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Certifying Health IT: Let’s Set the (Electronic Health) Record Straight

Mark LeavittThe Stimulus bill catapulted health IT – previously the domain of clinicians with a passion for applying  technology to improve healthcare – onto the national stage.  When you inject billions of taxpayer dollars, politics inevitably comes with it.  There have been valid observations that CCHIT’s approach needs to change in this new world, and I wholeheartedly agree.  But I’m stunned by the level of dishonesty a few have stooped to in a desperate attempt to toss aside years of work by hundreds of public-spirited contributors.  Perhaps they want to bypass the challenge of supplying robust electronic health records and re-educating clinicians to use them meaningfully in transforming care, and just get unfettered access to some stimulus dough. 

For months, I’ve been “turning the other cheek” to Dr. David Kibbe because I believe in devoting my energy to solving problems rather than to criticizing other people or worrying about what others think of me.  But his 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.

David, in your most recent quote for the  Washington Post, you called CCHIT a “vendor-founded, -funded and -driven organization.”  So let’s take a look at the Commissioners, in chronologic order of service, who have served since our founding in 2004 — people who have been at the core of an organization you claim to be tainted:

Martin Harris MD, Doug Henley MD (whoops, your boss!), John Hummel, Sam Karp, Charles Kennedy MD, Graham King (vendor), Jane Metzger, Susan Postal, Wes Rishel, John Tooker MD, Reed Tuckson MD, Andy Ury MD (vendor), Abha Agrawal MD, Richard Atkin (vendor), Stephen Badger, David Bates MD, Karen Bell MD, Ned Calonge MD, Jane Delgado PhD, Suzanne Delbanco,  Jeff Hillebrand, Chris MacManus, Denni McColm, Susan Miller RN, Jim Morrow MD (signed up with a vendor recently, so stepping down), Jonathan Perlin MD (big trouble — the scandal spreads to the new Standards Committee), Andrea Gelzer MD,  Michael Ubl, Andy Wiesenthal MD, Jonathan White (AHRQ apparently in cahoots too),  Steve Arnold MD (vendor),  Rick Benoit (vendor), Sarah Corley MD (vendor), John Derr RPh, Linda Hogan, PhD, Mike Kappel (vendor), Joy Keeler, Jennifer Laughlin, David Merritt, Rick Ratliff, David Ross ScD, Don Rucker MD (vendor) – I’ll stop here, since those who want more information about our founding, funding, history and leadership have always been able to find it at our  HYPERLINK “” website.  Again quoting you in the Post, “even the appearance of a conflict of interest could poison the whole process.”  In support of this heartfelt concern for transparency, could you arrange for the Washington Post to append to your statements a disclosure of any possible conflicts of interest you might have?  Such as financial relationships with companies that market health IT products or services?  I have none.  Our standard regarding conflict of interest is the Federal one: any financial compensation, or any stock holdings over $10,000 by you or a family member.  David, the biggest challenges for health care lie ahead for all of us.  I hope we’ll see more of your talent invested in creating great new ideas rather than wasting it in this way. 

Mark Leavitt, MD, PhD, is Chair of the Certification Commission for Healthcare Information Technology (CCHIT).

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  1. Why is gold used in electronic products as a conductor instead of
    silver? I believe silver is the better conductor of the two metals,
    but sometimes they seem to use gold instead of silver. Could this be
    because the electricity passes on the surface of the metal and
    silver’s surface is more easily tarnished than that of gold which
    doesn’t tarnish? (The tarnished silver surface doesn’t conduct as well
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  2. If you were a doctor…..what would you think of a patient who is “mentally ill”?
    Here in Texas, there are some hospitals and medical centers that are talking about integrating mental health care and general health. In plain English, this means that if a general hospital pulls up your electronic health record, it will also know if you’ve had mental health treatment. So, if you are “mentally ill” and see your primary care doctor, he/she will know immediately.

  3. I believe in record keepng. I should be to one who controls the flow of information. This matter only concerns my doctors and insurance companies, not the
    federal government.

  4. “A small software company that caters to primary physicians practices in their community will undoubtly find the cost of entry to market extremely high and almost impossible.”
    “Unfortunately, I see CCHIT as a strong arm to deny independent developers the right to continue in this arena.”
    Amen.
    The software world itself is changing, and if Health IT ever wants to be on the cutting edge, it needs to change too.
    Dr. Leavitt, being the chairman of a committee on health IT certification, I can only assume that you have some technical background. Have you noticed that this very blog is hosted on the Apache web server? It’s open source, and the very best web server there is. Given that it was written on zero budget, I wonder where this blog would be if the authors had to pay $30,000 to certify compliance with a standard?
    I have nothing wrong with commercial standards certification companies as long as they bill themselves as such. But when Federal money is concerned, and it becomes a national standard, we as Americans have a responsibility to support all innovation, to support the development of the best software possible. And the fact of the matter is, in this day and age (just look at the web, Apache, Mozilla Firefox, Linux, etc. as examples) that innovation may very well come from someone with much less money than a certification costs.
    -Jason Antman
    Systems Programmer, Rutgers University, NJ
    NJ EMT-B.

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  20. I believe the certification process for the EHR should involve more than one certifying body. CCHIT should not be the ultimate certifying body. The price is outrageous! I agree it caters to the larger vendors and leave the door nearly closed for the smaller vendors. Large is not always better. After working with some larger vendors (Epic and Cerner)and then experiencing smaller vendors (StatCom)I was much more impressed as a clinician with the StatCom product and what it had to offer for what it had to offer. Larger vendors tend to have more management than support persons who are intimate with their product.

  21. Electronic Health Records: Why They Won’t Help Patients
    The patient is blaringly absent from the health portion of the 2009 Economic Stimulus Act. Billions of dollars have been earmarked by Congress to encourage doctors to create electronic patient health records. But, no where is the focus on sharing the computerized information with patients.
    I have supported electronic health records for two decades. In fact, in 1997, I co-authored a book for the Financial Times (UK) entitled “Electronic Patient Records, Smart Cards and Confidentiality.” We wrote:
    To provide quality health quality healthcare, medical providers need to know a patient’s complete medical history, have quick access to laboratory and diagnostic test results, and be aware of treatments and medications that have been given or are currently being taken.
    Each patient needs personal medical data in hand when they require medical care. So I was happy that my many medical doctors have put information about my health conditions on their computers. I am unhappy that I cannot get access to my medical information electronically.
    I asked each of my specialists (7doctors in total) to e-mail my records to me. “Oh no, the HIPPA law prohibits this,” each exclaimed. I offered to sign a release from liability if they would do so, still the answer was no. “Can I read my record?” I asked, and was told that I could not. Some offered to mail me a copy.
    Furthermore, I asked them to send my records electronically to my other physicians and hospital based doctors. They answered no, because they did not know if my other doctors’ computers had interoperability with their computer systems.
    I know that medical mistakes occur when patients are wrongly diagnosed, patients are prescribed wrong medications and patients are given wrong treatments. Mistakes can be reduced if health providers have the correct information. This can be provided electronically, if the patient can carry a copy her own computerized records.
    Should I need emergency care, I want health personnel to immediatly know:
    • I have had cardiac bypass surgery and an angioplasty procedure with a medicated stent. Yet, I have no heart damage;
    • I am taking a medication that lowers my blood clotting time;
    • I have diabetes and that I take specific drugs to keep it under control.
    And I want them to know all my information quickly, before treatments are begun. Not after waiting until they hear from my internist’s, cardiologist’s endocrinologist’s and oncologist’s computers.
    Therefore, I decided to create my own electronic health record, because I haven’t seen any legislation that focuses on patients’ needs. I will place my information onto a flash drive. I intend to wear this computerized drive around my neck or wrist in order to have my data readily available and accessible. In fact, if I decide to move, like so many of my young colleagues, I can take my record to new doctors.
    Now that I have told you of my concerns, I have some constructive suggestions:
    1. Amend HIPPA to state clearly that a patient has the right to obtain her own medical record.
    2. If the record is computerized, the patient has the right to get the record electronically.
    3. Physicians should be required to give the patient a “read only” CD with her pertinent information on completion of a visit.
    4. Use state and local health insurance assistance centers to help people create their own electronic medical records.
    Eleanor G. Feldbaum, Ph.D.
    Co-Founder of http://www.triphealthy.com

  22. (I apologize for the duplicate Comment. It did not show up for quite a long time after I first attempted it. Thank you for your forbearance.)
    Reed D. Gelzer, MD, MPH, CHCC
    Advocates for Documentation Integrity and Compliance

