, diabetes, women’s health, asthma and nutrition.
    In operation since 1991, the mobile clinic offers services to vulnerable populations at a variety of sites throughout Sonoma County identified by need, this clinic is not an FQHC or RHC Clinic.
    Following is a press release from last year, the article was picked up in the NorthBay Business Journal in June 2010:
    “Taking it curbside; mobile health clinics save money while saving lives”
    Working with mobile health programs around the country, including St. Joseph Mobile Health Clinic in Santa Rosa, CA, researchers from Harvard Medical School have led the development of a “return on investment calculator” that measures the value of preventive health services.
    The web-based calculator measures the impact of the more than 2,000 mobile health programs in the United States. Ten of these clinics have beta tested the tool and found that the mobile health sector provides an aggregated return on investment of 20:1 ($20 returned for every $1 invested).
    The return on investment locally for St. Joseph Mobile Health Clinic was calculated to be $28 for every dollar invested in operations.
    “This study proves what we have known for some time: mobile health clinics play a vital role in augmenting the level of healthcare in the United States and are extremely cost effective,” says Kathy Ficco, executive director, Community Health Clinics & Programs. “As healthcare costs continue to spiral out of control in the United States, preventive actions are clearly one solution.”
    Researchers used published data from the National Commission on Prevention Priorities (NCPP) that assigned values to a broad array of preventive practices, as well as published data on the cost-savings of preventing avoidable emergency room visits, to develop an algorithm that calculates a return on investment ratio, thereby quantifying the value of mobile healthcare to the overall healthcare system. The calculator is available at http://www.mobilehealthmap.org.
    In a 12-month period, the calculator showed that the 10 mobile clinics saved more than $78 million in Quality Adjusted Life Years (the measure of disease burden, including both the quality and the quantity of life lived) and more than $7 million by avoiding unnecessary emergency department visits. This is the first time the financial value of investing has been quantified in non-traditional prevention programs such as mobile health clinics.
    “People talk about the value of preventive measures all the time, but no one has ever really captured the important contribution of the many non-traditional prevention programs like mobile health clinics,” says investigator, Nancy Oriol, HMS dean of students and an obstetric anesthesiologist at Beth Israel Deaconess Medical Center. “This value is underscored by the unique role that mobile health plays in reducing disparities in health outcomes, increasing access to care, and its ability to reach out to particularly vulnerable, at-risk communities.”
    The calculator tool also demonstrated that mobile health clinics are widely distributed across the United States, providing services to a large number of people in medically underserved communities including minority populations and the uninsured. Mobile health clinics are a non-traditional method of healthcare delivery that has been employed for decades both nationally and internationally.
    Our mobile health clinic is one of a number that our health system offers in California and West Texas.
    Thank for considering my request to remedy this funding issue on behalf of all non FQHC and RHC clinics nationally, who serve the vulnerable and are in need of these ARRA HIT Funds to become meaningful users of technology to improve the health and quality of life for those we serve.

  22. Many of the Federal Health IT Plan’s objectives would be obtained through a major flux of health savings accounts. I believe HSA’s will play a major role in health care reform. We need a drastic increase to HSA contributions from employers. The benefits of HSA’s combined with employer contributions and a smooth HIT interface for individual account access will make an incredible difference.

  23. Marlon says:

    I am wondering how IT professionals can take advantage of the future growth of this field. I have submitted my application to a local college for their HITECH ACT-supported 6-month training on HITECH IT/Software Support. I have a solid background in IT. I wonder if that 6-month training will make me eligible to support HITECH/EHR infrastructure.

  24. Eugene Richardson says:

    If ambulance services are expected to be part of the project for data collection of patient care issues, thought needs to go into who will pay for the $10,000.00 cost per ambulance unit to provide that data. Currently, most ambulance services are too restricted for cash flow, to be paying for yt nother unfunded federal mandate. Financial assistance is definitely needed.

  25. Elisa Gorton says:

    I fully understand and recognize the significance of moving forward with HITECH. It will greatly enhance our ability to treat and provide safe effective care. But, I can’t keep wondering where are the safeguards for ‘high risk’ information/medical records like mental health and substance abuse. Will these records remain at their current level of privacy and confidentiality or will the state and federal regs governing this PHI need to be changed to reflect the changes in this new legislation? How will we be able to ensure that ‘high risk’ PHI is only released with specific authorizations?

    • David Hager, M.D. says:

      Looking at the recent, massive Verizon Epsilon data breach, the following favorite quotes come to mind:

      A computer lets you make more mistakes faster than any invention in human history – with the possible exceptions of handguns and tequila. ~Mitch Ratcliffe

      In a few minutes a computer can make a mistake so great that it would have taken many men many months to equal it. ~Author Unknown

      http://www.quotegarden.com/computers.html

      Given the facility with which electronic data can move en masse, how CAN we make EHR data at least as secure as paper charts?

  26. Jane Turner, M.D. says:

    As a pediatrician, I have had the experience of using an EMR system that was not designed with the care of children and youth in mind. Our EMR system has provided a legible record that can be accessed at many sites but has not met expectations in terms of helping us improve care.
    I hope we can establish criteria for systems that address the needs of young patients as well as the adult population.
    Here is my wish list:
    1. clinical decision support for preventive care based on the Bright Futures Guidelines.
    2. registry function for children and youth with many different diagnoses. Most registries are disease specific. That works for asthma and ADHD. Many, many children with special health care needs have uncommon or rare conditions. All together, they make up 5 to15 % of most practices. These are the children that can benefit most from a registry. We need a registry that helps us monitor components of care that are important for chronic care management whatever the specific diagnoses, such as last visit, preventive care, immunizations, most recent update of the care plan, pending referrals to specialists, and more. It makes sense to have EMR registries communicate with immunization registries housed at a state web sites.
    3. An electronic template for a care plan helps coordinate the care of individual patients and can be an effective tool for communicating between primary care providers, medical subspecialists and others involved in the child’s care. Those of us who use a care plan based on the template developed by the AAP had to design our own electronic version in house. EMR systems should offer a template for a care plan that includes child and family demographics, problem list, medications and medical devices, nutrition plan, school program and contact information, all specialists involved and a list of concern/goals/plans with who will do what and when.
    4. For ease of documentation, it is helpful to have descriptive terms for physical exam to be age specific. The examination of a two week old is very different from that of a 12 year old — we look for different things and use different words to describe our findings.
    I realize my comments are very pediatric centric. The care of children is so often overlooked as we try to control costs by focusing on care for adults. My hope is that the standards set for vendors to be certified for meaningful use take into consideration the special needs of children and youth

    • horseshrink says:

      The uniqueness of vocabularies/dictionaries inherent to different specialties highlights one level of challenge. The fact that these evolve constantly over time highlights another. Just who will assiduously track these evolutionary changes and update legion EHR dictionaries accordingly?

      Or, at a basic structural level, should EHRs even get that much into splitting? Is it better to lump?

      When I evolved paper templates for myself, I tried the splitting route first. Awkward. Missed descriptive nuance. Couldn’t boil encounters into enough checkboxes. So, I backed off and settled on categories into which I free texted (hand writing.) Encounters became easier to read and more descriptively unique. There was no doubt the patient was seen by me. No copy/paste artifact. Minimal eye-numbing repetition.

      I certainly hope the human condition cannot be boiled down to a finite number of menu choices, dictionary terms and radio buttons. If so, I guess I’ll go flip burgers, because “Watson” will be taking over, and the idiosyncratic “art” of medicine will run slack.

    • We are Pediatrics also. Our frustration is that MU requirements focus on adults, but the ship has already sailed on many of the problems MU addresses. We ought to have our own set of MU guidelines tailored to prevention.

      That will make the most impact in the future, and realize the benefits of this plan.

  27. Anthony says:

    I searched for the word ‘Pharmacy’ and found only one occurence. I think improvement in e-prescribing are necessary and even include the creaiton of an open source platform instead of relying on a monopoly (RxHub).

    I also believe that the implementation of a national ID card that includes health-related information will help.

  28. Tony says:

    It’s ironic that my credit card company can keep my credit card records secure but securing my health record is a big problem. I have a WebMD health record. It’s a free service. I store all of my information myself in this health record. When I go to a new doc, they usually hand me a clipboard with maybe ten pages to fill out. I refuse to fill out their papers and I hand them my printed WebMD health record. If that’s not good enough, I move on the the next doc. I refuse to play the “clipboard game” any longer. If more people would refuse the clipboard and papers, maybe docs would wake up and get their offices computerized. By the way, HealthIT is taking way too long. Obama signed the Affordable Care Act into law over a year ago and we are still required to fill out reams of papers on clipboards in doctor’s offices. It’s insane! HealthIT is rolling out like molasses on a winter day in Vermont. What could possibly be so darn hard? GET REAL!

  29. As has been demonstrated at HIMSS, the best, lowest cost, easily implemented solution for data gathering, that will let the doc’s continue to practice medicine the way they want, is digital writing, mobile data capture. Its ease of implementation, low cost, lack of behavioral challenges, and ease of integration of data into EMR/EHR systems, is a profound solution that cannot be ignored. The” System” benefits, and the patient now has a very effective way for his providers to access that most important piece of medical information- the notes prepared by health care professionals. It is about time for this technology to be embraced.

  30. Dennis Kelly says:

    Two comments:
    1. The HIT efforts to date have not addressed the EHR or HIE needs of jails and prisons, pretty much the only healthcare delivery area untouched by HIT to date. There is no indication in the Federal HIT Strategic Plan that the EHR / HIE needs of jails and prisons are even an issue, and at some point, somehow, the strategic approach to address these needs should be outlined.
    2. Generally speaking, the Federal HIT Strategic Plan focuses on routine day to day healthcare; it touches briefly on emergency room treatment and public health departments’ management of public health emergencies. Two additional issues should be at least touched upon: HIT and emergency responder delivery of services in the field; and HIT and large scale disasters–in which emergency responders in the field play an important role.
    Thank you.

  31. Dan says:

    Tony is right. HealthIT is taking too long and too much money is being wasted getting it “perfect”. No wonder opponents in Congress are winning the arguement. They say Obamacare, and specifically HealthIT, costs way too much. I’m beginning to understand their arguement. HealthIT should not be taking this long to implement. The VA health care system has computerized records. Veterans can go to any VA facility anywhere in America and their health records follow them. Why is HealthIT so hard to get done? My suggestion, stop wasting time getting stupid public comments and get HealthIT fully implemented before I start writing my members of Congress and tell them to repeal the entire law. This is absolute nonsense!

  32. I think we can take a leaf out of the Pharma industry however much we may not want to do so. Clinical Data Interchange Standards Consortium was established and two important data standards emerged – SDTM and ODM. ODM (Operational Data Model) is designed to facilitate the archive and interchange of the metadata and data for clinical research, its power being fully unleashed when data are collected from multiple sources.

    Bringing the focus on data harmonization through creating operational standards model can help achieve the goal of Information exchange (aka HIE).

  33. David Mix says:

    Hello,

    This strategy guide does not currently mention how we can make the patients environment safer in order to reduce heath care costs from unnecessary repeat treatments. Both physicians and patients need further education on how their homes can affect their overall health.

    Government funding is going into “under served communities” however the patients home is not being addressed. Many health complications come directly from living conditions and many low-income families do not have the education or the means to stop the vicious cycle of visiting their doctor.

    We need to implement and educate a healthy home initiative for all homes to achieve a complete healthcare strategy.

  34. Mellal says:

    If ambulance services are expected to be part of the project for data collection of patient care issues, thought needs to go into who will pay for the $10,000.00 cost per ambulance unit to provide that data. Currently, most ambulance services are too restricted for cash flow, to be paying for yt nother unfunded federal mandate. Financial assistance is definitely needed.

  35. I commend the HHS for having “Consumer Empowerment” as one of their key goals for the Health IT Strategic Plan.

    Today, with the rise of social media, mobile devices like smart-phones and tablets, digital-wireless connectivity, as well as other emerging technologies, our culture is changing more than ever before. And consumers are changing right along with it. Look no further than the emerging trend of the “self-service consumer.”

    Increasingly, consumers are developing a do-it-myself mantra: trading stocks online, self check-out at the grocery store, self check-in at airports and ATM banking, to name a few. And understanding how to communicate and engage with this self-service consumer is crucial.

    The emerging empowered self-service consumer is also transforming the healthcare industry, as consumers utilize self-service technology to expand their healthcare access, knowledge and empower them to put their healthcare in their own hands. The healthcare industry needs to take note of this trend. It’s not a fad; it’s here to stay. The current healthcare environment—culturally, politically and socially—is ready for self-service consumer healthcare.

    I see this trend as highly important in the health and wellness market and I believe in the simple philosophy: Education + Awareness = Action.

    Think about the huge advances in retail healthcare innovation—like the retail clinics at CVS/Walgreens, Hearing Aid Centers at Sears, to the optical shops located inside mass merchandisers. And I’m sure you’ve all checked your blood pressure at the pharmacy before, yes? There are even eye health kiosks that provide free vision screening, as well as soon-to-be launched comprehensive healthcare kiosks for overall health assessments. (In full disclosure, SoloHealth has our inaugural EyeSite® kiosk in retail locations nationwide, and is currently developing the SoloHealth Station with a sizeable grant from the NIH.) All around are offerings that deliver convenience while empowering and educating consumers.

    Much focus has been on “patients” (assuming that people are already sick) instead of focusing on keeping the healthy people, well. Consumers (not patients) need to feel empowered to learn about their own health and take the appropriate actions to stay healthy. In my opinion, we need them to provide the tools and education for people to take care of themselves.

    Further, we need to engage with the public where they are, and not expect people to search for informaiton. Retail grocery stores have an opportunity to be the “front-line” or portal for consumer healthcare. Despite the rise of the Internet, people still go to brick-n-mortar stores. According to Food Marketing Institute’s October 2010 data, consumers frequent a grocery store or drugstore 2.1 times per week. According to the National Community Pharmacists Association, the average consumer lives within 5 miles of a drugstore. And, according to Media Week, drug/shopping stores continue to have tremendous foot traffic: Walgreens (30 million/week), Safeway (44 million/week), Kroger (68 million/week) and Walmart (150 million/week).

    Finally, we need to use data to help motivate people to live a better, healthier life. Imagine if you were able to test your blood pressure, weight, body mass index and screen your vision; then compare your results in real time, to others your age, your ethnicity, your gender… accross the country, then in your own zipcode. Knowing where you are in relation to the rest of the “pack” is a strong motivator to a healthy lifestyle.

    The time is now to embrace and engage today’s self-service consumer.

    • horseshrink says:

      Involvement of non-clinicians in healthcare … a double-edged sword.

      Example:
      * Using “consumer” instead of “patient”

      Reflects basic philosophical differences of approach.

      Etymology of “consumer” derives from the act of destroying.
      Etymology of “patient” derives from the experience of suffering.

      As a clinician, I form a relationship with people who are suffering, or at risk of suffering. Without “suffering,” there is no need for my services. Without a relationship, the process loses meaning for the patient and the clinician. Clinical workflow historically has been a reflection of this.

      Administrators, bureaucrats, programmers, etc., don’t seem to see “relationships” and “suffering.” Rather, clinicians are akin to installers in the tire department at WalMart, taking care of “consumers.”

      Their approaches, policies and products reflect this.

      For example … why have docs not stampeded spontaneously to EHRs?

      In part … because paper charting intrudes less than an EHR on the face-to-face “relationship” in the exam room.

      Find me an EHR that is less obtrusive upon the patient encounter than paper charting.

      EHRs compete either for my visual/kinetic attention (via clunky/bulky input/review interfaces), or for privacy (“Let me introduce my scribe who will type while I check your prostate”), or for time (dictation/finalization after encounters = fewer patients per day.)

      I think EHR technology will eventually reach a point at which docs cannot imagine going without it because it’s so clinically helpful. We aren’t there yet.

      EHR technology still primarily benefits non-clinicians – the ones who aren’t charged with in-the-trenches implementation – the number crunchers who see widget “consumers.”

  36. Louis Wenzlow says:

    Please consider adding performance measures that break out and track the HIT adoption of (1) rural hospitals and (2) physicians practicing in small practices. These are the providers at greatest risk of not being able to meet the meaningful use requirements, and ONC has invested funds through the REC program to help them. It’s important that as a nation we understand how successful we are in these efforts over time.

  37. d.erasmus says:

    It seems you have the cart in front of the horse. I believe that some public and private incremental benefits will accrue from Health Information Tech (HIT), but some public and private damage that is likely to occur is not being taken seriously. The foregone conclusion of benefits has swept away concerns:
    1. Definitions are not in place for secure networks, much less what wireless network security will entail (NIST is still evaluating IT security). Use policies for personal wireless devices do not exist at most health care facilities, and the medical egos (including business leaders) are so large that most policies are aimed at the “little people,” which makes personal wireless devices with password access in the age of Immunity’s Silica or other automated wireless hacking tools very vulnerable.
    2. IT security history makes a great case for slowing IT at this point due to technical difficulties (RSA breach / Wikileaks / HIPAA Breach list, etc.).
    3. Personal privacy is nonrenewable (I have not seen a Monte Carlo simulation showing the costs for some unfortunate family entering a program similar to the federal witness protection program).
    4. Paul Ohm’s article on the surprising failure of HIPAA, and Ms. L. Sweeney’s 2010 testimony)
    5. Risk of damage to people by institutions implementing HIT while stretching too far and distracting their focus on patient care (some studies indicate full implementations carry a substantial penalty for institutions that lose their focus on health).
    6. The black market 2ndary use market ($250 billion) is estimated to be 10x the “legitimate secondary use” market ($25 billion), so information sold to “legitimate data miners” increases the liability of exposure to crooks.
    7. No health record exists without the patient (or guardian) giving permission. The creative choices for selecting providers and methods of care are done by the patient (or delegated person(s)) as attested to by the signature required for administration of care, so people can claim their copyright as editor of the body of work represented as a EHR / MHR / personal health record / or any other primary health information record, which is the exclusive basis for all health records whether they are considered Protected Health Information (PHI) or not.

    Yes we need to use technology for our advantage, and just because the horse is in front of the cart does not mean I want to shoot the horse, but it does mean we ought to slow this process down.

  38. Terri Rafalik says:

    I’ve reviewed the plan and am interested in hearing where communications are occuring with consumers. I’ve worked as a health information data analyst for many years, and am currently a student of HITECH via Pitt Community College in North Carolina. I’ve been looking for any public forums to educate consumers regarding Public Heatlh Records. Living in a rather strong health delivery area–Duke and UNC, I’m curious as to where they’re occuring. The plan says they’re already occuring. My colleagues in the health industry haven’t seen anything either. The media hasn’t covered anything either. If the goal is patient-centered care, when will we become active participants?

  39. Encouraging consumers to be proactive and involved in their own healthcare is always a worthy goal. Perhaps the Health/IT act would do this, but the question is are their more effective and efficient ways?We have to remember that healthcare reform is emerging in the context of a vulnerable economy, the likes of which we haven’t seen for a couple of generations. Also, whenever you increase the flow of information, which this act does, then privacy is effected simultaneously. So, I’d be interested in understanding how information is stored, what exactly would be in it, who has access to it, and, does the patient have the right to opt out? Do the benefits supercede or outweigh citizens rights to privacy? This is a national debate that won’t be going away anytime soon, and certainly is deserving of primary consideration. Thank you Dr. Blumenthal for an informative article report, and, please keep us “in the loop” of knowing what’s going on.

  40. C K says:

    After studying and watching this system evolve, I am strongly opposed to it. I do recognize its intent appears honorable and has many fine opportunities. For instance, improved patient care, faster id of common issues, etc. However, the risks and unaddressed issues outweigh benefits and will be too costly in several terms, mostly to the patients. However, I remain totally concerned about the ultimate lack of transparency, patient privacy, lack of informing patients as to each entity that will have access to records, lack of sufficient financial incentives to patients. Meanwhile, there are too high incentives to providers (like mailing checks to their homes around the time of year – that bothers me a lot), sales of patient data to researchers and unknown companies, and more. This system has too many personally identifiable steps attached to it. Also, as these information bases are built, other sources indicate that info will be accessible to researchers, labs, companies, a long list of entities which only need to sign off on a form and we have to “trust” them. Right. One terrorist can do considerable damage with this system. So, in short, unknowing patients go to their trusted doctor, only to learn down the road, their information was entered in an IT system, then eventually sold on the open market. Then, as with the recent Epsilon case, those weakly “protected” systems are hacked and the info is out there in unknown hands. The patient has zero control of his or her care records and worse than that has NO way of even knowing who, beside their doctor, has access to their information or what will be done with it. To me, this makes the program unacceptable. Add to that, as the system IDs medical classes and issues, say people with cancer since that is already happening, the patient is the subject of even more secret scrutiny than a person with a less watched medical issue. Next comes an additional Pandora’s Box of privacy and treatment issues. Add to that issues of electronics and IT constantly changing. There is no opt-out program for patients, which violates their constitutional rights to free speech. There is no specific law connected to this that will hold criminally accountable anyone who misuses or disseminates information. There are inadequate protections for patients overall. In fact, I see this as yet one more step in separating the classes and who gets the best care. (That is because a recent AHRQ notification contains “incentives” that groups patients in classes or categories, higher costs to those with system id’d medical issues, is what it looks like to me.) Also, with so little participation from all providers at this point, grouping any patients at all is unfair in that it targets some and does not include others. While this seems wonderful on the surface, it is not practical as it relates to security, privacy, patient fairness and patient rights. In my observation, there has been too much taxpayer money spent on this program and it has way too many flaws to be safe or cost effective for the patient.

  41. Family Voices NJ Comments to ONC on the Federal Health Information Technology Strategic Plan

    Submitted on April 11, 2011

    Thank you for accepting comments on the Federal Health Information Technology Strategic Plan. Family Voices is a national network that advocates on behalf of children with special healthcare needs and the NJ Affiliate is housed at the Statewide Parent Advocacy Network (SPAN), NJ’s federally funded Parent Training and Information Center which is also NJ’s Family-to-Family Health Information Center and a chapter of the Federation of Families for Children’s Mental Health. The Family Voices Coordinator also serves as the NJ Caregiver Community Action Network representative for National Family Caregivers Association in a volunteer capacity.

    SPAN and Family Voices of NJ strongly support the use of Health Information Technology (HIT) under healthcare reform. We believe that the efficient use of HIT will be cost effective and result in better health outcomes. HIT benefits include utilization of personal health records, consumer tools like the Build Your Own Care Notebook from the American Academy of Pediatrics, e-prescribing, lab results, making appointments, and telehealth which allows increased healthcare access to underserved populations. Preliminary research indicates that HIT has already reduced medication errors. We think that medical error reporting should be monitored using HIT, particularly in light of the fact that Medicaid is no longer providing reimbursement for preventable medical errors. This would also allow data tracking resulting in decreased morbidity and mortality, and ultimately better systemic health outcomes.

    However, we also strongly believe that HIT has the potential for misuse and abuse if sufficient consumer protections are not specifically included in the HIT plan and monitored to ensure that those protections are maintained.

    Our specific comments are as follows:

    Goal I: Achieve Adoption and Information Exchange through Meaningful Use of Health IT

    OBJECTIVE A: Accelerate adoption of electronic health records

    Strategy I.A.1: Provide financial incentive payments for the adoption and meaningful use of certified EHR technology.
    We agree that there needs to be financial support for HIT implementation. We support the meaningful use of objectives of recording patient information into EHRs, clinical decision support tools, e-prescribing, and patient privacy.

    Strategy I.A.2: Provide implementation support to health care providers to help them adopt, implement, and use certified EHR technology.
    We also strongly agree that there must be support to providers on actual implementation. This would include raising awareness of HIT benefits for providers both in terms of cost effectiveness and better health outcomes.

    Strategy I.A.3: Support the development of a trained workforce to implement and use health IT technologies.
    We agree that there needs to be specific training on HIT including personnel roles and responsibilities in this area.

    Strategy I.A.4: Encourage the inclusion of meaningful use in professional certification and medical education.
    We strongly support the inclusion of meaningful use for certification of professionals.

    Strategy I.A.5: Establish criteria and a process to certify EHR technology that can support meaningful use criteria.
    We agree that providers must utilize “certified HER technology that meets established criteria…aligned with Medicare and Medicaid …meaningful use requirements.”

    Strategy I.A.6: Communicate the value of EHRs and the benefits of achieving meaningful use.
    As stated above, we feel providers need to be aware of meaningful use and benefits of HIT. Rather than just viewed as another requirement, providers need to know that once set up, HIT will save time, money, and most importantly improve outcomes. We agree with the 4 aims of raising awareness of benefits, privacy, participation in HITECH programs, and increase understanding of different products and services available.

    Strategy I.A.7: Align federal programs and services with the adoption and meaningful use of certified EHR technology.
    We were pleased to see that that various federal agencies are already developing plans to align with meaningful use. These departments include Defense, Veterans Affairs (VA), Indian Health Services, Health Resources and Services Administration (HRSA), Federal Communications Commission, and the Substance Abuse and Mental Health Services Administration (SAMHSA).

    Strategy I.A.8: Work with private sector payers and provider groups to encourage providers to achieve meaningful use.
    We agree that besides governmental agencies, that there must be outreach to private sectors as well to encourage the achievement of meaningful use across sectors.
    Strategy I.A.9: Encourage and facilitate improved usability of EHR technology.
    We agree that the “usability of EHRs is…a key barrier to meaningful use and adoption”. We were pleased to see that there is government collaboration with “industry and researchers to improve usability of EHRs.”

    OBJECTIVE B: Facilitate information exchange to support meaningful use of electronic health records

    Strategy I.B.1: Foster business models that create health information exchange.
    We support the use of vendor developed “information networks” which will “facilitate information sharing among providers.” We support the ONC’s “Direct” project which will enable a “simple, secure, scalable, standards-based way to send authorized, encrypted information directly to known, trusted recipients” as part of the boarder Nationwide Health Information Network. This is an initiative to “pilot secure health information exchange using the National Health Information Network standards, services, and policies.” Consumer protections and consumer access are also critical here.

    Strategy I.B.2: Monitor health information exchange options and fill the gaps for providers that do not have viable options.
    We support this measure for areas in which there are few hospitals and providers who are not “supported by sustainable information exchange models” in order to reach underserved populations. We understand that the “government will also encourage consumers to gather and exchange their own individual health information,” but recognize that not all consumers will have the capacity to do this on their own.

    Strategy I.B.3: Ensure that health information exchange takes place across individual exchange models, and advance health systems and data interoperability.
    We understand that this will help support business models (e.g., bundled payments). We support the government development of a “standards and interoperability framework.” This will include “transport standards…enable one provider to exchange data with another provider…or systems.” It would also set “vocabulary and terminology standards” which will aid consistency.

    OBJECTIVE C: Support health IT adoption and information exchange for public health and populations with unique needs

    Strategy I.C.1: Ensure public health agencies are able to receive and share information with providers using certified EHR technology.
    We agree with the notion of meaningful use to include surveillance data, immunization registries, and lab reporting to public health agencies. This would also include emergency preparedness. We also support the Centers for Disease Control “helping public health agencies prepare their systems”. In NJ we have registries for immunizations, birth defects/autism and other developmental disabilities, and newborn screening. Again, consumers would need to be educated on the benefits of registries to allay fears. For example, some families misinterpreted that the autism registry would be cross referenced with the immunization registry resulting in mandated vaccines.

    Strategy I.C.2: Track health disparities and promote health IT that reduces them.
    We strongly support the use of HIT to look at health disparities and underserved populations. We also agree that this information should be used to “focus resources on areas of greatest need to mitigate disparities” because it’s not enough just to identify them. We strongly agree with the CHIPRA recommendations on health disparities for children. We also agree that technology such as telehealth will help reach the underserved and result in better outcomes. We strongly encourage the review and adoption of “messaging” consistent with the Robert Wood Johnson report on messaging regarding social determinants of health to ensure that the terminology used in the Strategic Plan doesn’t “turn off” certain segments of the population. For more information, go to http://www.rwjf.org/pr/product.jsp?id=66428.

    Strategy I.C.3: Support health IT adoption and information exchange in long-term/post-acute, behavioral health, and emergency care settings.
    We support the collaboration of both long term care and behavioral health in this area. We support the work of ONC with SAMHSA and HRSA on adoption of HIT.

    Goal II: Improve Care, Improve Population Health, and Reduce Health Care Costs through the Use of Health IT

    OBJECTIVE A: Support more sophisticated uses of EHRs and other health IT to improve health system performance

    Strategy II.A.1: Identify and implement best practices that use EHRs and other health IT to improve care, efficiency, and population health.
    We agree that “clinical decision support” tools are helpful. We also agree that CHIPRA has demonstrated “promising practices and lessons learned from the …Quality Demonstrations” to promote best practices of HIT and improving care.

    Strategy II.A.2: Create administrative efficiencies to reduce cost and burden for providers, payers, and government health programs.
    We agree that there needs to be “measures that simplify administrative processes and help lower costs in the clinical setting” as well as a transition from the ICD-9 to ICD-10 coding (Institutional Classification of Diseases).

    OBJECTIVE B: Better manage care, efficiency, and population health through EHR-generated reporting measures.

    Strategy II.B.1: Identify specific measures that align with the National Health Care Quality Strategy and Plan.
    We agree that under ACA (Affordable Care Act) there needs to be a National Health Care Quality Strategy to “establish national priorities for quality improvement and coordinate efforts across federal departments…with input from the public,” and strongly support the importance of such a strategy. We also agree that “development of e-measures that are aligned” and supported by HER Incentive Programs.

    Strategy II.B.2: Establish standards, specifications, and certification criteria for collecting and reporting measures through certified EHR technology.
    We support the development of standards and certification criteria for HIT. This will enhance the ability of providers to monitor their performance and improve care.

    OBJECTIVE C: Demonstrate health IT-enabled reform of payment structures, clinical practices, and population health management.

    Strategy II.C.1: Fund and administer demonstration communities to show how the advanced use of health IT can achieve measurable improvements in care, efficiency, and population health.
    We support the concept of the pilot Beacon Communities programs through ONC with the support of VA and HRSA.

    Strategy II.C.2: Align health IT initiatives and clinical and payment reform pilots and demonstrations.
    We agree that this would include bundled payments as previously mentioned, and medical home pilots. We strongly support AAP’s concept of the medical home and feel this is enhanced through the use of HIT. Under Medicaid this is the “health home” but so far in our state (NJ) the Medicaid Health Home initiative only includes adults.

    OBJECTIVE D: Support new approaches to the use of health IT in research, public and population health, and national health security

    Strategy II.D.1: Establish new approaches to and identify ways health IT can support national prevention, health promotion, public health, and national health security.
    We support that this should include national health security and that HIT can help during a public health emergency.

    Strategy II.D.2: Invest in health IT infrastructure to support the National Prevention and Health Promotion Strategy.
    We support the inclusion of preventing and reporting diseases, identifying at risk populations, and communicating with consumers under the National Prevention and Health Promotion Strategy.

    Strategy II.D.3: Ensure a mechanism for information exchange in support of research and the translation of research findings back into clinical practice.
    We agree that, with appropriate privacy protections, information should be available to researchers and most importantly to translate research findings into practice.

    Goal III: Inspire Confidence and Trust in Health IT

    OBJECTIVE A: Protect confidentiality, integrity, and availability of health information.

    Strategy III.A.1: Promulgate appropriate and enforceable federal policies to protect the privacy and security of health information.
    We strongly agree with the protections of HIT under HIPAA. We do however have concerns about privacy of personal health records. Despite HIPAA’s current privacy protections, confidential medical information has been obtained and released inappropriately to spouses, schools, or the court system. We have seen cases, for example, in which a spouse developed mental health issues as the result of domestic violence yet confidential mental treatment information was released to the abusive ex-spouse and used in child custody cases to the detriment of the abused spouse. We have also seen outdated and unauthorized mental health information affect families dealing with police, parenting time/visitation, DYFS, children’s mental health services, schools, and doctors refusing to communicate information to custodial parents. We’ve heard cases where employers learned that children had special needs so either dropped their coverage, fired their parents, or refused to hire their parents solely due to their child’s medical condition, rather than the qualifications of the employee. There should be fines associated with breaches, reimbursement to families, and increased sanctions for repeat offenses. As far as emerging technologies, text and voicemails can be retrieved by anyone on a cellphone if not erased. Social networking sites like Facebook must have “closed” groups and listservs disallowed from public view to be secure. Even then there must not be personally identifiable information.

    Consumer concerns should be addressed such as, for example, for pharmacy records, specific medications could identify the condition being treated such as HIV/AIDS, so there must be protections in place to avoid inadvertent disclosure of health conditions. We would like to see the same precautions for HIT regarding the importance of confidentiality particularly as it relates to mental health or substance abuse and would suggest using the additional protections for mental health, substance abuse, and exemptions to disclosure that appear on page 12 of the summary of federal HIPAA regulations. The consumer voice should be heard in HIT development as proactive, rather than reactive after policy is developed. Consumers should also have access to their personal health records (and parents should have access to their children’s records), even if it is in “read only” mode.

    Other consumer protections would have to take into consideration states in which there is minor consent for reproductive and/or mental health. Conversely, parents who are legal guardians of their adult children with disabilities must be able to access health records past the age of majority.

    Clarification is needed on vendors who serve in a dual role as a business associate of a HIPAA-covered entity and a direct provider of personal health records to the public. Of concern is the fact that the entities applying to become HIT providers, at least in our state, are all for-profit companies and there need to be mechanisms in place to prevent the sale of information for targeting advertising, etc. We are concerned with “PHR related entities” as non-HIPAA covered entities, non-HIPAA covered entities that offer products or services through websites of HIPAA covered entities, and non-HIPAA covered entities that access information in a personal health record or send information to a personal health record. We are also concerned with “third party service providers” who may provide services to a vendor of personal health records as well as access, maintain, retain, modify, record, store, destroy, or otherwise hold, use, or disclose unsecured PHR identifiable health information. There must be procedural safeguards in place for both PHR related entities and third party service providers to avoid inadvertent disclosure of personal health information.

    We would recommend one additional area for possible clarification: the relationship between HIPAA and FERPA, the Family Educational Rights and Privacy Act. There are entities, such as early intervention entities located in Departments of Health, which are bound by both HIPAA and FERPA. Unfortunately, these two privacy laws are not always consistent, sometimes leading to lack of clarity regarding applicability of both laws and which law “trumps” the other in the case of inconsistency. We recommend that a joint review of the provisions of these two laws be conducted and any inconsistencies or lack of clarity be addressed. We feel that, to ensure adequate privacy and security protections for personal health information, protections must be consistent with HIPAA. Also for services in schools like CHIP (Children’s Health Insurance Program) enrollment, access to public or private insurance for related services such as physical, occupational, and speech therapy under the Individuals with Disabilities Education Act, etc., schools must be both HIPAA and FERPA compliant.

    Strategy III.A.2: Enforce existing federal privacy and security laws and maintain consistency with federal policy.
    See statements on HIPPA and FERPA under A1 above.

    Strategy III.A.3: Encourage the incorporation of privacy and security functionality into health IT.
    We support the Medicaid HER Incentive Programs stage one requirements of encrypting information, access only for authorized users, audit logs, and automatic log off.

    Strategy III.A.4: Identify health IT system security vulnerabilities and develop strategic solutions.
    We strongly agree that there must be monitoring of system vulnerabilities and strategies to address them.

    Strategy III.A.5: Identify health IT privacy and security requirements and best practices, and communicate them through health IT programs.
    We also support recommending best practices and coordination on health information exchange between states with different privacy policies.

    OBJECTIVE B: Inform individuals of their rights and increase transparency regarding the uses of protected health information
    Strategy III.B.1: Inform individuals about their privacy and security rights and how their information may be used and shared.
    We agree that consumers must be educated to safeguard their information. Consumers must also be aware of their rights regarding privacy breeches such as the acquisition on information without the authorization of the individual. Examples include theft of a laptop, hard copies, and downloading/transferring files, and hacking. There must be multiple strategies to inform individuals about their privacy and security rights that take into account language spoken/read, literacy levels, existence of a disability, etc.

    Strategy III.B.2: Increase transparency regarding the development of policies and standards related to uses and sharing of protected health information.
    We support ONCs policy committee and the “Tiger Team” that has developed “recommendations on various privacy and security issues, including meaningful use criteria, certification criteria, individual consent, and use of intermediaries.”

    Strategy III.B.3: Require easy to understand reporting of breach notifications.
    We strongly agree that individuals need to be “appropriately notified when their personal health information has been compromised.” Conversely, consumers need to be aware of the consequences if they opt out of information sharing (i.e., unconscious in hospital and can’t communicate).

    OBJECTIVE C: Improve safety and effectiveness of health IT

    Strategy III.C.1: Provide implementation and best practice tools for the effective use of health IT.
    We appreciate that the ONC is working on resources for providers to avoid “common challenges and legal issues.” We urge the piloting of such resources with potential users prior to finalization to ensure that they will be useful for end users.

    Strategy III.C.2: Evaluate safety concerns and update approach to health IT safety.
    We appreciate that the ONC has commissioned IOM (Institutes of Medicine) to study HIT patient safety concerns and strategies to address them.

    Strategy III.C.3: Monitor patient safety issues related to health IT and address concerns.
    We also agree that HIT safety concerns must be monitored and addressed.

    Goal IV: Empower Individuals with Health IT to Improve their Health and the Health Care System

    OBJECTIVE A: Engage individuals with health IT

    Strategy IV.A.1: Listen to individuals and implement health IT policies and programs to meet their interests.
    We agree with the objectives to engage individuals in HIT, accelerate individual and caregiver access as appropriate, and “integrate patient generated information… with clinical applications”. We support consumer input and there must be additional consideration given to health literacy and cultural competency included here. We recently attended our first statewide health literacy summit and strongly recommend the use of the models developed by WI and MO (see http://lvnj.org/content/health-literacy ). Indeed in regards to cultural competency, for something as simple as smoking cessation we found in our Spanish speaking focus groups, women who said they couldn’t tell their husbands not to smoke inside even if it affected their children’s health. Thus, alternative messages (encourage your husbands to smoke near open windows, etc., i.e., messages that would help the mothers “make the best of a bad situation.”) had to be developed and used to help these families minimize their children’s exposure to second-hand smoke. Interestingly, over time, we found that these efforts often led to increased efforts by the fathers to avoid their children’s exposure to second-hand smoke.

    Strategy IV.A.2: Communicate with individuals openly and spread messages through existing communication networks and dialogues.
    We agree that there must be public input and recently successfully advocated for, and were invited to join, a consumer subcommittee on our state HIT workgroup. Again, we support the consideration of health literacy and cultural competency in these outreach and communication initiatives.

    OBJECTIVE B: Accelerate individual and caregiver access to their electronic health information in a format they can use and reuse

    Strategy IV.B.1: Through Medicare and Medicaid EHR Incentive Programs, encourage providers to give patients access to their health information in an electronic format.
    As mentioned previously, we support the notion of shared responsibility in terms of shared decision-making. However, we note that for certain populations, electronic access to information is not very useful given their limited use of technology. This will likely change over time, but there is still less use of technology by seniors, people with disabilities, lowest-income Americans, and Americans with limited English proficiency.

    Strategy IV.B.2: Through federal agencies that deliver or pay for health care, act as a model for sharing information with individuals and make available tools to do so.
    We support the “Blue Button initiative [which] provides individuals with a copy of available health information through a simple download function.”

    Strategy IV.B.3: Establish public policies that foster individual and caregiver access to their health information while protecting privacy and security.
    We appreciate that HHS supports, and strongly support, a “transparent, understandable, and easy to use online process”, a range of user “capabilities, languages, and access considerations”, and strong privacy and security protections.
    OBJECTIVE C: Integrate patient-generated health information and consumer health IT with clinical applications to support patient-centered care

    Strategy IV.C.1: Support the development of standards and tools that make EHR technology capable of interacting with consumer health IT and build these requirements for the use of standards and tools into EHR certification.
    We think that consumers should be educated on the benefits of HIT. The use of HIT should lead to measurable improvements and support patient engagement. A good example of this is the concept of shared decision making in the materials developed at http://www.healthdialog.com . In our state, we are using Take Charge of Your Health, a national chronic disease patient management program developed at Stanford which improves health outcomes. For more information, see http://patienteducation.stanford.edu/programs/cdsmp.html . This program could be effectively monitored though the use of HIT. Indeed, a 1/09 report from AHRQ (Agency for Healthcare Research and Quality) demonstrated the effectiveness of HIT on chronic disease; for more information see http://healthit.ahrq.gov/images/jan09cdmreport/cdm_issue_paper.htm.

    Strategy IV.C.2: Solicit and integrate patient-generated health information into EHRs and quality measurements.
    We agree that patient generated information could include both written materials such as journals or “device generated data” such as mobile glucometer readings.

    Strategy IV.C.3: Encourage the use of consumer health IT to move toward patient-centered care.
    We agree that HIT will help consumers verify information correctness, “test results, email providers, schedule appointments…and refill prescriptions.” In fact, research indicates the earliest benefits of HIT are e-prescribing resulting in less medication errors. We agree that quality improvements in patient centered care include: self management, shared decision making, health outcomes, and access to community resources through care coordination. However, there must be culturally competent, linguistically appropriate, and varied mechanisms to assist consumers to use health IT.

    Goal V: Achieve Rapid Learning and Technological Advancement

    OBJECTIVE A: Lead the creation of a learning health system to support quality, research, and public and population health

    Strategy V.A.1: Establish an initial group of learning health system participants.
    We support the notion of “learning systems” as pilots using a “select number of institutions that collect…large amounts of data”.

    Strategy V.A.2: Develop standards, policies, and technologies to connect individual participants within the learning health system.
    We appreciate that ONC is working on efforts regarding “standards, certification, and governance of a nationwide health information exchange.”
    Strategy V.A.3: Engage patients, providers, researchers, and institutions to exchange information through the learning health system.
    We agree that the “learning health system will only be as valuable as the information that is exchanged.”

    Strategy V.A.4: Grow the learning health system by adding more members and expanding policies and standards as needed.
    Related to A3 above, we agree that increasing members will increase the flow of information sharing. We encourage supporting Family to Family Health Information Centers, Federally Qualified Health Centers, and other sources of consumer education and support, to participate in the learning health system and in providing information, education and support to consumers.

    OBJECTIVE B: Broaden the capacity of health IT through innovation and research

    Strategy V.B.1: Liberate health data to enable health IT innovation.
    We agree that a priority is individual access to their PHR in a time fashion. We also agree that “outside of individual health information, the government is the leading generator of healthcare data” but stored in “disparate datasets”. We appreciate that HHS is “getting this data in the hands of developers to activate innovation”.

    Strategy V.B.2: Make targeted investments in health IT research.
    We appreciate that NIH and ARHG are funding research projects on HIT development.

    Strategy V.B.3: Employ government programs and services as test beds for innovative health IT.
    We agree that “government agencies are leaders in adopting innovative health IT…applying advanced health IT to the government’s own health care practices…creates a large market for technologies, …improve their value, and creates best practices for wider adoption.”

    Strategy V.B.4: Monitor and promote industry innovation.
    We agree that the government has facilitated this through “panels, conferences, white papers, and similar outreach efforts”.

    Strategy V.B.5: Provide clear direction to the health IT industry regarding government roles and policies for protecting individuals while not stifling innovation.
    As stated previously, we appreciate that ONC commissioned IOM to study patient safety concerns and strategies to address these as well as “define the role of public and private sectors in ensuring safety of health IT”.

    Appendix A: Performance Measures
    Under Goal 1, we support increasing the number of eligible hospitals, PCPs, FQHCs who have adopted electronic health records.
    Under Goal 2, we agree with increasing the proportion and number of practices participating in Beacon Communities.
    Under Goal 3, we support decreasing the number of consumers who are concerned about security of HIT, and note that this can only be achieved if (a) appropriate protections are mandated and enforced, and (b) appropriate education and communication is provided to consumers to allay security concerns.
    Under Goal 4, we agree with increasing the number of individuals who have electronic access to their health records, and note that this also requires education and support for individuals to be able to use mechanisms for such access and to understand what they find there.
    Under Goal 5, we cannot comment as the performance measure is yet to be determined.

    Thank you again for accepting comments on the Federal Health Information Technology Strategic Plan.

    Our Mission: To empower families and inform and involve professionals and other individuals interested in the healthy development and educational rights of children, to enable all children to become fully participating and contributing members of our communities and society.

  42. The national plan glaringly does not include the needs for behavioral health (mental health and substance use disorder) treatment. These entitites were not included in the HITECH Act for subsidies, yet they will be paying penalties in years to come. There are national policies, such as 42 CFR that must be addressed for behavioral health to be able to share information with physical health. Lastly, there are many smaller healthcare organizatons (both physical and behavioral health providers) that are going to have a very difficult time affording the costs of HIT. Yet, these small providers are essential and in some communities are the backbone of healthcare delivery. The plan needs to address how these organizations will not get left behind as we move towards a healthcare deliver system that uses more information and technology.

  43. Zach Horton says:

    I have just a few questions with hope to have some insight from fellow members of the public and professionals alike. I have been researching EHR adoption for a class of mine and have come across a paper “A Progress Report On Electronic Health Records In U.S. Hospitals Ashish K Jha; Catherine M DesRoches; Peter D Kralovec; Maulik S Joshi Health Affairs; Oct 2010; 29, 10; ABI/INFORM Global
    pg. 1951″ that has some very intriguing data about the lack of EHR adoption by the countries hospitals. What are the plans to provide assistance (primarily financial) to hospitals whom are smaller or rural in regards to helping them be able to afford to implement an EHR system? HIT takes an huge capital investment to get started and be able to have in place with trained personnel and doctors to be able to be effective and have the HIT operate at its intended effeciency. Where are these hospitals going to come up with the capital to do such projects? What about physician groups who must invest their own money into such a system? What about the pharmacies which are privately owned (while yet becoming extinct)? Along with the unprecedented debt that this country now faces and looming budget cuts to many programs to get a hold of the debt, where is the money going to come from and how will it be alloted to such hospitals? How much interoperability is in place for all the different EHR/HIT systems and how will a purely “electronic” hospital react to a patient where they can not access their personal medical file because they two systems do not operate together? There are just too many questions right now.

  44. •In Goal III, we highlight efforts to step up protections to improve privacy and security of health information, and discuss a major investment in an education and outreach strategy to increase the provider community and the public’s understanding of electronic health information, how their information can be used, and their privacy and security rights under the HIPAA Privacy and Security rules.
    In regards to Goal III, I have a suggestion that may be helpful in physically securing the fiber that transmits all of information belonging to hospitals, doctors, patients, pharmacies, etc.
    Some people forget that, while it is important to prevent unauthorized access to computers and information inside hospitals, criminals don’t actually have to enter the building to gain access. And yes, they can hack from an undisclosed location or worse they can actually get into the fiber outside the building.
    By securing manholes and fiber boxes that contain the fiber you can prevent someone from tapping the fiber, destroying the fiber (which could take down the network or portions of it). In securing the manholes and handholes that contain the fiber it allows the hospital (or other medical customer) to control access of who is entering their infrastucture. They maintain control of who adds fiber, who fixes fiber and it gives them control of who’s coming and going, who they are and most importantly, why is that person doing what they are doing. There are quite a few hospitals that are adding this measure on top of the current security they already have in place.

  45. The convergence of regulatory mandates from 2011 to 2014 on physicians is unprecedented and merciless: HITECH/meaningful use, the HIPAA 5010 standard, the ICD-10 transition, healthcare reform, the push for accountable care organizations, intensified pay for performance and the renewed threat of capitation payments.
    Reporting requirements continue to increase, disregarding the challenges faced by primary care practices in collecting and reporting data, revenue loss with limited budgets, internal staffing and resource restrictions while we continue to be viewed as the “Gatekeepers” forced to perform prior-authorizations for radiology procedures, nuclear cardiology studies, hospital admissions and most new medications. Future funding by CMS forces us to provide documentation for the “Medicare Advantage Plans Risk Assessments and Analysis adjustments”.
    In 2006 the US Agency for Healthcare Research and Quality (AHRQ) held a national conference of stakeholders in the area of reporting performance data by office practices. The AHRQ report suggested that the cost associated with reporting performance measures, particularly when juxtaposed against the shrinking profit margins of primary care practices, may be a major factor underlying many of the identified barriers to adoption of quality reporting programs.
    The North Carolina Family Medicine Research Network in collaboration with the US Agency for Healthcare Research and Quality held a 2009 study to determine how much it costs primary care practices to participate in programs that require them to gather and report data on care quality indicators determined: “Clinicians are increasingly asked to be externally accountable for the quality of their work and the health of the patient populations they serve. Reporting activities have occurred with little regard to the challenges primary care practices face in collecting and reporting requested data. These challenges include inadequate data collection and reporting systems, multiplicity and inconsistency of measures required by different quality improvement organizations, the need to converge multiple paper and electronic data sources, and insufficient financial resources to maintain office systems and educate personnel. Major expenses included planning, training, registry maintenance, visit coding, data gathering and entry, modification of electronic systems, and lack of interoperability among IT systems; underscoring the challenges to performing quality improvement work in primary care.”
    In conclusion from the reports to date, “The question of whether participation in quality-reporting is worth the time, effort and expense is largely unresolved and in light of the cost of performance measurement and reporting, programs seeking to engage primary care physicians should choose measures judiciously.”
    Despite the enthusiasm for providing quality medical care, these challenges will force even the most efficient physicians into retirement or bankruptcy and our nation into healthcare crisis as the overall quality of care deteriorates as a result of programmatic and data management demands.

    • “The convergence of regulatory mandates from 2011 to 2014 on physicians is unprecedented and merciless: HITECH/meaningful use, the HIPAA 5010 standard, the ICD-10 transition, healthcare reform, the push for accountable care organizations, intensified pay for performance and the renewed threat of capitation payments.”

      Oh, I couldn’t have said it better. It’s a crushing load. There won’t be any time for patients. I’m surprised there is now. And we have used full EMR for 7 years.

  46. I want to share two comments about the Federal Health IT Strategic Plan that stress the importance of information tools in addition to the well-recognized importance of EHRs. The insights underlying these comments come from our work at SimulConsult on decision support software for medical diagnosis. Both comments arise from the observation that our linking of diseases to other information tools such as GeneReviews, OMIM and our linking of findings to the consensus Malformation Terminology (http://research.nhgri.nih.gov/morphology/) creates the capability to record diseases and findings as standardized, computable data. In addition to the inherent benefit of information tools in reducing diagnostic errors, test-related costs and diagnostic errors, these information tools have capabilities that are important in two non-obvious ways:

    1. Decision support tools are an excellent way to add coded information to an EHR

    Clinicians dislike taking extra time to code diagnoses and findings, yet having such information as computable data in the EHR is very important. Traditionally this is seen as a trade-off to be solved with incentives or regulation, or as something to be handled in a subsequent process of automated coding, which introduces errors. However, deploying decision support tools that clinicians want to use breaks the trade-offs: the information added by the clinician to the decision support tool is automatically coded in a way that makes it computable. Clinicians are glad to be involved in this process since they get assistance with diagnosis and they get fast entry of pertinent positives and pertinent negatives using a system that focuses dynamically on the findings most likely to be relevant, and induces the clinician to check and document these findings. The findings entered are automatically tagged with codes, and therefore immediately computable. Similarly, potential diagnoses, an emergent property of this process, become computable data as well. Therefore, in addition to the benefits of decision support tools in themselves, the willingness of clinicians to use such tools has wider benefits in making information computable.

    2. Standardization arises most naturally from interacting information tools, rather than from individual EHR environments

    Processing unstructured text to extract diagnoses and findings as data is error prone and discourages standardization because clinicians differ in their use of terminology, including granularity of the detail. Despite this issue, it has been conventional wisdom that terminology is a local client function that is inserted into the EHR. But another model is emerging of terminology standardization arising from interacting information tools, with the Standards & Interoperability framework for findings and diseases arising naturally from such interactions. We have seen many examples of this with the interactions of our SimulConsult diagnostic decision support software and other information tools. When we link diseases or findings in SimulConsult to other information tools all we have to do is do the linking once, and subsequently all the information arising from using such tools is coded properly and computable.

    Many benefits of such computable information are obvious, but we are seeing some non-obvious benefits as well. As examples, GeneReviews is now treating diseases as computable information and hyperlinking from their new or revised articles (e.g. http://www.ncbi.nlm.nih.gov/books/NBK1274/#hunter.Differential_Diagnosis) into SimulConsult. A clinician reading a GeneReviews article about a particular disease can now click directly from that article to enter pertinent positives and negatives about their patient into a profile of the disease in SimulConsult, getting a differential diagnosis tailored both to the patient in question and to the disease suspected. After settling on a diagnosis, the clinician can explore other GeneReviews articles or other resources, or return with the new coded information to the EHR. Another non-obvious benefit is that our use of the consensus Malformation Terminology in SimulConsult is facilitating the adoption of the Malformation Terminology among users of SimulConsult. In addition, through our involvement in the review process for GeneReviews articles, our use of the Malformation Terminology is helping spread this terminology to the text of GeneReviews articles, and thereby to its readers.

    In general, the emergence of interoperability and standardization among interacting information tools is a process that is already far along and represents an important opportunity to add such capabilities to EHRs simply by connecting in the network of information tools, rather than expecting such tools to originate within individual EHR varieties and then become interoperable later.

    These two points stress the importance of information tools, including diagnostic decision support, in producing three of the key goals of the Health IT Strategic Plan:
    Goal I: Information Exchange and Meaningful Use of Health IT: the ability of information tools such as diagnostic decision support software to turn information into computable data is a direct implementation of information exchange. The ability to increase diagnostic accuracy and decrease errors is a direct implementation of meaningful use.
    Goal II: Improve Care and Reduce Health Care Costs: the ability of information tools to increase diagnostic accuracy and decrease errors is a direct implementation of this goal.
    Goal V: Achieve Rapid Learning and Technological Advance: the computable information produced by information tools allows systems in general to learn and advance, as outlined in the strategic plan, but less obviously the information tools themselves can have architectures that learn from the wisdom of the community, as does SimulConsult.

    Focusing too much on EHRs and not including information tools would be a mistake

    Although much of the focus of the Health IT Strategic Plan has been on EHR, many of the key goals are being achieved using information tools that are interoperable among EHRs. Building such an information infrastructure is crucial to making Health IT worthwhile. Not only do such information tools deserve increased attention, support and incentives, but they are the parts of Health IT that clinicians are most eager to adopt, and by the principle of “building boldly on what works”, their interactions with EHRs are a crucial way of achieving the other benefits of EHRs.

  47. Jay Wack says:

    It might be a good idea for the healthcare industry to consider taking advantage of work done by others.
    All information systems have the same basic characteristics and issues;
    maintaining the confidentiality, privacy, and control of that information.

    The PCAST report reflects this in the recommendation of the use of encryption and the focus on data at the object level and the use of XML schemas.

    The American National Standards Institute, (ANSI) has spent many years developing and codifing these techniques and have published a standard, X9.73-2010, Cryptographic Message Syntax-ASN.1 and XML.

    This document has been peer reviewed and signed off by over 50 organizations, including the National Bureau of Standards and Technology (NIST), the National Security Agency (NSA) the Federal Reserve Bank, Hewlett Packard, IBM and Unisys.

    We all can benefit from the work of ANSI and other Standards organizations. Why reinvent the wheel?

    Jay Wack
    President
    Tecsec, Inc
    Herndon, Virginia

  48. S.Whitney says:

    As a player in this industry for 30 years , I see minimal impact to the quality of care to the vast majority of patients at a huge cost . A fraction of the investment in preventive medicine would have a far greater impact and would allow needed resources to be applied to quality of life measures for those truly in need . We are a self absorbed lot and replacing systems that have years of useful life is an awful waste of capital. Healthcare has become the new military industrial complex .

    • David Hager, M.D. says:

      Reminds me of the difference between the latest/greatest high priced antibiotic vs. clean water sources for reducing population infectious illness burden.

      I wonder how many people out there have a genuine appreciation for the initial and ongoing expenses of EHR technologies.

  49. Jim says:

    One issue, in my opinion, is behavioral health sharing of information with HIE’s. Yes technically we can do it with releases, but managing that can be a nightmare. However, the issue comes in with revoking the authorization. How do we “tag” data to know that it should no longer be released? There needs to be a standard for this type of data sharing. It’s not a simple matter of exporting and importing information from one system to the next. I think the feds will need to address 42CFR Part II if they are serious about having behavioral health as part of this overarching health plan. They even mention this in the strategic plan to some degree.

    Another issue that many people forget about is the cost. There are three types of cost when it comes to EHR’s: initial purchase, implementation/maintenance and security infrastructure. Initial purchases costs are generally budgeted for and are a fixed number. Implementation costs are those hidden costs that no one knows about until you are hip deep in it. I am talking about staff time. Agencies don’t hire “new” staff to implement the EHR. This task is given to existing staff to complete. So there is the cost to the agency of potential OT or staff morale due to the tremendous amount of work involved. Unfortunately, staff don’t get to “stop” doing what they were doing before the EHR showed up. The amount of time to implement an EHR properly, is often under estimated.

    Infrastructure costs are those costs an agency pays to keep up with technology that help secure this information. It is not enough for the EHR vendor to “secure” the data within the EHR. Agencies need to ensure they are securing how staff access the data, where they access, from what type of devices they access, etc. All this takes planning, time and money. Unfortunately, this is not a one-time investment either. Keeping up with infrastructure is an ongoing cost that needs to planned for annually. That’s not to say you have to spend hundreds of thousands of dollars, but many agencies lack the foresight to continually plan ahead. Buying an EHR is expensive, paying out fines because you did not plan your security properly could bankrupt you.

  50. WGBH NCAM comments on Federal Health IT Strategic Plan

    Health care is being re-structured to take advantage of technology’s promise to improve quality of care, deliver cost efficiencies, speed information exchange, and build consumer health literacy. However, there is vital work to be done to ensure that people with disabilities are able participate equally in all the opportunities that new health IT networks and tools have to offer and be able to independently access and manage their personal health care information.

    The needs of people with disabilities — as patients, caregivers and professionals — must be addressed in the development of health IT requirements for information design, exchange and display within both public and private products and services, and the standards governing health IT. Although existing accessibility requirements require federal agencies to purchase or deploy electronic and information technologies that can be used by persons with disabilities, there are numerous documented cases of lack of compliance, oversight and enforcement of these section 508 rules. Efforts to address the existing gaps are underway at the White House and at the CIO Council of Federal agencies. In the meantime, numerous health IT standards and certifications are being approved and deployed and new health IT products and services are being used by major health care providers and employers – all with little to no attention to the usability and accessibility requirements of people with disabilities.

    The Strategic Range plan states that HHS will support approaches that:

    “Accommodate the range of user capabilities, languages and access considerations, including effective strategies for ensuring accessibility and usability of electronic health information for people with disabilities and meaningful access to such information for individuals with limited English proficiency.”

    With this statement of principle, it is now essential that basic software and web accessibility requirements, based on accepted industry standards, become as high a priority as privacy and security, with Federal policies making it an irreversible requirement for all health IT deployment.

  51. Blinded Veteran says:

    I am neither Health nor computer informed, but I do have demands based on my needs for this as a consumer and patient.
    1) Must be more secure than the majority of Fed and Public IT stuff.
    2) Must be accessable to blind and visually impaired people using a variety of screen readers and such accessibility products.
    3) Must be user friendly and be reasonable simple in language and free of enuendos and cryptic meanings.
    4) Must be easy to use for seniors and disabled consumers/patients.

  52. Anita Aaron says:

    The World Institute on Disability (WID) agrees that “we are only beginning to unlock the vast promise of electronic health information to improve decision making, help individuals better manage their health, and improve the health system’s capacity for rapid learning.” As healthcare information, treatment and information exchange becomes more patient-centered and moves away from a medical professional to professional model, individuals with disabilities become much more able to take a central role in managing their healthcare needs. That is, of course, if the software applications, platforms and products are accessible and usable by people with disabilities.

    We have section 508 which requires the government to develop, certify and distribute only electronic systems usable and accessible to people with disabilities. That requirement, however, is often overlooked or worked around resulting in development and use of many programs, products and applications that are not technically accessible and certainly not usable by individuals with disabilities.

    It’s time for accessibility and usability to be elevated to the same level as privacy and security.

  53. Chantal Worzala says:

    On behalf of our more than 5,000 member hospitals, health systems and other health care organizations, and our nearly 40,000 individual members, the American Hospital Association (AHA) appreciates the opportunity to comment on Federal Health Information Technology Strategic Plan (2011 – 2015) released by the Office of the National Coordinator for Health Information Technology (ONC).

    The AHA is very supportive of the goals of this comprehensive and ambitious strategic plan. Hospitals work every day toward the shared vision of an e-enabled health care system to support informed and engaged patients, the safest, best possible care, and improved population health. Hospitals also support the goals of information exchange to ensure that the right information is available at the right time and in the right place to inform care.

    The plan outlines five goals:
    1. Achieve adoption and information exchange through meaningful use of health IT
    2. Improve care, improve population health, and reduce health care costs through the use of health IT
    3. Inspire confidence and trust in health IT
    4. Empower individuals with health IT to improve their health and the health care system
    5. Achieve rapid learning and technological advancement

    While the AHA supports the vision behind all of these goals, our comments pertain mostly to Goals 1 and 2. They focus on the need for appropriate coordination across various programs, the use of health IT for measuring provider performance, and the need for strong mechanisms to assess whether the plan is workable and achieving desired results. We also note that we have provided detailed comments to the meaningful use workgroup of the Health IT Policy Committee regarding the current challenges of the meaningful use program, including the unrealistic timeline and the need to learn from the experience from Stage 1 before we move on to Stage 2. These comments are all relevant to Goal 1, and we recommend that ONC take them into consideration when finalizing the strategic plan.

    Coordination. The AHA is pleased to see an emphasis on coordination across federal agencies in the strategic plan. We caution, however, that alignment of programs does not require duplication of policies and requirements, and is best achieved by ensuring that programs fits logically together without overlap. Hospitals, physicians and other providers must comply with all federal regulations. Duplicative efforts across programs at best unnecessarily increase burden at a time when we are all working to reduce costs. At worst, they risk confusing providers and resulting in incompatible and contradictory requirements. For example, the Centers for Medicare & Medicaid Services (CMS) is charged with regulating the health care administrative transaction standards under HIPAA, which all Medicare providers must use. Page 23 of the plan suggests that the Department of Health and Human Services (HHS) will also leverage the meaningful use program to increase standardization and automation of health care administrative functions. The AHA strongly supports keeping administrative transactions out of meaningful use as they are generally not part of electronic health records (EHRs) and are already subject to regulation by CMS.

    Duplication of requirements could also prevent needed progress. For example, on page 13, the plan notes that other agencies, including the Health Resources and Services Administration and the Federal Communications Commission could require providers to become meaningful users as a condition of receiving grants from broadband deployment or other programs. Repeating the meaningful use requirements in other programs is redundant, as the Medicare program contains both positive and negative incentives for meaningful use that grow over time and continue in perpetuity. Given the current challenges of meeting meaningful use, this approach also could unfairly deny providers access to resources that they need to adopt and fully deploy EHRs. For example, we know that providers in rural areas are less likely than their urban counterparts to have adopted EHRs. They are also more likely to lack access to reliable and affordable broadband access. As ONC rolls out the strategic plan, we encourage an emphasis on coordination and alignment to ensure that policies and programs across agencies are complementary and supportive of common goals, without being duplicative.

    Performance measurement through health IT. Goal 2 outlines the use of health IT for quality and outcomes measures to assess provider performance. While the AHA supports the efficiencies that may be gained through automated reporting, we caution that e-measures must be carefully developed to ensure their scientific validity, reliability and fairness for judging performance. Use of automated measures is a relatively new endeavor and we have much to learn. Measure development is difficult and takes time. Measures must also be widely field-tested before being deployed to ensure that data collection and reporting are feasible. We know from early experience with the Stage 1 meaningful use hospital clinical quality measures that e-specification is very challenging and the kinds of clinical judgment and rich clinical data that are used in today’s manually abstracted measures cannot be easily extracted from EHRs. In this area as well, coordination is critical to ensure focus on priority areas and avoidance of duplicative burdens across programs. As measures are used in multiple programs that tie payment to performance, we must also guard against multiple penalties being assessed due to poor performance on a single measure.

    Evaluation. Any strategic plan must include mechanisms for ongoing evaluation of progress and changes to the plan, where needed. It should also consider the resource requirements and availability of resources for all those affected by the plan, both public and private. An ambitious plan that charts a course in new areas of federal investment and regulation should have a rigorous evaluation plan that specifically includes touch points to ensure that the pace and scope of change is feasible for all involved. While Appendix A does provide a small set of performance metrics, the strategic plan would be strengthened by inclusion of more discussion of both resource requirements and ONC’s plans to evaluate progress over time, including mechanisms to systematically obtain input from stakeholders, and, if needed, make revisions.

    Thank you for the opportunity to provide comment.

  54. SUE H. LIMING says:

    “Accommodate the range of user capabilities, languages and access considerations, including effective strategies for ensuring accessibility and usability of electronic health information for people with disabilities and meaningful access to such information for individuals with limited English proficiency.”

    This would by definition include videos with captions, and usability with JAWS/WINDOW EYES and other text to voice software in multiple medias both PC and Mac based. Wonderful!

  55. CIOCHIME says:

    April 18, 2011

    Farzad Mostashari, MD, MPH
    National Coordinator for Health Information Technology
    Department of Health and Human Services
    Submitted electronically

    Re: ONC Federal Health Information Technology Strategic Plan 2011 – 2015

    Dear Dr. Mostashari:

    The College of Healthcare Information Management Executives (CHIME) appreciates the opportunity to respond to the request for comments regarding the Office of the National Coordinator (ONC) for Health Information Technology’s Federal Health IT Strategic Plan (“the Plan”).

    CHIME’s 1,400 members represent chief information officers (CIOs) and other top information technology executives at many of the nation’s largest hospitals. CHIME members have frontline experience in implementing clinical systems, and have learned by trial and error what works and what doesn’t in implementing such electronic systems and optimizing the value derived from them. Healthcare CIOs share the vision of an e-enabled healthcare system as described by the HIT Policy Committee, ONC, and the Centers for Medicare & Medicaid Services.

    CHIME appreciates the efforts put forth by ONC to articulate the federal government’s role in the evolving health IT landscape. As evidenced by the host of accomplishments and ongoing activities listed in the Plan, we understand the complex nature of ONC’s vision and its limited ability to detail all facets of those activities in this Plan. CHIME agrees overwhelmingly with the five Goals espoused in the Plan, but would like to take this opportunity to comment on issues of particular importance to healthcare CIOs.

    Confidence and Trust in Health IT

    CHIME members understand the critical role trust plays in healthcare. Patient confidentiality and privacy are fundamental to providing quality care. Several of the objectives listed throughout the Plan foresee the fluid exchange of the right information, at the right time, for the health and safety of patients. In order to make sure this information is shared responsibly, ONC needs to further define how consent management should be handled and it must address the responsibility of patients, physicians, hospitals and insurers on how consent will be stored and transmitted through health information exchanges (HIEs). The consent process must also support exchange with personal health records (PHRs) so that information between patients and their providers – no matter the source – is accurate, secure and furthers the goal of improved care.

    Contingent upon the ideas of trust and shared responsibility in keeping health information private is making sure laws across state boundaries are harmonized. CHIME urges ONC to establish standards for a national privacy regulatory environment that would apply to all health information exchange. We consider this yet another example of how the current HIPAA preemption policy creates problems by essentially allowing geographic variation in privacy rules, which complicates compliance and makes it more costly. We, therefore, urge the Office for Civil Rights (OCR) to re-examine its stance with respect to federal preemption in a way that facilitates, not hinders, health information exchange across jurisdictional boundaries.

    Performance Measures

    CHIME believes that ONC has taken the correct approach in quantifying hospital and physician performance by measuring the percentages of eligible Medicare and Medicaid EHR Incentive Program payment recipients. As previously outlined by CHIME in its comments on Stage 2 of Meaningful Use (MU), we believe this is a vital measure for ONC to monitor. We would like to reiterate that moving to Stage 2 MU objectives and criteria before 30 percent of eligible hospitals (EHs) and eligible professionals (EPs) have achieved Stage 1, may be unduly ambitious, even unattainable, for many EHs and EPs. We believe this approach – setting a reasonable percentage for EP and EH attainment of MU – would strike the right balance between the desire to push EHR adoption and MU as quickly as possible and the recognition that unreasonable expectations could end up discouraging EHR adoption if providers conclude that it will be essentially impossible for them to qualify for incentives.

    Patient-accessed and Patient-added Health Information

    CHIME understands the incredible opportunity that real-time data flows and remote monitoring systems can have on healthcare. We also acknowledge the potential for empowering patients to access their health information in a timely manner. CHIME believes there are two issues that need to be addressed regarding timeliness and appropriateness of instant access to information.

    First, in past comments we have noted discrepancies in HHS regulations regarding timeliness. The timeliness standard under HIPAA is significantly different from that under the electronic health record meaningful use regulations recently adopted by HHS (30 days for information maintained on-site vs. three business days). CHIME considers the three business day standard unreasonable and is also troubled by the failure to adopt more consistent timeliness standards across HHS regulations.

    Second, CHIME questions the wisdom in granting patients instant access to all health information, like lab results, which will likely require explanation. This kind of access could be counterproductive, and even dangerous, without the proper context and clarification from health professionals. We believe that providers and health professionals need to have a say in which information is beneficial – and not harmful – when it is instantly accessible to patients.

    EHR Evolution

    CHIME is encouraged to see that more resources will be directed towards the Agency for Healthcare Research and Quality (AHRQ), the Strategic Health IT Advanced Research Projects (SHARP) Program and others to focus on the “usability” of EHRs, clinical decision support, health information exchanges, and telehealth tools. As EHRs move from process requirements to requirements for improvement in outcomes and quality of care, it will be important to keep healthcare CIOs engaged about how their constituent physicians, nurses and other clinicians are interfacing with EHRs and re-engineering their work processes. However, it should also be noted that while CHIME supports the ongoing development of EHR capabilities and acknowledges their importance in broader changes to ONC’s strategy, caution should be exercised when expecting EHRs to do too much, too fast – such as accommodate multiple languages and disabilities.

    We hope these comments are helpful. We look forward to continuing our dialogue with ONC as we work to improve health and healthcare through the use of information and technology. If you have any questions about our comments or need more information, please contact Sharon Canner, Senior Director of Advocacy.

    Sincerely,

    Richard A. Correll, President & CEO
    CHIME

    And

    Dr. Lynn Vogel
    Chair, CHIME Board of Trustees
    Vice President & Chief Information Officer,
    The University of Texas M. D. Anderson Cancer Center

  56. This is a comment on the National Coordinator for Health Information Technology (ONC)’s Federal Health IT Strategic Plan. Please ensure that technologies developed and adopted, in this strategic plan and future Federal Health IT efforts, addresses the need of people with disabilities and functional limitations associated with aging. Please ensure that all IT developed and adopted is fully accessible. I am a VP/Director at Arizona Bridge to Independent Living, a non-profit organization that provides advocacy by and for people with disabilities. As the baby boomers age, many will acquire visual and hearing impairments, so the number of American’s with disabilities will increase over the next 20 years. Thank you for your consideration.

  57. Dave Lushbaugh says:

    page 10
    “For providers ineligible for incentive payments (for example, long-term and post-acute care facilities, community mental health centers, or substance use disorder treatment providers), the government is developing technology and policy solutions that build on meaningful use and fit their unique needs”.

    Mental Health is not included in the current strategic plan. According to the NIMH and World Health Organization the numbers of people affected and cost is very significant. The process for significant improvement of treatment and services delivery may be available and could be implemented now.

