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Arguments for Maintaining the Health IT Status Quo on Defects Nondisclosure Clauses

As I wrote at Healthcare Renewal <a href="http://hcrenewal.blogspot.com/2009/12/web-petition-transparency-and-openness.html">here</a>, I recently posted a web petition "Transparency and Openness in Electronic Patient Records and Other Healthcare Information Technology Systems" at <a href="http://www.webpetitions.com/cgi-bin/print_petition.cgi?99504454" target="_blank">http://www.webpetitions.com/cgi-bin/print_petition.cgi?99504454</a> , calling for an end to Nondisclosure Clauses [of defects, problems, EHR-related adverse events, etc.] in HIT contracts. The petition reads: <blockquote> We, the undersigned, believe in transparency, accuracy, and accountability in scientific research, especially in matters related to healthcare. We believe contractual nondisclosure clauses [1] that prohibit or restrain unfettered disclosure and dissemination of information about healthcare information technology problems related to bugs, design defects, suboptimal user interfaces, other factors that can adversely affect care, and the adverse events and near accidents these problems cause, are unethical. We believe that patients and clinicians have a right to knowledge of healthcare information technology problems and defects that can distract clinicians and/or reduce clinician effectiveness and productivity. We also believe that hospital governance personnel have the fiduciary responsibility as well as obligation under Joint Commission safety standards to protect patients, clinicians and others working within and for their organizations from the potential consequences of healthcare information technology problems [2]. We believe that only through transparency about healthcare information technology can medical ethics be maintained, the rights of patients to the best possible care be protected and medical science advanced. Therefore, we call for such clauses to be refused by governance bodies, vendors of healthcare information technology to refrain from including such clauses in their contracts, and the U.S. Congress to prohibit nondisclosure clauses related to medical devices and healthcare information technology. Furthermore, retaliatory actions against those who in good faith report such matters or incidents should be prohibited. [1] Koppel R, Kreda D. Health Care Information Technology Vendors' "Hold Harmless" Clause: Implications for Patients and Clinicians, JAMA. 2009;301(12):1276-1278. [2] Silverstein S. "Health Care Information Technology, Hospital Responsibilities, and Joint Commission Standards." Letter to the Editor, JAMA. 2009; 302: 382.</blockquote> As I had spelled out many months ago at "Health Care Information Technology Vendors' Hold Harmless and Keep Defects Secret Clauses" <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/failurecases/?loc=cases&sloc=koppel_kreda">here</a>, and in a <a href="http://jama.ama-assn.org/cgi/content/extract/302/4/382">July 22, 2009 letter to the editor in JAMA</a> entitled "Health Care Information Technology, Hospital Responsibilities, and Joint Commission Standards", I believe these clauses: <ul><li>Are responsible for stagnation in health IT industry thinking that requires an unrelenting focus on the needs of clinicians and patients;</li></ul><ul><li>Cause hospital executives to violate their fiduciary and Joint Commission safety obligations to patients and staff;</li></ul><ul><li>Perhaps even put clinicians themselves in a conflict of interest with their own professional ethics (that call for widely sharing information about potential risks to patients). </li></ul> The Joint Commission nor any other healthcare regulatory body has done anything about such contract clauses since that time, to the best of my knowledge despite being made aware of these issues by direct email to JC leadership. I've noted few signatures to the petition so far, but have received some feedback and noted other justifications for maintenance of the status quo. The arguments fall into several categories that defend the status quo of HIT defect/problem nondisclosure clauses. The categories of argument include: <ul><li> Legal arguments (or perhaps I should say 'legalistic'): e.g., HIT is not a "medical device", is not regulated, therefore such clauses are nobody's business but the seller and buyer.</li></ul> <ul><li>Semantic arguments (arguing about words): e.g., the Joint Commission safety standards calling for "the organization to communicate information related to safety and quality to those who need it, including staff, licensed independent practitioners, patients, families, and external interested parties" really do not mean communication to other healthcare organizations, regulatory bodies, the press, etc.</li></ul> <ul><li>Corporatist arguments: the clauses are needed to protect the industry and protect "innovation" - however, innovation without adherence to patient's rights and medical ethics is not innovation at all in my mind (cf. the <a href="http://en.wikipedia.org/wiki/Tuskegee_syphilis_experiment">Tuskegee Study of Syphilis</a>).</li></ul><ul><li>Statist arguments: e.g., we know what's best for medicine, and even if HIT today does have problems and hurt people, it's for the greater future good that their diffusion should be unimpeded by free dissemination of information on downsides.</li></ul> <ul><li>Logically fallacious or irrational arguments: e.g., the circular argument that there's no reason to prohibit nondisclosure clauses about HIT defects and patient incidents, since these problems do not occur in the first place -- or if they occur patient harm is "always" averted by clinicians.</li></ul> While these type of arguments are interesting and may make for excellent debate, (and medical ethicist George Annas at BU taught his medical students, myself included, well on such issues): none of these arguments are aligned to the ethics, customs and traditions of medicine and the oaths taken by its practitioners. The oaths taken by healthcare IT companies (i.e., to the speculators investing in this technology) leave much to be desired in that regard. On the other hand, here is a sentinel reason for supporting their quick abolishment, a strong informatics-based reason to abolish nondisclosure clauses: As admissions such as "We are unable to share documents [relating to likely problematic EHR's - ed.] as our contract with XXXX includes a confidentiality clause" at <a href="https://exchangeweb.drexel.edu/owa/redir.aspx?C=8b72802e565a46c89aeaba37b9a8ecbd&URL=http%3a%2f%2fwww.computerweekly.com%2fblogs%2ftony_collins%2f2009%2f11%2fclaim-of-censorship-over-cerne.html" target="_blank">http://www.computerweekly.com/blogs/tony_collins/2009/11/claim-of-censorship-over-cerne.html</a> indicate, to the point of rejecting a FOI request for information, there are unknowns in health IT (as Tim the proprietor at <a href="http://www.histalk.com/">Histalk</a> wryly noted, the refusal probably is not on the grounds of having glowing praise to report). How many other data points have not made it to the literature, either peer reviewed or press? Does anyone know definitively? Do we really know that Medical Informatics research therefore represents a valid sampling of the events that transpire when HIT is designed and implemented? A parallel and currently controversial issue in pharma is the deliberate suppression of negative or neutral clinincal trials results, with an emphasis on the positive, to protect a drug candidate or an actual drug in postmarketing surveillance. Does this not potentially taint the science? -- SS

