healthy4u: CCHIT

On EHR's: See No Evil, Hear No Evil, Speak No Evil: Part 1

This is the first of a series of posts I plan on the issue of "See No Evil, Hear No Evil, Speak No Evil" regarding EHR's.  Frequent reminders are needed by all stakeholders, I believe, to think critically about, and take with a big grain of salt, effusive praise by key opinion leaders, politicians, etc. about health IT, and accompanying attempts to deride those critical of the technology, to counterbalance ongoing HIT hyperenthusiasm (e.g., <a href="http://www.youtube.com/watch?v=ZQIzdBg5gXw" target="_blank">link</a>). In face of growing evidence of risk and adverse outcomes of bad health IT from multiple sources and organizations (such as <a href="http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html" target="_blank">this</a>, as just one example), growing advice on risk remediation from government (such as <a href="http://www.nist.gov/healthcare/usability/upload/NIST-IR-7865.pdf" target="_blank">here</a>), and mass privacy violations (see the multiple posts under <a href="http://hcrenewal.blogspot.com/search/label/medical%20record%20privacy" target="_blank">this query link</a>), it might also be entitled a series on what health IT <a href="http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html" target="_blank">hyper-enthusiasts</a> "knew, should have known, or should have made it their business to know." Let's start out with an extract from a post I wrote on June 29, 2003 entitled "<a href="http://hcrenewal.blogspot.com/2009/06/mark-leavitt-head-of-cchit-behind-times.html" target="_blank">Mark Leavitt, Head of CCHIT: Behind the Times and Uninformed on Health IT Realities?</a>". At the time Leavitt was head of <a href="http://www.cchit.org/" target="_blank">CCHIT</a>, a tester and MU compliance/safety certifier of electronic health records systems:  <blockquote class="tr_bq">... The head of CCHIT, Mark Leavitt, has penned the following at iHealthBeat:  <a href="http://www.ihealthbeat.org/perspectives/2009/health-it-under-arra-its-not-the-money-its-the-message.aspx">June 19, 2009 - Perspectives</a>  Health IT Under ARRA: It's Not the Money, It's the Message by Mark Leavit   ... Before ARRA, most surveys concluded that cost was the No. 1 barrier to EHR adoption. But as soon as it appeared that the cost barrier might finally be overcome, individuals with a deeper-seated "anti-EHR" bent emerged. Their numbers are small, but their shocking claims -- that EHRs kill people, that massive privacy violations are taking place, that shady conspiracies are operating -- make stimulating copy for the media. Those experienced with EHRs might laugh these stories off, but risk-averse newcomers to health IT, both health care providers and policymakers are easily affected by fear mongering. </blockquote> "Laugh these stories off?"  That was, and is, simply perverse. Ironically, this statement was written less than a year before my own mother was seriously and fatally harmed as a result of a health IT-related error.   <table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhMLAOY-zSe3l0ImSmaQsj6EX7UtY9yNRp6gka3ZuuCaH9i3Rdu3NYYL1b0ybojlliYFz96WUIKGEutgtICnhM9O1lk7TPB9a8hwgzlVaia499PLd_nvDohorpZqIeYoEp8M5eKdQZTrUnv/s1600/Cute-Chimpanzees.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="150" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhMLAOY-zSe3l0ImSmaQsj6EX7UtY9yNRp6gka3ZuuCaH9i3Rdu3NYYL1b0ybojlliYFz96WUIKGEutgtICnhM9O1lk7TPB9a8hwgzlVaia499PLd_nvDohorpZqIeYoEp8M5eKdQZTrUnv/s200/Cute-Chimpanzees.jpg" width="200" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">On EHR's:  See No Evil, Hear No Evil, Speak No Evil</td></tr></tbody></table> While I don't proffer claims of "shady conspiracies" (international health IT expert Dr. Richard Cook explains that in a recent guest post "<a href="http://hcrenewal.blogspot.com/2013/03/dr-richard-cook-on-health-it-sectors.html" target="_blank">Dr. Richard Cook on the Health IT Sector's Ills</a>"), I do proffer alternate explanations including arrogance, <a href="http://hcrenewal.blogspot.com/2013/03/solutionism-are-all-healthcare-issues.html" target="_blank">Radical Solutionism</a>, and <a href="http://www.amazon.com/Assholes-A-Theory-Aaron-James/dp/0385535651" target="_blank">this</a>. More to come in this series. There are many more statements like this one already on this blog, and elsewhere. -- SS Note:  Part 2 is <a href="http://hcrenewal.blogspot.com/2013/03/on-ehrs-see-no-evil-hear-no-evil-speak_8.html" target="_blank">here</a>.

On EHR's: See No Evil, Hear No Evil, Speak No Evil: Part 1

This is the first of a series of posts I plan on the issue of "See No Evil, Hear No Evil, Speak No Evil" regarding EHR's. Fr...

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Third-Party Reviews of Medical Devices Come Under Scrutiny at the FDA - Except Healthcare IT Medical Devices, Which Get Special Accommodation