  58. Sandwich Generation says:

    In addition to updates in IT, please consider other big picture costs of delivering health care. Incentives for hospitals and large facilities to install Solar panels that sometimes generate more electricity than can be consumed , water conservation apparatus and LED lighting, energy efficient appliances and medical equipment, electric powered/ hybrid ambulances, computer software that cuts down on paperwork and support personal, Decentralized hospitals like maternity hospitals or female related issues, etc . If hospitals specialized, they would not be forced to buy all types of equipment and could focus on getting the state of the art equipment needed for their specialty. Also consider incentives to acquire medical products at reduced prices rather than using “medicare approved” vendors. Asking the public to donate medical equipment such as crutches and walkers that are no longer in use or offer a small reimbursement for returning them. There should be incentives for people who can find medical equipment at lower cost than medicare or their insurance company providers pay for.

  59. Avraham Avi Ayalon says:

    Sir/Madam,
    Back in 2003 and before the huge financial, time and other resources investment began, my view was and is still today, that the preferred process would be using: an existing mobile technology (widespread, user-friendly, well-known and proven) instead of a new one, as well as an opt-in method (voluntary) instead of an opt-out.
    Thus, it was possible to transfer the most essential data required in order to prevent mistakes and even lives of patients also in rural areas or in the middle of the street, and not only in the clinic/hospital, save lots of $ and of human years investment, and at the same time overcoming major pitfalls such as; the big brother issue, the interoperability, the assimilation and learning processes, the need for a “reader” device in order to get the information and the TIME it already took and will take until the goal is met.
    I rest my case.

  60. Eric S. Lichtenstein, MD says:

    In brief, as I noted above in my response to the typewriter / word processor analogy, the analogy just doesn’t work. Think about it… The data entry is the same for computer word processing and typing on a typewriter. The advantage is in the post data entry processing with the computer system.

    The electronic health record systems may or may not be good at data processing (GIGO), but the problem is that data entry is not ready for prime time… neither efficient, nor reliably accurate, and dependent upon the skill and knowledge of the user. The cost effectiveness ratio is inversely proportional to the user’s level of knowledge and responsibility, because of the data entry inefficiency. The more valuable the person’s time required for the data entry, the less cost effective.

    In the era of decreasing reimbursement for the time of highly trained physicians, the available EHR systems either decrease the efficiency of the health care encounter with the person ultimately responsible, the physician, or rely upon less knowledgeable personnel with attendant reduction in the reliability and accuracy of the data, especially when involving standardized check box / drop-down list and template systems. These types of data provide wonderful fodder for data processing and statistical interpretation, but often miss the patient’s unanticipated individual or unique features that differentiate them, their diagnosis or treatment from others. Improved diagnostic coding may help, but will again require the attention and expensive time of the responsible physician, in an era of falling appreciation for the effort, diminished respect, and absent compensation.

    The problem of cost effective data entry really needs to be solved, or at least have a significantly improved ratio. Management processes, whether IT or business management, can neither assume the responsibility of, nor replace the physician. Without recognition and careful attention to this issue, largely ignored as the data processors do and sell what they can do well, the intended benefits of information technology in health care will not be realized.

    • David Hager, M.D. says:

      I agree.

      A proverbial rhinocerous in the living room.

      Whichever company fixes that might just see a line of physicians outside its door, with eagerly open wallets.

  61. One of the biggest problems with the whole policy is that it focuses on where IT is today, not where it will be tomorrow.

    “Cloud” technology is the probable future, but there are so many security issues that we will be stuck on that for some time to come.

    Banking, business and education did not become computerized in 1-5 years. It took many years of development, mistakes and experiments to get where they are now.

    Computerizing the medical field is more complicated, and yet everyone wants it overnight. I suggest we will be disappointed if we continue this approach.

  62. James E. D. Cline says:

    Establishing a Health IT system, composed of EHRs and associated data processing, seems likely to be seen as intruding into many powerful business territories. And “defense” of those business territories is likely to happen, interfering or prohibiting the use of Health IT.

    Another significant factor is the formatting of the EHRs. A human being is a very complex being, and the fully descriptive parameters would involve a huge data field indeed. So, approximations need to be done, probably derived from standard medical parameters – such as blood pressure – and case history event descriptions. These EHRs will enable quick call up of a patient’s records in case they show up in an ER, but also enable more consistent evaluation by multiple medical practitioners giving opinions.

    If this is all the Health IT system is to accomplish, it would be worthwhile, of course, Yet the purpose is said to eventually greatly reduce the cost of health care while also greatly improving its quality. To do that, the overall health IT system will need to also have room for adaptability in the EHR formatting for entirely new kinds of human data, to accommodate the parameters of health systems already well proven quietly in the alternative health sector, yet are kept out of availability to the average American because of a territorially closed medical system in America, which proclaims it as the sole possessor of all valid medical skills and products; and the authorities automatically back them up without verifying those kinds of assertions, lacking means to evaluate. But Health IT might be a means to provide data for doing that kind of evaluation.

    Ultimately there needs to be a national agency for evaluating the actual efficacy of protocols for improving health, if the goal is actually to significantly improve American strength through good health. An agency free to fully and competently unbiasedly evaluate new “alternative” health modes such as those which can perform detailed evaluation utilizing a mere sample of saliva; and to competently evaluate the electro-health devices already well proven very effective by people who have actually used them for a long time, such as suppressed technologies based on the H R Clark “Zapper” and R R Rife discoveries, evaluating efficiacy without regard to what it would do to the profit bottom line of the existing pharmaceutical industry, among other currently dominant corporate interests defending their business territories from potential newcomers that might even put them out of business, or at least cut back on their profitable lines of products and services.

    The choice needs to be considered: is America’s health system to maximally enable best possible health for all Americans; or is it going to continue to focus on primarily providing maximum profits to the health industries. We have not shown much wisdom on that up to now. Health IT needs to walk a fine line to gain acceptance, balancing the health industry’s needs to make maximum profit with least effort, with the needs to strengthen the nation by enabling efficacious health for all American people.

    • Sing it, brother. The biggest barrier I see to fully enabling medicine’s customer base (commonly called patients) to manage their care is that their voice is shut out of the decision-making conversation. Cherchez l’argent: look for the money (silver) – since patients aren’t seen as the customers in health care, we’re not invited to participate other than as meat-puppets. Done-to, rather than participants, in our health.

      Who will own the records in an EMR system? Will patients be able to access them to ensure they don’t contain errors? Who will run the M&M metrics on EMR-related errors?

      What’s being called “health care reform” is really “health PAYMENT reform” – it doesn’t really address the underlying issue of declining overall health in the US. To do that, we’d have to have patients educated, empowered, and expected to manage their care. The current system, where US business is expected to foot most of the bill for US health care, doesn’t encourage that in any way. Decades of paying for health care with other-people’s-money hasn’t delivered better health care, it’s delivered a huge health-care-industrial complex – yep, just like the military-industrial complex. With the same threat to overall economic health and growth.

      Those of us able to manage our own care should be encouraged to do that. We should all be responsible for ensuring/insuring our health – if employers choose to offer us help, as a true benefit rather than as a government requirement, that’s a more sustainable model. And one that would have us making more conscious choices about our health.

      All the EMR technology in the world won’t do us any good at all if we’re not put in charge of our own health, our own records, and our own future.

  63. 4/19/11

    Office of the National Coordinator for Health Information Technology
    200 Independence Avenue, NW
    Washington, DC 20201

    NACHC’s Comments on Federal Health IT Strategy 2011 – 2015

    The National Association of Community Health Centers (NACHC) appreciates the opportunity to comment on the Federal Health IT Strategy 2011 – 2015 and is pleased to provide the Office of the National Coordinator for Health Information Technology with our comments.

    There are, at present, approximately 1200 FQHCs serving over 23 million patients nationwide through 8,000 urban and rural delivery sites. Most FQHCs receive federal grants under Section 330 of the Public Health Service (PHS) Act (42 U.S.C. 254b) from the Bureau of Primary Health Care (BPHC), within the Health Resources and Services Administration (HRSA) of HHS.

    Under this authority, health centers fall into four general categories: (1) those centers serving medically underserved areas, (2) those serving homeless populations within a particular community or geographic area, (3) those serving migrant or seasonal farm worker populations within similar community or geographic areas, and (4) those serving residents of public housing.

    To qualify as a Section 330 grantee, a health center must be located in a designated medically underserved area or serve a medically underserved population. In addition, a health center’s board of directors must be made up of at least fifty-one percent users of the health center and the health center must offer services to all persons in its area, regardless of his or her ability to pay. BPHC’s grants are intended to provide funds to assist health centers in covering the otherwise uncompensated costs of providing comprehensive preventive and primary care and enabling services to uninsured and underinsured indigent patients, as well as to maintain the health center’s infrastructure. Patients from eligible communities, who are not indigent and are able to pay or who have insurance (public or private) are expected to pay for the services rendered. Currently, 37 percent of health center patients are Medicaid recipients, 7.3 percent are Medicare beneficiaries, and 38 percent are uninsured.

    FQHCs provide comprehensive primary care services and serve as medical homes for the over 23 million patients. As such, FQHCs utilize a team model approach with primary care services provided by physicians, nurse practitioners, nurse midwives, physician assistants, case managers, health educators, and other staff. Most health centers also provide dental services and behavioral health services, and these staff are integrated into the medical team. Over seventy percent of health centers provide these services onsite.

    NACHC makes the following comments on the Federal Health Information Strategy 2011 – 2015:

    Goal I: Achieve Adoption and Information Exchange through Meaningful Use of Health IT

    OBJECTIVE A
    Accelerate adoption of electronic health records
    Strategy I.A.2: Provide implementation support to health care providers to help them adopt, implement, and use certified EHR technology

    The recognition of the HRSA Health Center Controlled Network Program (HCCNs) is an important component of this strategy. As identified later in the Strategy document on page 56

    ….Health Center Controlled Networks (HCCNs) improve operational effectiveness and clinical quality in health centers through the provision of management, financial, technology and clinical support services. An overwhelming number of community health centers who have signed on with an HCCN have successfully adopted an EHR system…..

    We encourage ONC to work with HRSA to build on this established and successful infrastructure and further develop the existing HCCNs. Programs should be developed that focus on and incentivize health centers that have not implemented EHRs to work with a HCCN. The HCCN model should be supported and other safety net and behavioral health providers encouraged to utilize HCCNs in their efforts to implement Health IT. NACHC is engaged with SAMHSA on such a project at the present time where NACHC has coordinated HCCNs providing a series of 13 webinars to behavioral health providers ranging from HIT 101 to Workflow Analysis, Contracting and Implementation to advanced uses of Health IT such as Data Warehousing. These types of activities and more intensive training and technical assistance provided by HCCNs to other safety net providers and behavioral health providers should be supported financially and implemented. The goal would be to utilize this successful infrastructure to provide the platform for these providers to implement Health IT and better serve the underserved and vulnerable populations in their care. We also request that ONC work with HRSA to financially support operational funding for the HCCNs in order to allow them to provide additional services to their members and assist them to implement more advanced Health IT functionality such as mHealth and telehealth solutions.

    HCCNs also provide the optimal training ground for the graduates who will be coming out of the Health IT Workforce Development Program. A more focused and concerted effort should be made to firmly establish HCCNs and their constituent health centers as training sites for the Community College Consortia graduates. NACHC would be happy to play a key role in coordinating this effort.

    I.A.6: Communicate the value of EHRs and the benefits of achieving meaningful use
    We are supportive of an outreach campaign to increase the awareness of the HITECH Act programs, to talk about the benefits of EHRs, educate providers around privacy and security protections, and encourage participation in the meaningful use program. NACHC recommends, however, that the outreach be done via the trusted provider associations. In California last year, the Office of Health Information Technology, contracted with outside consulting firms to build a strategy and plan for launching and building the meaningful use program in the state. One of the findings from the consultant’s research was that providers by and large are most trusting of the information provided by their trade associations. It’s likely this sentiment would extend throughout the national provider community, and we encourage the ONC to identify the national provider groups/associations and allow the nationals to formulate strategies that would best meet the needs of their respective provider communities and provide resources to support their efforts to educate providers.

    OBJECTIVE B
    Facilitate information exchange to support meaningful use of electronic health records
    Strategy I.B.2: Monitor health information exchange options and fill the gaps for providers that do not have viable options

    HCCNs can also play a significant role in assisting ONC to meet this objective. Most HCCNs have already implemented interfaces and are exchanging data with pharmacies, hospitals and other providers. Targeted initiatives to connect HCCNs with other safety net and behavioral health providers in their area can assist these providers to adopt Health IT at an accelerated pace and to begin to exchange data with hospitals, pharmacies and other providers. Most HCCNs work in collaboration with the RECs and implementing EHRs that already have the National Health Information Network Direct interfaces built in will assist in lowering the costs of exchange for these providers.

    I.B.3: Ensure the health information exchange takes place across individual exchange models, and advance health systems and data interoperability.

    CPCA, and our members, are fully supportive and appreciative of the work the ONC is spearheading in developing a standards and interoperability framework to harmonize existing standards and improve sharing of standards across different organizations and federal agencies, making it easier to broaden interoperability through shared standards for data and services. Clinics and health centers operate on thin bottom lines, and investments in IT are hard to sustain. Anything that can be done to standardize products and offerings, like interfaces, will save the safety net resources that can be better spent on patient care.

    OBJECTIVE C
    Support health IT adoption and information exchange for public health and populations with unique needs
    Strategy I.C.2: Track health disparities and promote health IT that reduces them

    NACHCs supports ONC working with states to increase medical licensure portability by streamlining licensure application and credentials verification processes so providers can more easily apply for a license in multiple states. We also urge ONC to work with HRSA to develop a report to Congress for the use of health information technology in underserved communities and we encourage ONC to work with CMS to consider changing the rules allowing for payment for telehealth services used when both the provider and the patient are in an urban area. In many urban areas, and for many vulnerable individuals, ten blocks is as much of a barrier to treatment as 60 miles in a rural area. Utilizing telehealth services in urban areas is especially necessary and beneficial for providing quality care and improved health to the underserved and vulnerable populations that FQHCs serve.

    Strategy I.C.3: Support health IT adoption and information exchange in long-term/post-acute, behavioral health, and emergency care settings

    HCCNs are a prime resource to assist with the health IT adoption and information exchange with behavioral health providers. NACHC and HCCNs are willing to work with SAMHSA and ONC to support the adoption of certified EHR technology within the behavioral health community. HCCNs have a proven track record and can assist behavioral health providers to adhere to the standards, implementation specifications, and certification criteria adopted by the Secretary and assist providers participating in the program to select certified EHR technology and participate in health information exchange.

    NACHC also applauds ONCs, HRSA and SAMHSA’s recognition that integrating behavioral health data into the primary care and related safety net systems is essential for coordinating care.

    We recognize that the issue of segmentation is not an easy one to reconcile. For example, is a note that includes treatment of a person’s diabetes and his substance abuse treatment considered a behavioral health note or a medical note? How would a provider separate the two? This situation occurs frequently in FQHCs. If a patient decides to not allow information of any kind to flow from one provider to another, it will be imperative that the receiving provider be alerted that there is additional information available which the patient will not allow to be shared, This will put the treating provider on notice that the information that was sent was incomplete and to dig further into history.

    Goal II: Improve Care, Improve Population Health, and Reduce Health Care Costs through the Use of Health IT

    OBJECTIVE A
    Support more sophisticated uses of EHRs and other health IT to improve health system performance
    Strategy II.A.2: Create administrative efficiencies to reduce cost and burden for providers, payers, and government health programs

    NACHC fully supports all efforts to reduce the burden for providers when reporting required data to federal agencies.

    OBJECTIVE B
    Better manage care, efficiency, and population health through EHR-generated reporting measures
    Strategy II.B.1: Identify specific measures that align with the National Health Care Quality Strategy and Plan

    NACHC fully supports the development of e-measures that can collect and report data through EHRs that are aligned across reporting programs to reduce the burden on providers and that can be supported by the implementation of the Medicare and Medicaid EHR Incentive Programs.

    OBJECTIVE C
    Demonstrate health IT-enabled reform of payment structures, clinical practices, and population health management
    Strategy II.C.1: Fund and administer demonstration communities to show how the advanced use of health IT can achieve measurable improvements in care, efficiency, and population health

    NACHC fully supports the idea and intent of Beacon Communities. In reviewing Beacon Community membership, however, NACHC must note that FQHCs are represented in only a few. Including FQHCs in all Beacon Communities is imperative if we are to obtain a true picture of improvements in care, efficiency and population health in any given geographic area. On average 40% of the population served by FQHCs nationally are uninsured. In some areas this average is higher. By not including an FQHC in the Beacon Community mix those communities will not have a true picture of the actual population that requires treatment and whether they are improving or not. They will not be able to identify gaps in treatment for underserved populations and invent solutions to close those gaps. We recommend that the Beacon community program be reviewed and require that at least one FQHC be included in each Community to ensure that the needs of underserved populations are included in any evaluation of improvements in efficiencies and or improvements in population health. NACHC can assist Beacon Communities in identifying FQHC partners in their areas.

    Goal III: Inspire Confidence and Trust in Health IT

    FQHCs are faced with providing coordinated primary care and behavioral health services (including alcohol and drug abuse) on a daily basis as they provide comprehensive primary care services. NACHC and FQHCs would like to continue to work with SAMHSA, ONC and OCR to address the issues of confidentiality and sharing information in an IT environment. We recommend that NACHC and/or FQHC representatives be sought out and specifically included in all discussions and planning on confidentiality issues between primary care and behavioral health.

    OBJECTIVE B
    Inform individuals of their rights and increase transparency regarding the uses of protected health information
    Strategy III.B.1: Inform individuals about their privacy and security rights and how their information may be used and shared.

    NACHC and FQHCs would like to partner with OCR and ONC to execute the education and outreach strategy to inform individuals about how their information is safeguarded, how their information may be used and shared, and how individuals can exercise their rights under the HIPAA Privacy Rule and inform individuals about best practices that they can use to protect the privacy of health data they generate or maintain in consumer health IT tools. FQHCs are medical homes for their patients and working with OCR and ONC to provide this information targeted to underserved and vulnerable populations would be more readily received from the FQHC as a trusted source and the provider of choice for these populations in their communities.

    Goal IV: Empower Individuals with Health IT to Improve their Health and the Health Care System

    We believe the wording of this goal would lead organizations and underserved populations and those without access to health information technology to believe that they will be left out of the benefits of health IT. The wording would encourage a “digital divide” between those that do have access to Health IT and those that do not. We agree with the goal of empowerment of individuals to improve their health and the health care system, however, it should include those individuals with access to and without access to health IT. Our suggestion would be to change the wording to “Empower Individuals to Improve their Health and the Health Care System by using Health IT or with the use of Health IT. This would send a clear message to those that do not currently have IT available to them that the government’s goal is to reach out and make IT available to them e.g. in libraries, schools, other public venues or at provider offices etc.

    OBJECTIVE A
    Engage individuals with health IT
    Strategy IV.A.2: Communicate with individuals openly and spread messages through existing communication networks and dialogues

    NACHC and FQHCs applaud the goal and the strategy and would like to partner with HHS on its education and outreach efforts aimed at helping people understand the transition to EHRs, the value of health IT and how health IT can be leveraged to make informed choices related to their physical and behavioral health and care. FQHCs provide an ideal existing communication network of community based organizations with strong affiliations and the trust of their patients.

    OBJECTIVE B
    Accelerate individual and caregiver access to their electronic health information in a format they can use and reuse
    Strategy IV.B.3: Establish public policies that foster individual and caregiver access to their health information while protecting privacy and security

    We encourage ONC to consider accelerating programs that will accommodate the range of user capabilities, languages and access considerations, including effective strategies for ensuring accessibility and usability of electronic health information for people with disabilities and meaningful access to such information for individuals with limited English proficiency. This is especially necessary for FQHCs who are dealing with patients from many different languages on a daily basis. FQHCs require solutions at the present time and five years is a long way to wait for them to have the tools necessary to communicate with their patients. Currently, FQHCs serve 1 in 8 of all Latinos patients.. We recommend a pilot or demonstration projects targeted to FQHCs that can be quickly expanded.

    Goal V: Achieve Rapid Learning and Technological Advancement

    OBJECTIVE A
    Lead the creation of a learning health system to support quality, research, and public and population health
    Strategy V.A.3: Engage patients, providers, researchers, and institutions to exchange information through the learning health system

    For many of the reasons identified in the Strategy NACHC is engaged in developing a Comprehensive HIT Strategy for health centers. This plan will assist and encourage health centers to exchange information among each other and to share information with their local system as well. NACHC welcomes the opportunity to work with ONC to accelerate information sharing in FQHCs.

    Strategy V.A.4: Grow the learning health system by adding more members and expanding policies and standards as needed

    HCCNs provide an ideal opportunity to leverage already existing infrastructures and to add large numbers of provider organizations and thereby add significantly to the learning health system. Targeted investment in the NACHC Comprehensive HIT Plan which focuses on utilizing the HCCNs as its base can move these initiatives forward. NACHC and the HCCNs would like to engage with ONC to discuss how additional resources can be utilized to move this forward more rapidly.

    Strategy V.B.3: Employ government programs and services as test beds for innovative health IT.

    Innovation in health IT should include all individuals and not leave out vulnerable or underserved populations. FQHCs provide excellent test beds for innovative health IT. We encourage ONC to work with NACHC and the HCCNs to drive innovative health IT which can be targeted to underserved populations. Innovations targeted to these populations can have significant benefits for quality and lowering the costs of health care for all Americans.

    Acknowledge the transition from ‘doctor – patient’ care to ‘health team – patient’ care.

    There are numerous references throughout the Plan to patient centered health care. We acknowledge and appreciate these references because it highlights that the ONC is aware of the move in the health care industry away from a provider to patient delivery model to a more team oriented, coordinated care approach to health. FQHCs have fully embraced this model for some time. Our members are of course building on their existing delivery systems and aligning with the array of the patient-centered health home certifications, however the foundation of the clinic and health center model is a team based approach. One example of this team based model is the clinic billing model; the clinic or health center as a legal entity bills for a patient visit, rather than the individual provider billing, and it is the clinic or health center that receives reimbursement for the visit. Within that one visit there are multiple staff that touch the patient, be it through dietary counseling, transportation to and from the site, and social service linkages.

    This distinction on billing is important, and we believe this distinction has been overlooked by ONC and CMS in the creation of two of the main health IT regulations: meaningful use and the regional extension centers (RECs). Both meaningful use and the RECs are programs targeted at providers (eligible professionals and priority primary care providers). This targeting of resources directly at providers has and continues to create a tremendous amount of complication and confusion, mainly as it relates to Medicaid Meaningful Use Incentives. We understand that the original statute targeted providers, however, we believe that the regulations could have provided avenues to make participation in these programs, particularly meaningful use, more seamless for entities that contract or employ with providers and bill on their behalf. Reassignment of the incentive payments alone is not sufficient to solve the dilemma faced by health centers. There are issues with reassignment, proving of costs, proving adoption/ implementation/ upgrading, proving eligibility, all of which are complicated because the rule is targeted at individual providers. We appreciate the clarifications provided by CMS around group proxy eligibility and that CMS will be creating third party registration capabilities. These complications could be lessened in the future if both the ONC and CMS crafted regulations on the front end that were more inclusive of the entities that employ/contract with providers and bill on the providers behalf. It should not be a state’s choice to implement group functionalities or third party systems, but rather a requirement.

    As health care continues to move into a more team oriented coordinated delivery system, it is important that the national health leadership recognizes the transition and creates programs that are supportive of this movement.

    We would like to thank ONC for the opportunity to comment on the Federal Health IT Strategy 2011 – 2015. NACHC is interested in continuing to engage with ONC and other federal partners in furthering the goals of this Strategy.

    Sincerely,

    Michael R. Lardiere, LCSW
    Director Health Information Technology
    Sr. Advisor Behavioral Heath
    National Association of Community Health Centers

    Roger Schwartz, Esq.
    Associate Vice President, Executive Branch Liaison
    Legislative Counsel

    Submited via: the Health IT Buzz Blog: http://www.healthit.gov/buzz-blog/from-the-onc-desk/hit-strat-plan/.

  64. Catherine says:

    This program fails us, as patients, as follows and more:
    1) not enough patient involvement
    2) patient has no control or involvement in the his/her data dissemination
    3) not secure enough
    4) has insufficient disclosure to patient as to whom has accessed or accessed patients’ records and data (this will be a huge issue as our private data is sold to labs, researchers, marketers, manufacturers, etc.)
    5) is not private enough
    6) no opt out provision
    7) no monetary incentive to patients for use and resale of their data (yet billions to doctors and hospitals – why is that?)
    8) there are already charts in place (more will follow) that will separate patients into categories, affecting them in various ways that are not all good
    9) insufficient checks to safeguard against fraudulent access/use of data
    This program fails us, as Americans, as follows:
    1) does not protect well enough our rights to privacy
    2) does not respect our consitutional right to speech when it fails to allow us to opt out of the program
    3) wastes literally billions of tax dollars via excessive incentives to doctors and hospitals
    4) offers billions of dollars to doctors and the medical world, but not one incentive penny to the patients whose records will be used, sold and manipulated by others.
    5) not enough sunshine on the matter, too many important details buried in the fine print.
    While commendable on the surface, this program is beyond flawed and is not ready to be implemented — yet that has already happened, has it not? These are not minor issues either. This program already fails us, as patients, at crazy costs to taxpayers IMHO.

  65. The scope of this strategic plan is far too ambitious for such a short timeline. Physicians are the key healthcare decision-makers, and although practices are consolidating, most are still small group practices. Keep the strategic plan smaller in scope and more realisitic, and reduce the amount of Federal Government expenditure on this project.

    For example, the government should set up a free, bullet-proof, easy to use claims clearinghouse. Give the software away to all healthcare providers and insurers. Also build an eliegiblity checking feature and give that away as well. It would be wonderful if you could check all major insurers for patient eligibility and effective dates of coverage from one place.

    If you mandate usage for something that is easy to use and free, you can realistically gain technology acceptance and near-uniformity over time. This will start getting the costs out of the system from lack of standardization.

  66. On behalf of the 60,000 primary care pediatricians, pediatric medical subspecialists, and surgical specialists of the American Academy of Pediatrics who are committed to the attainment of optimal physical, mental and social health and well-being for all infants, children, adolescents, and young adults, thank you for the opportunity to respond to your request for comments on the draft Federal Health IT Strategic Plan. The Academy is committed to the meaningful adoption of Health Information Technology (HIT) for improving the quality and safety of care for children.

    General Comments

    While the draft strategic plan’s focus on outcomes is laudable, the outcomes that are most often cited relate to short-term successes in adult chronic care. As health data collection is most effective when it begins at birth, the Academy encourages ONC to also consider the longer-term benefits of high-quality pediatric care, which will ultimately lead to the development of healthy adults. Health IT must support the provision of high-quality pediatric care and then support the extension of that care through the lifespan.

    As many physicians are not yet convinced of the capacity of health IT to support such improvements in the quality and efficiency of health care, the Academy encourages more and better research in order to “build boldly on what works” to assure both the public and physicians that ongoing activities are successful. Success stories in all care settings, from small ambulatory practices to large integrated health care systems must be widely promoted to enable physicians to learn from the successes of their peers. Efforts must be made to improve the usability of health IT systems and to ensure that physicians are adequately trained in the efficient use of such systems. Systems must allow patient information to be summarized and reported easily to enable care coordination, research, and quality improvement.

    The Academy applauds your principles of putting patients first and encouraging innovation. In order to accomplish these goals, administrative barriers must be minimized. The Academy encourages the availability of grant funding for research, development, and testing of innovative tools to support improved health care quality and efficiency.

    The Academy cautions that overly ambitious timelines can lead to costly failures and work against the principle of stewardship of the country’s money and trust.

    Goal I Comments

    Pediatric practices are at a disadvantage when it comes to qualifying for financial incentives because only about half will meet the 20% threshold of Medicaid patients. At the same time, pediatricians do not typically see Medicare patients. The Academy encourages private payers to provide additional financial incentives to physicians to support adoption of certified EHR technology.

    The Academy supports the strategy of encouraging and facilitating improved usability in EHRs. This effort will help assuage the concerns of many physicians that implementing an EHR cost them in terms of practice efficiency. The Academy encourages the Office of the National Coordinator (ONC) to establish certification criteria for usability and to publicize and reward systems that maximize usability and efficiency based on real-life physician workflows.

    The Academy is concerned that the use of health information exchange is progressing slowly and based on each vendor developing interfaces to specific labs, hospital systems, and regional health information exchanges. Such interfaces are often offered to physicians at an additional cost that may be more than a small practice can bear. The Academy encourages the ONC to promote best practices, require labs to adhere to data exchange standards that EHR vendors are required to follow, and publicize success stories to educate physicians on the real-life use of health information exchange to improve health care quality and efficiency. In addition, pediatricians face significant barriers to the effective use of state immunization information systems (IIS). These barriers include lack of funding for the IIS to implement data exchange standards and local political and regulatory issues around the sharing of patient immunization data.

    Meaningful Use Stage 1 has made some significant advances toward supporting the medical home; for example, requiring the maintenance of a problem list. However, the current measures lean heavily on the assumption that the physician is an adult primary care physician. The medical home concept is important for children and in pediatric specialty care. The Academy recommends the use of incentives to encourage coordinated care in these environments as well.

    Barriers to effective health information exchange in pediatrics include:
    • The need to exchange child health data with schools and child care settings;
    • Limited ability to exchange data with state immunization information systems;
    • Limited use of clinical data summaries for care coordination purposes;
    • Financial investment required to develop interfaces, even within the context of a regional health information exchange;

    Many of these barriers require involvement beyond that of the individual physician, practice or hospital and the EHR. Often, regulatory and political factors impede progress that data exchange standards and EHR certification might otherwise make. The Academy recommends that strategies to encourage health information exchange also address barriers at the state and local level.

    We believe that communication between pediatricians and public health agencies is critical to improving child health through health information exchange. The Academy encourages the development of certification criteria and information exchange standards that will allow patient data to be submitted to public health agencies without requiring an additional step by the physician.

    The development of robust information networks which have the capability to exchange data from health-related agencies such as Child Protective services, state registries for newborn screening for metabolic disease and hearing, lead screening, school attendance records, etc are important for the tracking of health of the most vulnerable population, our children. Due to our highly mobile society, the need to share this data over the entire is imperative.

    The Academy notes that, in addition to direct data exchange with public health agencies, physicians also must be able to exchange patient medication with pharmacy systems. Primary care physicians must receive summary reports, including any medications prescribed, from emergency departments and behavioral health providers.

    Goal II Comments

    The Academy supports these objectives and associated strategies. However, the limited availability of appropriate quality measures of both process and outcomes in child health creates a barrier to achieving this goal. Administrative efficiencies achieved through health IT will be most effective if paired with physician payment reform to ensure that physicians are paid appropriately for all the work that they do.

    We strongly urge that certified EHR technology be capable of generating the required reports with a minimum of effort by the physician. As stated above, these strategies will be most effective if aligned with physician payment reform efforts.

    The Academy encourages ONC to ensure that pediatricians and pediatric practices are included in demonstration and pilot projects. Pediatricians must have the opportunity to share in a defined financial arrangement to encourage the use of quality indicators which will ultimately lead to reduced costs. It must be financially viable for pediatricians to participate in health care redesign efforts.

    The Academy supports the provision of grants through federal agencies to support the strategies above and encourages the inclusion of pediatricians and pediatric informaticians in the development of these new approaches.

    Goal III Comments

    Privacy and security issues are poorly developed in areas such as school health, foster care, adoption, adolescence, and maternal-fetal health. Additionally, there is a poor scientific evidence base on what is good security and privacy. For example, it is doubtful that forcing individuals to change passwords every 3 months improves security and privacy. A better evidence base is needed.

    The Academy believes that most physicians rely on their health IT vendor to ensure that their systems are compliant with privacy and security regulations and will serve the needs of their patients. Therefore, the Academy supports the need for EHR certification criteria to support appropriate privacy and security protections.

    While the Academy recognizes the need to safeguard patient health information, our members continue to report difficulties in receiving the necessary communications from other healthcare providers in order to effectively coordinate care. Ongoing education of all health care professionals, along with improved functionality through health information technology systems, can improve patient privacy and security while reducing administrative barriers for physicians.

    It is critical to monitor the safety issues of increased implementation of HIT and especially its impact on children. Children are not just small adults, but frequently health IT systems are designed for adults and implemented in settings where children receive care, including community hospitals and emergency departments. Inadequate or incorrect algorithms for weight-based dosing and other forms of clinical decision support can increase the risk of, or actually cause, serious errors when caring for pediatric patients.

    Goal IV Comments

    The Academy supports the family-centered medical home model of care, in which pediatricians and families work together to meet the healthcare needs of a child. This objective is well-aligned with the goals of the family-centered medical home. However, several barriers will need to be addressed in implementing the identified strategies:
    • Health IT can be extremely effective in engaging adolescent patients in their own healthcare; however, difficulties in appropriately protecting the privacy of adolescent patients while allowing their parents access to some of the information in the patient’s record often means that adolescents are excluded from using tools such as patient portals.
    • Often the most vulnerable populations have the least access to technology. To fully engage these populations, mechanisms must be in place to provide them with appropriate Internet access. In addition, educational resources developed at appropriate literacy levels must be available.

    There remains ambiguity as to how parents and their children access personal health records and online portals. This is especially problematic as children transition through adolescence to adulthood. Notions like separate parent and child access to the child’s health information should be explored.

    In addition to incentive payments through Medicare and Medicaid, private payers should be encouraged to provide incentives to physicians who provide electronic access to patient health information. Electronic patient portals are frequently available only at an additional cost to the physician or practice, with no direct compensation offered to recoup the investment.

    The Academy supports the use of consumer health IT and other tools to enable patients and families to take a more active role in their own care. We recommend that appropriate standards be developed so that such data can be imported into the EHR with a minimum of effort by the physician, while appropriate documentation of the source of such data.

    Goal V Comments

    The Academy supports the development of a learning health system that includes child health care providers and children’s hospitals.

    The Academy supports efforts to increase innovation and research in health IT. We recommend:
    • That pediatricians and pediatric informaticians be included in research efforts.
    • That research be conducted into the usability of EHRs to support health care professional workflow at the point of the care.
    • As it becomes more common for public health agencies to monitor deidentified data for early warning of problems and trends, children and child health issues must be included in such efforts. Social markers must be studied in addition to illness markers.

  67. David Fisher says:

    April 19, 2011
    U.S. Department of Health and Human Services
    Office of the National Coordinator for Health Information Technology

    RE: Federal Health IT Strategic Plan: 2011-2015

    Dear Sir/Madam:

    This letter represents the comments of the Medical Imaging & Technology Alliance (MITA), and comes in response to the Notice in the Federal Register, 76 FR 17419, March 29, 2011, which is seeking comments on the proposed Federal Health Information Technology Strategic Plan for
    2011-2015.

    The intent of the proposed Strategic Plan is to update the current 2008 Federal Health IT Strategic Plan. Section 3001(c)(3) of the Public Health Service Act requires the Office of the National Coordinator for Health Information Technology (ONC) to update the 2008 Federal Health IT Strategic Plan in consultation with other appropriate Federal agencies, and in collaboration with private and public entities.

    The proposed Strategic Plan states that achieving adoption and information exchange through meaningful use of health IT is the “centerpiece of the government’s health IT strategy over the next five years.” As stated in the proposed Strategic Plan, ONC intends to focus on adoption and information exchange in Stage 1 and Stage 2 of “meaningful use,” with the aim of achieving improved health outcomes in Stage 3 of “meaningful use.”
    MITA supports the achievement and adoption of information exchange through “meaningful use of health IT.

    However, the proposed Strategic Plan is flawed because ONC has failed to incorporate the communication of imaging information, as a vital component of the Strategic Plan to fulfill the goal of achieving information exchange through the “meaningful use” of healthcare information technology. In fact, the communication of imaging information between providers has not been explicitly mentioned in the proposed Strategic Plan. MITA believes this is a major omission and is inconsistent with ONC’s strategic goals.

    MITA manufacturers, in collaboration with the American College of Radiology (ACR), created the Digital Imaging and Communications in Medicine (DICOM) Standard, which is the standard for the communication of images and imaging information. MITA manages, deploys and tests the DICOM Standard on an ongoing basis in order to serve changing clinical needs. In the U.S. market, over 99.5% of imaging systems shipped today include DICOM capability. The DICOM Standard has been accepted nearly universally and is available now for implementation.

    MITA is the medical division of the National Electrical Manufacturers Association (NEMA). MITA member companies manufacture medical products and services which are essential to the sharing of images, including: Imaging modalities, Picture Archiving and Communication Systems (PACS), Radiology Information Systems (RIS) and Hospital Information Systems (HIS). MITA appreciates the opportunity to share our views with you. Our
    specific comments on the proposed Federal Health Information Technology Strategic Plan for 2011-2015 are set forth below.

    Specific Comments

    The Office of National Coordinator has established five goals
    in its proposed Strategic Plan for 2011-2015. These goals are:

    1. Goal I: Achieve Adoption and Information Exchange through Meaningful Use of Health IT;

    2. Goal II: Improve Care, Improve Population Health, and Reduce Health Care Costs through the Use of Health IT;

    3. Goal III: Inspire Confidence and Trust in Health IT;

    4. Goal IV: Empower Individuals with Health IT to Improve their Health and the Health Care System; and

    5. Goal V: Achieve Rapid Learning and Technological Advancement.

    We will provide comments below on “Goal I: Achieve Adoption and Information Exchange through Meaningful Use of Health IT.”

    Goal I: Achieve Adoption and Information Exchange through Meaningful Use of Health IT”

    ONC states that, “The first priority in realizing the benefits of health IT is to achieve nationwide adoption of EHRs and widespread information exchange.”

    MITA Response:

    In the proposed Strategic Plan, ONC has failed to recognize the currently existing capabilities of the DICOM Standard and its critical role in exchange of imaging information. Imaging information is a critical piece of a patient’s health information, and thus must be included as a
    vital component of the electronic health record. Achievement of a complete electronic health record (EHR) will not be possible unless imaging
    information becomes an integral part of the EHR. The failure to incorporate imaging information in the EHR, will impede, rather than facilitate, the realization of the benefits of health information technology.

    Goal I: Objective B; Facilitate information exchange to support meaningful use of electronic health records

    Objective B, under Goal I, states that:
    “For future stages of meaningful use, the plan is to propose health information exchange and interoperability requirements that are more rigorous, so that patient information follows patients to the point of care and informs critical health decisions.”

    MITA Response:

    Imaging information is key to clinical practice and is essential to informing critical healthcare decisions, and enabling the provider to make a complete diagnosis. The availability of imaging information will result in more efficient care by helping to reduce the incidence of duplicative
    imaging examinations, with their associated burdens, costs and potential for increased radiation exposure.

    To realize efficiencies in the delivery of care to patients, comprehensive patient information, including laboratory results, clinical findings and imaging information should be available to the provider at the point of care whenever they are needed. The DICOM Standard is an essential
    tool to achieve this capability.

    “Goal I: Strategy I.B.1 – Foster business models that create health information exchange”

    Under Strategy I.B.1, ONC states that: “For as many providers as possible, the first priority is finding the right combination of already available exchange models that will enable them to electronically exchange lab results, patient care summaries, and medication histories.”

    MITA Response:

    MITA supports the achievement of the capability for the electronic exchange of laboratory results, patient care summaries and medication histories. However, the failure of the proposed Strategic Plan to include the capability of the exchange of imaging information, along with
    laboratory results, patient care summaries and medication histories, is a critical error. Provider access to imaging information, as well as laboratory results, patient care summaries and medication histories, is essential to the delivery of good patient care. As stated previously, the
    DICOM Standard, and other standards-based tools, are already available and in widespread use to enable the exchange of imaging information.

    “Goal I: Strategy I.B.3 – Ensure that health information exchange takes place across individual exchange models, and advance health systems and data interoperability”

    ONC states that Strategy I.B.3 recognizes the importance of utilizing the experience and leadership of federal agencies and private sector standards development organizations. Accordingly, as part of this strategy, ONC states that it intends to leverage existing standards and standards processes where possible.

    MITA Response:

    MITA agrees that utilizing the experience and leadership of federal agencies and private sector standards development organizations to achieve health information exchange is critically important. However, ONC has failed to make use of the extensive experience and expertise of MITA as a standards development organization in the planning, deployment and testing of the
    DICOM Standard, and to leverage existing standards such as DICOM to ensure health information exchange and to advance data interoperability. MITA is the leader in the management, deployment and maintenance of the DICOM Standard. Active MITA participation is key to the successful implementation of the DICOM Standard, and advancing achievement of data interoperability. MITA can play a valuable role in enabling the DICOM Standard to facilitate data interoperability.

    MITA Recommendations

    MITA believes that the following steps should be taken to ensure that ONC will successfully achieve its goals and objectives under the proposed Federal Health IT Strategic Plan for 2011-2015:

    1. The Strategic Plan should be revised to fully recognize the importance of the communication of imaging information through the DICOM Standard, and other standards-based tools, as an integral part of the exchange of clinical information.

    2. Representatives of medical imaging device manufacturers, information technology companies, and those organizations with expertise in the creation, adoption and testing of the DICOM Standard, others standards-based tools, and health data infrastructure, should be included as active participants in the strategic planning process for the planning,
    development, deployment and testing of the necessary data exchange models to facilitate achievement of the Nationwide Health Information Network.

    Conclusion

    Communication of imaging information must be incorporated as an integral part of the Strategic Plan to ensure that the capability of providers to exchange critical clinical information is achieved, through the use of the DICOM Standard and other standards-based tools. MITA and other key stakeholders must become active participants in the strategic planning process to ensure that the necessary steps to achieve this capability will be taken in a careful and coordinated manner.

  68. Anthelio Healthcare Solutions’ response to the Federal Health Information Technology Strategic Plan 2011-2015:

    Anthelio Healthcare Solutions is pleased to submit comments concerning the ONC’s Federal HIT Strategic Plan. We applaud the efforts of the ONC and are pleased to see a national focus on patient care. We agree with Dr. Blumenthal in his message in his recent post in HealthITBuzz, ONC Seeks Public Comment on the Federal health It Strategic Plan: 2011-2015, as found here: http://www.healthit.gov/buzz-blog/from-the-onc-desk/hit-strat-plan/ . Specifically, we agree that it has been a fundamental time for health care with the HITECH portion of the ARRA and the Affordable Care Act being recently put into place. We look forward to continued growth within the industry as we still have a long way to go to achieve healthcare that is patient centered, evidence based, affordable, efficient and equitable. We strongly agree with Dr. Blumenthal in that meaningful use is necessary, but not sufficient enough to harness the power of health IT to transform health care over the next five years.

    It’s our concern that the strategic plan, much like the meaningful use requirements, paints a laudable vision without a clear plan for accomplishment, from a financial standpoint. During a time when many hospitals are struggling to survive, where physicians are looking at the looming Medicare and Medicaid cuts with a sense of doom and where we expect a shortage of physicians, particularly in primary care in the coming years; a clear plan to pay for accomplishing the tasks ahead of us needs to go hand in hand with the strategy itself.

    The plan addresses the money that was put into Medicare and Medicaid to reward meaningful use of electronic health records, but fails to mention that the investment needed by most hospitals to achieve meaningful use today far exceeds what they will receive in incentive payments. Note that there was only brief mention made of the PCAST report, which implied that the government’s vision is noble, but that our current methods of trying to achieve that vision may not be on the right track.

    While the ONC is taking steps in the right direction in regards to developing the plan, measurement remains to be a major shortcoming throughout. Simply put, there is a lot of what, but not much how.

    Here are Anthelio’s thoughts on the following focal points, as drawn from the plan:

    ELECTRONIC HEALTH INFORMATION
    In Dr. Blumenthal’s piece, he argues that electronic health information is the “lifeblood” of Modern Healthcare. While that’s true, we need to figure out a way to keep that lifeblood flowing. If the government intends to be a worthy steward of the country’s money and trust, as they indicate in their federal Health IT Principles, they must further convince us that the current investments hospitals are making are on track. We have seen hospitals buy into the idea that a single certified EHR vendor will get them to the Promised Land only to realize that the additional dollars needed to be invested, after they thought they were almost there can be a show stopper and potentially, a door closer.

    HEALTH CARE COSTS
    Goal II of the plan discusses the reduction of health care costs through the use of health IT. Though this can and should be accomplished, it can’t be done through health IT alone. For too long our processes have been broken. The implication that health IT will reduce health care costs is misleading. IT along with significant process re-engineering, a smart approach to efficient use of labor and the appropriate use of health care services by consumers is what will ultimately cut costs. We would like to see a method put into place to measure the reduction of costs relative to changes that are put in place.

    PATIENT INTEREST
    There is a disconnect in the plan concerning individuals and their interests, while focusing on outcomes and improving population health. The two don’t necessarily go hand in hand. The idea of improving population health through the use of evidence based medicine and the emergence of equitable care is a healthy one, but let’s be careful not to overstate individual interests. Protecting the rights of each individual is important but meeting the needs of each individual is subject to interpretation.

    INNOVATION
    Innovation is fundamental, but we’re concerned by the lack of it in the rapid implementation of “one size fits all” solutions in many hospitals and health systems. As was implied in the PCAST report, a large amount of money is being spent by hospitals in trying to achieve meaningful use, but not enough thought is going into the bigger picture, potentially causing dollars to be spent now for processes that may need to be undone in the future. Incentives are still not appropriately aligned to achieve our end goals.

    ELECTRONIC MEDICATION RECONCILIATION
    Electronic medication reconciliation to reduce unnecessary hospitalizations is spot-on, but a clear plan is necessary to measure the effect and to sort out what benefits we get from an electronic process compared to paper based medication reconciliation.

    REGIONAL EXTENSION CENTERS
    There is a lot of credence paid to the creation of the Regional Extension Centers in the plan. Again, we need to measure their success.

    MEANINGFUL USE REWARDS
    The mention of private insurers mirroring Medicare with rewards for meaningful use is noteworthy. We would like to see steps toward legislation to make that happen. With more potential cuts in Medicare on the horizon, others will need to carry some of the ball.

    ELECTRONIC HEALTH RECORDS
    The efforts toward making EHRs more usable are noteworthy and necessary. We agree with comments that point out that many EHRs on the market are not meeting our needs, but are being pushed anyway, despite the possible cost prohibitive repercussions. Healthcare organizations need to be educated on EHR systems and what makes some more usable than others. . Additionally, more discussion about the role of personal health records is vital, as is more discussion about the potential use of open source. Clearer steps need to be put in place to measure the return on our investment.

  69. The American Association of People with Disabilities (AAPD) is pleased at the opportunity to comment on the Federal Health Information Technology Strategic Plan for 2011-2015 as developed by the Office of the National Coordinator for Health Information Technology (ONC).

    Comment re Strategy I.A.3: We are pleased to see development of a trained workforce to implement and use health IT as part of the plan. We urge efforts be undertaken to ensure students with disabilities at community colleges and universities are recruited into the programs cited in the Strategic Plan (page 12). We note that students with disabilities are more likely to enroll in community colleges since these are often more affordable and flexible environments for learning as such students are often already struggling with higher living and insurance costs, assistive technology expenses, and skyrocketing medical fees. This may also be another way to help sustain the government’s commitment to reducing the extraordinary high levels of unemployment that people with disabilities experience.

    Comment re Strategy I.A.5: We continue to urge that certification of EHR technology – and other HIT technologies — evolve in future rulemakings to incorporate directly the accessibility and usability needs of people with disabilities –such as people with sensory disabilities and people with intellectual disabilities — to ensure meaningful use for both consumers of health care and for health care workers using EHR and other HIT technologies. We have previously made recommendations for use of Section 508 standards and other emerging communications standards, depending on what technologies are used for the purpose of HIT usability (and which includes accessibility).

    Comment re Strategy I.A.6 and I.A.9: We encourage education of providers about privacy and security protections as they relate to EHRs and other health IT with specific reference to the privacy needs of people with disabilities. Full implementation of the Americans with Disabilities Act is still occurring and there remains much discrimination, stigma, prejudice, bias and misinformation about people with disabilities. Privacy and security education must be targeted to all levels of staff to avoid creating new forms of discrimination.

    Comment re Strategy I.B.3: We support advancing health information exchange across models and interoperability of health data systems for the purposes of empowering consumers with disabilities. However, as we also mentioned in our comments in January 2011 on the report of the President’s Council of Advisors on Science and Technology (PCAST), dated December 2010 (“PCast Report”), we continue to raise caution about use of a standards and interoperability framework involving metadata transport standards that is not first and foremost consumer-centered and focused. We remain deeply concerned about how health information within a common infrastructure is shared, by whom and under what authority. That is, the privacy and security of health information records within such a searchable infrastructure and how it is managed is of central concern to consumers with disabilities. Therefore we continue to urge caution and a strict regard for the civil rights of consumers who expect their health care records to not be widely available for searching and who see themselves as “the owners” their medical records.

    Comment re Strategy I.C.3: We support health IT adoption and information exchange in long-term/post acute, behavioral health and emergency care settings that will lead to better coordination of care. However, we believe that the range of providers should be expanded to the full range of entities that support the health care of people with disabilities such as rehabilitation service providers and the various clinicians (e.g., in the fields of occupational, speech and physical therapy, in assistive technology, mental health services, and related disability-specific providers).

    Comment Re Strategy II. A 1: We are concerned about the HITRC and REC programs that would make “patient registries” available to providers throughout the country. While we do not fully understand the scope of what these registries would contain and therefore recommend extensive discussion about such a tool, we believe there are serious privacy concerns. These could be highly sensitive databases for many in our disability community, such as people with mental health conditions, people who are HIV+, people with communicable diseases, and others for whom there remains much stigma. We note also that updating and maintaining ‘registries’ of people and their medical conditions can be problematic and labor intensive over time and the information is only as good as it is fresh.

    Comment Re Strategy II.C.1: While we support dissemination of the key findings from the Beacon Communities that will identify and show improvement on care, efficiency and population health outcomes through the use of HIT and how this will be incorporated into guidance for RECs, state HIE programs and meaningful use proposed objectives, AAPD would like to see such findings and guidance better disseminated as knowledge also transferred to our disability communities. With consumer education and awareness activities on improved care, efficiency and population health outcomes due to HIT, there will more likely be more trust developed and faster adoption of EMRs, PHRs and related electronic systems.

    Comment Re Strategy III.A.1: We fully support the crafting of rules that would impose direct liability on business associates for compliance with provisions of the HIPAA Privacy and Security rules. We endorse establishing new restrictions on disclosing health information for marketing purposes, and recommend a default approach where there is no marketing without consumer opt-in. We support efforts to ensure increased transparency regarding how health information is disclosed; for instance we recommend notifications when and where information is shared by providers and automatic and swift notification to consumers of health care by the provider when breaches of records occur. We encourage greater specificity of the conditions when providers of health care must notify individuals during breaches, and recommend a deadline of within a month of the breach, for instance, and that such notifications should be in very easy-to-understand language and include an 800 number for concerns by consumers.

    Comment Re Strategy III.A.2. We fully support enforcement of existing federal privacy and security laws and maintenance of consistency with federal policy. This is essential for consumers with disabilities who may have, or could experience, discrimination as a result of violation of these laws. We would support efforts by OCR to conduct periodic and random audits to assess covered entities’ and business associates compliance with HIPAA rules.

    Comment Re Objective B in Goal III to inform individuals of their rights and increase transparency regarding the uses of protected health information. We support strongly all three Strategies in this section.

    Comment re Goal IV Objective A: We do not believe sufficient or enough effort has been undertaken so far to engage individuals with disabilities in health IT policies, programs and efforts. We urge greater effort be made and targeted to different constituencies within the disability community such as with service provider organizations, rehabilitation providers, advocacy and membership organizations and with coalitions working on disability policy. We recommend funds be allocated so that awareness, education and outreach efforts can be undertaken by the trusted advocacy and membership organizations in our community so that individuals with disabilities, their family members and representatives, can better understand EHRs, the value of Health IT and how Health IT can be leveraged for informed choices and better health outcomes.

    Comment re Strategy IV.B.3: We fully support the proposals to establish public policies that foster individual and caregiver access to their health information such as ways to enable individuals to directly access laboratory and test results and other health care information within an electronic medical record system. We encourage use of links to summary or explanatory information within the health care technology ecosystem. We note that people with disabilities and the elderly often do not have computers and/or broadband availability so will rely on their health care providers for information. We endorse fully the proposal to accommodate the full range of user capabilities, including strategies for ensuring accessibility and usability of electronic health information for people with disabilities. We note that accessibility and usability are two different functionalities and one does not necessarily include the other. That is, accessibility may be provided but it is effectively unusable, such as in the case of expensive assistive technology work-arounds or “special” processes or equipment required. We also take issue with health information technology developers and deployers who assert that “making things accessible to people with disabilities stifles innovation.” We believe making things accessible, and usable, REQUIRES innovation on the part of developers and deployers. Ref here to Strategy V.B.5 in regard to protecting individuals, which seems to assume also that the health IT industry, in protecting individuals, will suffer stifling of innovation.

    Additionally, in regard to the domains discussed, the one regarding “Patient health outcomes” should be better formulated. That is, “when measures are developed to assess the degree to which the care provided affects disease/disability,” we believe this would lead to a confounding of outcomes as disease and disability are not necessarily correlated or connected. For instance, a person with a severe disability such as cerebral palsy may be very healthy and without disease. Likewise, a person with a disease may not have functional limitations that amount to a disability. We recommend that outcomes can be better measured if these two notions are separated.

    END

    • Diane Greig says:

      I agree with the important distinction between disease and disability.
      In fact, let me suggest another word to unify the two. The word CONDITION is more neutral and all of these categories neccessitate further explantion anyway.
      The additional benefit of being able to address WELLNESS with the word condition is a huge plus. Is wellness not the ultimate outcome?
      Language is so very important that it can actually guide us all to our goal in addition to include and empower all at the same time.
      Refuse vs. decline.
      Complain vs. describe.
      You get the idea.

  70. Mark Segal, PhD says:

    Please see the following comments regarding the “Federal Health IT Strategic Plan: 2011-2015″ respectfully submitted on behalf of GE Healthcare (GEHC), GEHC’s healthcare information technology (HIT) products cover a broad span of clinical, administrative, and financial applications serving customers that range from small physician practices to large enterprises and integrated delivery networks. GEHC is passionate about how electronic health records (EHRs), health information exchnage (HIE) and other HIT can enhance healthcare quality and efficiency.

    General Comments

    We agree that electronic health information is the “lifeblood” of modern health care and support the plan’s five goals. We support the need for a plan that spans federal efforts and suggest strengthening ONC’s role in coordinating and aligning across disparate federal efforts. We also agree that adoption and “meaningful use” of EHRs is the appropriate “unifying focal point” for ONC efforts. We emphasize that the promise of EHRs and other initiatives, such as health information exchange (HIE), expands beyond “meaningful use” (MU) and urge ONC to take a broader view of the opportunity for these tools. For HIE, it is important to view investment as akin to the creation of the Interstate Highway system, with a focus beyond the initial stages of meaningful use. Finally, the Strategy Map is an excellent visualization of where we need to go and the six principles supporting this vision are excellent.

    Specific Comments

    Goal 1: Achieve Adoption and Information Exchange through Meaningful Use of Health IT. The goal, strategies and objectives are appropriate and we highlight the importance of Strategy I.A.7/8 on aligning across federal programs and private payers. Also, Strategy I.A.9, on usability, should be done in a way that does not hinder innovation nor create federal dictates for EHR interfaces or architecture and that uses valid and reliable measures that enhance and do not interfere with the EHR technology market.

    For Objective B, facilitating information exchange to support MU, we agree with plans for more robust and rigorous HIE use later MU stages and urge ONC to build from the proven base of standards-based HIE, with a rapid shift to bi-directional and robust HIE that supports “pull” and query as well as “push”. We agree with the importance of ONC’s Standards and Interoperability Framework, which should rely on broad-based, consensus driven standards and standards-processes. Although we support meta-data tagging of healthcare data, we urge caution in pursuing the specific PCAST approaches. HL7 CDA documents, like the CCD, provide a robust approach to meta-tagged data. Please see recent EHR Association analyses on this issue, here and here.

    Goal 2: Improve Care, Improve Population Health, and Reduce Health Care Costs through the Use of Health IT – We agree with the importance of HIT to increase individual and population health, improve outcomes, and increase efficiency, using tools like clinical decision support, quality measurement/reporting, and analytics. Although we agree with the importance of HIT for administrative simplification, MU is not the best vehicle to promote these proven tools.

    Goal 3: Inspire Confidence and Trust in Health is a critical area, with generally appropriate objectives and strategies. It will be essential that this effort strikes the right balance between protection and practicality so as not to hinder development and use of HIT to achieve the best healthcare outcomes. For example, ONC should not insert itself into contracting between providers and vendors. We do agree with the balanced approach to patient safety in the plan and welcome IOM’s work in this area.

    Goal 4: Empower Individuals with Health IT to Improve their Health and the Health Care System, is a very important strategy. For Strategy IV.A.1, which focuses on listening to individuals and implementing HIT policies and programs to meet their interests, we urge ONC to focus on data collection among patients and consumers with clear examples of user experience. Such prototypes, working demonstrations, and available services will be critical to showing consumers what is available and what is possible, and how it will improve their lives. Additionally, we suggest that ONC involve research entities with tested collection methodologies. Strategy IV.B.2 focuses on federal agencies being models for sharing information with individuals and making available applicable tools. Although an important component of data-sharing, we do not believe that the “Blue Button” model is the “best practice” to securely share data with patients but rather closer to a minimum approach to provide patient’s access to EHR data. In particular, sharing CCD formatted data, along with human readable data, provides a higher level of shareable, clinically relevant, comprehensive health data patient profiles to enhance continuity of care.

    For Strategy IV.C., on standards and tools that make EHR technology able to interact with consumer health, we are very supportive, but ask that the pace of this work as it relates to MU and standards reflect the tight timing of new Stage 2 functionality. For Strategy IV.C.2, on soliciting and integrating patient generated health information into EHRs and quality measurement, we again are supportive but also mindful of Stage 2 timing constraints as well as the critical non-technical limiting factors in this area, which ONC should address. One such important factor is providers’ concern with the legal risks of using poor quality data or not using good data.

    Goal 5: Achieve Rapid Learning and Technological Advancement We support the focus on learning health care systems and the ability of HIT to push out new knowledge and facilitate its use. We are concerned, however, that the current plan appears very federal government centric and encourage ONC to reach out to and encourage broad private sector involvement.

    • David Hager, M.D. says:

      “electronic health information is the “lifeblood” of modern health care”

      Nope.

      Patients and clinicians are.

  71. Farzad Mostashari, MD, MPH
    National Coordinator for Health Information Technology
    Department of Health and Human Services
    Submitted electronically

    Re: ONC Federal Health Information Technology Strategic Plan 2011 – 2015

    Dear Dr. Mostashari:

    Docs 4 Patient Care welcomes the opportunity to respond to the request from the Office of the National Coordinator for Health Information Technology for comments regarding the 2011 – 2015 Federal Health IT Strategic Plan (“the Plan”).

    Docs 4 Patient Care is an organization of concerned physicians committed to the establishment of a health care system that preserves the sanctity of the doctor-patient relationship, promotes quality of care, supports affordable access to all Americans, and protects patients’ freedom of choice.

    We share the vision of bringing health care into the information age to improve quality of care and lower cost of care. However, review of the Plan reveals several areas of concern to us and to practicing physicians everywhere. They are as follows:

    The Plan significantly underestimates the barriers to EMR adoption in the medical community. Although the barriers mentioned (cost, lack of information exchange, perceived lack of financial return) are accurate, the latter is underemphasized and other important barriers remain unrecognized.

    The greatest barrier to health IT (HIT) adoption is not financial but cultural. Contrary to popular belief, physicians are not tech-savvy. The practice of medicine is far more interpersonal than technical. Physicians go into medicine because they like to work with people, not computers. The physician practice has never before been an IT-based environment. Bringing a medical practice into that environment takes time.

    The Plan fails to adequately recognize the need for medical practices to redesign their internal workflows, leveraging the investment in EMR / HIT in order to achieve an adequate financial return as well as improve care. Physicians and their administrators as a group do not have the business process management skills to complete this task. As a result, EMRs are regarded by many physicians as a poor investment. Meaningful use incentives are not nearly enough to overcome these obstacles. The Plan must therefore offer a convincing argument regarding the return on investment (ROI) for EMR that is independent of Meaningful Use incentives. It must also incorporate a more aggressive strategy to support medical practices in upgrading their internal workflows.

    Success in Goal I – HIT Adoption and Information Exchange – will not occur until Goal III – Inspire Confidence and Trust in Health IT – is reached. In the medical community there is mistrust of both the HIT community and the government. The mistrust runs in both directions. Some physicians fear that HIT will be used by government as a covert instrument to undermine the doctor-patient relationship to promote government controlled patient care. Some also suspect the existence of hidden agendas that pressure physicians to consolidate into large groups, further advancing government control of care.

    We acknowledge that as our health care system enters the information age the doctor-patient relationship must evolve. The doctor-patient relationship will be changed by HIT – we must ensure that these changes protect the sanctity of the doctor-patient relationship and support patients’ freedom of choice. The Plan should offer some assurance that it supports an autonomous doctor-patient relationship over government control of care.

    Health information technology will certainly bring unplanned consequences to the practice of medicine, including unintended and potentially undesirable de facto changes to the standard of care. For example, health information exchanges will bring terabytes of patient information to the clinician’s fingertips. Will the clinician be responsible to review all of it? What will the standard of care become?
    The Plan should include objectives that protect physicians from these unplanned changes in the standard of care until they are examined, modified if necessary and formally recognized.

    Goal V – Rapid Learning and Technological Advancement. This section introduces exciting concepts for the health care system of the future. But can they be safely accomplished by 2015? We are already concerned that Goals I – IV will force changes in the health care system to occur at an unsafe rate.

    The introduction to the Plan cites the banking industry as example to follow, stating that, “While many consumers access their banking information online daily, less than 10 percent use the web to access their personal health information.” This is an excellent example. The banking industry took delivery of its first computer in 1959. It has taken 50 years since then to give banking consumers online access to their banking information. Over that time banking technology and culture evolved together, creating a stable, regular sequence of innovations to the banking system.

    The Plan imposes the same magnitude of change to the health care system over only 5 years. In health care, technology has evolved far ahead of culture. Cultural and operational changes, not technology, are the rate limiting steps to improving the system. We know what can happen when new drugs and medical devices are approved and introduced too quickly. Do we want to take that risk with our entire health care infrastructure? The welfare of our patients is at stake.

    We are grateful for the time you spend reviewing our comments. If you have any questions we would be delighted to communicate further.

    Sincerely,

    Michael J. Koriwchak, MD
    Medical Director, Health Information Technology
    Secretary, Georgia Chapter
    Docs 4 Patient Care

    Hal C. Scherz, MD, FACS, FAAP
    President & CEO
    Docs 4 Patient Care

    Richard A. Armstrong, MD, FACS
    Chief Operating Officer- Docs 4 Patient Care

    Arvind R. Cavale, MD, FACE, FACP
    Docs 4 Patient Care

  72. April 22, 2011
    Farzad Mostashari, MD, ScM
    National Coordinator for Health Information Technology
    Department of Health and Human Services
    Dear Dr. Mostashari:
    The College of American Pathologists (CAP) appreciates the opportunity to comment on the Office of the National Coordinator (ONC) for Health Information Technology’s (HIT) Federal Health Information Strategic Plan 2011-2015. The CAP is a national medical specialty society representing more than 17,000 physicians who practice anatomic and/or clinical pathology. CAP members practice medicine in clinical laboratories, academic medical centers, research laboratories, community hospitals and federal and state health facilities. The CAP has significant HIT expertise; CAP is the original creator of SNOMED Clinical Terms® (SNOMED CT®), and CAP STS continues to develop and maintain SNOMED CT.
    In general, the CAP supports the goals and use of health information technology (HIT) to improve the quality of care for patients and populations and to realize reduced cost through efficiencies resulting from enhanced patient-centric coordination of care using information exchange and data management to the benefit of patients and the public. We very much embrace the vision stated in the five-year plan for federal HIT, “A health system that uses information to empower individuals and to improve the health of the population.” Pathology was one of the earliest specialties to embrace health information technology (HIT). Pathologists and their laboratories have long relied on computerized laboratory information systems (LISs) in order to support the work of analyzing patient specimens and generating test results, and it is with these laboratory information systems that EHRs or enterprise-wide clinical information systems exchange laboratory and pathology data.
    The College recommends that ONC test the viability of the Strategic Plan’s goals against the current capabilities of EHRs, standards and exchanges and their likely near-term capabilities. While many of the objectives and goals in this report are laudable, a note of caution on the current and short-term ability to achieve them may be well-advised.
    Below please find the College’s comments on specific goals.
    Goal 1: Achieve Adoption and Information Exchange through Meaningful Use (MU) of Health IT
    While we support the use of EHRs, the objectives and measures in the current program are focused on the ambulatory office and clinic setting for primary care and internal medicine providers and are fundamentally not applicable to pathology even though pathologists meet the definition of eligible providers (EPs). If the idea behind MU is to incent adoption of the appropriate electronic clinical system, such an incentive is unneeded in pathology given essentially universal adoption of LIS’s and related HIT in pathology practice and laboratories. Further, pathologists generally do not currently directly use EHRs to input data. Therefore, pathologists regardless of practice setting, cannot meet the MU Stage 1 requirement to maintain 80% of patient records in certified EHRs. This requirement will prevent pathologists from qualifying under MU, regardless of any changes that might be made to the objectives and clinical quality measures to bring them into the scope of practice for pathologists. Additionally, even when pathologists — for example, in large integrated systems — do use EHRs, they do not generally have control over purchasing, implementing, and maintaining them. In fact, currently pathologists’ access to EHR’s is often blocked, to the detriment of patient care. Pathologists have an increasingly central role on the patient care team that generally requires their direct interaction with the full EHR (e.g. advising on appropriate test selection and resultant follow-up care), but outside of large integrated health systems, this role is largely in development in the ambulatory setting and is not consistent with the MU rules as currently written.
    The majority of the MU Stage 1 and draft recommended Stages 2-3 objectives are outside the scope of pathology practice and usual interactions with patients, as are the Clinical Quality Measures (CQMs) for Stage 1. While several Stage 1 objectives have exclusions that pathologists could use, others do not.
    The potential of the imposition of penalties in 2015 for EPs for failure to comply with the MU requirements is an unneeded distraction for pathologists and other similarly situated EPs from ONC’s objectives of accelerating the adoption of EHRs; facilitated information exchange to support MU of EHRs and to support health IT adoption and information exchange for public health populations with unique needs. HHS must recognize and address this problem expeditiously. Failing to do so will distract from the achievement of the Strategic Plan’s objectives. In partnership with CMS, ONC must reach out to affected stakeholders and the Congress to ensure that penalties under the MU program are not applied to those who cannot comply with the MU requirements through no fault of their own or alternatively, come up with a completely different set of requirements –objectives, clinical quality measures and certification – that reflect the realities of pathology practice.
    Strategy I.A.2: Provide Implementation Support to Health Care Providers to Help Them Adopt, Implement and Use Certified EHR Technology
    The CAP supports this strategy and believes it is essential to the achievement of Goal 1. EPs achievement of MU depends on laboratory data, since many measures rely on laboratory data. Therefore, we recommend that at least one focus of this strategy should be support for LIS-EHR interfaces so that laboratory data can more seamlessly and cost-effectively be included in certified EHRs. There are considerable hidden or underestimated costs in interface deployment (labor, validation, customization, connectivity) that are often underestimated or overlooked in initial funding planning. However, as the Exchange Subcommittee of the ONC HIT Policy Committee recognized in a December 15, 2009 presentation, these interfaces often cost from $5,000 to $25,000 each. (These numbers are for results systems only; the cost would be considerably higher for Computerized Physician Order Entry interfaces. It is also not clear that they reflect the license and labor costs discussed herein.) Laboratories (and by extension the hospitals or healthcare organizations that operate them and in some cases pathologists), and not the ordering physician practices, often end up paying for the laboratory-EHR interfaces. Many EHR and LIS vendors may have a vested financial interest in maintaining proprietary, costly interfaces. This is a significant obstacle to interoperability. Incentives need to change that favor standardization of data exchanges for these systems, lowering the cost of interfaces.
    Laboratories must build multiple expensive interfaces with client EHRs. This threatens the ability of all but the very large regional or national commercial laboratories to provide these interfaces economically, thereby resulting in a consolidated and less competitive market for laboratory services.
    Related to the need for EPs to establish the necessary business relationships and interfaces with laboratories, is the need for sound technology standards necessary to support the electronic transfer of laboratory data. As noted by HHS’ own Health IT Standards Advisory Committee in October 2009 and the HHS Clinical Laboratory Improvement Advisory Committee (CLIAC) in February of 2010, both industry and HHS experts agree that the standards necessary to support the electronic transfer of laboratory data and accommodate this MU measure are lacking. Specifically, HHS cited the need to continue efforts necessary to facilitate the completion of national and uniform standards for:
    1. laboratory data transmission,
    2. compendiums and vocabularies,
    3. patient identification methods, and
    4. laboratory interface system legacy system integration.
    That said, both government and industry experts agree that until these standardization efforts are realized, the requirement to mandate the integration of laboratory data into the EHR in a standardized and structured format may need to be modified to support inter-provider transfer of laboratory data in a standardized fashion.
    The ONC’s work on a standards and interoperability (S&I) framework to harmonize existing standards is an important first step, but more needs to be done.
    Strategy I.A.4: Encourage the Inclusion of MU in Professional Certification and Medical Education
    While the CAP wholeheartedly supports the notion that using HIT is essential to the practice of modern medicine, we have serious reservations about the federal government essentially dictating the qualifications for practice in a given medical specialty, particularly given the fact that MU requirements as currently constructed do not fit well within pathology’s scope of practice. That being said, however, pathologists’ expertise in laboratory testing and interpretation is essential to the development of appropriate laboratory standards in the MU rules. The CAP would welcome the opportunity to work with ONC to ensure that any requirements on the display, transmission and use of laboratory results in EHRs help to improve the quality of patient care.
    Objective B: Facilitate Information Exchange to Support MU of EHRs
    The CAP supports the plan’s statement that “patient information follows patients to the point of care and informs critical health decisions.” Almost all patients have laboratory tests, and pathologists are responsible for all laboratory tests. Laboratory testing is a key point of care and pathologists are essential to appropriate test selection that leads to therapy recommendations, particularly in the case of genomic tests. Standards of practice should recognize that pathologist access to the EHR is essential to improve patient care and overall quality improvement through laboratory testing, reporting and clinical interaction. The issues related to laboratory data exchange, interfaces, standards, etc., are an essential component of this issue and need to be further defined. For example, who will take responsibility to ensure that laboratory data managed in a health information exchange (HIE) or other will be handled properly (e.g. appropriate display and format of data elements) if ownership is distributed across multiple parties?
    Strategy I.B.3: Ensure that Health Information Exchange (HIE) Takes Place across Individual Exchange Models and Advance Health Systems and Data Interoperability
    We applaud ONC’s work on the S&I framework to harmonize existing standards and have been pleased to be able to participate in some of the laboratory interface work. However, the effort to date has been focusing only on laboratory results and has not looked at laboratory orders. These are inherently inter-connected and should not be developed in isolation.
    Objective C: Support Health IT Adoption and Information Exchange for Public Health and Populations with Unique Needs
    The CAP believes that this is indeed an important objective and is pleased to be the recipient of a CDC grant in cooperation with Surescripts and the American Hospital System to link hospital laboratories with public health agencies so that laboratories can electronically transmit reportable test results. We look forward to exploring with HHS and other stakeholders other ways that CAP can help to advance the public health through HIT partnerships.
    Goal II: Improve Care, Improve Population Health and Reduce Health Care Costs through the Use of Health IT
    Strategy II.D.3: Ensure a Mechanism for Information in Exchange in Support of Research and the Translation of Research Findings Back into Clinical Practice
    The CAP is pleased that the discussion of this strategy recognizes the importance of personalized medicine including biorepositories. Personalized medicine does indeed have the power to improve health care, public health surveillance and research on comparative effectiveness. CAP has recently announced a pilot biorespository accreditation program. The CAP would also recommend that in refining this Strategy that HHS consider the recommendations of a Brookings paper, released in January, entitled Enabling Personalized Medicine through Health Information Technology. (See http://www.brookings.edu/papers/2011/0128_personalized_medicine_west.aspx.) As leaders in personalized medicine, we would welcome the opportunity to work with HHS and other stakeholders to develop objectives, quality measures and certification requirements for personalized medicine.
    Goal III: Inspire Confidence and Trust in Health IT
    We agree that patient trust in the health care system is imperative. However, privacy rules must balance the need to instill patient confidence in the system with legitimate data needs. Overly restrictive privacy rules in some cases have precluded reuse of information necessary to advance medical research. The complexity of the privacy rules along with the threat of penalties have harmed patient care by restricting the free flow of patient information and diagnostic materials for legitimate clinical and research purposes and proved a barrier to translational research as well.
    Strategy IV.B3: Establish Public Policies that Foster Individual and Caregiver Access to Their Health Information While Protecting Privacy and Security”
    CAP favors greater patient engagement in care. In fact, pathologists are at the forefront of personalized medicine where such engagement can be crucial given the unique nature of each case. However, depending on how CLIA interacts with state laws (see http://www.chcf.org/publications/2010/01/electronic-release-of-clinical-laboratory-results-a-review-of-state-and-federal-policy), this requirement may be impossible for pathologists to meet. Specifically, some state laws define the “authorized persons” under CLIA who are allowed to receive laboratory results in such a way as to preclude laboratories and their pathologist directors from sharing this information with the patient. Further, several states have laws and regulations that prohibit pathologists from providing test results to patients and that allow such contact only upon authorization of the treating physician. Currently, several states expressly prohibit the release of laboratory test results to patients without the permission of the person who ordered the test. Therefore, the mandate for data access should not be placed on pathologists in situations where by law they are precluded from doing so.
    Furthermore, efforts to engage patients in their care must not sacrifice the accuracy of the underlying records. For instance, the turn-around time expectations stipulated by the CMS Final Stage 1 MU regulations (e.g. patients have the ability to view and download relevant information contained in the longitudinal record, which has been updated within four days of the information being available to the practice) are inconsistent with the current standard of care in regards to proper communication between pathology and other clinicians. Traditionally “errors” and/or “clarifications” may be addressed during the period of time between which pathology data is first published and the time at which it is discussed with a patient. With the advent of electronic delivery directly to patients, this may no longer hold true. Preservation of the pathologist – clinician interaction and its role in providing optimal patient care should not be lost in the quest to meet MU metrics and implement “certified” systems.
    Strategy IV.C.2: Solicit and Integrate Patient-Generated Health Information into EHRs and Quality Measures
    The Strategic Plan states that the FDA and other federal agencies will promote standards to enable integration including standards for interoperability and data integration. CAP would like to sound a note of caution on the source and reliability of laboratory (and other) data in integrated health records. Patients will often bring in results from outside institutions and independent laboratories when arriving for an office visits. The dangers of unsupervised incorporation (e.g. scanning) of this information into an institution’s EHR should be well understood. The data may not align well with local reporting standards, resulting in misinterpretation by a physician. Further, the results may simply be wrong or in conflict with local EHR data. Careful review of “external” data by the appropriate physician must be performed to ensure that patient care is not compromised.
    Goal V: Achieve Rapid Learning and Technological Advancement
    The CAP very much supports the concept of a learning health system. As the plan recognizes, health care quality will improve if data can flow freely to research consortia, registries and biorepositories with a legitimate research/process improvement use for such data. As mentioned above, CAP is beginning to pilot test biorepository accreditation that will help to ensure adequate protection of such data and specimens.
    Further, we are committed to evidence-based medicine and the importance of quality measures including MU objectives and CQMs being evidence-based whenever practical. In fact, in 2009, the College launched the CAP Center for Pathology and Laboratory Quality (The Center) which develops evidence and consensus-based practice guidelines and white papers focused on patient care outcomes. Specifically, the Center works to ensure quality in diagnostic medicine, its linkage with patient outcomes, and the role of the pathologist in improving quality and contributing to patient care. Most of these guidelines are developed in partnership with other relevant medical societies. (See http://www.cap.org/apps/docs/membership/transformation/new/center_index.html)
    CONCLUSION
    We appreciate the ONC’s consideration of these comments. To this end, we look forward to providing further input to HHS regarding its efforts to realize the goals contained herein. Should you have any questions or concerns, please contact Julie Cantor-Weinberg, Director, Public Health & Scientific Affairs.