  23. This has been a fascinating discussion. My (lengthy) nickel’s-worth, donning one of my EHR domain hats, that of a three-year volunteer to CCHIT (and, incidentally, spouse to a past Commissioner) I would disagree with Dr. Leavitt’s assessment of Dr. Kibbe’s remarks in the Post. On the contrary, I found the Post article a helpful “status check” and Dr. Kibbe’s remarks, if somewhat strident, nonetheless reasonable concerns.
    However, as I’ve discussed with Dr. Kibbe in other settings, I would also point out that Dr. Kibbe is at least partially in error on a point that seems to be implied, but not stated. In truth, though, he is in good company with this error it is very common in discussions about CCHIT. That implication is that CCHIT was intended, at its origin, to have an overarching charge to serve the public good which is not accurate.
    It is much easier to understand, accept, and move forward from the current state of CCHIT if one returns to its actual original functional purpose. That purpose was, in advance of comprehensive EHR Functional Standards (which HHS had tasked to HL7 in 2004), to provide a platform where a subset of stakeholders-payers, vendors, and providers, could establish a process to “normalize” a basic set of EHR functions, a “floor” if you will, for initial, basic qualifications. At that time, HHS was pressing payers to, in some manner, favor EHRs but the payer community reasonably asked, “any EHR?”. The main, if not the only overt public purpose was to also increase interoperability, again as described on CCHIT’s website.
    In other words, to fault CCHIT for representing its limited component stakeholders’ interests instead of the broader public good is to hold it to purpose it was never intended to meet. It also then deems a failure what has been its major success. It has, in fact, provided a platform by which those few represented stakeholders have greatly advanced the US towards what the Institute of Medicine’s seminal 1990 Computer Based Patient Record report said would be accomplished by 2000. (So much for EHRs for everyone by date X.)
    Now we are simply realizing that the original limited stakeholder configuration has accomplished a given state, but that that state is not acceptable to the entire range of actual stakeholders and is not ready for mass deployment. It isn’t that the objectives reached are flawed, they are simply insufficient, with too many gaps, oversights, and limitations remaining as a direct result of its limited purposes. Once this is understood we can move to the next step and, given the increases in deployments envisioned by the Obama administration, its critical we move to that next step quickly because some existing limitations must be rapidly addressed as they represent such significant risks to the health care enterprise that mass deployment is unconscionable, yet today that is what is being mapped out under HITECH.
    So, as Dr. Kibbe and many others, including myself, say, it is now time to assess the state of Certification and to reconfigure the stakeholders and governance to fill in the gaps and better attend to the weaknesses. In effect, the HITECH Policy and Standards Commitees are intended to accomplish this (though their stakeholder composition may raise concerns as well). Whether this necessitates CCHIT’s demise, augmentation, or facilitating competition remains to be seen and will be, fundamentally, a political question. CCHIT has adapted and is undoubtedly capable of further adaptation. Indefensible claims of virtue can suggest a certain lack of adaptability. On the other hand, a recent CCHIT acknowledgment that anti-fraud supports in EHRs are needed speaks for adaptability. Only time will tell. In the meantime, there is zero practical risk that the legacy of work done to date by so many committed volunteers will be discarded. It simply represents too valuable a resource, however insufficient, to wholly discard. Much of it is based on existing standards and stands as is, some will be superseded by updated and new standards, including the newly completed HL7 Records Management and Evidentiary Support Profile, an addition to the HL7 EHR-S Functional Model Standard (itself finally passed in 2007). (That said, I wager we confront the reality that, as of June 2009, there is no such thing as an HL7 EHR Functional Model-adherent EHR.)
    Whatever the future configuration of Certification, I would, though, additionally and most strongly caution CCHIT about overstating the comprehensiveness and meaningfulness of its current requirements. For example, at the recent HIMSS convention, updating EHR testing showed that none of the four CCHIT-certified ambulatory EHRs I evaluated produced an accurate record of the test scenario used, with two authors providing different parts of the services in the course of a routine patient visit (a basic requirement in Ambulatory, where commonly there are at least two people contributing to the each encounter record).
    The recently passed added accuracy and Compliance supports in 2009 Ambulatory will necessitate the capture multiple authors, but actually producing an output showing accurately which author did did what won’t be required until 2010 by the current schedule (now delayed to align CCHIT with ARRA-HITECH timelines).
    Until the 2009 requirements (again not yet in effect), an EHR could obliterate the original version of an amended record and still pass Certification.
    (Continued on next Comment)

  24. My apologies, this is a lengthy comment. I hope, though, it will clarify some fundamental points and suggest an approach for concord over discord.
    Donning one of my EHR domain hats, that of a three-year volunteer to CCHIT (and, incidentally, spouse to a past Commissioner) I would disagree with Dr. Leavitt’s assessment of Dr. Kibbe’s remarks in the Post. On the contrary, I found the Post article a helpful “status check” and Dr. Kibbe’s remarks, if somewhat strident, nonetheless conveying reasonable concerns.
    However, as I’ve discussed with Dr. Kibbe in other settings, I would also point out that Dr. Kibbe is at least partially in error on a point that seems to be implied, but not stated. In truth, though, he is in good company with this error as it is very common in discussions about CCHIT. That implication is that CCHIT was intended, at its origin, to have an overarching charge to serve the public good. This is not accurate.
    It is much easier to understand, accept, and move forward from the current state of CCHIT if one returns to its actual original purpose. That purpose was, in advance of comprehensive EHR Functional Standards (which HHS had tasked to HL7 in 2004), to provide a platform where a subset of stakeholders-payers, vendors, and providers, could establish a process to “normalize” a basic set of EHR functions, a “floor” if you will, for initial, basic qualifications. At that time, HHS was pressing payers to, in some manner, favor EHRs but the payer community reasonably asked, “any EHR?”. The main, if not the only overt public purpose was to also increase interoperability, again as described on CCHIT’s website. As a prior commenter notes, it is a fairly basic set of functions, though, as I’ll detail later, not basic enough in some key respects.
    In other words, to fault CCHIT for representing its limited component stakeholders’ interests is hold it accountable to a goal it was never intended to meet. It also then deems a failure what has been its major success. It has, in fact, provided a platform by which those few represented stakeholders have greatly advanced the US towards what the Institute of Medicine’s seminal 1990 Computer Based Patient Record report said would be accomplished by 2000. (So much for EHRs for everyone by any date X.)
    Now we are simply realizing that, while the original limited stakeholder configuration has accomplished a given state, that state is not acceptable to the entire range of actual stakeholders. It’s not that the objectives reached are fundamentally flawed, they are simply insufficient and too many gaps, oversights, and limitations remain serving the purposes of some, but not all. Some of the existing limitations, though, must be rapidly addressed as they represent such significant risks to the health care enterprise that mass deployment is unconscionable, yet today that is what is being mapped out under HITECH.
    So, as Dr. Kibbe and many others, including myself, say, it is now time to assess the state of Certification and to reconfigure the stakeholders and governance to fill in the gaps and better attend to the weaknesses. Whether this necessitates CCHIT’s demise, augmentation, or facilitating competition remains to be seen and will be, fundamentally, a political question. CCHIT has adapted and is undoubtedly capable of further adaptation. Indefensible claims of virtue can suggest a certain lack of adaptability. On the other hand, a recent CCHIT acknowledgment that anti-fraud supports in EHRs are needed speaks for adaptability. Only time will tell. In the meantime, there is zero practical risk that the legacy of work done to date by so many committed volunteers will be discarded. It simply represents too valuable a resource, however insufficient, to wholly discard. Much of it is based on existing standards and stands as is, some will be superseded by updated and new standards, including the newly completed HL7 Records Management and Evidentiary Support Profile, an addition to the HL7 EHR-S Functional Model Standard (itself finally passed in 2007). (That said, I wager we confront the reality that, as of June 2009, there is no such thing as an HL7 EHR Functional Model-adherent EHR.)
    I would, though, additionally and most strongly caution CCHIT about overstating the comprehensiveness and meaningfulness of Certification requirements. For example, at the recent HIMSS convention, updating EHR testing showed that none of the four CCHIT-certified ambulatory EHRs I evaluated produced an accurate record of the test scenario used, with two authors providing different parts of the services in the course of a routine patient visit (a basic requirement in Ambulatory, where commonly there are at least two people contributing to the each encounter record).
    The recently passed added accuracy and Compliance supports in 2009 Ambulatory will necessitate the capture multiple authors, but actually producing an output showing accurately which author did did what won’t be required until 2010 by the current schedule (now delayed to align CCHIT with ARRA-HITECH timelines).
    Until the 2009 requirements (again not yet in effect), an EHR could obliterate the original version of an amended record and still pass Certification.
    So, current (2008) CCHIT Certification does not yet require basic records accuracy and trustworthiness supports which, as both Dr. Leavitt and Dr. Kibbe know, has been a primary point advanced by my organization but remaining unfulfilled by CCHIT Certification. Why basic medical records business rules can continue to be violated under Certification is, to me, a key point that demonstrates that CCHIT, as currently configured, has outlasted its utility. It is not bad, it has simply reached the end of its current configuration’s abilities to provide the necessary full range of stakeholders with EHRs supporting accuracy, trustworthiness, and so, comprehensive value. If it persists in its current form, it will simply be a continuing drag against accurate, trustworthy EHRs by also abetting the persistence of improperly designed systems that, even when used as intended, cannot auditably support standard medical record functional requirements.
    Back on track, where must Certification go, now given the HIT stimulus money to flood into the marketplace? Unfortunately, we have a sudden new reality and no time to incrementally evolve CCHIT. We’re going to spend billions to stimulate uptake of EHRs that, if current CCHIT requirements are used, cannot even be 2007 HL7 Functional Model Standard compliant. Furthermore, even by 2014, the likelihood that they could additionally be compliant with the Records Management Evidentiary Support (RM-ES) Profile, is zero. There simply isn’t sufficient time to incrementally modify CCHIT requirements by its current guidelines, even if the only changes the market demanded were Functional Model and RM-ES Profile compliance, which clearly cannot be so.
    So, generally speaking, today and for near future I see three broad choices for where to go from here for EHR Certification:
    1. Explicitly accept that we’ll spend many billions (the stimulus money only being the incentives, not the actual costs of course) on getting many, most, or everyone onto non-standardized, non-compliant, less-than-trustworthy but nonetheless incrementally and minimally “Certified” systems by 2014. To get a trustworthy medical record, place the burden for basic records management due diligence on the purchaser/user, the defects burdens on the patients and providers.
    2. Augment current requirements immediately with basic Records Management requirements that raise the “floor” to match other business domains’ minimum necessary, such as Federal Rules of Civil Procedure requirements for legal admissibility as business records, as the “minimum necessary trustworthiness”. (This would put the emphasis for assurance more onto the marketplace, favoring those existing systems that already been built to support trustworthiness and integrity and that have advanced onto modern program designs and force obsolete designs to change or fail. Think Toyota, Ford vs. GM.)
    3. Set aside HITECH’s timelines, pending a HITSP, Policy Committee, Standards Committee, etc. consensus that robust, compliant, trustworthy records systems exist in sufficient numbers, at low enough cost, and are sufficiently interoperable to testably assure an accurate reliable bedside longitudinal record, basic trustworthiness is a “minimum necessary” for all.
    Unfortunately, the current majority plan is item 1.
    Like Dr. Kibbe, I have the audacity to hope that we can do better, based on science, engineering, and good clinical care, with the minimum of wishful thinking and well-meaning though uninformed rhetoric. As a realist, though, to provide for the option that item 1 will remain the national policy, due diligence testing tools are available. One thing Dr. Leavitt, Dr. Kibbe, and thousands of others share is certitude that HIT is a critical component for improving all aspects of health care, we just disagree on the path to achieve that promise. (BTW, the HL7 Functional Model, Interoperability Model, and Records Management-Evidentiary Support Profile, as well as, undoubtedly, other EHR-related Standards, already merit updating. We’ll be improving Standards and systems for generations, so let’s also work on adjusting expectations and settling in for a more comfortable ride because it is going to be a long one.)
    That’s my rant for today, sorry it ran on for so long. Remember we all are working toward the same end, just debating who should navigate and whose benefits first. Cheers!
    Reed D. Gelzer, MD, MPH, CHCC
    Advocates for Documentation Integrity and Compliance.