Arguments for Maintaining the Health IT Status Quo on Defects Nondisclosure Clauses

As I wrote at Healthcare Renewal here , I recently posted a web petition " Transparency and Openness in Electronic Patient Records and ...

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With Leaders Like These...

My current favorite book about the global financial meltdown, aka great recession, <a href="http://www.harpercollins.com/books/9780061892486/The_Sellout/index.aspx">The Sellout, by Charles Gasparino</a>, featured vivid portraits of the bad leadership that lead to the collapse.  For example: Richard S Fuld, Jr, former CEO of Lehman Brothers (now bankrupt) - <blockquote>Fuld had become more isolated and arrogant. (p.208) As the firm's leverage increased, Fuld's grip on his management and board grew. He was revered by so many people in his circle of senior advisers that almost no one dared to speak out about the firm's risk and leverate, and almost never to Fuld himself. Everyone else was so scared to be cursed at in public or even fired that they simply kept their mouths shut. Fuld's leadership was more like that of a cult leader than even that of an imperial CEO. (p. 209) </blockquote>Maurice R ("Hank") Greenberg, former CEO of AIG (now bailed out by the US government) - <blockquote>Greenberg had begun the financial products group that sold all those [now discredited] credit default swaps in the late 1980s.... Greenberg had a love-hate relationship with the group and its various leaders. He hated the risks they took and the independence the top people in the group sought. But he loved the profits the financial products group ... produced. Yet Eliot Spitzer, the New York State attorney general and by now Wall Street's most famous enforcer, believed Greenberg ran a company that regularly committed accounting fraud and created fictional profits through a series of sham transactions that had nothing to do with credit default swaps. Greenberg considered these possible transgressions so trivial that he called them 'foot faults,' as in a minor foul in tennis. Greenberg eventually did resign.... (p. 204) [and the financial products unit nearly drove AIG bankrupt] </blockquote> John A Thain, former CEO of Merrill Lynch (bailed out by being forcibly merged into Bank of America under pressure from the US government) <blockquote>Over time, it became difficult to keep track of every statement coming out of Thain's mouth that turned out to be wrong since nearly the moment he had taken over as CEO. (p. 417) Thain was becoming unhinged; during a briefing in one of his finely decordated conference rooms that had been part of the $1.2 million office spending spree, people close to the firm said, he completely lost his compusure when an aide informed him about the size of the [company's] losses. What Thain did isn't clear, but Merrill Lynch had to replace a shattered glass panel that appeared to have been the target of the CEO's rage. (p. 419) </blockquote> - Sanford I Weill, former CEO of Citigroup (bailed out by the US government) <blockquote>But in reality, Will never really ran anything. He was a visionary, to be sure, but one whose vision was so myopically focused on building the empire had lusted for for so long and on its share price that he ignored just about everything else. (p. 144) </blockquote> So here we again have reminders of how bad leadership of major US financial firms lead to the collapse. We had <a href="http://hcrenewal.blogspot.com/2009/12/health-care-bubble-parallels-with.html">discussed </a>a series of such factors and how they obtain in health care, suggesting that health care is undergoing a bubble likely to burst just as badly as did the financial/ housing bubble. However, I supplied these quotes not just to underline this point.  It turns out that Mr Fuld, Mr Greenberg, Mr Thain, and Mr Weill have something in common other than having helped to lead their financial firms toward the brink, something in common with relevance to health care. We recently <a href="http://hcrenewal.blogspot.com/2009/12/98-million-dollar-man.html">discussed</a> the outsize compensation given to the current CEO and other top leaders of one of the country's revered medical centers, New York - Presbyterian Hospital.   I suggested that such "compensation madness" will continue to inflate the health care bubble.  What that post did not discuss was how these leaders got to be so well paid.  Presumably, their compensation was set, or at least acquiesced to by the Board of Trustees of the hospital.  So I thought it might be entertaining to see who is currently on this Board. According to the <a href="http://nyp.org/about/board-trustees.html">medical center web-site</a>, the Board of Trustees as of October, 2009, was quite large (including 88 people by my count).  The web-site lists only names, not biographies, so that who most of the members are was not obvious.  This lack of transparency, which is not uncommon in health care organizations, would make figuring out who all the people ostensibly responsible for the $9.8 million dollary man are quite laborious.  However, I did recognize a few names immediately.  These were Richard S Fuld, Jr, Maurice R Greenberg, John A Thain, and Sanford I Weill.  Thus, the Board of Trustees of New York - Presbyterian Hospital includes four of the most well-known architects of the global financial meltdown.  Thus, is it any wonder why the Board of Trustees was happy paying the CEO of a not-for-profit health care institution at a level comparable to a for-profit corporate CEO?  (And is it any wonder that the Dean of the Faculties of Health Sciences and Medicine, and Executive Vice-President for Health and Biomedical Sciences at Columbia University, one of the two medical schools that provide students, trainees and faculty at New York - Presbyterian Hospital, once admitted that the school's main criterion for faculty success was ability to generate external funds, which he called being a <a href="http://hcrenewal.blogspot.com/2007/04/medical-schools-to-faculty-show-me.html">"taxpayer,"</a> rather than ability to teach, research, or take care of patients?) As we have discussed before, boards of trustees of not-for-profit health care institutions have a primary duty to uphold the institutions' missions.  Thus, one would think such boards would be selected according to their dedication to their missions.  But perhaps, in the grubby real world, there may be more important criteria, possibly such as the size of their donations to the institution.  Furthermore, those likely to donate the most  may be more likely to be richest (and perhaps most in need to making themselves appear philanthropic and public-spirited) than the most fervent upholders of patient care, teaching and research. Maybe giving stewardship of our once proud health care institutuions to people most likely to defend their missions, rather than most likely to donate a lot of money, would result in somewhat poorer institutions which do a better job of patient care, teaching and research.