This WSJ article caught my eye: <a href="http://online.wsj.com/article/SB10001424052748703447104575117892340074732.html"></a><blockquote><a href="http://online.wsj.com/article/SB10001424052748703447104575117892340074732.html">Third-Party Reviews of Devices Come Under Scrutiny at the FDA </a> March 15, 2010 By ALICIA MUNDY and JARED A. FAVOLE WASHINGTON—When medical-equipment makers like Philips Electronics NV, Siemens AG and General Electric Co. need approval for some new devices, they don't always have to start at the Food and Drug Administration. They can pay companies to do the reviews, which are then routinely approved by FDA officials most of the time. Now this third-party outsourcing program has come under fire at the FDA, and the agency is weighing whether to end it. Agency officials question the quality of the reviews and whether they have served the program's original purpose: saving U.S. taxpayers money. The "real value to industry may be that this is perceived as a way to 'sneak things,'" said an FDA official at a December meeting on device approvals, according to minutes reviewed by The Wall Street Journal. Some third-party reviewers advertise speed and a friendlier process. </blockquote> At a time when the FDA is moving against third party device reviews, HHS and its Office of the National Coordinator for health IT (ONC) are soliciting to create third party EHR "certification" bodies for <a href="http://hcrenewal.blogspot.com/2009/11/2009-pivotal-year-in-healthcare-it.html">healthcare information technology (HIT) medical devices</a> such as electronic medical records systems, decision support tools, clinician order entry and alerting, etc. (see RIN 0991-AB59, "Proposed Establishment of Certification Programs for Health Information Technology", PDF available <a href="http://www.federalregister.gov/OFRUpload/OFRData/2010-04991_PI.pdf">at this link</a>.) This comes at the same time as FDA admitting this technology harms and kills patients, but the extent is unknown (existing FDA data is likely the "tip of the iceberg" reports Jeffrey Shuren MD JD at the HIT Policy Committee, Adoption/Certification Workgroup, special meeting on health IT safety on February 25, 2010). See: "FDA on Health IT Adverse Consequences: 44 Reported Injuries And 6 Deaths, Probably Just 'Tip of Iceberg'" at <a href="http://hcrenewal.blogspot.com/2010/02/fda-on-health-it-adverse-consequences.html" rel="nofollow" target="_blank">http://hcrenewal.blogspot.com/2010/02/fda-on-health-it-adverse-consequences.html</a> and "On ONC's "Proposed Establishment of Certification Programs for Health Information Technology" at <a href="http://hcrenewal.blogspot.com/2010/03/on-oncs-proposed-establishment-of.html" rel="nofollow" target="_blank">http://hcrenewal.blogspot.com/2010/03/on-oncs-proposed-establishment-of.html</a> More from the WSJ article: <blockquote>... The agency's concerns about the third-party reviews come as the FDA is re-evaluating its entire device-approval process. In addition, the agency has recently announced tighter regulation of some machines that deliver radiation in the wake of reports of more than 300 cases of overdoses from CT scanners at four hospitals. Changes under consideration at the FDA include terminating the third-party program, limiting the kinds of devices that it covers, or giving the outside reviewers more data on devices to improve the quality of their work, according to the minutes and interviews with agency officials. Jeffrey Shuren, the device division director, said the FDA will release proposed changes later this year and cautioned that no decisions have been made. To qualify for an outsourced review, a new device must be similar to a device already on the market, and it must carry low or moderate risk to the patient. The December 2009 minutes say "third parties often don't have appropriate expertise." The minutes cite "poor quality of review documents— they often just repeat what is in the submission, and don't provide any analysis of the data."</blockquote> (The point on lack of expertise is a point I raise in my aforementioned commentary on ONC's "Proposed Establishment of Certification Programs for HIT." I wrote: HHS should not be creating new, potentially (likely?) amateur organizations and bureaucracies overseeing these new virtual medical devices that will have variable (or no) experience in software validation, certification, regulation, postmarketing safety surveillance, etc. Rather, HHS should be leveraging existing governmental expertise in certifying, validating and regulating mission critical IT.) The industry as always is looking out for - itself, patients coming in second: <blockquote>Terry Sweeney, vice president of clinical affairs at Philips Healthcare, said the third-partyprogram benefits industry and helps relieve the FDA of a burden. "Every week's delay [i.e., in rigorously assuring medical device safety - ed.] can cost the company a large sum of money," he said.</blockquote> It's not like the time differential is enormous: <blockquote> It takes an average of about 72 days for a company to get final clearance for a device when it goes the third-party route, according to the FDA. That includes the time for the agency to sign off on the outside reviewer's conclusion and compares with an average 109 days for similar applications that go directly to the FDA.</blockquote> So, the vendors seem to be saying, let's compromise the device safety evaluation process via third party reviewers so we can get to market a month sooner. The FDA is having serious second thoughts about this state of affairs. Worse, on health IT devices, the HHS itself via ONC is soliciting for the creation of third party reviewers for HIT, while the FDA itself seems marginalized or even unwilling to shoulder the burden of patient protection from faulty HIT. Odd. Why do computerized HIT medical devices such as EMR's get special government accommodation? -- SS <div style="text-align: justify;">For more on HIT challenges see "Contemporary Issues in Medical Informatics: Common Examples of Healthcare Information Technology Difficulties" - <a href="http://tinyurl.com/healthITfailure" style="font-style: italic;">http://www.tinyurl.com/healthITfailure</a></div>

Third-Party Reviews of Medical Devices Come Under Scrutiny at the FDA - Except Healthcare IT Medical Devices, Which Get Special Accommodation

This WSJ article caught my eye: Third-Party Reviews of Devices Come Under Scrutiny at the FDA March 15, 2010 By ALICIA MUNDY and JARED A. FA...

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CCHIT Has Company

It appears CCHIT, an offspring of the large HIT trade association HIMSS, won't get its wish for Health IT Certification hegemony. I think the outcome of a multidisciplinary HIT policy workgroup's deliberations on this issue reasonable: <h2 face="Georgia,'Times New Roman',Times,serif" size="1.333em" style="border-width: 0px; margin: 0em 0.5em; padding: 0.05em 0em; outline-width: 0px; font-weight: bold; font-style: inherit; vertical-align: baseline; line-height: 1.15em;"></h2> <blockquote>Aug. 17, 2009 iHealthBeat.org <a href="http://www.ihealthbeat.org/Articles/2009/8/17/Policy-Committee-OKs-Plan-To-Establish-Multiple-EHR-Certifiers.aspx" style="font-weight: bold;">Policy Committee OKs Plan To Establish Multiple EHR Certifiers</a> On Friday, the [HHS] Health IT Policy Committee adopted recommendations that called for multiple entities to certify electronic health record systems, Health Data Management reports. The committee's certification and adoption work group issued the recommendations (Goedert [1], Health Data Management , 8/14). To receive official certification, EHR systems must meet a minimum set of criteria and achieve the "meaningful use" objectives of the federal economic stimulus package. Under the stimulus law, health care providers who demonstrate meaningful use of EHRs will receive Medicare and Medicaid incentive payments (O'Harrow, Washington Post , 8/15). Recommendations The work group recommended that: * Certification criteria allow for open-source software; * Certification processes should let health care organizations qualify for EHR subsidies under Stark Law exceptions that allow organizations to subsidize the cost of EHRs for physicians; * Certification should last for four years; * Multiple groups perform HHS certification under a single set of criteria; * The National Institute for Standards and Technology should participate in accreditation and certification decisions; * The Office of the National Coordinator for Health IT should define certification criteria; * ONC should create an accreditation process for certification groups; * Officials develop alternative certification processes for self-developed software; and * Vendors are required to receive certification from only one group ( Health Data Management , 8/14). The work group said it envisions the establishment of 10 to 12 different EHR certification groups, in addition to the Certification Commission for Health IT (Manos, Healthcare IT News , 8/14). The recommendations now go to HHS for consideration ( Health Data Management, 8/14).</blockquote> The workgroup said CCHIT is too closely aligned with the health IT industry, noted that the industry trade group HIMSS helped found CCHIT, and noted that CCHIT's members includes several people with ties to HIMSS and health IT companies. They were clearly uncomfortable with the potential conflicts of interest, especially if CCHIT gained sole responsibility for HIT "certification." [A term I put in quotes since it really is "features qualification" at this point, not certification such as a physician receives after passing Specialty Boards - ed.] Having been on the receiving end of CCHIT bullying myself ("<a href="http://hcrenewal.blogspot.com/2009/06/open-letter-to-mark-leavitt-chairman.html">Open letter to Mark Leavitt, Chairman, Certification Commission for Healthcare Information Technology on Penalties For Use of Non-Certified HIT</a>"), it's clear most Americans don't like bullies, especially bullying from powerful lobbying organizations such as HIMSS and its progeny. (It's also become clear they don't like 1000+ page healthcare reform plans shoved, unread, down their throats by political bullies.) By the way, since the July 21, 2009 publication of my JAMA letter "<a href="http://hcrenewal.blogspot.com/2009/07/health-care-information-technology.html">Health Care Information Technology, Hospital Responsibilities, and Joint Commission Standards</a>" and Koppel and Kreda's reply, pointing out the terrible situation that HIT "defects nondisclosure" and "hold harmless" clauses create for hospital executives, physicians and patients, I have heard from the Joint Commission, but not from HIMSS. Perhaps HIMSS leadership believes I have nothing worthy to add to the discussion. (Perhaps another 'Open Letter' is called for.) -- SS

