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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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University of Miami Lays Off 800, Cuts Research Funding, Builds New Presidential Mansion

Despite the trillions of dollars flowing through the US health care systems, prominent not-for-profit health care organizations seem to be complaining more often that the money going to them is not enough.  The Lay-Offs and Research Cutbacks Recently, for example, the University of Miami announced that its medical center would have to tighten its belt.  In April, <a href="http://www.miamiherald.com/2012/04/24/2765289/um-medical-school-cutbacks-coming.html">according to</a> the Miami Herald, <blockquote>University of Miami President Donna Shalala announced Tuesday that the medical school will take 'difficult and painful but necessary steps' next month to reduce costs, including staff cuts.In a letter to employees, she called the cuts 'significant' but provided no details about how many employees might be laid off. 'The process will take place in stages, and affected employees will be notified during the month of May,' Shalala wrote. 'Reductions will not impact clinical care or our patients and will primarily focus on unfunded research and administrative areas.' Shalala said the cuts were necessary because of 'unprecedented factors' including the global downturn of 2008, decreased funding for research and clinical care, plus cutbacks in payments from Jackson Health System. The Jackson reductions 'have had a profound effect on our finances,' she wrote.</blockquote> Placing the blame for the medical school's financial problems on Jackson Health System, the local safety-net health system, did not sit well with that organization's leadership. In another Miami Herald <a href="http://www.miamiherald.com/2012/04/17/2753691/jackson-health-system-chairman.html">story</a>, its chairman stated that the real problem might be: <blockquote>'investments that they have made that may or may not have panned out,' including the purchase in 2007 of Cedars Medical Center, across the street from Jackson Memorial, for a price that several experts say was far too high.</blockquote> In fact, we discussed <a href="http://hcrenewal.blogspot.com/2011/06/embedded-networks-of-influence-in.html">here</a> allegations that the University of Miami Medical School's purchase of a facility that was renamed the University of Miami Hospital adjacent to Jackson was meant to take insured patients from that already struggling facility. Nonetheless, the Medical School proceeded with its cuts, which resulted in 800 layoffs (see Miami Herald story <a href="http://www.miamiherald.com/2012/05/08/2789495/um-laying-off-800.html">here</a>.) The next Miami Herald <a href="http://www.miamiherald.com/2012/05/12/2795449/university-of-miami-job-cuts-could.html">story</a> suggested that the cuts would disproportionately impact worthy researchers, for example, <blockquote>When Nobel Laureate Andrew Schally arrived in South Florida six years ago, he was greeted with great fanfare and named a distinguished professor of pathology at the University of Miami medical school. Now he says his work is one of the many casualties of the school’s budget slashing. Schally says UM told him several weeks ago that his annual funding of $150,000 for research would end May 31, part of widespread cuts in the medical school that could eliminate up to 800 jobs this month and trigger major reductions in research. 'I was shocked... We developed so many drugs for the university,' Schally says. 'They are killing the goose that laid the golden egg.'</blockquote>The President's New House The headline of another Miami Herald <a href="http://www.miamiherald.com/2012/05/28/2821494/um-presidents-house-sells-for.html">story</a> last week suggested that things had gotten so bad that the cuts were even going to affect top university leadership's lifestyle: <blockquote>UM president’s house sells for $9 million</blockquote> We had <a href="http://hcrenewal.blogspot.com/2006/02/tale-of-three-ironies-university-of.html">posted</a> about University of Miami President Donna Shalala's lavish university funded living conditions a while ago. Now it seems she would be giving up <blockquote>'tropical ambiance,' 4.6 acres of lush gardens, and a prestigious Gables Estates address.</blockquote> This "rare piece of Florida history" also had <blockquote>a guest room created specifically to host the Dalai Lama during His Holiness’ visits to South Florida.</blockquote> So can we conclude that the University is really tightening its belt when its President is forced to move out of such a lush environment? Not really. In fact, Ms Shalala may be moving to even more plush surroundings, courtesy the university's supposedly challenged budget: <blockquote>The 32-acre Pinecrest development, built on land donated to the university by UM law grad-turned-philanthropist Frank Smathers Jr., exclusively houses UM faculty. Shalala will now join their ranks as both boss and neighbor. Decades ago, the grounds were home to Smathers’ Arabian horses and world-renowned mango collection. The UM-built homes are clustered in the center one-third of the acreage 'to safeguard the botanical integrity of the estate,' according to the university’s website. The remaining land is dominated by lush plants and fruit groves, and is maintained by Fairchild Tropical Botanical Gardens.</blockquote> In particular, <blockquote>“It’s a very bold house,” Taylor said of Shalala’s new digs. “It’s a dominant house in the neighborhood.” Taylor said the all-white exterior of the new home is a noticeable contrast to the more-earthy tones of other houses nearby. The university is calling it the 'Ibis House' after UM’s beloved (and also all-white) mascot. Shalala’s new home will sit on a quarter-acre of land — dramatically less property than she enjoyed before. On the plus side, Shalala, just as in her old home, will enjoy about 9,000 or so square feet of interior space, and an in-home elevator connecting the first and second floors. The new home is also situated in a unique gated community that offers a community clubhouse, tennis courts and pool, and meticulously landscaped gardens.</blockquote> Was anyone really expecting that Ms Shalala would have to find her own housing, like the 99 percent have to? Summary So here we have another example of how the notion of CEO exceptionalism has filtered down from large for-profit corporations to even non-profit, ostensibly mission-oriented health care institutions. Leaders of health care organizations are now deemed to be so important, at least in the eyes of their hired public relations staff, that they must be given every luxury. Perhaps if housed in any space smaller than 9000 feet, Ms Shalala would be so confined as not be able to think great thoughts anymore, like how many layoffs would be needed to sufficiently cut costs. Worse, maybe without such free housing, she would just decide that the institution would not be showing enough gratitude, and so her amazingly brilliant leadership would have to seek new pastures. Maybe, on the other hand, Ms Shalala's new house is just another demonstration how health care has become dominated by leadership whose own compensation and privilege seems to come before the mission., and sees no problem in asking for "difficult and painful" cuts from those who do the real work on the ground while building itself new mansions. So as usual, it is time to say that true health care reform would foster leadership  that upholds the core values of health care, and focuses on and are accountable for the mission, not on secondary responsibilities that conflict with these values and their mission, and not on self-enrichment. Leaders ought to be rewarded reasonably, but not lavishly, for doing what ultimately improves patient care, or when applicable, good education and good research.

