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Banking as the Standard Healthcare Should Look Up To On Medical Information Security?

At past posts "<a href="http://hcrenewal.blogspot.com/2012/03/at-my-oct.html" target="_blank">Don't Worry, Your Electronic Medical Records Are Getting Safer With Every Passing Day</a>", "<a href="http://hcrenewal.blogspot.com/2011/09/another-episode-of-dont-worry-your.html" target="_blank">Another Episode of "But Don't Worry, Your Records are Safe...</a>" and "<a href="http://hcrenewal.blogspot.com/2011/10/still-more-ehr-chaos-pandemonium-bedlam.html">Still More Electronic Medical Data Chaos, Pandemonium, Bedlam, Tumult and Maelstrom: But Don't Worry, Your Data is Secure</a>", "<a href="http://hcrenewal.blogspot.com/2012/04/dont-worry-your-records-are-safe-part.html" target="_blank">Don't Worry, Your Records are Safe - Part IV</a>" and others, I wrote on the issue of medical record security. Banking has been held as the standard as to which medicine has been compared, with medicine being called archaic and behind the times for its reliance on paper.  Banking security is cited as a reason why electronic medical records can also be secured. There's this: <blockquote class="tr_bq"><a href="http://news.sky.com/story/952931/fraud-ring-in-hacking-attack-on-60-banks" target="_blank">Fraud Ring In Hacking Attack On 60 Banks</a>  June 27, 2012 Some 60m euro is stolen from bank accounts in a massive cyber raid, after fraudsters raid dozens of banks around the world. By Pete Norman, Sky News Online Sixty million euro has been stolen from bank accounts in a massive cyber bank raid after fraudsters raided dozens of financial institutions around the world. According to a joint report by software security firm McAfee and Guardian Analytics, more than 60 firms have suffered from what it has called an "insider level of understanding". "The fraudsters' objective in these attacks is to siphon large amounts from high balance accounts, hence the name chosen for this research - Operation High Roller," the report said. "If all of the attempted fraud campaigns were as successful as the Netherlands example we describe in this report, the total attempted fraud could be as high as 2bn euro (£1.6bn)." The automated malicious software programme was discovered to use servers to process thousands of attempted thefts from both commercial firms and private individuals. The stolen money was then sent to so-called mule accounts in caches of a few hundreds and 100,000 euro (£80,000) at a time. Credit unions, large multinational banks and regional banks have all been attacked. Sky News defence and security editor Sam Kiley said: "It does include British financial institutions and has jumped over to North America and South America. "What they have done differently from routine attacks is that they have got into the bank servers and constructed software that is automated. "It can get around some of the mechanisms that alert the banking system to abnormal activity." The details of the global fraud come just a day after the MI5 boss warned of the new cyber security threat to UK business. McAfee researchers have been able to track the global fraud, which still continues, across countries and continents. "They have identified 60 different servers, many of them in Russia, and they have identified one alone that has been used to steal 60m euro," Kiley said. "There are dozens of servers still grinding away at this fraud – in effect stealing money."</blockquote> That's all very reassuring.   Let's put all of our personal medical secrets online ASAP.  Don't worry, your information's safe and secure. -- SS

Banking as the Standard Healthcare Should Look Up To On Medical Information Security?

At past posts " Don't Worry, Your Electronic Medical Records Are Getting Safer With Every Passing Day ", " Another Episod...

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"More Marketing Than Science" - An Anonymous Confession About Deceptive Marketing Published in the British Medical Journal