  25. Mark Leavitt, WHERE ARE YOU? Will “Uncle Steve” give you permission to come out and play?

  26. Mark Leavitt, WHERE ARE YOU? He is waiting for “Uncle Steve” to give him permission to speak.

  27. In a recent New Yorker article (http://bit.ly/64H1P), Dr. Atul Gawande accurately depicts the root cause of our health care crisis – misaligned incentives.
    Two additional articles, one in BusinessWeek (http://bit.ly/Ei4QQ), the other in the Washington Post (http://bit.ly/Jn5xq), suggest that some aspects of health information technology actually may not be part of the solution, but potentially may be part of the problem.
    To paraphrase Shakespeare, Dr. Leavitt “doth protest too much, methinks.” His remarks, by their nature, tend to prove the very points he is disputing.

  28. Dr. Silverstein: In general I found the documents you provide links to to be enlightening. For example these points you cite above, drawn from those documents, make sense to me:
    · user-centric design practices in industry through studying health IT problems that legitimately cause physician resistance,
    · empowerment of Chief Medical Information Officers (CMIO’s) with executive presence and managerial authority,
    · reformation of the hospital MIS department “designer-centric” culture,
    · improved financial incentives for IT adoption,
    · studies of systemic organizational and societal barriers with an aim to improve them.
    Regarding Ludditism, the behavior of physicians, likely most physicians, can be accurately characterized as Luddite, as defined as resistance to change that they fear will disrupt the patterns of activity that they feel comfortable with. None of your points seems to me to contradict that assertion.
    In this posting the change “agent” resisted is the adoption and use of computer technology to record clinical activity, so that the data recorded can later be manipulated or transmitted electronically, rather than manually.
    The source of the resistance goes further than resistance to incorporating computer interaction in regular clinical activities, it extends to “work processes” that physicians and clinical/administrative support staff are used to. The economic structure of providing medical services, as I repeatedly note, insulated service providers to the pressures exerted in a competitively-determined market. Therefore these providers are largely oblivious to those pressures that providers of other services or products experience continually, with the consequence that they change work processes to deliver services at every lower prices.
    In regard to the delivery of medical services, I have been reading a recently published book by a noted management scholar, Clayton Christensen, whose academic work is centered on what he calls “disruptive” innovation, the source, in his study, of much positive change in economic activity.
    He and his two co-authors, both practicing (one died before publication of the book) physicians, analyze the healthcare system in the USA using this perspective. In my opinion the analysis presented in the book (1) is accurate, (2) shows how the healthcare industry as now constructed can be changed to permit “disruptive agents” to take hold.
    One key element of enabling the disruptive agents is the universal implementation of EMR systems which is the topic in this posting.

  29. This is really getting funny. EMR Update, Kibbe, Lynn, Planchart, Margaret A. and many others have taken pot shots at CCHIT for years. Where were they 4 years ago when there no way for a physician to compare one EMR to another? What have they done to help the process? Kibbe has tried, can’t say about the rest. How about lighting a candle before you curse the darkness. When Leavitt finally stands up to answer the incredible charges that slander CCHIT’s staff, mission and volunteers everyone runs back to their holes and acts like they are the victims. Get real, maybe CCHIT’s time has passed, but your actions and charges do not bring credit to your reputations.

  30. “2. Provide allowance for data entry personnel for private practices. HIT represents, in fact, the largest transfer of clerical work to skilled professionals, ever.”
    “2. Technology as is is intrusive. Physicians can’t give quality care with a computer shoved between their face and the face of the patient. This would also create jobs. I agree.”
    Gentleman:
    Are you really saying that for HIT to be “efficient” each provider would need to be accompnied from exam room to exam room by a full-time data entry clerk?
    That would increase my payroll by 50%. And this saves the system money by . . . ?
    Thanks.

  31. aten.olol,
    Could you use a name other than a medicine?
    What do you mean by: “your own conflicts and self interest”? Please expound.
    Thanks,
    Michael Planchart

  32. As someone who has worked with small practices and independent physicians, I can say that CCHIT does serve a purpose. At the very least it qualifies companies to be financially stable enough to pay for certification. It wasn’t long ago when all 500 EMR vendors were out competing for business, and physicians bought the system was functional enough for them at a price they could afford. Unfortunately many of those initial 500 vendors are gone, leaving these practices to support themselves.
    More importantly, transitioning data from one EMR to another has not exactly been proven effective or affordable at this time. Without CCHIT, I suspect many more practices would be investing in systems that may not be around in 2 years.
    Like Reality Check said, it is irresponsible/insane to let patients suffer because physicians don’t have the guidance to choose the right EMR the first time around.
    That said, I respect the argument that CCHIT increases barriers to entry and limits innovation.

  33. “2. Provide allowance for data entry personnel for private practices. HIT represents, in fact, the largest transfer of clerical work to skilled professionals, ever.”
    “2. Technology as is is intrusive. Physicians can’t give quality care with a computer shoved between their face and the face of the patient. This would also create jobs. I agree.”
    Gentlemen:
    Are you really saying that effective use of HIT requires a full-time data entry clerk assigned to follow each provider from exam room to exam room?
    With four providers in our office, we utilize a part-time transcriptionist/medical records clerk. Hiring 4 data entry clerks would be tremendously expensive.
    Thanks.

