Electronic Health Records (EHR)s Now Permitted By CLIA
On March 1, 2010, CMS, in collaboration with ONC, released guidance clarifying that the Clinical Laboratory Improvement Amendments (CLIA) permit labs to electronically exchange lab data and addressing some confusion regarding laboratory data and health IT. This guidance was put forth in a Survey and Certification letter, including interpretive guidance and frequently asked questions.
Underlying this guidance is the clear recognition of the need for privacy and security of laboratory test results. When such information is shared, there should be a commitment that the all test results will be protected and used by the right people and for the right reasons.
Early in 2009, I saw the need for guidance related to the electronic exchange of laboratory data since it is a key part of improving health care quality and care coordination. We subsequently asked the Information Exchange Workgroup of the HIT Policy Committee to hold hearings on barriers to exchange of lab data and how these barriers could be overcome. Based on this input, the Center for Medicare and Medicaid Services drafted guidance that solves the following problems:
- Encourages the use of HL7 2.5.1, LOINC, and federally recognized Nationwide Health Information Network (NHIN) specifications in the electronic exchange of lab data,
- States that visual inspection of laboratory interfaces within an EHR installation is not required,
- Permits patient access to test results if not prohibited by state law,
- Supports the goals of meaningful use, and
- Expressly allows laboratory data to be transmitted through a health information exchange (HIE).
While this guidance furthers the ability of laboratories and EHRs to electronically send and receive laboratory data, it is not a panacea and more work must be done.
If States want widespread health information for their population then they must take into account that some State laws currently prohibit the release of test reports directly to patients and even to other providers treating the patient.
We are addressing state concerns by working on policies and frameworks that allow health information to be securely exchanged. And “securely” is an important word. I want to be clear that in all our Health IT investments, patient privacy is our top priority. And as we move toward a new age of electronic health information technology, we are committed to putting forth policies and technology that will meet this expectation of privacy.
We encourage you to review the Survey and Certification package and provide feedback to both ONC and CMS on additional issues that remain regarding the Federal CLIA law and health IT.
–David Blumenthal, M.D., M.P.P. – National Coordinator for Health Information Technology
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This is a great move and long overdue. Hopefully, your conversations with States regarding their antiquated laws will finally put the patient/citizen in the driver’s seat allowing them FULL ACCESS to their lab data. And why not, they did pay for it after all.
Also, in future, would be good if you could provide a link directly to the new rules for review/analysis.
When people can get a more efficient service through these new measures, then it will be great. The only problem for many people is the question over security of their information. If this issue can be dealt effectively then these systems will benefit all of us.
I would imagine that if we have been able to securely process credit card information and bank transactions, we should be able to keep patient information secure.
HHS must address the privacy threats to consumers from Internet-based pharmaceutical and health marketing. Health marketers are using the latest interactive advertising techniques, including behavioral profiling, to target consumers–including using so-called “medical condition” online channels. There are consequences to the well-being of U.S. consumers unless appropriate privacy and other safeguards are enacted. For more see: http://www.democraticmedia.org/press-release-drugs-and-health-marketing
GGH is required by law to report certain pieces of information about our patients to health care agencies, including the following: the provincial Ministry of Health (billing information), the Canadian Institute for Health Information (coded discharge abstracts), Public Health and Health Canada (public health surveillance), and Cancer Care Ontario (pathology reports). This is done to ensure the health care system is running optimally, and to conduct statistical comparisons of population health characteristics over a broad geographical range.
There is still a problem with making people understand the economic gain of exchanging data electronically. And some people just hates computers and MUST have everything printed. Such a waste on the environment…
There is still a problem with making people understand the economic gain of exchanging data electronically. And some people just hates computers and MUST have everything printed. Such a waste on the environment…
Yes i agree.
There is still a problem with making people understand the economic gain of exchanging data electronically. And some people just hates computers and MUST have everything printed. Such a waste on the environment…
Despite all the gurantees and the argued benefits, I still see this as the thin edge of the wedge. This year it’s a little bit of shared lab information, next year a little bit more and so on. We have also seen many many instances of where private information thought as secure has been breached. All it takes is one rogue employee. Sure they may go to jail for their deeds but one can not unring a bell – the deed will be done.
