Raising Legitimate Questions and Concerns About Health IT Certification, Without Getting Personal

By DAVID C. KIBBEKibbe

In a recent blog post on THCB, Mark Leavitt wrote this about me:  “[Dr. Kibbe’s] repeated use of  falsehoods and innuendo to attack CCHIT have found an audience in the national media, reaching a level that can no longer be ignored.  By implication, he demeans the integrity of everyone who has contributed to that work – and I must rise to their defense.”

The truth is that I respect both Dr. Leavitt and, equally important, the many fine people who have contributed to CCHIT work.  I regret that he has made me the target of his anger about investigative reporting in the Washington Post, which I certainly did not initiate.

To clarify what I actually said, after a brief interview, quoted in the second of two articles in the Washington Post by Robert O’Harrow, Jr, a Pulitzer Prize finalist :

“One has to question whether or not a vendor-founded, -funded and -driven organization should have the exclusive right to determine what software will be bought by federal taxpayer dollars,” Kibbe said. “It’s important that the people who determine how this money is spent are disinterested and unbiased . . . Even the appearance of a conflict of interest could poison the whole process.”

Raising questions and concerns like these does not reach the level of “falsehoods and innuendo.”  In my opinion, it is entirely appropriate to ask tough questions about whose interests are being served when $36 Billion of tax payers’ money is involved, and the future of health IT in the U.S. will be the result of certification.”

I am not the only one with these concerns. Many other health care and health IT professionals have raised legitimate questions about CCHIT and its practices, its relationship with HIMSS, and yet to date these have not been resolved. A response that attacks me personally and labels me a liar is far from adequate, and so the questions will remain.

The stakes are too high to simply look the other way.

David C. Kibbe MD MBA is a Family Physician and Senior Advisor to the American Academy of Family Physicians who consults on healthcare professional and consumer technologies.

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  1. Gilles: Many thanks for these references, and I’ll study them. It looks as though there may some applicability to the current EHR technology conundrum. Back to you when I’m finished reading…
    Joe: Thanks for your comments. I have had many, many conversations with the smaller vendors who feel they’ve been shouted down and kept out of the CCHIT group, and it’s good to hear some voices from that corner.
    Regards, DCK

  2. As a vendor to small practice doctors I applaud Dr. Kibbe and the others who continue to ask tough questions regarding “certification” and “meaningful use” in this important HIT debate.
    The CCHIT certification process and requirements are seriously flawed when applied to small medical practices.
    I’m dumbfounded at Dr. Leavitt’s comments in his video posted on this site where he states the certifcation process and fee structure are not a ‘barrier to entry’ for small specialty software companies and startups.
    Dr. Leavitt’s post above does not address any of the serious issues raised by Dr. Kibbe or anyone else in this debate. Dr. Leavitt’s argument is a classic “straw man”.
    I hope sanity will return so “certification” and “meaningful use” will not limit the market for small practices to adopt the current group of overpriced and complex packages that CCHIT certified vendors currently offer wasting billions of taxpayer dollars.
    Many small companies like ours exist by creating innovative and affordable solutions for the medical field.
    The CCHIT certification process is heavily weighted towards large vendors that support HIMSS, not innovative small companies and startups.
    Joe Buckle
    Trigram Technology
    http://www.trigramtech.com

  3. David,
    you can start with the history of the SRS: http://bit.ly/CJlQU
    You should also look at Amendment 11: http://bit.ly/WOWMo
    The following is of particular interest in our current situation:
    “In order to create an environment conducive to the development of robust competition among domain name registrars, NSI will, either directly or by contract, develop a protocol and associated software supporting a system that permits multiple registrars to provide registration services within the gTLDs for which NSI now acts as a registry (Shared Registration System).”
    I think you’ll enjoy this simple presentation: http://bit.ly/FaAeM
    And this one from Vinton Cerf: http://bit.ly/mB1O5
    For a full historical perspective, you can read portions of “Multi-Stakeholder Governance and the Internet Governance Forum” online at Amazon: http://bit.ly/4VBEk

