Health IT Certification Programs Proposed
Today the Department of Health and Human Services released a Notice of Proposed Rulemaking for the Establishment of Certification Programs for Health Information Technology (Health IT). The rule first proposes the creation of a temporary certification program for Electronic Health Records (EHRs) and EHR modules. This serves as a bridge to the second, permanent certification proposal, which establishes detailed guidelines to support an ongoing program of testing and certification of health IT. The meaningful use of certified EHR technology is a requirement for qualifying for incentive payments under the Medicare and Medicaid EHR Incentives program. The temporary program therefore is critical as it assures the availability of Certified EHR Technology prior to the date on which health care providers may begin demonstrating meaningful use.
While we are making significant strides toward modernizing our health care system, these efforts will only succeed if providers and patients are confident that their health information systems are safe, secure, and meet standard functionality requirements. Certification isn’t just about meaningful use; at its core, it is about providing assurances to patients and providers that EHR technology can deliver the benefits of improved quality of care and protect personal health information.
Significant stakeholder feedback was taken into account as we developed these rules, including formal recommendations from the HIT Policy Committee (a Federal Advisory Committee), but your input on the proposed rule is critical to this process. I hope that you will provide formal feedback at http://www.regulations.gov during the public comment period.
Certification of HIT programs is another critical step in the path to achieving the vision of the HITECH Act and we appreciate your engagement in the process. In addition to your formal comments, we hope you will use this blog as a forum for a lively discussion about certification and its role in achieving meaningful use.
– David Blumenthal, M.D., M.P.P. – National Coordinator for Health Information Technology
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OK, I can’t believe I’m typing this, but I am.
As anybody that reads things I write, or listens to things I say, knows, I had lots of issues with the way CCHIT operated in the past and the effects it had on the EHR industry. However, currently CCHIT has a complete certification infrastructure in place ready to service both comprehensive EHRs and EHR modules immediately. No other organization is even remotely close to such capabilities.
I do believe your long term accreditation plan is good and much needed.
However, I would like to suggest that the entire temporary certification program needs to be scratched and that CCHIT be awarded ONC-ATCB status so certification processes can begin now. I don’t really see the value of engaging in a formal lengthy process just to create temporary bodies of certification. I also don’t see how submitting a bunch of forms and documentation to ONC and taking a quiz can provide assurance to both vendors and physicians that these newly accredited temporary bodies really know what they are doing, considering they have never tested an EHR before.
I believe ONC is underestimating the complexity of certification and the infrastructure required for a successful program, even a temporary one. Please remember that if all goes well, there will be a tremendous wave of adoption in the coming year and it will all be done under temporary certification bodies. In order to sustain future expansion of HIT, it is imperative that physicians have a good experience in 2010-2011.
I can easily envision horror stories, particularly regarding EHR modules, created by small underfunded vendors, getting temporary certification and providing nothing but disappointment and financial loss to customers.
In the engineering world, reinventing the wheel is not considered a worthy endeavor. CCHIT is there. It is experienced. It is up to date in it’s infrastructure and readiness. It has created a pared down ARRA certification and kept up with all ONC/CMS changes.
So why not let CCHIT start working on a temporary basis, while ONC begins the long term accreditation process for all applicants? Wouldn’t it serve the market and all our goals better?
It’s the simplest, cheapest, fastest and least risky solution and it’s the right thing to do.
the information is really well-written.
The certification process might want to consider a “certification with contingencies” approach, similar to JCAHO, in order move quickly.
See full discussion here: http://www.ehrbloggers.com/2010/03/rules-for-designating-ehr-certification.html
Certification is definitely a requirement for delivering safe and effective technology for physicians and patients. However, certification by itself is not enough. Certification allows experts to test features of the software that physicians and patients can’t verify for themselves: does it meet privacy and security requirements? Is the database robust and scalable? Can the query engine run without crashing the system?