The British Medical Journal just published an anonymous article by a pharmaceutical company insider that explained once again how pharmaceutical companies turn research studies, apparently scholarly articles, and medical education into stealth marketing efforts.  (See Anonymous.  Post-marketing observational studies: my experience in the drug industry.  Brit Med J 2012; 344: 28.  Link <a href="http://www.bmj.com/content/344/bmj.e3990">here</a>.) We have previously discussed examples of health care corporate insiders confessing their individual efforts to turn medical research and education into marketing.  For example, peruse <a href="http://hcrenewal.blogspot.com/search/label/key%20opinion%20leaders">this</a>.  We have also discussed how documents made public through litigation have revealed marketing plans for specific drugs that used apparently academic, educational, or scholarly publications and venues to market without revealing this transformation.  For example, see the Neurontin marketing plan (see post <a href="http://hcrenewal.blogspot.com/2006/08/stealth-marketing-of-neurontin.html">here</a>), and the Lexapro marketing plan (see post <a href="http://hcrenewal.blogspot.com/2009/09/lexapro-marketing-plan-was-meant-to.html">here</a>).  We have also discussed numerous examples of <a href="http://hcrenewal.blogspot.com/search/label/manipulating%20clinical%20research">manipulation of particular research studies</a> by those with vested interests, and outright <a href="http://hcrenewal.blogspot.com/search/label/suppression%20of%20medical%20research">suppression of studies</a> whose results did not favor such vested interests. Yet I suspect majorities of health care academics and professionals, health care policy makers, and the public at large do not realize, or would not admit that the evidence base for making health care decisions, and the general academic and professional discourse has been so corrupted.  So it is worthwhile to review once again how an insider summarized this corruption. Research Studies Designed Primarily as Marketing Vehicles In general, the anonymous author suggested that at least some studies were done for marketing, not scientific purposes: <blockquote>some of the studies I worked on were not designed to determine the overall risk:benefit balance of the drug in the general population. They were designed to support and disseminate a marketing message. Whether it was to highlight a questionable advantage over a 'me-too' competitor drug or to increase disease awareness among the medical community (particularly in so called invented diseases) and in turn increase product penetration in the market, the truth is that these studies had more marketing than science behind them.</blockquote> Furthermore, the studies were supervised not by physicians or scientists, but by marketers in the marketing department, <blockquote>Although the medical department developed the publication plans, designed the study, performed the statistical analysis, and wrote the final paper (which when published was passed on to marketing and sales to be used as marketing material), the marketing team responsible for that product were directly involved in all stages. They also closely supervised the content of other educational 'scientific' materials produced in the medical department and intended for potential prescribers. Instructions from marketing to the medical staff involved were clear: to ensure that the benefits of the drug were emphasised and the disadvantages were minimised where possible.</blockquote> Manipulation of Research Design, Implementation, or Analysis The author described how the marketers manipulated research studies so they would produce the results desired from a marketing perspective, regardless of their underlying truth, <blockquote>Since marketing claims needed to be backed-up scientifically, we occasionally resorted to 'playing' with the data that had originally failed to show the expected result. This was done by altering the statistical method until any statistical significance was found. Such a result might not have supported the marketing claim, but it was always worth giving it a go to see what results you could produce. And it was possible because the protocols of post-marketing studies were lax, and it was not a requirement to specify any statistical methodology in detail. On the other hand, the studies were hypothesis testing (such as cohort studies, case-control studies) rather than hypothesis generating (such as case reports or adverse events reports), so playing with the data felt uncomfortable. Other practices to ensure the marketing message was clear in the final publication included omission of negative results, usually in secondary outcome measures that had not been specified in the protocol, or inflating the importance of secondary outcome measures if they were positive when the primary measure was not.</blockquote> So to summarize, the marketers would control the statistical analyses, promoting multiple analyses to attempt to come up with the "right" result that would support the marketing message (although the more kinds of analyses one tries, the more likely one is likely to come up with false results by chance alone). Presumably the marketers did not care whether or not the results were really true, which is perhaps why even they felt "uncomfortable" in some circumstances. They would also foster the suppression of negative results, and the dredging of data for extra outcome measures when analysis showed no advantage in terms of the real primary outcomes. Suppression of negative results could be viewed as plain lying. Deliberate analysis of multiple end-points again risks identifying random error as true results. The Role of Key Opinion Leaders The author described how key opinion leaders, that is, health care professionals thought to be especially influential on practice or policy, were hired to become marketers presumably without revealing this intention. <blockquote>Every big international observational study had a large advisory board. This was critical since the success of a newly launched drug in the market would depend on how many key opinion leaders were part of the study. Not only would they add credibility to the results, but they would also be key in influencing decision makers and other prescribers. In regional studies with thousands of patients, the study’s advisory board was formed by at least one key opinion leader from each country in that region, ensuring that areas important in terms of possible sales were covered. The contributions of the key opinion leaders to the study were always positive, but in my experience more directed towards designing new studies to answer their specific clinical questions rather than critically appraising our results and conclusions. In general, the relationship was amicable. We took them to the best hotels and restaurants during our advisory board meetings, and they appeared as authors in our research. Later, they would act as the company’s 'ambassadors,' giving conferences, teaching doctors, or talking to the media about the benefits of the drug.</blockquote> Note that even the anonymous author could not bring him or herself to call the key opinion leaders salespeople, or marketers, but used the ambiguous wterm "ambassadors." Nonetheless, the role of key opinion leaders described would clearly be that of marketers or salespeople. However, it is extremely doubtful that any of these KOLs felt they had to declare that they were paid salespeople when presenting at conferences, teaching doctors, or talking about the media. I would suggest that their actions would therefore fit <a href="http://www.transparency.org/whoweare/organisation/faqs_on_corruption">Transparency International's definition</a> of ethical corruption, "abuse of entrusted power for private gain." The KOLs are entrusted to be professional, and in many cases, scholarly. Using a professional or scholarly guise to act as a salesperson appears to be abuse of that entrusted power, in my humble opinion. In nearly every case, KOLs are paid, often handsomely, by the companies whose products they are selling. Thus, key opinion leaders acting as described by the anonymous author appear to be ethically corrupt. Summary The evidence of unethical marketing practices by commercial health care firms is mounting. Although I am most familiar with evidence from the US, there is mounting evidence that these practices are global, often done by companies that are not US based, and meant to influence practice and policy world-wide. As the evidence mounts, it becomes increasingly clear that many such marketing practices are corrupt, at least in an ethical sense. Whether they may break laws in particular countries is a question for someone else. The latest BMJ article is a reminder how skeptical the shrinking group of health care professionals who do not have conflicts of interest, are not biased in favor of particular products, and who put patients' interests first must be about ALL published research, scholarly publications, and apparently educational activities. Advocates of true evidence-based medicine must be extremely careful to try to use the least biased and manipulated parts of the evidence-base. The mounting evidence suggests that at a minimum, all research reports, scholarly articles, media reports, conferences, and educational programs should provide full, detailed disclosure of all conflicts of interest. Perhaps having to make a declaration like "I am paid 50,000 Euros a year by the marketing department of company X to help market drug Y" before a supposedly educational talk would make some health care professionals think twice about such relationships. However, even such detailed disclosure may not be sufficient to hamper marketing practices that now appear overtly corrupt. In my humble opinion, it is time to consider a global ban on the funding or influencing of human research by companies and other organizations which stand to gain financially according to the results of the research, or whose products and services are subject of such research. It is also time to consider a global ban on the funding or influencing of health care education by such organizations. However, so many people are making so much money from the current practices that I doubt such proposals would get much support, or even public notice beyond this humble blog.

"More Marketing Than Science" - An Anonymous Confession About Deceptive Marketing Published in the British Medical Journal

The British Medical Journal just published an anonymous article by a pharmaceutical company insider that explained once again how pharmaceut...

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FDA: Software Failures Responsible for 24% Of All Medical Device Recalls

At "<a href="https://threatpost.com/en_us/blogs/fda-software-failures-responsible-24-all-medical-device-recalls-062012" target="_blank">FDA: Software Failures Responsible for 24% Of All Medical Device Recalls</a>" via Kapersky Labs, a software security company, it is observed (emphases mine): <blockquote class="tr_bq">Software failures were behind 24 percent of all the medical device recalls in 2011, according to data from the U.S. Food and Drug Administration, which said it is gearing up its labs to spend more time analyzing the quality and security of software-based medical instruments and equipment. The FDA's Office of Science and Engineering Laboratories (OSEL) released the data in its 2011 Annual Report on June 15, amid reports of a compromise of a Web site used to distribute software updates for hospital respirators. The absence of solid architecture and "principled engineering practices" in software development affects a wide range of medical devices, with potentially life-threatening consequences, the Agency said. In response, FDA told Threatpost that it is developing tools to disassemble and test medical device software and locate security problems and weak design. ... "Manufacturers are responsible for identifying risks and hazards associated with medical device software (or) firmware, including risks related to security, and are responsible for putting appropriate mitigations in place to address patient safety," the agency said in an e-mail statement. </blockquote> <a href="http://hcrenewal.blogspot.com/2011/04/fda-decides-regulating-implantable.html" target="_blank">Health IT medical devices</a> are the exception, of course.  A health IT virtual medical device is always of <a href="http://sydney.edu.au/engineering/it/%7Ehitru/essays/Pt%207%20-%20The%20Integrated%20Assessment%20-%20The%20Washup.pdf" target="_blank">rock-solid architecture</a>, always uses "<a href="http://hcrenewal.blogspot.com/2011/10/nist-on-ehr-mission-hostile-user.html" target="_blank">principled engineering practices</a>" in software development, and never has <a href="http://hcrenewal.blogspot.com/2011/06/babys-death-spotlights-safety-risks.html" target="_blank">life-threatening consequences</a>, of course. Hence its special regulatory accommodations over non-virtual (tangible) medical devices. -- SS

FDA: Software Failures Responsible for 24% Of All Medical Device Recalls

At " FDA: Software Failures Responsible for 24% Of All Medical Device Recalls " via Kapersky Labs, a software security company, it...