With Leaders Like These...

My current favorite book about the global financial meltdown, aka great recession, The Sellout , by Charles Gasparino , featured vivid port...

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Teaching Would-be Health Care Leaders About Health Care: Why Is This News?

The Wall Street Journal just published <a href="http://online.wsj.com/article/SB10001424052748704398304574598132733849334.html">a story</a> on a big innovation in the business school curriculum: <blockquote>David Song was in the middle of a two-year executive M.B.A. program at University of Chicago's Booth School of Business in February when he got the idea to create a course to help business people better understand the inner workings of medicine. Dr. Song, chief of plastic surgery at the University of Chicago Medical Center, believes the course may help close the gap between such industries as pharmaceutical and biotech, and the medical community they serve. 'Why not help reveal how things run and how we make decisions, particularly in this time of immense overhaul to the system?' says Dr. Song, who began collaborating with one of his marketing professors, Sanjay Dhar, to put together the course, titled 'Understanding the New Breed of Healthcare Decision Makers'—a five-day $7,650 program slated for May. The program is designed to give participants a look at the administrative workings of an academic medical center, including how doctors make decisions about the way to treat patients, and which devices and products they choose to purchase. Booth, like other business schools, is struggling to keep up enrollment in executive education at a time when companies are pulling back on training budgets. Dr. Song's health-care program is the only new addition to the curriculum for the academic year, says Stephen LaCivita, associate dean of executive education. The program is geared toward professionals who work in areas like pharmaceuticals, medical devices and financial services, who may have a limited understanding of the physicians, nurses and other clinicians who are their customers. Some of the issues addressed in the seminars, which will be taught by medical and business faculty, include: how doctors and hospitals define value; how reimbursement strategies work; and how supply chain, purchasing decisions, patient flow and operations are managed. </blockquote> And here is the course's big feature: <blockquote>As an added bonus, on the second to last day students will change into scrubs and observe a surgery, make rounds with doctors and see how patients are prioritized in the emergency room. 'This is getting a glimpse of what it's like and how we make decisions,' says Dr. Song. </blockquote> Earlier this year we <a href="http://hcrenewal.blogspot.com/2009/08/ny-times-proclaims-anyone-can-run.html">noted</a> a NY Times article which breathlessly promoted management jobs in health care, partially by implying that they were available to those who knew little to nothing about what health care actually entails, with, at most "a little studying up." This new article suggests how little "studying up" may actually be needed.  The fact that a five-day course to teach budding MBAs a little bit about health care is considered a newsworthy business education innovation by the Wall Street Journal certainly suggests that the prevailing business culture allows management of heatlh care organizations by people with almost no knowledge of or experience in actual health care. We noted in August that the NY Times article had the whiff of a bubble about to burst.  Indeed, we just <a href="http://hcrenewal.blogspot.com/2009/12/health-care-bubble-parallels-with.html">noted</a> an article that listed some of the salient characteristics of the recently burst financial/ housing bubble, including "major organizations lead by the clueless."  For that post, we used examples of three leaders of huge financial firms that have now failed (that is, are bankrupt or bailed out) who did not understand the complex derivatives their firms were buying and selling.  In the earlier post, we noted examples of leaders of two big American automobile companies that have now similarly failed who seemed to know little about automobiles.  So here we have would-be leaders in pharmaceutical, medical device and other health care corporations "who may have a limited understanding of the physicians, nurses and other clinicians." This reinforces my thesis that health care is now in a bubble that will soon burst.  It also suggests why health care in the US costs so much, out of proportion to the quality or access provided.  Even setting aside how the business culture in the last 20 years has put short-term revenue and personal enrichment ahead of everything else, why would we expect that health care leadership by people who know little about health care, and care less for its values, would be anything but disastrous?