  4. Dear Scot: I DO think that your writings have been noticed, I certainly pay attention to your blog, and that there is still the need for a much larger public debate about health IT. Again, I think leadership, transparency, and money are all important to what creates “newsworthy-ness” in the mainstream press. Notice that Mark Leavitt said or wrote very little in defense of CCHIT until the Washington Post covered the story. I wish that Mark and CCHIT leaders would have spent the time and energy responding directly the many questions that have been raised rather than “raise their ire” against me personally. But I also do think that there is a larger public debate about “certification” as a result, and that’s a good thing. Regards, dCK

  5. David,
    I find it interesting that sites such as mine (http://www.tinyurl.com/hit-misadventure) that challenge the HIT status quo, as well as my writings on Healthcare Renewal, have never drawn the ire your writings have.
    Perhaps it’s because those who would proffer such ire know they would be eaten alive in a public debate, and that such a debate would raise visibility of the issues I and like-minded medical informatics colleagues raise.

  6. Gilles: Very, very interesting analogy. I do remember the story, but am not familiar with the details, so thank you for bringing to our attention. Do you have other resources, perhaps something available on the ‘net, that we could look at to get a better idea of the ICANN history?
    Thanks, DCK

  7. I was re-reading the history of ICANN, the Internet Corporation for Assigned Names & Numbers, after thinking that the disagreements expressed during its creation and subsequent transformation parallel the conversation (if you can call it that!) between David Kibbe and Mark Leavitt. ICANN failed while people thought it had an unduly strong connection with commercial entities who clearly intended to keep the status quo. The original monopoly for domain name registration was clearly a problem and opacity of the process didn’t make things easier.
    How did this mess get resolved? ICANN “introduced new principles in global policy-making like bottom-up coordination, rough consensus, openness and transparency … ” There is much to learn from the ICANN story, first and foremost in seeing how having many registrars, instead of a monopolistic situation for certification/registration, brought competition, innovation, ease of use and lower costs.
    As its original development showed,failure is guaranteed if only those already at the table (“the experts”) can choose the future when there is an explosion of needs and use unforeseen by these experts.
    A good read is “Multi-Stakeholder Governance and the Internet Governance Forum” (Wembley: Terminus 2008) by Jeremy Malcolm.

  8. Dear Bev M.D.: I think the situation is worse than you think – the two sides can’t agree on the size of the table, who should sit around it, or what should be put on it!
    My viewpoint, one that seems to be generally shared by many commenters, is that we need to have a very open debate, that includes a lot more people than are now included (patients/consumers, for instance), around a very big table onto which we put everything we can think of as an issue before anything is excluded. If only the “experts” can understand what’s going on with the spending of $36 Billion of our money, then it’s de facto going to be mis-spent.
    Someone once said, “where facts are few, experts are many.” We need more facts, and fewer experts, in my opinion.
    So, Bev…please ask questions and collect facts, and then ask more questions. Talk to your friends and keep at it until you understand the basic issues. This isn’t rocket science. It’s about achieving better patient care through care coordination and communications, the use of evidence based and scientific methods, and the avoidance of unnecessary and wasteful treatments. It’s about making care more convenient, and helping people to learn about alternatives and how to make better decisions. And, finally, it’s about how IT can be helpful as a tool for these goals, these “meaningful uses” of health IT.
    Regards, DCK

  9. The term “certification” is indeed a problem. It implies far more than the substance behind what actually occurs. “Features qualification” would be more precise.
    As I wrote at http://hcrenewal.blogspot.com/2009/03/few-not-so-random-thoughts-on.html :
    Having worked in pharma (Merck), I would like to know how CCHIT functions differently from a fictional “Drug Certification Commission.” Imagine such a Commission founded by PhRMA and other pharmaceutical industry advocates, partly staffed at high levels by pharmaceutical executives, and “certifying” drugs for consumer purchase simply on the basis of their being manufactured under cGMP guidelines (current good manufacturing processes). Imagine this Commission declaring drugs “certified” without clinical trials, impartial regulatory oversight, postmarketing surveillance and in the face of equivocal studies and outright unfavorable studies showing increased risk of adverse events. How is CCHIT conceptually and substantively different from this fictional drug certification commission?