CCHIT Has Company

It appears CCHIT, an offspring of the large HIT trade association HIMSS, won't get its wish for Health IT Certification hegemony. I thi...

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HIMSS: Hospital CIO's Should Not Only Manage Healthcare IT, But Also Biomedical Engineering

I have written in the past about the territoriality of the IT department in hospitals, observing that the departments I was exposed to seemed more political than the clinical departments themselves. This territoriality came at the expense of clinicians' and patients' best interests. This phenomenon seems to go beyond the confines of the hospital IT shop, perhaps as a manifestation of the IT culture. For example: Other have observed - unapprovingly so - how the health IT trade group HIMSS, via a <a href="http://hcrenewal.blogspot.com/2009/05/machinery-behind-healthcare-reform-how.html">massive lobbying effort</a> and via its offspring, the CCHIT, has sought to gain hegemony over health IT through a "certification" process, a service for which CCHIT desires to be the sole provider. It's become worse. Now control over biomedical instrumentation (which includes such safety critical devices as ventilators, cardiac and other physiologic monitors, heart-lung machines, radiological devices, etc.) is sought. <div dir="ltr" align="left">In the June 2009 HIMSS analytics report "Devices in Hospitals" (<a href="http://www.himssanalytics.org/docs/HA_MedDevices.pdf">link to PDF</a>): <a href="http://www.himssanalytics.org/docs/HA_MedDevices.pdf"> </a></div> Page 7: <div style="margin-left: 40px;"> ... It appears that the IS department [a.k.a. IT department, or Management Information Systems department - ed.] is becoming the key support department for interfaced intelligent medical devices. This is a natural extension as IS departments build and support a cadre of interfaces to improve the collection and use of data within the hospital. </div> Then at the end of the report, in the Conclusion, a leap of logic of gargantuan proportions: <div style="margin-left: 40px;"> What is less clear at this time is whether the biomedical operations will be placed under the IS department for management. We believe that it should be , ala the movement of responsibility for telecommunications to the CIO when telecommunications and information technologies merged in the last 15 years . </div> Au contraire ... it is very clear to those who know what they're doing that this is a very bad analogy and suggests HIMSS does not understand the vast differences between the discipline and functions of biomedical engineering, versus the IT department role of management of computer and other ICT's (information and communications technologies). I find this astonishing. Having done a clerkship in biomedical engineering in medical school, and being somewhat knowledgeable about electronics as an <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/medinformatic1/ham.htm">FCC-licensed radio amateur</a> at the Extra class (highest certification attainable by a series of FCC examinations), I find the HIMSS Analytics position risible and dangerous. It suggests a desire to expand territory even further into an area for which CIO's and hospital IT personnel are even less qualified - indeed, far less qualified - than clinical IT. Apparently, CCHIT wants to have hegemony over "certification" of clinical IT, and the parent organization HIMSS through its research arm opines IT should also take over "medical devices" (while still excluding clinical IT from that categorization to avoid regulation, of course).As I first asked <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/medinfo.htm">over ten years ago</a> after observing IT personnel in hospitals : <blockquote> Who, exactly, are the IT personnel in hospitals, and what, exactly, in their backgrounds qualifies them for major involvement in clinical affairs, let alone leadership roles regarding safety-critical clinical devices?</blockquote> Perhaps the Joint Commission, FDA, and other regulators need to start asking the same question.-- SS

HIMSS: Hospital CIO's Should Not Only Manage Healthcare IT, But Also Biomedical Engineering

I have written in the past about the territoriality of the IT department in hospitals, observing that the departments I was exposed to seeme...

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Mark Leavitt, Head of CCHIT: Behind the Times and Uninformed on Health IT Realities?