    Sincerely,
    College of American Pathologists

  73. The National Latina Institute for Reproductive Health (NLIRH) appreciates the opportunity to submit comments regarding the Federal Health IT Strategic Plan: 2011-2015 (the Plan). NLIRH works to ensure the fundamental human right to reproductive health for Latinas, our families, and our communities. At NLIRH we understand the value of confidentiality for women as we view it as an extension of respect and promotion of dignity for Latina women in this country. Considering the sensitive nature of family planning services, confidentiality is critical for Latina women seeking reproductive health services, such as STD testing, contraception, and abortion. Thus, ensuring confidentiality in regards to family planning services for women of all ages is essential to improving the health of women in our community. Lack of confidentiality and culturally competent health care deters Latina women from seeking reproductive health services disparately impacting those that experience intimate partner violence, adolescents, and women in families of mixed immigration status.

    Intimate partner violence (IPV) is connected to low socioeconomic status, intimate partners’ substance abuse, age, and marital status. It impacts approximately 1.5 million women across the United States every year; however, Latina women are more likely to report IPV. A national survey found that 20.2% of Latinas reported some form of physical assault [1]. Another study conducted on predominantly Mexican origin women found that 33.3% had experienced physical violence, 20.9% experienced sexual coercion, and a surprising 82.5% experienced psychological aggression [2]. The impacts of these numbers are great as Latina women that experience IPV are more likely to have unintended pregnancies relative to whites, refrain from prenatal care after 20 weeks, and suffer from mental health issues [3, 4]. Women suffering through IPV often find solutions from medical professionals. However, these solutions can remain out of reach if confidential care is unavailable. Therefore, it is necessary for confidentiality to be ensured, particularly when contraception, abortion, or STD/STI testing is sought. Increased confidentiality measures will ensure that all women have the autonomy to make personal health decisions free from coercion or fear of partner violence.

    Adolescents are another sector of the population whose level of care is impacted directly by the level of confidentiality available. Latina adolescents are easily deterred from seeking family planning services when they are not ensured confidentiality. Studies have shown that adolescents are more likely to disclose information on topics of sexuality and more likely to follow up with health care providers if guaranteed privacy [5, 6]. A study conducted in California, for example, showed that there is a significant association between contraception use and attending family planning centers. The study found that these services must be confidential, culturally competent, and respectful for young Latinas to use them [7]. Thus, ensuring the privacy of these young women is an important piece of the health and well-being for Latinas. Moreover, confidential systems encourage young Latinas to seek medical and preventive care at higher rates thereby reducing complications from postponed treatment.

    Families with mixed immigration statuses are dissuaded from seeking family planning services, or basic health care services, for their families because of fear of deportation. Therefore, confidentiality is particularly important for these families. Mixed status families are comprised of members who have current immigration documentation or are citizens and members without immigration documentation or whose documentation is expired. Children of mixed status families are more likely to be uninsured and go without treatment and yearly physicals. One in five low-income citizen children in mixed status families are uninsured, compared with one in eight of children with citizen parents [6]. Fear of deportation keeps immigrant women from accessing health care for their families [8] if they are unsure whether identifying information will be transmitted to non-medical institutions. Thus, it is important that confidentiality include confidentiality from federal immigration authorities for women to feel comfortable accessing reproductive health care and basic health care needs for their family and children. It is equally important that the level of confidentiality not only be technically sound but also be conveyed in an appropriate language and cultural manner so that women may make informed decisions for their families.

    NLIRH is pleased to see that a critical aspect of the plan includes informing patients of their rights. It is important to note that this goal can only be accomplished with a dynamic use of communication methods that take into account various primary languages as well as comprehension levels. Many Latinas prefer Spanish over English, which is important in delivering culturally competent content. In 2006 the Pew Hispanic Center conducted a poll about language use within the home. Thirty-nine percent of Latinos spoke only Spanish in their homes, 17% said Spanish more than English and another 17% said they spoke Spanish and English equally [9]. Additionally, according to the 2009 American Community Survey over 57 million American residents over the age of 5 years speak a language other than English at home. Of these approximately 35 million speak Spanish. Spanish speakers constitute 12.4% of the American population [10]. Therefore, the use of multiple languages to inform patients of their rights is important to furthering the empowerment of individuals. It will also make Latina women of all ages feel more comfortable and respected when accessing reproductive health services.

    NLIRH is encouraged that a fundamental goal of the Health Technology Strategic Plan is to inspire confidence and trust in health IT by ensuring privacy and confidentiality to patients. It is very important to us to have an ally in helping Latina women and all women of reproductive age access family planning services, which can be sensitive, stressful, and embarrassing for some. Thank you for the opportunity to comment on the plan to expand electronic health records. We look forward to continue working with you.

    Footnotes:
    [1] Tjaden, Patricia and Nancy Thoennes. “Full Report of the Prevalence, Incidence, and Consequences of Violence Against Women: Findings from the National Violence Against Women Survey. US Department of Justice, Washington, D.C., 2000.
    [2] Hazen, Andrea L. and Fernando I. Soriano. “Experiences with Intimate Partner Violence Among Latina Women.” Violence Against Women 13 no. 6 (2007): 562-582.
    [3] Rodriguez, Michael A., MarySue V. Heilemann, Eve Fielder, Aflonso Ang, Faustina Nevarez, and Carol M. Mangione. “Intimate Partner Violence, Depression, and PTSD among Pregnant Latina Women.” Annals of Family Medicine 6 no. 1 (2008): 44-52.
    [4] Borrero, Sonya, Charity G. Moore, Li Qin, Eleanore B. Schwarz, Aletha Akers, Mitchell D. Creinin, and Said A. Ibrahim. “Unintended Pregnancy Influences Racial Disparity in Tubal Sterilization Rates.” Journal of General Internal Medicine 25 no. 2 (2010): 122-128.
    [5] Ford, Carol A., Susan G. Millstein, Bonnie L. Halpern-Felsher, and Charles E. Irwin. “Influence of Physician Confidentiality Assurances on Adolescents’ Willingness to Disclose Information and Seek Future Health Care.” Journal of the American Medical Association 278 no. 12 (1997): 1029-1034.
    [6] Thrall, Jeannie S., Lois McCloskey, Susan L. Ettner, Edward , Joan E. Tighe, and S. Jean Emans. “Confidentiality and Adolescents’ use of Providers for Health Information and for Pelvic Examinations.” Archives of Pediatrics and Adolescent Medicine 154 no. 9 (2000): 885-892.
    [7]Santelli, John S., Illene S. Speizer, Alexis Avery, and Carl Kendall. “An Exploration of the Dimensions of Pregnancy Intentions Among Women Choosing to Terminate Pregnancy or to Initiate Prenatal Care in New Orleans, Louisiana.” American Journal of Public Health 96 no. 11 (2006): 2009-2015.
    [8]Capps, Randy, Genevieve Kenney, and Michael Fix. “Health Insurance Coverage of Children in Mixed-Status Immigrant Families.” Snapshots of America’s Families III no. 12 (2003): 1-4.
    [9] Bauer, Heidi M., Michael A. Rodriguez, Seline Szupinkski Quiroga, and Yvette G. Florez-Ortiz. “Barriers to Health Care for Abused Latina and Asian Immigrant Women.” Journal of Health Care for the Poor and Underserved 11 no. 1 (2000): 33-44.
    [10] Pew Hispanic Center. Interviews conducted by International Communications Research. Survey Question Search: August 2006, .
    [11] U.S. Census Bureau, 2009 American Community Survey. .

  74. Dear Dr. Blumenthal:

    As Chief Executive Officer of the National Nursing Centers Consortium, I am pleased to submit the following comments on The Office of the National Coordinator for Health Information Technology’s Federal Health IT Strategic Plan 2011-2015.

    The National Nursing Centers Consortium (NNCC) is the first and largest organization representing nurse-managed health clinics in the United States. We work to advance nurse-led health care through policy, consultation, programs, and applied research to assist nurse-managed health clinics in reducing health disparities and meeting people’s primary care and wellness needs. For the past 40 years nurse-managed health clinics have provided primary care, health promotion and disease prevention to the nation’s most vulnerable people. Our 200 member nurse-managed health clinics are safety net providers committed to caring for underserved and vulnerable populations throughout the country.

    Sometimes called a nurse-managed health center or NMHC, the Affordable Care Act defined a nurse-managed health clinic as “a nurse practice arrangement, managed by advanced practice nurses, that provides primary care or wellness services to underserved or vulnerable populations and that is associated with a school, college, university or department of nursing, federally qualified health center, or independent nonprofit health or social services agency.” (42 U.S.C. § 330A–1 (2010)). NMHCs provide a full range of health services, including primary care, health promotion, and disease prevention, to low-income, underinsured, and uninsured clients. Approximately 58% of NMHC patients are either uninsured, Medicaid recipients, or self-pay. (2008 NNCC Membership Surveys). In addition to providing health care, NMHCs in both educational and community settings play an important role in training the next generation of nurses, physicians, and other allied health professionals.

    NMHCs face challenges in a health care system that does not always recognize the value that nurse practitioners and nurse-managed health practices bring to the system and the communities they serve. For example, when nurse-managed health clinics are affiliated with educational institutions, they can rarely meet the governing board requirements to become federally qualified health centers (FQHCs). Thus, these clinics are often excluded from initiatives and payment mechanisms designed to help providers give innovative, high quality care to patients because the mechanisms are often restricted to FQHCs. In addition, nurse-managed health clinics are excluded from initiatives that are limited to physician-led practices, even if the nurse-managed health practice is otherwise qualified for the initiative.

    As an example, NMHCs are ineligible to participate in the Medicare Electronic Health Record Incentive Programs. Accordingly, we ask that the Office of the National Coordinator for Health Information Technology (ONC), include nurse-managed health practices throughout the implementation of the Strategic Plan, by not restricting participation in a way that leaves out nurse practitioners and nurse-managed health practices.

    The NNCC fully supports the overall goal of the ONC to promote health IT as the “lifeblood” of modern health care.

    Strategic Plan Goal I: Achieve Adoption and Information Exchange through Meaningful Use of Health IT

    The NNCC’s Health Information Systems Administrator has successfully implemented and now manages the electronic health records (EHRs) for four local nurse-managed health clinics. The NNCC is also a partner with the Pennsylvania Regional Extension and Assistance Center for Health Information Technology (PA REACH), Pennsylvania’s regional extension center, to build expertise in implementing and maximizing EHRs in community-based settings. The goals of the NNCC’s EHR database are to:

    1. Increase the number of primary care providers who actively use electronic health record (EHR) systems;
    2. Engage in health information exchange; and
    3. Report quality data that demonstrates “meaningful use.”

    These goals are being achieved through technical assistance to practices, outreach, and education efforts. To continue to progress in this area, we respectfully request that the ONC include nurse-managed health clinics in future programs.

    Unfortunately, the HRSA Health Center Controlled Network Program described in Strategy I.A.2 is for FQHCs and therefore NMHCs cannot benefit from the resources given to the participating community health centers. Accordingly, we request that future initiatives not be restricted to FQHCs, but instead be open to all safety net clinics recognized by Congress, such as nurse-managed clinics. (42 U.S.C. § 330A–1 (2010).)

    We applaud the ONC efforts in Objective C to support health IT adoption and information exchange for public health and populations with special needs, two important areas in nurse-managed health care. In addition, we applaud efforts to ensure privacy and safety standards for this data. It is important that individuals can trust their privacy with health IT, to foster its use and to protect the providers who rely on it.

    Strategy I.C.2, tracking health disparities and promoting health IT that reduces them, is particularly relevant to NMHCs. NMHC operate in underserved and vulnerable communities, where health disparities are the dominant health predictor for the patients. ONC investments and initiatives that support and include nurse practitioners and nurse-managed health care will translate into important health disparity data from these clinics and promote efforts to reduce disparities.

    Strategic Plan Goal II: Improve Care, Improve Population Health and Reduce Health Care Costs Through the Use of Health IT

    Objective A, supporting more sophisticated uses of EHRs and other health IT to improve health system performance, is laudable and the NNCC encourages the ONC to continue to develop tools and programs in this area. NNCC participation in the PA REACH has allowed us to assist nurse-managed health clinics in reaching these goals.

    The NNCC has established a health clinic controlled network – the Public Health Datamart Network (PHDN). Formed to provide ongoing support and facilitate collaboration between member clinics on health IT projects, research, and data related activities, the PHDN is a network of eleven NMHCs and the NNCC that study service utilization and clinical outcomes of care and actively pursue opportunities to participate in quality improvement and research projects. All members of the network use an EHR and practice management system to collect and report business and clinical performance measures of patient, provider, and practice quality. The network is recognized as a primary care practice-based research network by the U.S. Agency for Healthcare Research and Quality. Unfortunately, due to the scarce resources available to NMHCs, the NNCC has been limited in its ability to develop the potential of the PHDN .

    The NNCC supports the strategies in Objective C and encourages the ONC to support pilot and demonstration projects and studies to develop standards for evidenced-based practice in the use of health IT to improve care, efficiency, and population health in nurse-managed health practices. Due to the limited resources available to NMHCs and our goals of providing high-quality patient centered care, we submit that these evidence-based standards should be developed prior to their implementation across the health care system, developed with nurse and advanced practice nurse input, and be relevant to nurse-managed health practices.

    Through the implementation of the Strategic Plan the ONC should include nurse-managed health practices in initiatives to align health IT with clinical and payment reforms, as well as in pilots and demonstrations.

    Strategic Plan Goal III: Inspire Confidence and Trust in Health IT

    There is uncertainty related to primary and secondary use of health IT and the personal health information that it contains, specifically because of federal privacy laws and the myriad of state privacy laws. In addition, there are huge consequences for health care providers in the event of a privacy or security breach, in addition to the consequences for the people whose health information was involved.

    The myriad of state level privacy and security laws adds an additional layer of complexity to any efforts to create a multi-state health information exchange. The current quagmire imposes large burdens on health IT users, both because of the demands of current laws and because of uncertainty about laws and regulations for secondary uses of EHRs. Accordingly, we applaud the objectives in the strategic plan related to inspiring trust in health IT and encourage the ONC to continue to work with the appropriate federal and state agencies to develop universal, definitive, clear, and concise regulations and standards for the privacy and security of electronic health information in primary and secondary uses.

    Strategic Plan Goal IV: Empower Individuals with Health IT to Improve their Health and the Health Care System

    NMHCs are committed to serving underserved and vulnerable populations. These vulnerable populations, are often poor, elderly, without insurance, or facing cultural, linguistic or other barriers to receiving services. By partnering with NMHCs, the ONC can directly reach communities across the country who are marginalized and overlooked–precisely the populations who would benefit from empowerment. Nurse-managed health clinics are located in public housing and on blighted urban streets; on Native American reservations and in rural communities; in senior citizen centers and in elementary schools; in storefronts and in churches. Accordingly, the effort to empower individuals with health IT should include NMHCs because of their service to underserved and vulnerable communities.

    We would encourage the ONC to look at the underlying issues that cause barriers for individuals in accessing health IT including literacy, health literacy, English as a second language, poverty, and a lack of physical access to technology. Many of the individuals we serve are unable to meet their own basic needs for food, shelter, safety, and health care and are unable to afford technology. As an example, if access to personal health record technology is expensive or requires personally owned technological equipment, then many people will be excluded from participation.

    In addition, the ONC should encourage health IT vendors to develop mechanisms for individual patients to access their medical records, and ways to aggregate the records of a single patient from multiple providers. This falls within vendor purview, because they have the expertise to develop the necessary solutions.

    The ONC National Partnership for Action seeks to eliminate health disparities and health IT is reportedly a critical element of the strategy. Each and every day the nation’s NMHCs work with communities of color to meet their needs. Accordingly, NMHCs should be included as essential partners in this Goal and its implementation.

    Strategic Plan Goal V: Achieve Rapid Learning and Technological Advancement

    NMHC are ready to aggregate, analyze, and leverage health care data but do not always have the economic or technical resources to do so. Accordingly, we respectfully request that the ONC include NMHCs in programs designed to enable innovation and health IT use to improve knowledge about health across populations.

    Summary

    NMHCs are the quintessential safety net providers, committed to caring for underserved and vulnerable populations throughout the country. NMHCs have embraced health IT and the incredible potential it offers. Nurse practitioners across the country are ready and willing to partner with the ONC to implement the Strategic Plan and harness the power of health IT.

    Thank you again for the opportunity to comment.

    Very truly yours,

    Tine Hansen-Turton

    NNCC Executive Director

  75. Nancy Hailpern says:

    Dear Dr. Mostashari

    The Association for Professionals in Infection Control and Epidemiology (APIC) appreciates the opportunity to provide input to the Federal Health IT Strategic Plan for 2011-2015. APIC is a nonprofit, multi-disciplinary, international organization representing over 14,000 infection preventionists (IPs), whose mission is to improve health and promote safety by reducing the risks of infection and adverse outcomes in patients and healthcare personnel. Our members’ expertise is an integral component to efforts that provide meaningful data for internal facility quality improvement, as well as public health efforts.

    Critical Issues & Recommendations from APIC for Select HIT Goals:

    Goal I, “Achieve Adoption and Information Exchange through Meaningful Use of Health IT,”
    APIC fully supports meaningful use of Health IT (HIT). To date however there has been fairly modest – and in several instances, no –engagement of infection preventionists in the development, application, and most importantly the use of the electronic health record (EHR). Our members, along with other key stakeholders have published a review that highlights specific applications that are increasingly important in ensuring this goal is met as it gets to the critical issue of measuring and assessing performance of providers.1 Too often our members are not engaged when their affiliated systems are evaluating or even installing EHR systems. This results in a missed opportunity to optimize the potential value and meaning of information derived from same. By example, our members calculate rates of device-associated infection using device days in the denominator. Ideally an EHR system could automate collation of these denominators which are now done manually. There are some exceptions but engagement of IPs early on would add significant value and efficacy of electronic platforms used for patient.2,3

    Recommendation: Add a strategy to this goal that emphasizes the need to engage key stakeholders (e.g. industry, direct care providers, infection preventionists, performance improvement professionals, risk management, patient safety, etc.) in convening a summit to identify essential elements of the EHR that will enhance meaningful use.

    Goal II, “Improve Care, Improve Population Health, and Reduce Health Care Costs through the Use of Health IT:
    We are in full support. HIT can support improvements in patient care and health of the populations we all serve.

    Recommendation: We recommend that this strategic plan for HIT emphasize the universal access across accountable care networks. This platform also may be able to engage patients more directly in their daily care needs that emphasize prevention strategies to improve health and minimize risk of a healthcare-associated infection (HAI).

    Goal IV, “Empower Individuals with Health IT to Improve their Health and the Health Care System,”
    Consistent with the recommendation under Goal II, we agree with this goal. There are many examples in our field wherein HIT can improve health and lessen risk of a HAI. These include use of real time decision support at the point of care so providers can make the best decisions possible for the individual patient. This will in turn lead to improved care for the population. Decision support includes selection and use of antibiotics, which in some cases, could avoid use and improve stewardship and lessen chances of creating multidrug-resistant organisms. Other benefits include reminders to patients and providers that they are in need of vaccinations, algorithmic analysis and identification of patients at higher risk of infection that lead to strategic interventions needed for one patient but assure efficient conservation of resources for those who don’t.

    Recommendation: Consider elements under this goal that may include a registry system wherein health promotion strategies can be captured, e.g. vaccines for adults, and perhaps outcomes of care as patients move across the continuum of care.

    Goal V, “Achieve Rapid Learning and Technological Advancement,”
    APIC wholeheartedly supports this goal. Rapid, real time calibration and adjustment to the needs of the patient population will be more efficient and appropriate for use of limited health care resources. Our members are experiencing increasing demands on their time related to reporting HAI data to a wide range of organizations including consumers. This is taxing our members’ ability to work within a patient care team to improve care at the point of delivery. As a result APIC has published a position paper on Surveillance Technology.4 This, plus recent research by Lin et al., have demonstrated the benefits of moving from manual systems to collect data on HAIs toward one that is automated.5

    Recommendation: Engage key stakeholders in developing applications within EHR systems that will facilitate use of automated, algorithmic detection of HAIs or at least a proxy for same that can be used to assess performance and progress with prevention of HAIs. This needs to include a realization and utility that is both scalable and can extend across the many points of care under an accountable care model.

    Additional Points for HIT Strategic Plan:
    APIC supports objectives and strategies that encourage aligning EHR with federal programs and services; with local, state, and federal public health agencies; and that ensure health information exchange takes place across individual exchange models, and advance health systems and data interoperability. In order to ensure consistency in reporting HAIs throughout every government agency, APIC supports using definitions and quality measures already in place and which have been validated by the Centers for Disease Control and Prevention (CDC)’s National Healthcare Safety Network (NHSN). A good example of inter-agency cooperation is new Centers for Medicare and Medicaid Services (CMS) rules of participation passed in 2010 requiring hospitals to report central line-associated bloodstream infections (CLABSIs) and surgical site infections (SSIs) through NHSN for public reporting and future Medicare reimbursement determination. Using NHSN definitions and metrics for the purpose of both HAI surveillance and to determine Medicare reimbursement allows for meaningful and actionable use of the same data. Likewise, NHSN data can be made accessible to state health departments for state HAI reporting requirements as well. In addition, CDC, CMS and the American College of Surgeons are currently working together to harmonize definitions in NHSN with the National Surgical Quality Improvement Program (NSQIP) for reporting SSI data.

    APIC also supports objectives and strategies that provide for financial incentive payments for the adoption and meaningful use of EHR. Given that many healthcare providers are still in the early stages of designing and installing electronic health records, we appreciate the continuing efforts of the Office of the National Coordinator (ONC) for HIT to take into account time, costs and resources necessary to develop and/or upgrade to new systems. We believe data should be retrievable from existing data sources without causing a demand for additional human resource needs, and those systems should allow for secure data sharing across systems and providers. Ideally, these electronic data technologies will shift time IPs spend on data management to front-line targeted infection prevention activities.

    The Health Information Technology for Economic and Clinical Health (HITECH) Act offers financial incentives for hospitals and other healthcare providers to purchase computer systems that meet “meaningful use” criteria. Facilities that use NHSN have already done much of what meaningful use requires for public health informatics, therefore infection surveillance networks through NHSN should serve as a model for other public health specialties. Furthermore, automated surveillance technology would improve the interface between facility data collection and NHSN. APIC supports the use of automated surveillance technology as an essential part of infection prevention and control activities, and supports financial incentives for NHSN user’s thereby assisting facilities in adopting these standardized methods of surveillance.

    APIC encourages and supports ONC’s continued work with federal partners to ensure that strategies for ongoing implementation of EHR align with other national plans for healthcare quality improvement, including the National Strategy for Quality Improvement in Health Care and the HHS Action Plan to Prevent Healthcare-Associated Infections.

    Again, APIC appreciates the opportunity to comment on the Federal HIT Strategic Plan for 2011-2015, and we look forward to continuing to assist ONC in its efforts to improve healthcare quality through meaningful use of HIT.

    Sincerely,
    Russell N. Olmsted, MPH, CIC
    2011 APIC President

    1. Atreja A, Gordon SM, Pollock DA, et al. Opportunities and challenges in utilizing electronic health records for infection surveillance, prevention, and control. Am J Infect Control. 2008 Apr;36(3 Suppl):S37-46

    2. Grota PG, Stone PW, Jordan S. Electronic surveillance systems in infection prevention: organizational support, program characteristics, and user satisfaction. Am J Infect Control. 2010 Sep;38(7):509-14

    3. Wright MO, Fisher A, John M, et al. The electronic medical record as a tool for infection surveillance: successful automation of device-days. Am J Infect Control. 2009 Jun;37(5):364-70

    4. Green LR, Cain TA, Khoury R, Krystofiak, SP, Patrick, M, Streed S. APIC Position Paper: The Importance of Surveillance Technologies in the Prevention of Healthcare-Associated Infections (HAIs), May 29, 2009. http://www.apic.org/Content/NavigationMenu/GovernmentAdvocacy/PublicPolicyLibrary/Surveillance_Technologies_position_paper_2009-5_29_09.pdf

    5. Lin MY, Hota B, Khan YM, et al. Quality of traditional surveillance for public reporting of nosocomial bloodstream infection rates. JAMA. 2010 Nov 10;304(18):2035-41.

  76. Erie Lawyer says:

    I just wanted to say that the comments to this post are very insightful. I’m glad to see that the professional community is taking the time to educate the rest of us on how these new health directives will play out.

  77. Luz Rodriguez says:

    I am Computer Engenier and I know about this program. I had some experience in Colombia with a similar project. I started the process to get in at Westchester Community College, Valhalla, NY, Id like to know wich other colleges in New York offer this program.

    I will ‘apreciate to hear from you opportunely.

    Cordially,

    Luz Rodriguez

  78. Dear Friends at the ONC,

    I pretty much think, write and paint about Meaningful Use and patient data access constanly. So I would like to submit public comment in the form of a painting done on site at the RTI forum:Patients as Paterners in Care: Engaging Patients through Health IT. Here is the link: http://reginaholliday.blogspot.com/2011/04/one-of-us-one-of-us.html

    I think this work applies to Goal IV: Empowere Individuals with Health IT to Improve Their Health and the Health Care System.”

    I grow concerned at some of the comments I have read here on these pages. I hear many of the same tired arguements against patient access aired during stage one Meaningful Use. That patients should not have timely access, that we cannot possibly understand imaging results, that we are uneducated and will be emotionally disturbed by reading our own record.

    I once again must say, there is nothing worse than being sick in a hospital bed with no access to data and be left alone with no idea what is going on.

    Thank you for your time.
    Regina Holliday

  79. Chris Santos-Lang says:

    Machine Learning is key. For goal 1, it can translate data between different EMRs and allow EMRs to capture more data (through computer vision, listening, reading). For goal 2, it can extract data to facilitate reporting and reduce cost through automation, and better decision-making. For goal 4, it can learn patient preferences and take initiative to engage them. Yet you make machine leaning goal 5, as though it could be separated out (and perhaps delayed, while we work on the other goals). That’s like having a separate MBA class for ethics (as though ethics needn’t permeate business management).
    The barrier to machine learning is the EMR; academia proved the concepts years ago. IBM’s Watson team has demonstrated the development required for EMRs to develop the capacity—about 15 machine learning specialists given 3-5 years—the quality of your policies requires knowing why some big EMR vendors still lack such a team. Here are the excuses: (a) we are afraid of the liability of supplying technology crucial to clinical decision-making, (b) we are too busy satisfying meaningful use, (c) we are too loyal to doctors to promote technology that would allow patients to buy more directly from pharma.
    “Intergration” is the big selling point for an EMR, yet your goal 5 is a vision of a disintegrated EMR, where a third-party provides the learning technology and forces EMR vendors to cooperate (via legislation). Please reconsider the value of integration; clarify the liability laws; to qualify for meaningful use, require EMR vendors to demonstrate capacity for machine learning; offer a vision of an economy in which doctors have a crucial new role in healthcare (perhaps ensuring quality and security of data?) rather than losing their importance and economic power.

  80. April 21, 2011
    Honorable Farzad Mostashari, MD
    Director of the Office of the National Coordinator for Health Information Technology (ONC)
    Washington, DC

    Dear Dr. Mostashari,

    The Advisory Board Company (ABC) has reviewed the ONC Federal Health Information Technology Strategic Plan 2011 – 2015 to provide ONC with insights we believe are pertinent for improving the proposed strategy. We believe, overall, the strategy is well positioned to move the US to a higher quality of healthcare services at a lower cost of delivery. We believe guidelines that drive incremental improvements, and not “big bang” adjustments (as proposed by the PCAST report), will be the most successful approach for implementing these changes. The Direct and Connect Projects are an excellent example of incremental improvements supported by technologies that are available and easily implemented by all healthcare stakeholders. We believe the framework of interoperability supported by the HL7 Clinical Document Architecture (CDA) standards is spot on, and we encourage ONC to drive additional vocabulary and medical terminology standards that will create the foundation for semantic interoperability in Stage 2 of Meaningful Use.

    The specific areas where we believe modifications may be needed for improving the strategy are as follows:

    Timeline – page 6: We believe ONC needs to maintain the current timeline for meaningful use (MU) adoption, and we also believe that future guidelines should maintain at least the current level of proposed electronic health record (EHR) functions/capabilities for MU Stage 2 and Stage 3.

    Relative to attestation timelines for providers that have already commenced their reporting period in 2011, they should be allowed some leeway in FY 2013, especially if the final rule for Stage 2 won’t be out until Spring 2012. Alternatives could involve a two step Stage 2 program with Step 1 in FY 2013 requiring them to only achieve a higher performance bar on Stage 1 criteria in Stage 2 (menu items become core items) and allowing them to achieve Step 2 of Stage 2 which would be the new capabilities implemented and adopted by FY 2014. This will prevent early attesters from getting squeezed for being early adopters. Alternatively, they should be allowed to demonstrate Stage 2 for any 90 day period in FY 2013 – again allowing them more time to ramp up to Stage 2.

    Vision – page 7: We believe the vision should incorporate the need to drive down healthcare costs and their impact to gross domestic product, while improving healthcare affordability, quality, safety, and outcomes.

    Mission – page 7: We believe that the mission needs to stress an agnostic view of technologies that can be used to deliver the desired vision. Innovation in this industry is driven by small emerging companies, and we do not want to see vendors with proprietary solutions creating significant barriers of entry to this market. This position is endorsed by the Federal Health IT Principles, but we believe it should be elevated as part of the mission statement.

    Federal Health IT Principles – page 8: we support the principle “Encourage Innovation.” We believe as part of that we need a health IT environment (e.g. applications and infrastructure) that supports both care delivery and clinical research that supports not only health IT innovation but innovations in preventive, diagnostic, therapeutic and care management approaches.

    Goal 1, Objective A, Strategy I.A.2 – Provide implementation support to health care providers to help them adopt, implement, and use certified EHR technology: We believe the current actions of Regional Extension Centers (RECs) of recommending EHR vendors is not in the best interest of the market or healthcare providers. We understand the approach of RECs for providing support for the many small primary care clinics in the country, but we believe PPACA will drive market consolidation. As many of the independent clinics will begin to become more aligned with accountable care organizations (ACOs) that are derived from the larger healthcare delivery systems, they will be offered EHR services and support via these business relationships, which will result in replacement of many of the systems that were recommended by the RECs. We are also concerned that RECs will not be able to staff effectively for supporting EHR selection and implementation processes as the market is currently constrained by the lack of qualified resources driven by vendor, consulting company and healthcare organization demand. We do support RECs for supporting quality outcome reporting and driving the use of evidence-based medicine protocols within the healthcare environments they support.

    Goal 1, Objective A, Strategy I.A.3 – Support the development of a trained workforce to implement and use health IT technologies: We believe this is a high priority risk element of the overall strategy as the market is already constrained by the lack of qualified resources needed to support the implementation and support of EHR systems. Hospitals and clinics are already experiencing issues with finding skilled clinical resources with IT experience as healthcare IT vendors and consulting companies are competing for these already scarce resources (as identified in the REC position above). We believe that this IT resource issue will only become more exacerbated as revenue cycle management systems become impacted by new ACO payment processes. This is a critical element that could decide the overall success of transforming healthcare delivery processes

    Goal 1, Objective A, Strategy I.A.5 – Establish criteria and a process to certify EHR technology that can support meaningful use criteria: Our data show that the current EHR certification process is driving healthcare providers to enterprise applications with common architectures that span acute and ambulatory services. We understand the need to minimize IT heterogeneity as the industry does not have the necessary process interoperability standards to effectively integrate disparate systems to support healthcare delivery across the continuum of care at this time. But, we do believe that this approach may stifle innovation if healthcare providers are expected to “possess” all applications their clinical vendors certify for meaningful use. The current certification process needs to be modified to ensure that vendors are not forcing the licensing of non-core EMR solutions by the providers. Meaningful Use of Certified Technology should be amended (or further clarified) to explicitly permit any module of a system that has received “complete” certification to be replaced by another module that has received “modular” certification without requiring site certification.

    Goal 1, Objective A, Strategy I.A.9 – Encourage and facilitate improved usability of EHR technology: Usability must be tied to change management projects. We as an industry have done a poor job in analyzing how to best implement technology solutions relative to improving workflow and usability. A program that specifically focuses on this aspect of EHR facilitation should be implemented to provide cogent insights as to how to best establish the culture and processes necessary to successfully implement an EHR.

    Goal 1, Objective B, Strategy I.B.1: Foster business models that create health information exchange: We have observed few health information exchange (HIE) models that have delivered viable business models to support an ongoing concern. We believe the viability of HIEs will not be realized until reimbursement reform drives the use of these exchanges. But we believe the success of the Direct Project and the potential of the NHIN and Connect project may drive models for exchanging information into new standards-based paradigms. We support the ongoing efforts of both projects as information exchange solutions that will drive more cost effective information sharing in the industry. We believe It would be much more productive if CMS would focus on fostering business models that promote the growth of a National Network of Personal Health Record (PHR) Banks. Without this approach, the NHIN will always be plagued by security, privacy, and completeness issues.
    Goal 1, Objective B, Strategy I.B.2: Monitor health information exchange options and fill the gaps for providers that do not have viable options: We believe the current level of HIE investment should be focused on developing and delivering the Direct and Connect projects and fostering the growth of a national network of PHR banks. We also believe that providers should be required to participate in state and national directories as part of MU stage 2. As part of MU stage 2, providers should be required to securely submit CCDs (and later other documents) to a patient designated PHR.

    Conversely, we believe the monies spent on the FCC Rural Healthcare Program will generate a return on investment by providing the necessary infrastructure access for rural providers. We encourage continued investment in rural healthcare that supports a significant segment of elderly and indigent citizens in our country.

    Goal 1, Objective B, Strategy I.B.3: Ensure that health information exchange takes place across individual exchange models, and advance health systems and data interoperability: Vocabulary and terminology standards are a critical requirement that will fuel the success of interoperability across the industry in our opinion. We encourage ONC to drive quickly to vocabulary and terminology standards that are mandated for MU Stage 2. We believe SNOMED-CT would be the best standard to pursue. We also encourage ONC to fund research into the extension of the HL7 Clinical Statement Model, Content Modules and Templates and to continue and expand their collaboration with IHE, Health Story and HL7. We also believe the use of CCD standard transactions should be mandated in Meaningful Use Stage 2, and that CCR transactions should not be allowed as an accepted transaction standard.

    The PCAST report damns HL7 CDA with faint praise and fails to give sufficient weight to its strength as a proven technology for steady, incremental progress toward semantic interoperability in the US environment, which is characterized by the wide variability and generally lower capability of providers to create or consume healthcare data that has been encoded or tagged using reference terminologies.
    The PCAST report seems unaware that HL7 CDA is capable of supporting the highest level of atomized healthcare data tagged with reference terminologies adopted by ONC today, and richer ontologies in the future. Furthermore, the PCAST report seems willing to disregard the critical importance of the context provided by CDA’s document paradigm for research and future uses of healthcare data, in favor of an untested distributed approach to content tagging which has rather obvious issues of privacy and performance which the PCAST report waves its hands at in an unconvincing manner.

    In the context of the excellent progress made to date under ONC leadership, ONC’s published plans and our evaluation of ONC’s approach to technology and standards, we consider the PCAST report to be well intentioned noise, capable of being a destructive distraction from continued progress if taken as anything more than a speculative exercise.

    On the subject matter addressed by the PCAST report, we recommend that ONC support on-going and future research into HL7’s Clinical Statement language, HL7 CDA’s Content Modules/Templates and the development of a freely available, internationally standardized medical ontology, including supportive open source software which will move well beyond the limited ontology built into SNOMED-CT.
    We support the ongoing use of the HIT Policy and HIT Standards Committees for providing guidance to ONC, as long as these committees continue to represent a fair balance of industry representation.

    Goal 1, Objective C, Strategy I.C.2: Track health disparities and promote health IT that reduces them: We believe that the market should be allowed to influence the design of EHRs. We believe that NIST can provide guidance on necessary functions and features, but that the collective experience of the market will be the best determination of technology and design innovation. Government intervention in EHR design could negatively impact the market if it is heavy-handed.

    We support the suggested streamlined approach for federal licensing for telehealth solutions that will support improved care delivery to remote populations. We believe that reimbursement/payment programs for telehealth services should be further enabled to drive the adoption of telehealth implementations.

    Goal 2, Object A, Strategy II.A.2: Create administrative efficiencies to reduce cost and burden for providers, payers, and government health programs: Simplifying administrative processes is critical to driving cost and inefficiency out of the system. Healthcare organizations are struggling to meet the needs of both state and federal reporting requirements, and this effort is adding to their operating expense. ONC can start by coordinating data reporting to minimize the impact on organizations for this task as a beginning. ONC should drive the consolidation of reporting efforts across all state and federal agencies as appropriate and justified. Some suggested approaches include:
    • Ensuring that metrics are consistently defined and that the same metrics are used for similar domains/conditions across all major reporting requirements
    • 2. That reporting for one of the above is deemed to satisfy reporting for the related requirements from other federal and state reporting initiatives, and
    • 3. That the reporting for these various initiatives is either unified or automated so that it only needs to be done once.

    Goal 2, Object B, Strategy II.B.2: Establish standards, specifications, and certification criteria for collecting and reporting measures through certified EHR technology: We believe that all reportable data should be created as a by-product of the EHR environment either directly, or indirectly via certified enterprise data warehouse environments. We believe that ONC should specifically address the concerns of providers considering the adoption of more sensitive methods of adverse event detection (e.g., trigger tools, surveillance systems) that this information will be “discoverable” or reportable and be compared unfavorably with providers using much less sensitive and older methods. Either all should be required to use the latest methods, or the more sensitive data should be deemed private.

    Goal 2, Objective D, Strategy II.D.3: Ensure a mechanism for information exchange in support of research and the translation of research findings back into clinical practice: We believe this is another example of where standardized medical terminology and vocabularies will be most valuable, and why ONC needs to step forward and mandate these standards as soon as possible. We would encourage ONC to endorse SNOMED-CT as the standard vocabulary for this effort.

    We would like to see a unified national effort to use analytics across growing databases of reported data to identify best performance, and to investigate and document in detail (not just generally) the IT tools that support the performance.

    Goal 3, Object B, Strategy III.B.2: Increase transparency regarding the development of policies and standards related to uses and sharing of personal health information: We believe the position of ONC should be “the needs of the many outweigh the needs of the few” when it comes to the use of personal health information. ONC will never be able to satisfy all consumers relative to the use of personal health information, and should formulate a policy that incentivizes consumers to allow for the use of their data to improve healthcare deliver, quality, outcomes and safety. Those who do not want their information used in support of these objectives can pay the potential consequences for not participating – such as poorer outcomes or higher cost insurance.

    Goal 3, Object B, Strategy III.B.3 : Require easy to understand reporting of breach notifications: We believe there needs to be due process for organizations that report breaches to insure fair treatment and punishment. Penalties for infractions need to be specific and not subjective. This is an area where we encourage ONC, the U.S. Department of Health & Human Services’ Office for Civil Rights, and the Federal Trade Commission to work to ensure objective enforcement of the rules.

    Goal 3, Object C, Strategy III.C.1: Provide implementation and best practice tools for the effective use of health IT: We believe that EHR vendors need to also be included in these discussions as they have significant experience and insights into this environment.

    Goal 3, Object C, Strategy III.C.2: Evaluate safety concerns and update approach to health IT safety: We believe that ONC should coordinate with the FDA relative to all IT safety related issues to ensure a single voice and approach. We also believe that these organizations should develop a taxonomy of health information technology induced adverse events that can be used to track these issues and define new testing approaches to eliminate them.

    Goal IV: Empower Individuals with Health IT to improve their Health and the Health Care System – page 37: We believe that CMS needs to develop incentives for consumers to use PHRs. The “build it and they will come” strategy will not work for Americans. We have the technologies to deliver on this capability today, but we do not have the patient engagement factors/incentives in place to drive this through the majority of the US population. This may be partially accommodated by accepting personal health record (PHR) information into EHRs and conversely updating PHRs from the EMRs.. We believe the single biggest lever to individual empowerment is not only the access to data, but the convenience for supporting and managing healthcare delivery for the consumers. Providing the ability to establish secure messaging with providers, accessing healthcare service scheduling functions for busy mothers, and not having to repeatedly enter the same demographic information for each visit to a care provider would significantly drive consumer empowerment and adoption. Again, another driver for semantic and/or process interoperability between IT systems and applications.

    The government’s approach gives insufficient emphasis and regulatory support to personal health records. A robust national network of PHR banks with mandatory content submission requirements would obviate the need for much of the NHIN beyond public health, regulatory and quality data submission requirements, would simplify privacy regulations and stimulate innovation. The notion of a distributed network of patient data federated by a NHIN is fatally flawed from the perspective of privacy, security, identity management, completeness of access, patient engagement and potential for innovation. The inadequacy of the current NHIH approach to assembling a lifetime medical record for a patient will be revealed in detail as genomic information on individuals becomes pervasive.

    We agree with ONC’s statement, “The single biggest lever to individual empowerment is access to data.” Unfortunately, that is a necessary but not a sufficient condition for patients to be “activated” – i.e. active participants in their own health and health care. For example, very few smokers could honestly say that they didn’t know that smoking is harmful to their health. To achieve ONC’s goal of improving population health, much more must be done including changing societal norms (e.g. regarding obesity), providing appropriate financial incentives and disincentives, and working with employers and schools. A concerted, coordinated effort across multiple public and private stakeholders will be required to sustain behavior changes in empowered, activated individuals, thereby improving population health. We believe that as we collect more patient data and are able to provide meaningful insights from that data to support better healthcare behavior, new patient engagement applications for smart devices will emerge to drive patient engagement.

    Goal IV, Object C, Strategy IV.C.2: Solicit and integrate patient-generated health information into EHRs and quality measurements: “Patient generated insights” need to be accepted by the physician community before they will have any impact to the care delivery process. We believe that ONC needs to establish a panel of physicians and patient advocates to evaluate how this information can be gathered to insure appropriate structure without destroying the narrative components that in many cases are also useful.

    Goal IV, Object C, Strategy IV.C.3: Encourage the use of consumer health IT to move toward patient-centered care: We believe “patient self management/activation” can be achieved only if there are incentives and penalties for patients to be active participants in this care delivery model, and smart applications emerge that will provide guidance and suggestions for patients to achieve an optimal health status. The IT strategy is sound, but the adoption is counter to the current US consumer culture. Providers cannot be expected to drive or force adoption or use by consumers even if they have the appropriate IT solutions to support this effort.

    The Advisory Board Company appreciates the opportunity to comment on the ONC IT Strategy, and we hope our positions are useful and valuable to guiding and supporting the long term vision of ONC for delivering the IT environments necessary to support new healthcare delivery models that improve quality and patient safety, while reducing delivery costs.

    Respectfully submitted by,

    David E. Garets
    Executive Director
    The Advisory Board Company Healthcare IT Program Suite

  81. Thank you for the opportunity to provide comments on the HIT Strategic Plan. Mercy Health is an multi-state, integrated healthcare provider with 28 acute care hospitals and 1,400 integrated physicians in the MidWest. In general, we support the goals put forth in the draft Strategic Plan since they support the longer term HHS goals of improved quality patient care delivery and clinical outcomes. We would like to provide a few focused comments rather than comment on each proposed section:
    I.A.1 We would like to see all providers integrated into an incentive program to improve quality outcomes. Although the stated rationale for exclusion of some groups may be true on its face, the best clinical outcomes will come from leveraging the strengths of the entire team. As we subsequently progress to an ACO environment, the team effort will become even more critical to success.
    I.A.7 Mercy feels that alignment of all stakeholders in improved patient quality and outcomes is absolutely key to efficient and effective progress. Today, our various states have different variations on required metrics, non-NQF-standard measure definitions, and variably focused incentives driving providers’ behaviors. We cannot continue to waste effort and capital on non-aligned projects and high-overhead implementations and reporting. It would be an outstanding accomplishment for HHS/CMS to be able to catalyze forums where such alignment can be negotiated and consensus products identified. The savings would fund additional IT-related add-ons and improvements going forward.
    V.B.3 While government organizations may be directly connected to HHS/CMS for control and funding purposes, we believe that involving additional organizations, private and public, in exploring new solutions is more effective and helps generalizability and face validity of any gains. Mercy Health, as a non-profit organization, stands ready to assist in any way it can in such efforts to decrease the cycle time of new idea exploration in HIT.

    Respectfully submitted,

    Glenn W. Mitchell, MD, MPH, FACEP, CPE
    Chief Medical Officer
    Mercy Health System

  82. Bob Coli, MD says:

    Honorable Farzad Mostashari, MD, ScM
    National Coordinator for Health Information Technology
    Department of Health and Human Services

    Re: ONC Federal Health Information Technology Strategic Plan 2011 – 2015

    Dear Dr. Mostashari:

    The updated Federal Health Information Technology Strategic Plan accurately reflects ONC’s strategy for coordinating with the public and private sector to realize the health IT agenda of Congress and the Administration to improve the quality, efficiency, safety and patient-centeredness of health care.

    One key clinical IT component of this national strategy that has been overlooked is the substantial long-term value of significantly improving the industry-wide processes still being used to report the results of diagnostic tests to physicians and patients.

    Patient test results are an integral data component of EHRs and electronic HIE and a critically important source of information for medical decision-making. Clinical experience and research confirm that test results comprise some 70 to 80 percent of the data contained in the medical record and approximately 70 percent of clinical decision-making is based on or assisted by test results. (1) Unfortunately, EHR, PHR and HIE platforms are still using infinitely variable reporting formats to display clinical lab and other test results as incomplete, fragmented data that is difficult to read and analyze.

    Viewing and sharing test results efficiently will require the development of a standardized reporting format that can display results as complete, clinically integrated, actionable information. Improving the usability of test results will achieve data liquidity, semantic and process interoperability (2) and platform-neutrality and help create a complete view of the patient and an application or portal interface that clinicians will welcome.

    Antiquated electronic test results reporting format design represents a hidden, but important clinical data management problem for all physicians and patients. Its successful solution will contribute to supporting goals I, II, III and V of the Federal Health IT Strategic Plan and advancing adoption of EHR, PHR and HIE platforms.

    (1) http://www.chcf.org/publications/2010/01/electronic-release-of-clinical-laboratory-results-a-review-of-state-and-federal-policy

    (2) http://wiki.hl7.org/images/f/f5/090511EHRInteropProjects.pdf (HL7 EHR Interoperability WG (May 11, 2009 Gary L. Dickinson, Gora Datta Co-Facilitators)

    Sincerely,

    Bob Coli, MD
    Founder & CEO,
    Diagnostic Information System Company

  83. [process comment]
    Thank you for holding this public forum. It is a sign of good government that all can participate and also see what others have written. For the next iteration of this process, I request that you consider the addition of three features:
    1) threading – having folders, perhaps one for each of the 52 strategies in the case of this specific document, would simplify the process of identifying topics of greatest interest. It would also markedly shorten this page, making it less daunting to read. Within each folder, threaded discussions would be much easier to follow, both for individuals providing testimony and also for government workers who must collect, collate, and respond.
    2) search – enhancing the ability to find areas of interest among the multitude of posts might increase participation. To be most effective, it should be possible to limit search to one discussion forum only, even if multiple discussions are ongoing, and not provide search results from all of the ONC web site.
    3) notification – the process would be much improved if individuals, whether they have posted or not, could request an email notification when a new post was made to a topic (folder) or thread

  84. My View: Federal Health IT Strategic Plan 2011-2015

    Only Goal: Improve Patient Care and the Health of All Citizens

    Observed History to Date:

    (A) Nursing notes: Before electronic records nursing notes actually provided physicians with useful information concerning what happened to their patient between visits. Since electronic records they have become useless, rote fabrications to justify charges made to insurance companies and Medicare/Medicaid.

    (B) Hospital records: Page after page after page after page of misinformation that cannot be corrected, but must be correct, because it is digital, interspaced with a few bits of useful lab and radiology reports. I remain astonished to discover that my 63 year-old male patient has had a hysterectomy and oophorectomy. I fall into a cold sweat of fear for the lives of my patients when nearly half the drug reports in their Electronic Record are WRONG!

    (C) Office notes: Impossible to follow documents due to no consistent organization such as SOAP. They all challenge ones ability to believe that all the questions supposedly asked and answered were done. Frequently they are amusing as when a general surgeon did a serial sevens exam on a 16 year old with appendicitis. I am embarrassed to admit that one positive comment was, “EHR, they’re great – with a single key stroke an OV#2 becomes an OV#4.”

    Health IT is a religion it is not a science. There is NO science to back up your mandates. You may even be violating all health care recipient’s 1st Amendment rights by creating a state religion. Even as staunch an advocate as Vagelis Hristidis in Information Discovery on Electronic Health Records admits that it is a “Belief” that all these measures will improve patient care or efficiency and admits “details on how well are absent”.

    It defies understanding how Bureaucrats have the audacity to pretend that they know better how to care for patients’ needs than medical researchers and practitioners.
    Do you remember your Great Society? You INCREASED poverty. (Charles Murray
    Losing Ground) Remember your Hegel. You are a withered limb.

  85. The Blumenthal era smartly focused success around the concept of “meaningful use,” first as a measure of electronic health record (EHR) adoption and usage, and later as a rallying cry for IT health transformation in general.

    Usage is, after all, tantamount to success. And the converse is also true. “No one knows how many computer-based applications designed at great cost of time and money are abandoned or expensively overhauled because they were unenthusiastically received by the intended users.”
    (“Power, Politics, and MIS Implementation,” M. Lynne Markus, M.I.T. June 1983)

    This is a critical point. The draft Health IT Strategic Plan has, as its ultimate end-goal, improved patient outcomes. This goal cannot be achieved without widespread public adoption of EHR’s. But does the Strategic Plan do enough to address the potential pitfalls and impediments that could undermine EHR usage?

    In my opinion, no. Security and privacy requirements must be made more prominent both in the plan and in practice, with more stringent, regular testing and reporting. Although security and privacy are one of the 5 primary goals of the Plan, the topic commands only 6 pages of the 80-page document (pp 29-35). Also by being listed as Goal number 3 out of 5, the implication is these critcial issues are third in priority or third in time sequence.

    While perhaps an unintended impression, it still conveys the wrong message. Privacy and security are not simply goals; they are foundational to adoption and usage. Thus they are necessary conditions for achievement of all of the other 4 primary goals, and of any continued advancements of the health IT agenda.

    Even the language used in describing “Goal III” is tepid (“stepping up protections,” “discussing major investment in education and outreach”). Notably absent are calls to action that inspire real commitment to regular monitoring and measuring, self-enforcement, and driving continuous improvement.

    Perhaps the ONC believes that more stringent breach notification requirements and increased financial penalties will act as “an invisible economic hand” that guides healthcare providers to implement reasonable and appropriate measures to safeguard ePHI. But a fully comprehensive strategic plan must also include contingency planning – what if breaches continue to increase despite strict breach notification rules and more costly penalties?

    And how does the ONC address the inherent incongruity of requiring public breach notifications for large incidents (500 records or more), while aiming to “inspire confidence and trust in health IT.” How can the health care industry combat the undermining of public trust by being forced to publicize its biggest failures? Personal notification for those impacted is an obvious necessity but is there a cumulative psychological impact to frequent breach PR’s, a repetitive stress injury to the ultimate goal if you will.

    We suggest immediately elevating privacy and security to a higher plane. Rather than a goal, make it as foundational an element as meaningful use, the bedrock of the strategic plan. At Redspin, we suggest calling it “Meaningful Healthcare IT Security.” In fact, we’ve applied to trademark the tagline, not for any proprietary purpose, but to make a point. (We’ll gladly license its use to the ONC for free).

    So what is “Meaningful Healthcare IT Security?” First, it’s an acknowledgement of the complex challenges healthcare organizations face in meeting the sophisticated levels of privacy and security necessary to protect the public. This will not simply materialize out of the “carrot and stick” approach of incentive payments and breach penalties. Second, privacy and security need to be understood as pre-conditions to meaningful use not just a “part of.”

    Next, the “security risk analysis” identified as Core Measure 15 should be defined as more than compliance with the HIPAA security rule. Effective security is a process-driven cycle of regularly-scheduled assessments, validation, remediation, and reporting that delivers continuous and durable improvements in information security and helps develop a culture of security awareness within organizations.

    We want to help meet the ONC’s ultimate goal of improving patient outcomes “by unlocking the vast promise of electronic health information.” But we don’t want to unlock the doors protecting privacy and security.

  86. Nice enthusiasm. Adoption of new technology is usually not driven by choice, but out of necessity. I agree with Dr Hager and add that while adoption is an advantageous ideal it can not be achieved by forcing clinicians to adapt.
    Boxing/MMA Supplies

  87. April 28, 2011

    Honorable Farzad Mostashari, MD, ScM
    National Coordinator for Health Information Technology
    Department of Health and Human Services

    Re: ONC Federal Health Information Technology Strategic Plan 2011 – 2015

    Dear Dr. Mostashari:

    Successful integration of EHRs into the DNA of healthcare delivery will facilitate health information exchange on a global scale with the goal of improving both coordination of care and public health but only if those EHRs are shaped around standards and best practices for capturing and managing patient health information in a practical, patient-centric manner. As the ONC turns its attention toward the usability of EHR systems, it will be critical to define usability from two important perspectives:

    • Usability of the EHR system – Does the system complement the diagnostic process and practical work flow of care providers? Or does the technology ask providers to compromise the care process to “fit” the system?
    • Usability of the information – Does the EHR system facilitate the capture of care encounters in a way that generates truly meaningful information? Or will the critical detail of that care encounter be forced through an EHR filter that results in data that, while capable of aggregation and analysis, is of no practical benefit to or legal support for the provider?

    At great risk of extinction in our pursuit of health information exchange is the patient health story. Every patient has one, and it’s more than just an aggregation of care “data.” It is the chronicle of every care encounter, treatment decision, clinical conversation, and health outcome in a patient’s life from birth to death. Preserving that story will be critical to capturing an information-rich care record for coordinated care and treatment decisions, facilitating truly practical adoption and integration of electronic health record (EHR) systems, and engaging patients in their own care story in a way that empowers them to make better health decisions and meet care compliance goals. And if the goal is a meaningful NHIN, then the story has to matter. The sum is greater than its parts.

    We are in danger of losing this story in the EHR. Physicians and other care providers need the freedom to record as much detail as they feel necessary when documenting a care encounter with a patient. Many EHR systems are forcing physicians into point-and-click entry that is radically changing the way they document patient care, and many are complaining that restricted “data” fields in EHR systems are prohibiting them from documenting the way they need to. (See New York Times article The Doctor vs. the Computer – http://well.blogs.nytimes.com/2010/12/30/the-doctor-vs-the-computer/.) EHR systems should not ask providers to compromise either the care process or the way they choose to document it simply to “fit” the system. This is not, on any level, usability.

    EHR systems must be required to interface with dictation/transcription systems. The dictation-transcription process remains the preferred method of physicians for documenting healthcare encounters because it is easy to use and is time-efficient, allowing physicians to focus on reconnecting with and treating their patients. By making the dictation-transcription process a required component of “meaningful use,” physicians will be more likely to embrace the push for greater EHR adoption and to find the experience of using an EHR to be a positive one for them, their healthcare teams, and patients.

    Required data elements can be tagged and exported from information-rich narrative notes into EHR systems. Contrary to what EHR vendors are reporting, physicians do not have to give up narrative dictation in order to comply with EHR adoption goals. The healthcare documentation/medical transcription sector is already deploying technologies to codify narrative reports, using established clinical nomenclature systems like SNOMED, to tag data elements in those reports and export them to EHR systems to meet meaningful use, core measures, and other clinical reporting criteria.

    In December of 2010 the President’s Council of Advisors on Science and Technology (PCAST) released and discussed its report entitled “Designing a Digital Future: Federally Funded Research and Development in Networking and Information Technology.” Per the press release of December 16, 2010:

    “But achieving the full potential of health information technology will require the development and adoption of a robust information-sharing infrastructure to facilitate the exchange of data among institutions, the report concludes. Unlike conventional electronic health records, which are effectively digital versions of paper charts that are trapped in the offices where they are created, such a
    system would allow health data to follow patients wherever they are, with appropriate privacy protection and patient control, while giving patients’ various doctors a more complete picture of those patients’ medical conditions and needs.”

    If it is truly the goal of electronic health record integration and adoption to improve patient outcomes and quality of care as well as reduce the cost of care for the US healthcare delivery system, the considerations outlined here will be an important part of ensuring that health information, and not just health data, is the compelling objective. Narrative capture must be factored into the equation for generating a meaningful health record if the goal is to create one that truly provides that “more complete picture.”

    You’ll find the position of the clinical documentation/medical transcription sector outlined in our official Comments on Meaningful Use Stage 2 (http://www.ahdionline.org/Portals/0/downloads/CommentsMeaningfulUseStage2CDIA_AHDI.pdf), submitted to HHS last month. We urge the ONC to make protecting the patient story a critical priority in these and future considerations of EHR standardization, integration, and usability.

    Lea M. Sims, CMT, AHDI-F
    Director of Professional Programs
    Association for Healthcare Documentation Integrity
    Clinical Documentation Industry Association

  88. Daryle Gardner-Bonneau, Ph.D. says:

    This is a very ambitious plan (perhaps unrealistically so), and places HIT, as opposed to the physician -patient interaction, at the center of the health care universe. Thus, I am not optimistic that it can succeed. Nevertheless, I have two very specific comments to make.

    In several places throughout the plan reference is made to the need for clinical workflows to be adapted during the implementation of EHR systems. This runs counter to the basic tenet of human factors engineering, which state that tools should be designed to accommodate the needs of the user, the user’s tasks, and the environmental context in which the work is performed. NOT the other way around! Hospitals have spent a lot of time and energy attempting to optimize clinical workflows – only to be told that they need to modify them to accommodate the technology? In a recent webinar attended, it was clear from comments that disruption of clinical workflows created by EHRs are serious. Further, it seems clear that there has been little consideration of the health care professional as a primary user of these systems. Although there is a nod to user-centered design in the plan, there appear to be little interest in assessing the impact of these systems on physician workload or on the quality of the patient-health care professional interaction during, for example, office visits. Patients already complain that their doctors don’t listen because they are too busy multi-tasking. If EHR documentation will require 25% of a physician’s time (as indicated at the webinar), it’s hard to believe that these systems will make the most cost-effective use of these individuals’ skills and abilities. And they may well cause further deterioration in doctor-patient communication.

    My second comment relates to Goal IV. Throughout this section of the plan, the terms “data” and “information” are used interchangeably, but they are NOT the same thing. What is information to a physician may be an utterly worthless mish-mash of data to a layperson. There is little to indicate that the ONC truly understands what patients want and need from EHRs or HIT, generally, and the sparse actions planned for achieving an understanding of patient and layperson needs do not seem likely to be very effective. Do patients really want a summary report of every office visit within three days? I certainly don’t; in fact, this wouldn’t even make my top 10 list of things I want/need from EHRs or HIT. If we’re to design systems that serve patients and laypersons, we need to better understand how they manage their health and their health care. Otherwise, we will never meet their needs. Once again, this argues for a user-centered design process, where both patients and health care professionals are considered as users of the EHR system. And the ONC should distinguish between data and information more clearly. Otherwise, it will provide patients with data they can’t use, rather than information that they can (e.g., don’t send me a medical report of my MRI results – I won’t understand it. Instead, tell me if it’s normal or not and, if it’s not, what I need to do next, if anything).

    HIT is NOT at the center of the health care universe. It has the POTENTIAL to achieve many benefits, some of which were almost stated as “givens” in the plan. But it also has potential to create more problems than it solves, and to increase the cost of health care, if implemented poorly. Unless the needs of all stakeholders are considered via a user-centered design process, the latter outcome is more likely than the former.

  89. I have been in the healthcare documentation industry (in HIM and medical transcription) now for over 30 years. Technology is always changing and many times, it adds value to the health care process. I do, however, have some major concerns about where we are headed now and how it will imipact the quality and safety of patient care.

    With the move to an EHR and the requirements to meet meaningful use criteria, many healthcare providers are moving to things like click box systems. This leaves out the narrative part of the health care record that we have always seen through transcribed reports. Reports from physicians have said that sometimes even when there is room for a narrative, it is limited to so few characters they have to leave something out of the patient’s story. The narrative in a record tells the patient’s story. Without how, how can we, as patients (which we all are at one time or another) begin to trust that our care will be complete or meaningful.

    In addition, the attempt to remove the humans who actually understand the health care documentation process has the potential to lead to even greater errors in the documentation. That cannot possibly serve a patient well. Medical transcriptionists correct and/or flag these kind of errors on a daily basis, working as a part of the health care team to assure that those things that are erroneous do not end up in the final record. In the end, this offers a greater protection to the patients we all serve in health care.

    The medical transcriptionists that are a part of the community at the MT Tools Online site are quite supportive of moving to an electronic health record. What we do not wish to see is the loss of the patient’s story simply to implement technology that, in the end, provides only a part of the story necessary to truly treat the patient. In addition, we have grave concerns that removing the humans who touch those records now will result in even greater discrepancies and misinformation in the healthcare record.

    When physicians find themselves in a situation where doing data entry becomes a major portion of their day, it’s not uncommon to see frustration, and now we have a new emerging “profession” of scribes, who document for the physician. In most training programs for these roles, the training is very short, way too short to truly understand the medical language and adequate document a patient encounter.

    Systems should be planned out with all of the stakeholders involved. It does not seem this is happening as things are being done now. I would urge that we take a step back and be sure the systems we implement indeed do what we need it to do–improve efficiencies and still protect the patient and provide for ways to assure quality patient care.

  90. Dr. Mostashari -

    I appreciate the opportunity to comment on the Federal Health Information Technology Strategic Plan. I would like to first state that I am a supporter for the utilization of electronic health records and believe that health information technology can serve an important role in healthcare delivery. There is a major omission in the proposed Strategic Plan, however, that I find to be a significant area of concern.

    Throughout the proposed Strategic Plan, there is the complete absence of a major component for any successful healthcare – responsibility. Responsibility is lacking within this Strategic Plan both figuratively and literally, as the word “responsibility” does not even appear within the document.

    The absence of responsibility extends throughout the Plan. The government’s proposal includes efforts to “encourage”, “enhance”, “inspire”, and “promote” efforts for the implementation of health information technology, but at no point does the government take ownership or direct responsibility for the results of these efforts.

    The establishment of the Nationwide Health Information Network serves as an example. This Network is supposed to serve as “the preferred solution to securely exchange information nationwide to support meaningful use.” While ONC will establish “a governance mechanism through rulemaking” for the Network, “governance rules will be established as a voluntary solution to health information exchange” and “the government will pursue various options to encourage participation in this preferred solution.” So while the government will create the rules for the health information exchange, and encourage participation in it, it abdicates any responsibility for the outcomes associated with the use of this Network as it remains a “voluntary solution.”

    This aversion to responsibility is even more clearly evident in regard to the proposed requirements that are to serve as the foundation for stages two and three of the EHR Incentive Programs. The Plan calls for these stages to include incorporation of “more sophisticated uses of health IT, such as clinical decision support, patient registries, reminder systems, and changes to workflow and clinical care redesign.” The current Strategic Plan, however, fails to address or even consider the repercussions that these requirements will have on the participating providers.

    Specifically, the Strategic Plan does not contain any assessment or consideration for the legal consequences and liabilities that these government programs will create. These consequences include important and very practical issues, such as the medical malpractice implications that may result from the incorporation of clinical decision support into the EHR system. The handling and management of patient data caused by participation in registries is another source of significant legal questions, such as when the provider’s responsibility for securing the patient’s data ends and the health information exchange’s responsibility begins.

    To address this deficiency regarding the legal responsibilities, I would recommend adding an additional “Goal VI” to the current Strategic Plan. This Goal would be to “Address and Clarify the Legal Ramifications of the Adoption and Utilization of Health IT.”

    Finally, the most significant omission of “responsibility” in the Federal Health IT Strategic Plan is the lack of any discussion regarding the responsibilities of one of the major participants in U.S. healthcare – the ‘private’ commercial insurance companies.

    If the Mission for this Plan is “to improve health and healthcare for all Americans”, then the commercial insurance companies must be an active participant in this program. These companies play a major role in the management and utilization of healthcare resources in this country. If the current Strategic Plan truly represents the national health IT agenda, then the private insurance companies must be integrated into this plan to a degree commensurate with the position that they currently hold in healthcare, including fully defining their role, the degree of their participation, their financial contribution, and their responsibilities.

    Once again, I am very thankful for the opportunity to comment on the Federal Health IT Strategic Plan. I hope that my comments are helpful and constructive, and I look forward to the final version.

  91. The Personalized Medicine Coalition (PMC), recognizing the vital importance of health information technology (HIT) as an enabler and accelerator for the adoption and development of personalized medicine, wishes to highlight a recent paper by the Brookings Institution calling attention to the need for federal investment in HIT to facilitate the connectivity, integration, and data analysis necessary to help researchers understand what types of therapies will work for what types of people and to spur innovation in personalized medicine.

    The PMC believes that the current meaningful use guidelines for federal funds for HIT insufficiently consider how they can and should assist the advancement of personalized medicine. As a result, the nation may lose an opportunity to transform health care. With the declining costs of genome sequencing and rapid advancements in the field of personalized medicine, it is critical that federal policies are developed to utilize these advances. The Brookings paper seeks to improve policymakers’ understanding of the critical intersection between HIT and personalized medicine.

    We would also like to point to the specific policy recommendations from the paper:

    1) creating “meaningful use” rules from the Office of National Coordinator of the Department of Health and Human Services that facilitate more effective use of health information technology for personalized medicine.
    2) reducing the isolation of health research from clinical practice, and creating mechanisms that connect information from multiple sources into databases for secondary usage.
    3) developing privacy rules that strike the right balance between privacy and innovation.
    4) having differentiated codes for various molecular or genetic tests so that researchers can link genomic information to disease diagnosis and treatment.
    5) building data systems and language semantics that help researchers compare, evaluate, and frequently update information.
    6) enabling feedback loops so that new discoveries get incorporated into treatment. Faster knowledge management would enable “rapid learning” models and evidence-based decision-making on the part of physicians and public health officials.
    7) deploying predict models in physician practices to help them handle the flow of information from medical history, vital signs, genetic background, and lab testing into diagnosis and treatment.
    8) funding CMS and NIH projects demonstrating the value of innovation in health care.

    The full text of the Brookings paper is available for download at http://www.brookings.edu/papers/2011/0128_personalized_medicine_west.aspx.

    Thank you for your consideration.

    Sincerely,

    Timothy A. Swope
    Policy & Communications Analyst
    Personalized Medicine Coalition

    About the Personalized Medicine Coalition
    The Personalized Medicine Coalition (PMC), representing scientists, patients, providers and payers, promotes the understanding and adoption of personalized medicine concepts, services and products to benefit patients and the health system. For more information on the Personalized Medicine Coalition, please visit http://www.PersonalizedMedicineCoalition.org.