But certification does a poor job of answering the following questions: Does the software improve provider efficiency? Does it help providers increase patient safety (not theoretically, but actually)? Is the software easy to use –in daily use and for population based care? In Canada, we have had the ironic situation where an EMR passed certification, but could not deliver the functionality in the clinical setting. When we complained to the certification authority, they took the allegation seriously, but after re-testing came back and told us that the software pass certification and there was nothing they could do. A real tragedy, since physicians had purchased that software on the basis that it could deliver functionality in the clinical setting, not a laboratory setting.
That particular type of issue can be picked up by a ‘consumers guide’ type of service, since it is an egregious violation of a clinical expectation. However, consumers guides (like KLAS) have a more difficult time quantifying meaningful use type of functionality, since meaningful use is not simply a function of a software, but also a function of workflow, business process and clinical intent.
I think it would be valuable to physicians and patients to know which software vendors are best at delivering meaningful use in a quantitative sense, by posting meaningful use results by EHR vendor. Vendors have a lot of control over whether physicians can achieve meaningful use through innovations in software and in the quality of the services they provide to physicians. If there are ‘incentives’ for them to provide innovative software and excellent services, they will do so. If they can get away with marketing and promises, they will. Physicians will be on the hook for paying, so EHR vendors won’t lose. But ONC will lose because physicians will not trust vendors to deliver and will not adopt EHRs. If there is a lack of transparency about vendor performance, bad vendors will be able to sell their software to unsuspecting physicians for quite some time to come. Making vendor performance available to physicians as soon as it is available will sharpen up the vendors and provide physicians with evidence-based decision making information.
I’m not sure that I would feel altogether safe with my information out there like that.
Certification is definitely a requirement for delivering safe and effective technology for physicians and patients.This is a good site.I have gone through many site regarding health queries and i found it good among some of the site i have visited.
Family wellness center Florida
The EHR certification process has its problems, but those of us guiding physicians through the selection and implementation processes have had a continuously updated reference point, albeit imperfect, but CCHIT has earned brand recognition as a relatively trusted resource among purchasers. This new temporary and permanent certification process has not made any promise about consistency in an industry that was finally maturing. Confusion over this certification process has poured a wet blanket on the fire-in-the-belly that the Meaningful Use IFR generated, essentially diluting trust in a stable certification process. Practitioners were finally driven by a single focus. I do believe that every organization – whether for profit or non-profit — should be periodically subject to a review. The timing of this review, however, is very risky creating yet another series of stumbling blocks that begs for clarification and dependability if you want to keep the adoption of health information technology momentum moving forward.
certification cost is an issue, there seems to be some profiteering going on with a not-for-profit CCHIT which call itself “commission” charging $40,000 per complete certification and $6000 per specialty area, this could be a siginificant barrier to entry for a small software vendor, certification should be free to vendors while government reimburses certification bodies per number of certifications performed
I’m all for certification programs if they help move the industry forward. I can see this being a very hot field in the very near future.
I appreciate the comments on the CCHIT certification process, past and present. As a medium-sized, ambulatory EHR vendor, I can tell you that the legislation of EHR under ARRA/HITECH created 2 pivotal changes in process:
1. It kicked-off 2 new federal advisory committees (HITPC and HITSC), inserting much needed authority into the EHR standards process through a non-trade group-related entity. Introducing these committees into criteria development eliminated actual/perceived standards setting by a “good ‘ol boys club”. Whether real or perceived, this is a good thing.
2. The ONC is opening the certification process to multiple certification bodies, unbolting the door for others to participate. Competition is never a bad thing.
My company was an early adopter of CCHIT certification. Having gone through multiple certification testing processes, I can tell you that CCHIT has done a great job of providing a thorough (although costly and resource intensive) course of action for some level of benchmarking in an industry where it was previously lacking.
Our biggest challenges at this point include:
• Positioning our customers for success under this legislation; and,
• Trying to anticipate standards, develop needed solutions, and place ourselves on a future course without specifications, rules, and/or appropriate timelines
Everyone knows, ARRA created very aggressive timelines. Recognizing the new realities created in this legislation, I believe that CCHIT has done its best to deliver a continued certification process to parallel the undefined criteria of our government – critical to keeping pace with the goals for EHR adoption by 2015 and something our hemorrhaging health care system desperately needs.