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Huge Insurance Company WellPoint Settles Once Again, Providing a Window On the Ethical Questions Its Birth Presented

Another month, another question about the ethical conduct of for-profit insurance giant WellPoint.  WellPoint Settles Allegations its Predecessor Anthem Cheated its Former Policy-Holders This time the issue was how the company treated people insured by its now Anthem subsidiary a long time ago.  Here is the Reuters <a href="http://www.reuters.com/article/2012/06/15/us-wellpoint-settlement-idUSBRE85E1F020120615">version</a>: <blockquote>Health insurer WellPoint Inc has agreed to pay $90 million to settle a class-action lawsuit against its Anthem unit over accusations the company did not fairly compensate former members when Anthem was converted from a mutual company into a stock company.</blockquote> The Indianapolis Star <a href="http://www.indystar.com/article/20120616/BUSINESS03/306160003/WellPoint-settles-former-Anthem-policyholders-90M">noted</a>: <blockquote>WellPoint had fought the lawsuit for seven years in court. The lawsuit alleged that WellPoint's Anthem subsidiary underpaid policyholders who opted to receive cash instead of stock when the Blue Cross-Blue Shield franchisee converted in 2001 into a stock company.</blockquote> Of course, a WellPoint spokesman denied the company had done anything wrong, per Reuters, <blockquote>Anthem spokeswoman Kristin Binns said in an e-mailed statement. 'We continue to believe that in all ways the company acted appropriately and in the best interests of its former members,...' </blockquote>The Historic Context: the Conversion of Non-Profit Health Insurers into For-Profit Corporations This may seem very dry and only of historical interest, but consider the historical context. Per <a href="http://wendellpotter.com/deadlyspin/">Wendell Potter's Deadly Spin</a>, after the Clinton administration's failed attempt at health reform, leaders of previously non-profit Blue Cross and Blue Shield insurance plans saw a new opportunity. In the mid-1990s, <blockquote>the Blue Cross and Blue Shield Association took a little-noticed but monumental step. The trade group, a bastion of non-profit health insurers that included the founders of the modern health insurance system, modified its bylaws to permit members to convert into public-stock companies.</blockquote> Potter opined about the executives' main motivation for conversion to for-profit status, and then consolidation of the resulting companies, <blockquote>They would earn bigger pay packages for managing larger businesses, and if they could convert them to for-profit companies, they would earn even more.</blockquote> So, <blockquote>Fourteen Blue Cross plans, most of which dominated their state-wide markets, converted from nonprofits to for-profits, and by 2004 all fourteen wound up as wholly owned subsidiaries of WellPoint.... </blockquote>The Anthem Demutualization as a Step to WellPoint Executives' Enrichment Anthem began as a non-profit insurance company, Blue Cross/Blue Shield of Indiana. Its hired managers first converted it into a mutual insurance company, a company that was owned by its policy-holders, and hence somewhat a non-profit in spirit. Then the executives started to acquire other formerly non-profit Blue Cross and Blue Shield plans. Then they converted the mutual insurance company into a pure for-profit. The for-profit Anthem eventually acquired WellPoint, taking that company's name. The resulting company then had become the biggest for-profit US health care insurer. In 2003, as the acquisition of WellPoint was pending, the Indianapolis Star <a href="http://www2.indystar.com/articles/2/135877-3402-031.html">reported</a>: <blockquote>The top executive at Anthem Inc. will receive a $42.5 million stock-and-cash award for guiding the company as it became the state's largest firm and now stands to become the nation's largest health benefits company. Larry C. Glasscock will receive the merit-based performance award over the next three years on top of his salary, bonus and other compensation of $3.73 million last year. It's the most compensation Glasscock has received since he became the company's chief executive in 1999 and helped convert it to a publicly traded concern in 2001</blockquote> Furthermore, <blockquote>Award amounts of $16 million each went to Glasscock's two highest-ranking associates: executive vice presidents David R. Frick, an attorney and former Indianapolis deputy mayor, and Michael L. Smith, a former chief executive of moving company Mayflower Group. In addition, the president of Anthem Midwest, Keith R. Faller, will get a stock-and-cash award of $11.9 million, while Anthem Southeast President Thomas G. Snead Jr. got $4.36 million.</blockquote> The allegation that the company's hired managers failed to adequately reimburse policy-holders for the policy-owners' ownership interests in the mutual version of Anthem was the basis of the law-suit that was just settled. The Anthem demutualization was a key step in the formation of the WellPoint behemoth. Its creation was the rationale to make the executives listed above rich. The allegations made in the lawsuit just settled suggest that they earned these huge windfalls on the backs of the policy-holders who at one point thought it was their company, and formerly thought that their insurer was a benign non-profit organization. A Continuing Record of Ethical Misadventures Thus, the lawsuit just settled suggests that WellPoint was born in ethically questionable circumstances, and that its creation served more to enrich its hired executives, who may have started as hired leaders of mission-oriented non-profit organizations. So in retrospect maybe it is not so surprising that WellPoint's leadership has continued to generate a series of ethical questions. Since we began <a href="http://hcrenewal.blogspot.com/">Health Care Renewal</a>, we have noted that the company: <ul><li>settled a RICO (racketeer influenced corrupt organization) law-suit in California over its alleged systematic attempts to withhold payments from physicians (see 2005 post <a href="http://hcrenewal.blogspot.com/2005/07/wellpoint-settles-rico-law-suit.html">here</a>).