  10. The magnitude of the dangers of HIT gear being deployed to control the care of patients has been kept from view by contractual gag clauses well described by Koppel and Kreda in JAMA.
    Despite Koppel (JAMA) reporting 22 new mistakes generated by CPOE devices and Han (Pediatrics) showing a 2.4 fold increase of deaths of babies, we all know that never ever ever, according to the HIT zealots and industry CEOs and CMIOs, has any defect, flaw or abject failure (“unplanned downtime”) of such equipment ever resulted in the death of a patient. It is always user error.
    Yet, there are numerous studies in the scientific literature indicating that the dangers are real and can cause death. The most recent report, published in Archives of Internal Medicine, indicate numerous hard to discover high risk errors caused by CPOE contrivances.
    http://www.ihealthbeat.org/Articles/2009/5/28/Inconsistent-Messaging-in-CPOE-Systems-Leads-to-Errors-Study-Finds.aspx
    And how did the US HIT industry come up with these billion dollar savings numbers for Congress when HIT debacles cost England’s NHS £12 billion? Who paid for the results? The Washington Post reported that HIMSS has an “alliance” with a Harvard foundation called CITL. How was the Hillestad RAND “study” claiming billions of savings (later refuted by the GAO) funded? Certainly not by International Paper.
    It was interesting to learn that Leavitt knew nothing of the UK NHS HIT disaster caused by American HIT companies when queried. So maybe, just perhaps, his response to Kibbe is revealing of deeper problems with HIT industry and CCHIT conduct? And why is Glen Tullman on the CCHIT Board and not Dr. Kibbe?
    The HIT industry and its trade groups consisting of CCHIT, HIMSS, and AHIMA, to name a few, have failed all patients and physicians by ignoring the scientific method. The HIT equipment, especially CPOE devices, have not been methodologically studied for safety and effectiveness. These things remain experimental medical devices.
    CCHIT ignores matters pertaining to safety and is not interested in hearing of the defects of the equipment it certifies after it is out there in the market. Leavitt and his team of staffers have stated this.
    However, when our country’s lawmakers are told that HIT is certified, their erroneous understanding is that it has been proven safe and effective. Thus, is CCHIT contributing to a charade affecting patients’ lives?

  11. Unfortunately, CCHIT will not answer why they charge a fee of $30,000.00 for a certification of an EHR.
    CCHIT relies on volunteers for most of their functioning.
    Dr. Leavitt expressed his support for Open Source software at HIMSS 2009. For the FOSS community a 30K wack is not support.
    We need multiple certification commissions that compete one against the other. Maybe the fee will drop down to a realistic 3K or less. I’d say less.
    Prehistoric vendors must accept that this is a new era. An ice age is upon us. Dinasours will succumb to the striking meteor of healthcare modernization. Rest assured.
    Michael Planchart

  12. Well, the 56 comments on Dr. Leavitt’s post were too much to do more than skim, but here’s my outsider’s, IT know-nothing’s take on these 2 posts:
    1. Nothing Dr. Kibbe has ever written on this blog has given me any idea that he is anything less than professional, whether I agree with him or not.
    2. Dr. Leavitt’s post, as noted by others, revealed a level of smoking anger which makes me wonder where the fire is.
    3. This whole health IT discussion is beginning to take on the dimensions of the 2 countries (which ones? help me remember) years ago who couldn’t negotiate an important issue because they couldn’t agree on the size or shape of the conference table at which they would negotiate. This lasted over a decade, if I recall.
    Heaven help us all, because we are all, or will be, patients. Let’s decide about the conference table and move on, people.