  34. aten.olol,
    You need to study the lesson here:
    http://www1.ca.nizkor.org/features/fallacies/ad-hominem.html
    I forgot to respond to this statement of Wendell Murray
    “Comments such as R. Watkins’ about the the poor performance of EMR software do not reflect reality. All well-designed commercial products that have been introduced or refactored since, 2000 to arbitrary set a date are good and function well. Failure is inevitably caused by poor implementation of one type or another”
    Mr. Murray, the National Research Council of the National Academies has much more to say on this issue, and they make their statements that refute the view of HIT as “working well” based on rigorous observational study and decades of expertise. The press release is at the link below; read the full report.
    http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=12572

  35. CCHIT criteria are the bare minimum expectations of functionality that is needed in a system to perform workflows and improve care. What is the point of installing EHRs if you can’t improve patient health through basis preventative things like smoking cessation counseling, mammograms and flu shots.
    Read the criteria yourself (http://www.cchit.org/certify/index.asp). They are mostly minimum functions needed for real workflows and certification is very open to innovative ways of meeting the criteria. Some are non-obvious and are typically things that have put patient’s at risk when vendors didn’t do them in the past.
    With the new stimulus gold-rush even more half-baked systems are sure to pop-up. Putting patient’s at risk and wasting a hospital or clinics time and money figuring out which vendors are all talk and no functionality is insane.

  36. Dear Michael P,
    I am impressed by your intelligence. Your comments are most articulate but you proffer a disdainful intolerance for concepts that do not espouse your views. You project an ulterior motive for your judgmental comments, such as perhaps, your own conflicts and self interest. Tell us what it is like to deal with the FDA. Have you had any experience with CCHIT? Have you used any CCHIT certified gear?
    Thanks

  37. Responding to Dr. Silverstein:
    BTW: I didn’t mean to mispell your last name in the previous post. These blogs don’t give second chances!
    1. Penalties will have negative effects and they will be impossible to enforce. I agree.
    2. Technology as is is intrusive. Physicians can’t give quality care with a computer shoved between their face and the face of the patient. This would also create jobs. I agree.
    3. I think Private physician practice EMRs are overpriced. Excessively. I don’t agree.
    4. The deadline is ridiculous and it reminds me of incompetent project managers that I have worked with that had no idea what they were doing but they would set pleasing deadlines. I agree.
    Thanks,
    Michael Planchart

  38. Michael Plankart writes:
    “You do leave me thinking about the ARRA incentive in point #5. What would be an adequate incentive approach?”
    1. No penalties. Use persuasion, as under Bush and the prior two ONC chiefs (Brailer and Kolodner, the latter was from the VA where the excellent VistA/CPRS system was created, free working demo at http://www1.va.gov/cprsdemo/ )
    2. Provide allowance for data entry personnel for private practices. HIT represents, in fact, the largest transfer of clerical work to skilled professionals, ever.
    3. Provide remediation of expenses over and above what is currently allocared – tax exemptions would be one example.
    4. End the time pressure. 2014 is an absurd, politically motivated deadline. See “Predicting the Adoption of Electronic Health Records by Physicians: When Will Health Care be Paperless?”, Ford et al., JAMIA 2005, http://www.jamia.org/cgi/content/abstract/13/1/106 .
    People actually have studied most of the issues the “HIT industry elite” often proffer in the throwaway journals from the seat of their pants.
    Finally, CCHIT would not have found problems like this:
    http://www.ischool.drexel.edu/faculty/ssilverstein/DUCOM_EMR_Complaint.pdf

  39. Cepy,
    Thank goodness there is only one FDA in the universe!
    If CCHIT would have FDA’s attributes then we wouldn’t have 1% of hospitals with an EHR. We probably wouldn’t have very many computers in the whole healthcare domain in the US.
    Precisely, I work in the radiology sub-domain and I know what it is to deal with the FDA.
    CCHIT can NOT include assessment of any machine. CCHIT only certifies functionality of software according to pre-defined criteria. CCHIT has absolutely nothing to do with machines! CCHIT is not a regulatory or enforcing entity.
    Comparing the role of CCHIT with the one of the tobacco institute is ludricous!
    Let’s please keep this discussion intelligent and without unsubstantiated accusations.
    Thanks,
    Michael Planchart

  40. To know about CCHIT, it is sufficient to just know that the CEO of Allscripts, Chicago, Ill., Mr. Glen E. Tullman is a Trustee of CCHIT, Chicago, Ill. One of Tullman’s other claims to fame is to be an HIT counselor to President Obama, Chicago, Ill.
    CCHIT functions as an HIT industry trade promoting group and is not unlike the Tobacco Institute’s role for the tobacco industry.
    When asked, Mr. Leavitt, Chicago, Ill., acknowledged that CCHIT certification does not include any assessment of safety and efficacy of the machines it is certifying, nor is CCHIT providing any modicum of after market surveillance to protect patients from the flaws and defects of its industry’s products.
    Thus, if a CCHIT certified device results in the death of a patient (and they do), there is no body to which to report any such adverse event. CCHIT DOES NOT DO THAT WORK. This goes hand in hand with the HIT industry wide policy of contractual gag clauses to hide the dangers of its products.
    The certification that CCHIT provides has undoubtedly deceived Congress.
    It has given lawmakers the erroneous impression that CCHIT is performing rigorous FDA like approval. If Congress had known that HIT products had not been proven safe and effective, I would give them the benefit of the doubt and say that ARRA would not have wasted taxpayer dollars on such an experiment.
    Cepy

  41. Dr. Silverstein,
    Excellent response. I have to admit to concur with you on most of them if not all. Your input has added enourmous value to what has become a great discussion.
    I would include that the CTO figure with healthcare IT background should be present and with managerial authority as well. The role of the CIO has proved not being able to balance business with technology very well. This is with respect to larger healthcare organizations, of course.
    You do leave me thinking about the ARRA incentive in point #5. What would be an adequate incentive approach? What would work?
    Thanks,
    Michael Planchart

  42. Michael Planchart writes:
    “I was asking for your main ideas. Seven bullets would suffice”
    They are at the end of the main essay at my academic website at http://www.tinyurl.com/hit-misadventure .
    From that site:
    “We believe there are a number of key issues that need to be addressed. These might be categorized as follows:
    1. Resistance of some clinicians to rigorous information practices that support quality and safety (which is inclusive of, but not exclusive to, IT resistance);
    2. Resistance of the clinical IT vendors to high-quality user-centered design practices;
    3. Resistance of IT personnel within delivery organizations to user-centered design practices i.e., in customizations of vendor-acquired products, or internal development of specialized systems;
    4. A belief in IT solutions by many stakeholders as a “magic bullet” or panacea – i.e., build an IT system and miracles in clinical quality, operational, compliance and documentation improvements will occur.
    5. Financial disincentives for many providers, expecially community based clinicians, to adopt clinical IT [even the ARRA incentives are not really adequate];
    6. Knowledge that existing systemic organizational faults do contribute to errors in health care delivery.
    As leaders in the transformation of modern medicine, addressing these issues requires consensus to build strength and voice for which the informatics community must lobby. The policy initiatives that informaticists pursue should result in:
    · user-centric design practices in industry through studying health IT problems that legitimately cause physician resistance,
    · empowerment of Chief Medical Information Officers (CMIO’s) with executive presence and managerial authority,
    · reformation of the hospital MIS department “designer-centric” culture,
    · improved financial incentives for IT adoption,
    · studies of systemic organizational and societal barriers with an aim to improve them.
    I would also add these points from the article “Hiding in plain sight: What Koppel et al. tell us about healthcare IT” (read the whole thing) by Nemeth and Cook at http://www.ctlab.org/documents/Hiding%20in%20plain%20sight.pdf :
    … The workers that Koppel et al. studied recognize that their CPOE system is not a team player [8]. This kind of failure is not limited to clinical healthcare IT. IT has not been a good team player in other work sectors either, despite enormous investments of time and effort. Klein et al. [9] contend that any participants in joint activity, including automation components, must:
    · Enter into a basic compact—Agree that participants intend to work together.
    · Be mutually predictable—Enable others to know what to expect through shared knowledge and idiosyncratic coordination based on long experience or by substituting explicit procedures and expectations.
    · Be mutually directable—Able to deliberately assess and modify others’ actions as conditions and priorities change and respond to the influence of others as activities unfold.
    · Maintain common ground—Take action to preserve the pertinent knowledge, beliefs, and assumptions that involved parties share.
    This by all means includes avoiding stereotyping of physicians as “Luddites.” Not only is it crass, simpleminded and bigoted, it is quite inaccurate. Unlike those who guess, I’ve supervised a PhD thesis that created a pre-HIT implementation survey of physician attitudes using well known technology diffusion theory and validated instruments.
    Like most of the world, the reality of physician attitudes is quite complex, as in any other group, perhaps skewed by the responsibility and (absolute) accountability physicians hold.
    I say “absolute” due to the “Hold Harmless” and “Defects gag” clauses under which most HIT is sold – see this article:
    Health Care Information Technology Vendors’ “Hold Harmless” Clause: Implications for Patients and Clinicians
    Ross Koppel, PhD; David Kreda, BA
    Journal of the American Medical Association 2009;301(12):1276-1278
    http://jama.ama-assn.org/cgi/content/extract/301/12/1276