</li><li>subsidiary New York Empire Blue Cross and Blue Shield misplaced a computer disc containing confidential information on 75,000 policy-holders (see 2007 story <a href="http://www.nytimes.com/2007/03/14/business/14insure.html">here</a>).</li><li>California Anthem Blue Cross subsidiary cancelled individual insurance policies after their owners made large claims (a practices sometimes called rescission).  The company was ordered to pay a million dollar fine in early 2007 for this (see post <a href="http://hcrenewal.blogspot.com/2007/03/wellpoint-fined-1-million-for-canceling.html">here</a>).  A state agency charged that some of these cancellations by another WellPoint subsidiary were improper (see post <a href="http://hcrenewal.blogspot.com/2007/07/more-than-half-of-wellpoints-policy.html">here</a>).  WellPoint was alleged to have pushed physicians to look for patients' medical problems that would allow rescission (see post <a href="http://hcrenewal.blogspot.com/2008/02/wellpoint-halts-attempts-to-have.html">here</a>).  It turned out that California never collected the 2007 fine noted above, allegedly because the state agency feared that WellPoint had become too powerful to take on (see post <a href="http://hcrenewal.blogspot.com/2008/07/wellpoint-settles-but-has-it-become-too.html">here</a>). But in 2008, WellPoint agreed to pay more fines for its rescission practices (see post <a href="http://hcrenewal.blogspot.com/2008/07/fines-re-statements-and-more-fines-just.html">here</a>).  In 2009, WellPoint executives were defiant about their continued intention to make rescission in hearings before the US congress (see post <a href="http://hcrenewal.blogspot.com/2009/06/managed-care-executives-will-not-limit.html">here</a>).</li><li>California Blue Cross subsidiary allegedly attempted to get physicians to sign contracts whose confidentiality provisions would have prevented them from consulting lawyers about the contracts (see 2007 post <a href="http://hcrenewal.blogspot.com/2007/11/physicians-and-contracts-cautionary.html">here</a>).</li><li>formerly acclaimed CFO was fired for unclear reasons, and then allegations from numerous women of what now might be called Tiger Woods-like activities surfaced (see post <a href="http://hcrenewal.blogspot.com/2008/01/more-managed-care-management-mumbo.html">here</a>).</li><li>announced that its investment portfolio was hardly immune from the losses prevalent in late 2008 (see post <a href="http://hcrenewal.blogspot.com/2008/10/if-this-is-how-wellpoint-has-managed.html">here</a>).</li><li>was sanctioned by the US government in early 2009 for erroneously denying coverage to senior patients who subscribed to its Medicare drug plans (see 2009 post <a href="http://hcrenewal.blogspot.com/2009/01/wellpoint-sanctioned.html">here</a>).</li><li>settled charges that it had used a questionable data-base (built by Ingenix, a subsidiary of ostensible WellPoint competitor UnitedHealth) to determine fees paid to physicians for out-of-network care (see 2009 post <a href="http://hcrenewal.blogspot.com/2009/02/wellpoint-settles.html">here</a>).  </li><li>violated state law more than 700 times over a three-year period by failing to pay medical claims on time and misrepresenting policy provisions to customers, according to the California health insurance commissioner (see 2010 post <a href="http://hcrenewal.blogspot.com/2010/02/argument-over-insurance-rate-hikes.html">here</a>). </li><li>exposed confidential data from about 470,000 patients (see 2010 post <a href="http://hcrenewal.blogspot.com/2010/06/wellpoint-dont-know-much-about-computer.html">here</a>) and settled the resulting lawsuit in 2011 (see post <a href="http://hcrenewal.blogspot.com/2011/10/still-more-ehr-chaos-pandemonium-bedlam.html">here</a>).</li><li>fired a top executive who publicly apologized for the company's excessively high charges (see 2010 post here).</li><li>California Anthem subsidiary was fined for systematically failing to make fair and timely payments to doctors and hospitals (see 2010 post <a href="http://hcrenewal.blogspot.com/2010/12/health-insurers-sanctioned-fined.html">here</a>).</li><li>management was accused of hiding the company's political contributions from the company's own stock-holders (see 2012 posts <a href="http://hcrenewal.blogspot.com/2012/04/some-of-wellpoints-owners-stockholders.html">here</a> and <a href="http://hcrenewal.blogspot.com/2012/05/wall-street-journal-defends-hired.html">here</a>).</li></ul>Meanwhile, top hired managers have continued to draw bloated compensation from the company.  For example, as we noted <a href="http://hcrenewal.blogspot.com/2012/04/some-of-wellpoints-owners-stockholders.html">here</a>, current WellPoint CEO Angela Braly got $13.2 million compensation, and received an additional $6.9 million from newly vested restricted stock units in 2011, despite falling company earnings. Summary: A Company Too Big to Manage Except to Enrich Its Executives Thus, we have seen an amazing string of incidents suggesting that company leadership has consistently put short-term revenues, and the resulting exaggerated management compensation, before stock-holders' interests, and before patients' interests.  Yet this pattern, so plain above, has largely not been assembled from its component pieces in public other than on Health Care Renewal.  Lack of perception of this pattern may explain why this incredible compilation of ethical missteps has failed to generate any calls for massive revisions in how this company is lead and governed, or perhaps calls to dismantle such a large for-profit company as unmanageable except as a source of nearly unlimited dollars for the enrichment of its top insiders. True health care reform would require the leaders of health care organizations to uphold the health care mission ahead of their own self-interest, and to be accountable to the organizations' owners, when they exist, and to patients and the public at large.