Signs that a leader who alleges himself or herself to be objective and a scientist is, in fact, neither objective nor scientific include:<div> </div><div><ul><li>Resorting to <a href="http://www.nizkor.org/features/fallacies/ad-hominem.html">ad hominem</a> attacks when questioned or criticized.</li><li>Deficient familiarity with the current literature.</li><li>Opining that others' concerns expressed in that literature could be "laughed off." </li><li>Years-behind view of the situation on the ground.</li></ul></div><div> </div><div>The head of CCHIT, Mark Leavitt, has penned the following at iHealthBeat (emphases and comments in red italic mine):</div><div> </div><div> <blockquote><a href="http://www.ihealthbeat.org/perspectives/2009/health-it-under-arra-its-not-the-money-its-the-message.aspx">June 19, 2009 - Perspectives</a></blockquote><blockquote>Health IT Under ARRA: It's Not the Money, It's the Message by Mark Leavitt... Estimates by the Congressional Budget Office suggest the total incentive payout could reach $34 billion, although with expected savings the net cost is half that. Add to that another $2 billion that the Office of the National Coordinator for Health IT can use on various initiatives in support of the goal of having an EHR for every American by 2014. [Note the catchy marketing slogan, which carries the implicit message "what manner of people would oppose Mother and Apple Pie?" - ed.]But more important than the money itself is the message implicitly conveyed along with it. Will incentives be perceived as an intrusive, carrot-and-stick manipulation of health care providers' business decisions? Or will health care providers interpret ARRA as the correction of a reimbursement anomaly, welcoming the opportunity to modernize their information management and transform the care they deliver. [Cybernetic Miracle™ Alert - note the grandiose term "transform", as opposed to "facilitate" or "improve" - ed.]Some of the early signs have been worrisome. Before ARRA, most surveys concluded that cost was the No. 1 barrier to EHR adoption. But as soon as it appeared that the cost barrier might finally be overcome, individuals with a deeper-seated "anti-EHR" bent emerged. Their numbers are small, but their shocking claims -- that EHRs kill people, that massive privacy violations are taking place, [As an information scientist, I'm almost embarrassed to post <a href="http://news.google.com/archivesearch?q=hipaa+violation+complaint&btnG=Search&hl=en&ned=us&um=1&scoring=a" style="font-weight: bold;">this link</a> and <a href="http://www.ncbi.nlm.nih.gov/sites/entrez?db=pubmed&cmd=link&linkname=pubmed_pubmed&uid=18369111&ordinalpos=1&log$=relatedarticles&logdbfrom=pubmed" style="font-weight: bold;">this link</a>, the results of just a few minutes' work with public resources. Thorough, robust searches in <a href="http://www.dialog.com/sources/">Dialog</a>'s suite of databases, Current Contents, Lexis Nexis, SciFinder etc. would show far more - ed.]that shady conspiracies are operating -- [i.e., <a href="http://www.ehrstimulustour.com/" style="font-weight: bold;">HIT industry lobbies</a> - ed.]make stimulating copy for the media. Those experienced with EHRs might laugh these stories off, but risk-averse newcomers to health IT, both health care providers and policymakers [i.e., those who take due diligence and <a href="http://hcrenewal.blogspot.com/2009/03/health-it-hold-harmless-and-defects-gag.html" style="font-weight: bold;">fiduciary responsibilities</a> seriously - ed.]are easily affected by fear mongering. </blockquote>  </div> That is, Bah! to the apostates' narratives -- -- even though many of these narratives are in the peer-reviewed biomedical science and biomedical informatics literature ... <div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEihjCTKnPgicc5ejVkr4Ex4OyrM2g1xnJVBBk6asH_ruJA_eC4iHj6sCB5fu-41HiMhGkDTur9LhwNe6gwuO0v52VKqj6SzqfXOaz1RsX3hfoxzTCdpc2P22sDi_3uwR5o_PeWW6rWTO05Q/s1600-h/dogbert.gif" onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5350412883081586530" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEihjCTKnPgicc5ejVkr4Ex4OyrM2g1xnJVBBk6asH_ruJA_eC4iHj6sCB5fu-41HiMhGkDTur9LhwNe6gwuO0v52VKqj6SzqfXOaz1RsX3hfoxzTCdpc2P22sDi_3uwR5o_PeWW6rWTO05Q/s320/dogbert.gif" style="margin: 0px auto 10px; display: block; text-align: center; cursor: pointer; width: 166px; height: 165px;" /></a>Bah! </div> I'm really tired of amateurish political rhetoric and marketing puffery masquerading as substantive debate on critical issues as above. However, being experienced with EHRs, their design, implementation and lifecycle, and concerned with widespread irrational exuberance over health IT (a facilitative tool that carries risk to patients and medical organizations if not done well) I am not at all "laughing these stories off", and will critique the above in a quite serious manner. Indeed, "laughing off" stories from credible sources and personnel (e.g., many AMIA members) about potential harm from an experimental technology affecting patients seems the height of hubris, or blindness of a kind mediated by incomplete knowledge or conflicts of interest. First, binary thinking. It seems those who critique health IT's drawbacks are "individuals with a deeper-seated anti-EHR bent." That is, they don't buy into the consensus of the industry "experts" and must therefore be biased and wrong. <div><div> <div><div>I, in fact, am a health IT proponent, but simply abhor poor HIT such as at my series <a href="http://tinyurl.com/b28s74">here</a>, or HIT sold to my organization in an unusable (but "Certified") state as in the Civil Complaint <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/DUCOM_EMR_Complaint.pdf">here</a> (PDF). I believe the rush to <a href="http://www.jamia.org/cgi/content/abstract/13/1/106">national EHR by 2014 is premature</a>, will waste massive amounts of money, and will cause disruption to an already strained healthcare system with resultant adverse effects. I believe far more research remains to be done before our social and technical understanding of "how to do clinical IT well" justifies mass government-mandated cybernetic re-engineering in healthcare. (See literature list below.)<div><div> </div><div>On the issue of ad hominem attacks against questions and critique, I documented those at Healthcare Renewal at "Open letter to Mark Leavitt, Chairman, Certification Commission for Healthcare Information Technology on Penalties For Use of Non-Certified HIT" <a href="http://hcrenewal.blogspot.com/2009/06/open-letter-to-mark-leavitt-chairman.html" style="font-weight: bold;">at this link</a>. Both I and another physician, David Kibbe, MD, MBA, Health IT Consultant at American Academy of Family Physicians, were subjected to "nonlinear" commentary. It also seems Dr. Leavitt is unfamiliar with or deliberately downplaying a growing body of literature on health IT risks and failures. [Health IT failure never, ever puts patients at risk, as I wrote <a href="http://hcrenewal.blogspot.com/2009/05/health-it-failure-never-puts-patients.html" style="font-weight: bold;">here</a>, of course - ed.] Examples of this growing body of "unknown" or "ignored" or "downplayed" literature include: </div>  <div><div> </div><div>1. The article "<a href="http://www.jamia.org/cgi/content/full/16/3/291">Health IT Project Success and Failure: Recommendations from Literature and an AMIA Workshop</a>", Bonnie Kaplan and Kimberly D. Harris-Salamone, Journal of the American Medical Informatics Association 2009;16:291-299. DOI 10.1197/jamia.M2997 - and the references cited.</div><div> </div><div>There are more than 70 references at the end of this article (See fulltext at link above), and my comments on the findings and recommendations of the multi-working group informatics workshop that created it are in the post "Health IT Project Success and Failure: Recommendations from Literature and an AMIA Workshop" <a href="http://hcrenewal.blogspot.com/2009/03/health-it-project-success-and-failure.html">at this link</a>.</div><div> </div><div>2. This corpus of literature below. These are just examples and not a comprehensive listing:</div><div> </div><div><blockquote>Joint Commission: <a href="http://www.jointcommission.org/SentinelEvents/SentinelEventAlert/sea_42.htm">Sentinel Events Alert on HIT</a>, Dec. 2008. National Research Council report. <a href="http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=12572">Current Approaches to U.S. Healthcare Information Technology are Insufficient</a>. Computational Technology for Effective Health Care: Immediate Steps and Strategic Directions, Jan. 2009 <a href="http://www.publications.parliament.uk/pa/cm200809/cmselect/cmpubacc/153/15302.htm"> The National Programme for IT in the NHS: Progress since 2006,</a> Public Accounts Committee, January 2009. Summary points <a href="http://www.publications.parliament.uk/pa/cm200809/cmselect/cmpubacc/153/15304.htm">here</a>. <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/medinfo.htm">Common Examples of Healthcare IT Difficulties</a> (my own 10-year-old website). S. Silverstein, MD, Drexel University College of Information Science and Technology. <a href="http://jama.ama-assn.org/cgi/content/extract/301/12/1276">Health Care Information Technology Vendors' "Hold Harmless" Clause - Implications for Patients and Clinicians</a>, Ross Koppel and David Kreda, Journal of the American Medical Association, 2009; 301(12):1276-1278 <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/regulation_and_oversight_hoffman.pdf">Finding a Cure: The Case for Regulation And Oversight of Electronic Health Records Systems</a>, Hoffman and Podgurski, Harvard Journal of Law & Technology 2008 vol. 22, No. 1 <a href="http://www.ncbi.nlm.nih.gov/pubmed/18213422">Failure to Provide Clinicians Useful IT Systems: Opportunities to Leapfrog Current Technologies</a>, Ball et al., Methods Inf Med 2008; 47: 4–7, <a href="http://jama.ama-assn.org/cgi/content/extract/301/9/919">IT Vulnerabilities Highlighted by Errors, Malfunctions at Veterans’ Medical Centers</a>, JAMA Mar. 4, 2009, p. 919-920. <a href="http://pediatrics.aappublications.org/cgi/content/abstract/116/6/1506">Unexpected Increased Mortality After Implementation of a Commercially Sold Computerized Physician Order Entry System</a>, Han et al., Pediatrics Vol. 116 No. 6 December 2005, pp. 1506-1512 <a href="http://jama.ama-assn.org/cgi/content/abstract/293/10/1197">Role of Computerized Physician Order Entry Systems in Facilitating Medication Errors</a>. Ross Koppel, PhD, et al, Journal of the American Medical Association, 2005;293:1197-1203 <a href="http://www.ctlab.org/documents/Hiding%20in%20plain%20sight.pdf">Hiding in Plain SIght: What Koppel et al. tell us about healthcare IT</a>. Christopher Nemeth, Richard Cook. Journal of Biomedical Informatics. 