  43. Following are a few more questions that I ask those who have apparent authority in the healthcare IT domain:
    1. Would multiple certification commissions competing against each other help lower the fee?
    2. Are the fees set in such a way that it is the actual cost of certification, even with the use of volunteers to help in the process?
    3. Should the fee be regulated by the government since it is a requisite imposed on EHRs in order to meet the “Meaningful use” misqualifier?
    4. You can certify functionality and you can validate “Meaningful results” but how can you certify “Meaningful use”?
    Thanks,
    Michael Planchart

  44. OK….. I’ve been patiently waiting and reading what the folks are posting here. It seems many are addressing questions to the author. Alas, no reply….
    So, Dr. Leavitt, (assuming you are at least reading this blog)was this just a drive-by blog post in order to throw out some vague accusations at Dr. Kibbe, just to level the media field? Or is CCHIT willing to engage in a meaningful dialog with the rest of the world?

  45. Dr. Silverstein,
    I appreciate your recommendations and I will follow through on purchasing those books and reading them.
    I was asking for your main ideas. Seven bullets would suffice.
    Thanks,
    Michael Planchart

  46. Michael Planchart writes:
    “Anyways, in brief terms, what would you suggest to us commentors of this blog for modernizing healthcare in terms of Electronic Health Records?”
    Start by reading three books. They hold much wisdom as to best IT practices to emulate, and worst practices to avoid.
    “Medical Informatics 20/20: Quality And Electronic Health Records Through Collaboration, Open Solutions, And Innovation by Goldstein et al., Jones & Bartlett Publishers, 1st edition.
    “Managing Technological Change: Organizational Aspects of Health Informatics.” Nancy M. Lorenzi & Robert T. Riley, Springer; 2nd edition (2004).
    “Understanding And Communicating Social Informatics” by Kling, Rosenbaum & Sawyer, Information Today, 2005

  47. Dr. Leavitt,
    Could you please answer the following questions on this blog:
    1. What is the breakdown of the $30,000.00 fee?
    2. How many man-hours does require (Please provide human count and days involved)?
    3. If the process fails the first time what does the vendor have to do? Are there second chances?
    4. Did the first vendors have to execute major modifications when they first attempted to certify?
    5. Can a small software developer become a volunteer in the certification process so that he can learn before he attempts it the first time?
    Thanks,
    Michael Planchart

  48. Wendell Murray writes:
    “Dr. Silverstein, I disagree. Ludditism is alive and well many places including among physicians. What percentage I do not know, but my guess is that the percentage is quite high.”
    You disagree, you don’t know, you guess?
    Did you review any of my links?
    Physicians, lo and behold: here is the type of cross-occupational invasion by “professionals” who “guess” in telling you how to run your profession.

  49. Dr. Leavitt,
    What is the breakdown of the $30,000.00 dollar fee for the certification process?
    How long does it take? How many technicians are involved in the testing process? Man-hours?
    If it fails on the first iteration what happens next?
    When the major vendors first certified with CCHIT did they have to significantly modify their applications?
    Thanks,
    Michael Planchart

  50. “With smart card technology”
    There something akin to this now: EMRyStick: http://www.emrystick.com/
    Dr. Silverstein, I disagree. Ludditism is alive and well many places including among physicians. What percentage I do not know, but my guess is that the percentage is quite high.
    The cottage industry nature of physician practices, the predictable and steady gross cash flow into practices (not to mention hospitals) in addition to next-to-no competitive market pressures, as found in other industries, equates to a lack of incentives, interest and knowledge to economize or to seek productivity-improving techniques or technology. Investments are made in equipment or technology that will be reimbursed on a predictable cost-plus basis, not on the basis of projected, but uncertain, gains in productivity.

  51. Had too much to say on this topic to put it here (also wanted links) so did a quick post that you’ll find here: http://chilmarkresearch.com/2009/05/27/cchit-attempts-to-set-record-straight/
    Bottomline:
    CCHIT certification has failed to drive increasing levels of adoption.
    CCHIT and HIMSS are quite close and share information and staff extensively.
    We will need a pluralistic or self-certifying process for EHRs if we wish to foster innovation and broaden he choices/options available to clinicians.
    As a side-note, completely agree with Wendall that many an EMR/EHR failure can be traced back to poor process planning, implementation, and training. It is time to stop bashing the software and point the blame where it most often belongs, with the adopting organization that fails to invest.

  52. Dr. Siverstein,
    I partially read your post on your website today, I would gladly like to finish it sometime tonight.
    I am sorry to learn of the terrible experience you had with the hospital management in that large U.S. hospital. I have also been at hospitals and have witnessed situations that would cause anyone to succumb to by mere disgust. To my perception it has always been due to a culture of negligence in that particular institution and it wasn’t only IT that was the problem it was more like a metastasis with the primary tumor located in the leadership.
    Anyways, in brief terms, what would you suggest to us commentors of this blog for modernizing healthcare in terms of Electronic Health Records? What approach would you take? Let’s assume that apathetic physicians represent a minuscule minority. Let’s also assume that the computer devices and all other related peripherals that are placed near patients are hospital grade.
    Thanks,
    Michael Planchart

  53. Dr. Leavitt,
    As a active practitioner who developed an EMR starting in 2002, I have tried to follow some of the CCHIT promotion. I find it difficult to keep up with the latest info and admit my ignorance, but would like to ask,
    Why is CCHIT Certification limited to a “one size fits all” process? It is reasonable to have a basic set of operational “requirements” e.g. demographic data collected, basic histories and problems. However, I do not feel that all EMRs should be expected to meet all the same standards. An EMR that is designed for use by Family Practice would have a different set of needs than an Oral & Maxillofacial Surgery practice. A behavioral health practice would not need the same requirements as an OB-GYN. A hospital need would be different than that of a cardiologist.
    Is there not some thought to defining levels of CCHIT certification e.g. Bronze, Silver, Gold & Platinum? If not, why not?
    Unfortunately, I see CCHIT as a strong arm to deny independent developers the right to continue in this arena.
    R. Terry Ellis
    DescriptMED, LLC

  54. Re: “Well, it took the stethoscope a very long time to be widely accepted by the medical community”:
    And a toaster for $100 is a bargain, compared to buying a Ferrari.

  55. Well, it took the stethoscope a very long time to be widely accepted by the medical community.
    History is repeating itself.
    The purple elephant with pink stripes glows in the dark. Turn off the lights!
    Thanks,
    Michael Planchart

  56. Dear Dr. Leavitt,
    I am surprised by your comments and sharp attacks on Dr. Kibbe. I do not need to defend him since his record and views are well established and for the public good. Instead I am dismayed that you, a government official, find a need to criticize a voice of reason instead of building a better model for us all. The CCHIT process is a process that thwarts and does not enable. It modulates the market place by placing barriers to innovation and deployment. The barriers are financial (pay to play) and the future as the only game in town. The barriers are also practical, requiring specific functionality that are not vested as best practice or evidence based nor are the requirements a “fit” for many subspecialty practices. Rather than having faith in the market to determine what products survive and what products do not, CCHIT imposes application “solutions” to the end user. I would have thought that you would spend time bringing as many products to the market as possible and not limiting the available products. This is an inherent and seemingly unsolvable problem. You may do the best for the field by considering leaving government service and rejoining private/industry focused efforts. That would be a better fit for all, transparency for you and an effective voice for the established vendors.
    James Kahn MD
    Professor of Medicine, UCSF

  57. Re: Wendell Murray and “Luddite Physicians”:
    Mr. Murray:
    The stereotype against physicians being “luddites” is so ignorant, I’d give any of my students raising such an accusation a severe rebuke.
    It’s clear those who raise such accusations are either ignorant of the HIT literature, or are simply ignorant.