Huge Insurance Company WellPoint Settles Once Again, Providing a Window On the Ethical Questions Its Birth Presented

Another month, another question about the ethical conduct of for-profit insurance giant WellPoint. WellPoint Settles Allegations its Predec...

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AMIA Board: specification of core competencies in Biomedical Informatics

In 1998 I launched a website called "Medical Informatics and Leadership of Clinical Computing" (now entitled "Contemporary Issues in Medical Informatics- Common Examples of Healthcare Information Technology Difficulties" at <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/" target="_blank">this link</a>). Its theme was that leadership of IT in healthcare was severely lacking in the formal competencies needed to reach any measure of success, and in fact the lack of informatics competencies in the usual IT actors was causing wasted resources and patient harm. I had also commented that the term "Medical Informatics" itself was being misappropriated by anyone claiming to do anything with computers in medicine, even the creation of trivial and/or low-value programs. Sadly, little has changed in that regard since 1998; in fact things are much worse.  The meaning of the term "Medical Informatics" itself has become severely blurred, and job listings that use the term are largely misguided.  They often seek a nurse (most common) or doctor (less common) without formal education in the domain, who's dabbled with hospital IT systems, to lead clinical IT projects.  This is a totally inappropriate and even dangerous approach (example <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=leadership" target="_blank">here</a>). The American Medical Informatics Association has released a paper "AMIA Board white paper: definition of biomedical informatics and specification of core competencies for graduate education in the discipline" that is long, long overdue.  As of this writing, full text is available a this link:  <a href="http://jamia.bmj.com/content/early/2012/06/07/amiajnl-2012-001053.full">http://jamia.bmj.com/content/early/2012/06/07/amiajnl-2012-001053.full</a>. This paper certainly provides a robust affirmation of ONC's recommendations on healthcare IT leadership roles that I wrote of in my Oct. 2009 post "<a href="http://hcrenewal.blogspot.com/2009/12/onc-defines-taxonomy-of-health-it.html" target="_blank">ONC Defines a Taxonomy of Robust Healthcare IT Leadership</a>." Some highlights of the new AMIA paper: <blockquote class="tr_bq">Abstract <div id="p-2">The AMIA biomedical informatics (BMI) core competencies have been designed to support and guide graduate education in BMI, the core scientific discipline underlying the breadth of the field's research, practice, and education. The core definition of BMI adopted by AMIA specifies that BMI is ‘the interdisciplinary field that studies and pursues the effective uses of biomedical data, information, and knowledge for scientific inquiry, problem solving and decision making, motivated by efforts to improve human health.’ Application areas range from bioinformatics to clinical and public health informatics and span the spectrum from the molecular to population levels of health and biomedicine. The shared core informatics competencies of BMI draw on the practical experience of many specific informatics sub-disciplines. The AMIA BMI analysis highlights the central shared set of competencies that should guide curriculum design and that graduate students should be expected to master. </div></blockquote> Note that Biomedical Informatics, which the Board feels is a broader term encompassing all of the information-science disciplines in healthcare and biomedical research, is defined as "a core scientific discipline underlying the breadth of the field's research, practice, and education."  One does not acquire expertise in a scientific discipline without first rigorously studying that discipline, e.g., as is done in medical school to gain optimal understanding of clinical medicine. <blockquote class="tr_bq">... The present articulation of BMI core competencies is intended to support AMIA and its members in promoting the discipline as a career choice, and to provide guidance to students and curriculum developers when choosing, designing (and implementing), or re-designing graduate-level academic BMI programs.</blockquote> (Who needs graduate education in Biomedical Informatics when all that seems to be needed is a little on-the-job dabbling?) <blockquote class="tr_bq">... Defining BMI as the scientific core of a discipline that has broad applications across health and biomedicine highlights its foundational role and refutes the kind of reductionism that superficially explains BMI simply as the application of information technology (IT) to biomedical and health problems.</blockquote> I termed that phenomenon "Medical Instamatics" on that late 1990's site.  Unfortunately, the "reductionism" is all too prevalent today.  People whose BMI education and skill levels (which I define as the ability to apply deep knowledge and experience to successfully manage the unexpected, not just manage traditional activities via a book of "process"), are often at the amateur level -- in the same sense that I am a <a href="http://www.arrl.org/" target="_blank">radio amateur</a>, not a telecommunications/engineering professional -- or worse.  This wreaks havoc (as <a href="http://hcrenewal.blogspot.com/2011/02/updated-reading-list-on-health-it.html" target="_blank">here</a>) in health IT, especially when led by senior management also incognizant of the issues. <blockquote class="tr_bq"><div id="p-11">Definition: Biomedical informatics (BMI) is the interdisciplinary field that studies and pursues the effective uses of biomedical data, information, and knowledge for scientific inquiry, problem solving, and decision making, driven by efforts to improve human health. </div></blockquote><blockquote><blockquote class="tr_bq"><div id="p-12">Scope and breadth of discipline: BMI investigates and supports reasoning, modeling, simulation, experimentation, and translation across the spectrum from molecules to individuals and to populations, from biological to social systems, bridging basic and clinical research and practice and the healthcare enterprise. </div></blockquote></blockquote><blockquote><blockquote><div id="p-13">Theory and methodology: BMI develops, studies, and applies theories, methods, and processes for the generation, storage, retrieval, use, management, and sharing of biomedical data, information, and knowledge. </div></blockquote></blockquote><blockquote><blockquote><div id="p-14">Technological approach: BMI builds on and contributes to computer, telecommunication, and information sciences and technologies, emphasizing their application in biomedicine. </div></blockquote></blockquote><blockquote><blockquote><div id="p-15">Human and social context: BMI, recognizing that people are the ultimate users of biomedical information, draws upon the social and behavioral sciences to inform the design and evaluation of technical solutions, policies, and the evolution of economic, ethical, social, educational, and organizational systems. </div></blockquote></blockquote> There is also a call for experts to: <ul class="list-unord" id="list-3"><li id="list-item-6"> <div id="p-24">Acquire professional perspective: Understand and analyze the history and values of the discipline and its relationship to other fields while demonstrating an ability to read, interpret, and critique the core literature.</div></li></ul> In effect, health IT amateurs, including those in traditional business computing, have little to no formal education or experience in reasoning, modeling, simulation, experimentation, and translation; developing, studying, and applying theories; building on and contributing to computer, telecommunication, and information sciences and technologies; and drawing upon the social and behavioral sciences to inform design of these complex systems. <blockquote class="tr_bq">BMI is the core scientific discipline that supports applied research and practice in several biomedical disciplines, including health informatics, which is composed of clinical informatics (including subfields such as medical, nursing, and dental informatics) and public health informatics (sometimes referred to more broadly as population informatics to capture its inclusion of global health informatics). There are related notions, such as consumer health informatics, which involves elements of both clinical and public health informatics. BMI in turn draws on the practical experience of the applied subspecialties, and works in the context of clinical and public health systems and organizations to develop experiments, interventions, and approaches that will have scalable impact in solving health informatics problems. However, it is the depth of informatics methods, shared across the spectrum from the molecular to the population levels<a class="xref-bibr" href="http://jamia.bmj.com/content/early/2012/06/07/amiajnl-2012-001053.full#ref-3" id="xref-ref-3-2"></a> that defines the core discipline of BMI and provides its coherence and its professional foundation for defining a common set of core competencies.