  92. April 29, 2011
    Farzad Mostashari, MD, ScM
    National Coordinator for Health Information Technology
    Department of Health and Human Services

    Dear Dr. Mostashari,
    The eHealth Initiative welcomes the opportunity to comment on the 2011-2015 Federal Health IT Strategic Plan.

    eHealth Initiative (eHI) is an independent, non-profit, multi-stakeholder organization. Its mission is to drive improvements in the quality, safety and efficiency of healthcare through information and information technology (IT). eHI advocates for the use of health information technology (HIT) that is practical, sustainable and addresses stakeholder needs, particularly those of patients. The comments below were developed through our multi-stakeholder consensus process.
    eHI commends ONC for producing an update of the 2008 Strategic Plan that reflects the impact of the HITECH Act and the Affordable Care Act. We also appreciate the creation of new goals, objectives and strategies that support the vision of a health system that uses information to empower individuals and to improve the health of the population. The comments that follow address the Strategic Plan objectives, rather than the plan’s strategies. Before commenting on the objectives, we offer the following general comments:
    1. The inclusion of a wide group of healthcare settings and providers is important to the successful execution of the objectives and strategies of the Strategic Plan. Facilities and providers that are not currently eligible for Meaningful Use Incentive Payments, including home health, long-term care, substance abuse, mental health and dialysis, should be included in the Plan to support its goals.
    2. Some of the objectives in the Plan may require greater detail in order to operationalize their respective strategies.
    3. The objectives and strategies should more clearly articulate the expectation that HIT and HIE will support empowerment of individuals as participants in the healthcare system as our understanding of the needs of the individual and as technologies addressing those needs develop over time.
    4. It is important that an evaluation component for the objectives and strategies is included in the Strategic Plan, to facilitate appropriate modifications based on experiences in the field. This addition should be aligned with the ongoing effort to evaluate whether current standards can support the objectives and strategies of the Plan. Since the Plan is a multi-year strategy, a continuous learning element is appropriate.
    5. It is important that ONC appreciate the scope of potential and concurrent federal healthcare reporting and regulatory activity in the Strategic Plan. Alignment of the Strategic Plan with the health system redesign efforts will enable the HIT and HIE infrastructure expansion to be aware of rising expectations. The eHealth Initiative, in comments on Stage 2 Meaningful Use preliminary recommendations, also noted the multiple healthcare regulatory requirements that are impacting the healthcare system simultaneously. For your reference, our February 25, 2011 comment letter is found at http://www.ehealthinitiative.org. Additionally, recommendations from reports ranging from the National Broadband Plan, the National Health Security Strategy Biennial Implementation Plan, and the Comprehensive National Cybersecurity Initiative also may influence and should be factored into the direction of the Strategic Plan.
    6. The broad array of federal departments and agencies should be considered in the context of programs and activities can support the Strategic Plan goals. Some, such as the Department of Education, support the delivery of healthcare services via prescribed care plans, and their inclusion within the scope of coordinated government activity can improve the Strategic Plan overall.
    7. Participation by broad stakeholders, large and small, should be facilitated and ONC is urged to continue utilizing varied different approaches to incorporate diverse audiences.
    8. A strengthened role for ONC is needed in the coordination and alignment of disparate federal efforts, and this alignment activity could include the identification and removal of duplicated requirements. To enable this role, we recommend that ONC establish a coordinating committee that defines the alignment and coordination of federal activities and proceeds in an open manner, with public reporting and opportunities for the public to participate.
    9. It is important that ONC take a broader view of the opportunities associated with EHRs and other initiatives, such as health information exchange. The opportunity extends beyond meaningful use (MU). For HIE, it is important to view the investment as akin to the creation of the Interstate Highway system, as the value of EHR adoption and HIE extends beyond the initial stages of meaningful use.
    10. The Federal Health IT Strategic Plan should support the connectivity and exchange between the healthcare delivery system and the public health system. This plan should support efforts to improve the health and wellness of the public, as people live, work and recreate outside of the clinical environment.

    eHI comments on specific objectives:
    Goal I: Achieve Adoption and Information Exchange through Meaningful Use of Health IT
    1. The efforts to accelerate adoption of EHRs by providers should consistently convey the value of EHRs as a tool for improved engagement by providers and patients. Objectives in goals 1 and 4 are mutually supportive.
    2. The Federal government can foster business models that support greater information exchange. Objectives in this goal should include strategies to encourage the review and removal of regulatory barriers to sustainable exchange, with federal health programs setting the example
    3. The goal, strategies and objectives are appropriate and we highlight the importance of Strategy I.A.7/8 on aligning across federal programs and private payers, while urging a measured and monitored approach to penalties so as to avoid unintended adverse consequences. Strategy I.A.9, on usability, should be done in a way that does not hinder innovation nor create federal dictates for EHR interfaces or architecture and that uses valid and reliable measures that enhance and do not interfere with the EHR technology market.
    4. For Objective B, facilitating information exchange to support MU, we agree with plans for more robust and rigorous HIE use in advanced MU stages and urge ONC to build from the proven base of standards-based HIE, with a rapid shift to bi-directional and robust HIE that supports “pull” and query as well as “push”. We support the continued drive toward widespread exchange capacity, while urging continued awareness that this progression will occur at varying rates in communities around the country.
    5. With respect to steps to implement the recommendations of the PCAST report as discussed in the Strategic Plan, although we support the overall goals of that report, including meta-data tagging of healthcare data, we urge caution in pursuing the specific PCAST implementation recommendations. Like others who have reviewed this report, including the HIT Policy Committee, we have substantial concerns about the practicality and desirability of many of these recommendations and urge an approach that builds on current standards and technology, such as the ability of HL7 CDA documents, like the CCD, to provide a robust approach to meta-tagged data and the availability of standards based health information exchange, using Integrating the Healthcare Enterprise profiles, to provide for effective queries of distributed healthcare information.
    6. While we support the notion that using HIT is essential to the practice of modern medicine, we urge caution that requirements driving HIT adoption not become mandates that are the equivalent of an additional certification or accreditation requirement for the practice of medicine. The variation among and the distinct qualifications for practice within given medical specialties necessitate a flexible approach that leverages health professional education and ongoing professional development to support the appropriate use of HIT by clinicians and their ability to meet MU requirements.

    Goal II: Improve Care, Improve Population Health, and Reduce Health Care Costs through the Use of Health IT
    1. We support the identification and implementation of best practices that use EHRs and other HIT to improve care, efficiency and population health. We encourage ONC to include evaluation metrics as a means to measure achievement.
    2. As EHR adoption information is received by the RECs and the HITRC, there should be evaluation criteria to identify best practices that are applicable broadly and those which allow for flexibility to accommodate particular circumstances. In addition, we encourage the release of best practices and educational information beyond the RECs and to the public at large.
    3. We encourage ONC to include strategies to identify and disseminate best practices in the use of HIT and HIE in population and public health.
    4. Although we agree with the importance of HIT for administrative simplification, MU is not the best vehicle to promote these proven tools.
    5. We urge the inclusion of strategies that anticipate the advancement of personalized medicine in the diagnosis and delivery of healthcare through the accelerated capture of data on various diseases.

    Goal III: Inspire Confidence and Trust in Health IT
    1. The reference to final regulations implementing the HITECH modifications to the HIPAA Privacy and Security Rules and breach notification is vital, as communication about these regulations will build consumer awareness of their rights and government efforts to protect them. eHI encourages ONC to continue efforts to advance the Goal III objectives at a concurrent pace with Goals I, II and IV, in order to build consumer trust and awareness.
    2. We suggest ONC support the communication to the general public about the best practices identified and implemented by Cooperative Agreement awardees in order to build confidence in HIT and HIE.
    3. We are concerned that a two-year strategy of education and outreach to patients may not adequately address new developments and best practices and urge ONC to reconsider the timeline to reflect efforts to improve safety and security that may occur in later years.
    4. It will be essential that this effort strikes the right balance between protection and practicality so as not to hinder development and use of HIT to achieve the best healthcare outcomes. We urge the federal government to continue to collaborate with scientific and technical standards organizations as well as the public to develop solutions that balance the interests of all stakeholders. In addition, in pursuing Strategy III.C.1, it is important that ONC and the RECs not seek to dictate contracting approaches between providers and vendors.
    5. We agree with the balanced approach to patient safety in the plan and welcome IOM’s work in this area.

    Goal IV: Empower Individuals with Health IT to Improve their Health and the Health Care System
    1. Although an important component of data-sharing, the Blue Button model should be considered a minimum approach to provide patients access to EHR data. In particular, sharing CCD formatted data along with human readable data, provides a high level of shareable, clinically relevant, comprehensive health data to enhance continuity of care.
    2. eHI agrees that consumers are an important voice in the policy making process. By involving consumers actively in the policy-making process, they are able to contribute critical information and potential solutions that other stakeholders might never consider. As a result, they become invested in new approaches and will help ensure their success. Full engagement of consumers in leadership and decision-making roles at the policy and gov-ernance levels is essential, not just for gaining their trust and buy-in, but also for maximizing the likelihood of meeting patient and consumer needs.
    3. Further, eHI believes consumers are ready and will¬ing to work collaboratively in a number of expanded roles: as agents of change; informed decision-makers; sources of verification and contextual information; and decision-makers about how best to integrate better health into the context of their lives. Individuals must be supported by health IT in each of these transformational roles.

    Goal V: Achieve Rapid Learning and Technological Advancement
    1. We believe that a learning health system will require greater incorporation of educational information in EHRs in addition to healthcare information.
    2. We suggest that ONC acknowledge future healthcare trends, such as personalized medicine, as factors that will impact the healthcare system and factors that the Strategic Plan will need to support.
    3. eHI believes that it is important to continue efforts to improve upon the principles of privacy, consent, data use and other issues associated with this goal.
    4. ONC cites many distinct initiatives in this goal, and eHI encourages ONC to facilitate the sharing of findings and results across all of the initiatives to avoid building redundancies, as well as to ensure that they are incorporated as broadly as possible.
    5. We are concerned, however, that the current plan primarily focuses on the public sector, and we urge ONC to reach out to and encourage broad private sector involvement.

    eHealth Initiative appreciates the opportunity to comment on ONC’s Health IT Strategic Plan. We look forward to providing any further information in support of your efforts.

    Sincerely,
    Jennifer Covich Bordenick
    Chief Executive Officer
    eHealth Initiative

  93. Mary Louise Lowe says:

    April 29, 2011

    U.S. Department of Health and Human Services
    Office of the National Coordinator for Health Information Technology

    RE: Federal Health IT Strategic Plan: 2011-2015

    Dear Sir/Madam:

    Thank you for the opportunity to make comments on Federal Health IT Strategic Plan. This comment addresses the third goal of the strategic plan: To inspire confidence and trust in health information technology.

    Thus far ONC’s focus on privacy and security for health information exchange (HIE) appears to be built upon the existing ‘trust” fabric of our current health system. This means it is leveraging off of the relationship of the patient with their provider. This patient-provider trust is founded on the historical premise that the conversations with their healthcare provider will remain confidential. In developing the HIPAA Privacy Rules, healthcare providers emphasized that they already had an ethical duty to limit the sharing of unnecessary medical information and most already have well-developed guidelines and practices in place. (65 FR 82462, 82712.)

    Certified electronic record systems do not require segregation of the data to enable sophisticated role-based access to the patient’s medical information. It is questionable if the guidelines and practices developed for paper records can even be used. Recognizing that as technology in the heath sphere becomes more sophisticated, it will permit more granular policies to reflect this historical preservation of confidentiality, the question becomes what will be the driver for this evolution in the use of technology to protect privacy: “patient demand” or government requirements? What would “patient demand” look like?

    With the financial incentives and governmental drive to implement HIE without these needed protective security functionalities in the electronic record systems and the failure to provide for or to recognize the role of the patient in making an informed decision on when, to whom and why their information will be used is a significant failure in the design of this element of health care reform. The unnecessary disclosure of confidential medical information to even authorized users breaches the traditional notions of privacy.

    Similar to the failure in education reform, we do not have metrics to determine when patients no longer trust their health system. We now have nearly a third of high school students not graduating. We need to pause when we see populations acting against their own their self interest and their abandonment of our educational system at such great numbers will have long term impacts on our society. What metrics do we have as we go forward with the current electronic medical record systems to see the impact? It took us years to learn the “Texas educational success” was the result of low performing students leaving the system and not improved educational outcomes.

    As a patient, if you seek healthcare, and your provider is an implementer of an electronic record system that does not segregate the data and does not have robust access controls, what is written by the doctor is equally available to anyone who has access to the system. Medical information in the unstructured notes and all of your historical medical information, family history, social and lifestyle are all available for accessing and in large systems there can be thousands of individuals with authorized access. This means a records clerk in another business building down the street can get access to these records and the expense and technology to audit and detect these individuals reduces the probably that it will be detected. Currently, only a 60% detection rate is reached through self-detection.

    This is the current state of technology and practice that is serving as ONC’s “foundation for trust” for the development of HIE. It is a fragile foundation for HIE and without metrics, we won’t know if we have succeeded or failed. Measuring costs and quality outcomes will not measure the patients who delay treatment or develop mistrust of their health care provider and do not discuss their symptoms or lifestyle factors. Medicine has always promised confidentiality and under these current electronic medical record systems, it can’t.

    Certification of electronic record systems must include segmentation of the data, robust access controls and auditing practices. Requiring affirmative consent, after an informing of the vulnerabilities of these systems, will provide the needed metric. Poor enrollment is an indicator that the systems do not meet consumer expectations. ONC needs to take a longer view and get this fundamental of healthcare- maintaining the confidentiality between the patient and their provider-functioning first. Expanding HIE without adequately addressing privacy and security is folly, especially without appropriate metrics to detect unintended consequences.

  94. David Harlow says:

    I am writing as Chair of the Public Policy Committee of the Society for Participatory Medicine. The Society represents individual and institutional members nationwide including patients, non-professional caregivers, and clinicians. It was founded to study and promote participatory medicine, which is centered around networked patients shifting from being mere passengers to responsible drivers of their health, and providers who encourage and value them as full partners. For further background on the Society and its tenets, we invite you to peruse the Society’s website (http://participatorymedicine.org), its online journal, The Journal of Participatory Medicine (http://jopm.org) and its blog, e-patients.net (http://e-patients.net).

    Our comments focus on Goal IV of the Federal HIT Strategic Plan – “Empower Individuals with Health IT to Improve Their Health and the Health Care System.” This Goal breaks down into three Objectives, and a number of Strategies to achieve each Objective. The Goal and Objectives are laudable, but we would seek to strengthen the Strategies — by involving patients in the development of the system — so as to increase the likelihood of achieving the Goal in a meaningful way, and to do so sooner than five years from now.

    One overarching comment on this Goal is that it is not integrated with the concept of care coordination, which is discussed elsewhere in the strategic plan. In order to fully realize the goal of patient centeredness, the patient must be involved in the coordination of his or her care. This omission highlights the perspective of the ONC on health care as something that is provided to patients rather than as a partnership process that involves patients, clinicians and non-professional caregivers. The patient-centeredness criteria promoted as part of the proposed rule on Accountable Care Organizations should be incorporated into the Strategies used to achieve this Goal. While these criteria are not all health IT-specific, the ONC makes the point in the strategic plan that that health IT enables patient empowerment, transparency, and achievement of the Triple Aim. Thus, all process, systems and standards improvements called for in the patient centeredness portion of the ACO rule should be brought to bear on the health IT strategic plan.

    Objective IV.A: Engage Individuals with Health IT.

    Strategy IV.A.1: Listen to individuals and implement health IT policies and programs to meet their interests.

    Comment: We applaud ONC’s willingness to participate informally in online public dialogue, but we would like to see greater transparency to this informal communication so that each conversation is not known only to members of a particular group. We would also like to see ONC crowdsourcing suggestions of additional forums in which to participate, and documenting these interactions in a central online public repository. The Society would welcome the opportunity to participate in the more formal mechanisms for public input (i.e., the federal advisory committees, and their subcommittees and workgroups). We believe that the voice of the patient could be better heard, and individuals more effectively engaged, if there were a patient advisory council established to advise the ONC on further development and implementation of the strategic plan, rather than limiting patient input to a seat on a subcommittee or workgroup. The Society would welcome the opportunity to participate in such an advisory council as well.

    Strategy IV.A.2: Communicate with individuals openly and spread messages through existing communication networks and dialogues.

    Comment: We would encourage ONC to pursue its strategy of communicating through existing networks and social media. We further recommend that ONC work with the Society to initiate annual, national and perhaps regional patient-oriented symposia or conferences on patient-oriented health IT to share developments and seek input on what is working and not working from a patient perspective.

    The existing forms of communication with patients, and even inventories of resources for patients, are disappointing. For an eloquent comment on how this is so, please see Regina Holliday’s recent blog post entitled “One of Us. One of Us.” at http://reginaholliday.blogspot.com/2011/04/one-of-us-one-of-us.html (4/22/2011). It is a compelling explication of a recent allegorical painting of hers. A brief excerpt follows:

    >I went to the [HHS Health IT meaningful use] site and at the top of the page you can click on a large link field with a picture of a stethoscope labeled Information for Providers or you can click on a field with two faceless Caucasian avatars labeled “Information for Consumers”. On the provider side you will learn about the importance of accurate patient data, the power of CPOE and CDS and the money saved by implementation. You will see that CMS has incentives tied to implementation. You will see the ONC is available to help you. You will find out about REC’s, HIE’s and Beacon Communities. There are 22 active links on this page that will lead you to hundreds of other links that will explain the legislation and process more fully.

    >But if you hit that faceless link for Consumers you will see two Paragraphs. The first is a very brief overview of the power of EHR’s to improve medicine. It has one active link to a dead end pdf explaining EHR’s more in depth. The next Paragraph is about Privacy. If you hit that link it will lead you to a page entitled, “Privacy and Security.” This page contains 20 links to various white papers and pdf’s about privacy in relation to the EHR.

    >Has comparing two links on HHS page ever made you cry? It made me cry. It made me cry to see so little was expected of patients. On those pages it seems as though we are only consumers worried about privacy and security and little else. It seemed our research paths are one way communication only and not open to discourse.

    Objective IV.B: Accelerate individual and caregiver access to their electronic health information in a format they can use and reuse.

    Strategy IV.B.1: Through Medicare and Medicaid EHR Incentive Programs, encourage providers to give patients access to their health information in an electronic format.

    Comment: Mere access is not sufficient. It must be linked with education of patients and providers regarding the value that may be created by active sharing of information, so that information is not simply provided in a printed or electronic visit summary. It is critical to link clinical information to diet, exercise and other lifestyle and behavior choices made by patients between visits to their health care providers, and to resources patients can access in making healthy choices. In addition, clinical summaries should contain references to online information and communities that the provider can recommend to the patient as being most reliable and relevant to his or her condition. Finally, there should be greater standardization across visit summary formats (think: nutrition label on packaged food) so that patients may have reasonable expectations about what information they will receive from providers, and so that they may readily absorb information presented in these records.

    Strategy IV.B.2: Through federal agencies that deliver or pay for health care, act as a model for sharing information with individuals and make available tools to do so.

    Comment: The Direct Project and Blue Button projects have demonstrated the ease with which information may be transferred, but they are not conduits for secure messaging or structured records. Patients need the ability to access structured data and share it with other providers, regardless of network affiliations, and with family members, friends or other caregivers. Easy access to data in the ways that make the most sense to patients is critical, and input from a patient advisory board would allow ONC to better focus government investment in the right tools.

    Strategy IV.B.3: Establish public policies that foster individual and caregiver access to their health information while protecting privacy and security.

    Comment: ONC should promote easy sharing of patient health care data (including claims data) with patient-oriented computer and smartphone applications (“apps”). This sharing and aggregating of data will allow for analysis of data in new and potentially useful ways.

    Objective IV.C: Integrate patient-generated health information and consumer health IT with clinical applications to support patient-centered care.

    Strategy IV.C.1: Support the development of standards and tools that make EHR technology capable of interacting with consumer health IT and build these requirements for the use of standards and tools into EHR certification.

    Comment: OCR should shy away from reinventing the wheel when seeking to systematize standards for interoperability and data integration. The perfect is the enemy of the good, and pursuing development of new standards (a la PCAST) rather than building upon existing standards and protocols may unnecessarily delay achievement of the goals of the ONC Health IT Strategic Plan, to the detriment of patient care and patient centeredness in the meantime. (Without endorsing a particular standard, the Society notes that the Continua Alliance has developed one, and seems to have achieved a critical mass of device and communications systems constituents.)

    Strategy IV.C.2: Solicit and integrate patient-generated health information into EHRs and quality measurements.

    Comment: Every patient encounter already starts with patient-generated insights. ONC should seek to leverage health IT to implement real-time two-way communication between patients and care teams. Patient insights, together with data generated by monitors (the two types of patient-generated information identified in the strategic plan), must be integrated in to the clinical information workflow. I am the leading expert on my own health, and the information that I provide should not be discounted or distrusted merely because I am not a clinician.

    Strategy IV.C.3: Encourage the use of consumer health IT to move toward patient-centered care.

    Comment: ONC should promote certification of apps based on their utility in managing care as demonstrated through research, so that apps that work to improve quality and reduce cost may be provided to patients by their providers or insurers at no additional out-of-pocket expense. Identifying resources and removing price barriers in this manner is the health IT equivalent to making primary care available without copayments, as promoted by the Affordable Care Act. This is another sort of investment that should be encouraged by ONC which may be expected to yield significant returns in terms of improved care, efficiency and population health outcomes.

    • Ray Arias says:

      David, Very insightful comments, thank you for taking the time to share such detailed thoughts. I will certainly look into your website. All this is well and good but to meet some of these goals there must be a language services perspective. The fact is, there is a very large segment of our healthcare patient population that does not speak English. 60 million heathcare encounters in 2009 of over 1 billion encounters were non-English speakers, these make up a very large portion of the health disparities cost that our nation pays.

  95. How is this relevant to The Federal Health IT Strategic Plan? Last published in 2008, I’ll give the updated plan points for “adjusting” to the rapidly changing landscape of health IT. The past few years were marked by truly major legislation – the HITECH Act and the Patient Affordable Care Act have galvanized organizations throughout the industry; each mapping out their own specific organizational goals and initiatives. We are now on the verge of dramatic changes.

  96. Comments of the California Medical Association on the Draft Federal HIT Strategic Plan

    Dr. Moshtashari,

    On behalf of the California Medical Association (CMA), thank you for the opportunity to comment on the draft HIT Strategic Plan (HITSP). CMA is deeply committed to helping physicians to access the opportunities provided by the HITECH Act, and, more importantly, to prepare their practices for the
    advent of health reform.

    CMA has prepared a list of comments on the proposed plan, presented below. We have organized our response by the goals laid out in the plan document.

    Thank you in advance for your consideration of our comments.

    Leslie Kim, MD
    Chair, CMA Council on Information Technology

    Comments on Goal I

     Objective A, Strategy I.A.8: Work with private sector payers and provider groups to encourage providers to achieve meaningful use.

    CMA supports the intent of this objective and would like to work with the ONC to make it a reality in California.

    If the HITECH Act is successful in encouraging providers to adopt EHRs, and in developing robust HIE networks, most of the benefits of those technologies will not accrue to physicians, they will go to patients (who receive better care) and to payers. The payers may save substantial amounts of money if there is a marked reduction in duplication and waste because of better data systems.

    With that in mind, the private payers should be more involved in fostering EHR adoption than they are at the moment. For example, private payers could follow the government’s lead in providing incentives to providers for demonstrating effective EHR use and reduce barriers to adoption. They could also provide funding to support the development of health information exchanges.

     Objective A, Strategy I.A.4: Encourage the inclusion of meaningful use in professional certification and medical education.

    CMA acknowledges the intent of this strategy, to encourage the inclusion of properly-implemented
    HIT in medical education. We believe, however, that this strategy needs to be restated to meet its intent. We recommend that the strategy read: “Encourage the inclusion of health information technology in medical education.”

    Meaningful use, as it is used in this context, is a brand new concept specific to the HITECH Act. As of the writing of these comments, the very first providers are submitting their attestations of meaningful use to Medicare. Thus, it is not well known whether meaningful use is properly constructed, or whether it will provide true benefits in patient care. Therefore, it would be very premature to encourage its inclusion in medical education.

    What will be necessary, however, is that students in medical school and medical residents learn about the proper use of health information technology. The students and residents of today are going to practice in a very different world than the one that exists today. They need to be comfortable with new technologies which will be part of the practice of medicine in the future.

     Objective A, Strategy I.A.6: Communicate the value of EHRs and the benefits of achieving meaningful use.

    CMA would recommend a more balanced wording of this strategy. The ONC needs to present, to providers and patients, the benefits and the risks of EHRs.

    Having an honest and open discussion about the risks of EHRs will allow everyone involved to collaborate and develop strategies for mitigating them. In addition, ONC will be seen as a more credible messenger if you are providing a more balanced message.

    CMA recommends the following wording: “Communicate the benefits of EHRs and engage stakeholders to develop strategies to identify and mitigate risks.”

     Objective B, Strategy I.B.3: Ensure that health information exchange takes place across individual exchange models, and advance health systems and data interoperability.

    This is a laudable goal, but we believe that the reverse must be stated as well.

    Many HIEs currently functioning are privately held by IPAs, hospitals, and others. In addition, several of the large HIE companies are now held by private health plans. This makes it possible that exchanges will, for competitive reasons, attempt to block the flow of data from one place to another.
    With that in mind, CMA recommends adding: “Prohibit exchange networks from blocking exchange for reasons other than patient privacy.”

     Objective C, Strategy I.C.1: Ensure public health agencies are able to receive and share information with providers using certified EHR technology.

    CMA supports this objective, and asks that the ONC make this a priority. Specifically, CMA believes that the federal government should make more resources available to the help modernize the public health infrastructure and bring them into the world of HIT. This will help physicians to access meaningful use incentives, and help improve public health overall.

    In the requirements of meaningful use, providers select five measures out of a “menu set” of ten. One of these five measures must be a public health item – either reporting to public health agencies or reporting to immunization registries.

    The problem is that many of these public health agencies are not currently able to receive electronic submissions. The federal funding that has been allocated to date has not addressed this problem. If adoption of HIT is going to improve public health, this will have to be addressed.
    Beyond meaningful use, there are many other entities that should be brought into a broad-based public health infrastructure. These include school-based health centers, nursing homes, and long-term care facilities. A public health crisis could well appear first in one of these settings. It is important that they are able to share data electronically.

    Objective C, Strategy I.C.2: Track health disparities and promote health IT that reduces them.

    While CMA supports the use of telehealth to expand access to care, we object to the notion of lowering standards for licensure to allow physicians to provide care across state lines.
    CMA has long advocated for California to have very rigorous licensing standards in order to protect patients. All physicians providing telehealth services should be fully licensed in the state where the physical office visit is taking place.

    Comments on Goal II

     Objective A, Strategy II.A.2: Create administrative efficiencies to reduce cost and burden for providers, payers, and government health programs.

    CMA strongly supports this objective.

    One of the strongest arguments for widespread HIT adoption for individual physicians is the promise of creating administrative efficiencies. This simplification, however, has been slowed by multiple redundant processes created by both public and private payers.

    There are many policy changes the ONC could support which would speed this process. These include uniform prior authorization, immediate responses to authorization requests, uniform coding and billing, and many others.

    While some of these changes would have to be made in state laws, support from the federal government for them would help state medical societies and others to advocate for them.

     Objective B, Strategy II.B.1: Identify specific measures that align with the National Health Care Quality Strategy and Plan.

    Besides meaningful use, public payers are pursuing many other quality reporting programs right now. Medicare’s Physician Quality Reporting Initiative (PQRI) is probably the best known. Under federal health reform, Medicaid (Medi-Cal) will also be instituting quality reporting measures.
    For physicians, the proliferation of different quality reporting schemes will be administratively difficult if all of these programs select different measures. Therefore CMA requests that the federal government standardize quality reporting across all programs, and encourage the private payers to do the same.

    For example, meaningful use requires all physicians to report on six clinical quality measures, almost all of which were taken from the PQRI program. These measures should become the standard for Medicaid programs and private payers, since certified EHRs will already be built with templates for reporting them.

     Objective D, Strategy II.D.3: Ensure a mechanism for information exchange in support of research and the translation of research findings back into clinical practice.

    In this strategy, the ONC indicates that data in EHRs should be “accessible by researchers, research systems, biorepositories, registries, and other research databases.” Ostensibly, this data would be used for research about clinical treatments and effectiveness.

    While there is some promise to this approach, it would be beneficial to ensure that data flowed back to the physician creating it to inform them about their own practices. This would give individual physicians the chance to analyze their own data, possibly relative to other similar practices, and learn from their results.

    CMA requests that the ONC work with state HIE grant recipients to build mechanisms whereby physicians could access the same data which is proposed to be gathered for research purposes.

    Comments on Goal III

     Objective B, Strategy III.B.1: Inform individuals about their privacy and security rights and how their information may be used and shared.

    Often, the best advocate for the privacy of a patient’s data is their physician. Since the physician develops the medical record, they should have some knowledge and control over how it is used. Therefore, it would be beneficial for the ONC to work with provider organizations as well, to educate physicians about how to advocate for their patients in this regard.

    CMA requests that this strategy be amended to state “Inform individuals and health care providers about their privacy and security rights and how their information may be used and shared.”
    CMA, and probably many other medical societies, would be more than willing to help ONC with such an education campaign.

     Objective B, Strategy III.B.3: Require easy to understand reporting of breach notifications.

    Under the changes made to HIPAA in the Stimulus Act, physicians will be responsible for notifying their patients if their records are compromised – known as a “breach notification.” The OCR is developing final regulations to implement this rule.

    One step the ONC and OCR could take to make this rule more workable for physicians is to create a standard breach notification that physicians could download and use. This would eliminate confusion for both physicians and the public.

    Comments on Goal IV

     Objective A, Strategy IV.A.1: Listen to individuals and implement health IT policies and programs to meet their interests.

    Although the ONC has several advisory committees – most notably the HIT Policy Committee (HITPC) and the HIT Standards Committee (HITSC) – these committees meet in and around Washington, DC. This limits the public’s ability to engage in their deliberations.
    CMA respectfully requests that the HITPC and the HITSC hold regional meetings to hear from physicians in various parts of the country. This would probably be most beneficial to those living in the West, who have the hardest time getting to meetings on the East Coast. These regional meetings may also have the effect of engaging interested parties who may not currently be actively involved in HIT issues.

     Objective B, Strategy IV.B.3: Establish public policies that foster individual and caregiver access to their health information while protecting privacy and security.

    Giving patients access to their own health information, and thus involving them in their own health care, is a central part of the promise of health IT adoption. That being said, CMA would like to raise a concern that there are complexities that need to be considered in this process.

    For example, the document indicates that CMS and the OCR are looking at methods through which individuals would be allowed to request access to their lab results directly from laboratories. A lab result, absent the interpretation of a physician, may not mean anything to a patient. Worse, it may mislead the patient into trying to interpret their own results and thus self-diagnose.

    Through the adoption of personal health records (PHRs), individuals should receive lab results in a much more timely fashion than they do right now. But they will still receive them through their physician, who is trained to interpret them.

    CMA urges the ONC to look for the balance between engaging patients in their own care and overwhelming them with information which may not be beneficial.

     Objective C, Strategy IV.C.2: Solicit and integrate patient-generated health information into EHRs and quality measurements.

    CMA would like to express serious concern about this strategy. A medical record is a clinical document, and it needs to be as clear and cohesive as possible. While it is important for physicians to listen to their patients’ insights into their own care, physicians need some discretion to maintain the integrity of the record.

    There are currently no standards for patient-generated content, so the technology to consistently and effectively implement this strategy nationally does not exist today, nor is it likely to be available for several years. To then add this as a quality measure by 2015 seems premature. CMA would request that this strategy be reassessed to include only technology which currently exists and can be implemented by providers at reasonable cost or eliminated altogether.

    Comments on Goal V

     Objective A, Strategy V.A.1: Establish an initial group of learning health system participants.

    CMA believes there is real promise in the idea of a learning health system. Our only caution is that the health care system across the country is very diverse – different patient populations, different delivery systems, etc. Therefore, what is learned in one location may be very different than what is learned in another.

    CMA would urge the ONC, as you develop the list of participants, to ensure that they represent a wide variety of practice, geography, specialty, and patient mix. It is only with this diverse set of providers that the ONC will get truly meaningful results.

  97. May 3, 2011

    Farzad Mostashari, MD, MPH
    National Coordinator for Health Information Technology
    Department of Health and Human Services

    RE: Public Comments on the ONC Federal Health IT Strategic Plan 2011 – 2015

    Dear Dr. Mostashari,

    Practice Fusion Electronic Health Record welcomes the opportunity to provide comment on the proposed 2011 – 2015 Office of the National Coordinator (ONC) Federal Health Information Technology Strategic Plan (the Plan). Our perspective is that of a rapidly growing web-based EHR community.

    We would like to congratulate the ONC on the development of a thorough approach to improving health in the US through strategic deployment and Meaningful Use of health information technology. Practice Fusion believes the ONC’s holistic approach will be highly successful in addressing the significant gaps in HIT adoption and utilization across the US and would like to present comment on a few key areas of the Plan.

    Achieve Adoption and Information Exchange Through Meaningful Use of Health IT
    Web-based EHRs are currently experiencing the mature stages of the ‘tipping point’ phenomenon described in the Plan. In fewer than three years, vendors have reached a critical mass of providers, worked with them to fully utilize their EHR system, and built significant functionalities that enable instant connectivity. This tipping point phenomenon will require significant, nimble manpower on behalf of legacy EHR vendors employing the client-server model to service the needs of thousands of doctors in the US.

    The staged approach to Meaningful Use for eligible professionals will enable a positive transition to digitized medical records, but it will also put intense pressure on vendors to distribute updated software versions to providers. Adoption of the Stage 1 certified version of EHR software has been very slow among legacy EHR vendors. Currently, legacy vendors have significant queues for software updates. Recently, a major legacy EHR vendor announced that an estimated 16% of their clients had upgraded to the certified version of their software over the course of approximately 6 months. If this adoption rate is held constant for all of their clients, it would take the company over 3 years to upgrade all users to the Stage 1 version of their EHR system.

    Web-based EHRs operate on a model that provides an inherent advantage for certification updates – they are available to providers over the course of weeks rather than years. Given the short time that will be required both for engineering and distribution under the current Meaningful Use timeline, web-based EHRs are likely to become increasingly dominant, particularly among small-practice providers. The Plan does not explicitly address this issue. We recommend that the ONC accounts for this likely reality by building provisions into the Plan that compel the ONC to analyze the ability of legacy EHR vendors utilizing a client-server model to distribute the certified version of their software. The Plan must support providers who will not be able to achieve Meaningful Use due to legacy vendor upgrade queues, which has the potential to significantly slow HIT adoption and progress towards Meaningful Use.

    The Plan also states that the federal government will work in close coordination with state governments to help evolve current information exchange models to serve every health care provider in the country. Current information exchange models do not necessarily account for the web-based EHR and its innate form of connectivity. The Plan indicates that new models of connectivity will be of a lower priority than existing models, yet models such as that offered by web-based EHRs present a highly appealing connectivity opportunity that is much faster than traditional models. Web-based EHRs currently can connect tens of thousands of users to each other instantly with no local or regional level middlemen.

    The local connectivity model works very well for legacy vendors that enable users to store their data at the doctor office or hospital level. Web-based EHR vendors have innovated to find creative answers to difficult connectivity questions. For example, web-based EHRs users utilize a centralized connection hub to a national e-prescribing network. This hub requires development, support, and maintenance of just a handful of interfaces, rather than the typical tens of thousands of unique interfaces that have historically been required to connect this many providers. Web-based EHRs offer a highly unique form of connectivity that should be explored further within the Plan.

    Connectivity on the web-based platform facilitates rapid and seamless information exchange. Web-based EHR’s growing user base will be capable of securely exchanging health information among providers with no need for an intermediary. These vendors will be involved in information exchange with external providers as well. This effort will again require strict adherence to standards. The Plan does not address how the ONC will ensure this strict adherence.

    Empower Individuals With Health IT to Improve Their Health and The Health Care System
    Practice Fusion is proud to fully support the ONC’s goal to empower individuals with HIT. Web-based EHRs committed to helping to create a patient-centric health system will ensure that their platforms are open for device and application connectivity. An API enables developers to quickly and easily create communication between devices and the EHR, which gives patients the ability to easily populate their personal health record (PHR) with key health data and create a virtual mode of communication between provider and patient.

    Practice Fusion applauds the ONC’s vision of vision a future where care is centered on the patient and health data flows easily between the patient and provider. This will create a more holistic view of a patient’s health and he or she will take greater responsibility for their health by generating data that will provide greater insight to physicians. Diagnosis and treatment are better tailored to meet the patient’s individual needs, outcomes are dramatically improved, and costs are lowered.

    General Comments
    The Plan is comprehensive and includes a holistic strategy for dramatically improving the health care system with a strong focus on patient care and experience. Practice Fusion applauds the authors’ vision as well as their strategic prioritization of key areas.

    Given the significant emergence of web-based EHR platforms and the connectivity opportunities they afford, Practice Fusion would like the Plan to reflect greater clarity on how web-based EHR vendors will be integrated into key policy and standards decisions. The voice of the web-based vendor must be heard and integrated in discussions that will have significant downstream effects on the use and positive benefits of HIT.

    We sincerely hope that you find these comments useful in the development of the final draft of the 2011-2015 ONC Health IT Strategic Plan. Practice Fusion is excited to play a strong and active role in helping the ONC to realize its vision. If you have any questions about our comments or would like any further information, please don’t hesitate to contact us.

    Sincerely,

    Dr. Robert Rowley
    Chief Medical Officer
    Practice Fusion

    Thomas McMennamin, MBA, MPH
    Health Policy Manager
    Practice Fusion

  98. Dan Rode says:

    Given that the formatting of these comments has changed, we will send an attachment copy to the Coordinator’s Office.

    May 2, 2011

    Kathleen Sebelius, MPA
    Secretary
    US Department for Health and Human Services (HHS)
    Room 603 Hubert H. Humphrey Building

    Farzad Mostashari, MD, ScM
    National Coordinator
    HHS Office of the National Coordinator for Health Information Technology (ONC)
    Room 729-D Hubert H. Humphrey Building
    200 Independence Avenue, SW
    Washington, DC 20201

    RE: Federal Health Information Technology Strategic Plan

    Dear Madam Secretary and Dr. Mostashari:

    In response to the Office of the National Coordinator (ONC) request for comments on the Federal Health Information Technology Strategic Plan (Plan), this letter is written on behalf of the more than 62,000 members of the American Health Information Management Association (AHIMA). While the comments are due to ONC, AHIMA believes that the Plan impacts much more than the ONC efforts regarding health information technology (HIT). We believe the Plan needs to incorporate a variety of HHS efforts and requirements if the goals of the Plan and legislation including the ARRA-HITECH and ACA are going to succeed.

    AHIMA
    AHIMA is an 83-year old non-profit professional association comprised of individuals educated and certified in health information management (HIM) or closely aligned with HIM functions and principles. These HIM professionals work throughout the healthcare industry performing a variety of functions associated with healthcare data and information as well as the protection and analysis of health information.

    With this background and given the Association’s history of promoting the use of electronic health record (EHR) systems and electronic health information exchange (HIE) we scrutinized the Plan and would like to offer our comments, questions, and concerns. This letter is divided in two parts. We begin with general comments on the Plan and its goals, and then we have devised a table, based on Appendix F to comment on the strategies.
    General Comments on the ONC Strategic Plan

    ARRA-HITECH Mandate
    • AHIMA believes that in HITECH Subtitle A – Promotion of Health Information Technology – Congress mandates the National Coordinator and ONC take on the promotion of health information technology (HIT) for the nation. This task, as stated, is not just applied to the federal government and HHS programs but the healthcare industry as a whole. This belief is reflected in Section 3001 (b) and further reflected in the makeup of the HIT committees required by this Subtitle. Healthcare providers must interface with both public and private entities in the course of exchanging health information. Any activity to change this process or spur it on must therefore include all the parties in the healthcare industry (industry) if it will successfully synchronize the adoption, implementation, and use of HIT for the entire US population and not just those covered by Medicare and Medicaid. Never before have our members seen such an opportunity for advancement in the use and protection of health information and we recommend that HHS, ONC and other engaged federal departments move to engage the industry and its consumers to meet the goals expressed in the Plan.

    • In the belief that the HIT committees should reflect the interest of consumers and the healthcare industry, we suggest that improvements in quality, efficiency, safety, and patient-centeredness will not be achieved, even with EHR systems, if providers’ systems and processes must be different for communicating or reporting to healthcare entities outside of the federal government. This same barrier of variety applies to of non-standards based consumer electronic applications. As long as the US healthcare has a multi-payer (health plan) systems and consumer applications, the need for uniformity in communication and data standards is absolutely required.

    • A clear HHS strategic plan with industry input and commitment would serve to be a guide path for the entire industry to allow for the proper budgeting and planning by all stakeholders in order to see the necessary goals achieved. Accordingly, in addition to expanding this Plan across the government and the industry, AHIMA recommends that there be additional hearings and comment periods to achieve consensus on a plan to move HIT forward.

    • We want to be clear that in suggesting this federal role for health information policy and standard, we are not suggesting it is the government’s role to determine technology. As we have seen over the past decade US technology is capable of moving the healthcare industry forward in a number of innovative ways; however, without uniform policy and standards, better technology will not bring us closer to the goal of interoperability, and the improvements highlighted in the Plan.

    • Privacy and security protections are a significant part of building trust in the healthcare system; however, there is a balance between privacy and the benefits of EHR systems and HIE. This is the balance of confidentiality. The more uniform our confidentiality practices can be the better trust that can be maintained, but inconsistency in requirements breeds inconsistency in compliance. AHIMA believes that the federal government should be working much more closely with state governments to achieve uniformity of privacy and security requirements.

    Specific Comments on the ONC Strategic Plan and Goals (Pg. 4)

    Introduction
    • The Introduction begins with a discussion on technology. There is no doubt that technology is a significant enabler in achieving the stated goals, as is the funding Congress has set aside. However, there are also the enablers of applied health information management and informatics to address how the technology will be used effectively to achieve the Plan’s goals and other Quality and Patient Safety goals not only for implementation but also on an ongoing basis. The technology and the management of the technology must be sustained by the collective users of the systems, process structures, and the data. This includes healthcare providers and consumers of healthcare as well as a myriad of partners engaged in quality measurement, research, public health, and other appropriate uses.

    • The Introduction also stresses the Plan as “developed in collaboration with other federal partners, for realizing Congress and the Administration’s health IT agenda.” As we indicated above, AHIMA believes to achieve the Plan’s goals this “partnership” must be expanded to the entire industry and its consumers.

    Goal I: Achieve Adoption and Information Exchange through Meaningful Use of Health IT (Pg. 9)
    • Recognition of all federal requirements: While it is clear that significant resources have been made available under HITECH, we remain concerned that the resources, such as Regional Extension Centers (RECs) and federal EHR certification have not recognized the EHR needs of providers beyond the Meaningful Use (MU) requirements. Other HHS programs under the Centers for Medicare and Medicaid Services (CMS), the Centers for Disease and Prevention (CDC), Health Resource and Services Administration (HRSA), and the Substance Abuse and Mental Health Services Administration (SAMHSA) also have needs that must be met or these providers will fail to qualify for healthcare payments and be subject to other penalties. This Plan should account for other federal and perhaps industry changes (known or unknown) throughout its life to support administrative simplification and compliance.

    • LTPAC involvement: Goal I’s introduction identifies long term care or post acute providers (LTPAC) and promises their integration into the Plan and its goals. To build systems and improve communication and quality, these LTPAC providers must be built into the program, now! For example, not all discharges of a hospital result in the patient going home with follow up care rendered by a practice plan (that hopefully is another meaningful user). Many patients receive care from home health agencies, nursing homes, etc., and must have real time information if the goals of this Plan will succeed. It is unfortunate that Congress did not anticipate this need; however this must be addressed soon.

    Goal I Objective A: Accelerate adoption of electronic health records (Pg. 11)
    • Meaningful Use in Professional Certification: AHIMA also suggests requiring medical education programs to include health information management principles and best practice education domains for electronic health information exchange in relationship to cost savings, quality outcomes, and incentive programs. Included in such education must be the value of documentation related to what clinicians should ensure are entered into the record for both clinical care as well as population and continual learning objectives.

    • Encourage and facilitate improved usability of EHRs: AHIMA supports the convening of workgroups that will provide perspective on improved EHR use and encourages HHS to ensure inclusion of health information management professionals in these workgroups.

    Goal I Objective B: Facilitate information exchange to support meaningful use of EHRs (Pg. 14)
    • Inclusion of federal and state programs: While the paradigm of payment is transforming, the change itself depends on transformation that is cost prohibitive. Aligning plans and requirements such as state and regional HIEs and Medicaid programs by HHS will help to facilitate this transition at a much lower cost. Among the different programs such as MU and Accountable Care Organizations (ACOs) the incentives are defused among HIE, Direct, and similar programs and the message on moving forward is not necessarily consistent. Furthermore there must be a concerted effort with State administrations and legislatures to develop uniform laws and regulations for the exchange of information across state lines and recognition that healthcare services have no border. Otherwise, problems for providers whose patients have crossed these artificial boundaries will continue to hamper the Plan’s goals.

    • AHIMA applauds the Goal’s standards discussion (18); however:
    o Best practices: It is important to realize that beyond standards for the electronic storage, transmission, access, and use of health information, there also exists “standards” or best practices that relate to the surrounding work flow. Organizations such as AHIMA have been involved in developing and maintaining these best practices for years and should be consulted to ensure best practices are used for effectiveness and potentially for efficiency (See http://www.ahima.org/resources for more information).

    o Active industry involvement: To be effective, standards must apply to the entire industry. AHIMA believes that HITECH has provided a framework for such an approach as noted under HITECH Section 3001. We further believe that all sectors of the industry must be actively included in this structure as members of these committees and their respective workgroups and task forces. The transparency of these committees is also extremely important to achieve trust in the process from the industry as well as consumers.

    o Involvement in and governance of data standards: The Plan identifies the various federal agencies involved in healthcare-related terminologies and classifications, but does not acknowledge that in the US there are other terminologies and classifications used in the industry or the fact that many terminologies and classifications are international which calls for active US involvement. Because these terminologies and classifications must work as a set and not individually, it is important that the US establish public-private governance over all of these terminologies and classifications.

    In 2007 AHIMA and the American Medical Informatics Association (AMIA) recommended how these terminologies and classifications might be governed. The environment has changed since then; but the concepts continue to be relevant:
     The need for such governance and harmonization continues to exist;
     The oversight for this governance needs to be specialized since terminology and classification standards require specialized knowledge; and
     This body must have an active involvement in international terminologies and classifications bodies.

    The National Library of Medicine is the best federal agency to serve as the directorate over such a governance and harmonization process; however, we suggest that it may be time for HHS to consider if there needs to be a consolidation of the federal terminology and classification standards bodies rather than operating them in the several sections of HHS. While the DRG system was the original cause for such division, now that we are working toward using clinical information and outcomes for payment, we believe it may serve the industry to move these into a more clinical setting.

    o Impact on Quality: The Plan appears to some extent to keep the status quo in terminology and classification standards use; however, it is clear from the Quality Strategic Plan that it may be time for the US to consider using one of the international classifications for functionality. The sooner this could be identified in the final strategic plan the better.

    Goal II: Improve Care, Improve Population Health, and Reduce Health Care Costs through the Use of Health IT (Pg. 22)
    • Administrative Simplification: AHIMA appreciates ONC’s recognition of the potential for improvement within the ACA administrative simplification section. As a leading advocate for the legislation creating this section, AHIMA believes that HHS must now move quickly to establish the uniform guides that the HIPAA transactions so urgently need. While the process is underway, under the National Committee for Vital and Health Statistics (NCVHS), given its voluntary nature, NCVHS is slow in developing its recommendations in comparison to other process and systems changes in the healthcare industry.

    Transaction changes in the future: AHIMA also suggests that HHS consider how guidance will be developed as the process for claims and reimbursement changes. We note that consideration must be given for the reporting mechanisms now served by the HIPAA transactions, as new reporting requirements are developed for MU and other CMS and ACA programs. The process of healthcare reimbursement is changing. Data that served the industry for the last 30 years (since DRGs in 1983) will not suffice for the needs and use of more granular data in reimbursement, quality, and public health. Therefore, it may be necessary to call upon the various standards development organizations (SDO)and industry data professionals to revise what data needs to be exchanged and how it can completely, uniformly, and economically be exchanged while maintaining patient confidentiality and the concept of minimum necessary and data integrity.

    It may also be necessary for the US healthcare industry to consider changing its transactions that have essentially represented decades old paper documents, format, and limitations in favor of considering the data to be reported and not the limitation of previous reporting systems. For example, already with the upgrade in HIPAA transactions using the ASC X12 designated transactions CMS has announced the desire to receive all diagnoses and procedures related to an encounter or admission rather than just truncating this information at nine diagnoses and 6 procedures due to previous paper limitations. The ability to now receive more information should provide significant data not always previously available, including the severity of the illness of an individual being served.

    • Streamline HIPAA transaction upgrades: Along with guidelines for the HIPAA transactions, the ACA administrative simplification legislation called for a more streamlined process to update the transaction standards. In light of the comments above and other activities in HHS, AHIMA suggests that HHS consider updating this process as soon as possible and also determining how updates might apply to the standards associated with HITECH and ACA clinical transactions as well.

    • Reporting quality measures: The ability to report on quality and outcome measures will also enhance US healthcare. However, AHIMA cautions HHS not to design measures that must be built into the EHR; rather, EHRs should be designed and updated to capture the information (documentation) that allow the EHR to be used to collect once – use many times. “Collect once – use many times” is AHIMA’s concept to ensure that documentation activities are performed for all information needs of an EHR and not just to meet reporting requirements. AHIMA believes that a well documented record, maintained with data integrity as a requirement, can serve a multiple of uses – most importantly primary care information, but also the many secondary uses pointed out in the Plan including its Learning goal. Documentation or record collection activities should consider not only information entered by the care givers and the patient, but also remote monitoring, tele-health, and other future applications being pursued by the healthcare industry.

    Goal III: Inspire Confidence and Trust in Health IT (Pg.29)
    • Support: AHIMA agrees with the Plan’s reliance on the Fair Information Practice Principles and the Nationwide Privacy and Security Framework for Electronic Exchange of Individually Identifiable Health Information. Likewise, we support the approach of working with all federal agencies whose privacy or security requirements impact the healthcare industry directly or indirectly.

    • Uniformity of confidentiality requirements: AHIMA recommends that the Plan be extended to include the States, territories, etc., in the development of a comprehensive privacy and security policy and requirements. AHIMA members are often the professionals (HIM directors, privacy, or security officers) that must direct the compliance with these requirements across governmental and geographical boundaries. Practical compliance to these varied requirements is difficult and often creates a barrier to EHR development and consumer trust in the organization’s stewardship of their health information. The inconsistency within federal programs did not necessarily improve with the implementation of HIPAA. In the years since HIPAA privacy and security rules were first implemented there have been a myriad of new federal and state laws and regulations, not to mention impeding changes brought about by ARRA-HITECH. In addition, Congress is now also considering Internet privacy legislation that could affect healthcare. The federal government must bring some order to this situation.

    • Access to health information: Too often privacy and security have been seen as designed to only relate to the disclosure of health information. AHIMA believes that the Plan must designate work with industry professionals such as HIM to determine the present and future policy, process, and technology that permits access to health information by the individual or designated representative and by other providers who need the information to treat the individual when and where it is needed. While goals and strategies can be set for five years, activities to ensure their success should be developed for an on-going process beyond five years given that technology development will almost certainly create new privacy concerns for the foreseeable future. We must also consider the impact of public health, research/clinical investigation, and other uses of healthcare data that are much too siloed from the data collected for clinical data in our process for consent.

    • Data Integrity: AHIMA also recommends that ONC and HHS add the element of data integrity to its approach to security and privacy. Our concern for data integrity directly relates to patient safety and the value of health information and is under-represented in the Plan. Patient safety can also be affected by a variety of requirements that ignore the movement of data or information from inception across a variety of primary and secondary users. Security requirements may be put in place, but must acknowledge the need for data integrity across all primary and secondary uses.

    • Privacy Protection and Enforcement: While significant work has been done in the information systems industry to ensure the security and protection of data, it is clear that there is no absolute security other than complete destruction. AHIMA, therefore recommends that the Plan be expanded to include HHS working with other federal departments and the courts to develop legislation and regulation that will:
    o Bar inappropriate discrimination against an individual on the basis of his or her health information;
    o Bar the intentional and unintentional misuse of health information by any entity or individual; and
    o Establish effective penalties for and active prosecution of these discriminations or misuses so that individual citizens will recognize and be confident in the industry and governments’ desire to ensure the confidentially and protection of health information wherever it exists.

    Goal IV: Empower Individuals with Health IT to Improve their Health and the Health Care System (Pg. 36)
    • Technology Gaps: AHIMA supports the goal of empowering individuals, but must note that technology innovations for individuals are outstripping the move forward in technology within the healthcare industry. Many providers in the industry are overwhelmed trying to establish a base in EHR systems involvement in HIE, as well as employing interoperable standards for transactions and data. The promise for individual empowerment is very bright and it is good to involve consumers with the industry. However, the state of the industry’s technology must be understood as to what it can deliver, especially as it moves from a disjointed paper-based set of systems to a hybrid state, and then on to an anticipated fully electronic, coordinated and interoperable system. Making early promises to the consumer or issuing over-stretched requirements may only serve to retard the movement forward. AHIMA believes that engagement of HIM experts can assist the development of federal government strategies as they have been for the Veterans Administration and other locations.

    Goal V: Achieve Rapid Learning and Technological Achievement (Pg. 42)
    • AHIMA supports the learning concept as discussed in this goal. We are concerned with the strategies related to inclusion of private entities and timing. We believe the strategies within this goal must be entwined in the previous goals and strategies and there must be recognition of what can be achieved in the technological advancements that are outpacing the healthcare industry. We have suggested throughout our comments the need to ensure that HHS and ONC develop strategies and an implementation plan or map that considers the healthcare environment and its interdependencies and all HHS and state requirements as it moves forward to achieve the goals of the Plan and HHS. It is crucial for the federal government to include the industry in the planning and implementation of this Plan, as well as consumers, so that no one is left behind and the Plan becomes a means of achieving the overall goals of health improvement and efficiency. Along with technology, our learning must be one of constant assessment of the healthcare environment and the application of learning, policies and technologies to keep progressing.

    Other General Comments
    • The strategic Plan must include “crossover” activities that include other federal departments, agencies, or offices. For instance, the Bureau of Labor and Statistics (BLS), Department of Labor, should be charged with following those job classifications that will maintain electronic health records, record systems, registries, analysis, exchange, and protection to ensure a well functioning and maintained infrastructure in the future. Current BLS job categories do not reflect today and tomorrow’s anticipated functions with EHRs and HIEs.

    • The Plan should provide more depth in the anticipation of the National Institute of Standards and Technology (NIST) activities that should be engaged so the healthcare industry does not ignore advances made by NIST and other industries in areas that also apply to HIT.

    Specific Strategy Comments and Recommendations

    Our specific comments and recommendations with regard to the strategies are as follows:

    Goal I: Achieve Adoption and Information Exchange through Meaningful Use of Health IT
    Objective I.A Accelerate adoption of electronic health records
    I.A. Strategies AHIMA Comments
    1 Provide financial incentive payments for the adoption and meaningful use of certified EHR technology (Pg. 11) • Certified Technology should meet the needs for all HHS requirements beyond MU, and should be used to ensure policy and standards also conveyed to purchasers.
    • This strategy suggests that in MU Stage 3 HHS will move from technology to outcomes. The strategy should also specify how providers will be engaged to incorporate changes in healthcare delivery into the requirements. Such changes could impact interactions with other health plans/payers.
    • It is crucial that EHR systems and the ancillary systems that are also engaged support provider and patient decision making within an organization or network.
    2 Provide implementation support to health care providers to help them adopt, implement, and use certified EHR technology (Pg. 11) • The Plan’s discussion on barriers should be rewritten to recognize the other competing resources being used to meet government and industry requirements and does not recognize or suggest the need to integrate and prioritize HHS programs and goals to make for the most efficient and effective implementation over a reasonable period of time.
    • RECs and HCCN should be required to include all HHS required implementations and readiness into their component offerings to assist providers in meeting all requirements not just MU.
    3 Support the development of a trained workforce to implement and use health IT technologies (Pg. 11) • The strategy should be expanded so that HRSA and/or HHS and the Department of Labor (DoL) must examine and acknowledge the future needs for various healthcare workforce members, including HIM professionals, and take steps to work with educators and agencies to accommodate the necessary programs and students needed to meet this need. The initial HITECH funding will end soon and will not meet the need for this decade. More assistance is needed for healthcare professions as a whole and especially in the area of HIM and informatics expertise if the investment being made is to fulfill its expectations.
    4 Encourage the inclusion of meaningful use in professional certification and medical education (Pg. 12) • HIM professionals are educated and certified to be the stewards of health information ensuring its integrity, protection, and availability to benefit consumers and their healthcare providers. The components of meaningful use exist in HIM education from the associate degree though master degree programs and certification similarly exists from the basic coder through Registered Health Information Administration. At one point in time it was a Medicare requirement that the health information management certification was needed to manage a health information management function in a hospital to ensure that these stewardship principles were engaged. While the process of HIM is changing from paper and manual processing to electronic the need for such expertise is only growing. HHS should consider not only certification and education, but also consider requiring such certification to ensure adequate stewards of health information no matter where it exists.
    5 Establish criteria and process to certify EHR technology that can support meaningful use criteria (Pg. 12) • As noted, EHR systems or modular certification must incorporate all appropriate HHS requirements not just MU.
    • EHR certification must also be directed to all healthcare providers and not those currently identified in MU.
    • Certification should Incorporate PHR-EHR standards as developed by HL7 so that there is some standard for consumer access or transfer.
    • ONC should look at the previous work done by the Certification Commission for Health Information Technology to determine if other work not previously accepted by ONC should now be mandated and also look at work done beyond acute and physician care.
    6 Communicate the value of EHRs and the benefits of achieving meaningful use (Pg. 12) • The strategy should indicate that HHS will work with professionals engaged in the adoption, implementation, and use of EHRs for this education effort. Such an education effort needs to tell the story of how EHRs and HIE can facilitate and enhance the significant progress being made in healthcare delivery and science as well as how information needs to be used on a secondary basis for quality, public, and the advancement of healthcare science. These secondary uses should not be siloed in the minds of the population from clinical care and the public need to know of existing barriers that should not exist and the benefits from information use that must be permitted. Such stories must also include a meaningful approach to safeguard individuals from discrimination or the misuse of their information through prosecution of those who use data inappropriately. While it is true that given today’s exchange of information socially, medically, and for other reasons negates the potential for 100% de-identification much can be done to minimize the risk and achieve even greater advances in healthcare.
    7 Align federal programs and services with the adoption and meaningful use of certified EHR technology (Pg. 13) • AHIMA applauds this action but suggests that the strategy show that HHS and ONC will include consistency of data, systems, terminologies and classifications, etc., in such an alignment.
    • Federal programs like VA and Tricare, Indian Health Services need to be integrated; however, goals will be achieved sooner if other private health programs can be standardized and integrated into the criteria as well.
    8 Work with private sector payers and provider groups to encourage providers to achieve meaningful use. (Pg. 13) • This “encouragement” strategy must recognize the needs of providers and plans to succeed – therefore uniformity of requirements should also be achieved throughout the industry.
    • Meaningful use and EHR system criteria should take on the concept of “Collect once – use many times” which AHIMA has been advocating. Providers should be encouraged to use the system and data to improve quality internally. All stakeholders should achieve consensus so that the various uses of secondary data can be achieved with the data included in the record and not attempt to put requirements directly in the record itself.
    • HHS must also work to encourage innovation in the documentation processes associated with EHR systems since an EHR is only as good as the information that is entered into the systems.
    • HHS and ONC’s work must include states healthcare programs including Medicaid.
    9 Encourage and facilitate improved usability of EHR technology (Pg. 13) • AHIMA agrees and encourages ONC and industry stakeholders to share usability results to encourage not only MU reporting, but improved internal use of information.

    Goal I: Achieve Adoption and Information Exchange through Meaningful Use of Health IT
    Objective I.B. Facilitate Information exchange to support meaningful use of electronic health records
    I.B. Strategies AHIMA Comments
    1 Foster business models that create health information exchange (Pg. 15) • Direct provides a means for data exchange on an immediate basis – but the Plan should indicate how it will step up providers using Direct to the next level of exchange (state or regional exchanges) and beyond.
    • Neither MU nor the Accountable Care Organization NPRM reflect the geography of HIE. While Direct providers a means to move data outside of the HIEO’s boundaries, it does not alleviate the multiple issues facing HIEOs. The strategy needs to be demonstrating a clearer, staged, transformation to address all of these issues including privacy, security, and consumer involvement.
    2 Monitor health information exchange options and fill the gaps for providers that do not have viable options (Pg. 16) • The steps taken have been good ones; however, states need to be working together (not just ONC monitoring) to address geographic issues with healthcare delivery and the need to exchange information across political boundaries.
    • As states support providers and enhance key trading partners’ capabilities, AHIMA strongly recommends that the Plan indicate that health information management policies and best practices will be examined and appropriately incorporated in exchange models. The HIM professionals have addressed the issues of master patient indices, record locators, and registries for a number of years and have accumulated a significant body of knowledge in this area.
    3 Ensure that health information exchange takes place across individual exchange models and advance health systems and data interoperability (Pg. 17) • The basis for all exchange is the healthcare data itself. While strides have been made to facilitate the exchange and reporting of data in a variety of ways (and this should continue to improve), the strategic plan must also address the technology and processes needed to ensure that documentation captures the information generated in the encounter, admission, procedure, or ancillary service that makes up the record. Without good documentation capture and assurance of integrity for the information that moves from initial documentation to the record to other data repositories for decision making, research, quality, etc. the data is useless or dangerous.
    • Terminology and classification use and exchange must also have a governance process to ensure crosswalks, versioning, and other factors that must exist are in place and used by ¬all healthcare providers in all cases. The Plan should include reference into the establishment of such a governance and oversight.
    • The Plan should note that the US will be looking for additional terminology or classification use that can provide even more data such as functional status classifications used around the world.
    • This information exchange highlights the need to integrate the Plan with other HHS activities such as the adoption of ICD-10-CM/PCS. This objective and strategy should be expanded to do so.
    • The use of meta data is important as AHIMA has pointed out in previous testimony and comments; however, outright adoption of the PCAST recommendations which are a significant shift from the strategy the industry has been following will not serve to move the industry forward in its existing proposal. Furthermore, to adopt the PCAST meta-data proposal with a new universal language will not only provide additional barriers, but also require a delay until such a language can be developed. The parts for an interoperable exchange of data already exist – they just have to be used and healthcare providers must agree that proper documentation for care will be created in the first place.
    • The Plan should reflect the need for the HIT Committees and ONC to expand their horizons beyond MU to promote true interoperability.

    Goal I: Achieve Adoption and Information Exchange through Meaningful Use of Health IT
    Objective I.C. Support health IT adoption and information exchange for public health and populations with unique needs
    I.C. Strategies AHIMA Comments
    1 Ensure public health agencies are able to receive and share information with providers using certified EHR technology (Pg. 19) • The objective comes across as though the US has a single public health (PH) system. Experience indicates this is not the case and, unfortunately, at a local level PH agencies are not consistently engaged nor are the various PH systems being integrated into HIEs. This is especially true where providers are turning to other means of communication such as Direct.
    • The Plan needs to signify that there needs to be a transparent local-state-federal (PH) approach to address these issues that includes the industry, state and local government, as well as the state HIEs. As pointed out in the previous administration’s AHIC deliberations, PH is very disjointed while disease does not recognize political borders. If the work this objective identifies is to succeed there must be broader and committed participation sought to achieve this goal.
    2 Track health disparities and promote health IT that reduces them (Pg. 20) • AHIMA applauds this strategy and the use of the RECs and Beacon Communities. As noted above this should not be a siloed activity, but fully integrated into the other activities so the industry understands where it will be expected to amalgamate these requirements into practices and systems.
    3 Support health IT adoption and information exchange in long-term/post-acute, behavioral health and emergency care settings. (Pg. 20) • AHIMA agrees that non-MU eligible healthcare providers must be integrated into EHR/HIE adoption as soon as possible. This strategy should point out that integration must also include the different offices within HHS that often through their regulations and requirements perpetuate segregation. AHIMA is aware that different federal oversight offices require different and sometimes conflicting data as part of their processes; this should not exist in the continuum of healthcare. Standards for data and data sets should exist across all HHS offices/federal health plans and not be permitted to vary.

    Goal II: Improve Care, Improve Population Health, and Reduce Health Care Costs through the Use of Health IT
    Objective II.A: Support more sophisticated uses of EHRs and other health IT to improve health systems performance.
    II.A Strategies AHIMA Comments
    1 Identify and implement best practices that use EHRs and other health IT to improve care, efficiency, and population health (Pg. 24) • AHIMA agrees with this objective given our HIM professionals’ decade’s old record of identifying and promoting best practices. Accordingly we suggest the Plan also incorporate a process and means to scan the industry for practices that can be use generically as well as practices that might fit one or more segments of the industry. AHIMA is very interested in participating in such a process and already has structure for such activities.
    • AHIMA and its related state associations stand ready to work with local REC and HRSA groups to assure consistent implementation of best practices that recognize all industry needs and not just those of the federal government.
    2 Create administrative efficiencies to reduce cost and burden for providers, payers, and government health programs. (Pg. 24) • AHIMA has been actively involved in a number of administrative simplification projects related to acute and non-acute care. We believe the Plan must recognized that the process of information collection and reporting must change as the concentration on clinical information becomes the basis for so many of the programs for quality, public health, research, etc., and not just for reimbursement purposes. This is a needed change and must bring together government and industry professionals to develop these new approaches and determine the best way to integrate and implement these changes into industry practice.
    • AHIMA could not agree more on the value that ICD-10-CM/PCS will provide; however, the implementation of ICD-10-CM/PCS needs to be better identified in the overall Plan and in the requirements for Meaningful Use and other programs. Such alignment must recognize the strain on provider and vendor resources and on the mixed messages currently being sent that MU is much more important than ICD-10 leaving the latter in a state of limbo in many healthcare leaders minds.
    • To fully benefit from the implementation of the ICD-10-CM/PCS, the industry through further development of the EHR, and HHS through its HIT standards committee, must integrate terminologies into the software that will permit the EHR data to be transformed into various classifications that can provide information for multiple purposes previously discussed and the ease and simplification sought in this goal.
    • Since the interaction (mapping) of these terminologies and classifications is not currently in place to the extent needed, HHS must develop in the Plan steps and entities that can integrate such mapping over time potentially starting now and extending well past 2015. This would not only include terminologies such as SNOMED-CT® and LOINC®, but also classifications like ICD-10-CM/PCS, CPT®, and functional status codes.
    • The HIM profession envisions an environment in the not too distant future where EHRs embedded with terminologies like SNOMED-CT can automatically develop the codes that are used for reporting via certified encoding-like software. This is another radical change that will ease the administrative costs associated with healthcare.
    • AHIMA has repeatedly called upon HHS and the industry to develop a public-private governance process that can be associated with the National Library of Medicine to oversee and manage this integration while assuring the integrity of the process and the data that will result from such an integration with the EHR and future government and industry requirements.
    • The issue of health insurance exchanges is also in flux in the industry and HHS needs to be more explicit on how such an exchange will be a part of, or overlap, the health information exchanges especially at the state level. There could be efficiencies, but such a marriage could also raise anxieties related to the security and privacy of PHI.

    Goal II: Improve Care, Improve Population Health, and Reduce Health Care Costs through the Use of Health IT
    Objective II.B: Better managed care, efficiency, and population health through EHR-generated reporting measures
    II.B. Strategies AHIMA Comments
    1 Identify specific measures that align with the National Health Care Quality Strategy and Plan (Pg. 25) • As noted previously the Plan, in order to accommodate the other goals such as quality, should ensure that the ability to use EHR based terminologies and related classifications for the ability of collecting once – using many times be developed and accepted.
    • AHIMA believes it is in the best interest of data integrity and administrative simplification that measures used should be uniform and consistently used among all entities collecting or reporting quality measures or value sets. We continue to support the work of the NQF in identifying value sets for this purpose and urge HHS to subscribe to a uniform approach in tandem with the industry and its providers.
    2 Establish standards, specifications, and certification criteria for collecting and reporting measures through certified EHR technology (Pg. 25) • As noted above this establishment must be done in tandem and concert with the industry and its providers

    Goal II: Improve Care, Improve Population Health, and Reduce Health Care Costs through the Use of Health IT
    Objective II.C: Demonstrate health IT-enabled reform of payment structures, clinical practices, and population health management.
    II.C. Strategies AHIMA Comments
    1 Fund and administer demonstration communities to show how the advanced use of health IT can achieve measurable improvements in care, efficiency, and population health. (Pg. 26) • AHIMA agrees with the concept of using these Beacon communities, but notes the importance to also pilot new ways of ensuring adequate collection of health information within the EHR systems and HIE options and reporting such data.
    2 Align health IT initiatives and clinical and payment reform, pilots and demonstrations. (Pg. 26) • AHIMA supports the concept of aligning and integrating reforms and demonstrations; however, HHS/ONC should further define how the industry and its various sectors, in full, will participate in this as an industry process and not a top down federal process.

    Goal II: Improve Care, Improve Population Health, and Reduce Health Care Costs through the Use of Health IT
    Objective II.D: Support new approaches to the use of health IT in research, public and population health, and national health security
    II.D. Strategies AHIMA Comments
    1 Establish new approaches to and identify ways health IT can support national prevention, health promotion, public health, and national health security. (Pg. 26) • The integration of public health needs to be much better integrated into the mainstream of healthcare at the local level including into programs such as health information exchange and accountable care organizations.
    • Along with this integration at a local level, the public health processes must be better integrated from top to bottom including addressing the relationship of various public health entities at the local, state and federal level. On and off since 2001, AHIMA and other professional groups have worked on various federal projects associated with transaction and data standards and government programs in HHS and the Department of Homeland Security, but we have yet to see a coordinated action that recognizes both the horizontal and vertical integration that must take place. We recommend that HHS expand this strategy to a full goal and incorporate all the knowledge that has been accumulated at the local, state, and federal levels, as well as in the standards development and maintenance arenas, and begin to look at this issue as a whole in concert with the industry and state governments, et al.
    2 Invest in health IT infrastructure to support the National Prevention and Health Promotion Strategy (Pg. 27) • If strategy II.D.1 can be accomplished, then the e-health infrastructure to support a public health infrastructure will become more obvious and include the use of HIEs and direct involvement by consumers. The late John Morgan, MD had often noted the power of public health if all entities were integrated into such an exchange. While the technology exists and will improve, the political infrastructure has yet to be developed.
    • Communication channels can be developed to accomplish provider, consumer, and public health agency reporting, but adherence to warnings and other information will only be achieved when there is trust in the infrastructure and an anticipation that the data reported is accurate and uniform so that the data in response can likewise be reported in a similar manner.
    • NEDSS has been around for some time, but NEDSS has been contained within a public health silo and not integrated. Again the strategic Plan needs to be better defined to:
    o Identify how public health will be integrated into the industry infrastructure (from top to bottom);
    o Identify how chronic disease organizations, such as the American Cancer Society, etc., can be integrated into the system to assure the collection and use of all knowledge are improved due to better reporting and data integrity as well as to determine best practices and response to health care needs, pandemics, and other situations that are identified by reporting of consumers and providers and other agricultural and biosurveillance mechanisms.
    3 Ensure a mechanism for information exchange in support of research and the translation of research findings back into clinical practice. (Pg. 27) • AHIMA agrees with this strategy, but would suggest its integration of infrastructure as suggested above. In addition the HHS/ONC strategic plan should integrate plans such as that developed by the NIH National Human Genomics Research Institute to ensure the ability to also integrate investigation and research better into the routine delivery of care.
    • In order for exchange to occur the infrastructure must also consider how information is and will be collected and integrated beyond the EHR. This infrastructure will of necessity consist of public and individual provider registries and similar data warehouses; which in turn point to the need for data interoperability and recognition of the transformation of information. The conversion to the more granular ICD-10-CM/PCS for instance will require system acknowledgement of data change before and after the compliance date.
    • The Plan should recognize that information professionals such as HIM and informatics must also be encouraged and supported to study how to best integrate knowledge coming from this system back into the EHR systems at the provider site as well as translation and explanation for consumer systems and education.