My organization developed and tested with CCHIT against HITPC and HITSC’s recommended criteria in December of this year – receiving 2011 certification. With the publication of CMS’ NPRM on meaningful use and the correlating IFR by the ONC, we took a deep cleansing breath and prepared for gap testing. Now, with the ONC’s NPRM on certifying the certifiers, the process could become greatly complicated, leaving us wondering how best to position tactically for the short-term, and strategically for the long-term.
So, what is the true goal of this newly proposed rule? I applaud the ONC’s 2 phased approach to delivering certified EHRs to the marketplace, so long as the temporary process does not decelerate the EHR adoption process. The temporary process should work to rapidly deliver EHR vendors to the marketplace while the ONC is finalizing the permanent certification process. Accrediting certification entities is a good thing. Having multiple certification bodies is a good thing. Creating governance of the process is a good thing. Delaying delivery of technology to the marketplace is a very bad thing for physicians, hospitals, vendors and government.
I strongly agree with Margalit Gur-Arie’s post. CCHIT has delivered solutions to this market space for over 3 years. Wisdom would suggest that the ONC deliver certified EHR technology to providers temporarily through this established certification entity – if no one else. Why wouldn’t the ONC leverage existing programs to accommodate legislative timelines, build upon the synergies created to date, and set the system up for success, innovation and progress?
Thanks for the blog. While this post is not directly related to the certification NPRM (for which we applaud ONC for communicating its availability and offering an open public comment process), there were several HHS RFPs (10, I believe) regarding standards harmonization, standards development, tools and standards repository, integration testing, and others. While it’s been stated at HIT Standards Committee meetings that these RFPs were issued in February, I’ve found it difficult to find most of these RFPs, and not much has been written about them in blogs or HHS announcements, except for the standards harmonization NIEM framework that was presented at the HIT SC on March 24th. In the interest of transparency and to engage the public, could more information about these RFPs be made available?
Perhaps there is some trick (that I’m not aware of) to searching fbo.gov, but I spent a lot of time trying various search options and could only five links to pages for five of the RFPs, and those pages only contained high level descriptions but not the RFPs themselves. In some of them, it would seem that collaboration with or responses from SDOs would be desirable, but I’m not aware of those SDOs being able to access these RFPs either.
Thank you.
David Tao
Where does the certification programs for Health IT dovetail in with existing certifications? I understand the motivation behind pulling out the aspects that are specific to health care, but are requirements being factored in to insure that these certifications fall on top of other technology certifications?
When HIPAA was first introduced the medical community felt like they were invaded by carpetbaggers looking to make a quick buck in consulting, trianing, etc in the field. While this may have been the case there, once you cross over to the IT field you are looking at needing some expertise beyond the medical field. If we limit ourselves to only those in health care and don’t educate administrators and other management on this complex topic of mixing IT and health concerns we can meet with a lot of resistance.
I believe any more red tape to get professionals into the health care field is going to create even more apprehension for new professionals looking to join health care. Coming from an IT standpoint, the more red tape you have to go through even after learning how to do your job the more difficult it is to justify starting in the first place. But that is just my thought
Really thank you for posting this. Appreciate you sharing
I believe ONC is underestimating the complexity of certification and the infrastructure required for a successful program, even a temporary one.
I can easily envision horror stories, particularly regarding EHR modules, created by small underfunded vendors, getting temporary certification and providing nothing but disappointment and financial loss to customers.
In the engineering world, reinventing the wheel is not considered a worthy endeavor. CCHIT is there. It is experienced. It is up to date in it’s infrastructure and readiness. It has created a pared down ARRA certification and kept up with all ONC/CMS changes.
Como vender en internet.
@Juan, I’m not in support of the ONC, but it must be said that they have got to be trying the best they can.