University of Miami Lays Off 800, Cuts Research Funding, Builds New Presidential Mansion

Despite the trillions of dollars flowing through the US health care systems, prominent not-for-profit health care organizations seem to be c...

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Cart Before the Horse, Part 3: AHRQ's "Health IT Hazard Manager"

<div style="text-align: center;">(Addendum: the AHRQ hazards manager taxonomy report can see seen at <a href="http://healthit.ahrq.gov/sites/default/files/docs/citation/HealthITHazardManagerFinalReport.pdf.">http://healthit.ahrq.gov/sites/default/files/docs/citation/HealthITHazardManagerFinalReport.pdf.</a>)</div> In a July 2010 post "<a href="http://hcrenewal.blogspot.com/2010/07/meaningful-use-final-rule-have.html" target="_blank">Meaningful Use Final Rule: Have the Administration and ONC Put the Cart Before the Horse on Health IT?</a>" and an Oct . 2010 post "<a href="http://hcrenewal.blogspot.com/2010/10/cart-before-horse-again-institute-of.html" target="_blank">Cart before the horse, again: IOM to study HIT patient safety for ONC; should HITECH be repealed?</a>" I wrote about the postmodern "ready, fire, aim" approach to health IT: In the first post, I wrote: <blockquote class="tr_bq">... These "usability" problems require long term solutions. There are no quick fix, plug and play solutions. Years of research are needed, and years of system migrations as well for existing installations. Yet we now have an HHS Final Rule on "meaningful use" regarding experimental, unregulated medical devices the industry itself admits have major usability problems, along with a growing body of literature on the <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=2009">risks entailed</a>. <div dir="ltr"></div><div dir="ltr">For crying out loud, talk about putting the cart before the horse... </div> <div dir="ltr" style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhbxjl-AlGATfarPayjaUYkCOG4sUrulp4D88Nk7_z-eEbaWRl-xi1g0neGKWDhEL1w6-_-FCu4iBoJx9AUlU-bccaAmEcMfmGI1uoa4gTohjch5gzcx5tA9Ru-uMB0Mip6NE0PuUsfDXJ5/s1600/horse-cart.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5493460657310735298" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhbxjl-AlGATfarPayjaUYkCOG4sUrulp4D88Nk7_z-eEbaWRl-xi1g0neGKWDhEL1w6-_-FCu4iBoJx9AUlU-bccaAmEcMfmGI1uoa4gTohjch5gzcx5tA9Ru-uMB0Mip6NE0PuUsfDXJ5/s320/horse-cart.jpg" style="cursor: pointer; display: block; height: 168px; margin: 0px auto 10px; text-align: center; width: 253px;" /></a>Something's very wrong here...</div> However, this situation is anything but humorous. How more "cart before the horse" can government get?</blockquote> In the second post, I wrote: <blockquote class="tr_bq">... So, in the midst of a National Program for Health IT in the United States (NPfIT in the U.S.), with tens of billions of dollars earmarked for health IT already (money we don't really have, but it can be printed quickly, or borrowed from China) the IOM is going to study health IT safety, prevention of health IT-related errors, etc. ... only now?</blockquote> Here we go yet again. The problem with the AHRQ (<a href="http://www.ahrq.gov/" target="_blank">Agency for Healthcare Research and Quality</a>, a division of HHS) announcement below of a webinar about a new tool for identifying, categorizing, and resolving health IT hazards, as I have written before, is putting the "cart before the horse" and throwing medical ethics to the wind. If we've just developed a tool "for identifying, categorizing, and resolving health IT hazards", the magnitude of which others such as IOM admit are unknown to our detriment (e.g., <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>, pg. S-2), then health IT is, it follows, an experimental technology. If it is an experimental technology, AHRQ and others in HHS should probably be raising the issue of a slow down or moratorium on widespread rollout under HITECH until risk management and remediation is better understood.  