  58. Mark, while we did business in the distant past, when I was key in selecting Logician for the hospital where I was CMIO, I cannot reconcile CCHIT’s “certifying” of health IT software I know from colleagues to have known defects, some possibly rising to the level of patient harm.
    I and like minded others have begun sharing our concerns with senior government officials who fortunately take a more critical approach to health IT safety issues than the “fair-haired” (i.e., elite) health IT academic and industry leaders themselves. The latter appear to have almost completely ignored the very serious issues raised at http://www.tinyurl.com/hit-misadventure , http://iig.umit.at/efmi/badinformatics.htm and other sites.
    I’ve tried to illustrate (within the limits of vendor gag clauses) some user experience issues at http://hcrenewal.blogspot.com/2009/02/are-health-it-designers-testers-and.html .
    Laissez-faire, hold-harmless, reveal-no-defects [1] attitudes are inappropriate when introducing experimental technologies into healthcare, where users and subjects of the technology have special rights and responsibilities compared to other industries (i.e., clinicians and patients).
    [1] Health Care Information Technology Vendors’ “Hold Harmless” Clause – Implications for Patients and Clinicians, Ross Koppel and David Kreda, Journal of the American Medical Association, 2009;301(12):1276-1278

  59. For The Record,
    I’m with you. CCHIT hasn’t proven to do anything effective yet, except instill a false (or at least unproven) confidence in an EHR system in order to sell more product. Until we see some data that CCHIT improves EHR adoption and implementation, I say out with it.
    I think it’s also interesting that no one’s pointed out that in a post talking about how CCHIT is not vendor driven has had so many vendor people as their commissioners. This image speaks volumes: http://www.emrupdate.com/cfs-filesystemfile.ashx/__key/CommunityServer.Components.PostAttachments/00.00.09.79.77/vendors.all.over.CCHIT.founders.jpg
    You can’t go for that many years driven by vendors money, vendors on the board and created by vendors and then later try to claim that you’re not vendor driven. Just doesn’t pass muster.

  60. Big picture… what has not been addressed is the efficacy of CCHIT-certified EHR systems in physician offices.
    Before we decide that CCHIT is the de facto standard for government-approved EHR purchases, shouldn’t we know the success rate of such systems?
    Does anyone have statistics regarding the rate of successful implementations of CCHIT-certified systems over the last 3 years since certification began?

  61. I’m curious why something like a smart card is not involved in the national conversation. Seems like we could get rid of a number of standards, exchange and certification orgs if we could come up with one smart card standard and every product be able to read from and write to it. Patients could carry it with them in their wallets. Those who oppose with arguments about patients not being capable of remembering their cards should realize that we’ve managed to hang on to our driver’s license and bank cards, so we can surely learn to keep our healthcare smart cards close to our breast. I’m just dumbfounded as to the enormity of dollars going into big databanks and in getting an infinite (as they are continually developed) number of products to talk to each other, when it seems that we could import and export a standard CCR via a smart card and everyone would have the information they need, when they need it, and all the same savings should apply in terms of safety and efficiency.
    With smart card technology, anyone who wants to create a homegrown EMR can do so as long as it can read from and write to the smart card. Voila! What am I missing? Wikipedia has a good overview, and there is a smartcardalliance.org web site.

  62. Leavitt says he wants to “re-educating clinicians.” This is the real agenda. It is also the reason CCHIT or whatever gov’t intiative is doomed. A gov’t or special interest mandarin trying to tell the peons what to do!
    The stimulus package is trying to save jobs of failed products unless it is open to EMR innovators like Medscribbler. A CCHIT is not open to innovation, built on a failed technology like gas guzzling cars.

  63. “Luddite physicians”
    In fact Ludditism among physicians is a factor in avoiding EMR system implementation. For their part the original Luddites did know where their immediate-term interests lay – in destroying machinery that supplanted their services. To a large extent something similar is true of physicians.
    Physicians in the USA are completely inured to generating income through adjusting volume of procedures which are compensated at a fixed price.
    Given that the current administered payment systems do not respond to learning or to productivity gains from productivity-enhancing tools (e.g. EMR systems) in the sense of lowering payments as productivity increases, as a payment system dictated by a competitive market would, physicians have no incentive to invest in equipment or processes that increase productivity.
    If payments were set to decrease at some assumed yearly rate of productivity gains, then the lower income from the same volume of work would incentivize physicians to think about tools that enhance their productivity and make appropriate investments.
    Comments such as R. Watkins’ about the the poor performance of EMR software do not reflect reality. All well-designed commercial products that have been introduced or refactored since, 2000 to arbitrary set a date are good and function well. Failure is inevitably caused by poor implementation of one type or another, usually a lack of commitment on the part of physicians, but sometimes from active resistance from clinical and administrative staff along with half-hearted commitment on the part of physicians who invariably call the shots and set the tone and sometimes from poor support from vendors.
    As I usually note, the cost of commercial EMR product is generally higher than it could or should be, thereby adding a legitimate reason for unwillingness to invest in a system.

  64. Dear Dr. Watkins,
    Thanks for quoting me even if you dissent from my opinion!
    You happen to be one of the non-apathic physicians as are most of the 17% that do use an EHR.
    In many cases being apathetic is not a negative characteristic.
    Throughout my career I befriended many physicians that allowed me to work very closely with in order to develop the applications required. Most radiologists I have worked with are technically inclined, so were the cardiologists, only to name a few. But a great majority would tell me that they didn’t want to put a computer between them and their patient because it broke the personable bond that they considered necessary. This is understandable.
    In hospitals where I implemented solutions I would always find technology champions among the physicians but most others really didn’t care much about it, and not that they blatantly opposed it either. I clearly understood that their priorities were the care of their patients and that technology was a necessary evil under such altruistic circumstances.
    And yes, there are many bad products out there that aren’t worth a nickel. But there are very many darn good ones too.
    I also believe that technology in the healthcare setting has to be non-intrusive. Unfortunately, we haven’t arrived at this tipping point yet. Artificial intelligence has a long way to go and this is probably the only way to accomplish a non-intrusive approach.
    I never said the appathy came from Ludditism but denying that it does exist is ignoring the giant purple elephant with pink stripes in the room.
    Thanks,
    Michael Planchart

  65. “But one aspect that I will always bring up is that of the technologically apathic physician population. I have worked my entire career with doctors and nurses in providing them with IT consulting, solutions, and services. Failure has always been due to apathy in actually using the software. It’s a shame that we have had to resort to a “carrot and stick” approach to win them over. This is very disheartening. Shame on them.”
    I’m sorry, but that’s a strawman that needs to be put to rest. I’ve been a practicing physician for 30 years, and I have yet to meet this “technologically apathetic physician.” MDs LOVE new technology, gadgets, toys, but only if they are proven to be of clinical benefit and are cost effective.
    I’m a case in point. I wrote my first computor programs at age 10 at the local university in 1963, but I’m still using paper charts. I have yet to find an EHR that is as well organized and efficient as what my staff and I have developed over the years using paper.
    We had our e-prescribing system removed after 18 months after we documented rigorously that prescription errors were 200% greater than they had been with hand-written scripts. As the consultant walked out the door at the end of that fiasco, he muttered something like “Some people just arent’ interested in progress” under her breath. I answered, “No, you’ve just got a lousy product.”
    EHRs are not being adopted quickly in this country, but I honestly don’t thinks it’s because of Luddite physicians!
    Thanks.

  66. How did the need for CCHIT even occur in the first place? The vendors bascially failed to provide a market driven solution. If HIMSS really wanted to prevent new entrants then why would some of its largest supporters be firms like Microsoft which doesn’t even have an EMR product (nor PHR actually just a platform for them)?
    It is simply because in the past the vendors primary stakeholders were large clinics where integration with in house lab and billing systems were more important then sending lab results down the street to a competitor was. There was no business case for clinics to do so (but there is for the payers).
    This explains for example why one vendor is at 3 different facilities in the same city (Palo Alto) but they currently cannot exchange records. The underlying database does make it a little more complex then most people realize but the technology wasn’t the reason for this failure nor some evil plot by the vendors or other organizations. The vendors simply met the needs of their purchasers and no one demanded being able to share data with the competition until now.
    Also ask yourself do any of the non-certified EMR players in this space have a business model that is partly based on selling the interface engine for software (the piece that allows software to speak to one another? Why are firms that don’t have an EMR sponsoring a national tour to educate providers about how to access the ARRA stimulus money?
    So what can we all agree on? That the goal is not standards or meaningful use but actually high quality, patient centered care that is affordable and accessible? That if you want that your technology must provide data liquidity, and plug and play standards are preferable to expensive interface engines? That the existing solutions like robust certification cases might not be optimal for new players in the space but that we don’t need to tear down existing organizations like the 20,000 members of HIMSS of CCHIT to change their services.
    To many of us it is clear that what we are really watching is a political campaign with the traditional two parties being played out in the field of Health IT. Big government or small? Public or private. Rules to restrict trade or rules to protect people? Who is controlling the message? Who is really winning? The providers? The patients? The community? Big business?