    Goal III: Inspire Confidence and Trust in Health IT
    Objective III.A: Protect confidentiality, integrity, and availability of health information
    III.A. Strategies AHIMA Comments
    1 Promulgate appropriate and enforceable federal policies to protect the privacy and security of health information. (Pg. 31) • Federal policies must be integrated and uniform not only across all federal departments, agencies, and offices, but also with state, territorial, etc, governments if there is going to be a practical, enforceable system of protections for EHRs, HIE, and health information wherever it is located. Currently, a myriad of laws and regulations exist that are contradictory and confusing resulting in a lack of compliance and barriers to data flow as needed for providers and individuals. It should be noted for instance that approaches such as “opt-in” or “opt-out” vary as to intent and use of data, bringing confusion to the industry and its consumers.
    • AHIMA suggests that the Plan note that secondary uses of health information should not be restricted to just quality improvement, public health, and research, but also be used for reimbursement, health administration, and other uses. The change in these activities over time, must call for uniformity and flexibility such that data integrity cannot be questioned.
    • AHIMA supports the desire to ensure authentication, identity proofing and other activities that must be in place for the protection of data as well as the privacy of the individual.
    2 Enforce existing federal privacy and security laws and maintain consistency with federal policy. (Pg. 32) • Federal privacy and security rules and regulations already in the regulation process should be promulgated as soon as possible so the full affect can be determined especially in light of a lack of technology to match these requirements, and a state of the industry that is neither all paper nor electronic.
    • AHIMA agrees with the need to enforce existing federal privacy and security laws; however, enforcement under new HIPAA and FTC penalties associated with ARRA-HITECH should be reviewed for effectiveness and assurance that penalty enforcement does not create issues with self-reporting requirements especially in situations where harm may not be shown to exist.

    3 Encourage the incorporation of privacy and security functionality into health IT. (Pg. 32) • AHIMA supports this strategy and suggests that active piloting of new technologies be encouraged and added to the certification process once such testing and piloting shows the value of new technology. Technology producers should also be encouraged to develop products that can be added to EHR and HIE systems easily and recognize the cost of systems that may call for major changes.
    • OCR and HHS should include in this strategy working with industry professionals including HIM to educate both the industry and its consumers to practices, requirements, and technologies that can protect health information appropriately.
    4 Identify health IT system security vulnerabilities and develop strategic solutions. (Pg. 32) • AHIMA agrees with this strategy but notes that in undertaking this approach the existing hybrid and multiple systems used within healthcare be understood, rather than tested in isolation.
    5 Identify health IT privacy and security requirements and best practices, and communicate them through health IT programs. (Pg. 33) • AHIMA recommends that the work previously undertaken by ONC, OCR, NIST and the industry be incorporated into this strategy. In addition, AHIMA suggests that individual industry practices (technologies, processes, and training) be examined for situations were no breaches occur – best practices should be built on what works and not just on what does not work. AHIMA also believes that NIST and organizations like AHIMA, AMIA, and HIMSS be incorporated into the strategy process given their previous work in this arena.
    • AHIMA supports the Plan to work with state government and HIEs; however, we note that in developing best practices, it would be best to also ensure uniformity nationwide and not just within state jurisdictions since healthcare services and the need to exchange health information do not stop at state boundaries.

    Goal III: Inspire Confidence and Trust in Health IT
    Objective III.B: Inform individuals of their rights and increase transparency regarding the use of protected health information.
    III.B. Strategies AHIMA Comments
    1 Inform individuals about their privacy and security rights and how their information may be used or shared (Pg. 33) • AHIMA supports this strategy and stands ready to incorporate information and education developed under the strategy in its myPHR consumer website. AHIMA suggests, however, that such information and education identify state privacy and security rights and other variances in existing regulations and practices.
    2 Increase transparency regarding the development of policies and standards related to uses and sharing of protected health information. (Pg. 34) • AHIMA agrees with the need for transparency, but also must note that for full consumer and provider participation there needs to be a more open process than exists to ensure participation in short webinar-type meetings. Likewise, ONC and HHS need to develop a means to allow public input as the discussion occurs and not after decisions are made (referring to the practice of public input at the end of a meeting rather than during the discussion).
    • Furthermore, AHIMA suggests that ONC determine a means for addressing these issues across the Department rather than in the current siloed approach.
    3 Require easy to understand reporting of breach notifications. (Pg. 34) • AHIMA agrees with this strategy, but suggest that HHS issue another RFI with ample time for HIPAA and FTC entities and others covered by these regulations to also provide their input into the development of any new requirements or the development of guides and communications to be used with consumers regarding breach notification. AHIMA also notes that this is one more arena where it would be helpful for the federal government to work across departments and with state governments so as to develop uniform requirements as well as communication with consumers and affected entities.

    Goal III: Inspire Confidence and Trust in Health IT
    Objective III.C: Improve the safety and effectiveness of health IT
    III.C. Strategies AHIMA Comments
    1 Provide implementation and best practice tools for the effective use of IT. (34) • Again AHIMA suggests the Plan add working with professional associations and state, territorial, and other government units to develop best practices.
    2 Evaluate safety concerns and update approach to health IT safety. (Pg. 35) • AHIMA is concerned that there is not enough attention focused on the integrity of health data/information, as EHRs, HIEs, and other HIT systems are being developed along with the practices and standards that exist in and around the use of these technologies. AHIMA urges ONC and HHS to expand this strategy to recognize the integrity issues accordingly.
    3 Monitor patient safety issues related to health IT and address concerns (Pg. 35) • AHIMA agrees with this strategy but suggests that healthcare providers and other users of health information be engaged to report, without inappropriate penalty, situations discovered where patient safety becomes an issue. We note that unintended consequences of EHR use are under study, but it is not clear if studies are retrospective or concurrent.

    Goal IV: Empower Individuals with Health IT to Improve their Health and the Health Care System
    Objective IV.A: Engage individuals with health IT
    IV.A. Strategies AHIMA Comments
    1 Listen to individuals and implement health IT policies and programs to meet their interests. (Pg. 38) • As noted, AHIMA supports this strategy as long as it recognizes the practical steps that must be taken to move the industry, as a whole, to a point where all of the consumer and provider interests can be met.
    2 Communicate with individuals openly and spread messages through existing communication networks and dialogues. (Pg. 38) • AHIMA agrees with the strategy and notes that it has offered consumer education through its myPHR website for several years. AHIMA stands ready to work with ONC/HHS to educate the public and has a unique resource of HIM professionals who have had to explain health information and processes to consumers for many years.

    Goal IV: Empower Individuals with Health IT to Improve their Health and the Health Care System
    Objective IV.B: Accelerate individual and caregiver access to their electronic health information in a format they can use and reuse.
    IV.B. Strategies AHIMA Comments
    1 Through Medicare and Medicaid EHR Incentive Programs, encourage providers to give patients access to their health information in an electronic format. (Pg. 38) • While AHIMA agrees with the concept behind this strategy, we must also note that the transition to the capability to provide a “record” to patients is still underway, and rests in part on the ability to translate records to consumer readable/understandable information. AHIMA recommends that the Plan be expanded to encourage the development of means to make healthcare information correctly translated to the audience for which it is intended and further recommends that CMS consider beneficiary incentives so that federal consumers be encouraged to use the various processes that will be developed to exchange information between provider and consumers.
    2 Through federal agencies that deliver or pay for health care, act as a model for sharing information with individuals and make available tools to do so. (Pg. 39) • AHIMA has supported, and its members have participated in, projects such as the “Blue Button,” however, as noted above timing and the ability to access the certified technology has yet to be determined.
    3 Establish public policies that foster individual and caregiver access to their health information while protecting privacy and security. (Pg. 39) • While AHIMA supports these comments, we must again stress that the Plan include a reasonable timetable for providers to access, implement, and pay for the certified technology and processes that will make this work in light of all the other requirements and demands of federal and state governments and private health plans.
    • AHIMA notes ONC’s comments on access to laboratory information and supports changes that will allow for such access as long as there is also recognition for provider interpretation of data including not only the results of such laboratory procedures, but also the intent for the original order and the context of the result with other health information.

    Goal IV: Empower Individuals with Health IT to Improve their Health and the Health Care System
    Objective IV.C: Integrate patient-generated health information and consumer health IT with clinical applications to support patient-centered care.
    IV.C. Strategies AHIMA Comments
    1 Support the development of standards and tools that make EHR technology capable of interacting with consumer health IT and build these requirements for the use of standards and tools into EHR certification. (Pg 40) • Standards are available to integrate the standard EHR systems with consumer PHRs, but ONC must also ensure that these standards are applied and used uniformly and that data integrity is maintained.
    2 Solicit and integrate patient-generated health information into EHRs and quality measurements. (Pg. 40) • AHIMA agrees with this strategy; however, we must stress that any process or technology used must recognize the EHRs use as a tool for care, as well as serving as a legal document, and information whose data will be used for a variety of secondary purposes. To this degree AHIMA has been working on the concept of a “legal” health record and the use of enterprise record management of data for some time and stands ready to share this information so that this strategy can be engaged appropriately.
    3 Encourage the use of consumer health IT to move toward patient-centered care. (Pg. 40) • Agree, with no additional comment. .

    Goal V: Achieve Rapid Learning and Technological Advancement
    Objective V.A: Lead the creation of a learning health system to support quality, research, and public and population health.
    V.A. Strategies AHIMA Comments
    1 Establish an initial group of learning health system participants. (Pg. 45) • AHIMA acknowledges this strategy and suggests consideration be given to the source of the information in as much as there has been and will continue to be for some time differences in data collected from administrative sources rather than clinical.
    2 Develop standards, policies, and technologies to connect individual participants within the learning health system. (Pg. 45) • AHIMA supports this strategy.
    3 Engage patients, providers, researchers, and institutions to exchange information through the learning health system. (Pg. 45) • As AHIMA has noted above there are a number of considerations that need to be taken in the development of infrastructure that can serve the primary and secondary requirements for EHR systems and HIE. This strategy should be associated with the other strategies above and not developed as a standalone approach.
    4 Grow the learning health system by adding more members and expanding policies and standards as needed. (Pg. 46) • Agree, with no additional comment.

    Goal V: Achieve Rapid Learning and Technological Advancement
    Objective V.B: Broaden the capacity of health IT through innovation and research
    IV.B. Strategies AHIMA Comments
    1 • Liberate health data to enable health IT innovation.(Pg. 46) • AHIMA agrees with the strategy, but continues to note the various federal and state requirements that must be acknowledged or modified along with much more education of consumers as to the value of this information collection and all of the protections provided through policy, enforcement, and technology to preserve their confidentiality and willingness to share their information.
    2 • Make targeted investments in health IT research. (Pg. 47) • Support
    3 • Employ government programs and services as test beds for innovative health it. (47) • While AHIMA supports the use of government programs and services to test technology and process innovation; we suggest that the federal government also test or pilot such concepts in private programs and services that are not replicated in the larger federal sphere.
    4 • Monitor and promote industry innovation. (Pg. 48) • AHIMA suggests that transparency be added to this strategy.
    5 • Provide clear direction to the health IT industry regarding government roles and policies for protecting individuals while not stifling innovation. (Pg. 48). • As noted often above, AHIMA supports such a goal, but suggests that the federal government must incorporate state government into this process as long as preemption exists to modify such roles and policies at the provider level. Uniformity of roles and processes is a must if we are to benefit from innovation.

    Conclusion
    Again, AHIMA applauds ONC’s work behind developing this strategic Plan and its objectives and strategies. It is long overdue and welcome. We hope that our recommendation that this Plan be expanded to be an HHS plan and one that through the efforts of the HIT committees can also become a healthcare industry plan in no way negates our appreciation to the ONC staff and the HIT committee members who s

  99. Farzad Mostashari, MD, MPH
    National Coordinator for Health Information Technology
    Department of Health and Human Services
    [Submitted online]

    Dear Dr. Mostashari,

    Thank you for this opportunity to comment on the ONC Health Information Technology Strategic Plan for 2011 – 2015. The proposed strategic plan is a very thorough assessment of what is necessary to effectively promote health information technology (HIT) throughout the nation. Everyone involved in this draft is to be commended.

    While this plan focuses on HIT and its many direct challenges, it may be prudent to explicitly acknowledge the larger context, that our efforts to promote HIT may be subjected to challenges from our healthcare system more generally. Government health plans often pay providers below their cost to treat these plans’ beneficiaries, limiting provider capacity for capital investment. Though outside of the ability of ONC or this strategic plan to address, it is a significant issue which may impact the plan’s success. Acknowledging and considering this challenge, as I have attempted to do below, may lead to solutions which help to reduce its negative effect.

    I.A.1
    Please consider that a new technology is adopted by an industry when it: increases revenues, decreases costs, provides a competitive advantage, or is mandated. No one requires a financial subsidy to buy an iPad for their business. The product makes the case on its merits. The manufacturer makes a product that fills a need and prices it where the market will buy. If EHR vendors offered an equally compelling product that was competitively priced which increased revenue, decreased costs, or provided a competitive advantage for providers, there would be no need for financial incentives (subsidies) or mandates. One alternative to this strategic plan would be to wait for EHR vendors to improve their products to the point where they meet the criteria that businesses apply to every other effective technology and let the market determine when to make the switch. Conversely, if we have the will and desire to promote the EHR industry even if it is not quite ready for the market, then perhaps that choice should be explicit. Parallel efforts to support a mature EHR market are also likely to promote adoption.

    The current cost to implement an EHR is far greater than the incentive payments being offered. The vast majority of decreased costs accrue to health plans, not providers. The clinical benefits accrue to patients. As Dr. Brailer has said, we have a misalignment of incentives. CMS has stepped forward to contribute its portion of this cost, but there is no coordinated effort in which private health plans pay for their portion of the financial benefit that they are expected to receive. Cost as a barrier to EHR implementation might be eliminated if strategy I.A.1 included developing a mechanism for private health plans to match existing public incentives for EHR adoption. This may most easily be accomplished in coordination with strategies I.A.7 and I.A.8. Failure to ensure adequate funding may put the goals of this entire effort out of reach.

    In addition to capital costs, there are ongoing operational costs for which there currently is no provider reimbursement. This cost is likely to be greater for most providers than even the potential 5% penalty coming in 2017. With the potential administrative savings that will accrue to both public and private plans, the incentive payment structure should be supplemented with an operational payment or CPT code to minimize the operational cost of this conversion.

    If financial incentives and penalties are ineffective, it is worth noting that an EHR mandate might not have the intended effect. In the context of below-cost federal payments for care, a mandate for implementation might instead lead to widespread withdrawal from federal health plans as the only way for many providers to remain financially solvent.

    I.A.2
    The key challenges facing the RECs are scale, workforce, and funding. Extending their funding to four years was a strong sign of support by ONC. Continuing to support building the necessary workforce (in I.A.3) and reducing the financial burdens to providers (in I.A.1 above) will increase their success rate.

    I.A.4
    Medical training provides scientific and clinical data and skills to providers so that they can deliver optimal patient care. Meaningful use measures are intended to evaluate statistically whether providers are using an EHR to provide good care to their patients.

    The strategy offered by I.A.4 is not a good strategy and may be counterproductive. I.A.4 suggests that the tail should lead the horse. If our training programs are teaching good patient care, then there is no need to teach meaningful use. Good patient care will lead to meaningful use. If anything, effective EHRs should make the need to know the meaningful use criteria completely unnecessary by embedding the assessment in the background.

    Please eliminate strategy I.A.4

    I.A.6
    Good medical science presents both the benefits of therapy and the risks. Pretending that risks don’t exist only makes practitioners blind to recognizing the occurrence of a complication. A cheerleader strategy (“Go EHR”) should be replaced with a more balanced approach. There is no therapy that carries no risk. If it cannot hurt, it probably cannot help either. There are risks in the software algorithms, the data integrity, the implementation process, the physical plant, and the end user. While the EHR offers many benefits over the paper record, it carries its own new set of risks which we should not pretend don’t or can’t exist. Please consider revising this strategy to: “Promote the benefits that EHRs can bring to patient outcomes while acknowledging and working to mitigate or resolve the risks as they become known.”

    I.A.8
    This strategy would be better if it encouraged health plans to pay additional incentives for adoption. Please consider changing this strategy to something like: “Work with private sector payers to fund additional incentive payments for EHR adoption and demonstration of meaningful use.” Methods for implementation might include creating a fund of pooled health plan resources or partial payments based on health plan participation.

    I.B.3
    This strategy is a good start, but please consider the contrapositive. In addition to supporting exchange, it may be necessary to prohibit exchange networks from blocking exchange for reasons other than patient choice. We cannot know the future, but we use history to predict possible events. There are many competitive reasons why one exchange network might not wish to share data with a competing network. Please consider adding language to this strategy which reflects the following: “Ensure that, unless explicitly prohibited by patient request, no information exchange network will refuse to transmit patient information to another exchange network which holds valid authorization to receive the data.”

    I.C.1
    This is a valuable strategy, but please indicate that certification criteria will require support for this possibility.

    I.C.2
    Health disparities have been better correlated with economic and social factors than with race, ethnicity, gender, or anything else. Health disparities exist primarily because of insufficient patient knowledge about health and healthy living, local social norms, and the resource limitations of a community. Even telehealth can only go so far to make up for the lack of providers, personnel, medications, and equipment. This strategy to use technology to reduce disparities should better reflect the limited role of HIT in reducing disparities. Please consider something more like: “Track health disparities, identify and promote technology where it can reduce disparities, and minimize any negative impact of health IT on disparities.”

    II.A.1
    This strategy generally is a good one, but also potentially dangerous. We should be very clear that we neither expect nor do we wish to see 100% compliance with best practices. While zero compliance would be associated with failing to render standard medical care, 100% compliance would be associated with failing to treat each patient as an individual and potentially subjecting them to increased risk of harm.

    Best practices are developed based on studies of populations which have variation. What was “better” in the study will not always be better for a similar patient, only better more often than not statistically. By definition, this is not 100% of the time. In addition, what constitutes a “similar patient” can be lost or expanded beyond what is supported by the data when the best practice is developed. While we may have a difficult time identifying what should be the optimal percentage of compliance with guidelines, we might choose to initially target compliance with best practices at a certain level. Careful review of the reasons offered when providers did not implement best practices would enable us to periodically adjust the desired percentage and reassess the practice guidelines in a more granular fashion.

    II.C.1
    This strategy is useful, but would be more powerful by supporting the value of learning from failures. We may learn more from failure than we do from success, how a failure occurred, why, and what should have been done differently. The greatest value accrues when we share this information so that others can avoid the same errors. Please consider adding language like: “Learn from the challenges and failures and disseminate those findings widely.”

    III.A.1
    This strategy is very important and should be expanded to recognize existing and future interstate challenges. As each state determines how it wishes to manage the patient consent process, the federal role of ensuring a minimum privacy standard should also be used to ensure that some states do not make privacy so tight that it is difficult to share with neighboring states. Many medical service areas cross state borders and some have already seen the challenges of trying to harmonize different privacy and security requirements. Please consider adding “while minimizing interstate privacy and security variation”.

    III.A.3
    The value of this strategy would be enhanced if it were extended to the EHR certification process. Please add “, including in certification criteria.”

    III.A.4
    It would be useful to identify private sector and open source communities which could significantly support this strategy.

    III.C.1
    Where possible, this strategy should utilize existing tools. Please indicate in this strategy that you are not planning to start from scratch.

    III.C.2
    Evaluation of risk is not a one time event, it is an ongoing process. As written, this strategy is insufficient, implying that we are done once we have completed our risk assessment. Please consider redefining this strategy as something closer to: “Support a culture of vigilance in rapidly identifying HIT risks, whether due to personnel, process, or technical factors, and work with the healthcare community to resolve or mitigate these risks.”

    III.C.3
    This strategy and its discussion don’t seem to match. Patient safety is much broader than data integrity and is addressed in other strategies. If this strategy is intended to address data integrity as a patient safety issue, then perhaps the strategy would be better worded as: “Identify risks to patient data integrity and work to resolve or mitigate those risks.”

    IV.A.1
    This strategy seems to be unbalanced. We want patients to be thoroughly involved in their healthcare, including how we share their information. We may not want patients to have absolute control over how to record their health information or what to exclude or include in provider records. If patient choices can take precedence over provider observations and measurements, health outcomes could worsen. A more balanced approach to this strategy would be to hear patient requests and consider those requests in the context of our healthcare system generally. This might be worded as: “Engage individuals and consumer groups in discussions about HIT policies and programs.”

    IV.B.1
    As part of our ongoing process of engaging patients in their care, this is an important step. The process should also recognize the cost of provider participation in this effort. To avoid this becoming an unfunded mandate, the provider should be explicitly permitted to charge a reasonable fee which might vary by the specific electronic format in which the data is provided. Please add: “supported by the provider and for a reasonable fee.”

    IV.B.2 and IV.B.3
    Please add a mechanism to ensure that certain results are not immediately shared without a provider discussion. There should also be a notice that results might be incorrect and subsequently change. We do not want patient access to an incorrect HIV result to lead to a suicide when the result was posted to the wrong patient who believes HIV to be a death sentence . Provider discussion should reduce that risk. Similarly emotional results, like pregnancy, require similar protections. In institutions where releasing results online has been implemented, results are subject to varying time delays depending upon the gravity of these risks, to ensure that providers have an opportunity to communicate with patients in advance of their online review.

    IV.C.2
    This strategy is premature. We want patient participation, but we cannot implement this strategy until IV.C.1 is accomplished. Without clear methods for determining data accuracy, some patients would be treated based on incorrect information. Until IV.C.1 has been implemented, this strategy is not clinically useful and potentially could harm patients, particularly if incorporated into quality measures. Please eliminate this strategy and reconsider it only after IV.C.1 has been accomplished (probably after 2015).

    V.A.1
    Not all care delivery methods are equal. What is learned from large systems is often not applicable in resource constrained environments, such as rural communities. Please ensure that participants of all sizes and in a wide range of geographies are included in order to optimize the chance that the results are valid nationally. Consider appending the strategy with: “that represent systems in dispersed geographies with varying resources and of varying sizes.”

    V.B.1
    The strategy and the discussion appear to be different. The concept of making data available to people who should have access to it does not seem to be what this strategy says. To me, this strategy says that health data should be available for innovation, which may conflict with patient choices. Perhaps the strategy would be better portrayed as: “Encourage patients to permit their deidentified data to be available to promote health innovation.”

    V.B.2
    Please include the following to specifically target in this strategy: user interfaces, clinical workflow, improved outcomes, and connectivity.

    V.B.5
    This strategy reads as one sided. To be an effective strategy, dialog would be preferable. This strategy might be more effective if worded similar to: “Collaborate with the HIT industry to develop government roles and policies that protect patient safety while promoting innovation.”

    In addition to the more detailed comments above, please note my strong support for strategies I.A.9, I.B.2, I.C.3, and IV.C.1 as written.

    We can all look forward to improvements in our healthcare system with HIT playing a strong supporting role. Thank you again for the opportunity to participate in this discussion.

    Respectfully,

    Larry Ozeran, MD
    President
    Clinical Informatics, Inc.
    author / editor “H.I.T. or Miss: Lessons Learned from Health Information Technology Implementations”, AHIMA Press, 2010

  100. Alan Morgan says:

    Farzad Mostashari, MD, ScM
    National Coordinator for Health Information Technology
    Department of Health and Human Services

    The National Rural Health Association (NRHA) is pleased to offer comments on the proposed Federal Health IT Strategic Plan. We appreciate the Office of the National Coordinator for Health Information Technology’s (ONC) commitment to the one-quarter of America’s health care beneficiaries residing in rural and underserved areas, and look forward to continued collaboration to ensure improved health care access and quality.

    NRHA is a non-profit membership organization with more than 22,000 members nation-wide that provides leadership on rural health issues. Our membership includes nearly every component of rural America’s health care infrastructure, including rural community PPS hospitals, critical access hospitals, doctors, nurses, researchers and individual patients. We work to improve rural America’s health needs through government advocacy, communications, education and research.

    NRHA is grateful to the ONC for its leadership in this important arena and appreciates ONCs continued work on the development and implementation of Health IT standards. This comment outlines suggestions that the NRHA believes will strengthen the Strategic Plan in regards to rural implementation. We support the Plan’s goals and look forward to its continuing development. We hope that it continues to recognize the significant separation of large and small, rural and urban facilities in their ability to meet meaningful use standards.

    Goal I: Achieve Adoption and Information Exchange through Meaningful Use of Health IT:
    As mentioned in the plan, Rural America faces significant challenges in meeting the meaningful use standards. A 2010 NRHA survey indicates that 50% of Critical Access Hospitals (CAHs), for example, will not meet meaningful use stage 1 within four years. CAHs and small rural acute care hospitals work on exceedingly small financial margins with an especially small workforce. (Studies indicate a rural HIT workforce shortage of 50,000.) ONC can assist these small, rural facilities by directing grant funds to CAHs and other small hospitals for HIT equipment or HIT workforce needs. Furthermore, to fully utilize available HIT capabilities, ONC should continue to coordinate with the FCC to ensure rural facilities and beneficiaries have access to broadband service. This will serve both the production and receiving end of EHRs.

    HITECH funds should also be more accessible to rural facilities struggling to become compliant with the early parts of stage 1 meaningful use. Targeting grants to small facilities that face the greatest need in meeting meaningful use would be a strong step in furtherance of the Plan’s goals. ONC should also make funds available for facility modernization that would help aging rural facilities accommodate new HIT systems. Avoiding the furtherance of the significant urban-rural divide in access to and implementation of HIT systems should be a central tenant of the Plan.
    NRHA supports increasing the timetable for becoming meaningful users from four to eight years. CAHs and other rural providers, again due to workforce and capital shortages, would better meet meaningful use requirements if given more time and flexibility. Penalty provisions will already start to kick in by the time many CAHs are able to meet early steps of stage 1 meaningful use. A rushed implementation that fails due to time constraints is worse than delayed implementation as it compromises both the safety and efficiency of patient care. Rural providers do not ask for a standard different than their urban counterparts, rather a timeframe adjustment that will ensure the continuation of their quality care and the fiscal ability to meet the challenging requirements of compliance.

    Similarly, NRHA supports the implementation of a respite period to learn from the experiences of stage 1 before moving on to the specific establishment of stage 2 guidelines. Specifically, ensuring that a majority of facilities meet stage 1 standards before making stage 2 recommendations is vital to ensuring the continued success and plausibility of full meaningful use implementation. NRHA is supportive of the Plan’s goal to continuously monitor and identify disparities with an eye towards focusing resources on areas of greatest need.

    Goal II Reduce Costs
    NRHA supports creating avenues to maintain sustainability and ensure that technology advances rather than stagnates, allowing for streamlining of systems and better, more efficient patient care. Again, because of health IT workforce shortages in rural areas, maintenance of health IT systems and functions is generally more difficult for CAHs, rural PPS hospitals and RHCs. Maintaining predictable assistance funds is vital to rural providers. This will, in turn, allow rural providers to use health IT more effectively and, ultimately, reduce costs.

    Goals III-V
    NRHA supports the efforts of the Plan to more fully include the individual in their care and to provide quality information to public health officials and researchers. We encourage ONC to make sure that these efforts, including allocation of resources and manpower for outreach purposes, are equitably dispersed and that rural beneficiaries are fairly included in any new programs. Specifically, the standards and tools mentioned by the plan to make EHRs interactive should be workable in rural settings given the access issues already mentioned. Furthermore, ONC should make special efforts to develop continuing strategies that will meet the unique health IT needs of rural beneficiaries, public health institutions, researchers, and other stakeholders. This may be accomplished by energetically educating them about the benefits of actively participating with their EHRs and instilling confidence that this will lead to better care.

    Sincerely,
    Alan Morgan
    Chief Executive Officer
    National Rural Health Association

  101. May 4, 2011

    Dr. Farzad Mostashari
    Office of the National Coordinator for Health Information Technology
    Department of Health and Human Services
    200 Independence Avenue, SW
    Washington, DC 20201

    Dear Dr. Mostashari:

    On behalf of the American Heart Association (AHA), its American Stroke Association (ASA) division, and our more than 22 million volunteers and supporters, we applaud the efforts made by the Office of the National Coordinator in updating the Federal Health Information Technology Strategic Plan.

    The AHA/ASA is dedicated to building healthier lives, reducing death and disability from cardiovascular diseases and stroke, and addressing issues of access, quality, and cost from the patient’s perspective. Although the United States has been successful in reducing death rates for coronary heart disease and stroke, much work remains to address these leading causes of death and disability. Among other issues, the fragmentation of services and the lack of coordination of care for people with chronic conditions are a major cause for concern. While health IT is not a panacea, it can, when used effectively, be a powerful tool to improve the quality and efficiency of care through the use of decision-support tools and by supporting better coordination of care. Providing health information and educational tools directly to patients can also improve personal involvement in self management of health problems, which is central to addressing chronic conditions, such as cardiovascular disease (CVD).

    The AHA is pleased by the inclusion of the comprehensive “Federal Health IT Principles” to guide the strategic plan’s goals, objectives and strategies. We particularly appreciate the principles’ attention to outcomes, their recognition of the need to leverage existing effective programs, and the acknowledged need for transparency and trust throughout the prioritized health IT areas. While we are pleased by these principles and their general reflection in the plan’s goals, there are some ways to strengthen these principles throughout the plan.

    • Federal Health IT Principle: “Focus on outcomes”
    The AHA commends the Strategic Plan’s “focus on outcomes” and the overall direction it provides in driving towards this end goal. Health information technology, however, is a means to the end of improved outcomes, not an end in itself. Several studies showing little or no connection between health IT implementation and healthcare quality improvement have gained recent attention in the trade press. These studies are evidence that in order for health IT to bring about meaningful change, supporting programs and changes, including workflow adjustments, culture change, or specific quality improvement programs, are needed. While we know that you and your staff are well aware of this fact, we believe that the strategic plan could provide additional emphasis in this area. In this way, we think that the plan should incorporate the concept of fostering quality improvement programs that are supported and furthered through a supporting health IT technical infrastructure. We recognize that the REC program serves to support providers in making the changes necessary to successfully incorporate health IT into workflows and the meaningful use objectives help them to use health IT to its full potential. We would have also liked, however, to see ONC specifically call out or dedicate an objective or strategy to promoting the diffusion of the quality improvement programs that health IT can facilitate and support. We believe that under Goal II, the plan could be strengthened by calling on the RECs or Beacon Communities to more actively support and integrate proven-effective national quality improvement programs.

    The AHA recognizes and supports the EHR Incentive Program and driving providers towards the meaningful use of EHRs. We also feel that there are circumstances in which other health IT tools may better address the particular health care delivery or quality improvement need. In this way, the AHA encourages ONC to broaden the scope of health IT included in the plan in order to better drive forward the “focus on outcomes” principle. While the plan references registries under the public health and national health security strategies, this placement potentially deemphasizes the role that registries and other health IT tools can play in the direct delivery of patient care to inform the provider-patient interface. We encourage ONC to increase its attention to alternative health IT tools throughout the plan.
    The AHA’s suite of quality improvement programs, Get With The Guidelines® (GWTG), that employ quality improvement programs through registries to provide data collection, aggregation, and feedback to providers, are illustrations of both of the points made above. Participating GWTG hospitals receive real-time reports on their care as compared to evidence based guidelines and real-time comparisons to national benchmarks. GWTGs’ program and its supporting registry have demonstrated high compliance with standards of hospitalized care in participating hospitals (Fonarow, G C, et al. Circ Cardiovasc Qual Outcomes published online Feb 22, 2010) and lower 30-day mortality rates in participating hospitals than their non-participating counterparts (Heidenreich, P A, et al. Hospital Performance Recognition with The Get With The Guidelines Program and Mortality for Acute Myocardial Infarction and Heart Failure. American Heart Journal. 2009; 158:546-53).

    • Federal Health IT Principle: “Build boldly on what works”
    We are excited by ONC’s indication, by way of this principle, to identify successful programs and leverage their experience to drive health IT adoption and healthcare system improvements even further. We believe the plan should call for taking advantage of the numerous successful private sector initiatives currently underway and demonstrating impact. One such example is the partnership among the American Heart Association, the American Diabetes Association and the American Cancer Society in launching “The Guideline Advantage®,” an outpatient quality improvement program aimed at the shared risk factors across the groups’ patient populations. While we recognize that ONC’s specific charge is to coordinate and develop synergies across federal programs, developing a truly comprehensive plan requires the incorporation of both public and private initiatives and their learnings. We understand that mechanisms are in place to more readily leverage and replicate accomplishments by other federal programs, but we believe that ONC could highlight private initiatives and encourage adoption of these existing programs.

    It is particularly important that ONC not overlook successful private sector programs that have achieved results in critical areas such as health equity. As the recently released 2010 National Healthcare Quality Report noted, significant deficits in health equity still exist. We believe that all promising programs should be utilized to address these disparities whether they originate in the public or private sectors. For example, participation in GWTG-CAD, one of the AHA’s GWTG programs, discussed above, was associated with an elimination of disparities in the quality of care for acute myocardial infarction regardless of race or ethnicity (Cohen, M G, et al. Racial and Ethnic Differences in the Treatment of Acute Myocardial Infarction. Findings from the Get With The Guidelines Coronary Artery Disease Program. Circulation. May 17, 2010).

    In this way, collaboration is critical to the success of this important work. Under Goal V, Strategy V.A.1, we note that the initial group of learning health system participants are limited to federal initiatives and that private organizations will be included in subsequent strategies to grow this network. We strongly encourage ONC to include private sector initiatives in the first round of learning systems. The outcomes of the AHA’s own programs listed above and the ambitious programs underway by the private sector, such as The Guideline Advantage®, are evidence of the high level of activity in the private sector, which hold promise for quickly and efficiently injecting knowledge back into the system.

    • Federal Health IT Principle: “Be a worthy steward of the country’s money and trust”
    Should the strategic plan incorporate private sector initiatives into the learning systems from the outset in order to leverage and build upon “what works,” this would also provide greater consistency between the plan and its stewardship principle. By incorporating a comprehensive and robust grouping of programs on which to base its efforts, ONC could minimize duplication in resource allocation and more fully leverage private dollars already in the system. In turn, this would enable ONC and the federal government to use its own resources more judiciously.

    Stewardship, as the principle acknowledges, is not only about allocating resources appropriately and responsibly, but also about implementing open and transparent processes. It is unclear from the plan what the process for recruiting and incorporating private sector learning systems will be. Whatever that process, however, we urge you to maintain transparency in structuring the projects that they are recruited to participate in, as well as transparency and feedback into the structures proposed as part of those programs. For example, federal agencies often seek input on the structure of a scope of work or a request for proposals it is drafting. Once the proposals are received, however, and the agency is reviewing them, there is minimal transparency in crafting or adjusting the programs before they are implemented. We would like to encourage ONC to maintain as much transparency as possible in developing the structure for the learning systems. We believe that providing this transparency, as well as multiple points for public comment into the structure of those programs will enable others who are not eligible or not participating in the learning systems to inject best practices back into the system, in a close to real-time format. We also believe that sharing the public comments received on the projects could foster a dialogue between participants and non-participants and provide constructive feedback before ONC takes a plan to the implementation phase.

    • Additional Comments
    We would also like to commend ONC for recognizing the emergency care system in strategy I.C.3. The AHA/ASA is very cognizant of the needs of and demands faced by the emergency care system, yet find that it is often overlooked in developing plans for reform and long-term systems planning. For the medical professionals who comprise it, however, quick response, coordination, and timely communication and information exchange is critically important and they must be included in any infrastructure intended to support information collection and exchange. We look forward to the ideas generated by ONC and the Assistant Secretary for Planning and Response (ASPR) and offer our organization as a resource in thinking through how to best achieve Goal I, Objective C.

    In the meantime, we would like to offer a few recommendations as to the areas on which ONC and ASPR should focus their attention. As many of our EMS volunteers learned during Hurricane Katrina, basic information on a patient to which they were administering emergency care was critical in addressing the need of the patient. One volunteer gives the example of a diabetic and psychiatric patient that presented with similar symptoms of very different underlying conditions. Without the ability to receive basic patient information, however, such as a medication list, patient allergies, and basic health history (e.g., heart attack), they were often unable to differentiate in order to make an accurate assessment and treat the patient appropriately and promptly. In this way, they learned that their ability to pull data from the exchange, and well as push episode of care information to the exchange, was critical. Additionally, we encourage ONC and ASPR to expand the current focus on hospital and clinic-based EHRs to incorporate the EMS/ambulance and nursing home as other originators of a patient record. As the initiator and generator of a very large number of episodic care medical records, EMS and nursing homes need to be the focus of, and targeted by, the federal government in future work related to health IT adoption and information exchange.

    Additionally, the AHA would like to voice its support for Goal II, Objective B, and its utilization of EHR-generated reporting electronic measures. In fact, several registries currently exist that are used to collect data on CVD and stroke, of particular interest given the National Health Care Quality Strategy’s emphasis on addressing major causes of mortality, staring with cardiovascular disease. Additionally, the AHA has a number of quality improvement modules for the inpatient and outpatient setting, which are part of our GWTG suite of programs. Each of these modules collects a number of measures and provides hospitals and physician groups with quarterly reports that allow them to assess their performance compared to national benchmark data. The AHA also believes that utilizing existing data sources, including registries, will help to reduce the administrative burden associated with data submission.

    We would also, however, like to urge ONC to keep in mind that electronic measures are not a one to one representation of their manually abstracted counterpart. We believe that it is important for data generated from e-measures to be evaluated against data generated from the manually abstracted version of these measures. This will help ONC and other agencies determine whether there may be differences in the measure construction due to exclusively using electronic data. This is critical to ensure that electronic measures do not create any unintended consequences or result in including or excluding patients from the measure inappropriately.

    In closing, AHA would like to reiterate our appreciation for the Office of the National Coordinator’s efforts to develop a comprehensive and ambitious strategic plan. We are also very excited about our recent discussions with your office to explore how the AHA and ONC might work together. We look forward to a long and successful relationship together as we work towards our common goals. If you have any questions or need any additional information, please do not hesitate to contact AHA staff.

    Sincerely,
    Ralph Sacco, MD, FAHA
    President
    American Heart Association

  102. The National Council for Community Behavioral Healthcare (National Council) welcomes the opportunity to comment on the Federal Health IT Strategic Plan from the Office of the National Coordinator for Health Information Technology (ONC). The National Council, a non-profit association representing 1,800 community-based mental health and addiction providers, is dedicated to fostering clinical and operational innovation and promoting policies that ensure that the more than 8 million low-income children, adults, and families our members serve have access to high quality services. Our community mental health and addiction organizations have more than 40 years of experience and expertise in providing a range of services and recovery supports for millions of individuals with multiple chronic conditions. We thank ONC for its vision and work in improving the quality, efficiency and safety of health care and advancing person-centered care.

    The National Council understands the complexity of the process involved in developing this Strategic Plan which must include collaboration from multiple government agencies and significant financial investments. We appreciate that ONC has put together a plan that is trying to assist in the promotion of electronic health care records and information systems in order to help inform providers’ decisions, help individuals better manage their health and improve the health care system.

    We strongly support the ONC Federal Health IT Strategic Plan as a starting place in the development of healthcare information technology and description for how everything will “fit together” with respect to health IT and its role in promoting health and healthcare reform. We appreciate the focus that ONC has placed on the inclusion of SAMHSA and those providers not eligible for the incentive programs. This focus indicates an understanding of the importance of including behavioral health and substance use disorder providers in the electronic health record system. We look forward to working with you to ensure that these goals of the IT Strategy are implemented.

    In addition, we have specific recommendations to ensure that behavioral health providers are included in the discussion as developments occur in electronic health records systems and the Federal Health IT Strategy. We ask that ONC consider our recommendations and their application to the Strategy.

    Goal 1: Achieve Adoption and Information Exchange through Meaningful Use of Health IT

    We appreciate that the first priority of the government is “developing technology and policy solutions” for providers ineligible for incentive payments that will build on meaningful use and fit their unique needs. We would request that ONC elaborate on this statement and provide some insight into how the government may do this and how the National Council and behavioral health providers may be of assistance.

    Objective A: Accelerate Adoption of Electronic Health Records
    Strategy I.A.6: Communicate the value of EHRs and the use of benefits of achieving
    meaningful use.

    The National Council appreciates that the Department of Health and Human Services plans to conduct outreach to providers to increase awareness of HITECH programs. We understand that there are many primary care providers who are currently working toward meaningful use and share evidence on the use of Health IT; however, we would suggest that behavioral health providers also be included as an audience for this strategy. It is imperative that all providers are given more information about the availability and benefits of health IT and EHRs.

    Strategy I.A.7: Align federal programs and services with the adoption and
    meaningful use of certified EHR technology.

    We strongly support ONCs mention that the government is planning methods to encourage providers not currently eligible for the Medicare and Medicaid incentive programs to achieve meaningful use. We commend ONC for its work with SAMHSA to ensure that implementation of EHRs is widespread among providers; however, we would ask ONC for additional information as to how SAMHSA is “working to foster adoption and implementation of certified EHRs among its providers that are ineligible for the Medicare/Medicaid Incentive Programs.” Additionally, we appreciate the specific mention of community mental health centers and substance use disorder treatment programs in this strategy.

    Strategy I.A.8: Work with private sector payers and provider groups to encourage
    providers to achieve meaningful use.

    The National Council is appreciative of ONCs work with private sector payers and provider groups to achieve meaningful use. We would encourage ONC to conduct outreach to behavioral and mental health professionals, psychiatric hospitals, mental health treatment facilities, and substance abuse treatment facilities, as well as other providers not currently eligible for incentive payments, regarding efforts that have proven successful in helping providers achieve meaningful use.

    Objective C: Support health IT adoption and information exchange for public health and populations
    with unique needs.
    Strategy I.C.2: Track health disparities and promote health IT that reduces them

    Monitoring and identifying disparities in Health IT adoption is important to ensure that resources are allocated to areas of greatest need. The National Council is supportive of the ONC’s investigation into better ways to monitor these issues. However, it is important to note that in order to achieve nationwide adoption and meaningful use of EHRs, that those providers who face challenges in adopting and using EHRs be included in governmental initiatives. The National Council would encourage ONC to reach out to Community Mental Health Centers, substance abuse treatment facilities, private providers and small group practices for whom the adoption of EHR technology may be exorbitant due to lack of incentive payments or size of agency. By supporting the adoption and exchange of information among different providers, ONC can provide support for community behavioral health organizations as they seek to implement electronic health records and improve care quality. Additionally, the RECs should be encouraged to provide outreach to behavioral health providers regarding the implementation and meaningful use of HIT.

    Strategy I.C.3: Support health IT adoption and information exchange in long-term/post acute,
    behavioral health and emergency care settings.

    The National Council is supportive of ONC and HHS’s attempts to identify opportunities in the Affordable Care Act to support the use of health information exchange technologies by behavioral health providers to improve quality of care. We appreciate that SAMHSA will collaborate with ONC to explore the creation of an incentive program within the behavioral health community. It would be beneficial for both SAMHSA and ONC to engage with stakeholders within this population, CMHCs, Substance Abuse Treatment Facilities, etc, to determine the most advantageous ways for these organizations to adopt certified EHR technology in such a way as to become meaningful users and improve the collaboration across organizations to improve the care of consumers with serious mental illness and addictions issues. The National Council is pleased that ONC feels that the integration of mental health data into primary care systems in “essential” for coordinating care.

    Goal III: Inspire Confidence and Trust in Health IT

    Objective A: Protect confidentiality, integrity, and availability of health information
    Strategy III.A.1: Promulgate appropriate and enforceable federal policies to protect the privacy and
    security of health information.
    Strategy III.A.3: Encourage the incorporation of privacy and security functionality into health IT

    We are appreciative of ONC and the federal partners working to ensure that federal privacy and security policies continue to evolve with the implementation and development of health information technologies and EHR systems. Many behavioral health providers have complicated releases of information that require consumers of our services to specify what specifically they want released and specifically to whom, with expiration dates. In order to be truly effective, the sharing of information needs to be quick and responsive to the consumer’s needs; however, the privacy and security concerns need to be addressed. An additional concern regarding privacy and security is the use of electronic health systems in regards to multi-location providers. Providers in rural areas may have several clinics that take advantage of the same EHR database; however, some EHR vendors may not be programming site location restrictions. This was not an issue with paper records since a provider would have to go to another site to see that information regarding those patients. No limits on the access to information based on location sites may result in unintentional breaches of confidentiality and security.

    While all healthcare providers must take HIPAA and state privacy laws into consideration, providers of substance use treatment must also ensure that their practices are compliant with 42CFR Part 2. This statute permits patient information to be disclosed to health information exchange systems; however, there are certain requirements for this disclosure, such as patient consent. A helpful resource for the ONC would be SAMHSA’s FAQ document regarding applying substance abuse confidentiality regulations to Health Information Exchange. The development of additional guidance for handling personal health information where 42CFR is concerned would be beneficial in order to make sure alcohol and drug treatment information is kept confidential.

    Goal IV: Empower Individuals with Health IT to Improve their Health and the Health Care System

    The National Council appreciates that ONC is going to participate in “on-going public” conversations about Health IT. We would suggest that consumers and providers of behavioral health and substance abuse treatment services must be included in these discussions in order to ensure that those populations are given an opportunity to share experiences and learn. It is also essential that behavioral health and substance abuse treatment providers and consumer advocates be included on the two committees utilized by ONC-The HIT Policy Committee and the HIT Standards Committee in order to assist the committees in making recommendations relevant to crucial policy issues of the behavioral health field.

    The National Council believes the establishment of the Office of the National Coordinator for Health Information Technology and the development of the Federal Health Information Technology Strategic Plan for 2011-2015 will be beneficial to those persons utilizing EHRs and those looking to start implementation and development. We thank ONC for putting together a plan that includes many federal agencies and stakeholders and which is an earnest attempt to assist in the promotion of electronic health records and information systems for all healthcare providers. We thank you for the opportunity to comment on the Strategic Plan and for your consideration of our comments.

    Thank you,
    Linda Rosenberg
    President & CEO
    National Council for Community Behavioral Healthcare

  103. Farzad Mostashari, MD, ScM
    National Coordinator for Health Information Technology
    Department of Health and Human Services

    Re: ONC Federal Health Information Technology Strategic Plan 2011–2015

    Dear Dr. Mostashari,
    The Center for Biosecurity of the University of Pittsburgh Medical Center (UPMC) would like to thank ONC for its work to put forward a Federal Health Information Technology Strategic Plan and for making the plan open for public comment. The Center for Biosecurity shares your sense of urgency and appreciates your leadership on this issue.

    In this letter, we offer comments intended to add value to the Federal HIT Strategy. Our comments address the need for greater inclusion of and coordination with public health in future HIT strategy and policy. We hope our recommendations will strengthen what is an already excellent federal HIT policy foundation.

    Federal HIT Strategy and Public Health

    Ongoing implementation of HIT and progress toward a National Health Information Network offers a tremendous opportunity to improve public health practice by increasing the amount and quality of data available to state and local public health practitioners. Increased availability of clinical and laboratory data is critically important for improving disease surveillance practice and informing public health response to disease outbreaks and other public health emergencies.

    Federal initiatives including the CDC’s Public Health Informatics Technology Program Office (PHITPO) and the State Health Information Exchange (HIE) Cooperative Agreement Program are a step in the right direction to develop public health capacity and capability for meaningful use of electronic health information.

    However, in our discussions with state and local public health practitioners, there continues to be major concern about public health departments’ ability to accept and use electronic health information. Currently, public health agencies do not have the technical guidance, informatics capabilities, and financial resources they feel are needed to create a robust system that will ensure better preparation and response to outbreaks and other public health threats.

    Public Health Information Needs

    The information that would currently be made available to public health through the Meaningful Use criteria Stage 1 and Proposed Stage 2, are useful initial steps in strengthening the digital connections between health departments and the clinical sector. However, the public health data categories contained in these early criteria do not adequately address the kinds of electronic health information that public health departments need in order to detect and manage outbreaks and other public health emergencies.

    As a first priority, it should be a goal of future Meaningful Use criteria to facilitate the widespread adoption of electronic laboratory reporting. It is a positive sign that laboratory reporting was included among the public health data categories in the Meaningful Use criteria that have been issued to-date. We encourage ONC to pursue ways to make ELR data exchange between public health and clinical sectors routine, rather than voluntary.

    Additionally, public health practitioners emphasize the importance of having flexible access to EHRs during outbreaks and other public health emergencies. Thus it would be extremely beneficial for public health to have the ability to perform queries of EHR data in order to help determine the number of patients that meet an outbreak case definition and to understand how many cases have underlying conditions that would put them at risk for severe outcomes.

    Public Health Capacity to Receive Health Information

    While the Federal Plan addresses the issues of public health adoption of IT and exchange of health information between the public health and healthcare sectors, it does not go far enough in this realm. In order to really enable this exchange of health information, it is important to first ensure that public health has the capacity to receive and analyze electronic health data.

    Many public health departments have indicated that the data resulting from Meaningful Use implementation will require significant upfront costs as well as sustained commitment and funding for data storage, receipt and clean-up, and analysis. Public health departments, for the most part, do not have the budgets to receive and process these data.

    Recommendations

    1. Expand HIT public health Meaningful Use criteria in stages 2 and 3

    • As a first priority, ONC should ensure that Meaningful Use criteria lead to the widespread standardization and adoption of electronic laboratory reporting efforts.

    • ONC should develop Meaningful Use criteria that promote the development of EHRs and that enable the public health sector to access and query electronic health information in order to identify and understand cases.

    2. Provide to state and local health departments financial incentives and technical support (analogous to those being provided to the healthcare sector), to prepare them to receive and use Meaningful Use data. A small fraction of the $18 billion that is reserved for incentive payments for healthcare providers who adopt EHRs would go far in helping state and local health departments to prepare to receive and make meaningful use of EHR data.

    Sincerely,

    Thomas V. Inglesby, MD, CEO and Director, Center for Biosecurity
    Anita J. Cicero, JD, COO and Deputy Director
    Jennifer Nuzzo, SM, Senior Associate
    Crystal Franco, MPH, Associate

  104. KPSS says:

    I searched for the word ‘Pharmacy’ and found only one occurence. I think improvement in e-prescribing are necessary and even include the creaiton of an open source platform instead of relying on a monopoly (RxHub).

    I also believe that the implementation of a national ID card that includes health-related information will help.

  105. Thanks for the opportunity to comment.

    On behalf of Wolters Kluwer Health, we want to express our strong support for the Federal HIT Strategic Plan. We are particularly supportive of the section that discusses the creation of the Learning Health System. The implementation of HITECH and the nationwide installation of EHR systems are just means to an end. The ultimate goal is to integrate patient-specific health data with the latest evidence-based clinical content to facilitate improved decision-making by providers. Only then can we achieve better patient outcomes, quality and cost savings as part of a new learning health system.

  106. Diane Greig says:

    I will address primarily the issue of meaningful use and empowering patient’s participation.
    My background is as Registered Nurse with most of my career of 39 years working with people with a variety of chronic conditions and disabilities.

    Every prescription should include the reason for use in plain language since medications can be used for multiple purposes. This will inform patients/families and help them: 1] know why they are taking something and 2] help them ‘back-up’ health professionals when we ask then if they are on anything for a specific condition. This reinforces learning both names of conditions and medications. This could also aid pharmacists with Medication Therapy Management.

    Next, I urge the ONC to consider a ‘third way’ in all questions. While the data is not as tidy, please recognize that something as simple as gender is, more than one would guess, not binomial. Transgender would be an option in my limited experience and may even warrant other considerations. As another example, when working with Hmong patients the religious option of shaman was not an option in an assessment form I have used. Careful cultural considerations should be invited in what seems like simple categories.

    Another seemingly simple data point is weight. But for people with mobility issues this can be a rare measure. Clarifying actual or approximate is important and adding a comment of last actual with particulars of date, weight of power or manual wheelchair to subtract as essential to our non-ambulatory patients.

    Please also consider fleshing out self-care details which can impact outcomes. Nurses are famous for working with this type of information. In this same light of critical details, I urge you to “MAP” out all the players in the health care team and caution that role distinction is essential to make this information useful. For example, a patient with Multiple Sclerosis may have one nurse who helps with setting up meds another nurse who specializes in wound care (Wound, Continence and Ostomy nurse, WCON) and a third nurse to supervise staff. This is not uncommon. Therefore, brief details must explain the roles just as with specialty physicians.

    A simple communication preference is also needed as a deaf patient may need email or specialized phones or another step to facilitate communication as would a person who needs an interpreter. Similarly, people with speech conditions often prefer email for complete and clear interchanges as do people with memory issues who need a record to refer to for recall.

    My last point is one of language choices and their impact. This initiative gives us an opportunity to replace ‘refused’ with ‘declined’ to extend a respectful and active role to the patient. This shift could also benefit healthcare overall by including a ‘wellness’ vs. illness tact. In fact, in my nursing practice I always try to understand my clients’ definition of health. Some people value comfort and function. Others may look at pain levels and still others at the actual numbers of medications they are on or how many times they visit the clinic.

    I believe that good healthcare is rooted in both good communication and good information. I am hopeful that the Federal Health IT Plan will benefit both.

  107. Hans Dethlefs says:

    I think the ONC document represents a great accomplishment given the challenges of addressing the most complex IT project in the world within the confines of the convoluted maze of political process and public interest. The 5 main strategic goals are key building blocks to a successful electronic health care system. The plan hinges on several assumptions: that incentives for adoption of EHRs will extend beyond phase 1 of meaningful use: that EHRs will improve quality, health, and reduce cost; that the public sector will embrace EHRs more than they have embraced healthcare reform; that providing individuals with their health information will lead to behavior change and increased engagement; and that taking the complex process of disseminating research findings (estimated to take 17 years) and integrating it into the complex process of EHR adoption (likely to span much more than 17 years) will in some way accelerate the dissemination of new knowledge and foster a learning healthcare system.

    I think the strategic plan needs greater depth to make the case that these assumptions will prove true. The spotlights on health outcomes in the grey sections of the document should be replaced with a more robust imagined future state when EHRs have progressed in quality and have been fully implemented and integrated across the country. Barriers to EHR adoption are lightly touched upon in the document, but their magnitude is grossly understated and the strategies to addressing the barriers need more substance.

    I am an advocate and enthusiast for the advancement and adoption of health information technology. Below is a narrative in which I strive to show many of the benefits and barriers of EHR adoption. The comments in the blog do a nice job of representing different perspectives and key issues many of which are echoed in the paragraphs that follow.

    EHRs and The Mission of Medicine

    It is 1997 and I find myself in a small town in the mountains of Honduras with a charge to provide medical care for 700 children from the town and surrounding villages. The children have 3 things in common: they are all poor, each has a sponsor in the United States that corresponds with them and sends them monthly financial support, and now they all have the same doctor.

    How do you provide good medical care to children whose parent’s earn on average $1 each day? In my 3 years in Honduras I found many answers to this question – buy Tylenol by the gallon, treat the child’s family and not just the child, deparasitize whole neighborhoods at a time, depend on your clinical skills more and expensive tests less, teach communities about prevention. Of the many additional answers, the one that is at the heart of this paper’s thesis could always be found in my back pack when I road my mountain bike to work – a laptop computer.

    An essential element in treating a population is to know who is in your population and what their needs are. To accomplish this in 1997 my approach was to create a rudimentary electronic health record (EHR) using Microsoft Access. I would use this to document the usual information obtained in a routine clinic visit, but also to log key health indicators such as problems with nutrition, anemia, when a child was last evaluated and so on. Generating reports from the data repository I was then able to use local outreach workers to do such things as assuring that each child was deparasitized twice yearly, that those families with malnourished children received an additional allotment of food, and that every child received a dental evaluation when we hosted visiting dental groups from the US.

    In Honduras for the price of a laptop I had an EHR that was as valuable to me as my stethoscope in providing high quality primary care to the poorest children in the western hemisphere. Paradoxically, 14 years and billions of dollars later, I find it a challenge to accomplish the same feat in the United States.

    Shortly after joining the community health center for which I have worked over the last 10 years, I was introduced to a federally funded quality improvement initiative called the Health Disparities Collaboratives (HDC). This initiative sought to empower Health Centers to apply key strategies to improve the care provided in the area of chronic disease management (diabetes, cardiovascular disease etc.). Two of the models of change employed were the Chronic Care Model (later renamed the Care Model) and the Model of Improvement. The language and change strategies employed by the Health Disparities Collaboratives eventually became the core of what is now called the Medical Home Model.

    A key element to the HDC was the utilization of a clinical information system (CIS). The majority of the health centers that participated in HDC used for this purpose an electronic chronic disease registry in which they would input key clinical information about their chronic disease patients (e.g. their A1C values, blood pressures etc.). The disease registry could then be used to run reports to identify which patients were due for appointments, which ones were in or out of control, and which ones were due for certain services (e.g. foot exams, eye appointments, pneumonia vaccines etc.). Chronic disease registries like this one became tools with which organizations could measure clinical process and outcome measures, manage populations of patients more effectively, and provide more complete services when patients presented for care. In short, their primary function was to improve the quality of care provided to patients with chronic disease.

    A major drawback of disease registries is that they contain only part of a patient’s medical information (that pertaining to certain chronic diseases), and they usually require duplicate data entry (first onto a paper record and then into the electronic database). Despite these limitations, our organization and hundreds like it across the country found a disease registry to be a powerful tool for quality improvement. Two of the key tools they provide for improving quality are the ability to generate population reports (e.g. who are my diabetic patients not seen in the last 4 months) and point of care clinical reminders (e.g. today a patient is due for an A1C, eye exam, and colon cancer screening).

    In the early 2000s as I worked with the clinical team that helped develop the chronic disease registry used by most Health Centers a key question that was asked on a regular basis was, why are we not working toward developing an electronic health record? The corollary to this was the question, why aren’t electronic health records working to develop the quality tools that chronic disease registries provide? The answer to the first question was that software development is too expensive and disease registry vendors did not have the resources to develop full EHRs. The answer to the second question is that EHRs were originally conceived as a substitute for paper in the documentation and billing of patient care, not primarily as tools to enhance the quality of that care.

    Despite our extensive use of our chronic disease registry, it was clear to our organization that an electronic health record was an inevitable part of our future. As such, in 2006 I began a year and a half search for an electronic health record. This involved sending out an initial request for information to about 60 EHR vendors. As an indication of the organizational capacity of EHR vendors at the time, I only received responses from about 20 of them. Of these 20 I did in depth reviews including one or more demos of about 15 of them, rating each of them on 18 key areas of functionality. Using this grading system we narrowed our choice down to 3. We then did site visits to health centers in various parts of the country using these 3 products and asked our top 2 choices to come on site to present to our entire staff.

    Though expensive and time consuming, the selection process of our EHR was only the tip of the iceberg. A lesson that I quickly learned was that you know very little of the EHR you select until after you sign the bottom line. It is only then that you get to start looking under the hood to see what you’ve gotten yourself into. One of the key reasons that we chose our product was because all of the EHRs we looked at did a poor job in the areas of population reports and clinical reminders, the two tools at the core of quality improvement. Although, pre-purchase, our EHR seemed to be fair in these areas, we found in the end that it was actually very weak.

    Another of the main selling points of our EHR was that it was very customizable. As most software developers can probably attest, “customizable” is a mixed blessing. It offers the opportunity to get things “your way,” at the high cost in time and resources that it takes to customize and test software and at the risk of isolating yourself from the upgrade path of your software vendor. Despite these risks, we were so desperate for a quality tool that we stepped off the slippery slope of customization. After thousands of hours of development we finally arrived to a point where our system could serve not only as a tool for documentation and billing, but as an engine to facilitate the high quality patient care that the Medical Home model and pay for performance initiatives are looking for.

    Though I consider our efforts a tremendous success – the reality is that we find ourselves in the midst of a US health information technology infrastructure that is a giant mess and my real experience is that the benefits of EHRs in their current state comes at some very real costs that go beyond the price of the software and hardware. The remainder of my discussion will focus on the divide between EHRs and the mission of medicine and how to bridge that divide.

    Defaults and Copy Forward – Easy but dishonest
    EHRs can make documentation faster by applying data as defaults. For example for a child under 1 year of age I always to do the same physical exam so an EHR can allow me to push a button “Normal” and it will populate my entire physical exam with my usual normals (e.g. Lungs CTA, heart RRR without murmur). Similarly I can view information from a prior patient visit and copy and paste it into my current visit.

    Both of these practices, though making documentation easier, have tremendous potential for both unintentional inaccuracies and intentional dishonesty. As regards to inaccuracies I have countless personal examples of this. My first experience was while shadowing a physician who was demonstrating his EHR to me. He was about to see a complex diabetic patient, and in preparation to entering the exam room he reviewed the electronic chart and showed me how he would enter his default values prior to entering the exam room. One thing he documented were the details of a normal foot exam, anticipating that he would perform the exam as part of the patient’s indicated care and that it would probably be normal. It turned out that the visit was more complex than the provider had anticipated, and since he was distracted by other needs of the patient, and behind in his schedule, he did not perform a foot exam. As I watched him for the remainder of his clinic he at no point went back and removed the documentation of the normal foot exam. The documentation was efficient, but false.
    I have had many similar experiences in my own EHR use where I will document “normal” and in the course of my physical exam will find an abnormality such as an innocent heart murmur that I will forget to go back and document in place of my “normal.”

    Copying and pasting data has similar benefits of ease and efficiency, but the same draw backs of potential inaccuracies. In copying the history of a prior complaint, or a piece of past medical history, to paste into a current encounter, it is easy to carry prior mistakes forward and to miss changes in the patient’s condition by assuming that the prior documentation is an accurate representation of their current state. Worse yet, it is likely common that patient histories are copied forward without any review whatsoever.

    Both defaults and copying forward are popular EHR features that vendors are forced to include in order to sell their products and clinicians are inclined to use since we often live in a perpetual state of being behind in our work. Both types of functionality save us time, but they insert into the medical record of patients false information. In most cases this is without harmful consequences, but given that a selling point of EHRs is that they can decrease medical errors, it would seem “most” is not good enough.

    Besides relying on providers integrity and attention to detail, there needs to be reasonable limits on the ability to copy information forward and apply defaults in EHRs. Examples of such limits include:
    1. limit the scope of defaults to populating only data that the provider sees on the screen at the time of applying defaults (e.g. don’t apply default information to remote templates that are not visible at the moment)
    2. Limiting defaults to the history or physical that any given provider would perform in the same fashion 99% of the time. (e.g “Lungs clear to auscultation” would be checked for 99% of respiratory exams, but “No intercostal retractions” would not for most providers)
    3. allow copying and pasting of only line items from prior encounters as opposed to complete sections
    4. Date stamp all discrete past medical history data for date last reviewed if the data can be anticipated to be dynamic (e.g. alcohol intake varies, having a history of an appendectomy does not)

    In the balance between ease and accuracy, accuracy should be the higher priority when the health of our patients is in the balance.

    Navigation
    EHRs, not unlike our paper charts, are forced to spread a patient’s health information across many different forms or templates. This requires frequently looking at a screen to find a link to the template that has the information to be viewed or entered. A patient’s information is typically distributed across dozens of templates, many of which may have multiple pages.

    This may sound simple enough, but the reality is that when you are trying to listen to a patient, integrating what you are hearing and seeing into complex medical decision making, and trying to maintain a compassionate presence to your patient, even a small amount of navigation is major distraction. By analogy it is akin to texting while you drive – either one is very manageable on its own, but put together they can have very negative consequences. Anything that impairs a provider’s ability to gather and process information during a clinical encounter has the potential to cause harm.

    Navigation on a computer is very distinct from navigation through a paper chart due to the tactile and visual difference of flipping through pages of a paper chart which is faster and easier than navigating within most electronic records.

    The key to optimizing navigation and minimizing its distracting effect lies in the difference between EHR usefulness vs EHR usability. Usefulness implies that a task can be accomplished in an EHR, while usability means it can be accomplished in an easy and intuitive fashion. Usefulness is accomplished when programmers have a to-do list that they encode in the software while usability happens when clinicians and programmers have a dynamic interaction of development and real time testing where subtle issues of flow and the “feeling” of the end user experience can shape every step of the design process. This requires a more robust design process than most vendors can accomplish.

    Entering and reviewing data
    Electronic codified data has several distinct advantages over hand written or type written uncodified text. Examples include the ability to search through a patient’s history or across a group of patients for specific information (e.g. has this patient had a heart murmur in the past or how many patients had influenza this month); organizing pieces of historical patient information in a chronological format (e.g seeing the history of how I have treated a patient’s diabetes); and improving the quality of patient care by allowing the computer to analyze what a specific patient is due for as far as health prevention (e.g. are they due for colon cancer screening) and which patients in my population are overdue for certain services (e.g. which children are overdue for immunizations).

    The main challenges that face the EHR world with respect to the above is that it is a tremendous burden for providers to input data into EHRs in such a way that it is codified, current EHRs underutilize the power of codified data, and codified data is presented in formats that are unreadable.

    Historically documentation in medical records has been hand written or dictated and later transcribed. Both of these methods are easy, relatively fast, and intuitive. The end result is a patient story that though sometimes illegible, is in a universal format that providers are taught as part of their training (e.g. SOAP notes, histories and physicals, discharge summaries, procedure notes) and can be recognized anywhere in the country. Utilizing these formats a provider can understand the story behind the patient which is invaluable in providing optimal care.

    Inputting data in EHRs involves a variety of avenues. Data can be captured by checking check boxes or radio buttons (e.g. No allergies – check); picking words or phrases from preconfigured lists; typing individual words, phrases, or whole paragraphs; pushing buttons that assign values to fields; having a scribe input information; or dictating on tape or via electronic voice recognition. All of these methods have short comings. Checking boxes and picking from lists requires focusing on the computer screen and not on the patient. It is impossible to capture the nuances of a patient’s story through such check boxes and lists, and even though key history pieces may be captured, there is much that is lost. On the other end of the spectrum – typing paragraphs or dictating – the story is more faithfully told, but the data is less codified, turning the EHR into a very expensive dictation system and losing the advantages of codified data.

    When data is actually captured in a codified fashion in EHRs the advantages of having it in this format are underutilized. As described above there are very specific ways in which codified data can be manipulated to help provide high quality care. Current EHRs fall short both in usefulness and usability for failing to recognize the key ways in which a provider needs to view data. Part of this relates to poor template design (e.g. a screen where a lab is ordered should show the results of the same test ordered previously to avoid redundant orders), and owes in part to weak data manipulation and reporting engines (e.g. inability for clients to develop new clinical reminders based on complex patient characteristics and inability to generate key patient population reports without expensive outsourcing).

    The universal, readable “patient story” has been largely lost in the transition to EHRs. EHRs typically take the information input during a patient encounter on different templates and pull the information into a document that can be printed and sent to other organizations. The format and quality of these documents is extremely variable and rarely stays true to the pre-EHR standard formats with which we are all familiar. The notes that we receive from emergency rooms have all sorts of nursing and triage information woven into the provider documentation and are long and difficult to interpret. I recently received a document from a nephrology office that was 27 pages of randomly arranged check boxes that did anything but help me understand the patient or what the nephrologist was doing with them. Concatenating is the process of taking check boxes, words, and phrases and automatically pulling them into paragraph format. This frequently used technique results in mechanical sounding text that is also often difficult to read and loses much of the patient story.

    Reaching beyond the above drawbacks to capitalize on the power of discrete data is going to require improved hardware (e.g. larger inexpensive touch screens) and software (e.g. better voice recognition) technology, better integration of providers into the design process and creation of design standards unique to EHRs, and intuitive standardized document formats that parallel those formats utilized in the pre-EHR era.

    Reviewing images
    Much of the information contained in EHRs is in the format of scanned images of documents (e.g. hospital discharge summaries, radiology results, consultant notes). The challenges with this are that such images are often hard to find, difficult to view, and represent information that is not codified. This basically takes all of the disadvantages of the paper world and makes them worse.

    In the short term, better searching and viewing tools are needed to be able to rapidly review large numbers of scanned images. In the long term a transition away from scanned images to codified, non-image formats that can be seamlessly shared across systems will be the solution.

    Interfacing
    We have found ourselves in an environment where there are hundreds of different EHR products that all adhere partially to electronic standards (e.g. HL7, snow med, CPT codes). The differences in products and the partial adherence to standards has resulted in the need to create electronic interfaces between each and every system if information is to be shared electronically between them. This is the greatest barrier between us and a great national health information technology infrastructure.

    Electronic interfaces are expensive to create (usual in the order of thousands of dollars each), are difficult to maintain (most EHRs are constantly changing requiring upkeep of existing interfaces), and insert a source of potential information error. It will be impossible to interconnect all of the systems that currently exist within our current national model. By way of example our organization sends lab tests to 4 different vendors. We have an interface with one of them so we send and receive those results electronically. We cannot afford an electronic interface with the other 3, so we send and receive those results via paper and fax.

    The direction that we are going on the national level is for each state or region to develop a health information exchange portal for sharing certain medical information with the hope of then interconnecting all of these systems at the national level. The end result of this will be to take the giant mess that we currently have and rearrange it into another giant mess over the course of 10 to 20 years and the expenditure of billions of dollars.

    The only affordable and timely model for a well connected national health information infrastructure is to use a central hub model funded by the federal government that faithfully uses standard medical terminology and interface language. Vendors would build a single interface to this central hub and EHR clients would bear no additional cost for interfacing. By way of example this would allow all labs to build a single interface to the hub and all EHR vendors to build a single lab interface to the hub through which all information would flow. This would decrease the number of interfaces and associated cost by 10,000 fold. The inherent error rate with the creation of each interface would decrease similarly. This would decrease the cost for EHR adoption, allow EHR vendors to redirect resources to more research and development, and allow for more fluid patient information along with a clear global picture of national and regional health trends.

    Portability of personal health information
    The subject of personal health information is closely linked to the issue of interfacing. About 8 years ago our clinic was approached by an organization that was developing credit card like devices that stored key personal health and insurance information. The idea was that patients and their providers would maintain the information current via a web link and local ERs and clinics would have card readers to extract the information. The concept was doomed for failure owing to dependency of duplicate data entry to maintain data and lack of critical mass. Critical mass in this context refers to the fact that for patient health information to be portable the majority of health systems in any given region and ideally nationally would need to use the same data format and exchange structure for the information to be truly portable. The critical mass issue would best be accomplished with the central hub interfacing model where a patient’s information could flow from any system into any system regardless of the region of the country or health care organization.

    Confidentiality of health information
    When patients are asked about their personal health information, the concern that rises to the top is confidentiality. The introduction of EHRs while offering the possibility for greater portability of information also introduces greater risk for breaches in confidentiality. This is made more complex by the fact that some patient information (e.g. behavioral health and social information) is more sensitive than other information which means that a patient may authorize the transfer of part of their personal information, but not all of it. This requires that EHRs have the ability to distinguish information by type as relates to confidentiality.

    As with paper medical records patients need to retain the ability to decide what information is sent to or withheld from external organizations and this needs to be managed as part of organizational policies and interfacing protocols. This too would be simplified greatly by having a central interfacing hub with universal standards.