  13. DEbate back and forth on the merits and risks of HIT is a healthy activity.
    Yet I fear the domain of health IT has left the realm of science and entered a world of cybernetic mysticism, or religion, where critique is viewed as apostasy.
    Robert Merton (1973) described four norms that are prerequisites to scientific activity:
    1. Organized skepticism: (Nothing is ever taken on trust) – yet the health IT skeptics (or, as I am, a gadfly of HIT mismanagement) are often chastised.
    2. Universalism: (acceptance of the integrity of research relies on its merits, and not status of the researcher, such a specialization, academic rank and status.)
    3. Communalism: Sharing of information, absence of secrecy (inappropriate refusal to release data or methodological information – a situation that Koppel’s recent article on “Hold harmless” and “gag clauses” points out – makes HIT unscientific by definition.)
    4. Disinterestedness: (Not committed to any ideology – able to criticize and accept research based on its merits, not on a prior view that “doctors are Luddites”, or “health IT will revolutionize medicine.”)
    If as I wrote at http://hcrenewal.blogspot.com/2009/05/harvards-emr-justification-we-just-have_27.html , we’re going to implement national HIT “just because”, we will have learned nothing from science.

  14. Evan Steele,
    Your company develops EMRs that are different from “classical” EMRs.
    You also compete against the certified EMRs and have indicated, from what I’ve read, in some blogs that these EMRs don’t guarantee a succesful implementation and I agree with this as well.
    I have also read that SRSoft has installed succesfully many hybrid Electronic Health Records where the “classical” ones have failed.
    I have a few questions for you:
    1. What are the essential differences between hybrid EMRs and classical ones?
    2. How has the industry-wide voluntarily certificacion adoption process impacted the hybrid EMRs?
    3. We can see forthcoming a certification process that will be mandated for those users that wish to receive ARRA HITECH Incentives. There will most likely be more than 1 certification commission too. What are the obstacles to certifying a hybrid EMR?
    4. What certification process would you recommend?
    Thanks,
    Michael Planchart

  15. Dear Michael: I’d be glad to work on a blog piece about open source, and how it differs from proprietary systems and from proprietary systems with open APIs. I think one thing to say now is that “openness” generally favors the consumer, but not all “openness” is open source. There’s a great book for background on this topic entitled “The Future of the Internet, and How to Stop It,” by Jonathan Zittrain, which is downloadable under an open source license from Creative Commons. http://futureoftheinternet.org/ Well worth the read.
    Very kind regards, DCK

  16. Dear Evan: Here is what I’m telling physician audiences who ask: “We don’t have an EHR technology. Should we go out and buy one of the CCHIT certified EHRs now, or wait and perhaps be able to purchase a lower-friction, less risky, and less expensive set of apps that will qualify me/our group for HITECH incentive payments?”
    First, be informed and fully understand that CCHIT is nowhere mentioned in the ARRA/HITECH legislation. Understand that any pressure you’re getting from vendors or HIMSS on behalf of vendors, is just that…pressure. You gotta love ’em! We don’t know who will be doing the “certification” or “qualification” for EHR technology under HITECH.
    So…think it through carefully. Are you looking for a comprehensive EHR from a single vendor? Have you done all the due diligence, spoken with physicians like you using the system(s) you like, in a practice like yours? And so on. If so, then proceed.
    But if you’re just starting to think about adopting and using EHR technology, consider waiting and taking a careful look at stand alone and potentially interoperable applications, such as a ePrescribing app that can plug-and-play with a disease registry and a patient web portal. Consider carefully the costs and risks you’re willing to bear if the implementation doesn’t go well, and judge your “adaptive reserves” with respect to change from paper to digital systems.
    I am quite sure that the HITECH regulations will be published by the end of 2009, and these provisions will tell us what “meaningful use” and “qualified EHR technology” actually mean, and also clarify what your practice must do to validate meaningful uses.
    And so on.
    I hope this is helpful.
    Kind regards, dCK

  17. David: Would you please consider writing a separate blog entry on this (Google Android and cell phones) event? Adoption of open-source technology in healthcare IT is key to its ultimate success and deserves a proper discussion.
    Thanks a bunch,
    Michael