  67. I forgot to mention this to our industry’s highly respected Dr. Kibbe.
    Our conversations aren’t arcane. I do have a passion for what I do and I hope to be of “Meaningful value” to this current health care modernization process. I may not agree with all of what you say. I do with some. But I definitely respect that wich you say that I don’t agree with.
    And since you have so much interest in removing all barriers for this process could you please waive the $100 fee for the ASTM CCR standard? It’s not much but it would help.
    Thanks,
    Michael Planchart

  68. With the participation of industry leaders that have been succesful at many endeavors such as: Microsoft, Google, Oracle, and others, I have a renewed faith in that we can actually make significant progress this round. Microsoft has made it a priority achieving universal interoperability and I believe they will succeed.
    Legacy companies that laid the IT foundation for healthcare will have to compete to maintain their quotas. MEDITECH has shown its willingness to sacrifice on unnecessary spending in order to stay ahead in the game. This is commendable. Staying ahead signifies breaking out of the legacy quick sand trap.
    The PHR revolution taking place will focus healthcare IT on the patient. For decades it has been focused on billing and wallets. The only concern of PHRs is that it will not be easy for our largest and most vulnerable patient population, elders and children, to benefit from them without a proxy. Remember not all elders and children can rely on their offspring or parents to be their proxies. This is a gap that has to be covered without letting it become another layer of economic exploitation.
    Succesful healthcare organizations like Kaiser Permanente and Mayo Clinic are trail blazing and giving the rest a clear path to follow.
    RHIOs and HIEs, albeit continuosly paraiding success stories, have to follow suit and help resolve the interoperability issue. They have been a money drain for way too long. Shame on them. There are practically only 2 states in the nation that have HIEs that provide “Meaningful service”.
    But one aspect that I will always bring up is that of the technologically apathic physician population. I have worked my entire career with doctors and nurses in providing them with IT consulting, solutions, and services. Failure has always been due to apathy in actually using the software. It’s a shame that we have had to resort to a “carrot and stick” approach to win them over. This is very disheartening. Shame on them.
    I’ve also been able to work in several countries. Our healthcare by far is better than in any other country of the world that I have been to. It is more expensive but better. Even with its errors. So don’t lose faith WW.
    Many bloggers have commented their frustration over the hermetic nature of our standards. I do ask HL7 to open up. This act would help this health IT revolution. Microsoft has opened the doors. Surely there will be many opportunities to make money down the road. Lots of it. So fear not!
    Lets make certification accessible. CCHIT has performed a commendable job in the past until present. It’s time for a radical approach. Certification must be a requirement but not a barrier to entry to market. Mark has indicated that he wholeheartedly understands this. Take one step, that’s all.
    Thanks,
    Michael Planchart

  69. Please, WW, don’t give up yet! I’m humbled, and honored, by the fact that you would participate in this set of somewhat arcane conversations about health IT. But to your credit you realize the larger implications of speaking truth to power. You feel totally resigned and disheartened by the current situation, in which special interests dominate the commonweal, as do so many people in our society. The industry is “sucking us dry” and you say so much by that statement.
    But it doesn’t have to be that way. I believe with all my heart and soul that we can have good health care in this country, health care that is affordable and of very high quality and safety, and that delivers valuable servicefor the middle class and the poor. But we can’t give up, ever.
    Again, thanks for your comments and I wish you all the best,
    Kind regards, DCK

  70. This isn’t in the right spot but I just want to say that “meaningful health care reform” is DOA. We might just as well save some of the taxpayer’s money and close down ALL committee hearings immediately.
    The simple fact of the matter is there’s no way ANYTHING about health care in this country is going to change. There’s still a boatload of money out there for the “industry” yet to reap. The best we can hope for (from what I’ve seen from the attitude of the various committee hearings) is the health care industry will be given 10 years to suck as much money from us as they can. After the ten years are up, Congress will hold more hearings and, once again, come to the conclusion that a “public option” won’t work.
    Congress will then give the industry another ten years to fix it on their own.
    By the time anything is done, there won’t be enough money left for the industry to suck, let alone fund the mythical public option.
    Nothing’s going to happen.
    People like me (people who’ve worked and saved their entire life, played by all the rules, you get the picture) will be driven into desperation after our homes, life savings and hope is all used up. We’ll finally be thrown onto the backs of the few remaining taxpayers (middle and lower class, BTW as no upper class taxpayer truly exists). The “industry” will have sucked all of us dry and it’ll all wind up on the taxpayer anyway.
    Go ahead and give up. Write (and read) blogs about something else. Save your energy, you’ll need it to carve your home from a cardboard box.

  71. CCHIT has certainly had its role in sorting out “valid” EMR/EHRs from “vaporware,” and hats off to all those who have worked to develop that certification mechanism. However, my belief is that the bulk of the criteria within CCHIT came from a time when massive, self-contained client/server EMRs were the leading edge, and these criteria may not be appropriate in a web-based, distributed, cloud-oriented world where newer EHR technologies have emerged. CCHIT, to its credit, is trying to modernize its criteria set to “catch up,” but my concern is that it may lag behind (and thus inhibit) technological innovation.
    My hope is that CCHIT will become one of several pathways for HITECH “certification.” The new “certification” and “meaningful use” criteria being worked on should be about achieving results, not so much “certification” of a proscribed feature-set.
    I have posted a more in-depth blog piece about this on the Practice Fusion blog here: http://practicefusion.typepad.com/weblog/2009/05/meaningful-use-and-what-it-means-to-physicians.html

  72. Mark Leavitt reminds me a little too much of Dick Cheney. Maybe CHCHIT decenters or those who fail the certification should be subject to waterboarding.
    Mark….Please “LEAVITT” to the government. HIMSS, CCHIT and the status-quo health care guard cannot be trusted.

  73. A good question to ask is: “Why does it cost $30,000.00 to certify an EHR?”.
    An inpatient EHR is complex and it must be rigorously validated. Most vendors in this category (e.g. MEDITECH, McKesson, and SIEMENS) do have BIG POCKETS. Also, very few startups venture into this world and if they do they are generally facing much more than a 30k cost of entry. And a hospital that is going to spend around 20 million dollars on an EHR would want some sort of certification no matter what it may cost.
    On the other hand, it does seem quite an excessive cost for ambulatory EHRs. Imagine year after year certifying with the new criteria.
    A small software company that caters to primary physicians practices in their community will undoubtly find the cost of entry to market extremely high and almost impossible.
    Large EMR vendors haven’t been able to tap into this ambulatory market with significance and I doubt they ever will. Large organizations can’t create an infrastructure that can provide the personalized and custom services required by these small organizations at reasonable costs. Large organizations have had enough trouble keeping their large healthcare customers up to date. Imagine that migrations from one version to another of the same product many times takes almost a couple of years, and sometimes longer with a trail of failed attempts.
    Small software companies can best accomodate this market segment. It takes specialized services to cater the primary physician practices and no big vendor is going to come up with a solution that is the panacea. Online EMRs have a long way to go.
    If Wal-Mart succeeds then I’ll change my mind. Until now it is just a possibility.
    Meanwhile, I concur with Alan Viars, and if it can’t be done for free based on reason, there should be a low cost process for certification of ambulatory EHRs.
    Thanks,
    Michael Planchart

  74. As the founder and CEO of an early stage company I can emphatically say that the ~$30,000 price tag for certification. creates a barrier.
    Couldn’t NIST provide a free tool for self certification that can be easily confirmed?
    -Alan

  75. Dear Dr. Leavitt,
    David Kibbe is certainly not the only person here that has been, and is questioning the deep-seated relationship between CCHIT and HIMSS.
    When 50% of the board members of a non-profit organization are officially related to a for-profit vendor-sponsored organization that can only benefit from the certification work of the non-profit organization it becomes VERY difficult to just “trust” because we are told to do so. I am not inventing the ratio since HIMSS itself is proud of it: http://bit.ly/14ruHN
    The stakes are too high and your reaction is far too angry and aggressive to make me feel at ease about the depth of the relationship between HIMSS and CCHIT. The financial connection between the 2 entities, as demonstrated by your salary being originally payed by HIMSS certainly doesn’t help allay my concerns.
    Besides the serious potential issue of conflict of interest, I am not alone in wanting to make sure that your organization does not become the only certifying body for EHR certification under HITECH. The Markle Foundation, not exactly known as a radical organization, specifically calls for a pluralistic approach, to “allow multiple entities, both public and private, to do the actual certification testing.”
    Considering the testimony of HIMSS, AHIMA and CCHIT at the NCVHS meeting, where the 3 organizations have been openly pushing each other recommendations, it is difficult to see how you can vouch for your organization strict independence.
    Furthermore, the ABSOLUTE lack of mention of the patient in your NCVHS testimony, associated with the fact that CCHIT has not even started looking into PHRs shows that the concept of participatory medicine and patient-centered medicine are foreign to you.
    Since certification of EHR is a fundamental element of HITECH, and since healthcare reform cannot happen without implementing nationwide full patient-centered medicine, it is pretty obvious that for those of us (who believe the voice of the patient must be heard loud and clear at every step of the medical care) your organization cannot be put in a monopolistic situation vis-a-vis EHR certification and the definition of meaningful use.