38 (4): 262-3. <a href="http://www.jamia.org/cgi/content/short/15/4/408">Workarounds to Barcode Medication Administration Systems: Their Occurrences, Causes and Threats to Patient Safety</a>, Koppel, Wetterneck, Telles & Karsh, JAMIA 2008;15:408-423 <a href="http://www.nytimes.com/2009/03/06/opinion/06coben.html">The Computer Will See You Now</a>, New York Times, Armstrong-Coben, March 5, 2009, <a href="http://iig.umit.at/efmi/badinformatics.htm">Bad Health Informatics Can Kill</a>. Working Group for Assessment of Health Information Systems of the European Federation for Medical Informatics (EFMI). <a href="http://archinte.ama-assn.org/cgi/content/short/167/13/1400">Electronic Health Record Use and the Quality of Ambulatory Care in the United States</a>. Arch Intern Med. 2007;167:1400-1405 <a href="http://www.jamia.org/cgi/content/abstract/13/1/106">Predicting the Adoption of Electronic Health Records by Physicians: When Will Health Care be Paperless?</a> Ford et al., J Am Med Inform Assoc. 2006;13:106-112 <a href="http://www.jamia.org/cgi/content/abstract/16/3/274">Resistance Is Futile: But It Is Slowing the Pace of EHR Adoption Nonetheless</a>, Ford et al., J Am Med Inform Assoc. 2009;16:274-281 <a href="http://archinte.ama-assn.org/cgi/reprint/165/10/1111.pdf">High Rates of Adverse Drug Events in a Highly Computerized Hospital</a>, Nebeker at al., Arch Intern Med. 2005;165:1111-1116. "<a href="http://articles.icmcc.org/2009/01/23/dutch-ehr-postponed-are-they-in-good-company/">Dutch nationwide EHR postponed: Are they in good company?</a>", ICMCC.org, Jan. 24, 2009 “<a href="http://www.ama-assn.org/amednews/2006/12/11/bisa1211.htm">Avoiding EMR meltdown</a>.” About a third of practices that buy electronic medical records systems stop using them within a year, AMA News, Dec. 2006. "The failure rates of EMR implementations are also consistently high at close to 50%", from <a href="http://www.infoclin.ca/assets/emr%20success%20methodologies%20framework%20development%20ishimr%202006%20v2.pdf">Proceedings of the 11th International Symposium on Health Information Management Research</a> – iSHIMR 2006 "Industry experts estimate that failure rates of Electronic Medical Record (EMR) implementations range from 50–80%.", from <a href="https://www.advancedmd.com/pressroom/white_papers/commonsense_to_emrs.pdf">A Commonsense Approach to EMRs</a>, July 2006 <a href="http://www.taxonomer.com/PublishTxgd001/index.htm">Adverse Effects of Information Technology in Healthcare</a>. This knowledge center presents a collection of information on the adverse effects of information technology in its application to healthcare. It also references sources of information on information security, and related media reports. <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/Goldfinch_pessimism_PAR.pdf">Pessimism, Computer Failure, and Information Systems Development in the Public Sector</a>. Shaun Goldfinch, University of Otago, New Zealand, Public Administration Review 67;5:917-929, Sept/Oct. 2007 The literature at my HIT website's "Other Resources" page (<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/failurecases/?loc=other">link</a>) The teachings of the field of Social Informatics about new Information and Communications Technologies (ICT's) and the unanticipated negative consequences they cause. An introductory essay entitled “Learning from Social Informatics” by R. Kling at the University of Indiana can be found <a href="http://rkcsi.indiana.edu/archive/SI/Arts/SI_report_Aug_14.doc">at this link</a> (MS-Word file). The book “Understanding And Communicating Social Informatics” by Kling, Rosenbaum & Sawyer, Information Today, 2005 (<a href="http://www.amazon.com/Understanding-Communicating-Social-Informatics-Communication/dp/1573872288/ref=sr_1_1/102-9749119-8288920?ie=UTF8&s=books&qid=1174318804&sr=8-1">Amazon.com link here</a>) was based on this essay. </blockquote></div><div> </div><div>3. The warnings of HIT dangers from the U.S. Joint Commission, the EFMI, as linked above, and others; doubts about cost savings from Wharton and Stanford professors (surely no amateurs). </div><div> </div><div>In the June 20, 2009 Wall Street Journal article "<a href="http://online.wsj.com/article/SB10001424052970204005504574235751720822322.html" style="color: rgb(102, 153, 204);">The Myth of Prevention</a>", Abraham Verghese, Professor and Senior Associate Chair for the Theory and Practice of Medicine at Stanford, echoed <a href="http://hcrenewal.blogspot.com/2009/06/wharton-on-healthcare-it-can-i-go-home.html" style="color: rgb(102, 153, 204);">several Wharton professor's doubts</a> about the cost savings and ultimate value of electronic medical records, touted as the cybernetic savior of healthcare:</div><div> </div><div>  <blockquote>... I have similar problems with the way President Obama hopes to pay for the huge and costly health reform package he has in mind that will cover all Americans; he is counting on the “savings” that will come as a result of investing in preventive care and investing in the electronic medical record among other things. It’s a dangerous and probably an incorrect projection.</blockquote></div><div> </div><div>There are also reports of problems from FDA-like agencies of other countries such as Sweden's, whose report entitled "The Medical Products Agency’s Working Group on Medical Information Systems: Project summary" (available in English translation at <a href="http://www.lakemedelsverket.se/upload/foretag/medicinteknik/en/Medical-Information-Systems-Report_2009-06-18.pdf" style="color: rgb(102, 153, 204);">this link</a> in PDF) stated:</div><div> </div><div style="font-family:georgia;">  <blockquote><div>It is becoming more common that electronic patient record systems and other systems are interconnected, for instance imaging systems or laboratory systems. It is obvious that such systems should not be regarded as “purely administrative”; instead they have the characteristic features that are typical for medical devices. They sort, compile and present information on patients’ treatments and should therefore be regarded as medical devices in accordance to the definition.Since the electronic patient record system often replaces/constitutes the user interface of “traditional” medical device systems, the call for 100% accuracy of the presented information is increased. Patient record systems have crucial impact on patient safety, and this has been proven to be the case after a series of incidents [including deaths - ed.] that has been reported to the Swedish National Board of Health and Welfare.  </div></blockquote></div><div> </div><div>On wonders if Dr. Leavitt would include the Swedish Medical Products Agency, who incidentally have a <a href="http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2006/ucm108646.htm">cooperation agreement with our own FDA</a>, under the category of "fearmongers." Finally, stories of HIT mayhem of which Dr. Leavitt seems blissfully unaware are making their way to appropriate political circles. The whistleblowers are afraid to speak out publicly due to fear of job loss or retaliation. However, when the case examples do come out, it may be Dr. Leavitt who will be found to be "fear mongering" about those who care more about patients and their rights than about information technology.</div><div> </div><div>Health IT Under ARRA: It's Not the Money, It's the Message. Indeed.</div><div> </div><div>And Dr. Leavitt's message about those who think critically about health IT seems quite ill informed and mean spirited. </div><div> </div><div>Finally, to get past the <a href="http://www.nizkor.org/features/fallacies/ad-hominem.html">ad hominem</a> and other <a href="http://en.wikipedia.org/wiki/List_of_fallacies">logical fallacy</a> nonsense I believe will be coming my way, I'll just admit to any and all of it. I'm an SOB, I'm a disgruntled curmudgeon, I'm an HIT dilettante, my uncle was in the mafia, I kick little cygnet swans in the park to be mean to Chucky, the cob (father) , and Princess, the pen (mother). /sarc :-) </div><div> </div><div><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh7_n2tP9xo0-LteaFfG7X7klaFrboNttoMfHWIPtseqS2hofqwvADV7FRi62-G0wyTVtUqur42848Q2a8QeC3UBLRfQSfUnPxraclf5_RItFd2DCOuVQ25bwDjjB6jkSpGIgqMPMnsAyL8/s1600-h/swan_family_june22_2009.jpg" onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5350396710705376466" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh7_n2tP9xo0-LteaFfG7X7klaFrboNttoMfHWIPtseqS2hofqwvADV7FRi62-G0wyTVtUqur42848Q2a8QeC3UBLRfQSfUnPxraclf5_RItFd2DCOuVQ25bwDjjB6jkSpGIgqMPMnsAyL8/s320/swan_family_june22_2009.jpg" style="margin: 0px auto 10px; display: block; text-align: center; cursor: pointer; width: 316px; height: 215px;" /></a></div><div style="text-align: center;">The Mute Swan family of Towamencin Twp., PA. Click to enlarge. The cygnets have really grown this past month (major cuteness warning if you click <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cygnus.jpg">this picture</a> from June 1!) </div><div> Now that we're hopefully past the expected <a href="http://www.nizkor.org/features/fallacies/ad-hominem.html">ad hominem</a>, perhaps the real issues can be addressed. As a final piece of advice to Dr. Leavitt, I can add that dismissing concerns of others, Dogbert-style, is not a way to win friends and influence people. </div><div>Humor and a little humility work much better. -- SS</div></div></div></div></div></div></div>