In built reviews and sunset clauses should be mandatory on any legislation regarding this so the system can be constantly reviewed and justified as workable.
Regards
I am going to have to disagree with this statement. The electronically exchange of data is integral to the way that our society functions. Credit Cards, Banks, ATMs, Pay At The Pump and all of the new Mobile Technologies that are changing the way that we learn and interact.
Every single sector of our society is advancing and at the risk of sounding like a fool – we can not stall innovation at the fear of a breach by an employee.
At one time this same basic argument was used against creating a directory that has everyone’s name and phone number in it. It just was not safe… Today all of the Phone Books are available online and as efficient as ever and a normalized data source.
Health IT should be given the same opportunity to innovate.
P.S. I do agree that any system should be constantly reviewed, adapted to actual work flow and justified as a workable system through audits.
It is a really good move I hope that in the end the patient is the one who owns the rights to the data.
I definitely agree about sharing health information on the internet. This is definitely a good step but security issues is a constant problem for many people sharing it online. If this can be fixed there systems will benefit all of us.
My hope is that the federal government will come up with some standards for data exchange. Right now, every lab uses different codes to identify the same tests. Without some kind of standard, all progress towards data exchange are fruitless.
In my experience, the need for standardized technology, systems, sites. etc always seems to be the first roadblock after a decision like this is made. I see it all the time in a smaller scale with my clients. They want to be able to share data across two sites but the systems in place are built on entirely different platforms. Looks like somebody has their work cut out for them!
The Clinical Laboratory Improvement Amendments is bring people new possibility. With the help of this document, people will be able to have an access to their lab data. Poepel who can use them are able to be creative and some people can enjoy the more efficient service.
“Also, in future, would be good if you could provide a link directly to the new rules for review/analysis.”
Agree
This is definitely a step in the right direction. With the current technology, we have more then enough secure data protocols for this to be implemented safely and securely. Hopefully the influence of the Federal government will encourage certain States to change law preventing the release of test reports directly to patients or other health care providers treating patients.
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The release of test reports directly to patients or other health care providers treating patients needs to be looked at and debated thoroughly. Patients should be allowed to see their laboratory results in my opinion.
Why does it have to be so hard and so difficult to come up with simple ways to exchange data electronically? Banks have been doing it for years with ATMs – how is dealing with money so secure and simple to use, but patient data isnt?
Quick access to relevant healthcare data is long overdue in my opinion. I really agree with John- how hard can it really be in today’s world to create a system that works while protecting people’s privacy at the same time?
Then again, with all the hype surrounding Facebook’s privacy issues in recent months, maybe it is too hard to please everybody?
If they actually follow through and do what they promise, this will be outstanding. I know this would help tons of our legal funding clients who now have no choice but to wait for funding until their medical documents are processed, and that can take almost forever. With this new process, we should be able to provide our lawsuit loans in a significantly reduced period of time.
I agree with yoga pants on the fact that patients should be allowed to see their laboratory results, however, do we know why some State laws currently prohibit the release of test reports directly to patients?
privacy will be an issue. how will the gov. make sure of data leakage and most of all who is the full owner of the data? while this a good initiative, it has to be strongly regulated and patients should be informed of this.
Privacy is not a protected under our constitution and further legislation is required. We should support and candidate at the state level that understands this issue and our need to protect our ever eroding privacy in this day and age.
Why can patients not see their own lab results? This seems like a huge slap in the face to the patients; why are they not able to see results?
I think that this change is long overdue, and if it is “followed-through” I think it would be great.
It’s about time. So many other industries exchange data (banking, retail, etc.), and as long as non-public identifying information is not shared, there are laws that already allow it. Research, of ALL things, should have been first on the list of industries to share, including labs.
Why would any states make it illegal to provide lab results to the patient? Information is useless unless it is shared or otherwise leveraged. And if it’s YOUR information, why shouldn’t you have access to it?
It’s not unreasonable to expect health care companies to implement data sharing measures over a secure network. Secure networks have been around since well before the dawn of the Internet, and contrary to popular belief, it isn’t always easy to hack into them. As long as data security experts are hired to implement and maintain the data sharing network, there shouldn’t be any problems.