    From the bench to the patient
    Estimates for the lag between new medical research findings and the application of the findings to usual patient care range from about 10 to 17 years. The lag derives from many barriers: the lack of good communication avenues between researchers and practitioners, incorporation of research findings into conflicting guideline sets, ineffective teaching strategies, and provider inertia being some of the key road blocks.

    Translational research is the field dedicated to shortening this timeline. One would hope that EHRs would be a fundamental tool not only in translating research into clinical practice, but also in enhancing the efficiency and quality of clinical research. Currently EHRs are not designed to facilitate a usable and dynamic influx of new research findings and guidelines nor for pooling data across different products for the purpose of new research.

    Not to sound like a broken record, but the only way that EHR vendors can incorporate usable and dynamic decision support tools into their systems is to draw from a centralized hub similar to that for electronic interfaces of patient information. New standards and guidelines need to be packaged and communicated in a standard format in order for individual EHR vendors to have any hope of incorporating the information in an efficient and timely fashion.

    The packaging of key research findings and guidelines should include standard elements in a toolkit format including such items as patient education materials, appropriate self management goals, the logic required for point of care clinical reminders and population reports, and brief abstracts and full journal articles that are tied in various formats to CME. If research is ever to be disseminated in a timely fashion it will have to be presented in a universal format which includes dynamic integration into EHR products without the need for upgrading versions of the products. Additionally EHR implementation will have to include creating workflows that can manage an influx of new clinical recommendations.

    Variation between products
    With hundreds of different EHR productions on the market we have the advantage of a lot of good minds looking at EHR development in innovative ways. This along with market competition to control costs are the main two advantages for this approach as opposed to a single national EHR. This approach is consistent with our economic model and is unavoidable, but results in certain problems that need to be strategically addressed

    Many of the weaknesses in current EHR products relate to the companies having insufficient research and development (R&D) funds. The companies are often small to medium in size and as the market gets saturated will shift from new sales to maintenance fees and services as their main sources of income. The cost of purchasing and implementing an EHR is so prohibitive that organizations that purchase products are “stuck” with them for a long time which will gradually reduce the impact of competition between vendors. The combination of insufficient R&D and a limited market will have a downward pressure on the rate of new development that current systems desperately need.

    The variability in products makes standardization and its advantages challenging. In the world of paper charts a provider could train anywhere in the country and readily adapt to a new job anywhere else in the country. Now providers need to learn a new complex system (and if they go to different hospitals then several systems) whenever they change jobs. Different data structures between systems make it impossible to map some data between products, making the data less portable.

    Versioning and customization of products will also serve as a major drag on forward progress. Most vendors have close to a decade of development history and along with this a decade history of old development baggage that they have to drag along since they have clients using those versions with important clinical data in them. When last I asked, our vendor had only 10% of its clients on its most recent version, which had already been out for a year. Pushing providers into purchasing products before standards have been well developed will result in a large parts of our health care system being stuck on pre-standard versions of products, with a resulting lag of several years as clients slowly upgrade to current versions.

    The certification process for EHRs as the primary avenue to assuring adherence to standards of data structure holds weight currently because companies can only hope to sell their products if they are certified. As EHR adoption expands, however, there will be less pressure for products to remain certified since their sales will depend less on this. This speaks once again to the need for a central hub along with its set of standards so that vendors can adhere to them in a more cost effective manner. Expecting each EHR vendor to interface seamlessly with 50 State level health information exchanges is unrealistic.

    Selecting diagnosis and procedure codes
    Though standardization is a key piece to the EHR puzzle, it is also part of the problem. ICD-9 (soon to be ICD-10) codes and CPT codes represent extremely long lists of names for diagnoses and procedures which do not match the names that providers use in common practice. The mismatch between nomenclatures and the sheer volume of options makes selecting diagnosis and procedure codes difficult. In the paper world a provider could just write down the name of a diagnosis or procedure and a coder would take it from there. In the EHR world it is often put on the provider’s shoulders to select the codes. This adds stress to EHR implementations and time to each patient encounter. In this area most EHR vendors get an A for usefulness and a C for usability, which is to say any code can be found, as long as you have enough time.

    Usability of EHR products depends on the external environment of standards and is a piece that also requires copious input from practicing clinicians. Additionally, the impact of new code sets like ICD-10 will have a Y-2K like impact on EHRs, creating a huge burden on vendors and clients alike. Shifts in code sets need to be handled in a whole new manner in the EHR world in to which we are entering.

    Unique patient identifiers and PCPs
    An integrated national healthcare network will require that each person have a unique identifier and if pay for performance is to have any hope of working then patient’s will need to be reliably identified with a primary care provider. Considering the challenge that we have had nationally with handling illegal immigration and identity theft, identifying patient’s uniquely is a goal that is many years away, but is essential for what we want to accomplish now. The fluid motion of patients from one provider to another and from one institution to another make assigning responsibility of a patient’s outcomes to a specific provider a loose association at best. Measurement of quality and incentives for improvement depend on being able to assign responsibility for particular patients to specific providers. Strategies are needed for making patient-provider associations that are acceptable to both providers and patients and that avoid the negative consequences inherent to pay for performance incentive programs.

    Quality tool
    The Federal government will be investing a huge sum of money via the Meaningful Use incentives to get providers to adopt EHRs. All of this is driven by the assumption that this will improve the quality of care and reduce costs. There is a body of research with conflicting results on this subject casting doubt on this very expensive assumption. Two main issues have prevented a notable improvement in quality with EHR adoption. Firstly, EHRs are poorly designed as quality tools. Secondly, EHRs are being adopted by organizations that are not prepared to utilize EHRs for quality improvement.

    There are a number of areas of functionality that give EHRs the potential for serving as quality tools. Clinical reminders (indicating what a patient is due for when they present for care) and population reports (listing groups of patient due for certain services) are at the top of the list of these tools. I carefully reviewed these pieces of functionality for 15 of the main EHR products and found them all seriously lacking. EHRs were originally designed to document and bill visits and it is only at this point that they are being retrofitted with quality tools which are still suboptimal in most if not all systems.

    The patient centered medical home model and accountable care organizations represent movements to transform health organizations into centers of quality. Nationally we are early on in this transformation and we are stuck in the messy quandary of how to meaningfully incentivize quality, with pay for performance efforts highlighting how complex this can be. Until EHRs better develop rich quality tools and healthcare organizations reorganize to utilize these tools effectively, it is unlikely that significant improvements will emerge with the transition to EHRs.

    Prescription Errors
    Reducing prescription errors has been a selling point of EHRs and in particular eprescribing. Our experience has been that though we have eliminated hand writing legibility issues, we introduced a new layer of errors unique to EHRs. Examples include selecting default sigs (prescription instructions) which are other than what was intended, mismatches in quantities prescribed and the duration recommended, renewing prescriptions which contain errors (thus perpetuating the error) and failure to manually cosign controlled substance prescriptions. We have undertaken a focused quality improvement effort to avoid these errors with good success, but this demonstrates again the fallacy that EHRs by themselves result in better quality.

    Networks and the Safety net
    Practicing medicine in a Federally Qualified Health Center, and serving as the medical director for a network of several health centers, I am surrounded by providers and staff who are very mission driven and seek to provide the highest quality of healthcare to the poor of our society. Though EHRs can lead to increased reimbursement in the private sector with limited gains in improvement, the opposite tends to be true in the safety net arm of our health sector where EHRs are a heavy cost burden, but are embraced for their potential to improve quality. When considering our national agenda of reducing health disparities, both vendors and the federal and state governments need to invest additional resources in supporting affordable EHR adoption for these organizations.

    Both for Federally Qualified Health Centers and small to medium private practices the only hope for meaningful adoption of EHRs is to join networks of similar organizations that can help manage the complexities of EHR implementation and maintenance. Regional extension centers, since they are not the involved in managing EHRs after implementation, will struggle to have the practical experience and resources to keep EHRs sustainable in the long run. The skills necessary to maintain these complex systems requires both local expertise and economies of scale – both of which can best be accomplished via networks. In the case of FQHCs, these networks will need ongoing operational funding to be sustainable.

    The human experience
    After 2 years of seeing patients utilizing an EHR I still find that the EHR serves as a wedge between me and my patients. It takes the human interaction between provider and patient and inserts brief redundant distractions, interrupting listening to my patient and impeding the clinical thought process. The EHR takes a human story, breaks it into pieces and gives it a mechanical feel. It takes that part of us that is healer and turns it into technician. This is an experience of degrees, not an absolute – but it represents a real harm of EHRs which needs to be recognized for what it is. The drastic shift in how we care for our patients implores that we adopt a national approach to EHR development and deployment that is rich in detail and that paints a clear picture of a better tomorrow, the core of which lies in EHRs and our national network remaining faithful to the mission of medicine.

    Hans Dethlefs, MD

    • David Hager, M.D. says:

      This piece is written by a practicing physician (and not a vendor, bureaucrat, or advocacy group.) Thus, it has greater credibility. Well written. I agree.

      The following sentences and sections stood out for me:

      * “In Honduras for the price of a laptop I had an EHR that was as valuable to me as my stethoscope in providing high quality primary care to the poorest children in the western hemisphere. Paradoxically, 14 years and billions of dollars later, I find it a challenge to accomplish the same feat in the United States.” (Innovation needs a big kick in the arse.)

      * “A lesson that I quickly learned was that you know very little of the EHR you select until after you sign the bottom line. It is only then that you get to start looking under the hood to see what you’ve gotten yourself into.” (Salesman vs. reality for the non-nerd clinician.)

      * Section: “Defaults and Copy Forward – Easy but dishonest” (To my chagrin, I catch myself with such errors, too.)

      * “Navigation on a computer is very distinct from navigation through a paper chart … difference between EHR usefulness vs EHR usability” (Usability is the best way to hook us into this technology. Is anybody listening?)

      * “The universal, readable “patient story” has been largely lost in the transition to EHRs.” (Information in our large system’s EHR is loculated into blind pouches. A separately hired person has to dump dozens of disparate reports into .pdf format and bind them together to have something that sort of captures the readability of a paper record.)

      * “The cost of purchasing and implementing an EHR is so prohibitive that organizations that purchase products are “stuck” with them for a long time which will gradually reduce the impact of competition between vendors.” (I would add here that data migration to a new product = one of the prohibitive costs. Clients are locked-in to vendors by the data constructs.)

      * Section: “The human experience” (Nice synopsis. I agree.)

      * * *

      Dr. Dethlefs deftly & eloquently describes discrepant perceptions between practicing clinicians and everybody else that’s involved re: HIT readiness.

      I do not oppose HIT, including EHR technologies. It’s just that people who aren’t actively seeing patients daily don’t “get it.” EHR technologies are currently too premature to push out by decree.

      I remain convinced that the market should determine when EHR technologies are ready. When delicious products are out there, clinicians will consume.

      How can the government help here?

      Catalyze formation/maintenance of data standards that would make it easier for clinicians to change products, thus fueling competitive market innovation. Data standardization also helps fulfill a powerful need to improve health information exchange.

  108. The strategy here seems to be missing real change to the medical industry. All this seems to do is gather information about the patients. The only benefits appear to be to the health care industry with this data sharing strategy. I would add to this strategy measures and federal guidelines of the public funding of each industry player. For example, if a pharmaceutical company recieves public funding for research for a drug then this should be stated. The idea here is that in the future, the public elected government shall move all patents garnered by any publicly funded private company to be licensed to the entire public. Any private company that recieves any public funding directly or indirectly must provide a license to the entire public. Also, all patents shall expire after 10 years and automatically move to the public domain. Mapping the funding that has been given to the industry would help map out moving to creating competition in the industry. This would provide real solutions and remove much of the current price corruption in the health care industry. This information should be the first information provided to the data sharing. I also could not find any information about accountability for the information sharing. If the information is ever used for advertising, misused, compromised, then what are the penalties for these actions? What is the process for litigation against any entity that has caused damages in identity integrity?

  109. California Tobacco Control Program says:

    The Centers for Medicaid and Medicare require that electronic health records be used to improve the quality, safety, and efficiency of health care systems and reduce health disparities. Currently, the California Medicaid program (Medi-Cal) insures 3.7 million adults. It is anticipated that there will be an additional one to three million new Medi-Cal beneficiaries in 2011. To reduce the adult Medi-Cal insured smoking prevalence of 20.3 percent (compared to 13.6 percent non Medi-Cal prevalence) the California Department of Public Health, California Tobacco Control Program (CDPH/CTCP) strongly supports the integration of an Electronic Medical Records (EMR) system into the operations of the California Smokers’ Helpline who is funded by CDPH/CTCP. To that end, CTCP is proposing to enhance and expand operations of the California Smokers’ Helpline by integrating the use of an EMR system that would allow health care systems to electronically refer tobacco-using patients to the Helpline for evidence-based tobacco cessation counseling services. Through such an e-referral system, patient information could safely be exchanged between certified secure servers. Such a system would increase efficiencies and provide the Helpline the ability to provide follow-up reports to health care providers which could include information about whether their patient enrolled or declined services as a result of the contact, and the number of counseling sessions received. Health care providers would have the capacity to immediately refer their patients to the Helpline at the time of their clinical visit resulting in efficiencies and positive support. Given that Medi-Cal beneficiaries smoke at a higher rate than the general population; the integration of an EMR system into the operations of the California Smokers’ Helpline would provide an additional tool to improve services to this population and reduce the health disparities . Tobacco use remains the number one preventable cause of death and disability in the United States. Decreasing barriers to the utilization of effective cessation services will likely result in cost-savings to Medi-Cal.

  110. Shannah Koss says:

    I want to commend ONC on the great strides it has made to advance the health system improvement goals of HITECH and ACA. I also want to thank you for the opportunity to comment on the Federal HIT strategic plan. I applaud your vision and efforts to date.

    My comments are primarily focused on consumer/patient engagement and why it is, in fact, a core component of all 5 priority goals and as critical to the early EHR and HIE adoption phase as it is to the future vision of fully empowering individuals. To achieve this necessary engagement I believe the strategy needs to explicitly state the importance of building consumer/patient tools in the emerging HIT infrastructure that will advance needed education, outreach and engagement i.e., eHealth literacy. Nation-wide adoption and particularly advancing HIE depends on consumers and patients understanding the benefits of HIT and ideally opting in or not opting out of HIEs.

    I prefer a distinct definition for ehealth literacy that incorporates Norman and Skinner’s definition, but in the context of HITECH and ACA, expands it to include leveraging the emerging infrastructure to make health information accessible and comprehensible to all individuals. We must build in tools that either directly help individuals, or help the providers and caregivers that in turn help individuals, better understand and engage in their health and healthcare needs.

    Advancing meaningful use, particularly the patient and family engagement component, has a direct dependency on enabling eHealth literacy. The emerging HIT infrastructure should be developed to support the full diversity of the patient population to directly, or with assistance, understand and engage in their care. The support needs to start with helping all individuals understand health IT, and their rights and responsibilities, if it hopes to become an infrastructure that will help improve and tailor care to a patient’s needs.

    The Federal Health IT principles that frame the intent of the strategy underscore the importance of building eHealth Literacy capacity and tools into the emerging infrastructure. In particular: Put individuals and their interests first; Support health IT benefits for all and Focus on outcomes. If we’re not helping all individuals understand the benefits of health IT and how to engage with their providers and access their information then we will be hard pressed to carry out these principles.

    Many will say the infrastructure is not sufficiently ready to start engaging patients, but this is not, and cannot, be the case. Even with only 25% of physician offices and 15% of acute care hospitals taking advantage of EHRs and perhaps only 10 or 15 states with operational HIEs, millions of consumers/patients are already being asked to consent to the sharing of their health information. Few are being educated about what HIE means and the benefits and risk of health IT adoption and HIE. Consequently few are sufficiently informed to make a meaningful choice to participate and with an understanding of the implications. If too many opt out the HIEs will struggle to reach sustainability. Absent more direct focus on eHealth literacy ONC and the state programs will be hard pressed to meet every strategic plan goal and particularly empowering individuals, meaningful use, improved care, and inspire confidence and trust.

    To make ehealth literacy an explicit component of the strategic plan and position the time to act consistent with meeting these goals, I recommend the following additions and revisions to the plan:
    Add or amend the Goals, Objectives and Strategies as follows:

    Revised: I.A.6. Communicate the value of EHRs and the benefits of meaningful use through ehealth literacy tools that support plain language, and culturally and linguistically appropriate content. Do not just target providers for increased understanding, we need to target patients and providers.

    New: I.B.4 Encourage consumer and patient understanding of and support for Health information exchange.

    Revised: I.C.2. Encourage eHealth literacy tools, track health disparities and promote health IT that reduces disparities and poor health literacy.

    Data from the National Adult Literacy Survey suggests that close to 50% of all adults face health literacy barriers and they are very often the same sub-populations that experience higher incidence of chronic illness and worse healthcare outcomes. We can’t afford to just track what will likely be a worsening trend rather than help engage these individuals.

    Revised: 11.D.2 Invest in health IT infrastructure to support the National Prevention and Health Promotion Strategy. Make explicit reference to the Plain Writing Act and the National Action Plan for Improving Health Literacy that would enormously benefit from eHealth literacy tools

    Revised: III.B.1. Inform individuals using plain language and culturally and linguistically appropriate communication about their privacy and security rights and how their information may be used and shared.

    Revised: IV.A.2. Communicate with individuals openly, using plain language and culturally and linguistically appropriate content, and spread messages through existing communication networks and dialogues.

    New: IV.A.3 Encourage accessibility to all automated health information for all individuals including those with disabilities and limited health literacy by supporting online eHealth literacy tools.

    Thank You again for the opportunity to comment.

  111. Comments of the Center for Democracy & Technology on the Federal Health Information Technology Strategic Plan 2011-2015:

    The past two years have been historic for health care and health IT in the United States. The passage of the HITECH Act in 2009 and the Affordable Care Act in 2010, and the subsequent work of federal agencies, the Health IT Policy and Standards Committees, and private industry have gotten health IT adoption off to a strong start. To capitalize on the gains made thus far and ensure public trust in health IT in the future, it is critical for the work of the next five years to be guided by a forward-looking vision with clear priorities. It is also important for the Office of the National Coordinator (ONC) and the Office of Civil Rights (OCR) to work together closely on the issues over which they share jurisdiction and leadership responsibility.

    The Federal Health Information Technology Strategic Plan (the Strategic Plan) describes numerous efforts of ONC and OCR aimed at inspiring public confidence and trust in health IT. These initiatives are laudable and CDT is very pleased to see the Strategic Plan note multiple areas in which ONC and OCR intend to work together. In particular, CDT looks forward to ONC cooperating with OCR to develop and disseminate comprehensive and clear policies on core issues in health privacy and security, including secondary uses of health information, regulation models for personal health records and de-identification of personal health information. (Pg. 31.) ONC, OCR and the Substance Abuse and Mental Health Services Administration’s (SAMHSA) also deserve praise for committing to ensuring best practices and privacy and security policies keep pace with advancements in technology. (Pg. 33.) Lastly, CDT is pleased that OCR intends to continue to strive to improve compliance with HIPAA; OCR has recently stepped up its enforcement of HIPAA from previous levels, and CDT strongly encourages OCR to more consistently enforce HIPAA. (Pg. 32.)

    Because the Strategic Plan describes so many ongoing privacy and security initiatives, it is unclear how each initiative can be accomplished effectively within the 2011-2015 timeframe. Unfortunately, the Strategic Plan gives almost no indication as to how these initiatives will be prioritized. The Strategic Plan would be strengthened with clear deadlines for individual initiatives and benchmarks for meeting each objective. For some initiatives, the Strategic Plan also does not indicate the end product or desired outcome; for example, ONC (in consultation with OCR and SAMHSA) promises to explore broader privacy and security policies, but does not say what is the expected or desired outcome or work product of this effort. While it can be difficult in the early stages to predict how initiatives will develop over time, the public will see progress and better understand how privacy and security is being advanced in concrete – not just rhetorical – terms if clear outcomes, priorities and deadlines are specified and met.

    One of the great potential benefits of electronic health records and health information exchange is that patients can be empowered to manage their own health through commercial services such as apps and personal health records. Yet HIPAA often does not cover health information in these contexts, leading to fewer privacy protections and a complicated and confusing legal structure for consumers. Although the Strategic Plan makes clear that the proposed list of core policy issues ONC, OCR and SAMHSA will explore is not comprehensive, CDT encourages these agencies to specifically develop and implement – with other federal partners, especially the FTC – consistent policies to protect the privacy of health data that migrates outside the jurisdiction of HIPAA. These policies, once developed, should be bolstered with consumer awareness efforts.

    The Strategic Plan refers to consumer education and outreach initiatives that includes best practices on how individuals can protect the privacy of health data they maintain in consumer health IT tools. (Pg. 33.) The Strategic Plan indicates that individuals will be educated on what their privacy rights are under HIPAA, which is indeed important, but individuals are increasingly using their health data in services not provided by HIPAA-covered entities. For this reason, consumer education and outreach efforts should not just inform individuals of when their HIPAA rights apply (i.e., a PHR provided by a covered entity), but also when those rights do not apply (i.e., a social networking site provided by a non-covered entity).

    Conclusion: Overall, the Strategic Plan is a positive step forward for strengthening health privacy policies and consumer education. CDT encourages ONC, OCR and other federal partners will take full advantage of the opportunities for cooperation listed in the Strategic Plan. CDT recommends including clear benchmarks and priorities for individual initiatives in the Strategic Plan to make progress focused and measurable. CDT encourages ONC, OCR and other federal partners to develop and implement clear policies to protect the privacy of health information that is used and disclosed outside of HIPAA coverage. Lastly, consumer education efforts should specify not just what individuals’ rights are under HIPAA, but also in what contexts those rights no longer apply. CDT thanks ONC for the opportunity to comment on its 2011-2015 Strategic Plan.

  112. National eHealth Collaborative
    Comments on the Federal Health Information Technology Strategic Plan 2011-2015

    INTRODUCTION

    National eHealth Collaborative (NeHC) is pleased to support and comment upon the Office of the National Coordinator for Health Information Technology’s (ONC) Federal Health Information Technology Strategic Plan.

    First, we would like to recognize and applaud the tremendous progress that ONC and the federal government has made in recent years to advance health information technology (HIT). Under the American Recovery and Reinvestment Act’s (ARRA) Health Information Technology for Economic and Clinical Health (HITECH) Act, the game changing concept of meaningful use was created. Currently, significant dollars are being invested to stimulate progress through financial incentives and supporting programs to address known barriers to adoption and effective use of HIT. Further, with the passage of the Affordable Care Act, we have the opportunity to transform healthcare financing and delivery in ways that will lead to better outcomes and more effective cost management. These are major accomplishments and big steps in the right direction. Thank you for your leadership and tireless efforts.

    Next, we would like to acknowledge that the Federal Health Information Strategic Plan is an excellent piece of work. The plan is clear and focused, and builds on all the great work that has been underway. It is good news that there is no change in course despite a recent change in leadership. It is also good news that the plan incorporates and expands on two very important new priorities – Consumer Engagement, and the Learning Health System. NeHC applauds the elevation of these vital strategic goals.

    The rest of our comments will provide a brief description of NeHC’s role and will focus on how we support ONC’s strategy already, as well as suggestions on how we can support the strategy going forward.

    NeHC’s ROLE

    NeHC enjoys a very close relationship with ONC. As you know, NeHC is a public-private partnership that enables secure and interoperable nationwide health information exchange to advance health and improve healthcare. NeHC is focused on working collaboratively across healthcare to tackle barriers and accelerate progress toward widespread adoption and use of HIT and health information exchange (HIE). We are a neutral convener of all healthcare stakeholders and play a unique role in collaboratively encouraging widespread adoption and use of HIE and HIT.
    Under a Cooperative Agreement with ONC, NeHC provides logistical, administrative and operational support for the Nationwide Health Information Network (NwHIN) Exchange. NeHC also operates NeHC University (formerly NHIN University), a series of web-based education programs on a wide range of timely and relevant HIT and HIE topics. The programs are designed to feature leading speakers, are highly interactive, and are well attended by diverse stakeholders.
    NeHC’s EFFORTS IN SUPPORT OF THIS STRATEGIC PLAN

    Goal I: Achieve Adoption and Information Exchange through Meaningful Use of Health IT

    NeHC supports Goal I in multiple ways. For example, NeHC provides logistical, administrative and operational support for the NwHIN Exchange. We look forward to assisting the NwHIN Exchange as it evolves from its current form to a scalable, sustainable enterprise.
    Additionally, NeHC is developing in-depth profiles of leading HIEs. The focus of this effort is to capture success stories on the value, impact, and sustainability of HIE on all stakeholders, including patients, providers and purchasers. The profiles will highlight examples of how organizations use different approaches to connectivity and exchange such as Direct, NwHIN, or state HIEs for various use cases. Through this project, NeHC will develop an understanding of critical success factors for HIE. The HIE profiles will be widely disseminated to help stakeholders understand how organizations have been successful with HIE, to help build knowledge, and accelerate progress.

    NeHC is conducting surveys of emerging HIEs as well. The focus of this project is to understand specifically what challenges they are struggling with, what resources are available to them, and what their most pressing unmet needs are. This will inform the need for programs or services to assist these emerging HIEs in being successful. It is expected that the HIE leader profiles described in the previous paragraph may be very helpful for these organizations.
    NeHC also provides education programs to encourage health information exchange. A few recent examples:
    • One Size Does Not Fit All: Exploring Various Forms of Exchange
    • Speakers from HealthBridge, Availity, Surescripts
    • Attended by 350+ from all segments of healthcare
    • 35 minutes interactive Q&A
    • Revisiting the Direct Project
    • Speakers from ONC, Rhode Island Quality Institute, Allscripts
    • Attended by 200+ from all segments of healthcare
    • 30+ minutes interactive Q&A

    Despite great efforts on behalf of ONC and others, there remains significant confusion in the market about the various approaches to connectivity and exchange such as Direct, NwHIN Exchange, state HIE, et cetera, and how meaningful use fits in. NeHC will be working with ONC and other stakeholders in an effort to create an HIE roadmap to try to bring some definition to the various approaches and how they fit together. It is hoped that the HIE profiles and an ongoing effort to educate stakeholders about the quickly evolving HIE landscape will help alleviate confusion and bring clarity to a cohesive national roadmap for HIE.

    Goal II: Improve Care, Improve Population Health, and Reduce Health Care Costs Through the Use of Health IT

    Goal II is extremely worthy and much progress is underway through meaningful use and HITECH programs such as the Regional Extension Centers, state HIEs, Beacon Communities, and more. However, it is clear that additional education, information gathering, and dissemination of best practices and lessons learned is needed. This is an area where NeHC can continue to support ONC’s efforts. Examples of needed education programs include offering updates on the work undertaken by the HIT Policy and Standards Committees and their various working groups and task forces. Many stakeholders are unable to keep up with that information and may have questions about what is being accomplished and how the work is being used, so NeHC and ONC are currently collaborating to launch such a program. The Beacon Community program is an innovative program whereby ONC has funded 17 communities to implement diverse health information exchange activities to address specific use cases such as improving care for diabetics, improving transitions of care, improving care for patients with heart disease, and more. NeHC hosted a program on the Beacon Communities in 2010 and could provide a forum for widely sharing the learnings from the Beacon Communities with all interested stakeholders.

    Under the Affordable Care Act, the Center for Medicare and Medicaid Innovation (CMMI) was created and funded with $10 billion. CMMI authorized a wide range of innovative programs that use payment reforms to promote quality, efficiency, and equity of care. These include bundled payment pilots, medical home pilots, and others. Important – even transformative – learnings may come from this program. NeHC would be an ideal vehicle to share these learnings with the industry more broadly through our NeHC University.

    In addition to disseminating information through NeHC University, NeHC can also assist ONC and other government agencies in gathering input from stakeholders through online communities that have been developed for this purpose. As an independent, public-private partnership, NeHC may have somewhat more flexibility than the government in convening stakeholders to disseminate information and gather feedback on particular topics of interest.

    Goal III: Inspire Confidence and Trust in Health IT

    NeHC recently conducted a stakeholder survey on top issues related to HIE. Survey results showed that privacy and security consistently ranks high as a top concern. Governance and privacy and security are among the top issues on which stakeholders would like regular updates. Privacy and security, adoption and use, and governance are the top issues on which stakeholders most want to work collaboratively on solutions.

    These survey results underscore the importance of Goal III and further highlight the critical need for multiple approaches to getting the word out to stakeholders, gathering input, and creating collaborative forums for developing solutions. NeHC can play a valuable role in this regard and welcomes the opportunity to work more closely with ONC to fill remaining gaps.

    For example, as practices work toward implementing EHRs and achieving meaningful use, many challenges are being encountered. Wide variation in functionality exists even among certified EHRs and there are challenges in coordinating the functionality associated with meaningful use with the workflow within practices. Even with the Regional Extension Centers and the HIT Resource Center, additional tools, best practices, and programs may be helpful to further evaluate EHRs above and beyond certification in terms of how well the EHRs support practices in succeeding with implementation. The investments of time and money to implement EHRs and achieve meaningful use are significant and there is considerable risk that the benefits may not be realized in the desired timeframe, given the variation in functionality and complexity of aligning workflows. NeHC may be well positioned to create a collaborative forum to highlight these challenges and coordinate the collection of best practices to help overcome some of these barriers.

    Based on its experience supporting the NwHIN Exchange and given its Board of Directors comprised of HIT and healthcare industry leaders, NeHC may also have a valuable role to play in supporting governance of the Nationwide Health Information Network. NeHC routinely provides stakeholder education programs related to the policy and legal framework undergirding the NwHIN ecosystem, and in gathering profiles of leading HIEs, NeHC will also have collected and studied a substantial amount of additional information and expertise on governance.

    There also seems to be a need for better understanding of the rules and regulations related to sharing health information across state boundaries. Many HIEs and health systems have a critical need to understand and ensure compliance with these rules. NeHC has convened a coalition of stakeholders interested in working on this but has been unable to find funding to support this work thus far.

    Goal IV: Empower Individuals with Health IT to Improve their Health and the Health Care System

    The engagement and education of consumers and patient-centered care aspired to in Goal IV is vitally important and we are pleased to see that ONC’s Strategic Plan emphasizes empowering individuals with health IT to improve their health and the healthcare system as one of its goals. One of the ways in which NeHC actively supports this goal is through its recently launched Consumer Consortium on eHealth. NeHC and a group of leading patient and consumer advocates are convening a broad cross-section of stakeholders to develop and coordinate a program to encourage individuals to become more engaged in their health and healthcare through the use of HIT. ONC is an active partner in this program and serves as co-chair with NeHC of the Consortium Steering Committee. By engaging and empowering consumers on the applications, tools and benefits of eHealth within their lives, we anticipate helping ONC lead the way for consumers to make better decisions and receive better care.

    The Consortium will serve as a collaborative forum for sharing best practices, initiatives, tools, resources, ideas, and experience related to effective consumer engagement on HIT. Building on the collective wisdom, expertise and credibility of the participants, we aim to reach consensus on strategies, tactics, approaches, and an overall program for consumer engagement on eHealth. This will allow participants in the Consortium to engage with their constituents within the context of a broader coordinated program and thereby increase our collective impact. Our goal with this program is better communication between individuals and providers to support further development and use of health IT to achieve meaningful use as well as improve overall health and healthcare. We feel that the Consortium, due to its inherently open and collaborative nature, is uniquely positioned to bolster the efforts of ONC’s Goal IV by striving to complement and support, rather than replicate, other efforts.

    We believe there are many opportunities to more fully leverage HIT to enhance consumer engagement, including encouraging the use of personal health records (PHRs), mobile health applications, patient portals, and other tools. NeHC recognizes and agrees that “(t)he single biggest lever to individual empowerment is access to data” and that “there are too many barriers to individual and caregiver access;” we hope to bolster ONC’s efforts to improve consumer awareness and consumer engagement through the Consumer Consortium on eHealth. As the public and private sectors invest billions in health IT, we will align our efforts with the ONC initiative to bring the voices and needs of consumers to the forefront in the early stages of developing this new generation of health IT infrastructure so that it can best serve this constituency. We will also ensure that all programs developed and implemented by the Consortium will be culturally appropriate/sensitive and accessible by all populations.

    Goal V: Achieve Rapid Learning and Technological Advancement

    NeHC is also currently supporting ONC’s work toward Goal V. NHIN University (now NeHC University) is widely recognized and highly regarded by many stakeholders as a credible source of education on HIT and HIE related issues. Going forward, NeHC will build on the successful NHIN series to provide a significantly expanded range of education programs based on identified needs. Key aspects of this initiative include creating an Advisory Council to help design and oversee the curriculum, serve as and recruit additional faculty, and assist with program promotion to increase attendance. Initial program ideas include new tracks covering HIT trends, HIT and quality improvement, patient engagement and HIT/HIE, HIE success stories and challenges, HIE sustainability, HIT/HIE and care coordination, HIT/HIE and public health, quarterly updates on HITECH programs, Beacon Community program lessons learned, and HIE and ACO lessons learned. As an example of the expanded education programs, NeHC has begun working with Dr. Charles Friedman, Chief Scientific Officer for the ONC to design a three class series on the ONC/Institute of Medicine vision for a Learning Health System (LHS). This series of classes will provide stakeholders with a focused discussion on the vision of a Learning Health System (LHS) in the U.S., including the intended goals of the LHS, possible use cases, and the steps necessary to achieve a rapid and participatory learning system. Following this introductory program, subsequent classes will focus on the technical and policy aspects of creating the LHS and how the effort will increase quality and improve care and clinical decision making across the U.S. healthcare system.

    CONCLUSION

    NeHC’s unique position as a neutral, multi-stakeholder, public-private partnership will allow us to continue to work with ONC and other stakeholders to help articulate and package a cohesive national strategy for HIE and to serve as a forum for communicating, seeking feedback from the industry, and refining the overall strategy. It is our mission to work collaboratively across healthcare to tackle barriers and accelerate progress toward widespread and successful deployment of HIT and HIE. We look forward to continuing this work.

    Thank you again for the opportunity to comment on the strategic plan.

  113. NAPHSIS says:

    Farzad Mostashari, MD, ScM
    National Coordinator for Health Information Technology
    Department of Health and Human Services

    Re: ONC Federal Health Information Technology Strategic Plan 2011–2015

    Dear Dr. Mostashari,

    As the national representative of the 57 U.S. vital record jurisdictions, the National Association for Public Health Statistics and Information Systems (NAPHSIS) is called upon to assess how the enactment of the Federal Health Information Technology Strategic Plan will impact our member organizations. Vital record jurisdictions have worked hard over the past ten years to develop state-of-the-art information technology to register and issue certifications of births, deaths and other vital events. These systems must underpin the statutory obligations of each vital record office to guard and protect the legal identity documents of our citizenry. Therefore, it is with caution that we provide our support for the overall objectives of the Plan, and offer our specific comments below.

    NAPHSIS is a strong advocate of applying health information technology (HIT) to improve the quality of patient care while reducing costs and optimizing scarce healthcare resources. Therefore, we find Objectives I, II and III of the Plan to be in line with our participation in the development of HL7 standards for the electronic transmission of birth, death and fetal death data. However, we remain concerned that personal information collected initially in an Electronic Health Record (EHR) may not meet the rigorous legal jurisdictional requirements for civil registration. Potential issues of data ownership and de-duplication of records are challenges to be addressed. Also, it will be necessary to specify which organization will bear the responsibility of making sure the exchanged information is complete, accurate and timely, particularly when there are multiple sources and systems to coordinate and validate.

    NAPHSIS agrees that there are many benefits to be derived from an interconnected network of health information. In particular, we support the use of a “Public Health Button” in its most expanded interpretation to achieve information exchange with public health departments. We feel it is critical to integrate electronic birth and death registration systems with EHRs, while maintaining them as separate systems. We have been working cooperatively with the CDC National Center for Health Statistics (NCHS) on several initiatives to develop standards for linking EHRs with state vital record systems in the future. However, we note that in Objective I.A.1, the recording of patient information in an EHR on gender, race, weight, smoking status and other important health indicators, may not meet the test for legal registration of a vital record, as we have previously detailed in our comments on Meaningful Use regulations.

    In conclusion, NAPHSIS does support the goals and objectives of the Plan but believes that the complexity of issues surrounding the legal registration of vital events requires concern and caution.

    Sincerely,
    Patricia W. Potrzebowski, PhD
    Executive Director
    NAPHSIS

  114. Alliance for Nursing Informatics Position to the
    ONC Federal Information Technology Strategic Plan 2011-2015

    The Alliance for Nursing Informatics (ANI) advances NI leadership, practice, education, policy and research through a unified voice of nursing informatics organizations. We transform health and health care through nursing informatics and innovation. ANI is a collaboration of organizations that represents more than 5,000 nurse informaticists and brings together 28 distinct nursing informatics groups globally. ANI crosses academia, practice, industry, and nursing specialty boundaries and works in collaboration with the nearly 3 million nurses in practice today.

    Given the nature of patient data collection, nurses are integral to proper collection of meaningful use data. As EHRs become more refined and integrated, nurses must be at the table to define additional meaningful use objectives. To do so, nurses must be in the right leadership positions to have that influence. Our key recommendations emphasize the importance of preparing and enabling nurses to lead change to advance health care services. Public, private and governmental health care decision makers should include nurses at every level. Nurses are the most trusted professionals, outranking medical physicians in recent surveys. The membership organizations of the Alliance for Nursing Informatics are well positioned to assist with future development efforts related to the implementation of technology in health care and we welcome the opportunity to collaborate on this important endeavor.

    Recommendations:
    ANI’s position is that “meaningful use” of health information technology, when combined with best practice and evidence-based care delivery, will improve healthcare for all Americans. This is an essential foundation for the ONC Federal Information Technology Strategic Plan and the effective use of information technology to impact the quality and efficiency of healthcare services. The ONC Federal Information Technology Strategic Plan must recognize that nurses have a profound impact on the quality and effectiveness of healthcare and therefore must be supported to enable their knowledge-based work as:
    • Integrating disparate information
    • Standardizing infrastructure within the EHR
    • Improving workflows
    • Preparing the current and future workforce
    • Fully partnering in decision making
    • Improving care coordination across disciplines and settings
    • Improving quality, safety, efficiency while reducing health disparities
    • Engaging patients and families

    Goal #1:
    Achieve Adoption and Information Exchange through Meaningful Use of Health IT

    Expand the Vision of the ONC Plan to All Care Providers
    We recommend that every instance of the term “physician” be broadened and replaced with the term “provider” to expand the vision of the ONC Federal Information Technology Strategic Plan; as demonstrated below:
    • p. 9 – in the box highlighting use of EHRs to improve outcomes – change “computerized physician order entry” to “computerized provider order entry”
    • p. 15 – right column, second paragraph, replace the “physician” with “provider in the following sentence “For example, by leveraging Direct, a primary care physician can send a secure email with a clinical summary of a patient to a referring specialist.”
    • p. 42 – in the box highlighting “A learning health system can contribute to improving health outcomes”, first sentence in the right column, change physician to provider in the sentence – “The nationwide adoption and meaningful use of EHRs could facilitate the collection of clinical and research data from disparate sources such as hospital systems, physicians’ offices, laboratories, biorepositories, registries, and other research databases.”
    • p. 49 Appendix A – change every instance of the word “physician “to “provider” in the objectives
    • Goal 1 – Objectives – Better performance for physicians: Increase the percentage of office-based primary care providers [replace physician] who have adopted EHRs

    The use of terms shapes the vision of who is providing care and affects patient outcomes. All health care providers are involved in the meaningful use of EHRs and the words used to represent this vision are important.

    In order to achieve the ONC Federal Information Technology Strategic Plan Goals, we must leverage sources of patient care technologies and information management competence to ensure that our investment in health IT and health information exchange (HIE) is implemented properly and effectively over the next five years. ONC should collaborate with CMS to expand the scope of the advanced nurse practitioners and midwives who are eligible for meaningful use incentive payments, to remove barriers for practicing at the fullest extent of their license and professional practice, and be appropriately reimbursed for their services. For instance, home health care nurses develop orders for home care and hospice which then must be signed by a physician. CMS prohibits nurse practitioners from independently signing orders for home care, even though it is within their scope of practice and educational preparation.

    In this regard, nurses have proactively contributed resources to the development, use, and evaluation of information standards for decades, and have assumed numerous leadership roles during this time. Sharing knowledge gained from these endeavors across the broader domain of nursing and healthcare will serve to advance the national health information infrastructure. Broad-based nursing involvement in setting the ONC Federal Information Technology Strategic Plan at all levels is essential if we are to achieve desired goals.

    Nurses are the “glue” of acute care and other health system venues yet EHRs often are not designed to support the cognitive processes and workflow of nurses. Since nurses are the caregivers closest to the patient, EHRs must be designed to efficiently support documentation of their care. The technology should wrap around and leverage the workflow, not the other way around. We recommend that the ONC Federal Information Technology Strategic Plan focus efforts on the partnership between nurses and informaticists to determine the future of health care. A focus on improving the cognitive support of technology and EHRs for nurses in the future should be considered, with integrative views of patient data, enhanced information and knowledge at the point of care and the use of technology and system design methods that facilitate nurses’ decision-making.

    In a recent study of the value and impact of informatics nurses, nurse informaticists had the greatest impact on patient safety, workflow, and end user acceptance. These findings suggest that the informatics nurse acts as a driver for quality care and as an enabler of clinician adoption within their organizations. Through ANI’s efforts and those of its members, nursing informatics experts are also perceived as valued resources for providing expert testimony and serving on national committees. These national initiatives include those focused on health IT policy, standards harmonization, and EHR adoption, certification, and providing guidance on the effective use of technology and content for nurses and other clinicians. Informatics nurses play a crucial role across a wide variety of settings and areas of technology innovation. It is essential to the ONC Federal Information Technology Strategic Plan that this specialty is leveraged to ensure that patient care needs and those of our profession are addressed in the evolving transformation of our healthcare system. Care plans need to be linked to documentation systems.

    Standardize Infrastructure within the EHR
    ANI endorses the use of recommended standards integrated across systems that record, transmit, collect, and share information that is clear, concise, and unambiguous in all settings of healthcare services. Health information that is usable, reliable, and universally understood must be available whenever and wherever clinicians and patients need it. Healthcare professionals as knowledge workers must have access to information and the knowledge of enabling technologies necessary for distilling data into information and information into knowledge so that it provides value in any clinical setting.

    Furthermore, ANI believes that an infrastructure using standardized nursing and other health terminologies enables the capture of structured nursing data that supports data sharing, aggregation, and the development and integration of new evidence derived from clinical research This terminology core is necessary and a prerequisite for decision support, discovery of disparities, outcomes reporting, improving performance, maintaining accurate lists of problems and medications, and the general use and re-use of information needed for quality, safety, and efficiency.

    ANI supports the ONC Strategic objective to facilitate information exchange to support meaningful use of electronic health records. Future stages of meaningful use should include interoperability requirements that are more rigorous, so that patient information follows patients to the point of care and informs critical decisions. Lack of integration and interoperability is a significant barrier to the adoption and use of EHRs.

    In the 2011 HIMSS Nursing Informatics Workforce Survey, and for the first time in this triennial survey, almost one-third of respondents mentioned lack of integration/ interoperability as the top barrier to their success, followed by lack of financial resources (26 percent) and lack of administrative support (23 percent). Financial resources had previously been the number one barrier in both the 2004 and 2007 surveys. For the majority of the 660 nurse informaticists that participated in this research, their work settings are hospitals where they reported frequently experiencing the negative impact of disconnected systems on transitions of care, medication reconciliation and their ability to achieve optimal patient outcomes.

    Systems must enable the sharing of integrated information while maintaining patient privacy and allowing for de-identification of subjects involved in clinical research to generate new knowledge about health and healthcare services. Patients and providers must be certain that privacy and security concerns are strictly and appropriately handled. This will ensure confidence in the technology and reliance in the accuracy and security of the information.

    Goal #2: Improve Care, Improve Population Health, and Reduce Health Care Costs through the Use of Health IT

    Improve Care Coordination across Disciplines and Settings
    ANI recognizes that patient care invariably requires collaborative interactions among multiple clinicians from a broad array of specialties, often in different locations. Therefore “meaningful use” of EHR systems should strive for nothing less than an integrated healthcare community, including the patient as an enabled, engaged, and active participant. Patients should be the “center of the (care delivery) universe,” where enabling technologies promote usable, efficient and seamless information flow. ONC should emphasize in the meaningful use criteria that the problem list as well as care plans be integrated and represent all care providers involved collaborating with patients to optimize their health. This would include patient documentation in EHR systems that can enhance cross-continuum, interprofessional communication, thereby enabling improved safety, quality, and processes of care delivery. Nurses are instrumental in coordinating the patient’s care across the continuum and as such, are often the focal point for connecting acute, ambulatory, long-term, community, home care, and public health based settings. As coordinators, nurses are central to ensuring that data and information necessary for managing specific patients and these populations is not only shared but translated into action.

    As we consider the ONC Federal Information Technology Strategic Plan, ANI recommends taking a broad perspective utilizing documentation from all members of the clinical team; specifically incorporating nursing and other clinical plans of care and progress notes into a patient centered EHR. To achieve this, EHR systems should integrate patient care information obtained from the patient by all healthcare professionals into the person’s health record, including the exchange of patient summary data after each transition of care. This integrated approach sets the foundation for evolutionary growth providing the building blocks for health information exchange between disparate HIT systems while promoting consistency and repetition of the patient care communication in transitions of care. Valid measures of continuity of care must include evidence that key information is available in the EHR and that members of the patient’s care team can utilize that information to deliver care.

    Improve Quality, Safety, Efficiency and Reduce Health Disparities
    ANI supports the electronic capture and reporting of coded patient information for purposes of care delivery, decision support, and outcomes analysis. Nurses have a profound impact on the quality and effectiveness of healthcare and are large contributors of the patient information contained within EHRs. Standardized clinical performance measures that are adapted to consider unique complexities of various environments of care should be collected as a byproduct of care delivery and clinician documentation. It is our belief that adaptation and further development of real-time and concurrent measures to address unique attributes of care environments are needed. This will serve two important national goals: a) clinical decision support and trending in patient outcomes for real-time decision making and intervention at the point of care delivery, and b) the ability to aggregate enterprise-wide performance evaluations in order to further understand the impact of interventions on patient care and add to the body of evidence that defines best practice. ANI applauds the work of the HIT Policy Committee Quality Measures Work Group in recognizing the ANI call (supported by the American Nurse’s Association) to include a New Pressure Ulcer Risk and Prevention Measure in their proposed Stage 3 Meaningful Use Quality Measures. ANI is also very supportive of the inclusion of a new Fall Prevention Measure in their proposed Stage 2 Meaningful Use Quality Measures. Including these two measures that evaluate the impact of nursing care demonstrate the need for an interprofessional team to achieve the highest quality health care.

    Goal #3: Inspire Confidence and Trust in Health IT

    Nurses Are Integrators of Information
    Nurses must be involved with every aspect of selecting, designing, testing, and implementing information systems. EHRs must incorporate nursing’s unique body of knowledge with the nursing process at the core. Technology must represent the clinical workflow of how nurses think and work in accordance with evidence-based practice. Additionally, nurses interface with every aspect of communicating continuing care needs from birth to death with all the derivations of care provided between them and across all settings. Therefore, in their role as the “central hub” of information, nurses have significant responsibility for quality and safety of patient care. When information systems are implemented in any healthcare setting, nurses must be involved in decision making about usefulness, efficiency, and satisfaction with information technologies to assure continuity of patient care is maintained.

    Nurses as Full Partners in Decision Making
    The nursing profession is the largest provider of healthcare today, and the National Sample Survey of Registered Nurses identified that the majority of nurses are employed in acute care settings. Subsequently, they are closely involved in all aspects of implementing technologies such as EHR systems. Nurses manage implementations, analyze workflow processes, build content for EHRs, analyze data, configure systems design, provide training, act as super-users, and support other disciplines in using EHRs. With their intricate role in information processing, nurses are in a position to identify what works and what does not work in the use of EHRs.

    For health information technologies to be effective, nurses must be at the table as full partners through design, implementation, and evaluation. Nurses must be included in committees within their own organizations and be supported and encouraged to participate in state and national policy committees. The health initiative for quality patient care is dependent on a nursing profession that continues to perform an instrumental role in patient safety, change management, design, quality improvement and system usability as evidenced by quality outcomes, enhanced workflow, and user acceptance. These areas highlight the value of nurses as knowledge workers and their role in the adoption of health information technologies with greater integration across systems to deliver higher quality clinical applications in healthcare organizations.

    Goal #4: Empower Individuals with Health IT to Improve their Health and the Health Care System

    Engage Patients and Families
    In order to effectively achieve health outcome improvements, patients and families need access to their health information along with health education services delivered in a patient-appropriate learning environment and format. Nurses have an extensive knowledge base in patient education methods and tools. ANI strongly recommends that this body of knowledge be leveraged to facilitate the definition of achievable objectives in the area of health information literacy. Patients and families should be provided with access to data, knowledge, and tools to make informed decisions about their health. This requires the development of resources that address literacy, culture and language levels. EHR systems should provide an integrated view of patient/family learning needs and facilities should provide access to condition specific, credible education material.

    A key recommendation of the IOM Future of Nursing report states that interoperable EHRs linked with personal health records and shared support systems will influence how collaborative care teams work and share clinical activities. Personal health information is a valuable resource to individuals, their families, and the doctors, nurses, and other healthcare professionals who provide treatment and care. The ultimate goal is to help clinicians offer a wider range of considerations and options for patients, while also providing patients with resources that encourage proactive behavior and empowering them to be active partners in their health plan

    Goal #5: Achieve Rapid Learning and Technological Advancement

    Preparing the Workforce
    Nurses are at the center of patient care and are expected to provide safe, competent, and compassionate care in an increasingly technical and digital environment. Nurses are directly engaged with information systems and technologies as the foundation for evidence-based practice, clinical-decision support tools, and the EHR. With the increasing appreciation of the importance of evidence-based practice comes the translation of research into practice. Evolution to this complexity in the health care environment mandates new competencies that in turn necessitate new educational strategies and curricular content to prepare the workforce. These changes are just beginning to emerge in some educational and practice settings. The TIGER Initiative’s goal of engaging more nurses in leading both the development of national healthcare information technology infrastructure and health care reform should be included in the ONC Federal Information Technology Strategic Plan. Nurses are cultivating informatics competencies in order to re-evaluate workflow design and participate in the current rapid pace of systems implementation. Historically, nursing informatics has been an American Nurses’ Association (ANA) recognized specialty since 1992, has had an ANA defined Scope of Practice since 1994, and has had a national specialty certification program through the American Nurses Credentialing Center (ANCC) since 1995.

    The TIGER Initiative is a national collaborative of nursing organizations, educational institutions and industry partners who have made recommendations for health IT to be the stethoscope of the 21st century. While many nursing education programs have focused on computer literacy skills, there are relatively few that have incorporated informatics competencies into their curricula. Today more than 70 professional nursing organizations, associations, vendors and governmental entities have come together through TIGER to develop and implement recommendations to achieve the following goals:
    • Developing a U.S. nursing workforce capable of using electronic health records to improve the delivery of healthcare
    • Engaging clinicians in the development of a Nationwide Health Information Technology infrastructure
    • Accelerating adoption of smart, standards-based, interoperable, patient-centered technology that will make healthcare delivery safer, more efficient, timely, accessible, and efficient in a new interdisciplinary approach

    The TIGER Initiative Informatics Competency Collaborative developed recommendations for all practicing nurses and graduating nursing students consisting of three parts: Basic computer competencies, information literacy, and information management. Hospitals and health systems can help ensure that nurses are competent to practice in the technology-rich healthcare environment of the future by implementing these recommendations. As Phase 3 of the initiative unfolds, nurses in acute care settings at all levels are becoming involved in implementing the TIGER recommendations.

    AMIA (American Medical Informatics Association) has asserted that the United States needs at least one physician and one nurse trained in applied health and medical informatics in every hospital in the country by 2010. The Department of Labor recently announced the availability of approximately $220 million in grant funds authorized by the American Recovery and Reinvestment Act of 2009 for projects that provide training and placement services to help workers pursue careers in healthcare. According to the September 2009 HIMSS Vantage Point Survey , two-thirds of the 352 respondents indicated that there is a current lack of clinical informatics positions to handle upcoming work at their organization, also noting that their organization would need to hire clinical informatics personnel. Nursing leaders in acute care settings must be prepared to support effective use of resources for health IT.

    *****************************

    ANI embraces the ultimate vision of the ONC Federal Information Technology Strategic Plan to enable significant and measurable improvements in population health through a transformed healthcare delivery system, enabled by the use of information technology. ANI submits the following position to achieve this vision that will require a nationwide effort to adopt and implement EHR systems in a meaningful way. This is an incredible opportunity to build upon our understanding of effectiveness research, evidence-based practice, innovation and technology to optimize patient care and health outcomes. The future of health care will rely on this transformation, as well as on the important role of nurses’ in enabling this digital revolution.

    The Alliance for Nursing Informatics (ANI)
    Sponsored by AMIA & HIMSS

    ANI Member organizations

    • American Medical Informatics Association (AMIA)
    • American Nursing Informatics Association-CARING (ANIA-CARING)
    • Association of periOperative Registered Nurses (AORN)
    • Association of Women’s Health, Obstetric and Neonatal Nurses (AWHONN)
    • Center for Nursing Classification and Clinical Effectiveness (CNC)
    • Central Savannah River Area Clinical Informatics Network (CSRA – CIN)
    • Cerner Nursing Advisory Board
    • Connecticut Healthcare Informatics Network (CHIN)
    • CPM Resource Center International Consortium
    • Croatian Nursing Informatics Association (CroNIA)
    • Delaware Valley Nursing Computer Network (DVNCN)
    • Health Informatics of New Jersey (HINJ)
    • Healthcare Information and Management Systems Society (HIMSS)
    • Informatics Nurses From Ohio (INFO)
    • MEDITECH Nurse Informatics program
    • Midwest Nursing Research Society – NI Research Section (MNRS)
    • Minnesota Nursing Informatics Group (MINING)
    • NANDA International
    • National Association of School Nurses (NASN)
    • New England Nursing Informatics Consortium (NENIC)
    • North Carolina State Nurses Association Council on NI (NCNA CONI)
    • Omaha System
    • Puget Sound Nursing Informatics (PSNI)
    • SNOMED CT Nursing Working Group
    • South Carolina Informatics Nursing Network (SCINN)
    • Surgical Information Systems – Clinical Advisory Task Force (SIS)
    • Taiwan Nursing Informatics Association (TNIA)
    • Utah Nursing Informatics Network (UNIN)

    Also affiliated with the American Nurses Association

    ANI Co-chairs: Judy Murphy, RN, FACMI, FHIMSS
    & Bonnie Westra, PhD, RN, FAAN

    This post has been edited to remove personal information.

  115. Farzad Mostashari, MD, ScM
    National Coordinator for Health Information Technology
    Department of Health and Human Services

    Re: ONC Federal Health Information Technology Strategic Plan 2011 – 2015

    Dear Dr. Mostashari:

    The West Wireless Health Institute (WWHI) appreciates the efforts that contributed to the ONC’s Federal Health IT Strategic Plan, as well as the opportunity to provide input regarding the final direction that the Federal Health IT initiative will take in America.

    In our mission to cut health care costs by accelerating the availability of wireless medical technology, we commend the Plan’s authors for promoting a strategy capable of carrying health technology into the future, particularly the strategies and objectives outlined in Goal IV: Empower Individuals with Health IT to Improve their Health and the Health Care System. The Strategic Plan is correct to note that innovation has allowed medical care to move beyond the doctors’ office through the use of wireless devices that can be as simple as a mobile phone and remote sensors generating personal health data.

    We strongly encourage ONC to act quickly on its strategy to support the development of standards to make EHR technology capable of interacting with consumer health IT and wireless health devices. As the Plan notes, there are a number of compelling examples of technologies that allow individuals to manage their own health care; however it is not always the case that EHRs are able to interact with these devices. The Plan also highlights ONC’s efforts to partner with the FDA and other federal agencies to promote standards to enable “integration, including standards for devices and EHR interoperability; and, standards for data integration, such as glucometer measurements and unique device identifiers, for identifying the source of the device generated data.”

    In its role as a nonprofit medical research organization, WWHI strongly supports this effort and the engagement of ONC in this effort. Too frequently, a lack of standards can create a chilling effect on innovation, as manufacturers and innovators cannot be certain of the regulatory framework in which they are operating. Clear standards will help to address that issue. Further, WWHI applauds ONC’s role in this process. It is important that ONC leverage its expertise in dealing with agencies such as the FDA and FCC. These agencies play an important role, but they may not have sufficient expertise or experience in-house to help foster the innovative environment needed to allow for manufacturers to bring these devices to market.

    Sincerely,
    Donald M. Casey
    Chief Executive Officer
    West Wireless Health Institute

  116. Michael Crampton says:

    Farzad Mostashari, M.D., ScM
    National Coordinator for Health Information Technology
    Department of Health & Human Services

    Dear Dr. Mostashari:

    I appreciate the opportunity to comment on the Office of the National Coordinator for Health Information Technology (ONC) Federal Health Information Technology Strategic Plan 2011-2015.

    I agree with the vision stated in the five-year plan for federal HIT, “A health system that uses information to empower individuals and to improve the health of the population.” Herein I submit comments addressing Goal 4 of the Strategic Plan: Empower Individuals with Health IT to Improve their Health and the Health Care System. I recommend the focus of Goal 4’s objectives be revised to:

    • better position U.S. consumers as equal stakeholders and partners in their personal health care and management; and

    • facilitate this positioning through strategies that promote all U.S. consumers having and effectively using a Personal Health Record (PHR) and affiliated health care, management and education applications.

    The ONC currently promotes Electronic Health Record (EHR) portals as an option for consumers to gain access to their health information, although the information is managed and controlled by other health care stakeholders – primarily medical providers and institutions but also pharmacies, medical laboratories and others. Currently that may be the sole option for some consumers. But I recommend that the ONC also assist U.S. consumers — in concert with technology companies, employers, health plans and government agencies — to obtain a PHR so as to become the owners of their own health information, equal partners in health care, and increasingly responsible for their personal health.

    I recommend that Goal 4’s objectives be revised to focus on strategies to:

    1. facilitate the ability of U.S. consumers to obtain and use an Internet-hosted PHR that they or their designated representatives own, manage, and control access by other health care stakeholders;

    2. educate U.S. consumers on the value of having a PHR and using it, its affiliated value-add applications and appropriate durable medical devices, to take responsibility for and effectively manage their personal health;

    3. provide incentives to U.S. consumers receiving government-funded or -provided health care services who achieve personal health gains, as documented on their PHR;

    4. promote the availability of Internet-hosted PHR options in the marketplace, e.g. from technology companies, employers, health plans and government agencies;

    5. promote as PHR/EHR capabilities the ability for consumers and medical providers to have secure, electronic clinical consultations and administrative functions such as appointment scheduling and medication prescribing;

    6. promote the availability of affiliated PHR value-add wellness, disease management, health education and information applications that meet the consumer’s personal health management needs;

    7. mandate that the consumer has authority, with a standards-certified PHR, to electronically send and receive, e.g. share, his/her personal health data securely and on a peer basis with all other health care stakeholders’ EHRs, health data or other health information repositories;

    8. support the development and utilization of standards for consumer durable medical devices to enable such devices to securely upload the consumer’s health data to the PHR; and

    9. support the integration of the consumer’s PHR with health applications residing on the consumer’s mobile devices, personal computers and tablets.

    U.S. employers, health plans, technology companies and medical institutions & organizations in the United States are currently executing strategies to achieve similar objectives. They believe that when their constituents become actively engaged in and take increasing responsibility for their personal health, with proactive support from their health care providers, their health quality improves and their health costs decrease. Results are bearing out their expectations.

    Successfully developing and executing strategies to achieve these recommendations, as the strategic plan underscores, requires effective consumer participation and active counsel. Consumers across the generations who live with and daily manage their wellness, their chronic diseases or other medical conditions can best counsel the ONC in this work. I recommend that the ONC establish consumer advisory board(s) comprised of these individuals, structured similar to “medical advisory boards” used by many health care companies and organizations.

    The ONC, in conjunction with other government agencies, is executing effective strategies promoting and enabling health care providers to deploy and meaningfully use EHRs and modernize the way health care is delivered. But critical work lies ahead to:

    • educate and assist all U.S. consumers to obtain and effectively use PHRs and affiliated health applications;

    • take greater responsibility for their personal health; and

    • better manage their health with support from their health care providers.

    Hopefully these comments assist the ONC to plan this critically important work.

    Regards,

    Michael Crampton
    I-Net Advisors LLC

  117. May 5, 2011

    Sarah Potter
    Office of the Assistant Secretary for Planning and Evaluation
    U.S. Department of Health and Human Services
    200 Independence Ave, SW, Room 404E
    Washington, DC 20201

    Dear Ms. Potter:

    I submit this letter on behalf of the The Biomedical Informatics Think Tank™ (BITT™), a division of Projectivity, Inc. in response to a request for comments on the Federal Health IT Strategic Plan 2011-2015. The Biomedical Informatics Think Tank brings together experts at major academic medical institutions who have been working in the fields of health information management, clinical informatics, public health informatics, clinical research informatics, bioinformatics, data mining, HIT training and high performance computing over the last thirty years. We are focused on efforts that integrate the needs of clinicians with the needs of medical researchers to improve comparative effectiveness research (CER), public health, clinical and biomedical research, and clinical decision support system (CDSS) design.

    We applaud your efforts to create health IT standards that encourage interoperability, as well as various programs that stimulate the adoption of EHRs, the growth of statewide health information exchanges, and the training of health IT experts to support this infrastructure. Looking forward, we recommend greater emphasis on building a new health information exchange infrastructure that supports comparative effectiveness research (CER), other public health, clinical and biomedical research, and clinical decision support systems (CDSS) design. This effort to build a stronger foundation for evidenced-based medicine (EBM) is essential to improving the health of Americans while decreasing the overall cost of health care. We recognize that this requires giving primary attention to the ability of individuals to control the privacy and security of their health information. The BITT has produced a white paper addressing the opportunity suggested by the President’s Council of Advisors on Science and Technology (PCAST) in their Health IT Report (1) to create a Universal Exchange Language that would support CER and other biomedical research (2).

    In particular, we encourage strengthening of Strategy II.D.3: Ensure a mechanism for information exchange in support of research and the translation of research findings back into clinical practice.
    “…information in an EHR, with the appropriate privacy protections, should be accessible by researchers, research systems, biorepositories, registries, and other types of research databases. In turn, adopted health IT interoperability standards should be used in research studies – and enhanced to cover unique research needs – in order to facilitate both the use of health care data in research and the translation of research results into clinical practice.”

    Health information exchange and the secondary use of health care information are essential for research, which is critical to the success of health care reforms proposed in the Affordable Care Act. Many of the members of the BITT have worked together to build just such a standards-based informatics infrastructure for the National Cancer Institute’s Cancer Biomedical Informatics Grid® (caBIG®), the largest single effort to integrate clinical and biomedical information for advancing biomedical research (3). Some of the members of BITT have also built semantic, grid and cloud infrastructures for a broader effort to increase shared use of information technology resources by biomedical research scientists (4). Many of the members are principle biomedical informatics experts with Clinical and Translational Science Awards (CTSAs) who are leading the charge to leverage the growing clinical and research data to allow for improvements in prevention and clinical care.

    Access to clinical data has been extremely difficult primarily due to fears about privacy and security. To solve this problem, Meaningful Use criteria for Stage 2 and 3 must include requirements that provide easy access to deidentified clinical data. We recommend that Institutional Review Boards be required to establish criteria for such access, and that such access criteria be standardized nationally. As part of this effort, the informed consent process should have clear standardized guidelines for increasing the secondary uses of an individual’s health information.

    Once the clinical data is accessed, then making sense of this data becomes a major hurdle. We recommend that the Federal government establish a national standard ontology that will be required in all clinical information systems in the near future, possibly as soon as the deadline for meeting Meaningful Use Stage 2 requirements. Such a national standard is necessary for building infrastructure to support CER and other public health, clinical and biomedical research, and CDSS design.

    As proposed in the PCAST Health IT Reportii, we recommend that the ONC create a Universal Exchange Language (UEL) Specification that defines an underlying metadata tagged graph structure based in an XML-like format that is compatible with the Semantic Web Specifications of the World Wide Web Consortium (W3C) and, like the W3C Specifications and relational databases, has a strong mathematical foundation. The vision of a UEL supports, enhances and extends the ability of researchers and clinicians to examine large volumes of data in a fashion that does not threaten the identity of the individuals providing that information. It creates a path to data in all relevant formats, states, and conditions. Using a UEL, researchers will be able to see things at a macro level as never before, bringing an enormous benefit at the micro level, i.e. to patients. Supporting Goal V, these efforts will move us toward a “learning health system”. The UEL will power the future of health care.

    A UEL in concert with Health Information Exchanges (HIEs) becomes a powerful, data resolving tool, giving a common parlance to diverse descriptions. A UEL provides the meta-language needed by doctors, patients and researchers to reduce the barriers to confronting life and death issues that patients face, as well as halting the mounting costs of health care facing individuals, employers and the nation.

    The common and readily adopted platform and data interpretation found in a UEL can be readily subsumed into many different health care delivery business models saving valuable time and money while clearing the way for further and more pertinent innovation that directly helps patients and providers make health improvements and improve health care. A UEL can be likened to a utility service, it is not the message, it is the means by which the medical ‘message’, whatever its format , can be safely and accurately retrieved and translated for use by doctors, nurses and researchers.
    Thus, we strongly recommend that methods using this UEL Specification be researched, designed, tested and then implemented for a number of use cases including securely aggregating information without the need for a universal identifier for each individual. The Biomedical Informatics Think Tank has created one proposal for just such a technology (5).

    To repeat our key recommendations:

    1. Include requirements that allow easy access to deidentified clinical data in EHRs as a part of the Stage 2 and 3 Meaningful Use requirements.

    2. Require that institutional review boards establish criteria for easy access to deidentified data, and work on creating a national standard of these criteria for IRBs.

    3. Establish a national standard ontology that will be required in all clinical information systems in the near future, possibly as soon as the deadline for meeting Meaningful Use Stage 2 requirements.

    4. Create a Universal Exchange Language (UEL) Specification that defines an underlying metadata tagged graph structure based in an XML-like format that is compatible with the Semantic Web Specifications of the World Wide Web Consortium (W3C).

    5. Research, design, test and implement first in pilots and then in national rollouts methods using this UEL Specification including methods for securely aggregating information without the need for a universal identifier for each individual.

    These recommendations are critical to the ability of researchers to perform CER, other clinical and biomedical research, public health analysis, and CDSS design. These recommendations will enhance the value of future investments made by the Patient-Centered Outcomes Research Institute (PCORI) into CER as described in the Affordable Care Act. In particular UEL is crucial in pressing forward with the national research agenda for CER that PCORI will be tasked with managing. As recognized in the Affordable Care Act, this research activity is essential for improving the quality of health care for Americans, while halting the increase in costs of providing health care.

    Sincerely,

    Thomas P. Caruso, PhD., MBA, PMP
    Member, Biomedical Informatics Think Tank™ and
    President, Business Ambitions

    —————–

    (1) President’s Council of Advisors on Science and Technology, Realizing the Full Potential of Health Information Technology to Improve Healthcare for Americans: The Path Forward, December, 2010. http://bit.ly/hRT1Z9.
    (2) Biomedical Informatics Think Tank ™, A Universal Exchange Language Supports Comparative Effectiveness and Biomedical Research, February 2011, http://bit.ly/eAvy5J.
    (3) About caBIG® — http://bit.ly/exJs19
    (4) Kevin Davies, “Democratizing Informatics for the ‘Long-Tail’ Scientist,” Bio-IT World Magazine, March 29, 2011, pp 23-26, http://bit.ly/gbfUAt.
    (5) Biomedical Informatics Think Tank ™, Secure Aggregation Model for a Universal Exchange Language, March 2011, http://bit.ly/huADBN.

  118. John Feikema says:

    May 5, 2011

    Farzad Mostashari, MD, ScM
    National Coordinator for Health Information Technology
    Department of Health and Human Services
    Hubert Humphrey Building, Room 509F
    200 Independence Avenue SW
    Washington, DC 20201

    Re: ONC Strategic Plan

    Dear Dr. Mostashari:

    ABILITY (formerly VisionShare) appreciates the opportunity to provide comments regarding the Office of the National Coordinator (ONC) for Health Information Technology’s Federal Health IT Strategic Plan.

    We commend the ONC, its leadership, and the many committed committee and workgroup participants for crafting standards that will both guide and grow with the evolving health IT landscape.
    For the last ten years, more than 3000 hospitals, tens of thousands of other providers and the federal government/CMS have trusted ABILITY as their healthcare network. Today, as the nation’s largest secure web-based healthcare network, ABILITY is helping transform care delivery. We connect thousands of hospitals, skilled nursing facilities, home health agencies, clinics, and tens of thousands of physicians with one another, with public health entities, and with the nation’s largest payer, CMS.

    ABILITY believes technology will play a critical role in assisting providers to coordinate care, improve patient outcomes, and reduce the cost of care for all Americans. HIT is foundational for new payment and delivery models, such as Patient Centered Medical Homes, ACOs and hospital readmission programs, to succeed. Implemented correctly, HIT can reduce duplicative tests and procedures and foster movement to clinical best practices through point of service, real-time clinical decision support. Finally, HIT can administratively simplify patient encounters allowing providers to spend more time focusing on patients.

    We understand the plan’s intricacies – and recognize the importance of each of the 5 Goals. For purposes of this opportunity, we focus on Goals 1,2, and 3 because they are most relevant to our organizational expertise and field experience. We look forward to continuing our collaborative work with the ONC in advancing and accelerating health IT adoption.

    In Goal 1, the strategy is aimed at fostering and supporting exchange in new places and across different business models. ABILITY believes this most critical piece of the plan addresses the infrastructure, end points and flow of information. Without this piece thriving, the remaining Goals are not achievable. We constructed our protocols to operate and grow where the privacy and security bar was already set highest – CMS. Making information exchange work in this space paved the way for expanded interoperability in the clinical realm. It’s not about silos – provider to provider, provider to payer, etc. It’s about every single end point that meets the standards participating in a meaningful way.

    We understand the obstacles. But the opportunities to accelerate adoption have never been greater. For example ABILITY is already:

    • Working with state and local HIEs to enable native support for the Direct Project
    • Investing in directory infrastructure to reduce exchange barriers
    • Promoting Direct to payers for additional use cases to spur adoption
    • Listening closely to new provider challenges emerging from Health IT integration – and systematically crafting solutions

    One of the few ways to achieve success is by reducing barriers to adoption. We help accomplish just that. Our platforms are currently in place in more than half the nation’s hospitals. That means in most cases, providers can utilize legacy systems for information exchange, significantly accelerating adoption and the meaningful use of their health information technology.

    Specific to Objective C (1C1), ABILITY strongly supports the concept of leveraging Health IT for public health. As evidence of our commitment to this endeavor, the first secure health information exchange on our platform shared cancer surveillance and newborn screening data between providers and the state department of health.

    Similarly, the very first DIRECT project live transaction was conducted via ABILITY – between a large county hospital in Minnesota and the state department of health. ONC has gone to great lengths to set standards that are adoptable, yet aggressive.

    As suggested, 2-way communication will be essential in making public health reporting operate at the highest level. This needs to be real-time, and include support care coordination at each stage of delivery. Our efforts with State HIEs and health labs can further smooth transitions and improve adoption and implementation rates. We are finally able to equalize data, meaning that it doesn’t matter which platform is being used by sender or receiver, as long as they are meeting the standards set.