Mark Leavitt, Head of CCHIT: Behind the Times and Uninformed on Health IT Realities?

Signs that a leader who alleges himself or herself to be objective and a scientist is, in fact, neither objective nor scientific include: Re...

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Open letter to Mark Leavitt, Chairman, Certification Commission for Healthcare Information Technology on Penalties For Use of Non-"Certified" HIT

A remarkable Bill (ASSEMBLY, <a href="http://www.njleg.state.nj.us/2008/Bills/A4000/3934_I1.HTM">No. 3934</a>, STATE OF NEW JERSEY, 213th LEGISLATURE) has appeared in NJ that would prohibit the sale or use of healthcare IT not "certified" (i.e., feature-qualified) by the industry-founded and connected group "Certification Commission for Healthcare Information Technology" (CCHIT). The Bill calls for monetary <a href="http://en.wikipedia.org/wiki/Civil_penalty">civil penalties</a> for such sale or use: <blockquote>A civil penalty or civil fine is a term used to describe when a state entity or a governmental agency seeks monetary relief against an individual as restitution for wrongdoing by the individual. </blockquote> I previously wrote about CCHIT in a series of linked posts that start here: <a href="http://hcrenewal.blogspot.com/2009/02/very-troubling-post-about-cchit.html">A very troubling post about the CCHIT (Certification Commission for Healthcare Information Technology)</a>. I have now written the following open letter to Mark Leavitt, MD, PhD, Chairman, Certification Commission for Healthcare Information Technology. <blockquote>To: <a class="Addr" href="javascript:noop()" onclick="BuK('%22Mark%20Leavitt%22%20%3Cmleavitt%40cchit.org%3E')" title="Create new mail memo with this address">"Mark Leavitt"</a> <script> if (window.s_IsEditPrint && window.s_IsEditPrint == "1") wM(window.s_DocCreated);else wM(window.s_DisplayDate);</script>Date: Sunday, June 07, 2009 02:10PM<a class="Addr" href="javascript:noop()" onclick="BuK('%22Mark%20Leavitt%22%20%3Cmleavitt%40cchit.org%3E')" title="Create new mail memo with this address"><mleavitt@cchit.org></mleavitt@cchit.org></a> Cc: Robert O'Harrow, Jr., Washington Post, and various AMIA working group mailing lists (CIS - clinical info systems, POI - people & organizational issues, OS - Open Source, and ELSI - Ethics, Legal & Social Issues) June 7, 2009 Mark Leavitt, MD, PhD Chairman, Certification Commission for Healthcare Information Technology www.cchit.org [6/8/09 - contact info from www.markleavitt.com removed per critique in response below -ed.] <div style="margin-left: 40px;">Re: NJ HIT Bill at http://www.njleg.state.nj.us/2008/Bills/A4000/3934_I1.HTM by Assemblyman Harb Conaway, Jr., District 7, and Upendra Chivukula, District 17 </div> Dear Mark, The NJ Bill at <a href="http://www.njleg.state.nj.us/2008/Bills/A4000/3934_I1.HTM" target="blank">http://www.njleg.state.nj.us/2008/Bills/A4000/3934_I1.HTM </a> by Assemblyman Harb Conaway, Jr., District 7, and Upendra Chivukula, District 17, calls for making it a violation of law to sell HIT not "certified" by CCHIT . Penalties are called for. The bill states: <div style="margin-left: 40px;">... No person or entity, either directly or indirectly, shall sell, offer for sale, give, furnish, or otherwise distribute to any person or entity in this State a health information technology product that has not been certified by the Certification Commission for Healthcare Information Technology. </div> As used in this section, "health information technology product" means a system, program, application, or other product that is based upon technology which is used to electronically collect, store, retrieve, and transfer clinical, administrative, and financial health information. b. A person or entity that violates the provisions of subsection a. of this section shall be liable to a civil penalty of not less than $1,000 for the first violation, not less than $2,500 for the second violation, and $5,000 for the third and each subsequent violation, to be collected pursuant to the "Penalty Enforcement Law of 1999," P.L.1999, c.274 (C.2A:58-10 et seq.). I and others find this bill remarkable. It really calls into focus the HIT community's concerns about CCHIT and its political connections, especially pursuant to the article " <a href="http://www.washingtonpost.com/wp-dyn/content/article/2009/05/15/AR2009051503667.html?hpid=topnews">The Machinery Behind Healthcare Reform: How an Industry Lobby Scored a Swift, Unexpected Victory by Channeling Billions to Electronic Records </a>" of May 16, 2009 in the Washington Post by Robert O'Harrow Jr. I therefore seek answers to the following questions: 1. Do you approve of the proposals in the bill at http://www.njleg.state.nj.us/2008/Bills/A4000/3934_I1.HTM ? 2. Did you, or anyone in a governance or leadership position at CCHIT, play a role in sponsorhip of this bill, through financial contributions, lobbying, advocacy for its proposals, and/or other means to prohibit sale of non-CCHIT certified HIT? 3. Did anyone with governance or leadership roles in CCHIT's founding or affiliated organizations (e.g,, HIMSS, CITL, and others) or business associates of such people, play a role in the bill's sponsorhip, through financial contributions, lobbying, advocacy for its proposals, and/or other means to prohibit sale of non-CCHIT certified HIT? 4. Did anyone (person or company) in the HIT industry, broadly speaking, who could directly profit from such a bill becoming law play a role in sponsorhip of, or advocacy for this bill? I believe candid and transparent answers to these questions are important in giving the HIT community confidence that CCHIT primarily serves the public interest, not interests of an HIT lobby. </blockquote> -- SS 6/8/09 Dr. Leavitt has candidly responded. I take his word on these issues at face value, having done business with him a bit over a decade ago (supporting the purchase of his company's EHR, Logician, for Christiana Care over the opposition of the IT department which preferred another vendor): <blockquote> From: "Mark Leavitt" <mleavitt@cchit.org> Date: 06/08/2009 02:51AM cc: cis-wg@mailman.amia.org, poi-wg@mailman.amia.org, os-wg@mailman.amia.org, els-wg@mailman.amia.org, oharrowr@washpost.com,sreber@cchit.org<cis-wg@mailman.amia.org><poi-wg@mailman.amia.org><os-wg@mailman.amia.org><els-wg@mailman.amia.org><oharrowr@washpost.com><sreber@cchit.org> Subject: RE: Bill to make illegal the sale or use of non-CCHIT "certified" systems </sreber@cchit.org></oharrowr@washpost.com></els-wg@mailman.amia.org></os-wg@mailman.amia.org></poi-wg@mailman.amia.org></cis-wg@mailman.amia.org></mleavitt@cchit.org><div dir="ltr" align="left">Scot, </div> <div dir="ltr" align="left"> </div> <div dir="ltr" align="left">Here are the answers to your questions: </div> <div dir="ltr" align="left"> </div> <div dir="ltr" align="left">1. No, I do not approve of this legislation -- which I'm reading for the first time in your email. Our goal, stated in almost every presentation I've given, and to which I've adhered in my leadership of the Commission, has always been to unlock positive incentives for health IT adoption. The bill does not fit that model at all, and it is a bad idea. </div> <div dir="ltr" align="left"> </div> <div dir="ltr" align="left">2. Neither I personally, nor CCHIT as an organization, have lobbied, advocated, sponsored, or had anything to do with that bill. We were unaware of it until it started showing up on listserves