</blockquote> Here is the diagrammatic represention of the above in the full article: <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/AVvXsEiX0WhgzQnpXO8Sql66EOfWJVSqULu2qvMhhkceeEnMfmVzwyYi4C_q3RTsX3ET_IucsBpfwlghcZdLrPFR8fAGmIzTHdsIut9g_tdM8_0ngC16xdZAyUqsYWzdqPb-qx2WJ0FRSGXGOIC8/s1600/F1.large.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="220" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiX0WhgzQnpXO8Sql66EOfWJVSqULu2qvMhhkceeEnMfmVzwyYi4C_q3RTsX3ET_IucsBpfwlghcZdLrPFR8fAGmIzTHdsIut9g_tdM8_0ngC16xdZAyUqsYWzdqPb-qx2WJ0FRSGXGOIC8/s320/F1.large.jpg" width="320" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">Biomedical informatics and its areas of application and practice, spanning the range from molecules to populations and society</td><td class="tr-caption" style="text-align: center;"></td><td class="tr-caption" style="text-align: center;"></td></tr></tbody></table> Finally, excerpts from the meat of the article on Prerequisite knowledge and skills.  This depth and breadth of knowledge does not come from studying business computing, dabbling with systems by nurses or physicians lacking formal domain education at the graduate level or beyond, or by guessing by the seat of one's pants: <ul class="list-unord" id="list-2"><li id="list-item-14"><ul class="list-unord" id="list-4"><li id="list-item-16"> <div id="p-34">Fundamental knowledge: Understand the fundamentals of the field in the context of the effective use of biomedical data, information, and knowledge. For example:</div><ul class="list-unord" id="list-5"><li id="list-item-19"> <div id="p-37">... Healthcare: screening, diagnosis (diagnoses, test results), prognosis, treatment (medications, procedures), prevention, billing, healthcare teams, quality assurance, safety, error reduction, comparative effectiveness, medical records, personalized medicine, health economics, information security and privacy.</div></li></ul></li><li id="list-item-22"> <div id="p-40">Procedural knowledge and skills: For substantive problems related to scientific inquiry, problem solving, and decision making, apply, analyze, evaluate, and create solutions based on biomedical informatics approaches.</div><ul class="list-unord" id="list-6"><li id="list-item-23"> <div id="p-41">Understand and analyze complex biomedical informatics problems in terms of data, information, and knowledge.</div></li><li id="list-item-24"> <div id="p-42">Apply, analyze, evaluate, and create biomedical informatics methods that solve substantive problems within and across biomedical domains.</div></li><li id="list-item-25"> <div id="p-43">Relate such knowledge and methods to other problems within and across levels of the biomedical spectrum.</div></li></ul></li></ul></li><li id="list-item-26"> <div id="p-44">Theory and methodology: BMI develops, studies, and applies theories, methods, and processes for the generation, storage, retrieval, use, management, and sharing of biomedical data, information, and knowledge. All involve the ability to reason and relate to biomedical information, concepts, and models spanning molecules to individuals to populations: </div><ul class="list-unord" id="list-7"><li id="list-item-27"> <div id="p-45">Theories: Understand and apply syntactic, semantic, cognitive, social, and pragmatic theories as they are used in biomedical informatics. </div></li><li id="list-item-28"> <div id="p-46">Typology: Understand, and analyze the types and nature of biomedical data, information, and knowledge.</div></li><li id="list-item-29"> <div id="p-47">Frameworks: Understand, and apply the common conceptual frameworks that are used in biomedical informatics.</div><ul class="list-unord" id="list-8"><li id="list-item-30"> <div id="p-48">A framework is a modeling approach (eg, belief networks), programming approach (eg, object-oriented programming), representational scheme (eg, problem space models), or an architectural design (eg, web services).</div></li></ul></li><li id="list-item-31"> <div id="p-49">Knowledge representation: Understand and apply representations and models that are applicable to biomedical data, information, and knowledge.</div><ul class="list-unord" id="list-9"><li id="list-item-32"> <div id="p-50">A knowledge representation is a method of encoding concepts and relationships in a domain using definitions that are computable (eg, first order logics).</div></li></ul></li><li id="list-item-33"> <div id="p-51">Methods and processes: Understand and apply existing methods (eg, simulated annealing) and processes (eg, goal-oriented reasoning) used in different contexts of biomedical informatics.</div></li></ul></li><li id="list-item-34"> <div id="p-52">Technological approach: BMI builds on and contributes to computer, telecommunication, and information sciences and technologies, emphasizing their application in biomedicine. </div><ul class="list-unord" id="list-10"><li id="list-item-35"> <div id="p-53">Prerequisite knowledge and skills: Assumes familiarity with data structures, algorithms, programming, mathematics, statistics.</div></li><li id="list-item-36"> <div id="p-54">Fundamental knowledge: Understand and apply technological approaches in the context of biomedical problems. For example:</div><ul class="list-unord" id="list-11"><li id="list-item-37"> <div id="p-55">Imaging and signal analysis.</div></li><li id="list-item-38"> <div id="p-56">Information documentation, storage, and retrieval.</div></li><li id="list-item-39"> <div id="p-57">Machine learning, including data mining.</div></li><li id="list-item-40"> <div id="p-58">Networking, security, databases.</div></li><li id="list-item-41"> <div id="p-59">Natural language processing, semantic technologies.</div></li><li id="list-item-42"> <div id="p-60">Representation of logical and probabilistic knowledge and reasoning.</div></li><li id="list-item-43"> <div id="p-61">Simulation and modeling.</div></li><li id="list-item-44"> <div id="p-62">Software engineering.</div></li></ul></li><li id="list-item-45"> <div id="p-63">Procedural knowledge and skills: For substantive problems, understand and apply methods of inquiry and criteria for selecting and utilizing algorithms, techniques, and methods.</div></li></ul></li><li id="list-item-49"> <div id="p-67">Human and social context: BMI, recognizing that people are the ultimate users of biomedical information, draws upon the social and behavioral sciences to inform the design and evaluation of technical solutions, policies, and the evolution of economic, ethical, social, educational, and organizational systems. </div><ul class="list-unord" id="list-13"><li id="list-item-50"> <div id="p-68">Prerequisite knowledge and skills: Familiarity with fundamentals of social, organizational, cognitive, and decision sciences.</div></li><li id="list-item-51"> <div id="p-69">Fundamental knowledge: Understand and apply knowledge in the following areas:</div><ul class="list-unord" id="list-14"><li id="list-item-52"> <div id="p-70">Design: for example, human-centered design, usability, human factors, cognitive and ergonomic sciences and engineering.</div></li><li id="list-item-53"> <div id="p-71">Evaluation: for example, study design, controlled trials, observational studies, hypothesis testing, ethnographic methods, field observational methods, qualitative methods, mixed methods.</div></li><li id="list-item-54"> <div id="p-72">Social, behavioral, communication, and organizational sciences: for example, computer supported cooperative work, social networks, change management, human factors engineering, cognitive task analysis, project management.</div></li><li id="list-item-55"> <div id="p-73">Ethical, legal, social issues: for example, human subjects, HIPAA, informed consent, secondary use of data, confidentiality, privacy.</div></li><li id="list-item-56"> <div id="p-74">Economic, social and organizational context of biomedical research, pharmaceutical and biotechnology industries, medical instrumentation, healthcare, and public health.</div><div id="p-74"> </div><div id="p-74"> </div></li></ul></li></ul></li></ul>While nobody is an expert in all of these areas, skills in many of them are essential for successful and safety-promoting leadership in the health IT domain. I repeat, this depth and breadth of knowledge does not come from studying business computing, dabbling with health IT, or by guessing by the seat of one's pants.  It comes about from rigorous education and experience in the appropriate domains at the graduate and (especially) post-doctoral levels. Amateurs mistakenly put in leadership positions, and their organizations, are going to increasingly find themselves in legal hot water over mistakes in design and implementation that result in patient harm, security breaches, overbilling and other issues. That is probably what it will take to have hospitals manage health IT talent more appropriately. Finally, I plead guilty to tooting my own profession's horn. Somebody needs to when the stakes are so high for patients. -- SS