    In response to the critical need to reduce health disparities by optimizing health IT (1C2), ABILITY supports ONC’s efforts to invest in improved ways to identify and track disparities in health IT integration. Unfortunately the same providers challenged by the adoption of health IT itself host the patient populations facing the greatest disparities in access, quality of care and outcomes. It is critical for organizations like ours to seamlessly integrate with EHR vendors and other technology providers as state health assets – as RHIOs to RECs attempt to better serve these resource-challenged healthcare settings.

    ABILITY recommends further leveraging DIRECT in this process so that both rural and small providers can jump onboard with far fewer barriers to initiate the exchange of health information.

    We also recommend a renewed focus on provider directories that can connect physicians in the simplest, yet most secure manner.

    It has required an unprecedented level of commitment, collaboration and openness to allow such great strides in a relatively short period of time. This, in a nutshell, is the concept of Direct: accessibility that speeds acceleration and adoption. It is clear that health IT is critical to making these systems work. Additionally, we believe these suggestions, if adopted, will leverage the technology and the Medicare and Medicaid incentives to promote system wide integration to support these reforms.

    In Goal 2, you outline how integral health IT is to the National Health Care Quality Strategy and Plan. We have long applauded the ONCs commitment to put patients first. Health IT can support every element of quality improvement, including patient safety, care coordination, and real -time collaboration and information exchange.

    We have seen an ambitious effort from the Administration, Congress and the provider, payer, employer and patient communities to more aggressively coordinate care through information systems that share clinical information. As such, we urge ONC to optimize its role as coordinator and collaborator. It is incumbent on leadership to ensure all agencies, departments and programs are in alignment and have transparent awareness of policies and standards being developed, implemented and measured. Nearly every stated objective hinges on this critical component of the ONC’s work. Without effective coordination in the health IT ecosystem, measures run the risk of slower adoption at best – failure at worst. Ultimately the patient still stands to reap the benefits of health IT and real interoperability if the ONC performs to its highest potential as lead coordinator, educator and awareness-builder among all constituencies. We believe the MU standards thus far can be improved to support emerging payment and higher level delivery structures like ACOs, medical homes, medication therapy management and hospital readmission programs. ABILITY recommends the following to ONC:

    • Promote more robust requirements for interoperability, strengthen standards for adoption and use
    • Increase system-wide interoperability by further leveraging Direct and incorporating some of the concepts outlined in the President’s Council of Advisors on Science and Technology report; and
    • Coordinate Meaningful Use standards across CMS programs (including new payment and delivery reforms

    ABILITY believes that the standards used for the Meaningful Use program can and should be strengthened to facilitate more robust interoperability and exchange. That said, we understand that health information exchange does not progress at the same volume or the same rate of adoption across the board. Even if the provider field was uniform, vendor interfaces to specific labs, hospital systems, and regional health information exchanges are not. ABILITY has thoroughly considered such variables in development of our platform and solutions. Using Direct as an example, we facilitate exchange for every size and scale of provider – and between every type of end point. That means a small rural clinic can connect with a large academic health center, or the state HIE, or the state’s newborn screening lab – as efficiently as larger facilities further down the road in health IT adoption.

    In Goal 3, you focus on improving the privacy and security of health information. ABILITY endorses the ONC strategic objectives for improving privacy and security standards, and has been privileged to be part of the workgroup process since inception. The TRUST fabric being established now will enable future programming to grow organically while protecting the vital privacy requirements that underpin every element of healthcare information.

    ABILITY’S primary focus in initially collaborating with ONC was to reinforce the need for high standards in privacy and security. We support the ONC’s leadership in this area – and encourage standards that protect critical health information while considering the challenges inherent in adopting what could become overly stringent new standards.

    As long as the bar remains appropriately high, providers simply require the appropriate level of guidance while allowing for flexibility in the mechanisms used for transport. ABILITY is particularly attuned to the issues surrounding digital certificates. We have long spearheaded a process that ensures senders and receivers are authentic and vetted. Certification, identity and integrity are core to a health IT system to embraces exchange and respects the privacy of both the patient and the provider. We believe continuing to provide high standards for the issue of digital certificates can align with ONCs objectives of security and workflow.

    Finally, ABILITY supports leveraging the technology that exists today, and adopting policies that promote creativity and foster the creation, analysis and sharing of data in the most impactful ways. We applaud the vision of a learning health system, and believe that given our experience with the Direct Project – and facilitating the first live production transaction of clinical health information via Direct – we are in a unique position to support a move beyond basic adoption of EHRs into full integration of the technology and exchange for providers and all end points.

    We stand ready to assist in every way possible. Thank you again for your tireless efforts in support of Health IT innovation and integration.

    Sincerely,

    Mark Briggs, CEO, ABILITY (formerly VisionShare)
    John Feikema, President, ABILITY

    This comment has been edited to comply with the ONC blog policy.

  119. Farzad Mostashari, MD, ScM
    National Coordinator for Health Information Technology
    Department of Health & Human Services

    Dear Dr. Mostashari:

    Health Level Seven International (HL7) appreciates this opportunity to comment on ONC’s Federal Health IT Strategic Plan. HL7 develops standards for interoperability of health information technology in over 55 countries.

    General Comments

    We appreciate the leadership of ONC in the development of the S&I Framework and would encourage even more ONC participation in standards development activities across the board. We would hope that ONC continues to follow the guidance provided with respect to the development and use of consensus-based standards as described OMB Circular A-119. HL7 and other SDOs have much to offer ONC. This includes mature processes for development and balloting of standards and implementation guides, with balanced representation, established governance, member participation and mechanisms supporting maintenance of the resulting work products.

    We refer ONC to our previous comments which we provided on the PCAST report, also relevant to this discussion.

    One of the challenges for implementers of Meaningful Use is obtaining access to all of the standards required by the various programs. There is ongoing Federal support for the maintenance and free access to SNOMED-CT® and LOINC®. HL7 would encourage expansion of these programs to include other standards and vocabularies, including those developed by HL7.

    Goal I: Achieve Adoption and Information Exchange through Meaningful Use of Health IT

    HL7 would like to thank ONC for selecting several of its standards and implementation guides in the Standards and Certification Rule. Many members have noted difficulties in implementation of the Meaningful Use requirements because the regulation names multiple standards in some cases, or provides little implementation guidance in others for the communication of patient information. We would hope that future stages would move towards a common representation of information, and appreciate the opportunities that ONC has provided within the Standards and Interoperability Framework to move in that direction.

    ONC should focus more attention on information exchange in subsequent stages of Meaningful Use. The Direct Project certainly addresses one set of use cases, but does not address wider exchange requirements. For example, it is not well-suited for query/response information exchange patterns often needed in clinical care, and which are needed to support public health and research in a learning healthcare environment.

    While providers have been incented to exchange information with public health, many barriers remain. More should be done to enable public health to implement standards to accept information exchanges from providers that are called for in the Meaningful Use regulations. Nationwide standardization is also called for, as many of our members have reported challenges addressing exchange requirements in multiple states using conflicting implementation guidance of the ONC selected standards.

    Goal II: Improve Care, Improve Population Health, and Reduce Health Care Costs through the Use of Health IT

    We would like to see more emphasis on the dependency between quality healthcare, measurement, and clinical decision support on standardized and computable health data. HL7 has developed a number of standards addressing clinical decision support, quality measurement, and structured clinical data that are designed to work together. We would encourage further ONC engagement with HL7 on these topics. Tell us how we can help.

    We would further hope that CMS and ONC collaborate on the development of the claims attachment regulation, and that CMS take advantage of the Health IT initiatives that ONC has been promoting. HL7 has been engaged in the development of Claims Attachment implementation guides in support of the need for final regulation since 1997. We would hope that CMS and ONC would converge on a common representation of clinical documentation that could be used for clinical care as well as claims attachments.

    We also encourage the use of Health IT standards and Health Information Exchange technology developed for Meaningful Use to support the exchange of information needed for claims and quality measurement. The development of separate information exchange infrastructures for treatment, payment and operations can only hinder the adoption of Health IT.

    Similarly, in the arena of public health, we believe that ONC should work with CDC to focus on how different initiatives can take advantage of a shared health infrastructure across the public health domain. Greater alignment of other federal agencies, including CDC and NIH, with the standards for health information used in EHR certification and the Meaningful Use program would be beneficial.

    Goal III: Inspire Confidence and Trust in Health IT

    HL7 recommends that ONC apply risk-based methodologies using existing standards-based approaches and frameworks. Risk analysis should be performed in an open and transparent fashion, engaging with existing standards workgroups responsible for these frameworks, including the HL7 Security Workgroup. HL7 has the following Security and Privacy standards published to be used to mitigate identified risks:

    • HL7 Value Sets using Code System Confidentiality (2.16.840.1.113883.5.25) – This vocabulary is used in the confidentialityCode metadata attribute to identify the data object sensitivity and confidentiality classification. This enables both segmentation of especially sensitive topics and also Role-Based-Access-Control that protects objects for both security and privacy.

    • HL7 Version 3 Domain Analysis Model: Medical Records; Composite Privacy Consent Directive, DSTU Release 2 – This document object captures the patient privacy preferences, authorizations, and consents. This document is used as evidence of a patient consent ceremony as well as triggers privacy policy engines to enforce the patient privacy.

    • Role-Based Access Control Permission Catalog (RBAC), Release 2 – This vocabulary enables communication of users permissions in an interoperable way. This vocabulary can be used at a multitude of points in the Privacy and Security system.

    • SAIF – Privacy, Access and Security Services (PASS)
    (a) Access Control Service – This is a service being defined for support of access control decisions and enforcement.

    (b) Healthcare Audit Services Release 1.0 – This service specification is available and enables security audit log recording. There are also service endpoints to enable different security and privacy audit analysis use-cases, including the creation of an accounting of disclosure.

    • EHR Functional Model, Release 1 – The EHR Functional Model includes a comprehensive set of security and privacy functions. This catalog includes detailed system level requirements that are actionable and testable. Profiles of this functional model are available for many functional systems including an EMR and PHR.

    • HL7 Version 3 Standard: Transport Specification, MLLP, R2 – The HL7 transport specifications include transport security (e.g. TLS).

    • HL7 Security and Privacy Ontology – Informative Ballot, May 2011 – Serves to name, define, formally describe and interrelate key security and privacy concepts within the scope of Healthcare Information Technology.

    Goal IV: Empower Individuals with Health IT to Improve their Health and the Health Care System

    We agree that ONC should provide more inclusive ways for patients to provide input on the healthcare system. We would also ask that ONC share the information that they learn widely with the healthcare industry for the same reasons. Furthermore, we have noted that while healthcare providers and Health IT vendors have been very much engaged by ONC in the development of Meaningful Use and EHR certification, very little has been done to inform patients of the impacts of this regulation and how they are currently being empowered by it.

    As you expand the use cases for patient engagement, HL7 stands ready to support ONC by expanding the existing base of standards and implementation guides. HL7 has already developed standards for connecting EHRs to PHRs using both its Continuity of Care Document and its functional model for Personal Health Records.

    Goal V: Achieve Rapid Learning and Technological Advancement

    This goal principally addresses what is being done in the Federal Government and does not include participation by industry. We strongly believe that broad industry participation is needed in developing a rapidly learning healthcare system. Rapid learning cannot happen without this stakeholder engagement. HL7 can provide access to a wide and balanced variety of stakeholders who are already engaged in advancing Healthcare IT.

    We look forward to continued collaboration with you and with your Office.

    Sincerely,

    Charles Jaffe, MD, PhD, FACP, FACMI
    Chief Executive Officer

    Robert Dolin, MD, FACP, FACMI, FHL7
    Chairman of the Board

  120. Amy J. (King) Caro says:

    The goals of the Federal Health Information Technology (HIT) Strategic Plan are straightforward and eminently laudable. HIT promises to improve patient outcomes, thus improving their health; to reduce costs; to provide for improved population health through analytics; to encourage more rapid discovery of and response to bioevents; and to further engage patients in their care by making quality data relevant and available to the consumer. Implementing a robust HIT transformation will generate enormous amounts of data, which must be put into “meaningful use” to achieve these goals.

    A necessary condition to facilitate increased HIT use across the nation is the protection of patient privacy through security controls and processes that prevent inappropriate access or use of health information. This heightened security and trust must be credible to both consumers and providers, or they will be much less likely to use HIT. While Northrop Grumman applauds the Office of the National Coordinator for Health IT (ONC) for including security and privacy in the HIT Strategic Plan, we suggest that more is needed to ensure that protection. The large amounts of potentially sensitive health data being collected, stored, analyzed, and used to improve the outcomes and efficiency of our health delivery system must be protected through the entire lifecycle to ensure that patients and practitioners alike will fully support the program. This means security must be a key consideration when data is collected, stored, transmitted, and used. Thus, while the first step of this process is to create the environment where such data is available and readily transferable for appropriate uses, the second step suggests a need for greater emphasis on the security and privacy aspects of healthcare information. We are concerned that the first goal in this strategic plan–providing an HIT foundation–may not be achievable unless greater attention is paid to the trust, privacy, and security, of the confidentiality of patients’ personal health information (PHI).

    The civilian health system has only recently begun considering security and privacy as a key component of the overall HIT strategy. Both our and others’ experience with other types of sensitive data (for example, with various military agencies) reveals that typical perimeter defenses are not sufficient to ensure the confidentiality and integrity of data. Cyber adversaries are persistent and technically sophisticated, and network perimeters are often breached, resulting in data loss or exposure. So security must extend beyond the perimeter to include protection of data at rest through techniques such as encryption; protection of data in motion through secure connections using encryption and strong authentication; and protection of data in use by securing applications used to work with the data. Only with a broad and comprehensive defense in depth can data custodians provide credible assurance that patient data is secure.

    Defense in depth also must be accompanied by appropriate policy and process improvements that ensure access to data is granted only through a strong identity and authentication system that enforces role-based access controls. These policies and processes must be backed up by credible enforcement to ensure the technical investments made in security are not easily compromised by poor security awareness or practices among the users of the data. It is not enough to equip practitioners and patients with a robust HIT capability; they must have training in the safe use of the capabilities. Healthcare professionals should get this outreach training alongside their medical education, so they can preserve patients’ privacy as well as their health. Thus, the Department of Health and Human Services should insist on greater attention to how privacy/security controls are implemented in the healthcare delivery system, as well as the training of healthcare providers to acquaint them with the threats and risks that they face.

    In summary, ONC can greatly influence the adoption of the HIT Strategic Plan by making clear that security and privacy are integral components of the implementation of any HIT system. Working with other government authorities to establish the standards and controls for security and privacy will set the strong foundation for creating a secure and trusted HIT system that enables gains in efficiency, improvement of outcomes, and the protection of patient privacy across the national healthcare landscape.

    Amy J. (King) Caro
    Vice President, Health IT Programs
    Northrop Grumman Information Systems

  121. On behalf of our 78,000 member physical therapists, physical therapist assistants, and
    students of physical therapy, the American Physical Therapy Association (APTA)
    appreciates the opportunity to submit comments to the Office of the National Coordinator
    for Health Information Technology (ONC) in response to the notice and request for
    comments published in the Federal Register on March 29, 2011, for the “Federal Health Information Technology Strategic Plan” (Strategic Plan). APTA is committed to advancing the safety and quality of healthcare through health information technology (HIT) innovation and we are eager to work with the ONC on health information technology’s evolving role in promoting health and health care reform. APTA’s commitment includes, but is not limited to, the adoption of electronic health records (EHR), implementation and enforcement of privacy and security protections, and utilization of electronic health information to support new payment models such as accountable care organizations, as well as fostering health information exchange where it is not currently taking place, supporting coordinated patient-centered quality care through utilization of electronic health information, and being an active participant in the evolution of a “learning health system.”

    APTA commends the ONC in its vision for and the development of the Strategic Plan and fully supports the five goals of the Strategic Plan and would like to take this opportunity to comment on particular areas of importance to physical therapists within these goals.

    GOAL I, “Achieve Adoption and Information Exchange through Meaningful Use of Health IT.”

    APTA is committed to educating and encouraging its membership to adopt EHRs. However, the cost of implementation and maintenance of EHRs is a barrier to adoption, particularly for small practices. APTA’s members practice in a variety of settings, including physical therapist-owned private practices. The Medicare and Medicaid EHR Program will provide incentive payments to physicians, hospitals and critical access hospitals that demonstrate meaningful use of certified E HR technology. However, physical therapists in private practice, inpatient rehabilitation facilities, home health agencies, and skilled nursing facilities are not eligible for the incentive payment for adoption of EHRs. We urge the ONC to expand incentives to other non-physician providers, such as physical therapists and providers in other post-acute care settings, who significantly impact patient care on a daily basis. Improving quality of care across the full health care delivery spectrum while also decreasing costs will require participation through the use of EHRs by all providers.

    We further emphasize the need for the ONC to develop an on-going value message for implementing EHRs and communicate to all providers – not just those providers eligible for incentives – the benefits and value of utilizing EHRs beyond receiving a monetary incentive (e.g., robust EHRs enable a provider the ability to deliver true patient-centered care.) In order to “achieve nationwide adoption” of EHRs and widespread participation in the health information exchange, all providers should be given the tools and information to understand the value in utilizing HIT in their care delivery, particularly if they are providers excluded from receiving incentives. The Strategic Plan states that the ONC will communicate the value of EHRs to primary care physicians. APTA recommends that the ONC expand the communication strategy to all providers and suppliers regarding the value of EHR implementation and the benefits of achieving meaningful use, not solely primary care practices. Receptivity to a new technology is an ongoing educational process. On page 10, the Strategic Plan states that the government is “developing technology and policy solutions” for providers ineligible for incentive payments that “fit their unique needs.” APTA would welcome the opportunity to be a participant in providing input as the government develops this technology and related policy solutions.

    In addition to burden of costs associated with EHRs, an impediment to EHR adoption is provider confusion in selecting an EHR system. The current threshold for certification has allowed hundreds of systems to gain certification. Providers are concerned that a system purchased today deemed “certified” will not have the wherewithal and compatibility as technology advances to maintain certification. Providers are also concerned about bad actors in the vendor industry, for example, there are questions as to whether vendors will survive over the long term or will providers incur excessive costs of total system replacement in the future. We commend measures as contained in Strategy I. A. 9 and NIST’s development of a set of objective and standard criteria to evaluate and improve the usability of HIT systems as a method which would help to lessen costs should a system replacement/transition be necessary. Other perspectives and input from various providers is crucial in the development of HIT to encompass true integrated care delivery models. Physical therapists practice in a number of health care settings, are integral members of the health care community, and offer a wealth of expertise that could be valuable to the ONC as they work to create an interoperable national health information network. Therefore, we support the rapid advancement of interoperability standards to reduce fragmentation and inconsistencies in system development. In the development of criteria in relation to the usability of HIT systems, APTA suggests developing a pilot study with alternative, non-eligible providers, such as physical therapists, for testing and improvement of the usability of EHRs.

    Although APTA supports the ONC’s strategy of taking advantage of the experience of federal agencies that deliver health care, such as the Department of Veterans Affairs (VA), we also encourage federal agencies to be cognizant of the differences in implementation of protocols in an integrated, closed health system such as the VA – where information can be shared freely and monitored closely – versus the disparities in the private market with multiple HIT systems, varying internal policies and procedures, proprietary information, etc.

    APTA has worked diligently to ensure the involvement of physical therapists in quality improvement programs including Medicare Provider Value-based Purchasing initiatives. HIT should allow providers and consumers to report and receive feedback on specific quality measures. As the discussion on how to encourage health care providers to adopt and use HIT in a meaningful way has progressed, many of the metrics that have been developed to assess progress are exclusive of non-physician specialties, including physical therapy. Physical therapists are involved in the development of quality measures and the consensus-based process for the endorsement of measures. This effort has been recognized through the incorporation of 8 individual measures via the Physicians Quality Reporting System (PQRS) as well as the ability for physical therapists to report 7 functional measures related to musculoskeletal outcomes and group measures related to the treatment of low back pain. At the March 2011 HIT Policy Committee meeting, there were discussions of merging CMS data, such as the PQRS data, into the meaningful use matrix. Therefore, it is important for the ONC to include such measures that are not currently in the matrix.

    Additionally, in an integrated care model of health care delivery, physical therapy and rehabilitation services are commonly a medically necessary service. Not including quality measures related to rehabilitation leaves a huge gap in properly accessing true quality of care on the dynamic health care continuum. As more providers acquire EHR systems, including many non-physician providers, their necessary contribution to patient care should not be absent from the analysis. As stated, physical therapists are not currently eligible to receive monetary incentives. We strongly urge ONC to broaden their perspectives and recognize the vital role of other health care professionals across the continuum of care in the development and implementation of HIT.

    APTA has made strides over the last 10 years to promote the use of HIT, and we are continually enhancing our services to advance the delivery of physical therapy and to effectively measure patient outcomes. These efforts include the inclusion of HIT educational tools on the APTA website and collaborating with internal and external stakeholders on HIT issues. Recognition of the need to capture rehabilitative services in the EHR has led to substantial growth in the development of EHR systems in the rehabilitation sector. This data is crucial to the development of a robust National Outcomes Database. APTA’s development of clinical guidelines and other important criteria has been the basis for the attributes of many existing HIT systems serving rehabilitative service providers. Additionally, APTA partnered with Cedaron Medical, Inc. to develop an electronic health record (EHR), called APTA CONNECT, which incorporates a National Outcomes Database for physical therapy. The EHR is specifically designed for physical therapists and is approved by CMS as a registry under the PQRS program. The National Outcomes Database consists of aggregated data from APTA CONNECT and will be used by APTA and independent researchers to answer questions important to improving the care of individuals receiving physical therapy services.

    To further improve quality of care, providers across different health care settings and different clinical specialties will need to share information with each other from their EHRs and coordinate their efforts to eliminate duplication of services and increase efficiency, which is a re-emphasis of the need for standards uniformity and system interoperability. For example, the information gathered by the acute care hospital during a patient’s stay and at discharge is critical in determining the appropriate level and focus of care once the patient is released to a post-acute care setting such as skilled nursing facility, inpatient rehabilitation facility, home health agency, or an outpatient therapy setting. Practitioners need an understanding of the patient’s goals, baseline functional status, medical and behavioral health problems, medication, family and support services, and durable medical equipment, prosthetics and orthotics needs. Standardized core content that can be shared through EHRs to inform care delivery is critical and will aid in ensuring effective care transitions. Without this information, service duplications may occur and important aspects of the plan of care may be overlooked.

    The focus of clinical interventions should be to improve health outcomes for the patient through quality measurement and coordination of care. Health information technology should facilitate both process and care measurement to improve patient safety, improve patient health outcomes, and reduce costs. As has been demonstrated by commercial health insurers, as well as Medicare, process measures improve patient care and reduce costs. Stakeholders continually stress the importance of preventive medicine, such as falls risk assessments and the administration of aspirin to patients with chest pain, both of which have demonstrated cost savings. Therefore, we strongly recommend that the ONC ensures that goals, objectives, and measures applicable to physical therapists and other rehabilitation providers are included in measurement criteria.

    APTA members and patients have experienced the detrimental effects, such as decreased access to care, resulting from disparate federal, state and local policies which hinder accurate and robust health information exchange. Therefore, we support rigorous standards to support interoperability so that data can be exchanged and utilized for multiple purposes. However, before this process can move forward in an effective and efficient manner, there must be a mechanism for assurance that policies do not conflict with existing state and federal regulations and there must be an on-going monitoring of the system to identify and immediately check any failures or inconsistencies within the systems. Under 42 CFR Part 1007, § 405.370
    through § 405.379, the Secretary of the Department of Health and Human Services (HHS) in consultation with the HHS Office of Inspector General (OIG) now has authority to suspend payments to providers in instances “based upon possession of reliable information that an overpayment or fraud or willful misrepresentation exists or that the payments to be made may not be correct, although additional evidence may be needed for a determination. APTA fully supports the eradication of fraud and abuse in the delivery of health care services. However, the threshold of payment suspension has been lowered to a “credible allegation.” Conceivably, this could happen due to system errors which incorrectly reject proper payments. If a system for rapid correction and deployment is not in place, the provider could suffer a substantial loss and perhaps be forced out of business as a result of the length of time involved in resolving the case.

    APTA encourages educational programs to include training related to EHR competencies in their curriculums, however, we caution on any requirement of mandatory use of EHRs as a basis for certification until EHR implementation becomes an affordable and effective tool for even the solo provider practice.

    GOAL II, “Improve Care, Improve Population Health, and Reduce Health Care Costs through the Use of Health IT.”

    To improve care through efficiency and reduce costs, clinical decision-making support should be a critical component of HIT. HIT should enable providers to access a patient’s medical history as well as information regarding current interventions and treatments to avoid duplication of efforts, ensure patient safety, and determine – based on evidenced-based practice – the most appropriate interventions specific to the patient’s presentation. This could include electronic documentation of items such as daily treatment or encounter notes, progress reports, and discharge summaries. Additionally, tools that remind the provider of important information and that generate reports about needed upcoming care (such as immunizations) help foster the patient/provider relationship. Information on evidenced-based practice, coverage limitations, specific patient information, and patient care reminders help providers make appropriate clinical decisions regarding patient care. Some EHR systems currently being utilized in the rehabilitation market include these critical aspects of clinical decision-making.

    APTA supports the Strategic Plan’s goal of incorporating clinical decision-making support through EHRs to ensure Meaningful Use so that EHRs can capture the variety of clinical information relevant to both individual patient and health care setting for optimal safety and quality of care. APTA emphasizes that continuity of care is accomplished through collaboration of all healthcare providers through HIT that ensures accurate, efficient, secure and protected communication. In addition to facilitating continuity of care, APTA believes that HIT should allow health care providers, including physical therapists, to report and receive feedback on quality measures and report and receive relevant health data to assist in disease monitoring and tracking. Inclusion of all providers in the health care delivery process is imperative to improving complete patient care, outcomes and reducing costs.

    APTA appreciates the expansive work of the ONC in its effort to develop a vision for what HIT may achieve. However, we want to ensure that the vision and matrix incorporate an even broader perspective; specifically, that the elements represent all health care providers that use HIT, including physical therapists. We appreciate that the ONC is cognizant of implementing strategies in the most cost effective and efficient ways, however, we caution the ONC to consider the future burden and costs of provider exclusion in approaches as outlined in the “Meaningful Use Matrix.” Although many health care professionals are currently excluded from receiving incentives, objectives and measures routinely used by these providers should not be excluded. Failure to account for this data now in the development of a matrix could be more costly in the future, both economically as well as archiving necessary data essential to patient care outcomes.

    While APTA supports the objectives outlined in the Strategic Plan, we feel that these objectives should be more inclusive of the variety of clinical specialties that may be involved in a patient’s care and is a critical link in the collaboration and coordination of care. With regards to the current Meaningful Use Matrix, APTA supports the intent to include quality measures as necessary capabilities of meaningful HIT. APTA has developed and will continue to develop appropriate measures for physical therapist practice in coordination with CMS’s PQRS and other initiatives. However, the appropriate and necessary measure(s) may vary significantly by patient need and professional scope of practice. We recommend language which ensures the intent of
    quality measure inclusion but that the listing of applicable measures be broadened to be
    more inclusive. For example, measures of great significance to consumers that are provided by physical therapists might include the change in functional status as a result of physical therapy intervention, risk and prevention of falls, participation in physical activity and activities of daily life.

    Many of the current goals and objectives of Meaningful Use are relevant for physical therapy practices, however, some are not. It is often mentioned that any electronic health record (EHR) should incorporate e-prescribing capabilities. However, for physical therapists and other health care professionals currently limited in their ability to prescribe medications, laboratory tests, or imaging procedures in many jurisdictions, some of the mandatory criteria related to e-prescribing are not relevant and, therefore, burdensome and costly. In the development of tools and resources for providers, we encourage the ONC to consider that to truly gather data and information for true “meaningful use” in its vision “to achieve nationwide adoption,” systems must be flexible enough to accommodate all providers across the continuum of care without the burden of unnecessary options, standards and costs. Therefore, as the ONC moves forward, we want to emphasize that EHRs are specifically designed for the needs of all patients receiving care from an array of health care professionals as recognized by CCHIT and other certifying bodies. This data is also important to track for safety, outcomes and costs reduction in the delivery of care. Failure to track and measure this data now, leaves a large gap in data that is important in measuring quality outcomes.

    APTA strongly recommends that physical therapists collaborate with ONC to develop the goals, objectives and measures that would best describe the Meaningful Use of HIT for rehabilitation providers. As soon as reasonably possible, the ONC and other government agencies should provide additional incentives to aid all healthcare providers in HIT implementation through the availability of grants to aid in decreasing unnecessary and burdensome implementation and maintenance requirements. Non-physician providers such as physical therapists, who also play an important role in improving the quality of care, earn less income than physicians and would greatly benefit from incentives.

    APTA supports the phased approach of Meaningful Use adoption, however, an impediment to early adoption of EHRs voiced by providers is often the concern that those providers who adopt systems in 2011, when there are more basic or minimal criteria, would incur additional costs, either through software upgrades or re-certification requirements, than those who wait to adopt in 2014 or later. APTA encourages the ONC to also consider safeguards for those providers who cannot afford to adopt EHRs for several years to allow them to effectively participate and survive in the provider market.

    As ONC progresses with its Strategic Plan, we also agree that the special health care
    challenges faced by vulnerable populations, such as children, persons with disabilities
    and individuals of various socio-economic, gender, ethnic, and racial backgrounds, must be an area of priority and also part of the improved access and quality of care. We realize the challenges facing the ONC in implementing their plan based on the government’s current fiscal condition, however, we emphasize that rehabilitative services, some of which are currently threatened with minimization, are crucial to cost effective care management, particularly in chronic disease management. Especially with these vulnerable populations, elimination of coverage for rehabilitative services leads to increased emergency department utilization, hospital readmissions and lengths of stay, increased imaging utilization and increased surgeries. For example, a chronic condition such as back pain – which often prevents an individual from working – has been shown to respond as effectively (and sometimes better) with a physical therapy regimen than costly surgery .

    GOAL III, “Inspire Confidence and Trust in Health IT.”

    APTA agrees that attention to the privacy and security of any and all personal information is of paramount importance. Stakeholders have expressed the detrimental impact inappropriate disclosure of this information could have on the level of trust and quality of relationship between the patient, whose personal health information is disclosed, and health care providers. Inappropriate disclosures of health information, such as mental illness or HIV status, could have negative consequences, including discriminatory impact, for the patient. The possibility of identity theft of health information also has serious implications. Manipulation of patient information, such as blood type, by an individual who compromised a patient’s privacy could lead to life-threatening consequences to the victim, particularly in an emergency room setting if the patient is administered the wrong blood type.

    APTA supports promulgation of appropriate and enforceable federal policies to protect the privacy and security of health information. We urge the ONC to conduct an analysis of overlapping privacy and security regulations among state and federal laws as well as among government agencies which may impose differing criteria than HIPAA followed by educating stakeholders. Inconsistencies or lack of clarification among regulations can result in impediments in accessing health care. For example, in order for rehabilitative services to be accessed under the Children’s Health Insurance Program (CHIP), schools must be compliant with both HIPAA and the Family Educational Rights and Privacy Act (FERPA). This impedes access to appropriate care because of varying regulatory requirements, increases administrative costs and leads to frustration for the beneficiary, their family members and providers of these essential health care services.

    With recent efforts from the Office of the Inspector General (OIG) to combat health care fraud and abuse, states are erring on the side on being overly cautious in administering and/or approving claims for services under Medicare and Medicaid. Although we commend the efforts of the OIG in their successes in combating fraud and abuse, we caution that policy miscommunications between state agencies and federal agencies have resulted in access to care issues. States become fearful of OIG audits and err on the side of underutilization versus overutilization which clearly does not put the patient first, especially those patient populations susceptible to discrimination who often rely on Medicaid and Medicare services. Such policy miscommunications can become indoctrinated in a States’ HIT infrastructure and have a trickle down negative effect in automated denials of legitimate payment claims by reviewing entities and auditors. Correcting such vagaries is both costly and burdensome. Therefore, APTA recommends that HIT systems undergo a mandatory continual evaluation process at state and federal levels to correct such mistakes. HIT programs need to be working and errors eliminated before advancing a system in actual use.

    APTA supports the development of an interoperable infrastructure to securely exchange health information among providers, patients and public health agencies with appropriate safeguards. We recommend the establishment of a process to align security and privacy requirements and regulations between federal and state agencies.

    GOAL IV, “Empower Individuals with Health IT to Improve their Health and the Health Care System.”

    APTA recognizes the vital importance of patient involvement in their care. Physical therapists evaluate the patient to determine the patient’s goals for treatment and community factors, such as the assistance of family and/or friends and home environment, to design appropriate interventions. To foster trust, cooperation, and appropriate decision-making on the part of the patient, the consumer should have the ability to learn how personal health information is being utilized and disclosed.

    APTA believes that HIT, specifically EHRs if interoperable, will allow for improved patient and public health outcomes by providing access to real-time health information. For example, an EHR would allow a provider to determine what medications the patient is taking. In the instance of physical therapy, this information could aid the therapist in determining the best method of treatment for the patient or understanding changes in the patient’s condition that will affect their progress towards their defined goals as indicated in the plan of care. Some medications may affect balance and, therefore, impact the physical therapist’s plan of care. In other instances, knowing that a patient is on blood pressure medication(s) would require the physical therapist to monitor the patient’s blood pressure and select interventions that minimize/prevent an elevated heart rate.

    In addition, it may be possible to conduct disease tracking through HIT that could lead to early interventions to prevent or slowdown the spread of disease. Patient advocates have demonstrated the detrimental effect on health that the delay in sharing this information can have on the patient. In addition, patients should be able to contribute to their medical histories and exchange information with their health care providers. One such example would be the exchange from the EHR to the patient health record information relating to lab results, discharge instructions, and other relevant information. Providing this information has the potential to improve health outcomes for patients. For instance, the ability to provide the patient discharge instructions could improve patient compliance and reduce hospital admissions. Therefore, APTA supports the ONC goal of consumer’s real-time access to care information. However, we recommend that mechanisms be in place to ensure that “real time” information is not released to a patient before the provider has the opportunity to review and fully explain the information being released. Further, we agree with the goal of focusing on non-clinical factors, including patient empowerment, patient needs, privacy, technical possibilities and capabilities, and
    development of health care efficiencies, as factors to include in quality measurements.

    APTA supports the objectives of educating the consumer and provider. In educating consumers and providers on utilizing personal health information (PHI) and EHRs, an educational strategy that takes into consideration the varying degrees of familiarity with this health information is necessary. Current use by health care providers should be clearly established so that time and resources are effectively spent in developing appropriate educational material and strategies to help providers understand what is being asked of them. We fully support the ONC in its goal of educating the consumer on the benefits of prevention, early intervention and plan of care compliance towards optimizing health outcomes and improving the individual’s quality of life. This behavior empowers the individual, allows them more control in their health care decisions, and is instrumental in minimizing disability and in achieving the optimum functional outcomes.

    GOAL V, “Achieve Rapid Learning and Technological Advancement.”

    Physical therapists are at the forefront of providing health services that reduce preventable hospitalizations. APTA and our members have gained a unique knowledge base through the development of data collection systems that would be valuable to the development of HIT learning health system. APTA is actively involved in other initiatives that warrant appropriate HIT adoption. Examples include: Medicare’s Physician Quality Reporting System (PQRS) and Provider Value-Based Purchasing (PVBP) projects that have specific components related to EHRs; working with CMS and its contractors on payment reform for therapy services; preparing our members for the transition to ICD-10 and the implementation of the revised Health Insurance Portability and Accountability Act (HIPAA) provisions. In addition, we are planning advancement to the EHR, CONNECT, that would enhance increase clinical decision-making. There are currently many projects underway that would benefit from a comprehensive and coordinated HIT system that includes physical therapy and rehabilitation.

    Conclusion

    In conclusion, it is vitally important that the adoption of HIT is approached comprehensively, including valid patient assessment tools, clearly identified health outcomes, interventions based on sound science and evidence, recognition that individuals with the same condition often present differently, and encompass a wide range of health care providers in health information technology adoption plans. Too often discussions about HIT and EHR expansion are centered on physicians and hospitals only. HIT development needs to focus on better performance by the health care provider and improved health outcomes to the consumer, as the Strategic Plan outlines. We strongly urge the ONC to expand the scope and to adopt as part of any strategic plan, the inclusion of all health care providers throughout the full spectrum of care. Improving the quality of care while decreasing costs will require participation through the use of EHRs by all providers and consumers. We look forward to working with the ONC as it looks for opportunities to assist health care providers in nationwide adoption of EHRs. Thank you for your consideration of our comments.

  122. Statewide HIE Coalition says:

    Dr. Farzad Mostashari
    National Coordinator for Health Information Technology
    U.S. Department of Health and Human Services
    200 Independence Avenue S.W.
    Suite 729-D
    Washington, D.C. 20201

    Re: Federal Health IT Strategic Plan 2011-2015

    Dear Dr. Mostashari:

    The Statewide HIE Coalition appreciates the opportunity to comment on the Federal Health IT Strategic Plan for 2011-2015 (the “Plan”).

    The Statewide HIE Coalition (the “Coalition”) is a coalition of states and state-designated entities (“SDEs”) with advanced health information exchange (“HIE”) plans or capacity that are working to build the infrastructure necessary for nationwide adoption and meaningful use of health IT.

    The regional and statewide HIE networks being developed and operated by Coalition members provide integral infrastructure for health care providers to reach outside of their clinical practice sites and connect with other points of care. Such networks are uniquely positioned to support interoperability by:

    - Facilitating the use of shared directories and technical services;
    - Creating economies of scale;
    - Reducing infrastructure development costs, including avoiding costly point-to-point interfaces for data exchange among health care providers in a community;
    - Increasing the success of HIE and electronic health record (“EHR”) deployment; and
    - Establishing governance structures that achieve broad-based stakeholder buy-in and trust.

    We offer our feedback, which reflects the important role of statewide HIE networks in nationwide HIE, on the current draft of the Plan for your consideration below.

    I. Support for the Plan’s Description of How Various HIE Strategies Fit to Together

    We appreciate the Plan’s description of how ONC’s many programs and policymaking activities interact to create an inclusive, nationwide system of HIE. We have asked ONC in the past to articulate a clearer vision of how the many health IT activities it is supporting relate to one another, and we think that the Plan begins to add clarity.

    The Plan suggests that a main focus of the State HIE Cooperative Agreement Program (the “State HIE Program”) is to “support providers by building on existing exchange activities, providing critical shared services and infrastructure such as provider directories, record locator services, and master patient indices, increasing the use of standards, services, and policies needed for widespread information sharing, and enhancing the information exchange capabilities of key trading partners including clinical laboratories, pharmacies, and public health agencies.”

    The Plan also suggests that State HIE Program grantees should be working “to find the right combination of already-available exchange models that will enable providers to electronically exchange lab results, patient care summaries, and medication histories.”

    At the same time, the Plan describes how ONC is making it “easier, faster, more secure and less expensive” to transport health information through the Direct Project.

    In the past, we’ve asked ONC to make clear that the Direct Project should not be considered an alternative to participation in statewide HIE networks. We appreciate that ONC did so in the Plan.

    As ONC continues to discuss the Direct Project, we encourage you to publicize examples of how the Direct Project’s transport protocols may be used to support – not obviate the need for – HIE networks.

    II. Need for More HIE In Meaningful Use

    While we are pleased to see ONC articulate a clearer explanation of how the various HIE modalities developing in the market are coming together, the Health Information Technology for Economic and Clinical Health Act’s (“HITECH”) vision for a nationwide, interoperable network of HIE that improves care quality simply will not materialize unless Meaningful Use (“MU”) is more closely tied to robust, pull-model HIE.

    The measures required under Stage 1 of MU did little to encourage health care providers to participate in HIE networks. It is critical that Stage 2 of MU support the concept of allowing health care providers to engage in HIE (the verb) through HIEs (the noun).

    The Coalition has commented previously that the MU Workgroup’s proposed Stage 2 measure, “Connect to at least three external providers in ‘primary referral network’ (but outside delivery system that uses the same EHR) or establish an ongoing bidirectional connection to at least one health information exchange,” is an important step forward from the Stage 1 MU measure to perform at least one test of certified EHR technology’s capacity to electronically exchange key clinical information. But it does not go far enough to ensure that HITECH’s investment in HIE networks is optimized, nor to ensure that health care providers’ meaningful use of EHRs yields the advances in care coordination and measureable quality improvement that interoperable HIE can facilitate.

    To achieve these goals, the Coalition recommended the creation of an alternative pathway that encourages health care providers to engage in the Stage 2 MU measures that involve HIE through “Qualified HIE Networks.” Under this alternative pathway, health care providers would be required to:

    - Have a participation agreement in place with a Qualified HIE Network;
    - Use the Qualified HIE Network to meet the Stage 2 MU measures that involve HIE; and
    - Permit the Qualified HIE Network to report on the volume and types of transactions carried out using their network services.

    By encouraging providers to participate in HIE through a common vehicle – Qualified HIE Networks – we will accelerate the development of an interoperable health information infrastructure that enables health information to follow the patient and drives significant improvements in health outcomes. The Coalition submitted its full comment letter on the MU Workgroup’s proposed Stage 2 MU measures on February 25, 2011 in response to the Workgroup’s Request for Comment. That comment letter can be provided upon request.

    III. Need for More Clarity about Governance

    The Plan is notably brief in its discussion of governance of the Nationwide Health Information Network (“NW-HIN”), stating only that it will establish a governance mechanism through rulemaking that seeks to include accountability and oversight of nationwide information exchange. Understanding that ONC may be subject to restrictions under the rulemaking process, we encourage you to include more details about how statewide HIE networks will relate to any governance mechanisms for nationwide exchange that ONC may propose. Specifically, we request that ONC describe how NW-HIN governance will support – not undermine – existing HIE governance mechanisms and policies.

    We also request that ONC further describe how national governance policies under NW-HIN will better support the needs of small providers.

    IV. Suggested Performance Measures

    ONC includes in the Plan a set of performance measures designed to reflect progress toward achieving the Plan’s goals, as well as the overarching goal that all Americans benefit from EHRs. Recognizing that these performance measures are not intended to be a complete set, but a subset of key indicators in assessing progress, we urge ONC to add additional measures related to HIE. As included in Appendix A of the Plan, there is only one measure relating to HIE: “Increase the percentage of community pharmacies in the U.S. that are capable of exchanging health information electronically,” which is to be measured by the Surescripts National Progress Report on E-Prescribing.

    We urge ONC to consider adding the following measures, which will help to evaluate the nation’s progress toward a nationwide system of robust, pull-model HIE:

    - Number of health care providers registered in states’ provider directories.
    - Number of labs able to send structured electronic lab results and consume structured lab orders.
    - Number of providers able to send and receive electronic patient visit summaries.
    - Number of hospitals able to send electronic discharge summaries.

    We appreciate the work in which ONC has engaged over the past year with its federal partners and the private sector (through the Health IT Policy Committee) to update the Plan. Please do not hesitate to contact us if we can be of any assistance as you continue the important work of finalizing it.

    Sincerely,

    Arizona Government Information Technology Agency
    Cal eConnect
    Colorado Regional Health Information Organization
    Maryland Health Care Commission
    Minnesota Department of Health
    Minnesota Department of Human Services
    Missouri Health Connection
    Nebraska Health Information Initiative
    New York Office of Health Information Technology Transformation
    Oregon Health Authority, Office of Health IT
    Utah Department of Health
    Utah Health Information Network
    Tennessee Office of eHealth Initiatives
    Department of Vermont Health Access

  123. We are concerned that the HIT Plan’s proposal to let accessibility policy evolve over time will be too little, too late. Failing to include accessibility for people with disabilities (i.e., meeting the functional needs of people with various disabilities) early will undermine HIT Plan’s ability to ever meet its goals, particularly Goals II, III, and IV. Without accessibility up-front, the Department will miss out on the input and insights of people with disabilities as it develops its health care and HIT plans until it is too late. For example, as the Department develops its privacy and security policies, the privacy and security concerns of blind people, elderly people, people with intellectual disabilities, and others who have difficulty using standard technology will be left out. Developing HIT without the input of these important constituencies could seriously undermine the effectiveness of the HIT.

    Accessibility features will make HIT usable by many groups, including
    o low-vision users, who require magnification and/or audio files in addition to text
    o blind users, who use screen readers or require Braille output
    o deaf and hard-of-hearing users, who cannot use audio, relying on text, captions or visual cues
    o people with limited mobility or those who use the keyboard-only, rather than a mouse, or who use other assistive technology devices to control the computer

    Moreover, accessibility is not just for patients, but for providers with a variety of disabilities.

    Accessibility standards are already available and would add little or nothing to the cost or technical difficulty of developing HIT. On the other hand, further delay in adopting accessibility standards for HIT will ensure that HIT is developed without accessibility, which will require expensive retrofits and work-arounds for technology developers, health care providers, and individual consumers.

    Health care providers are already legally required, under the Americans with Disabilities Act (ADA), Section 504 of the Rehabilitation Act, and other laws, to make health records available in accessible formats. Incorporation of accessibility in the development of HIT would help them meet their legal obligations and help people with disabilities, including people who are aging, benefit from greater access to their health information. However, instead of including accessibility as a core feature of HIT, the HIT Plan relegates accessibility to a vague group of policy issues expected to “evolve over the next five years.”

    We appreciate that HHS plans to support HIT that will “Accommodate the range of user capabilities, languages and access considerations, including effective strategies for ensuring accessibility and usability of electronic health information for people with disabilities and meaningful access to such information for individuals with limited English proficiency.” We hope this statement of principal will be made real and immediate.
    Thank you.

    Burton Blatt Institute

  124. May 6, 2011

    Kathleen Sebelius, MPA
    Secretary
    U.S. Department for Health and Human Services (HHS)
    Room 603 Hubert H. Humphrey Building

    Farzad Mostashari, MD, ScM
    National Coordinator
    HHS Office of the National Coordinator for Health Information Technology (ONC)
    Room 729-D Hubert H. Humphrey Building
    200 Independence Avenue, SW
    Washington, DC 20201

    RE: CompTIA Comments on Federal Health Information Technology Strategic Plan

    Dear Madam Secretary and Dr. Mostashari:

    We thank the Office of the National Coordinator for Health Information Technology for the opportunity to comment on the “Federal Health IT Strategic Plan: 2011-2015”. We offer our comments both as a non-profit trade association representing the IT industry (in particular the IT service providers: value added resellers, managed service providers, etc.) as well as an industry certification body that is dedicated to advancing the professionalization of the health information technology sector.

    CompTIA applauds the general goals of the plan: (1) achieve adoption and information exchange through meaningful use of healthcare IT; (2) improve care, improve population health, and reduce healthcare costs through use of healthcare IT; (3) inspire confidence and trust in healthcare IT; (4) empower individuals with healthcare IT to improve their health and the healthcare system; and (5) achieve rapid learning and technological advancement.

    CompTIA believes that the federal government has taken extremely productive steps toward achieving these goals. Nevertheless, in order to realize our shared commitment to better health outcomes, a more efficient delivery of medical services, and a satisfied patient base, the IT service provider must be made more of a partner in achieving these goals.

    I. About CompTIA

    The Computing Technology Industry Association (CompTIA) is a non-profit trade association representing the information technology (IT) industry. CompTIA represents over 2,500 IT companies. Our members are at the forefront of innovation and provide a critical backbone that supports broader commerce and job creation. These members include computer hardware manufacturers, software developers, technology distributors, and IT specialists that help organizations integrate and use technology products and services. CompTIA is dedicated to serving its membership by advancing industry innovation and growth through its educational programs, market research, networking events, and public policy advocacy.

    CompTIA is also the leading global provider of vendor neutral IT certifications to validate skills in the workplace. Over 1.4 million individuals hold one of our certifications, with the vast majority having completed one of our foundational certifications, A+, Security+, and Network+. The development and dissemination of these certifications serve the industry by adding to the level of knowledge and professionalization of the IT service provider. In turn, this allows the IT service provider to be an ambassador for the IT industry, bringing to its client a voice of technical knowledge and support.

    III. CompTIA Views on the Federal Health IT Strategic Plan

    Recent news articles have revealed a gap in adoption rates for EMRs between hospitals/larger medical facilities and smaller office-based doctors and other medical practitioners. The Office of the National Coordinator has projected that just 41 percent of this latter population will be compliant with digital health record requirements by 2014. In fact, the Strategic Plan itself notes that HITECH Act programs are focused on the providers that need the most help – solo and small group provider practices, community health centers, critical access hospitals, and providers located in rural and underserved areas. Still, trepidation exists. Cost is certainly a factor. The fear that adopting health IT solutions would slow down patient care is also gaining traction. Confusion over the Medicare/Medicaid reimbursement process may be a factor too.

    There is also an equal measure of hesitancy on the part of the small and medium sized IT solution provider to enter into this vertical. Consider CompTIA’s own experience. As noted previously, CompTIA has a member community devoted entirely to Health IT. There are 103 companies that are members of the Health IT Community. This means they have demonstrated a strong interest in this vertical space. Looking just at the resellers in that group (those companies that typically buy products such as computers in bulk from a manufacturer and then “add value” to the original equipment by including specific software applications or other components), only 18 members out of a total of 83 (or just 22%) actually are in the heath IT business. This relatively small number represents a lost opportunity to activate the IT service provider to be another crucial catalyst in bringing small and medium medical providers across the threshold to EMR and HIT adoption.

    At a fundamental, grass-roots level, CompTIA believes that the skilled IT service provider can (and must) be an important advocate, providing useful solutions that will encourage smaller medical practitioners to make the transition. Current estimates are that the Unites States will need 50,000 more health IT workers to help medical providers achieve meaningful use of electronic medical records. How do we develop this large workforce given the time frame put in place by the HITECH Act for medical practitioners to adopt meaningful use?

    A. Education

    Significant and important focus has been given to Universities and Colleges to graduate more individuals trained in Health IT. As noted previously, CompTIA very much supports this focus and thus our deep commitment to the Midwest HIT Regional College Consortium and to the HHS/DOL Career Clusters effort. Yet, from our experience, very little thought has been given to training existing IT professionals who already have basic IT skills but who need additional help in adding a health IT “bolt-on” to their considerable knowledge and experience in IT. Many of these professionals will go through private training centers and/or will audit courses at their local community college or university, and then take a certification test to validate those skills. These men and women could be activated very rapidly to help with the transition, but they need some economic assistance – such as an HIT education tax credit – to offset some of the costs of this sizable investment. While bringing new people into the profession is important, the existing IT community must not be forgotten and, indeed, should be leveraged more effectively.

    B. Making Technical Assistance More Effective

    The Federal Government has also taken painstaking efforts to provide technical assistance to medical providers by establishing Regional Extension Centers (REC). CompTIA sees the wisdom in this approach but suggests that some refinements could make RECs much more effective.

    In an effort to learn more about the Regional Extension Centers that were created under the HITECH Act, as a part of the Health Information Technology Extension Program, the CompTIA Workforce Development group set about conducting research with the hope of finding out how Regional Extension Centers and IT Service Providers could work together to effectively implement EHR solutions in medical practices nationwide. After a thorough review of all 62 Regional Extension Center websites, a clear, key finding is that there is a considerable amount of variance among these government-funded Regional Extension Centers. The range of variances amongst Regional Extension Centers includes:

    • Communication Mix

    o Some REC websites are easy to find, clearly communicate critical, up-to-date information, and
    are plainly engaged in the community

    o Other REC websites are difficult to find, as they are deeply embedded within the host organization website, and provide information that is spotty and out of date

    o Methods of contacting RECs vary greatly and are often limited

    • Preferred Vendor Lists

    o Most RECs identify themselves as vendor neutral; however, preferred vendor lists do exist on many websites, but differ significantly in terms of preferred vendors and list structures

    • Preferred IT Service Provider Lists

    o A limited number of RECs also list preferred IT service providers, but it seems as though the vetting process for many states is still in its preliminary stages

    Thus, due to the fact that the CompTIA Workforce Development group has uncovered a considerable amount of variance amongst the Regional Extension Centers, it has been decided that the CompTIA Workforce Development Group will take a more detailed look at strategically located Regional Extension Centers, in order to better evaluate the degree to which Regional Extension Centers could work closely with CompTIA’s Managed Service Providers.

    According to Strategy I.C.2 of the Strategic Plan: “The RECs are providing outreach and technical assistance to support providers who serve underserved communities and resource-poor settings, including small practice settings, rural hospitals/clinics, community health centers, and Critical Access Hospitals.” Similarly, we suggest that RECs integrate these outreach activities with the small IT service providers that are already serving IT needs of these providers. We would respectfully suggest that the RECs could play a much more robust role in linking medical professionals to IT service providers, and vice-versa. As we proceed further in our examination of the RECs, we would welcome the opportunity to share our observations with the Office of the National Coordinator of Health Information Technology.

    C. Inspiring Trust & Confidence in Healthcare IT

    In general, CompTIA applauds the efforts made under the HITECH Act to raise privacy standards for personal health information (PHI). Consumer and medical trust in health IT will only come to pass if there is strong respect for, and protection and enforcement of, personal health information.

    With that said, we are concerned that the some of the requirements could present a substantial burden on the small IT service provider that could chill entry into the HIT space. Under the HITECH Act, business associates and subcontractors of the covered entities are now directly liable under HIPAA for complying with the Security and Privacy rules. This represents a departure from HIPAA where the liability for business associates was based on the applicable business associate contract with the covered entity. This means that a small IT company could be exposed to criminal penalties and civil fines that can range up to $1.5 million – a crushing amount for a business with 20 employees or less. Carve outs from liability center around the number of individuals whose PHI is breached. A more beneficial carve out should be considered based on size of business in tandem with scope-of-breach and risk-of-harm threshold.

    In addition, section 13402 of the HITECH act sets out circumstances under which a breach triggers notification requirements. While these requirements in and of themselves are not problematic, the interplay between state and federal standards can be a source of great confusion to a small business in the HIT space. When do state rules preempt federal standards with regard to, for example, a risk-of-harm threshold? When is the obligation to notify triggered (which determines compliance with the federal sixty day requirement)? What does the extension of jurisdiction to States Attorneys General mean for aggressiveness in pursuing actions against business associates? CompTIA has long supported federal preemption for data breach standards and notification, and the evolution of HIPAA under HITECH makes this an even more attractive avenue to embrace.

    * * * * *
    In conclusion, the small and medium IT service provider can and should be a key partner in helping small and medium sized medical providers make the transition to EMR. Yet, this population to date has not been recognized as a partner in the development of the federal strategy. CompTIA would welcome the opportunity to work with the Office of National Coordinator of Health information Technology to ensure that IT service providers are more effectively made a part of the effort to achieve meaningful use of electronic medical records, as well as a broader embrace of health IT.

    This comment has been edited to comply with the ONC blog policy.

  125. Farzad Mostashari, MD, ScM
    National Coordinator for Health Information Technology
    Department of Health and Human Services

    Re: BCG Comments on ONC Federal Health IT Strategic Plan 2011 – 2015

    Dear Dr. Mostashari:

    Thank you for the opportunity to comment.

    The recently released US Federal Health IT Strategic Plan seeks to build on the 2009 HITECH federal stimulus and the 2010 PPACA health care reform to improve health care quality and reduce costs in the US. Conceptually, we refer to the paradigm of aligning the health care system towards improved quality and reduced costs as value-based health care (VBHC). Stakeholders can implement and achieve VBHC in a variety of ways including payment reform and the deployment of technology to enable Comparative Effectiveness (CE).

    The 2011 Federal Health IT Strategic Plan emphasizes five goals to “transform health care” towards a VBHC system: 1) meaningful use, 2) enabling health care reform, 3) confidence and trust in health IT, 4) empowerment, and 5) a learning health system. We agree wholeheartedly with these goals, and also concur with the necessity of leveraging of health IT to enable them. However, we believe that there is a gap, particularly for goals 2 and 5 focused on health system transformation, between the listed goals and the specific health information policy and data strategies outlined to achieve them. We propose that in addition to policies which advocate EHR and HIE adoption and use, a comprehensive national health information strategy is required to enable VBHC and a learning health system.

    ——Analytical capabilities enable a learning health system and value-based health care——

    A learning health system is defined as “an environment where a vast array of health care data can be …aggregated and analyzed turning data into knowledge that can be put to immediate use” and is the key to health system transformation. To achieve an adaptive learning health system that effectively utilizes health care data, it is important to have a clear understanding of the prototypical analytical capabilities that we are seeking to support. We propose that five core analytical capabilities enable VBHC:

    • Signal detection, mining data for previously unknown correlations between variables. Answers the question, “What outcomes should we care about?”

    • Performance assessment, evaluating differences in outcomes by provider or measuring against benchmarks. Answers the question, “How are we doing?”

    • Comparative effectiveness, evaluating differences in outcomes of two or more diagnostic techniques or treatments. Answers the question, “What are best practices?”

    • Patient stratification, segmenting patients into relevant sub-populations to understand patient drivers of variation in outcomes. Answers the question, “Are we doing better for some patients than others?”

    • Root cause analysis, assessing processes drivers of variations in outcomes. Variations in provider adherence to evidence based guidelines, for example, are particularly impactful to patient outcomes. Answers the question, “How can we improve?”

    These five capabilities are core to enabling VBHC, and are often, but not always, performed in succession. A longitudinal view of the patient and a clinical decision support system at the point of care are critical “first order” capabilities and are clearly central to meaningful use. However, a learning health system which can ultimately improve quality and reduce costs requires a comprehensive national health information strategy which also considers these “second order” analytical capabilities.

    ——Analytical capabilities require the right data ——

    Analytical capabilities to enable VBHC and a learning health system require high-quality, mostly clinical, data. In our experience, we have found that health care stakeholders often have challenges identifying, accessing, and leveraging health care data in part because there is no consistent way of characterizing the utility of different datasets for different purposes, and lack of clarity about what differentiates health data from different sources, such as claims, EHR, and registries. We therefore propose a taxonomy for characterizing data sources along three major dimensions:

    • Variables/Depth – Type and number of variables within a dataset
    o Determines what can be analyzed
    o Determines whether analysis can be adjusted for case-mix
    o Needs to be optimized to contain cost and complexity

    • Observations/Breadth – Size of the dataset, both in time and number of patients
    o Impacts the “power” of the analyses (how small an effect can be detected)
    o Impacts strength of the conclusions
    o Should be maximized as long as quality can be maintained

    • Quality control – Degree of syntactic and semantic consistency within a dataset and between datasets; validation – ‘correctness’ of each field, reliability of clinical reporting
    o Impacts whether analysis can be “trusted”
    o Determines whether data can be integrated between datasets or organizations
    o Impacts whether analyses can be compared across datasets (uniformity) and populations (generalizability)

    For example, data within EHRs may have excellent depth. There are many variables that pertain to a given patient, so EHRs may be well suited to enable root-cause analyses (i.e. identifying the process drivers which impact outcomes). However, because EHRs often lack breadth (e.g. large “n” or high penetration for a given disease or condition; longitudinal view of patients over extended periods of time) and quality may not be well controlled (data is originally entered for a purpose other than analytics), they are not ideal for comparative effectiveness. HIEs can provide broader datasets to enable more robust comparative effectiveness analyses. However, opt-in HIE models could result in skewed datasets with findings which are not generalizable.

    Outcomes registries, on the other hand, may have a significantly greater penetration for a disease of interest, and if collected at the national or international level, will provide excellent breadth for comparative effectiveness research. Of course, outcomes registries often require intentional data entry, thereby greatly improving the quality of the data, but potentially limiting the number of variables captured for a particular patient.

    The implication is not that certain datasets are inherently ‘better’ than others, but rather that multiple datasets are increasingly available, each having strengths and weaknesses along the depth, breadth, and quality control dimensions which make them more or less useful for particular uses. Also, by evaluating data sets according to these dimensions, each characterizable by a variety of sub-components, much more useful distinctions can be made between data sets than the current ‘clinical or claims’ characterizations.

    A comprehensive national health information strategy should consider the availability and accessibility of numerous datasets, should propose a general method of characterizing and evaluating them, and develop or incent infrastructure and processes to leverage the right data for to enable intended capabilities (such as standardized nomenclature, guidelines for common data definitions and uses, and the like).

    BCG recommends that ONC consider multiple health care data sources, and their strengths and weaknesses along the depth, breadth, and quality control dimensions, as core components of a federal health information strategy.

    ——Conclusion and recommendations——

    The ONC plan emphasizes the use of health IT to create a VBHC system focused on improved quality and reduced costs. BCG supports the fundamental goals of the ONC Strategic Plan, and we encourage policymakers to develop health IT policy and goals to support the strategic use of health care data. ONC, CMS, and AHRQ should seek to fill the policy gap between adoption/implementation of EHR/HIE (Meaningful Use) and health care transformation (learning health systems and VBHC). The missing gap is a comprehensive health information strategy.

    While the ONC Strategic Plan identifies key enablers of health IT adoption, we believe that it does not pay sufficient attention to the opportunities created to leverage this data to enable VBHC and a learning health system. Health IT adoption is important, but the use of the data beyond the point of care (e.g. ‘secondary use’) will enable true transformation of the health care system.

    Sincerely, the BCG VBHC/HCIT Team
    Benjamin Berk MD
    Simon Kennedy, Stefan Larsson MD PhD, Pete Lawyer, Craig Lawton, Sapna Shah
    The Boston Consulting Group

    This comment has been edited to comply with the ONC blog policy.

  126. May 6, 2011

    VIA Electronic Submission to http://www.healthit.gov/buzz-blog/from-the-onc-desk/hit-strat-plan/

    Farzad Mostashari, MD, ScM
    National Coordinator for Health Information Technology
    Department of Health and Human Services
    Hubert Humphry Building, Room 509F
    200 Independence Avenue, SW
    Washington, DC 20201

    Re: Federal Health HIT Strategic Plan

    Dear Dr.Mostashari:

    The American Society of Health-System Pharmacists (ASHP) is pleased to submit written comments regarding the role of pharmacists in the Federal Health IT Strategic Plan (Strategic Plan) released on March 25, 2011 by the Office of the National Coordinator for Health Information Technology (ONC). For more than 60 years, ASHP has helped pharmacists who practice in hospitals and health systems improve medication use and enhance patient safety. The Society’s 35,000 members include pharmacists and pharmacy technicians who practice in inpatient, outpatient, home-care, and long-term-care settings, as well as pharmacy students. These comments are intended to further amplify those of the Pharmacy e-Health Information Technology Collaborative (Collaborative) of which ASHP is a founding organization, which are being submitted separately.

    Our comments are organized by the Goals and Strategies as laid out in the Strategic Plan. The following Strategies are where the Society believes that the profession of pharmacy can play an integral role and contribute to ONC’s Federal Health IT Strategic Plan. ASHP feels strongly that pharmacists, as meaningful users of electronic health records (EHRs), can help achieve the goals of the Federal HIT agenda as specified in the Strategic Plan. The Society urges the ONC to refine and implement the goals in the Plan to ensure that pharmacist-provided services across all settings of care are represented in the meaningful use of EHRs.

    Strategy I.A.1: Provide financial incentive payments for the adoption and meaningful use of certified EHR technology.
    While ASHP supports incentive payments for the successful adoption of EHR technology, we believe that it is imperative that pharmacists be considered eligible providers under this strategy. Hospital-based, community, and ambulatory care pharmacists perform measures of meaningful use discussed in the Strategic Plan. Specifically, these health care professionals use software to order laboratory tests, record medication entries patient demographics, and other data used to inform clinical decisions across the inpatient and outpatient settings. Medication therapy management (MTM) is a partnership between the patient or a caregiver and a pharmacist, in collaboration with other health care professionals, which promotes the safe and effective use of medications. The Society believes pharmacists have a vital role in collaborative drug therapy management, which is defined as a multidisciplinary process for selecting appropriate drug therapies, educating patients, monitoring patients, and continually assessing outcomes of therapy. For these reasons, it is important that pharmacists be included as providers, for the purposes of the Strategic Plan, who adopt meaningful use certified EHR technology.

    Strategy I. A. 3: Support the development of a trained workforce to implement and use health IT technologies.
    The Health Information Technology for Economic and Clinical Health (HITECH) Act provide $118 million in training and development funds for the more than 50,000 expected new health IT professionals. This new workforce should include individuals who have worked in the pharmacy profession and understand how to best implement and integrate new technology into their practice sites appropriately. ASHP sees this as an opportunity for pharmacy professionals, including pharmacy technicians, to enhance their knowledge and skills in delivering patient care. The Society believes that pharmacists have the unique knowledge, expertise, and responsibility to assume a significant role in medical informatics. As governments and the health care community develop strategic plans for the widespread adoption of health information technology, pharmacists must use their knowledge of information systems and the medication-use process to improve patient care by ensuring that new technologies lead to safer and more effective medication use. The Society has long recognized pharmacy informatics as a unique subset of medical informatics that focuses on the use of information technology and drug information to optimize medication use.

    Strategy I. A. 4: Encourage the inclusion of meaningful use in professional certification and medical education.
    While The American Board of Medical Specialties has taken steps to assist and encourage physicians in the adoption and meaningful use of EHRs, meaningful use should also be incorporated into professional pharmacy education as well. Just as it is important for the medical profession to understand EHR and computerized physician order entry (CPOE), it is essential that pharmacist training include key elements of EHR. Promoting integration of meaningful use of EHRs in pharmacy education could also result in meeting the demand for an increased number of individuals proficient in informatics in the profession overall. ASHP sees this as a unique opportunity for the pharmacist to gain professional certification in the field of informatics and EHRs.

    Strategy I. A. 8: Work with private-sector payers and provider groups to encourage providers to achieve meaningful use.
    ASHP believes that the ONC should continue to support private-sector programs as they work with the Medicare and Medicaid EHR Incentives programs to achieve meaningful use objectives. We believe that it is critical that pharmacists’ clinical services be included as part of the EHR information exchange. As the Federal HIT infrastructure is currently framed, pharmacists’ exchange of information is limited to electronic prescribing. While data on drugs prescribed is an important exchange, pharmacists are limited in their ability to implement clinical recommendations without full clinical information. We believe that pharmacist documentation of clinical interventions and recommendations may assist in the assessment of positive patient outcomes. Recent meta-analysis has found that the effects of pharmacist-provided direct patient care on various health care outcomes extend beyond medication distribution. Because of their education and specialized training, pharmacists offer clinical expertise, unique insights, and beneficial recommendations regarding medication use/monitoring and patient management that result in improved therapeutic, safety, and humanistic outcomes, and may contribute to more cost-effective health care (Chisholm-Burns, et al, 2010).

    Strategy I. A. 9: Encourage and facilitate improved usability of EHR technology.
    The Society believes that the criteria and standards being developed by the National Institute of Standards and Technology (NIST) may facilitate decision-making across multiple settings of care as pharmacy staff and physicians will be using standarized criteria. In this way, health care professionals will be given an opportunity to better choose clinical decisions most appropriate for their clinical setting using universal testing methodologies.

    Strategy I.B.1: Foster business models that create health information exchange.
    As cited in the Strategic Plan, entities such as diagnostic laboratories and e-prescribing companies have created health information networks that allow for ready exchange of certain types of health information for those companies willing and able to pay for these services. Further, the National Health Information Network (NHIN) standards, services, and policies are being adopted by many health care organizations as well. However, cost may be a barrier to participation for smaller or non-profit providers. ASHP supports the Direct project at ONC which provides a simplified and standardized way to exchange health information. The Direct project may make it possible for smaller pharmacy providers, for example, to interact with other providers and suppliers to exchange health information while removing the cost prohibitive barriers to entry.

    Strategy I.B.3: Ensure that health information exchange takes place across individual exchange models, and advance health systems and data interoperability.
    ASHP strongly supports the Federal government’s development of the standards and interoperability (S&I) framework to establish meta-data standards. One goal of the S&I framework is standards to facilitate easy accessibility to medical information across providers (e.g., data entered by a provider and read by a pharmacist). This may help reduce the chances of adverse drug events and help ensure greater quality care for the patient through better medication management therapy. Further, better exchange of information has the potential to reduce the number of hospitalizations by reducing drug-drug and drug-allergy interactions. The integration of the Pharmacy Provider Electronic Health Record (once certified by national EHR organizations) should be integrated with other healthcare EHR’s. Not only will this reduce medication related adverse events, but help with preventive care as it relates to blood pressure monitoring, smoking cessation programs, and heart attack prevention.

    Strategy III.C.1: Provide implementation and best practice tools for the effective use of health IT.
    Finally, the Society encourages ONC to develop and make available best practice resources to pharmacy hospital settings in addition to providers so they will be adept at the management aspect of health IT such as legal contracts around software use, routine upgrade and maintenance, or potential outages that may occur.

    ASHP develops official guidance documents for the continuum of pharmacy practice settings in integrated health systems. The professional policies of ASHP represent a consensus of professional judgment, expert opinion, and documented evidence. They provide guidance and direction to ASHP members, pharmacy practitioners, and other audiences who affect pharmacy practice. Their use by members and other practitioners is strictly voluntary, and their content should be assessed and adapted to meet the needs of specific health-system settings.

    ASHP statements and guidelines directly relevant to the Strategic Plan are as follows:

    Remote Medication Order Processing: http://www.ashp.org/DocLibrary/BestPractices/AutoITGdlRMOP.aspx

    Pharmacy Planning for Implementation of Computerized Provider Order Entry Systems in Hospitals and Health Systems: http://www.ashp.org/DocLibrary/BestPractices/AutoITGdlCPOEprepress.aspx

    ASHP Statement on Bar-Code-Enabled Medication Administration Technology:
    http://www.ashp.org/DocLibrary/BestPractices/AutoITStBCMA.aspx

    The Society appreciates this opportunity to present these comments relating to the Strategic Plan. As our comments reflect, the ONC should integrate and highlight the important role that pharmacists can play in meeting meaningful use of health IT with the goal of improved patient care and outcomes. Should you have additional questions, I can be reached by telephone or by e-mail.

    Sincerely,

    Christopher J. Topoleski
    Director, Federal Regulatory Affairs

    This post has been edited to remove personal information per the ONC blog policy.

  127. May 6, 2011

    Office of the National Coordinator for Health Information Technology
    200 Independence Avenue, NW
    Washington DC 20201

    CalHIPSO Comments on Federal Health IT Strategy 2011-2015

    On behalf of the California Health Information Partnership and Services Organization (CalHIPSO) I am pleased to provide comments on the Federal Health IT Strategy 2011-2015. CalHIPSO is the federally-designated Regional Extension Center (REC) for all of California except for Los Angeles and Orange Counties, and most tribal lands. As such, CalHIPSO is charged with assisting almost 6,200 priority primary care providers in California with achieving meaningful use by 2014.

    We commend the Office of the National Coordinator for the vision that is detailed in this very thorough plan. We value the proposed strategic plan as an essential guide in articulating the goals and strategies that are needed to achieve that vision. To date, one important benefits of the federal government’s work is in bringing together a wide variety of organizations and efforts to leverage and enhance different but interconnected efforts. The Strategic Plan continues in this direction, describing how multiple programs, organizations and efforts can work towards improving our health care system through the use of HIT.

    CalHIPSO endorses the ambitious goals detailed in the Strategic Plan, and at the same time we are concerned that the goals are too ambitious. While as a REC we have made great progress over the past year we are also increasingly aware of the challenges that limit providers’ ability to efficiently and effectively meet all the requirements for meeting Meaningful Use. These challenges are very real to CalHIPSO and our stakeholders as we have engaged in supporting 6187 providers in implementing EHRs and achieving Meaningful Use over the past twelve months. Our comments therefore are focused on how the Strategic Plan can better reflect the resources and focus needed to build the foundation for moving ahead with the ambitious goals.

    CalHIPSO has identified four key areas where additional focus and/or resources are needed to strengthen current and future efforts.