Friday. The bill has never been mentioned in any of our Trustee, Commission, or staff meetings. </div> <div dir="ltr" align="left"> </div> <div dir="ltr" align="left">3. Trustees, Commissioners, and Work Group members serve in a volunteer capacity at CCHIT. We require disclosure of conflicts of interest, but we do not monitor all activities in their 'day jobs' or other volunteer roles. "HIMSS, CITL, etc" are not affiliated with CCHIT, and we don't know about all their advocacy activities. I'm not privy to the information you seek. </div> <div dir="ltr" align="left"> </div> <div dir="ltr" align="left">4. This question presumes that I would know everything that "anyone in the HIT industry, broadly speaking" has done regarding the bill. Naturally I do not have that knowledge either. </div> <div dir="ltr" align="left"> </div> <div dir="ltr" align="left">Now that I've responded, the AMIA listserve members can stop reading here, while I go on to chat with Scot. </div> <div dir="ltr" align="left"> </div> <div dir="ltr" align="left">Scot, in 15 years of medical training and practice followed by 25 years of healthcare informatics, I've encountered very few people -- and certainly no university professors -- who acted so disrespectfully toward me. Being a veteran of health IT, it's easy to find people who have worked with me or know me well, and to ask them about my integrity. Or to talk to some of the other 50 or so Commissioners who've served or the hundreds of work group volunteers. Shouldn't an informatics scientist do a modicum of research before undertaking a potentially harmful procedure such as attacking a person's or organization's reputation? Reading a news article by Mr O'Harrow does not qualify as due diligence. Would you let your informatics students get away with that before recommending a major, potentially disruptive or destructive IT project? </div> <div dir="ltr" align="left"> </div> <div dir="ltr" align="left">From your own blogging I see that your "early medical mentor, cardiothoracic surgery pioneer Victor P Satinsky, MD, believed in public embarrassment as a tool to fight bureaucracy and discrimination ." Well, that helps me understand. And your blogging about your frustration when you sought employment with a commercial EHR vendor <a href="http://hcrenewal.blogspot.com/2009/02/nextgen-and-vendordoctor-dialog-yet.html">http://hcrenewal.blogspot.com/2009/02/nextgen-and-vendordoctor-dialog-yet.html </a> explains even more. Knowing that, I forgive you for your tone and for inappropriately disclosing my home address and cell phone to everyone on these lists. I would be pleased to engage in a civil, rational debate with you along the lines of "EHRs -- do the benefits outweigh the risks?" C'mon out to the farm here sometime -- you know the address, and the dog's friendly -- or we could do it on the web. </div> <div dir="ltr" align="left"> </div> <div dir="ltr" align="left">Finally, my apologies to everyone on the mailing lists that Dr. Silverstein chose to include in his investigative journalism broadcast. If you object to his use of AMIA mailing lists for this kind of activity, you could let him know. </div> <div> </div> <div>Mark Leavitt, MD, PhD Chairman, CCHIT </div></blockquote> My response was simple: <blockquote>To: "Mark Leavitt" <mleavitt@cchit.org> Date: 06/08/2009 05:24PM cc: <cis-wg@mailman.amia.org>cis-wg@mailman.amia.org, poi-wg@mailman.amia.org, os-wg@mailman.amia.org, els-wg@mailman.amia.org, oharrowr@washpost.com,sreber@cchit.org<poi-wg@mailman.amia.org><os-wg@mailman.amia.org><els-wg@mailman.amia.org><oharrowr@washpost.com><sreber@cchit.org> Subject: RE: Bill to make illegal the sale or use of non-CCHIT "certified" systems Mark, I thank you for the answers to my questions. > Knowing that, I forgive you for your tone and for inappropriately disclosing my home address and cell phone to everyone on these lists. Mark, that information came from your page at <a href="http://www.markleavitt.com/">http://www.markleavitt.com/</a> which I found on a google seach for "Mark Leavitt." Image attached. I believed that to be your professional contact info. As to the rest of your response, you appear to attempt to discredit my arguments through ad hominem. I refer you to this page: <a href="http://www.nizkor.org/features/fallacies/ad-hominem.html" target="blank">http://www.nizkor.org/features/fallacies/ad-hominem.html </a> <div style="margin-left: 40px;">Translated from Latin to English , "Ad Hominem" means "against the man " or "against the person." An Ad Hominem is a general category of fallacies in which a claim or argument is rejected on the basis of some irrelevant fact about the author of or the person presenting <input name="IL_MARKER" type="hidden">the claim or argument. Typically, this fallacy involves two steps. First, an attack against the character of person making <input name="IL_MARKER" type="hidden">the claim , her circumstances, or her actions is made (or the character, circumstances, or actions of the person reporting the claim ). Second, this attack is taken to be evidence against <input name="IL_MARKER" type="hidden">the claim or argument the person in question is making (or presenting). This type of "argument" has the following form: </div><ol style="margin-left: 40px;"><li>Person A makes claim X. </li><li>Person B makes an attack on person A. </li><li>Therefore A's claim is false. </li></ol> The reason why an Ad Hominem (of any kind) is a fallacy is that the character, circumstances, or actions of a person do not (in most cases) have a bearing on the truth or falsity of <input name="IL_MARKER" type="hidden">the claim being made (or the quality of the argument being made). Ad hominem, sadly, is not debate. Neither is <a href="http://www.nizkor.org/features/fallacies/appeal-to-authority.html" target="blank">appeal to authority </a>. Scot</sreber@cchit.org></oharrowr@washpost.com></els-wg@mailman.amia.org></os-wg@mailman.amia.org></poi-wg@mailman.amia.org></cis-wg@mailman.amia.org></mleavitt@cchit.org></blockquote> Truth be told, I actually offered no arguments in my email message. I was asking very probing questions with concern they would be ignored, or responded to with "spin" as <a href="http://www.hcrenewal.blogspot.com/2009/02/cchit-dissolved-involuntarily-in-april.html">here</a>, and their tone offended him. Fair enough. I was a bit disappointed, however, by the "<a href="http://www.quotationspage.com/quote/25317.html">The lady doth protest too much, methinks</a>" ad hominem embellishments to an otherwise candid and convincing response. Such are the risks of directness and <a href="http://hcrenewal.blogspot.com/2009/03/disruptive-innovators-at-healthcare.html">disruptive innovation</a>, however. -- SS 6/9 Addendum: Additional views on the NJ Bill are at ePatients.net at "<a href="http://e-patients.net/archives/2009/05/david-kibbe-mark-leavitt-openness-vs-opacity.html">David Kibbe & Mark Leavitt:Openness vs. Opacity</a>" and "<a href="http://e-patients.net/archives/2009/06/dossia-microsoft-healthvault-google-healthillegal-in-nj.html">Dossia, Microsoft HealthVault & Google Health: Illegal in NJ?</a>". There are some now-familiar themes regarding CCHIT civility in those posts. 6/10 Addendum: As a result of a link sent by a commenter, I am adding the post "<a href="http://www.hcplive.com/mdnglive/The_HIT_Realist/Kibbe_Leavitt">The Kibbe/Leavitt Rumble in the High Tech Jungle!</a>" to the list of interesting views in the 6/9 addendum above.