Teaching Would-be Health Care Leaders About Health Care: Why Is This News?

The Wall Street Journal just published a story on a big innovation in the business school curriculum: David Song was in the middle of a two...

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The Door Revolves: Tufts Medical School Dean Goes Back to Merck

A little news item <a href="http://www.nj.com/business/index.ssf/2009/12/new_jersey_drug_maker_lures_tu.html">in the Newark Star-Ledger</a>: <blockquote>Merck announced the appointment of Michael Rosenblatt as executive vice president and chief medical officer. The appointment, which was announced this morning by the company, is effective immediately. Rosenblatt will be responsible for bringing greater focus to Merck’s global medical activities as well as shaping innovative medical strategies. He will report directly to CEO Richard Clark. Rosenblatt has served as dean of Tufts University Medical School since 2003. Earlier, he was senior vice president for research at Merck Sharp & Dohme Research Laboratories, where he co-led the worldwide development team for Fosamax, Merck’s treatment for osteoporosis. </blockquote> A quick Google tour revealed that while he was Dean, Dr Rosenblatt also served as a <a href="http://www.millenniapartners.com/OurTeam/TeamView.asp?TeamMemberID=63">Scientific Advisor</a> to Boston Millenia Partners, a venture capital firm; a Founder and then <a href="http://www.nuvios.com/founders.htm">Scientific Advisor</a> to Nuvios, which now is known as <a href="http://radiuspharm.com/sab.htm">Radius Pharmaceuticals</a>;  an <a href="http://www.puretechventures.com/content/team.asp?mainPage=team&subPage=advisors">Advisor</a> to Puretech Ventures, which <a href="http://www.puretechventures.com/content/strategy.asp?mainPage=about&subPage=strategy">specializes</a>"in company creation and early-stage investment in novel therapeutics, medical devices, diagnostics, and research technologies"; and a <a href="http://www.shire.com/shire/CorporateInformation/directors.jsp?tn=1&m1=3">Director</a> of <a href="http://www.shire.com/shire/CorporateInformation/index.jsp?tn=1&m1=29">Shire</a>, "one of the world’s leading specialty biopharmaceutical companies." This is a reminder how fuzzy the line has become between medical academics and health care corporations.  Here is an example of someone who alternated his main employment between leadership posts in academic medicine and in the pharmaceutical industry, but while in academia maintained a string of part time commitments to a further variety of biotechnology and pharmaceutical companies, and related venture capital firms.  Given all these positions and financial relationships, who knows where his main allegiance was?  I would hope that the Dean of  a medical school would be the primary steward of the academic and clinical missions.  But what kind of stewardship can one expect from someone who came from one lucrative position in the pharmaceutical industry, and was to go back to an even higher level position, and who worked for several biotechnology/ pharmaceutical firms, and venture capital firms on the side? Hat-tip to <a href="http://shearlingsplowed.blogspot.com/2009/12/new-merck-names-new-chief-medical.html">Shearlings Got Plowed blog</a>.

The Door Revolves: Tufts Medical School Dean Goes Back to Merck

A little news item in the Newark Star-Ledger : Merck announced the appointment of Michael Rosenblatt as executive vice president and chief m...