    State and local government Public Health capacity to exchange electronic information
    Strategy I.C.1: Ensure public health agencies are able to receive and share information with providers using certified EHR technology.
    The Strategic Plan states that “CDC is helping local and state public health agencies prepare their systems and processes for such changes. Through the State HIE Cooperative Agreement Program, state governments will play a key role in building the public health infrastructure to support meaningful use.“ The reality in California is that state and county public health systems, even with targeted resources from the federal administration, face very significant barriers to acquiring and implementing HIT to enable exchange of electronic information with health care providers. As an example, California does not have a statewide, bi-directional immunization registry. Regional immunization registries do exist but are not interconnected and do not cover all regions. While efforts have accelerated to address public health infrastructure to support a statewide immunization registry in the past twelve months, it is important to set realistic expectations about what can be accomplished with the resources available. Federal HIT programs have jump-started the relationship building and partnering that is necessary to begin developing public health capacity for electronic information exchange, however more resources will be needed to actually realize the goal.

    Health Care Providers’ ability to participate in HIE
    Strategy I.B.1: Foster business models that create health information exchange.
    This strategy states that “For as many providers as possible, the first priority is finding the right combination of already-available exchange models that will enable them to electronically exchange lab results, patient care summaries, and medication histories. State-level grantees in the State HIE Cooperative Agreement Program are identifying, articulating, and promoting adoption pathways that will help providers do just that. RECs will work with individual providers to identify and implement the right pathway.” At CalHIPSO we very much endorse this as the first priority and are actively engaged in implementing this strategy in collaboration with Cal eConnect, California’s HIE Governance Entity. Currently, the regional HIEs in our state are limited in scope and reach, posing challenges for REC provider members to identify HIE partners or, if they cannot be identified, to develop the technical infrastructure to electronically exchange information with their peers. Cal eConnect’s HIE Expansion Grant Program addresses this challenge by helping regional HIEs to expand their capacity, and its statewide HIE services to be offered in 2012 will enable all providers to meet HIE-related Meaningful Use criteria. The task of providing technical assistance to providers through the HIE adoption process will require significant effort from both RECs and State HIE Cooperative Agreement Programs. We recommend that the plan realistically describe the work that will be required to enlist providers in HIE, and provide support for RECs and State HIE Programs to manage this work together.
    Building Systems to Employ the Developing HIT Workforce
    Strategy I.A.3: Support the development of a trained workforce to implement and use health IT technologies.
    CalHIPSO has established a close relationship with the Community College HIT Workforce Development effort in our state. The $118 million allocated to support the training and development of more than 50,000 new health IT professionals is a good start, While the programs have been very successful in getting the training curriculum in place and many students have already completed the first certificate program, the system to engage these students in meaningful work is incomplete and/or non-existent. As a REC we are involved in working with the community colleges to create the processes that will move the students into full time employment or support incumbent workers in putting their training to use in their workplace. We recommend that the Strategic Plan include the following:
    • Financial subsidies for employers who hire students from the ONC workforce programs including utilizing the AmeriCorps program in conjunction with the community college HIT certificate training;
    • ONC leadership on tailoring curriculum to meet the HIT needs of providers in EHR adoption and optimization (currently there is a significant lack of alignment.)
    • Support for RECs and the workforce development programs to align their efforts for training to employment pathways such as internships, job shadowing, employment fairs and job posting websites. Additionally many of the students are currently employed in health care: developing and disseminating information on how these students can engage in HIT implementation at their workplace is essential.

    Supporting the Regional Extension Centers in Delivering and Expanding Services
    Strategy I.A.2: Provide implementation support to health care providers to help them adopt, implement, and use certified EHR technology.
    The REC role in supporting Eligible Providers to implement EHRs and achieve Meaningful Use is already acknowledged as essential and valuable. For instance the plan states that “using EHRs can alter current provider workflows, and many providers struggle to select systems, use them in ways that will improve care, and make the necessary changes to their processes“ (p.9): assisting targeted providers with this struggle is an essential role that CalHIPSO is developing expertise to fill. The Strategic Plan notes numerous other ways in which RECs either are currently or are anticipated to be engaged of which a few are listed here:
    • “The RECs are providing outreach and technical assistance to support providers who serve underserved communities and resource-poor settings, including small practice settings, rural hospitals/clinics, community health centers, and Critical Access Hospitals
    • RECs will disseminate best practices identified by Beacon Communities to providers and other organizations serving underserved communities. .
    • The HITRC and REC programs will make these best practices – such as using clinical decision support tools, patient registries, and reminder systems – available to providers throughout the country.
    • With the establishment of the REC program, the government now has a way to disseminate tools and best practices to providers that need the most help in implementing them into their practices. The RECs will build on their existing relationships with these providers to help them achieve improved health outcomes through more sophisticated uses of EHRs and other health IT.
    • Similarly, information on these privacy and security requirements and best practices will be channeled through the HITRC and the RECs, which offer opportunities to disseminate best practices to providers working to achieve meaningful use
    • NIST is developing guidance and tools for RECs and professional societies on available tools and resources to incorporate concepts of usability in selecting and implementing EHR systems
    • The RECs will promote EHRs that already have the Nationwide Health Information Network Direct interfaces built in, lowering the cost of exchange for small providers.

    At CalHIPSO over the past 12 months we have worked quickly and efficiently to begin developing the infrastructure and building relationships that will allow us to provide the core required services, as well as the trust among providers and our stakeholders that will enable us to be the resource for the activities described in the Strategic Plan. We see our role expanding to include being a resource to disseminate information on all aspects of EHR implementation, usability and transforming medical practice through the use of electronic information. However, as noted in the Plan, making the transition to a certified EHR is very challenging in our current environment. Vendors are still in the process of rolling out the certified versions to providers; the workforce that can support providers to use EHRs to meet Meaningful Use and transform work processes to fully take advantage of the shift to electronic information are just completing training and are not yet engaged in the process.

    While CalHIPSO is increasingly seen as a resource to provide EHR implementation services and support in achieving Stage One Meaningful Use, our current capacity is stretched thin in providing our core required services. In order to get full support, the Plan needs to take into account the time and resources still needed to fully realize the potential of what has been started. RECs are making significant process in engaging providers over the last year, however with so many aspects still in development, i.e. privacy and security regulations; training tools; workforce; HIE; the timelines must be set to allow the RECs to succeed.

    Further, our success as a REC in supporting providers in achieving Stage One Meaningful Use and developing the trust as a key partner in optimizing the use of EHRs must be sustained through additional resources. RECs will need to play a critical role in assisting providers to achieve Stages Two and Three of Meaningful Use. Therefore the Strategic Plan needs to include language detailing that role and the resources that will be provided to the RECs to leverage the initial efforts now underway.

    Thank you for your consideration of CalHIPSO’s comments on the Strategic Plan. CalHIPSO looks forward to working with the ONC to make the EHR incentive program successful for all providers in California.

    Sincerely,

    Speranza Avram
    Executive Director
    CalHIPSO

  128. Mr. Farzad Mostashari, MD, ScM
    National Coordinator for Health Information Technology
    Department of Health and Human Services
    Submitted electronically

    Re: Office of the National Coordinator (ONC) for Health Information Technology’s Federal Health Information Technology Strategic Plan 2011–2015

    Dear Dr. Mostashari,

    The Association of Public Health Laboratories (APHL) is grateful for the opportunity to provide comments in response to the recent update to the Federal Health IT Strategic Plan (“the Plan”) 2011-2015.

    As you may know, APHL continually works to safeguard the public’s health by strengthening public health laboratories (PHLs) in the United States and globally. APHL advances the development of laboratory systems and practices, and promotes policies that support healthy communities. The Association’s members include state and local public health laboratories, state environmental and agricultural laboratories, and other government laboratories that conduct testing of public health significance. The goals put forth by “the Plan” will certainly impact our members as your office continues to improve health care for all through the use of information technology.

    APHL appreciates the newest release of this Federal HIT Strategic Plan and recognizes the complexity of the current health information technology efforts set into motion by the various legislative initiatives. That said, we would like to take this opportunity to comment on certain points of critical importance to our member laboratories and communities.

    Goal I: Achieve Adoption and Information Exchange through Meaningful Use of HIT

    As the nationwide adoption of EHRs and widespread information exchange takes hold, we believe there is a need to develop a framework which expands achievement incentives beyond eligible professionals and hospitals. APHL recommends that ONC incentivize the Public Health domain as it has the private healthcare domain, in order to comply with ONC Meaningful Use regulations. Since Public Health Laboratories (PHLs) are a primary clinical data producer within both the Public Health domain and the private healthcare domain, APHL strongly recommends that as part of that public health incentive, PHLs receive funding to support their efforts furthering the Plan goals such as electronic laboratory reporting and interoperability. Since PHLs are contributing to the global achievement of electronic data interoperability which goes beyond their local funding budgets; incentives for PHLs are appropriate. PHLs should be similarly rewarded for expanding the use of electronic data exchange and adopting vocabulary standards required for semantic interoperability that will fuel the meaningful use of health data.

    Clinical entities are central to the Meaningful Use incentives, yet often times, our PHLs similarly function like clinical laboratories. PHLs provide critical testing for all newborns born in the US, prenatal screening, sexually transmitted disease (STD) testing, and hold the ability to perform specialized testing otherwise not handled by clinical laboratories. Also, when disaster or outbreak events occur, PHLs have the surge capacity to quickly respond and identify unknown agents.

    Goal II: Improve Care, Improve Population Health, and Reduce Health Care Costs through the Use of HIT

    Consensus and standards are fundamental to the success of any health system strategic plan. In HIT, we need to not only look at Nationwide Health Information Network (NwHIN) standards, services, and policies (including the Exchange and Direct protocols), but to established projects that are launching interoperability practices such as the Public Health Laboratory Interoperability Project (PHLIP) Initiative. This collaborative effort between APHL and the Centers for Disease Control and Prevention (CDC) supports automated, standardized electronic laboratory data exchange between state PHLs, other PHLs, CDC, and additional clinical partners.

    In the aftermath of the 2009 H1N1 Influenza Pandemic, a concerted effort was made to further electronic data exchange among CDC and partners to facilitate accurately and timely surveillance reporting. Through PHLIP’s demonstrated community, there are now are 24 PHLs sending real-time production level Influenza data using the same HL7 format and harmonized vocabulary to CDC. The byproducts of this effort are standard and scalable. Reusable components include harmonized tests and test results with the usage of LOINC and SNOMED, detailed vocabulary and messaging implementation guidelines, improved data quality and availability, specifications, and tested system architecture. APHL is well poised to build upon the PHLIP electronic surveillance message to report additional data elements such as bacterial DNA patterns, sentinel provider linkage data, and pyrosequencing profiles.

    We notice that there is language within the Plan that encourages provider and hospitals to use ONC’s Electronic Laboratory Reporting (ELR) format (i.e., HL7 2.5.1) for notifiable disease laboratory data to Public Health agencies. Given the expectation that PHLs will message electronic laboratory reports to/from local and state public health departments, the Plan must factor in adequate state or local funding streams so PHLs can meet these goals.

    Goal V: Achieve Rapid Learning and Technological Advancement

    In reference to Goal V, we’d like to remind ONC that PHLs play a crucial role. In many jurisdictions, PHLs are unique entities that generate clinical, population and environmental health data and have in-depth knowledge and experience as to how each of these types of data are related.

    The ONC should strongly consider state and local PHLs as candidates for “test beds” for novel HIT (Strategy V.B.3) methodologies. Our breadth of mission and flexibility would allow us to implement innovative measurable practices and technologies easily, that can be applied to other health care practices. This is not a stretch, as PHLs fulfill this role already with regard to analytic method development.

    In summary, PHLs serve as a unique public health partner with state and federal agencies in the areas of emerging infectious diseases, homeland security emergency response, and public health epidemiology. However, we cannot be successful at our business without the ability to exchange timely and accurate data with our customers. Given the existing economic landscape there is no funding allocated for PHLs to achieve the HIT Strategic Plan expectations. Currently, the only way for PHLs to fund critical infrastructure improvements in support of Meaningful Use objectives is to redirect funding and resources that are already being used for other vital public health programs. In many cases, this is simply not a viable option and therefore many PHLs have no choice but to refrain from participation in the HIT initiative activities. We hope this will change when the final Plan is published.

    Please contact us directly to learn more about APHL and ways we can work together. Thank you for your time and consideration.

    Sincerely,

    The Informatics Committee, APHL

  129. The American Psychiatric Association (APA), the national medical specialty society representing more than 37,000 psychiatric physicians, appreciates the opportunity to offer these comments to the Office of the National Coordinator (ONC) on its Federal Health IT Strategic Plan and to welcome Dr. Mostashari as the new National Coordinator. There has been enormous change in the level of federal support for HIT adoption since the publication of the last Strategic Plan in 2008, and ONC and its partner agencies now have the tools to make a real impact on the quality of care for Americans suffering from mental illness. While great progress has been made in this pursuit, there is still much to be done and challenges that need to be addressed.

    * Health Information Technology Adoption and the Mental Health Community

    The strategic plan emphasizes principles and goals on the need for prolific adoption of HIT throughout physician and patient populations and how these technologies can be leveraged towards wide scale quality improvement. Patients with mental illness are at significant risk for co-occurring conditions, for which care often must be coordinated across multiple settings and clinicians. It would be truly unfortunate and counterproductive for Americans suffering from mental illness to be left behind this wave of technological advancement and 21st century health information exchange. APA has several concerns regarding potential barriers to adoption of HIT and limitations on our patients’ ability to benefit from HIT initiatives. These barriers and limitations include impediments to psychiatrists’ participation in the administration’s meaningful use (MU) program, the statutory exclusion of mental healthcare facilities from the incentive, and information exchange policies that may disenfranchise our patients.

    Anecdotal evidence from our members and analysis of CMS meaningful use measures leads us to believe that psychiatrist adoption of HIT will lag behind primary care and other specialties, to our patients’ detriment. APA is encouraged that ONC is developing methods to track disparities in provider health IT adoption, and that ONC’s meaningful use advisory workgroup will be holding a public hearing that is dedicated to specialty adoption. We have responded to the administration with concerns about our ability to meet certain MU measures and their applicability to the practice of psychiatry, and we urge ONC to work with its partner agencies to ensure that this essential program does nt exclude psychiatrists and their patients or create requirements that are unrelated to psychiatric care. In recent comments we highlighted the need for reasonable exclusions from irrelevant measures and the problem with measures that require external dependencies outside of an Eligible Professional’s control.

    Potential disparities must also be considered in the provider education, training, assistance and community outreach programs ONC coordinates. APA urges robust outreach to and inclusion of psychiatrists and the mental health community in programs such as Regional Extension Centers (RECs) and Beacon Communities. Formal evaluation of the effectiveness and benefit of these programs should include their impact on addressing disparities in provider adoption and patient participation.

    The strategic plan also touches on the statutory exclusion of mental health facilities from the HITECH incentive program. Our members practice in public and private psychiatric hospitals, community mental health centers, and addiction treatment centers and we believe that federal support of HIT adoption in these facilities is critical for coordinated care of a particularly vulnerable population. While we have supported legislation that would fix this problem, we are glad to see the efforts of the Substance Abuse and Mental Health Services Administration (SAMHSA) to foster HIT adoption in these facilities highlighted. SAMHSA’s innovative HIT outreach programs are a critical supplement to the work of ONC and CMS, and it is well reasoned that SAMHSA serves on the Federal HIT Taskforce.

    * Information Exchange, Consumer Preference and the Privacy of Psychiatric Records

    As ONC is more than aware, special consideration must be given to health information exchange policy to prevent potential harmful disclosure of sensitive patient data. APA is an organization representing physicians who are likely to care for patients with sensitive health information (SHI), and we are particularly concerned with ensuring the confidentiality, privacy and security of the data in electronic medical records. Our patients’ trust in the privacy of their health information is critical to their care; it is well known that patients will withhold critical information if they do not have confidence in the system.

    The importance of segmenting SHI in an electronic medical record is also critical to the overall effort of creating a national, interoperable, and secure HIT network that has the trust of American patients. The HITECH statute specifically laid out this charge as a subject of study for the HIT Policy Committee. APA has endorsed the exploration of patient preference and segmentation of SHI, and we are encouraged by the framework development, studies undertaken, and pilot projects by ONC and its Privacy and Security Tiger Team. Our patients should not have to face a false choice between unlimited disclosure and wholesale exclusion of their records from interoperable exchange, and the sooner data segmentation policy is agreed upon the sooner it can be implemented by vendors and HIEs. It should be noted that this is not an issue particular to mental health, but rather is relevant to any number of medical conditions that involve data that the patient will consider to be sensitive.

    APA appreciates ONC’s publication of its Federal HIT Strategic Plan, and for its continued outreach for stakeholder feedback. While we have highlighted several concerns, we appreciate the hard work ONC and its advisory committees have put in to this effort. If you would like to discuss any of the issues raised here, please feel free to contact Matthew Sturm, Associate Director of Government Relations.

    Sincerely,
    James H. Scully Jr., M.D.
    Medical Director and C.E.O., American Psychiatric Association

    • David Hager, M.D. says:

      Re: “psychiatrist adoption of HIT will lag behind primary care and other specialties, to our patients’ detriment.”

      As a psychiatrist who uses a large system’s EHR daily, and who has monitored the emerging literature disputing clinical benefit from EHR technologies thus far, I’m not yet convinced that a delay in EHR implementation will be a detriment to our patients.

      Though I hope for this to change, the purported benefit of onerously expensive, awkwardly implemented EHR technologies remains an article of faith.

      I, too, share concerns re: privacy of records. Massive data breaches have cost the healthcare system billions of dollars and undermined patient trust. The public is exposed repeatedly to news of other, massive data breaches. (Sony and Verizon being recent news.) I’ve yet to have anyone hack into a paper chart.

  130. Farzad Mostashari, MD, ScM
    National Coordinator for Health Information Technology
    Department of Health and Human Services

    Dear Dr. Mostashari,

    We are pleased to submit these comments on behalf of the American Society of Clinical Oncology (ASCO) in response to the recent notice of the Federal Health Information Technology Strategic Plan (2011-2015) by the Office of the National Coordinator for Health Information Technology (ONC).

    ASCO represents over 30,000 physicians and other healthcare professionals specializing in cancer treatment, diagnosis, and prevention. Our members represent all oncology disciplines (medical, radiation, and surgical oncology) and sub-specialties. We have physicians and healthcare professionals participating in approved oncology training programs, oncology nurses, and other practitioners with a predominant interest in cancer care. These professionals set the standard for patient care worldwide and lead the way in carrying out clinical research aimed at improving the prevention, diagnosis, and treatment of cancer.

    ASCO appreciates the opportunity to comment on the Strategic Plan. ASCO is highly supportive of the use of health information technology (health IT) in the oncology community and believes that the judicious use of technology in medicine can have long-lasting and revolutionary effects on the quality of care. We are encouraged by the goals in the Strategic Plan and have the following comments:

    GOAL I: ADOPTION AND INFORMATION EXCHANGE
    In general, ASCO is supportive of the EHR Incentive Program and believes that financial assistance is crucial to higher rates of EHR adoption. ASCO recognizes the immensity of the task that ONC has undertaken in developing a program that applies to all of medicine; however, it is crucial that the EHR Incentive Program be as meaningful to specialists as it is to primary care physicians. We have submitted previous comments on individual meaningful use measures to both ONC and the Health IT Policy Committee to help ensure that oncologists’ participation in the program will drive improvements in cancer care. ASCO recommends that ONC continues to host avenues for input from specialty societies, particularly with performance and quality measures and guideline-based clinical decision support tools, for Stages 2 and 3 of meaningful use.

    We are encouraged by ONC’s attempts to align meaningful use with other federal programs and organizations. With that, we emphasize the need for alignment with two other incentive programs: PQRS and E-Prescribing. There are many areas of overlap among the EHR Incentive, PQRS and E-Prescribing programs and we believe that identifying common elements and streamlining the reporting requirements will reduce costly administrative burden for providers and increase enrollment in these programs. We understand work is being done in this area by ONC and the Centers for Medicare and Medicaid Services, and we highly recommend that solutions be identified soon to maximize alignment.

    Finally, we are appreciative of any federal leadership in defining syntactic and semantic standards for health IT. Establishing exchange and terminology standards will be critical to future health information exchange. ASCO also believes that a metadata approach, as recommended by the President’s Council of Advisors on Science and Technology (PCAST), will be an effective standard for the field.

    GOAL II: IMPROVE CARE, IMPROVE POPULATION HEALTH, AND REDUCE HEALTH CARE COSTS THROUGH THE USE OF HEALTH IT
    ASCO has a long and active history of initiatives aimed at improving the quality of cancer care, including our clinical practice guidelines and the Quality Oncology Practice Initiative (QOPI®). We believe that Health IT offers an unprecedented opportunity to enhance these efforts, and we support ONC’s strategic focus areas within this Goal. Specifically, ASCO strongly supports disseminating and promoting HIT-enabled best practices; enhancing quality measurement and establishing standards, specifications, and certification criteria for reporting measures through EHRs; and ensuring information exchange that supports research and the translation of research findings into clinical practice.

    GOAL III: INSPIRE CONFIDENCE AND TRUST IN HEALTH IT
    Strong regulation and security is crucial to ensure active participation in health IT, and to give our patients the protections that they need. As ONC crafts modifications to HIPAA, we urge you to ensure that policies do not render the secondary use of health information infeasible for quality improvement, surveillance, and research. We envision a thoughtful approach that secures protected health information, while also facilitating the learning required to realize the rapid learning and advancement central to Goal V.

    GOAL IV: EMPOWER INDIVIDUALS WITH HEALTH IT TO IMPROVE THEIR HEALTH AND THE HEALTH CARE SYSTEM
    Health IT has significant potential to enhance informed decision making and patient-centered care, and ASCO supports ONC’s strategic vision in this area. For several years, ASCO has worked with EHR vendors to seek integration of cancer treatment plans, treatment summaries, and survivorship care plans in their products. This has been accomplished with some success; however, we are frustrated that the related functionality and reports have generally not been integrated into the commercial products. ONC can play a key role in promoting these efforts. In especially complex diseases like cancer, patients and the public will be best served by ongoing attention to diagnosis-specific electronic access to education and decision making information; to portals for entry of patient-generated information and patient-reported outcomes; and to summary information generated from providers’ EHR systems. ASCO is enhancing our efforts in these areas and we invite open dialogue, coordination, and collaboration with ONC.

    GOAL V: ACHIEVE RAPID LEARNING AND TECHNOLOGICAL ADVANCEMENT
    ASCO applauds ONC’s long-term goal to create a rapid learning health system. Such a system would truly realize the promise of health IT and has the potential to transform the health care delivery and research. As concluded by the Institute of Medicine, oncology is a field that is particularly well suited for a rapid learning system designed to learn from every patient encounter, especially with the emergence of personalized cancer treatments. Oncology’s rapid rate of therapeutic development, off-label use, and focus on patient-centered care are also compelling reasons.

    To that end, ASCO will be paralleling and leveraging ONC’s efforts in this area; we have recently begun to synergize our guidelines, quality, and health IT programs in order to lay the framework for a rapid learning system. In 2009, we worked with the National Cancer Institute to define appropriate data elements and functionality needed for oncology-specific EHRs. ASCO will greatly expand upon that effort and have the following as short-term objectives: clear specification and proof-of-concept testing for a platform to support the standards-based capture and movement of electronic data, including to a central registry to support quality reporting and research analyses; a comprehensive set of computable guideline recommendations linked to clinical decision support tools; electronic quality measures specified according to the National Quality Forum’s Quality Data Model; and quality improvement support through ASCO’s QOPI® program. These elements will provide a strong basis for a rapid learning health system in oncology. This is a strategic priority for the Society. Federal funding that supports promising efforts in the creation of rapid learning systems would accelerate innovation.

    We highly recommend that our organizations continue to communicate openly and clearly about future efforts. While the Federal government plays a critical role in the development of health IT, ASCO has built significant clinical expertise and resources that are tailored for the oncology community. With the federal government’s focus on primary care and the need to serve multiple stakeholders, ASCO is concerned about programs that may inadvertently impact cancer providers adversely. We would encourage ONC to recognize programs by ASCO and other specialty societies, and to incorporate these initiatives as equal vehicles to achieving the goals laid out in the Strategic Plan.

    *****

    We are thankful for the opportunity to respond to ONC’s Federal Health Information Technology Strategic Plan (2011-2015). If you have any questions about our comments, please contact Kristen McNiff, MPH.

    Sincerely,

    Peter Paul Yu, MD
    Chair, ASCO Health Information Technology Work Group
    Director, ASCO Board of Directors

  131. May 6, 2011

    Farzad Mostashari, MD, ScM
    National Coordinator for Health Information Technology
    U.S. Department of Health and Human Services
    200 Independence Avenue S.W., Suite 729-D
    Washington, D.C. 20201

    Re: Office of the National Coordinator for Health Information Technology’s Federal Health Information Technology Strategic Plan, 2011-2015

    Dear Dr. Mostashari:

    On behalf of the member companies of the HIMSS Electronic Health Record (EHR) Association, which collectively have unparalleled experience in developing and deploying EHRs in hospitals, physicians’ practices, post-acute care organizations, and more, we offer our comments on the Office of the National Coordinator for Health Information Technology’s (ONC) Federal Health Information Technology Strategic Plan, 2011-2015. We congratulate ONC on publishing this milestone plan and for the enhancement to the nation’s healthcare system it supports. We offer the following comments on the ONC Strategic Plan in the spirit of our ongoing dialog and collaboration.

    The EHR Association fully concurs with the spirit and intent of the ONC’s Federal Health IT Strategic Plan, with the following comments and recommendations.

    The EHR Association supports the development of a nation-wide interoperable health IT system through a collaborative approach that maximizes industry expertise and domain knowledge rather than through overly prescriptive, top-down mandates. Our collective strategy should not only acknowledge and draw on federal agency initiatives, but it should build on the many initiatives that have had the advantage of private industry investment and have been successfully demonstrated in many settings in the US and abroad. The EHR Association appreciates ONC’s attempts to adopt a balanced approach between definitive guidance on standards and an environment that not only takes advantage of private industry creativity but encourages it. Clearly, there is incremental expense associated with an uncoordinated approach, but there is an even bigger price to be paid in lost opportunities by potentially stifling innovation.

    Goal I: Achieve Adoption and Information Exchange through Meaningful Use of Health IT
    The EHR Association fully supports the importance of EHRs and health IT as an essential enabler to overall improvements in the healthcare system. Healthcare transformation is inextricably dependent on broad adoption of EHRs and health IT. The full benefits of those attempts to transform the healthcare system cannot be realized with slow, uncoordinated EHR adoption.

    The Medicare and Medicaid EHR incentive funding provided by the HITECH provisions of the American Recovery and Reinvestment Act of 2009 is clearly essential to moving the nation’s healthcare providers toward the widest adoption of health IT as soon as possible. However, other issues are impeding providers’ timely adoption of EHRs – especially independent, small provider groups; small, rural hospitals; and those healthcare provider types not included in the scope of the HITECH program – including costs, system complexity, limited access to real EHR expertise, and rapid technological advancement.

    Objective A, Strategy I.A.1: Providers who are not included in the EHR incentive program face larger impediments to EHR adoption, leaving potential gaps in health information exchange (HIE) that compromise our shared objectives of connecting healthcare systems locally, regionally, and eventually nation-wide. Therefore, we recommend that ONC and CMS directly address non-incentivized providers in this strategy. Without system-wide information exchange capability, the full benefits of health IT cannot be realized for all patients.

    We also recommend that Strategy 1.A.9 on usability be accomplished in a way that does not hinder innovation nor create federal dictates for EHR interfaces or architecture, while at the same time using valid and reliable measures that take advantage of industry experience and build on lessons learned. The market is the best judge of usability, and regulations here will only hinder adoption going forward.

    Objective A, Strategy I.A.2:
    EHR software developers and their customers are significantly affected by the variety of government health IT-related regulations, including the concurrent adoption of 5010 and ICD‐10, ongoing quality reporting initiatives, etc. Therefore, we encourage ONC to collaborate actively with other federal agencies to establish a planning and coordination function to align these initiatives at a national level and, in that capacity, to more actively advocate – as the National Coordinator for Health IT – for policies that will advance the goals articulated in this Strategic Plan. Proper agency alignment and clear requirements will enable providers and other stakeholders to meet required timelines and achieve the objectives of these programs.

    As part of this coordination, we also recommend alignment of communications to providers and stakeholders that span these initiatives. Providers today are extremely challenged to find and interpret the many different communications from the various departments within HHS and related government agencies. A “one stop shop” is needed so that providers are able to fully understand the current state of these initiatives, and the timing and requirements to be successful in achieving them.

    Objective B: As we have expressed in earlier correspondence, the EHR Association has reservations about some aspects of the President’s Council of Advisors on Science and Technology (PCAST) report on health IT released in December 2010. Their assertions that the central element of a universal exchange language for healthcare information must be meta-tagged individual data elements does not reflect an understanding of the work that has been done to date by the health IT industry. The Universal Healthcare Data Exchange Language proposed in the PCAST document can be of significant benefit to healthcare delivery, but only if it is coordinated with a variety of other standards initiatives to form a well-integrated and rational approach. We suggest that the PCAST report is only one source to consider in developing a broader, integrated plan for capabilities that address the entire spectrum of healthcare information exchange requirements.

    Goal II: Improve Care, Improve Population Health, and Reduce Health Care Costs through the Use of Health IT
    We agree with the importance of health IT to increase individual and population health, improve outcomes and increase efficiency. We emphasize that the promise of EHRs and other initiatives, such as HIE as enablers to achieve the desired outcomes. We suggest ONC allow providers to implement HIT to achieve these outcomes and not try to use Meaningful Use as the vehicle to drive specific implementation of these requirements. This is consistent with the approach for the Shared Savings Program. The rule allows providers broad latitude in the use of HIT to achieve the desired outcomes.

    Goal III: Inspire Confidence and Trust in Health IT
    We encourage ONC to seek the right balance between protection and practicality so as not to hinder the development and use of health IT to achieve the best healthcare outcomes. For example, ONC should not insert itself into contracting between providers and vendors. We do agree with the balanced approach to patient safety in the plan and welcome Institute of Medicine’s (IOM) work in this area. We also encourage ONC not to encumber clinicians with managing privacy to the data element level. Instead, we suggest that privacy be managed at an appropriate level that avoids the arbitrary segmentation of patient records and the related patient safety risks (which have been documented), and gives physicians the ability to comply without disrupting the clinical workflow.

    Goal IV: Empower Individuals with Health IT to Improve their Health and the Health Care System
    Interconnectivity between personal health records (PHRs) and EHRs needs to be further explored to realize the full benefits of these systems. The balance between appropriate clinical functionality for the EHR and the benefits of PHR/EHR interaction needs to be investigated with collaboration between EHR and PHR developers, providers, policymakers, and – most importantly – consumers, being mindful of the tight timelines for Stage 2 meaningful use requirements.

    We urge ONC to focus on data collection among patients and consumers with clear examples of user experience. Such prototypes, working demonstrations, and available services will be critical to showing consumers what is available, what is possible, and how it will improve their lives.

    Goal V: Achieve Rapid Learning and Technological Advancement
    We wholeheartedly support the concept of a “learning health system” and call out the essential role of health IT in aggregating, analyzing, and leveraging data to provide patients, providers and policymakers with the information they need to make the best decisions. However, we are concerned that the current plan appears very federal government-centric, and we encourage ONC to reach out to and encourage broad private sector involvement, along with further collaboration with state and local governments.

    The EHR Association looks forward to continuing our collaboration with ONC – on behalf of our customers, their patients and our organizations – to achieve the broad adoption of health IT as a step toward accomplishing our shared objectives of better, more accessible, more efficient care delivery in the U.S.

    Sincerely,

    Carl Dvorak, Chair, EHR Association, Epic
    Charles Jarvis, Vice Chair, EHR Association, NextGen Healthcare

    HIMSS EHR Association Executive Committee
    Justin Barnes, Greenway Medical Technologies
    Pamela Chapman, eMDs
    Michele McGlynn, Siemens
    Rick Reeves, CPSI
    Jacob Reider, Allscripts Healthcare Solutions
    Mark Segal, GE Healthcare IT

  132. Association of periOperative Registered Nurses (AORN) Comments to the ONC Federal Information Technology Strategic Plan 2011-2015

    Submitted by Linda Groah MSN RN CNOR NEA-BC FAAN
    Executive Director/CEO, AORN

    The Association of periOperative Registered Nurses (AORN) welcomes the opportunity to comment on the ONC Federal Information Technology Strategic Plan 2012-2015. AORN, representing the interests of more than 160,000 perioperative nurses, provides nursing education, standards, and services that enable optimal outcomes for patients undergoing operative and other invasive procedures. AORN’s 40,000 registered nurse members facilitate the management, teaching, and practice of perioperative nursing, are enrolled in nursing education or engaged in perioperative research.

    Perioperative registered nursing is a specialized area of nursing practice. As a fundamental member of the surgical team, the perioperative registered nurse can function in the role of circulator, scrub person, or first assistant at surgery. In each of these roles, perioperative nurses work in collaboration with other members of the surgical team such as the surgeon, anesthesia provider, surgical technologist, and other assistive personnel.

    Given the nature of patient data collection, nurses are integral to proper collection of meaningful use data. As Electronic Health Records (EHRs) become more refined and integrated, nurses must be part of the leadership and decision committees to exert their influence. Our key recommendations emphasize the importance of nurse involvement in information technology and enabling nurses to bring that experience and expertise as leaders of change to advance health care. Public, private and governmental health care decision makers should include nurses at every level. The ONC Federal Information Technology Strategic Plan must recognize that nurses have a profound impact on the quality and effectiveness of health care and thus must be supported to enable their knowledge-based work as:

    · Standardizing Infrastructure within the EHR

    · Full Partners in Decision Making

    · Improving Care Coordination across Disciplines and Settings

    · Improving Quality, Safety, Efficiency and Reduce Health Disparities

    · Nurses Integral to the Improvement of EHRs

    Standardize Infrastructure within the EHR
    AORN believes that an infrastructure using standardized nursing and other health terminologies supports interoperability, aggregation, identification, use of evidenced-based practices, and development and integration of new evidence derived from clinical research. This terminology core is necessary and a prerequisite for decision support, discovery of disparities, outcomes reporting, improving performance, maintaining accurate lists of problems and medications, and the general use and re-use of information needed for quality, safety, and efficiency.

    AORN SYNTEGRITY® Standardized Perioperative Framework (SPF) data structure supports interoperability, data aggregation and the use of national standards and evidence-based practices providing a consistent and reliable documentation data model across the continuum of perioperative care. The foundation of the framework is built on the Perioperative Nursing Data Set (PNDS) language, the ANA recognized nursing terminology for perioperative nursing practice. The SPF provides the foundation for interoperability by creating a relational database built on the PNDS, a uniquely codified terminology mapped to SNOMED-CT®, that allows for nursing contributions to be linked to patient outcomes. The standardized data sets within the AORN SYNTEGRITY® Framework are associated with the PNDS terminology and cross-referenced to AORN standards and recommended practices, other health care organization standards, regulatory requirements, and accreditation criteria. Quality reporting requirements for reimbursement along with other patient safety measures, (e.g., wrong-site surgery and retained surgical items) are embedded into the end-users perioperative documentation system and clinical workflow.

    AORN supports the ONC Strategic objective to facilitate information exchange to support meaningful use of electronic health records. Future stages of meaningful use should include interoperability requirements that include perioperative nursing driven data so that patient information follows patients after discharge and informs critical decisions. Lack of integration and interoperability is a significant barrier to the adoption and use of EHRs.

    Improve Care Coordination across Disciplines and Settings
    “Meaningful use” of EHR systems should strive for nothing less than an integrated health care community, including the patient as an enabled active participant and “center of the (care delivery) universe,” where enabling technologies promote usable, efficient and seamless information flow. ONC should emphasize in the meaningful use criteria that the problem list, as well as care plans, be integrated and represent all care providers involved in collaborating with patients to optimize their health. Including information-rich, knowledge driven, and patient documentation in EHR systems that can enhance cross-continuum, interprofessional communication, thereby enabling improved safety, quality, and processes of care delivery.

    Improve Quality, Safety, Efficiency and Reduce Health Disparities
    AORN supports the electronic capture and reporting of coded patient information for purposes of care delivery, decision support, and outcomes analysis. Nurses have a profound impact on the quality and effectiveness of health care and are large contributors of the patient information contained within EHRs. Standardized clinical performance measures obtained from documentation frameworks such as, AORN SYNTEGRITY®, are adapted to consider unique complexities of the perioperative environment of care and should be collected as a byproduct of care delivery and clinician documentation. It is our belief that adaptation and further development of real-time and concurrent nursing measures to address unique attributes of care environments are needed. AORN applauds the work of the HIT Policy Committee Quality Measures Work Group in recognizing the call to include a New Pressure Ulcer Risk and Prevention Measure in their proposed Stage 3 Meaningful Use Quality Measures. AORN is also very supportive of the inclusion of a new Fall Prevention Measure in their proposed Stage 2 Meaningful Use Quality Measures. Including these two measures that evaluate the impact of nursing care demonstrates the interprofessional team needed for the highest quality health care.

    Nurses Are Integrators of Information and Full Partners in Decision Making
    Nurses must be involved with every aspect of selecting, designing, testing, and implementing information systems. EHRs must incorporate nursing’s unique body of knowledge with the nursing process at the core. Technology must represent the clinical workflow of how nurses think and work in accordance with evidence-based practice. Additionally, nurses interface with every aspect of communicating continuing care needs during patient care from admission through post-discharge across all settings. Therefore, in their role as the “central hub” of information, nurses have significant responsibility for quality and safety of patient care. When information systems are implemented in any health care setting, nurses must be involved in the decision making about usefulness, efficiency, and satisfaction with information technologies to assure that continuity of patient care is maintained.

    For health information technologies to be effective, nurses must be at the table as full partners through design, implementation, and evaluation. Nurses must be included in committees within their own organizations and be supported and encouraged to participate in state and national policy committees.

    AORN embraces the ultimate vision of the ONC Federal Information Technology Strategic Plan to enable significant and measurable improvements in population health through a transformed healthcare delivery system, enabled by the use of information technology. The future of health care will rely on this transformation, as well as on the important role of nurses’ in enabling this digital revolution.

    Contact: Linda Groah MSN RN CNOR NEA-BC FAAN
    Executive Director/CEO
    AORN
    http://www.aorn.org

    This post has been edited to remove personal information per the ONC blog policy.

  133. May 6, 2011

    Dr. David Blumenthal
    National Coordinator for Health Information Technology
    Office of the National Coordinator for Health Information Technology
    Department of Health and Human Services
    Hubert Humphrey Building
    200 Independence Avenue, SW
    Suite 729-D
    Washington, DC 20201

    Subject: Comments on the Federal Health IT Strategic Plan: 2011 – 2015

    Dear Dr. Blumenthal:

    Please find attached comments prepared by the National Indian Health Board (NIHB) in response to the request for comments on the draft Federal Health IT Strategic Plan: 2011 – 2015 (Strategic Plan).

    As stated in the Strategic Plan, the overall mission for the Federal health information technology (IT) effort is “to improve health and health care for all Americans through the use of information and technology.” The Strategic Plan goes on to indicate that one of the guiding principles of the Strategic Plan is that “the government will endeavor to assure that underserved and at-risk individuals enjoy these benefits to the extent as all other citizens.” NIHB is providing these comments in an effort to ensure that this guiding principle is applied to American Indian and Alaska Native communities and the providers that predominantly serve them, and American Indians and Alaska Natives are fully and effectively incorporated into this mission. Established nearly 40 years ago, NIHB is an inter-Tribal organization that advocates on behalf of Tribal governments for the provision of quality health care to all American Indians and Alaska Natives.

    The comments provided here are largely focused on Goal 1 of the Strategic Plan: Achieve adoption and information exchange through meaningful use of health IT. NIHB’s primary focus at this stage is to ensure that all Indian Health System providers (inclusive of the Indian Health Service, Tribes and tribal organizations, as well as urban Indian organizations) are able to adopt appropriate health information technology.

    NIHB offers the following comments and recommended modifications to the Strategic Plan –

    1. In the Strategic Plan, there is no reference to the need and responsibility of the Office of the National Coordinator for Health Information Technology to engage in Tribal consultation. As called for under Presidential Executive Order 13175, “Consultation and Coordination with Indian tribal Governments”, as well as under HHS tribal consultation policies, agencies of the Federal government are to consult with Tribes when establishing and implementing Federal policies and programs.

    2. On page 57 of the Strategic Plan, it states that the “Indian Health Service (IHS) is responsible for providing federal health services to American Indians and Alaska Natives.” IHS does have this responsibility, but not solely. IHS, Tribes and tribal organizations, along with urban Indian organizations, share the primary responsibility for providing health care services to American Indians and Alaska Natives. The following table indicates the types and number of facilities operated by IHS and Tribes/tribal organizations.

    3. Following from the identification of IHS as the (sole) organization responsible for providing health services to American Indians and Alaska Natives, the Strategic Plan does not include recognition of the need to address implementation concerns of other providers in Indian Country. NIHB recommends that the Strategic Plan be modified to indicate the intention of the Office of the National Coordinator for Health Information Technology (ONC) to undertake additional initiatives targeted to enhance implementation of health IT in Indian Country.

    4. The goals of the Strategic Plan, particularly Goal 1, may be frustrated because of the related issue of the potential overly restrictive application by the Centers for Medicare and Medicaid Services (CMS) of the definition of FQHC as it pertains to the calculation of Medicaid meaningful use incentive payments established under § 4201 of the American Recovery and Reinvestment Act of 2009 (ARRA). An analysis prepared by the Tribal Technical Advisory Group to CMS (TTAG) is attached that presents the concerns of Indian Country on this matter. If not rectified, there may be inadequate resources available for some Indian providers to adopt health IT systems.

    5. Health information exchange (HIE) in tribal areas will require specific attention to three major factors:

    a. The current status of broadband connectivity infrastructure existing in remote tribal communities and their technical capabilities to meet all health information exchange requirements.

    b. The lack of agreements with tribal patients and/or tribal governments permitting exchange of their personal health information through established health information exchange resources – e.g. National Health Information Network (NHIN) Exchange. Data exchange agreements may need to be established with tribal governments.

    c. The capability to transfer health information to entities such as pharmacies may pose unique challenges for small, remote tribal health care facilities.

    6. The Strategic Plan references only the RPMS (Resource and Patient Management System) as a health IT system serving American Indians and Alaska Natives. In fact, many Tribes run other systems and, as such, require assistance beyond the RPMS to establish meaningful use for adopted electronic health record systems.

    7. The establishment of a liaison in the ONC to interface with Tribes and tribal organizations would be beneficial to advancing the adoption of health IT in tribal areas.

    8. NIHB recommends establishing a “Tribal Health IT Outreach and Education staff” within the ONC to provide ongoing training/outreach to tribal communities across the United States. Successful implementation and use of health IT in tribal communities is dependent not only on the technical use of health IT by providers but also dependent on the understanding by patients of the bottom-line benefits of health IT.

    9. The original budget proposal by NIHB to support electronic health record adoption and use by providers in tribal communities across thirty-five states was $30 million based on IT infrastructure, outreach and education support, and other assistance needed by Tribes and tribal organizations. Subsequently, NIHB was awarded an ONC grant of approximately $16 million to establish a regional extension center (REC) to serve tribal communities nationwide. NIHB has established a REC service delivery structure and plans to make positive contributions to the adoption and use of EHRs in tribal communities. However, with only slightly more than 50% of the original funding request granted, communities with our nation’s highest health disparities may very well remain underserved.

    10. There are thirty-six Tribal Colleges and Universities (TCUs) across the U.S. that enroll students from over 250 federally recognized Tribes. However, not a single TCU received an ONC grant to participate in the “Community College Consortia to Educate Health Information Technology Professionals Program.” NIHB recommends that all TCUs be provided a new opportunity to submit a grant application to this critical national health IT workforce program.

    11. NIHB recommends that the education and outreach strategy that is being developed by ONC, CMS, and the Office for Civil Rights (OCR) that is referenced on pages 13-14 include specific components targeting the nation’s American Indian and Alaska Native population. The uniqueness of the Indian Health System and the remote, geographic distribution of American Indians and Alaska Natives require culturally-appropriate education and outreach strategies to effectively reach these populations.

    12. NIHB recommends the inclusion of tribal consultation and proactive outreach to ensure that tribal communities are adequately served by the USDA’s Broadband Technologies Opportunities Program (BTOP) and the Department of Commerce’s Broadband Initiatives Program (BIP). As noted in the Strategic Plan, these Federal agencies are collectively funded with over $4 billion through ARRA to support broadband grants around the country, and tribal communities are among the highest need areas for these grant funds.

    13. Significant health disparities exist within the nation’s American Indian and Alaska Native populations. NIHB recommends that ONC’s “Practice Consortium Policy” limiting the number of providers permitted to sign up in a single facility (group practice) to 10 providers be waived for health care facilities in the Indian Health System. The large geographic areas and remote patient populations served by these facilities support the inclusion of all providers in these facilities to be eligible to receive REC grant credits. REC funding is tied directly to provider grant credits to support technical assistance to providers who serve underserved communities and resource-poor settings, including small practice settings, rural hospitals/clinics, community health centers, and Critical Access Hospitals.

    14. NIHB recommends the inclusion of tribal communities in ONC’s Beacon Community Program. Currently, NIHB is not aware of any tribal community being a Beacon Community Grantee. These grantee communities are serving as test sites for the use of health IT for purposes of addressing critical health disparities.

    15. Given the sovereign status of tribal governments, NIHB recommends that ONC assist State HIE grantees to develop best practices to electronically exchange health information with Tribes and tribal organizations.

    16. NIHB recommends that ONC affirmatively state that it will engage in tribal consultation on matters such as ensuring the protection of privacy and security of health information of American Indians and Alaska Natives, achieving administrative efficiencies in order to reduce costs for providers and payers, and during the creation of a “learning health system” that can aggregate, analyze, and leverage health information to improve knowledge about health care across populations.

    Thank you in advance for consideration of these recommendations as we jointly work to advance the health status of American Indian and Alaska Native individuals and communities across the United States.

    Sincerely,

    Cathy Abramson
    Chairman, National Indian Health Board

    Cc: Valerie Davidson, Chair, Tribal Technical Advisory Group to CMS
    Stacy Bohlen, Executive Director, NIHB
    Jennifer Cooper, Legislative Director, NIHB

    Attachment: Tribal Technical Advisory Group to CMS, Determination of Patient Volume in Tribal and Urban Indian Health Programs for Meaningful Use Incentives
    (Find March 24, 2011 TTAG letter here: http://www.cmsttag.org/letters.html)

  134. May 6, 2011

    Farzad Mostashari, M.D., ScM.
    Office of the National Coordinator for Health Information Technology
    U.S. Department of Health and Human Services
    200 Independence Avenue, S.W.
    Washington, D.C. 20201

    Re: Office of the National Coordinator for Health Information Technology, Federal Health Information Technology “Strategic Plan” 2011-2015

    Dear Dr. Mostashari,

    Planned Parenthood Federation of America (Planned Parenthood or PPFA) is pleased to submit these comments on the Federal Health Information Technology Strategic Plan 2011-2015 (“Federal HIT Strategic Plan”), published on March 25th, 2011. Planned Parenthood understands the utility of health information technology (HIT) and electronic health records (EHRs) to enhance health care delivery and improve patient health outcomes. Accordingly, we commend the efforts made by the Office of the National Coordinator for Health Information Technology (ONC) to develop a comprehensive, detailed account of the goals, objectives and direction of the Federal HIT Strategic Plan.

    Planned Parenthood is a national not-for-profit organization that provides support services to 84 separately incorporated affiliates that operate more than 800 reproductive health care centers in 49 states. Each year, Planned Parenthood affiliate health centers provide reproductive health care including routine gynecological exams, breast and cervical cancer screenings, contraceptive services, and sexually transmitted infection testing and treatment to more than three million patients, the vast majority of whom have incomes at or below 150 percent of the Federal Poverty Level.

    As the nation’s largest provider of confidential reproductive health care to low-income and medically underserved women, Planned Parenthood recognizes that HIT and health information exchange (HIE) can provide significant health benefits for our overall patient population. While we applaud the new programs and HIT initiatives described within the Federal HIT Strategic Plan, we are concerned that it does not take into account the vital role that safety-net providers (other than Federally Qualified Health Centers (FQHCs)) play in our nation’s health care system. Further, to ensure that Planned Parenthood patients are fully protected in their use of HIT and within HIE, we implore ONC to broaden the scope of its efforts around sensitive services to encompass reproductive health care. Accordingly, we respectfully request that ONC incorporate the following recommendations in to the final Federal HIT Strategic Plan.

    SPECIFIC RECOMMENDATIONS

    1. ONC should increase the percentage of safety-net providers that receive funding to support the purchase and meaningful use of electronic health records.

    ONC’s Federal HIT Strategic Plan appropriately acknowledges a limitation in the HITECH Act which prevents many health care providers from being able to participate in the Medicare and Medicaid EHR Incentive programs. While we are pleased that ONC attempts to address this limitation by proposing the alignment of federal programs and services with the adoption and meaningful use of certified EHR technology (see Strategy I.A.7), we remain concerned that many safety-net providers who predominately serve low-income and uninsured individuals will be left out once again. To ensure that our nation’s most vulnerable individuals are able to benefit from the promise of EHRs, it is essential that ONC’s Federal HIT Strategic Plan recognize and support the vital role of the broader safety-net, not just that of FQHCs and rural health centers.

    For example, Title X women’s health centers serve over five million low-income individuals at more than 4,500 health centers located nationwide each year with comprehensive family planning services as well as a wide range of other preventive health care, including breast and cervical cancer screenings and sexually-transmitted infections-related services. Eighty-four percent of Title X clients have incomes below 150% of the federal poverty level, and sixty-one percent are uninsured. Given that current Medicaid eligibility levels are so low in many states, it will be difficult for many of the providers working in women’s health centers to meet the required Medicaid patient threshold to qualify for the Medicaid EHR incentive funding, despite the fact that they provide a large percentage of uncompensated care or care on a sliding fee scale.

    More than 6 in 10 patients who receive care at women’s health centers like those operated by Planned Parenthood affiliates consider it their primary source of health care[1], making these health centers a critical entry point into the health care system for millions of individuals. Unfortunately, despite the essential role women’s health centers play in serving our nation’s most vulnerable individuals, women’s health centers have not received the type of investment and infrastructure support as FQHCs and rural health centers to purchase and implement HIT and EHRs.

    Therefore, we respectfully request that ONC’s Federal HIT Strategic Plan acknowledge women’s health centers, as well as the broader safety-net, in Strategy 1.A.7 and throughout the rest of the Strategic Plan as appropriate, and incorporate strategies that encourage the adoption and meaningful use of EHRs for those providers. Specifically, public health programs that support women’s health centers, including Title X (our nation’s family planning program) and the Title V Maternal and Child Health program, among others, need additional federal funding that can be used to help providers purchase and use HIT systems and EHRs. In addition, to encourage more providers to participate in the Medicaid EHR incentive program, ONC should support legislative changes that make it easier for safety-net providers to qualify for the incentive funding.

    2. ONC should develop tools that protect the privacy and security of reproductive health information.

    Planned Parenthood applauds ONC for examining broader privacy and security policies that will establish trust in HIE. We recognize that ONC has made an effort to develop measures that protect sensitive behavioral health information and applaud their work with the Substance Abuse and Mental Health Services Administration (SAHMSA) to address the protection of information related to alcohol and/or drug use. We encourage ONC, however, to also address and dedicate resources to the privacy and security of reproductive health information. Reproductive health care requires heightened awareness and protection of individual privacy preferences to ensure that sensitive information such as family planning choices, STI treatment and HIV status is protected. ONC has stated that the data segmentation and consent management tools that are currently in development “will be broadly applicable, but particularly useful in the context of exchanging behavioral health information.” [2] Broadly applicable tools may not take into account the sensitivity, complexity and unique privacy and security concerns of reproductive health information, which are often highly individual and context-specific. Service specifications and reference models that can segment personal, electronic health care records into sensitive parts, so that only parts with appropriate authorization are shared, will be invaluable to reproductive health care providers nationwide. As a result, Planned Parenthood asks that ONC take reproductive health into consideration when designing and deploying tools that increase the privacy and security of sensitive health information.

    3. ONC should develop Meaningful Use and Quality Improvement program requirements that facilitate patient engagement by all patient populations, including underserved populations and populations with heightened privacy and security needs.

    The Federal HIT Strategic Plan recognizes the importance of patient-centered care and of empowering individuals to participate in and improve their health and the health care system through the use of consumer HIT. Planned Parenthood fully appreciates the value of and supports ONC’s efforts to promote the engagement of patients in their health care. We also recognize that a number of factors may influence a patient’s willingness to utilize consumer HIT as a means of more fully participating in their own care. These factors include, but are not limited to, access to appropriate technology and heightened concerns about the privacy and security of patient-generated insights and device-generated data in the context of sensitive care such as reproductive health care. While Planned Parenthood agrees that providers should be encouraged to solicit their patients’ participation in their own health care, we caution ONC to be mindful of the unique concerns of vulnerable patient populations when designing Meaningful Use objectives / measures and Quality Improvement program requirements. In particular, when designing objectives, measures and requirements that are tied to the integration of patient-generated health information into EHRs and Quality Improvement programs, ONC must be mindful not to penalize providers whose patients do not have the means to utilize consumer HIT or who are not comfortable using consumer HIT to record and distribute sensitive insights and data. In order to fully realize the NwHIN, ONC must ensure that all providers are able to successfully deploy and meaningfully use HIT and that patients preferences for participation in the use of consumer HIT are taken into account.

    Thank you for the opportunity to comment on the Federal Health Information Technology Strategic Plan 2011-2015. If you have any questions, please do not hesitate to contact me at 212-261-4709.

    [1] Gold, R.B. et al., Next Steps for America’s Family Planning Program: Leveraging the Potential of Medicaid and Title X in an Evolving Health Care System, Guttmacher Institute, 2009.
    [2] Federal Health IT Strategic Plan, Public Comment Period, Goal III, Objective A, Strategy III.A.3 page 32

    Respectfully submitted,

    Eileen Twiggs
    National Director, Information Systems & Strategy
    Planned Parenthood Federation of America

  135. Eva Powell says:

    The National Partnership for Women & Families would like to lend its strong support for this Strategic Plan and its five specific goals in particular. We support ONC’s vision of a health system that uses information to empower individuals and to improve the health of the population, and we want to focus our comments on Goal 4: “Empower Individuals with Health IT to Improve their Health and the Health Care System.” This is not only a critical priority in its own right, but its pursuit will go a long way toward achievement of some of the other Strategic Goals. (E.g., “Improve Care, Improve Population Health, and Reduce Health Care Costs through the Use of Health IT,” and “Inspire Confidence and Trust in Health IT,”

    Specifically, we appreciate ONC’s recognition that consumers, because they are directly affected by health care and health IT policies, must play an active role in the policy-making process. Consumers increasingly are understood to be the most significant untapped resource in health care, and we are eager to be partners in advancing implementation and use of technology to allow individuals to participate more actively in matters of their health.

    Consumers’ access to their own health information absolutely drives and enables them to take greater control of and responsibility for their health and health care. We appreciate ONC’s emphasis on access to information as a key lever to individual empowerment. We are working with numerous and varied stakeholders to ensure that Stage 2 Meaningful Use contains robust patient engagement criteria that support this, as well as supporting complementary initiatives such as the Blue Button download capability.

    We want to stress that individual empowerment is not just about access to information, but use of that information. Providers play a role in both using health information in meaningful ways to improve patient care, and in informing their patients about how they can use their own health data. Consumers bear responsibility, too, for being active participants in their own health. Consumers that have access to and are engaged with their health data are better equipped to take an active role in their health, working collaboratively as:
    o Agents of change;
    o Informed decision-makers;
    o Sources of verification and contextual information; and
    o Decision-makers about how best to integrate better health into the context of their lives.

    Finally, we want to voice our strong support for ONC’s efforts to align various federal programs toward fostering individual and caregiver access while protecting privacy and security. These dual aims will go a long way toward fostering consumer confidence and trust necessary for greater patient engagement in health and care. Consumers are enthusiastic about the benefits health IT will afford them, and we are eager to work actively to implement health IT in ways that result in better care, healthier communities and greater affordability.

  136. VitalSpring Technologies (VST) is the first enterprise technology company to deliver business intelligence solutions that enable large, self-insured corporations government agencies, payers, hospitals and providers to better manage and control healthcare costs and quality. VitalSpring is the only enterprise technology platform that is able to link data from every part of the healthcare supply chain from employer to the provider and everything in between. VitalSpring is the first company to provide a single platform through its connectors and analytical engine that is able to pull data beginning with the employer as it pertains to benefits all the way to clinical data in the doctor’s office. As such, VST is directly involved with the developing employer strategies related to managing the costs of healthcare while improving the quality of health for their workers. It is with the employers’ voices that we submit these comments.

    COMMENTS:

    Overall the Federal Health IT Strategic Plan is very aggressive considering the current status of health IT development and implementation across the country as well as health IT infrastructure at different levels of government. The federal government is outlaying significant amounts of financial and oversight resources to help states prepare local government and providers to embrace and apply health IT across the continuum of the healthcare system – patient, provider, employer, payer and other stakeholders.

    The time horizon for achieving the goals of the Plan extends to 2015; and arguably four years is not enough time, yet specific strategies within each goal are certainly attainable. For instance, Goal IV (Empower individuals through health IT to improve their health and the healthcare system) is being achieved today by CMS, VA and DoD through the Blue Button initiative are providing Medicare beneficiaries and Veterans access to personal health records/information.

    SPECIFIC COMMENTS

    Page 22 Goal II
    G-II: Improve care, improve population health, and reduce healthcare costs through the use of health IT

    Part of the challenge is to effectively demonstrate the “value added” of powerful analytics with which physicians and other healthcare providers can measure the effects of care against benchmark data. Goal II of the Federal Health Information Technology Strategic Plan is but one of the goals that VST can provide support to HHS through the VST channels of collaboration with large self-insured employer groups, already formed to address these specific concerns. VST stands ready to facilitate the communication with this group.

    It is readily apparent to VST that achieving the goals of the Accountable Care Organizations will require use of sophisticated business intelligence that is capable of analyzing financial claims and clinical data and generating risk-adjusted reports and models of care. Again, VST is prepared to illustrate the necessary capabilities for ACO success through demonstration and dialogue with ONC.

    Moreover, if HHS is looking for early wins/outcomes to fast track adoption of health IT that facilitates Goal II attainment- it would be helpful to institute a health IT purchase collaborative. The software models manufactured by the companies on the collaborative would come with certification signaling that they have meet or exceed the standards for interoperability and other such standards that are required by regulation or law.

    Page 26 Strategy II.C.1 – Line 11-26
    This time line is not likely flexible, which suggest that mistakes will be made and before public or private payers adopt these solutions, careful consideration and assessment of value is warranted.

    Page 37 Goal IV – Line 14-17
    G-IV: Empower individuals through health IT to improve their health and the healthcare system (VST product offering – Affynyty)

    VST certainly agrees with this assessment of the need for government to intervene and encourage more Americans to utilize PHRs and other consumer-facing focused health IT. Part of the strategies to spur use of PHRs could incorporate use of incentives. Again “value added” demonstration will be necessary for more individuals to take advantage of PHRs. A PHR capable of providing community-based coordination of care should be considered. To reach the full potential of implementation, PHRs will, of necessity require full compliance with HIPAA regulations. There were recommendations during the PHR public comment period that should be considered to fully meet Goal IV.

    VST agrees with CHIME’s comments pertaining to standardization of privacy rules at the federal level apply to all health information exchanges. In addition VST recognizes that changes to HIPPA policy is facilitating geographic variation in privacy rules and complicates compliance and makes it more costly to build and leverage regional HIEs and PHRs.

  137. Alan Spitzer says:

    Dr. Farzad Mostashari
    National Coordinator for Health Information Technology
    Submitted electronically

    Re: ONC Federal Health Information Technology Strategic Plan 2011 – 2015

    Dear Dr. Mostashari:

    Pediatrix Medical Group, Inc. (“Pediatrix”) is pleased to submit comments on the Office of the National Coordinator for Health Information Technology (“ONC”) Federal Health Information Technology Strategic Plan 2011-2015. We support ONC in its efforts to establish strategic goals aimed at transforming our nation’s healthcare infrastructure. We believe that health IT is essential in moving our healthcare system into the future, and we are pleased to be working toward the same goals outlined by ONC in the work that we do at Pediatrix.

    Pediatrix is a national group practice of more than 1,350 physicians that include more than 940 neonatologists, 100 pediatric cardiologists, 120 pediatric intensivists and pediatric hospitalists, and 170 maternal-fetal medicine specialists and obstetric hospitalists who provide primary care services for patients with high-risk pregnancies and premature births. Our physicians and nurses care for more than 20 percent of the patients in neonatal intensive care units in the United States.

    Pediatrix supports the goals outlined by ONC, and we believe that the strategic goal to “improve care, improve population health, and reduce healthcare costs through the use of health IT,” is especially important. In our eyes, this strategic goal is the central aim of the Strategic Plan and the key to ensuring that technology is utilized in ways that help improve patient care while reducing costs. As ONC moves forward with its health IT efforts, we urge you to consider not only the largest provider and patient populations, but also providers who serve as the primary point of care for smaller patient demographics. Pediatrix believes that efforts to improve health at the earliest stages in life have substantial benefits for improved health outcomes throughout the lifespan of the patient.

    Strategy II.B.1 proposes the identification of specific quality measures that align with the National Health Care Quality Strategy and Plan. We would like to take this opportunity to urge the ONC to think broadly about quality measures and to be sure to include specialty and subspecialty outcome measurements as well. While general health measures are of great importance to many patients and providers – some of the most concrete, measurable and significant outcome improvements have already been demonstrated for smaller patient populations. These efforts serve as outstanding examples of how data collection and intervention by providers servicing smaller patient populations can dramatically alter not only the nature of disease, but also the outcomes from those diseases. An excellent example in this regard is the work by Peter Pronovost at Johns Hopkins University Hospital, where the use of checklists in intensive care dramatically reduced infection rates in adult intensive care units in that institution. (Pronovost P and Vohr E. Safe Patients, Safe Hospitals, Hudson Street Press, New York, NY, 2010) Subsequently, work has been performed in other adult groups and pediatric populations with similarly dramatic improvements in reduction in rates of hospital-based infections. (Miller MR, Griswold M, Harris JM 2nd, et al. Decreasing PICU catheter-associated bloodstream infections: NACHRI’s quality transformations efforts. Pediatrics 2010; 125: 206-213) Furthermore, there is accumulating evidence in Neonatal-Perinatal Medicine that similar types of efforts involving EHRs yield valuable improvements in outcomes that may exceed the value of adult interventions. (Spitzer AR, Ellsbury DL, Handler D, Clark RH. The Pediatrix BabySteps—Data Warehouse and the Pediatrix QualitySteps Improvement ProjectSystem—Tools for ‘‘Meaningful Use’’ in Continuous Quality Improvement. Clinics in Perinatology 2010; 37: 49-70)

    Thoughtful selection of clinical and outcome measures in the field of Neonatal Medicine will affect not only critically ill babies, but healthy newborns as well. The measures to be considered can have high-level effects not only upon an infant’s health, but on the potential long-term health care cost savings to society. For example, meaningful value can be derived from the simple determination of whether infants are started on breast feeding shortly after birth and whether breast feeding has been continued beyond the first month of life. The value of breast feeding, both in the term and pre-term population of infants, has been well established in the medical literature. Not only is the nutritional value of breast milk optimal, but it offers infants added immune protection from infection and it reduces the risk of both childhood and adult obesity, as well as adult-onset heart disease. (Spitzer AR, Ellsbury DL, Handler D, Clark RH. The Pediatrix BabySteps—Data Warehouse and the Pediatrix QualitySteps Improvement ProjectSystem—Tools for ‘‘Meaningful Use’’ in Continuous Quality Improvement. Clinics in Perinatology 2010; 37: 49-70; Parikh NI, Hwang SJ, Ingelsson E, et al. Breastfeeding in infancy and adult cardiovascular risk factors. Am. J. Med. 2009; 122: 656-663) In the mother who nurses her infant, breast feeding appears to reduce the potential for breast and uterine cancer. (Stuebe AM, Willett WC, Xue F, Michels KB; Lactation and incidence of premenopausal breast cancer. Arch. Int. Med. 2009; 169: 1364-1371; Okamura C, Tsubono Y, Ito K, et al. Lactation and risk of endometrial cancer in Japan: a case-control study. Tohoku J Exp. Med. 2006; 208: 109-115; Jordan SJ, Siskind V, Green A, et al. Breastfeeding and risk of epithelial ovarian cancer. Cancer Causes Control 2010; 21: 109-116) These broad-based outcome results are the consequence of interventions early in life: when measures are defined and examined at this stage of life, the spread of favorable outcomes is often markedly enhanced because of the operative duration of the effect. Other quality measures in newborn/infant care that might also be of similar long-term benefit include adherence to current immunization schedules (even in the hospitalized pre-term infant) and assessment of appropriate infant growth rates.

    Quality measures should correlate directly with improved patient outcomes. While much work has been done in compiling quality measures that meet these goals for the general population, further work with smaller patient populations, particularly neonates, infants and children, can provide measureable outcomes that will greatly enhance progress in this area. For these reasons, we believe that ONC should enhance its focus on quality measures that affect smaller patient populations that have the potential for significant cost savings over the course of a lifetime. We also believe that these measures should be incorporated in future stages of meaningful use as they not only improve patient outcomes for the specific populations, but, as the breast feeding example above demonstrates, they have effects that reach beyond specific populations to improve health throughout the general population.

    Because of the inherent value of outcome evaluation during the early stages of life, we would strongly urge ONC to give additional consideration to measures in the field of newborn medicine, as it begins to identify measures that will help enhance patient care over the next five years. While many outcome measures can be developed for the general practice of medicine, few areas of intervention are likely to have as extensive and long-lived an impact as those affecting the newborn infant.

    In addition to supporting the increased use of quality measures for smaller patient populations, Pediatrix also supports Strategy II.D.3, which is to “ensure a mechanism for information exchange in support of research and the translation of research findings back into clinical practice.” As with the increased use of quality measures, a strong quality feedback loop allows practitioners to improve patient care based on past patient experiences and outcomes. This functionality is vital to any successful EHR system. For example, Pediatrix utilizes a quality feedback loop in its own EHR, called BabySteps. One of the significant successes we have accomplished with BabySteps involves using EHR data to provide data back to providers in order to help them improve patient care. Data about patients that is entered into BabySteps helps improve care in two ways. First, the data is de-identified and added to into our Clinical Data Warehouse, which is used collaboratively by clinicians and academicians for research on improving patient outcomes. The Clinical Data Warehouse is widely recognized as one of the most important tools for population outcome studies of critically ill neonates in this country. Second, BabySteps reports provide clinicians with continuously updated measures of their work,. These data allows individual clinicians and hospitals to focus improvement efforts locally, based upon the demonstrated needs of their patients as seen in the Data Warehouse. These two feedback loops demonstrate how collecting health data is only the first step in reaching the goals of health IT. We must ensure that health data is put to beneficial use by making sure that once patient data is collected, that data is subsequently used both to improve health outcomes for individual patients and also, in combination with other data, to improve health outcomes for broader patient population groups.

    Another important aspect of Pediatrix’s Clinical Data Warehouse’s functionality is the ability to track important health care practices such as medication use. Monitoring changes in practice allows us to offer educational feedback to change and enhance the practices of providers. Two examples are decreased utilization of cephalosporins and shorten time on antibiotics. (Clark RH, Bloom, BT, Spitzer, AR, and Gerstmann, DR. Reported medication use in the neonatal intensive care unit: data from a large national data set. Pediatrics. 2006; 117:1979-1987; Clark RH, Bloom, BT, Spitzer, AR, and Gerstmann, DR. Empiric Use of Ampicillin and Cefotaxime, Compared With Ampicillin and Gentamicin, for Neonates at Risk for Sepsis Is Associated With an Increased Risk of Neonatal Death. Pediatrics. 2006; 117:67-74. Clark RH, Ursprung, RL, Walker, MW, Ellsbury, DL, and Spitzer, AR. The changing pattern of inhaled nitric oxide use in the neonatal intensive care unit. J Perinatol. 2010; 30:800-804) Pediatrix has shared these types of data with the Food & Drug Administration (“FDA”) to help promote pharmacovigilance. (Medication Use in the NICU” FDA/NIH conference on Scientific Issues in Implementing Best Pharmaceuticals for Children Act (BPCA), Washington, DC; Nov. 9, 2004)

    Another great benefit of health IT, which ONC has captured in Goal IV, is its ability to empower individuals to improve their own health. We believe that health IT must engage patients and involve them in their own care. The BabySteps system allows our providers to create a discharge summary at the time of discharge. This discharge summary can either be given to the parents on the day of discharge or mailed to them within 24 hours if they prefer. An additional copy can be sent to the physician identified by the family as the subsequent care provider, thus insuring continuity of care for this high-risk population. We believe that providing a timely discharge summary is necessary as it not only gives the patient direction and information important to the patient’s continued care, but also gives any other providers that may see the patient after discharge relevant information necessary for proper care. We support this goal, and we support ONC’s efforts to begin to implement patient empowerment, such as by requiring timely discharge summaries in order to qualify for meaningful use incentive funds.

    One of the themes running throughout the Strategic Plan is that health IT investments will be successful only if the healthcare community is able to turn data into useful information. Not all health IT uses and not all EHRs are created equally. Some systems actually present barriers to quality and value improvements. As we move our healthcare infrastructure into the future, we believe that ONC should keep an eye towards the ultimate goals of improved outcomes and reduced costs. Merely having more data does not help sick patients. As we have tried to do with our own providers and our BabySteps system, we urge ONC to keep looking for ways to utilize health IT to drive quality and value in our healthcare system. We appreciate the work ONC has done to date, and we look forward to working with ONC and others on these important issues in the future.

    Pediatrix appreciates the opportunity to provide comment, and we are available to answer any questions related to these issues by contacting me.

    Sincerely,

    Alan R. Spitzer, M.D.
    Senior Vice President for Research, Education, and Quality
    Pediatrix Medical Group, Inc.

    This post has been edited to remove personal information per the ONC blog policy.

  138. May 6, 2011

    Honorable Farzad Mostashari, MD
    National Coordinator for Health Information Technology
    Department of Health and Human Services

    Dear Dr. Mostashari:

    On behalf of the National Association of Home Care and Hospice (NAHC) and the Home Care Technology Association of America (HCTAA), we are writing to request your consideration of our comments on the 2011- 2015 Federal Health Information Technology Strategic Plan. We appreciate the opportunity to provide our comments to the ONC as it continues its process of refining its vision and mission to develop and execute a federal health IT strategy that achieves a nationwide adoption of EHRs and widespread health information exchange.

    BACKGROUND:
    The Home Care Technology Association of America (HCTAA) is a wholly-owned affiliate of the National Association for Home Care & Hospice (NAHC), and is organized to advance the accessibility and use of technology in home care and hospice settings. HCTAA was established to unite the home care technology industry into a stronger, more effective voice to Congress, the Administration, state legislatures, the home care industry, consumers, and the media. HCTAA believes that home care and hospice providers that are properly equipped with technological solutions will serve a central role in the delivery of healthcare by ensuring quality, efficiency, and patient care coordination.

    Home care, including hospice, is a significant component of the health care delivery system. There are 33,000 home care providers delivering care to approximately 12 million individuals each year because of acute illness, long-term health conditions, permanent disability, or terminal illness. In 2009, annual expenditures for home care were projected to be $72.2 billion. In most cases, the delivery of quality home care services is very dependent upon the collaboration and exchange of health information among various health care providers across the continuum of care.