  76. The first sentence in this post is right on the spot. Enthusiasm of a small percentage of clinicians has been the driver to what has been accomplished in healthcare IT so far, 10% of healthcare providers and 17% of primary physician practices.
    The other vast number, over 83%, have been reluctant to get on board with a certified or a non-certified solution.
    Years ago the Healthcare IT industry heard their clamor which indicated that for them to invest heavily in an EHR they would only do it if it was certified. Hence the birth of CCHIT.
    In order to help those non-enthusiastic and non-technologically inclined folks, certification had been an excellent leverage.
    The whole idea of the HIMSS-CCHIT-Vendors conspiracy is ludicrous. And not understanding that each one of them represents critical stakeholder positions in the process falls close to ignorance.
    Certification validates functionality, according to pre-defined criteria, that an EHR application if used appropriately it will deliver “Meaningful results”. Certification can not guarantee “Meaningful use” as some of us may concur. The technologically apathetic physicians have to give products that have been certified to deliver “Meaningful results” a “Meaningful use”.
    A big problem we have is because we are simply using the “Meaningful use” qualifier and we have allowed the whole process to fall in unsubstantial politicking.
    Dr. David Kibbe, what would you do to solve the problem? Do you want to lead a certification organization?
    We are listening.
    Thanks,
    Michael Planchart

  77. Discrete functional area standards, interoperability and connectivity abilities, along with solutions that fit the needs and requirements of all touched by healthcare will lead to increased and better health information technology implementation. Removal of artificial and financial barriers to further innovation would be beneficial in moving healthcare information technology and it’s acceptance forward.
    A focus on issues outside of those areas and/or on emotions will not.
    The time and reasons are right to get “meaningful use” of healthcare information technology out to providers, patients and our healthcare industry.

  78. Dr. Leavitt,
    In the interest of looking forward rather then get mired in the murky past and present, I would like some clarification on your statement:
    “There have been valid observations that CCHIT’s approach needs to change in this new world, and I wholeheartedly agree.”
    What exactly is it that you see changing?
    1) Is CCHIT going to transform itself into a test bed for whatever standards the HHS defines? A free one…
    2) Is CCHIT going to toss all those rigid use cases that do not represent anything in real practices, and concentrate on validating whatever HHS defines as meaningful use and no more than that?
    3) Is CCHIT going to accept market driven, market adopted interoperability standards in lieu of the harmonized cross breeds that seem to reinvent the wheel?
    I’m sure you are aware of the fact that many a CCHIT certified product failed in real life and the opposite is also true. Maybe it is time for CCHIT to think outside the box. Is that what you are implying above, or am I being naive?
    I have typed and deleted multiple sentences here. I am just going to stick with positive, forwarded facing questions ….

  79. I didn’t see a single DDS among the stakeholders listed. What do you have in mind for dentistry? Nobody has said a thing so far.
    Dr. Leavitt, you should not assume that everyone who doesn’t trust you has a Health IT product that fails your certification. Some of us suspect malfeasance for more natural reasons.
    Some of us have invested instead in actually providing treatment to patients. What are your intentions?

  80. “the certification process favors the established industry players, is hostile to new entrants, is incompatible with legacy applications (especially those developed ‘in-house’)and has a built-in bias towards large integrated application suites which may not be the best way to implement health IT.”
    No question about this. I know little about the three individuals at “odds” with each other, Drs. Leavitt and Kibbe and Klepper, but there is no question that organizations such as the CCHIT are established to protect the interests of commercial interests and to restrict competition from upstarts.
    From the commentary from Dr. Kibbe in this weblog, his perspective seems to me to be mild-mannered, well-considered and factually-based, although I find that I disagree with him on a few points, in particular the point cited above by Mr. Klepper regarding “web-based” EMR systems as opposed to “client-server” systems.
    But aside from that I find I agree with what Dr. Kibbe writes, none of which appears to me to be based even remotely on personal animosity or on a desire to engage in unhelpful polemics.

  81. Could someone give me a citizen-layman’s introduction (concise!) about what CCHIT does, has done, and may do in the foreseeable future?
    In case it helps, here’s my perspective:
    I’ve been involved in a standards organization before (in digital printing) so I know what standards are basically about. I know they can be vital in enabling widespread adoption of a new wave of technology. But I also know (from many stories over the years, going all the way back to the OSI seven layer network model) that the “most standard standard” is not necessarily where people find sufficient value to adopt the thing. And I know that not every supposed standard is really standard (e.g. RS-232), but also (as with RS-232) what generally gets adopted is something that’s “standard enough.”
    I know (vaguely) that certification can be used to validate compliance with a standard, and that there are generally two purposes for this: safety/reliability (avoiding trainwrecks) and interoperability (which can become quicksand, with the certification eventually not carrying its own weight).
    Having said that, I don’t know what the intention of CCHIT is, what it costs, what it’s accomplished etc. etc. Is there a concise answer?
    (Concise doesn’t imply short. Just minimal wordiness.)

  82. Dr. Leavitt,
    Because I work and write with Dr. Kibbe and hold a similar perspective, please let me respond to your letter.
    First, Dr. Kibbe’s criticisms have never been personal, but professional.
    Second, perhaps the most interesting revelation in the Washington Post article you site was that, despite your protest that you were “not supervised by HIMSS,” you were paid by HIMSS through last year. In the world most of live in, it is difficult to reconcile those two facts without concluding that you have a significant conflict of interest. It is reasonable to assume that a person whose primary income is derived from a trade organization is devoted to that organizations interests.
    Finally, Dr. Kibbe and I have been most concerned about whether CCHIT’s certification criteria constitute an open or narrow “aperture of innovation.” The proof of HIMSS’ influence will be whether HITECH subsidy dollars promote more affordable, truly interoperable, Web-based tools over older, non-interoperable, more expensive client-server tools, and whether a very broad array of functionalities – many of which physicians turn off following implementation – should be required for certification.
    Since you are presumably working in a governmental role and are supposed to be representing the national, rather than the special interest, these question are paramount and deserve public airing. In keeping with that logic, I believe Dr. Kibbe’s comments have been not only correct, but a public service.
    If you are interested in discussing these issues further, I would be very pleased to meet and do so.
    Sincerely,
    Brian Klepper
    904.343-2921, bklepper@gmail.com
    http://www.brianklepper.net

  83. It looks like Mark L is starting a flame war but I don’t think we should take the bait and impugn the motives of those involved.
    However, I would like to comment on the issue which is that the certification process favors the established industry players, is hostile to new entrants, is incompatible with legacy applications (especially those developed ‘in-house’)and has a built-in bias towards large integrated application suites which may not be the best way to implement health IT.
    I would favor a more modular certification standard that looked at individual functions such as ePrescribing or decision support. In order for this to work, there needs to be a robust interoperability standard to allow communication.
    I would also allow for ‘self-certification’ to avoid the onerous cost of CCHIT certification. A vendor should be able to make the claim that they meet the standard… if you believe in the free market, it should quickly sort out false claims.
    CCHIT certification should not be required for reimbursement. If your use of the software meets the ‘meaningful use’ test, that use should be reimbursed.

  84. Mark,
    I am sure there are values to CCHIT. Afterall with so much of experience, it is bound to help.
    However, you have to look at it in the big picture and the needs of the time. I heard your interview here few weeks back. And I came back with the conclusion that it is not needed as much at this time.
    I think there may be a need to have a standard body but not certification. Besides, most of these certifications are expensive process which take away the small business abilities to compete. Unless you are willing to create a fee structure that is proportionate to the business revenue size etc, the big guys will eat the small people alive.
    The need is to focus on standards and not on certification….
    rgds
    ravi
    blogs.biproinc.com/healthcare
    http://www.biproinc.com

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