  18. Dear Dr. Kibbe:
    Thank you for your speaking up and for standing your ground. One has to wonder why Mark Leavitt sounds so defensive about CCHIT and its role!
    I am deeply concerned about the de-facto assumption that CCHIT will be the standards for EHRs qualified under the Economic Stimulus program. While the HIT Policy Committee and the Standards Committee are working feverishly to determine the qualification standards, their conversations seem to contain implicit acknowledgment of CCHIT as the standard. Even as these conversations are underway, CCHIT-certified EMR vendors are shamelessly promoting their products as being required in order to receive the government incentives. HIMSS, not surprisingly, has recommended that CCHIT be accepted as the standards, and is encouraging physicians to limit their EMR searches to CCHIT vendors.
    Even if we put aside the “allegations” of conflicts of interest and political motivations that were exposed in the Washington Post article, there are several problems with CCHIT’s applicability on a broad scale. Traditional EMRs have had historically high failure rates, and I am not aware of any studies that demonstrate improvement since CCHIT certification was established. Furthermore, whereas CCHIT products have had some success in primary-care practices, they have had much more limited acceptance by high-performance specialists.
    I do differ with you on one point—you mention that you would have liked to see more primary-care physicians with IT experience on the committees. If you meant community-based, practicing physicians, I agree. However, even more under-represented—in fact, not represented at all—are high-performance specialists. How are they to participate in the Stimulus program if they are not part of the conversation?
    Evan Steele
    http://blog.srssoft.com

  19. Dear All: I was struck today by the announcement that by the end of the year, Google’s open source Android operating system will be installed on 18-20 mobile phones internationally. Eighteen different phone manufacturers?! That is amazing growth, and because Android is an “open” platform, third parties are free to use the Android OS in all sorts of innovative ways, for example to power a new generation of mobile devices and computer-like products.
    Note that while the Apple iPhone is a proprietary operating system, it too has open APIs which allow third-party companies to build applications (over 35,000 apps at last count) that plug-and-play running on the iPhone and iPod Touch, including several dozen that are health and medically related, and at least one that is a fairly robust EHR technology (of course, not certifiable by CCHIT — can’t even get in the door.)
    This is the kind of burst of innovation and economic activity that could occur in health IT, but that many people are afraid might be stifled by a CCHIT that prohibits non-comprehensive EHR technology from getting to market or qualifying physicians (and patients) from the benefits of HITECH funding.
    For Pete’s sake, the iPhone alone has created billions of $$ of economic activity, and thousand of new jobs. Isn’t that the kind of stimulus we want?
    Kind regards, DCK

  20. I believe that the goal we are trying to reach is the one of a transparent process of certification.
    I would suggest the following:
    1. CCHIT remains as a certification commission.
    Why? Because it already has a defined process and it has been doing it for several years. The criteria CCHIT utilizes has been defined by a multitud of experts in the healthcare IT community. And, of course, it should continue evolving and adapting itself to new needs and trends. At this moment we should not be eliminating what we have. If it is flawed then it must be fixed!
    2. Competing certification commissions should be sponsored by the government and all the stakeholders (e.g. vendors, EHR users, SDOs, etc.). There should be a minumum of 3 certification commissions.
    Why? Because this would allow for further transparency and it would allow for competition that would result in a normalization of the fees which are currently excessive being set at $30,000.00 which takes me to the next point.
    3. The $30,000.00 fee should be reduced to a reasonable amount. It is a barrier for entry to market of what could be excellent products developed by smaller companies and open source projects.
    The explanations of keeping the “bar high” to avoid mediocre products entering the market has nothing to do with such an excessive fee.
    The public deserves a breakdown of the fee imposed to EHR companies:
    How many man-hours does it consume to certify an EMR? What is the cost per man-hour?
    What administrative costs are involved?
    CCHIT uses volunteers for its process. Is the $30.000,00 fee a capricious one? Is it set so high just to be a filter for emerging competition? Overcharging for the sake of protection doesn’t sound like a transparent process.
    These are just to name a few.
    Thanks,
    Michael Planchart

  21. Dear Susie,
    the interoperability functions serve the public good only? Have you read the most excellent description of e-patient Dave experience with the so-called interoperability? It is a joke so far because, as David Kibbe wrote in one of his comments, “CCHIT is out of balance as currently structured” and no one has spent the time to see and ask what are the real patient stakes in HIT. A year ago, I asked about the lack of patient representation at CCHIT and was summarily sent off without ever receiving an answer to this seemingly simple question.
    David would like to see more practicing physicians on the new HIT committees that will advice Dr. Blumenthal. We, the e-patients, would really like to see more direct patient representation in the same committees. But we are in basic agreement that the current imbalance is problematic and will clearly limit the positive impact HIT may have in reforming the healthcare system, unless the undeclared end point is ONLY to control costs, in the most extreme form of comparative effectiveness.