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British Medical Journal Interviews Dr Aubrey Blumsohn

About a year after we started Health Care Renewal, in late 2005, we wrote multiple posts about the complex and unfortunate case of Dr Aubrey Blumsohn's attempts to keep a research project honest.  Our most recent summary of the case was <a href="http://hcrenewal.blogspot.com/2009/09/reappearance-of-ghost-of-seasons-past.html">here</a>.  The case involved suppression and manipulation of research, ghost-writing, institutional conflicts of interest, and attempts to silence a whistle blower. It provides lessons about the downsides of letting commercial firms sponsor and hence control human research designed to evaluate the products or services they sell; and of academic medicine becoming dependent on research money from such firms for such research. The case was just re-capped in some detail on the occaision of an interview of Dr Blumsohn published in the British Medical Journal, just available on-line yesterday.  [Cyer C. Aubrey Blumsohn: academic who took on industry.  Brit Med J 2009; 339:b5293.  Link <a href="http://www.bmj.com/cgi/content/full/339/dec15_1/b5293">here</a>.]  Dr Blumsohn's final words in the interview were: <blockquote>It’s hard to encourage anyone to speak out about poor practice in the current environment. This case sums up what has gone wrong with systems set in place to ensure safety and integrity in scientific medicine. It would help if regulators put as much effort into responding to serious critics and whistleblowers as they do producing glossy brochures and yet more guidance. </blockquote> My hat is off to Dr Blumsohn for his determination to pursue this case, and to the British Medical Journal for getting it into the "main-stream" health care literature. Hat-tip to <a href="http://pharmagossip.blogspot.com/2009/12/dr-aubrey-blumsohn-pharmagossips-person.html">PharmaGossip</a>.

British Medical Journal Interviews Dr Aubrey Blumsohn

About a year after we started Health Care Renewal, in late 2005, we wrote multiple posts about the complex and unfortunate case of Dr Aubrey...

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Web Petition: Transparency and Openness in Electronic Patient Records and Other Healthcare Information Technology Systems

I have created a new Web petition "Transparency and Openness in Electronic Patient Records and Other Healthcare Information Technology Systems." It is at WEBPETITIONS.COM at this link: <a href="http://www.webpetitions.com/cgi-bin/print_petition.cgi?99504454">http://www.webpetitions.com/cgi-bin/print_petition.cgi?99504454</a> Aimed at clinicians, hospital governance personnel and other healthcare stakeholders including patients, the petition states: <blockquote> We, the undersigned, believe in transparency, accuracy, and accountability in scientific research, especially in matters related to healthcare. We believe contractual nondisclosure clauses [1] that prohibit or restrain unfettered disclosure and dissemination of information about healthcare information technology problems related to bugs, design defects, suboptimal user interfaces, other factors that can adversely affect care, and the adverse events and near accidents these problems cause, are unethical. We believe that patients and clinicians have a right to knowledge of healthcare information technology problems and defects that can distract clinicians and/or reduce clinician effectiveness and productivity. We also believe that hospital governance personnel have the fiduciary responsibility as well as obligation under Joint Commission safety standards to protect patients, clinicians and others working within and for their organizations from the potential consequences of healthcare information technology problems [2]. We believe that only through transparency about healthcare information technology can medical ethics be maintained, the rights of patients to the best possible care be protected and medical science advanced. Therefore, we call for such clauses to be refused by governance bodies, vendors of healthcare information technology to refrain from including such clauses in their contracts, and the U.S. Congress to prohibit nondisclosure clauses related to medical devices and healthcare information technology. Furthermore, retaliatory actions against those who in good faith report such matters or incidents should be prohibited. [1] Koppel R, Kreda D. Health Care Information Technology Vendors' "Hold Harmless" Clause: Implications for Patients and Clinicians, JAMA. 2009;301(12):1276-1278. [2] Silverstein S. "Health Care Information Technology, Hospital Responsibilities, and Joint Commission Standards." Letter to the Editor, JAMA. 2009; 302: 382.</blockquote> The signed petition will be sent to the U.S. Senate Finance Committee (currently investigating healthcare IT), the Secretary of HHS, the Director of AHRQ, the Director of the Office of the National Coordinator for Health IT, and the President of the Joint Commission. Please sign at the WEBPETITIONS.COM link <a href="http://www.webpetitions.com/cgi-bin/print_petition.cgi?99504454">http://www.webpetitions.com/cgi-bin/print_petition.cgi?99504454</a>, and spread the word. -- SS Addendum: as an example of the problems these nondisclosure clauses can create, see my post "<a href="http://hcrenewal.blogspot.com/2009/12/we-are-unable-to-share-documents.html">We are unable to share documents relating to problematic EHR's as our contract with Cerner includes a confidentiality clause</a>."

Web Petition: Transparency and Openness in Electronic Patient Records and Other Healthcare Information Technology Systems

I have created a new Web petition "Transparency and Openness in Electronic Patient Records and Other Healthcare Information Technology ...