I definitely think that if the sharing of data will benefit the greater good then it should be shared, minus personal information, ie. names, birthdays, etc. Anonymous data is just numbers or information if it doesn’t have a name attached to it. When someone’s information is attached to the data that is being shared, well then that is crossing the line. Medical information is extremely important to share because it leads to advances in health, which in turn saves lives. But that’s just my 2 cents.
I don’t think it’s a fair game though.
The patient must has a right to their test record, and it doesn’t make sense where the patients information can be sold to the third parties, but therefore when it is about getting access to their dosier it is “prohibit”.
What does that mean if we cannot have access to our own record…?
I would want to have access to my health records, in the past one doctor did not care to check my blood test results, I was anemic and he told me I was OK while I could hardly got up from bed. From that time I always request copy of my tests and read them carefully, the results are self-explanatory – if within limits quoted next to each item, you know they are good, you do not even need a doctor to interpret them. If it is something what I do not understand – I go on the internet and search, get better educated on medical terms and then go to the doctor and ask questions – I do not trust doctors. And if my tests show that I have cancer – I would want to know about it rather than doctors trying to hide it from me.
I just don’t understand the ‘fight’ for patients to see their own test results. Surely they belong to the actual person and because of that they SHOULD get to see them.
As for ‘selling’ patients details to third parties – that is just down right nuts. What will they do next?
It’s great to know that CLIA now have clear guideline in permitting laboratories to electronically exchange important data. This is very helpful in getting things done since labs can now work hand in hand.
We are addressing state concerns by working on policies and frameworks that allow health information to be securely exchanged. And “securely” is an important word. I want to be clear that in all our Health IT investments, patient privacy is our top priority. And as we move toward a new age of electronic health information technology, we are committed to putting forth policies and technology that will meet this expectation of privacy.
As the above quoted portion of the article states, “securley” is the keyword! Accomplishing this would definately save a lot of money and resources currently wasted on the system we have in place now. I’m all for the electronic transfer of health information as long as we can be assured the proper technologies are in place to protect our private information. As one of the other comments states, if we can protect credit card information online then we should be definately able to achieve this goal.
Hey there,
This is really good to hear that CLIA has permitted the electronic exchange of data. This is going to be very beneficial to all involved with healthcare. Great blog, keep the great posts coming!
Is my opinion than no patient data should be exchange without the written permission of the patient. Otherwise, where are we going to end up? Who will have access to our data? There are some cases known in countries outside the US, were patient information has been exchanged without permission and to unappropiate persons. It could become a terrible thing to happen. So first of all, security for the patients!
There is no real security on the internet. You have governments like China, N Korea and Iran spending millions of dollars working 24×7 “cracking site codes”, not just the lone nut hacker in the basement of his mother’s house. You also have individuals who are and will be bribed by these same governments for the entry procedure into these so called secured sites. Whatever information you decide to put on the internet, it is best to assume from the get go that if someone or some government wants to access or expose that information for whatever reason it can and has been done. And that’s not the only problem, computer viruses is another thing that could destroy all the information/records on a website. Worse yet a “smart” virus could be developed that could change/alter the lab results stored on a website without anyone knowing for who knows how long.
We need a comprehensive plan for healthcare, and a secure Patients Bll of Rights.
If more and more work in healthcare will be computerized and networked, it OUR data, it’s OUR bodies, and we should have the right to get our data and review it.
I think this is a move in the right direction when it comes to handling health information of individuals. Being able to exchange such data on a simple platform makes it easier not only for the patient, but also for the health care provider. I wish more states start moving in this direction in the near future.
Its time the CLIA has specific guidelines to permit labs to electronically exchange important data. This is extremely helpful being that a lot of labs work hand and hand. On the other hand its very important to keep this data private since it is not meant to be made for the public viewing. The internet in general can leak certain things and info and thats why its important for these guidelines to be strict.
Definitely a step in the right direction. Electronic records will allow the collaboration of doctors and other specialists and should, in the end, benefit everybody. It is also much more difficult to lose electronic records. The security is an important factor though, there needs to be either some encoding or a very secure pipeline to access that data. Getting there though!
nice post
I think it’s encouraging that technology is available which will greatly expedite health care for all. Electronic health record technology is greatly overdue and will benefit our country greatly.