AMIA Board: specification of core competencies in Biomedical Informatics

In 1998 I launched a website called " Medical Informatics and Leadership of Clinical Computing " (now entitled " Contemporary...

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Administrators at Pepper Spray U Found to Have Violated Medical Professor's Academic Freedom

There they, the management of University of California - Davis, go again. The Wilkes and Hoffman Op-Ed Questioning A University Sponsored Aggressive Prostate Cancer Screening Program According to the <a href="http://articles.latimes.com/2012/jun/14/local/la-me-ucdavis-20120614">Los Angeles Times</a>, and a post in <a href="http://www.insidehighered.com/news/2012/06/06/academic-freedom-committee-uc-davis-blames-administrators">Inside Higher Ed</a>, the trouble began when Dr Michael Wilkes, a professor of medicine at University of California - Davis, and Jerome Hoffman, a professor of emergency medicine, wrote an <a href="http://www.sfgate.com/cgi-bin/article.cgi?f=/c/a/2010/09/30/EDET1FLK3B.DTL">op-ed</a> in the San Francisco Chronicle in 2010 questioning the wisdom of a program run by UC-Davis promoting aggressive screening for prostate cancer with the PSA test.  They brought up problems with using PSA for screening that have been known for a while, including the poor ability of the test to detect cancer, the inability of the test or of prostate biopsy performed in response to the test to differentiate aggressive prostate cancer from cancer that will not progress, which is more common, the risks of such biopsies, and the poor effectiveness of available prostate cancer treatments, compared with the frequency with which they produce harms.  All these issues have again been brought to the fore by US Preventive Services Taskforce's <a href="http://annals.org/article.aspx?doi=10.7326/0003-4819-157-2-201207170-00464">latest recommendations</a> not to screen for prostate cancer, based on similar concerns. Not only did Wilkes and Hoffman question the basis for the university sponsored program's aggressiveness, they speculated that it might have to do with money.  The program was sponsored not only by UC-Davis but by the American Urological Association Foundation.  In fact, that foundation's <a href="http://www.urologyhealth.org/difference/corporatesponsors.cfm">current corporate sponsors </a>include:  Astellas Pharma, Inc., Endo Pharmaceuticals, Ferring Pharmaceuticals, Intuitive Surgical, Inc., Pfizer, Inc., and Qualigen, Inc., although the op-ed did not specifically list its commercial support. The University Slap(p?)s Back Nonetheless, per the Inside Higher Ed post, <blockquote>Michael Wilkes received an e-mail from an administrator at the University of California at Davis. Wilkes, a professor at the medical school, was told that he would no longer lead a program sequence that taught better patient care, and support for a Hungarian student exchange program he headed would be withdrawn. Within weeks, Wilkes was told that he would be removed as director of global health for the UC Davis Health System. He also received letters from the university’s health system counsel suggesting that the university could potentially sue him for defamation over the op-ed. </blockquote> Again, this occurred despite the facts that many distinguished people have questioned the wisdom of aggressive prostate cancer screening, and that this particular prostate cancer program was supported by an organization that in turn is supported by money from pharmaceutical devices and drug companies that may stand to gain from selling drugs and devices related to screening for prostate cancer, and the diagnosis and treatment of such cancer. Wilkes and Hoffman were raising valid clinical and policy concerns about the public actions of a government-supported university, in my humble opinion. Thus the university lawyer's apparent threat of defamation suits thus appears to be a SLAPP, a threat of strategic litigation against public participation. In California, a 1993 law provides recourse for people who have been threatened with SLAPPs (look <a href="http://www.thefirstamendment.org/antislappresourcecenter.html">here</a>). The Faculty Committee Responds Regardless, Prof Wilkes filed an internal complaint, and again, per Inside Higher Ed, <blockquote>Now, a committee on academic freedom at the university that investigated allegations of intimidation and harassment against Wilkes has found them to be true. The faculty committee said in its report, a copy of which was obtained by Inside Higher Ed, that the actions of the university administrators cast doubt on its ability to be a 'truthful and accountable purveyor of knowledge and services.' The group has asked the dean and other top officials at the university’s school of medicine to write letters of apology to the professor, admit to errors of judgment, stop proposed disciplinary actions against him and take steps to prevent future violations of academic freedom. This week, representatives of the university’s Academic Senate are expected to vote on similar resolutions against the administrators.</blockquote> Now, according to the LA Times, <blockquote>The next step is up to campus Executive Vice Chancellor Ralph Hexter, who in consultation with Chancellor Linda P.B. Katehi is expected to decide by fall whether to impose any discipline on the medical school executives, campus officials said.</blockquote> Good luck with that. The Context at UC-Davis I would be surprised if any such punishment occurs. After all, UC-Davis has a record of not tolerating dissent, but tolerating administrators who suppress such dissent.  We have previously discussed: - How the UC-Davis police infamously pepper sprayed peaceful student demonstrators, apparently at least partially in response to Chancellor Katehi's vague orders to clear the campus (see post <a href="http://hcrenewal.blogspot.com/2011/11/uc-davis-pepper-spray-case-as.html">here</a>). - A subsequent report blamed this incident on incompetent, or worse leadership by Katehi's administration, but so far it is not obvious that this has lead to any changes (see post <a href="http://hcrenewal.blogspot.com/2012/04/will-uc-davis-chancellor-be-held.html">here</a>). - How UC-Davis adminstrators tried to punish a medical student who got in a dispute with an overly officious student who apparently was "monitoring" his actions on an email list server, apparently on behalf of the administration, invoking "professionalism" as if that meant blind obedience to academic administrators (see post <a href="http://hcrenewal.blogspot.com/2012/03/using-professionalism-initiative-as.html">here</a>). Furthemore, Chancellor Katehi has a record of her own relationships to industry.  <a href="http://hcrenewal.blogspot.com/2011/11/john-wiley-and-sons-director-apologizes.html">Here</a> we noted that she sits on the board of a large publishing conglomerate that includes a medical education and communication company (a MECC) as a subsidy.  So I suspect she may not rush to punish subordinate executives because they suppressed criticism of the role of commercial money in medical academics. Summary So UC-Davis seems to be another academic medical institution run by people more interested in bringing in commercial support than the academic medical mission, including the support of free speech and academic freedom.  Its case is another example of how leadership that seems hostile to the mission in one instance is likely to be hostile to the mission in other instances. <a href="http://hcrenewal.blogspot.com/2012/03/using-professionalism-initiative-as.html">Here</a> I summarized what I believe to be the real threats against professionalism in the academic medical context.  As we have said again and again, true health care reform would encourage leadership who understand the mission and will put its support ahead of financial concerns and ahead of their own self-interest. See also posts in the <a href="http://www.healthnewsreview.org/2012/06/intimidation-tactics-prof-demoted-after-criticizing-university-for-psa-seminar/">Health News Review blog</a>, and the <a href="http://www.margaretsoltan.com/?p=36149">University Diaries blog</a>.

Administrators at Pepper Spray U Found to Have Violated Medical Professor's Academic Freedom

There they, the management of University of California - Davis, go again. The Wilkes and Hoffman Op-Ed Questioning A University Sponsored Ag...