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Tensions and Paradoxes in Electronic Patient Record Research: Critical Thinking on Health IT

In "<a href="http://hcrenewal.blogspot.com/2009/11/2009-pivotal-year-in-healthcare-it.html">2009 a Pivotal Year In Healthcare IT</a>" I wrote that: <blockquote>2009 is proving to be a pivotal year in healthcare IT. Recent authoritative articles and reports on health IT problems largely validate the issues presented at this blog and others focusing on health IT issues, and at my <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/medinfo.htm">academic website on HIT difficulties</a> started over a decade ago, in 1998, freely available to the industry.</blockquote> I then listed some of those articles and reports. 2009 is not over, however, and it has yielded another article, a systematic literature review and somewhat novel analytical approach, that supports the observations of numerous independent-minded investigators that health IT is very, very much harder than it looks, and that irrational exuberance unsupported by robust evidence (but perhaps -- in my own opinion -- supported by the color of money) is the prevalent health IT driver today. The new article is entitled "Tensions and Paradoxes in Electronic Patient Record Research: A Systematic Literature Review Using the Meta-narrative Method" by Greenhalgh, Potts, Wong, Bark and Swinglehurst at University College London. The article appeared in the Dec. 2009 <a href="http://www.milbank.org/quarterly.html">Milbank Quarterly</a>, a multidisciplinary journal of population health and health policy published for over eighty years. The study was based on findings from hundreds of previous studies from all over the world. The article is summarized at the Oct. 14, 2009 Healthcare IT News item "<a href="http://www.healthcareitnews.com/news/electronic-health-records-not-panacea-researchers-say">Electronic health records not a panacea, researchers say</a>." The summary includes these key points: <blockquote><ul><li>Large-scale electronic health record projects promise much, but sometimes deliver little, according to a new study.</li><li>Researchers said their findings have implications for President Barack Obama’s election promise to establish electronic health records for every American by 2014, and for other large-scale EHR initiatives around the world.</li><li>EHRs are often depicted as the cornerstone of a modern healthcare, capable of making care better, safer and cheaper. Yet, clinicians and managers the world over struggle to implement EHRs.</li><li>outside the world of the carefully-controlled trial, between 50 and 80 per cent of electronic health record projects fail – and the larger the project, the more likely it is to fail."</li></ul></blockquote> I have reviewed the full article, available free as of this writing at <a href="http://eprints.ucl.ac.uk/18821/">this link</a> (PDF). I note the following. The authors observed that the HIT literature is heterogeneous and at times conflicting (e.g., about benefits, risks and implementation challenges of HIT), not least because it covers multiple research traditions with different underlying philosophical assumptions and methodological approaches. The authors used a somewhat novel meta-narrative method of systematic review, and identified over 500 full-text sources. They used ‘conflicting’ findings to address higher-order questions about how the electronic patient record (EPR) and its implementation were differently conceptualized and studied by different communities of researchers. They noted a number of "tensions" in relation to and among: <ul><li>the EPR itself - is it a mere data container or a work-altering and defining ‘itinerary’?; the EPR user; the organizational context of the EPR (‘the setting within which the EPR is implemented’ or ‘the EPR-in-use’); the process of change including the 'politics' that accompany IT-mediated change; and other factors. </li></ul> In other words (mine), health IT tools are virtual clinical tools for use in complex medical/social environments that happen to reside on a computer, not computer applications that happen to be used by clinicians. The authors found that (emphases mine): <blockquote>... while secondary work (audit, research, billing) may be made more efficient by the EPR, primary clinical work may be made less efficient; that paper, far from being technologically obsolete, currently offers greater ecological flexibility than most forms of electronic record; and that smaller systems may sometimes be more efficient and effective than larger ones. </blockquote> They concluded that <blockquote>The tensions and paradoxes revealed in this study extend and challenge previous reviews and suggest that the evidence base for some EPR programs is more limited than is often assumed. </blockquote>The relevance of that statement towards national HIT initiatives cannot be understated. I am going to highlight some other key points in the paper: <blockquote>... We previously developed the meta-narrative method as a way of systematically making sense of complex, heterogeneous and conflicting bodies of literature (Greenhalgh, Robert, Macfarlane, Bate, and Kyriakidou 2004). We recommend that those unfamiliar with this approach access our methodological paper (Greenhalgh, Robert, Macfarlane, Bate, Kyriakidou, and Peacock 2005) ... ... The meta-narrative should be thought of not as the unified voice of a community of scholars but as the unfolding of what they are currently disagreeing on ... In a synthesis phase, we compared and contrasted the different meta-narratives and exposed tensions and paradoxes; and we sought explanations for these in terms of how researchers had conceptualized the world and chosen to explore it. [See full paper for further details -ed.] </blockquote> While some might consider such analytical methods "soft", unorthodox, and therefore not robust, I counter that traditional methods of analytics and validation in biomedicine right up to and including today's peer review, especially