  22. You people are all insane. Vendors, though most of them are too weak to admit it publicly, have no love for CCHIT. CCHIT has forced them to put features and functions in their product–especially in the areas of interoperability–that cost big software development dollars. These interoperability functions serve the public good only!
    No customer of EMRs really wants to make it easier for their patients to walk across the street to a competitor care provider. Where do you all live–in some ivory academic tower? Keep your friends close and your enemies closer–CCHIT is smart to keep vendors closer as they are NOT friends.

  23. Dear Epic Customer: I forgot to ask you your opinion. Please let us know what you think regarding the question you asked. Thanks. DCK

  24. There is a clear conflict of interest, and given that none of the major vendors has a clear winner, isn’t this like asking reps of GM, Ford, and Chrysler to determine which auto will be the military’s next fleet car?

  25. Dear Epic Customer: I appreciate your question and the manner in which you asked it. Thanks.
    To me, the major issues are transparency and leadership. I’ve met Ms. Faulkner and I’ve known Dr. McCallie for many years. They’re fine people, with a lot of talent and experience. Personally, I have no problems with them being on the new HIT Committees working under the direction of David Blumenthal. Personally, also, I would have liked to have seen more primary care physicians with IT experience on those Committees, because I think that experiential base is under represented. Again, personally, I don’t think this group needs more “pure IT specialists.” Certainly not! 😉
    Importantly, this is a group of people who will be working in the sunlight, so to speak. We will hear what they have to say, how they conduct their meetings, and we’ll be able to judge the extent to which they can or cannot put aside their narrow self interests (which we all have, of course) to work for the common good and the common objectives. This transparency is very important to establishing trust in the process.
    Ultimately, it is David Blumenthal’s responsibility to lead this group with skill and purpose, towards the objectives and goals that they have had set out before them by statute. And I do trust that he has the capabilities to do this. Even if I did not know something about him, I’d be willing to give him the benefit of the doubt. And we’ll be learning rather quickly what kinds of results we’ll get, and what kinds of compromises will be made.
    I’m not dogmatic on these issues. I believe that public policy ought to serve the public, first and foremost, and not so much the special interests. Yet there is always going to be a matter of balance between the two. My worry is that CCHIT is out of balance as currently structured, organized, and led. Can balance be restored? Sure. This is what I hope will occur, and to some large extent it will be up to the Committees and Dr. Blumenthal to oversee that process.
    Again, many thanks for a very good comment in what I hope will be a fruitful discussion that moves us forward and finds common ground.
    Kind regards, dCK

  26. If we are concerned about the role of CCHIT should we be concerned that vendors who developed and sell these products are now advising the ONC about the policy and standards for the industry?
    Do people have the same concern about having the President of one of the largest EMR vendor’s in the country (Epic’s Judy Faulkner) sitting on the new ONC Policy Committee?
    or that the new ONC Standards Committee includes another EMR vendor – Cerner VP of Medical Informatics David McCallie?
    Should they step down? Or in fact are these the very experts who you want to be staffing these organizations? Who would you like instead? Pure IT specialists?

  27. It is indeed important that these questions be asked. Dr. Leavitt’s unwillingness to have uncomfortable questions asked is a very good illustration of why they must be. Pluralistic democracy requires it.

  28. David,
    Sounds like you hit a hot button!
    The fact is, a great many people share your concerns and their positions should be aired before we blindly proceed down a path that may lead to very unsatisfactory unintended consequences.
    Don’t let Leavitt’s pique stop you from speaking up. Lots of us will vigorously support you! That’s what democracy is all about!

  29. David, I applaud you for taking the high road in responding to Dr. Leavitt’s impulsive, mean-spirited, and bizarre attack.
    Keep asking the right questions about the relationships among HIMSS, CCHIT, and Dr. L.d We deserve answers.
    Vince

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