At the very least they should be calling for patient informed consent that a device that will largely regulate their care is experimental, that a competency "gap" exists among healthcare practitioners within the "health IT environment" (meaning patients are at risk), and that patients should be offered the opportunity for informed consent with opt-out provisions.  The principals should not just be announcing a webinar: <blockquote class="tr_bq">Sent: Tuesday, June 05, 2012 12:23 PM To: OHITQUSERS@LIST.NIH.GOV Subject: Register Now! AHRQ Health IT Webinar "Purpose and Demonstration of the Health IT Hazard Manager and Next Steps" June 11, 2:30 PM ET Agency for Healthcare Research and Quality Purpose and Demonstration of the Health IT Hazard Manager and Next Steps June 11, 2012 — 2:30-4 p.m., EST The Agency for Healthcare Research and Quality (AHRQ) has identified a gap in a health care/public health practitioner’s competency within the health IT environment. This webinar is designed to increase practitioners’ competencies in several areas: improving health care decision making; supporting patient-centered care; and enhancing the quality and safety of medication management by improving the ability to identify, categorize, and resolve health IT hazards. The Webinar will explore the Health IT Hazard Manager—a tool for identifying, categorizing, and resolving health IT hazards. When implemented, the tool allows health care organizations and software vendors alike to learn about potential hazards and work to resolve them, including the use of data to communicate potential and actual adverse effects. The session will discuss how the Health IT Hazard Manager was tested and refined as well as strategies and implications for deploying it. The target audience includes AHRQ grantees/researchers; health care providers, including physicians and nurses; consumers/patients; and health care policymakers. ... Webinar learning objectives include: 1. Describe the rationale for developing the Health IT Hazard Manager and how it evolved through alpha and beta testing. 2. Explain the process for identifying and categorizing health IT-related hazards. 3. Demonstrate how the Health IT Hazard Manager would be used [i.e., it's not yet in use, despite mandates for HIT rollout with penalties for non-adopters - ed.] within and across care delivery organizations and health IT software vendors. 4. Discuss policy and process implications for deploying the Health IT Hazard Manager via different organizations (i.e., AHRQ; Office of the National Coordinator for Health IT; Patient Safety Organization(s); Accrediting bodies; IT entities). </blockquote> In effect, HHS seems to be saying "we're working on the HIT risk problem, but roll it out anyway; if you get harmed or killed, tough luck."  This seems a form of negligence. Have we thrown out all we know about <a href="http://grants.nih.gov/grants/policy/hs/ethical_guidelines.htm" target="_blank">medical research and human subjects protections</a> in face of the magical powers and profits of computers in medicine? -- SS

Cart Before the Horse, Part 3: AHRQ's "Health IT Hazard Manager"

(Addendum: the AHRQ hazards manager taxonomy report can see seen at http://healthit.ahrq.gov/sites/default/files/docs/citation/HealthITHazar...

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More Electronic Medical Record Breaches: You Could Not Do This With Paper