Open letter to Mark Leavitt, Chairman, Certification Commission for Healthcare Information Technology on Penalties For Use of Non-"Certified" HIT

A remarkable Bill (ASSEMBLY, No. 3934 , STATE OF NEW JERSEY, 213th LEGISLATURE) has appeared in NJ that would prohibit the sale or use of h...

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A few not so random thoughts on Healthcare IT

A few thoughts for a Wednesday morning: <ul><li>I had recently written on some (probably) minor issues about <a href="http://hcrenewal.blogspot.com/2009/02/cchit-dissolved-involuntarily-in-april.html">CCHIT</a>, the Certification Commission for Healthcare Information Technology. However, I have more substantive concerns. I would like to know how CCHIT functions differently from a fictional "Drug Certification Commission." Imagine such a Commission founded by <a href="http://www.phrma.org/">PhRMA</a> 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? </li></ul><ul><li>I would also like to know how the irrational exuberance over Health IT, vastly accelerated for reasons unclear to me by the "Economic Stimulus Bill", differs from the Madoff scandal. The "Bernard Madoff" version of HIT reality promotes the point of view that even in the face of flimsy and/or <a href="http://hcrenewal.blogspot.com/2009/03/reader-on-why-we-have-busywork.html">contradictory evidence</a>, billions of dollars in investment in today's HIT is guaranteed to reap massive rewards, no matter what. Worse than Madoff's scam, those clinicians who don't invest will be penalized. In effect, the government has now taken over Madoff's Acme Anvil EMR Securities, Inc. and is forcing everyone to invest - or else. </li></ul> -- SS

A few not so random thoughts on Healthcare IT

A few thoughts for a Wednesday morning: I had recently written on some (probably) minor issues about CCHIT , the Certification Commission fo...

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