related to issues of power and profit, have come under suspicion of corporate <a href="http://hcrenewal.blogspot.com/search/label/manipulating%20clinical%20research">manipulation</a> and other forms of taint. While the methodology will surely be subject to criticism and debate, which I will follow, I welcome possibly disruptively innovative methods that are probably clear of such pecuniary influences. <blockquote>We found a complex and heterogeneous literature characterized by diverse philosophical assumptions about the nature of reality (ontology), how that reality might be known (epistemology), and the preferred research approaches and study designs (methodology) ... Our exploratory reading identified a number of historical roots which informed later research on the EPR, including human-computer interaction (HCI), evidence-based medicine (EBM), symbolic interactionism and ethnomethodology, workplace redesign, safety-critical systems research, the social practice view of knowledge, complexity theory, and science and technology studies (previously known as philosophy of science). </blockquote> This only underscores the true complexity at the intersection of IT and medicine, a complexity I've repeatedly written has been glossed over by (and indeed, due to often narrow and limited backgrounds, may not be comprehensible to) HIT industry pundits and operatives. <blockquote>... The data suggested a significant difference in the likelihood of success between local ‘home grown’ EPR systems (developed in an ad hoc way by clinicians close to the operational detail of key work practices [such as in <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=Cardiology%20story">this personal example</a> I often cite- ed.]), and ‘off the shelf’ systems (developed either as commercial products or as public-sector systems of choice). </blockquote> In other words, local projects led by experts were far more likely to provide major benefits than the extant commercial and industrial models of "shrink wrapped" (and massively expensive) HIT. <blockquote>Studies consistently showed that introducing the EPR in an organization or across organizations is a complex task. It requires a well-articulated vision and strategy, strong leadership, adequate resources, good project management, an enabling organizational culture, effective communication, and attention to human resource issues [e.g., appropriate talent management and organizational structures - ed.]. Even when these preconditions were present, success was not guaranteed... </blockquote>In other words, hospitals, being generally in strained economic conditions and generally being an IT backwaters are highly risky environments for implementing health IT, which are still largely experimental technologies to start with. <blockquote> Information systems (IS) research is a heterogeneous tradition that emerged in business schools to consider the role of technology in business and management ... But very few such studies have been published on the EPR, perhaps because of the complexity and unpredictability of healthcare work and the highly institutionalized nature of the healthcare sector ... We found only three empirical studies ... all of which demonstrated that model-based analyses of the determinants of EPR success left much of the observed variance unexplained.</blockquote> In other words, as much is unknown about "doing HIT right" as is known and further cross disciplinary research is urgently needed. <blockquote> ...there are multiple and conflicting framings of the EPR by users (assumptions about it, expectations of it, versions of the problem to which it is seen as a solution), some of which are explained by deeply-held institutional values (e.g. what counts as ‘professionalism’ amongst doctors or what is seen as ‘good nursing care’); these contrasts partly explain the low adoption and slow spread of the EPR in many healthcare settings.</blockquote> In other words, HIT is primarily about people, not technology and grandiose promises of cybernetic miracles. <blockquote>... individuals, working collectively around common tasks in organizations, actively and explicitly shape both technologies and work routines in a way that is mutually adaptive ... It would appear that in relation to the EPR, this adaptation is not happening – or at least, not happening smoothly or unproblematically ... healthcare work is uniquely complex and dependent on the coordinated practice of multiple actors. Research to date has barely scratched the surface of what the introduction of the EPR means, at the level of fine-grained detail, for a healthcare organization and the staff and patients who practice and interact in that setting – and still less so when the EPR is part of a large-scale regional or national program.</blockquote> In other words, HIT is still largely a social experiment, and we as a society really don't know what we're doing or what the outcomes are likely to be. It raises the issue of slowing down the current locomotive of national HIT diffusion in five years. <blockquote>In ‘failed’ EPR projects, technical designers typically missed these subtleties and produced artefacts that fitted poorly with the situated nature of knowledge and the micro-detail of clinical work practices. Paper records, being flexible, portable and tolerant of ambiguity, support the complex work of clinical practice remarkably well. CSCW [computer supported cooperative work - ed.] studies have highlighted a telling paradox – that high-tech healthcare environments such as intensive care units often make extensive use of paper charts, white boards, sticky notes, and oral communication.</blockquote> In other words, paper has its place in healthcare, always will, and promises of "the paperless hospital" or office are utopian and not pratical. <blockquote> ... technologies reflect the interests and values of those who produce them, hence power struggles between bosses and workers, clinicians and managers, men and women, and the state and the citizen are played out partly through the design and use (or, indeed, non-use) of technology (Zuboff 1988). The EPR may be a focal point around which disputes of professional jurisdiction are fought.