I have written repeatedly on the dangers posed by poorly managed health IT regarding information breaches.  See "<a href="http://hcrenewal.blogspot.com/2012/01/2011-closes-on-note-of-electronic.html" target="_blank">2011 Closes on a Note of Electronic Medical Record Privacy Breach Shame</a>" and other posts at this query link:   <a href="http://hcrenewal.blogspot.com/search/label/medical%20record%20confidentiality">http://hcrenewal.blogspot.com/search/label/medical%20record%20confidentiality</a> Now this, from Kaiser Health News and The Washington Post: <blockquote class="tr_bq"><a href="http://www.kaiserhealthnews.org/Stories/2012/June/04/electronic-health-records-theft-hacking.aspx" target="_blank">As Patients' Records Go Digital, Theft And Hacking Problems Grow </a> <div class="byline">By David Schultz</div><div class="timestamp">Jun 03, 2012</div> As more doctors and hospitals go digital with medical records, the size and frequency of data breaches are alarming privacy advocates and public health officials. <div class="nosyndication"><div class="inlineImage300"> </div></div>Keeping records secure is a challenge that doctors, public health officials and federal regulators are just beginning to grasp. And, as two recent incidents at Howard University Hospital show, inadequate data security can affect huge numbers of people.  </blockquote> With paper, you'd need a stream of trucks to accomplish this magnitude of theft: <blockquote class="tr_bq">On May 14, federal prosecutors <a href="http://dl.dropbox.com/u/37285095/Napper%20Information.pdf" shape="rect" target="_blank">charged</a> one of the hospital's medical technicians with violating the Health Insurance Portability and Accountability Act, or HIPAA. Prosecutors say that over a 17-month period Laurie Napper used her position at the hospital to gain access to patients' names, addresses and Medicare numbers in order to sell their information. A plea hearing has been set for June 12; Napper's attorney declined comment. Just a few weeks earlier, the hospital <a href="http://huhealthcare.com/healthcare/hospital/data-breach/FAQ" shape="rect" target="_blank">notified</a> more than 34,000 patients that their medical data had been compromised. A contractor working with the hospital had downloaded the patients' files onto a personal laptop, which was stolen from the contractor's car. The data on the laptop was password-protected but unencrypted, which means anyone who guessed the password could have accessed the patient files without a randomly generated key. According to a hospital press release, those files included names, addresses, and Social Security numbers -- and, in a few cases, "diagnosis-related information."</blockquote> I add that they could also probably have booted the laptop from alternate media, and/or removed the hard drive and inserted into another computer, to access the contents. <blockquote class="tr_bq">Ronald J. Harris, Howard University's top spokesman, said in an e-mail that the two incidents are unrelated, but declined to answer further questions. In its press release about the stolen laptop, the hospital said it will set new requirements for all laptops used by contractors and those issued to hospital personnel to help protect data. Still it could have been worse. Much worse. Just days after Howard University contacted its patients about the stolen laptop, the Utah Department of Health <a href="http://www.health.utah.gov/databreach/" shape="rect" target="_blank">announced</a> that hackers based in Eastern Europe had broken into one of its servers and stolen personal medical information for almost 800,000 people -- more than one of every four residents of the state.</blockquote> How many trucks (and Stargate SG-1 style invisibility cloaks) would it take to inconspicuously steal 800,000 paper charts, I ask? <blockquote class="tr_bq">And last November, TRICARE, which handles health insurance for the military, <a href="http://www.tricare.mil/breach/old.htm" shape="rect" target="_blank">announced</a> that a trove of its backup computer tapes had been stolen from one of its contractors in Virginia. The tapes contained names, Social Security numbers, home addresses and, in some cases, clinical notes and lab test results for nearly 5 million patients, making it the largest medical data breach since the Department of Health and Human Services began tracking incidents two and a half years ago.</blockquote> Five million charts in a country of 300 million people... <blockquote class="tr_bq">As recently as five years ago, it's possible no one outside Howard University would have known about the incidents there. But, <a href="http://www.hhs.gov/ocr/privacy/hipaa/administrative/breachnotificationrule/index.html" shape="rect" target="_blank">new reporting rules</a> adopted as part of the 2009 stimulus act insure the public knows far more about medical data breaches than in the past. When a breach occurs that affects 500 or more patients, health care providers now must notify not only HHS, but also the media.</blockquote> Meaning there were breaches the public does not know about. <blockquote class="tr_bq">Deven McGraw, director of the health privacy project at the <a href="https://www.cdt.org/" shape="rect" target="_blank">Center for Democracy & Technology</a>, a Washington-based Internet advocacy group, said the number of incidents is growing with the increased use of digital health records. The health care industry, she added, has been slow to respond.</blockquote> A problem is not enough "motivation." <blockquote class="tr_bq">"Many financial companies have used encryption for years and they probably wonder what the heck is going on with the health care industry," McGraw said. "It's much cheaper to deploy safeguards than to suffer a breach."</blockquote> I offer a one word answer:  complacency. Now for the "spin control": <blockquote class="tr_bq">This growing problem puts HHS in a tough spot. It is pushing hospitals and doctors to adopt electronic health records, but it's also responsible for punishing health care providers who fail to properly secure their patients' records. "Mistakes happen, incidents happen, corners get cut from time to time," said Susan McAndrew, deputy director for health information policy at HHS's Office of Civil Rights. "That's where we come in."</blockquote> "From time to time" is a rather modest description of the millions of breaches mentioned in just this posting.  But as I've written before, don't worry, your records are safe. Just don't tell the doctor about that "incident" at that seedy club the other night, and find some other excuse to get the antibiotics you need, and that information will be safe, too. -- SS

More Electronic Medical Record Breaches: You Could Not Do This With Paper

I have written repeatedly on the dangers posed by poorly managed health IT regarding information breaches. See " 2011 Closes on a Note...

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