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Ellmers Calls on Sebelius to Address Health IT Safety Concerns: A Responsible Voice in Government on Health IT and HIT Safety

<h2 style="font-family: inherit;"> The following press release is very welcome, and speaks for itself.  There is a responsible voice in the government wilderness.  It is perhaps no surprise it comes from a Congresswoman who is also a registered nurse:</h2><blockquote class="tr_bq"><h3> Ellmers Calls on Sebelius to Address Health IT Safety Concerns</h3>06/12/12 <div align="center"> </div><div align="center">Safety Risks and Health IT-Related Errors Cited in IOM Recommendations</div> WASHINGTON – House Small Business Subcommittee on Healthcare and Technology Chairwoman Renee Ellmers (R-NC) today sent a<a href="http://smbiz.house.gov/UploadedFiles/Sebelius_Health_IT_IOM_report_followup_6_12_12.pdf" target="_blank"> letter to Kathleen Sebelius</a>, Secretary of Health and Human Services (HHS), inquiring about whether the Department has adopted the <a href="http://www.iom.edu/Reports/2011/Health-IT-and-Patient-Safety-Building-Safer-Systems-for-Better-Care.aspx" target="_blank">Institute of Medicine’s (IOM) recommendations</a> for improving the safety of health information technology (IT). </blockquote><blockquote class="tr_bq">The report, issued in November, recommended several steps to be taken by HHS and called for greater oversight by the public and private sectors. The Secretary was called upon by the IOM to issue a plan within 12 months to minimize patient safety risks associated with health IT and report annually on the progress being made.  The report further recommended that the plan should include a schedule for working with the private sector to assess the impact of health IT on patient safety, and recommended several other steps to help improve the safety of health IT. Specifically, Chairwoman Ellmers has requested a copy of the Secretary’s plan to minimize patient safety risks, a description of health IT-related errors that have resulted in patient risks, injuries and deaths, and the status of the development of a mechanism for health IT vendors and users to report health IT-related deaths.  She said that because health IT has the promise to improve health care delivery for patients, physicians and other medical professionals, she remains eager to work with the Secretary to ensure that health IT is safe, effective and affordable. In an <a href="http://smbiz.house.gov/UploadedFiles/HHS_Health_IT_Sebelius_8.11.11.pdf" target="_blank">August 11, 2011 letter</a> to Secretary Sebelius, Chairwoman Ellmers said that a modern, well-equipped office is critical to the practice of medicine, and asked the Secretary to undertake a study of health IT’s adoption, benefits and cost effectiveness, including medical error rates. On June 2, 2011, Chairwoman Ellmers’ Subcommittee <a href="http://smbiz.house.gov/Calendar/EventSingle.aspx?EventID=243286" target="_blank">held a hearing</a> on the barriers to health IT that are encountered by physicians and other health professionals in small and solo practices.   At the hearing, physicians expressed strong concerns about the cost of purchasing and maintaining health IT systems, as well as the staff training and downtime necessary to implement such a system.  Chairwoman Ellmers noted health IT’s great potential to improve health care delivery, decrease medical errors, increase clinical and administrative efficiency and reduce paperwork. For more than twenty-one years before being elected to Congress, Chairwoman Ellmers served as a registered nurse, focusing on surgical care as Clinical Director of the Trinity Wound Care Center and later helping to manage the family's small medical practice with her husband, Dr. Brent Ellmers, a licensed surgeon. As a registered nurse and the wife of a surgeon, Ellmers understands that a modern, efficient and well-equipped office is critical to the practice of medicine.     </blockquote> This voice of sanity is quite welcome.  I've spoken with Rep. Ellmers' office, pointing them to my Drexel Univ. <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/" target="_blank">writings and materials</a> and recommending Sebelius' reply be gone over with a fine-toothed comb, from the perspective of health IT realities, not merely from the perspective of the <a href="http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html" target="_blank">Ddulite's good intentions</a>.  (I also introduced her staffer to the concept of the Ddulite, the HIT hyper-enthusiast who ignores all downsides and ethical concerns.) I also pointed out the ethical lapse in IOM's position of "wait and see" while HIT is pushed nationally under penalty of law, at the cost of hundreds of billions of dollars, when their own report (along with reports from FDA <a href="http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html" target="_blank">here</a><a href="http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html" target="_blank"></a>, JC <a href="http://hcrenewal.blogspot.com/2008/12/joint-commission-sentinel-events-alert.html" target="_blank">here</a> and others) admits they don't know the magnitude of benefits, risks and harms: <blockquote class="tr_bq">... While some studies suggest improvements in patient safety can be made, others have found no effect. Instances of health IT–associated harm have been reported. However, little published evidence could be found quantifying the magnitude of the risk. Several reasons health IT–related safety data are lacking include the absence of measures and a central repository (or linkages among decentralized repositories) to collect, analyze, and act on information related to safety of this technology. Another impediment to gathering safety data is contractual barriers (e.g., nondisclosure, confidentiality clauses) that can prevent users from sharing information about health IT–related adverse events. These barriers limit users’ abilities to share knowledge of risk-prone user interfaces, for instance through screenshots and descriptions of potentially unsafe processes. In addition, some vendors include language in their sales contracts and escape responsibility for errors or defects in their software (i.e., “hold harmless clauses”). The committee believes these types of contractual restrictions limit transparency, which significantly contributes to the gaps in knowledge of health IT–related patient safety risks. These barriers to generating evidence pose unacceptable risks to safety. </blockquote><blockquote class="tr_bq">[IOM (Institute of Medicine). 2012. <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/Patient%20Safety%20and%20Health%20IT%20prepub.pdf">Health IT and Patient Safety: Building Safer Systems for Better Care</a> (PDF). Washington, DC: The National Academies Press, pg. S-2.] </blockquote> As I wrote in my Nov. 2011 post "I<a href="http://hcrenewal.blogspot.com/2011/11/iom-report-on-health-it-safety-nix-fda.html" target="_blank">OM Report - 'Health IT and Patient Safety: Building Safer Systems for Better Care' - Nix the FDA; Create a New Toothless Agency</a>", the IOM's response to their own study was reckless and unethical (at best): <blockquote class="tr_bq">... The panel also recommends that the HHS secretary publicly report on the progress of health IT safety each year, beginning in 2012. If the secretary determines at any time that adequate safety progress has not been made, only then should the FDA take the regulatory lead and be given the resources to do so, the report recommends, adding that the agency should be developing a framework now to be prepared. </blockquote> In the meantime, during each year of "watching for safety progress", innumerable patients are exposed to HIT's hazards and costs.  Pharma and other medical device industries are afforded no such special accommodation. -- SS

Ellmers Calls on Sebelius to Address Health IT Safety Concerns: A Responsible Voice in Government on Health IT and HIT Safety

The following press release is very welcome, and speaks for itself. There is a responsible voice in the government wilderness. I...

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