</blockquote> In other words, HIT projects are intensely political, especially with regard to medical affairs. (IMO management information systems IT personnel are far out of their league in attempting to lead such projects.) The synthesis in part concludes: <blockquote>Much of the literature covered in this review suggests, conversely, that (a) the EPR may be alternatively conceptualized as an ‘itinerary’, ‘organizer’ or ‘actor’ [in the latter concepts HIT is a medical device -- that should probably be regulated -- not a simple passive tool - ed.]; (b) seamless integration between different EPR systems is unlikely ever to happen because human work will always be needed to bridge the model-reality gap and re-contextualize knowledge for different uses [so much for dreams of 100% interoperability - ed.]; (c) whilst secondary work (audit, research, billing) may be made more efficient by the EPR, primary clinical work is often made less efficient; (d) the EPR may support, but it will not drive, changes in the social order of the workplace; (e) paper will not necessarily disappear as it offers a unique level of ecological flexibility (though workable paperless systems have been developed in one or two centres); and (f) smaller, more local EPR systems may often (though perhaps not always) be more efficient and effective than larger ones.</blockquote> Each item on this list contradicts nearly every precept of the national HIT initiative now underway in this country, at the expense of tens of billions of dollars. Two of the recommendations made by the authors are of special note: <blockquote>... as a cross-cutting theme in all the above areas, the realpolitik of EPR projects within and between organizations and interest groups should be more explicitly explored ... Orlikowski and Yates have called for more research on the “messy, dynamic, contested, contingent, negotiated, improvised, heterogeneous, and multi-level character of ICTs in organizations” (page 132) (Orlikowski and Yates 2006). We suggest that sponsors and publishers eschew sanitized accounts of successful projects and instead invite studies of the EPR in organizations that “tell it like it is” – perhaps using the critical fiction technique to ensure anonymity (Winter 1986).</blockquote> This recommendation is particularly intriguing to me. I am perhaps one of the few people in the HIT world to have undertaken that approach in the de-identified "tell it like it is" cases at my Drexel U. website "<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/">Common Examples of Health IT Failure</a>" begun over ten years ago. (I've made the lead author aware of the site and of the new multi author book "<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=hitormiss">HIT or Miss: Lessons Learned from Failed HIT Implementations</a>" that takes the same approach, to her approval.) <blockquote>... Finally, given the mismatch between what is known about the EPR in organizations and what many policymakers assume is known, there is also scope for research that addresses this mismatch ... The role of the systematic reviewer in this process is itself worth studying, since very little research on knowledge translation to date has addressed such turbulent waters.</blockquote> Yet, our government (and that of the UK as well) feel confident that HIT is such a perfected technology, investment of tens of billions of dollars on a frenetic timeframe will create massive quality improvements and cost savings. This is perhaps the height of magical thinking and political hubris. Finally, the authors identify what does NOT need be done: <blockquote> This review has also identified some areas where more research does not appear to be needed ... [including] simplified experimental studies based on functionalist and determinist assumptions of the general format “what is the impact of technology X on outcome Y?” or variations thereof ... the circumstances in which they add value are more limited than is often assumed. We [also] believe that surveys of attitudes of patients or staff towards ‘the EPR’ or ‘computerization’ which are not adequately contextualized have almost no enduring value.</blockquote> I note that these are the types of studies that seem to commonly appear in the soft "throwaway" literature aimed at the hospital governance board, CIO and IT worker. In conclusion, I believe this literature review supports the notion expressed in other studies and opinion pieces here and elsewhere that we really need to SLOW DOWN the current HIT stampede, largely promoted by the HIT industry lobby. We need to take the appropriate time to better understand how to "do HIT well" before plunging in as if we actually know what we're doing. In the authors' own words: <blockquote style="FONT-WEIGHT: bold">"It is time for researchers and policymakers to move beyond simplistic, technology-push models [for HIT] and consider how to capture the messiness and unpredictability of the real world."</blockquote> Indeed. They report, you decide. -- SS Addendum: this paper led me to the massive, near-600 page report "The Impact of eHealth on the Quality & Safety of Healthcare", A Report for the NHS Connecting for Health Evaluation Programme, Car et al., Imperial College, London, March 2008. This report was unknown to me but also validates much of the work of those studying the problems, risks and downsides of HIT. I will post on the report in the near future. It is available (warning - 7 Mb PDF) <a href="http://www.haps.bham.ac.uk/publichealth/cfhep/documents/NHS_CFHEP_001_Final_Report.pdf">here</a>. The executive summary is quite informative.

Tensions and Paradoxes in Electronic Patient Record Research: Critical Thinking on Health IT

In " 2009 a Pivotal Year In Healthcare IT " I wrote that: 2009 is proving to be a pivotal year in healthcare IT. Recent authorita...

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