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"A Study of an Enterprise Health information System" - Finally, an Informatics Scientist Does A Rigorous Review of a Commercial EHR System, by Cerner

Australian professor Jon Patrick, who I wrote about at this blog in the past such as at my Nov. 2009 post "<a href="http://hcrenewal.blogspot.com/2009/11/academic-freedom-and-ed-ehrs-down-under.html">Academic Freedom and ED EHR's Down Under: An Update</a>", has written what I consider the first truly serious, rigorous evaluation of a commercial EHR system. He has evaluated the Cerner FirstNet ED EHR, being 'forced' on hospitals in the Australian state of New South Wales by their government. His evaluation is entitled "A study of an Enterprise Health information System" and was released on March 4, 2011. In my view, all current EHR's should undergo this level of scrutiny and critique. His multi-part analysis, down the the level of the data schema, speaks for itself. The report is at: <a href="http://sydney.edu.au/engineering/it/%7Ehitru/index.php?option=com_content&task=view&id=91&Itemid=146">http://sydney.edu.au/engineering/it/~hitru/index.php?option=com_content&task=view&id=91&Itemid=146</a> or download directly from: <a href="http://www.it.usyd.edu.au/%7Ehitru/essays/Study%20of%20Enterprise%20Health%20IS%20-%20Parts%200-9%20PDF-ARCHIVE.zip">http://www.it.usyd.edu.au/~hitru/essays/Study%20of%20Enterprise%20Health%20IS%20-%20Parts%200-9%20PDF-ARCHIVE.zip</a> [Note: this is a 12 Mb .zip file]. Summary: <blockquote>This is a study into the roll-out of Cerner FirstNet into EDs in NSW. The original study was issued in Dec 2009 (Part 3.1). This has been added to with a new study in 2010 consisting of discussions with 7 ED Directors (Part 3.2), discussions with software experts who do performance evaluations on Cerner sites (Part 3.3), and reviews of Entity-Relationship Diagrams (Part 3.4), Schema descriptions and data tables from customer installations (Part 3.5 & 3.6). All this information is coalesced to establish a much more detailed picture of a Cerner installation (Part 3.7). A number of weaknesses are identified in the design and implementation and risk assessments are recommended for organisations using this software or intending to use it. Regulations that might minimise the risks to users of health software are recommended (Part 3.8). An alternative architecture and method for constructing clinical information systems is presented (Part 3.9).</blockquote> The .zip file contains the following files: <blockquote>3.0 Part 0 - Executive Summary 3.1 Part 1 - A Critical Essay on the Deployment of an ED Clinical Information System ‐ Systemic Failure or Bad Luck? First published here in Oct 2009, revised Dec 2009. 3.2 Part 2 - Discussions with ED Directors: Are we on the right track? 3.3 Part 3 - Discussions with Software Performance Experts. 3.4 Part 4 - Conceptual Data Modelling. 3.5 Part 5 - Database Relational Schema and Data Tables. 3.6 Part 6 - Coalescing the Analyses of the ER Diagrams, Relational Schemata and Data Tables. 3.7 Part 7 - The Integrated Assessment. 3.8 Part 8 - Future HIT Regulation Proposals. 3.9 Part 9 - Ockham's Razor of Design. Published at the IHI conference, Nov 2010 Washington.</blockquote> A non-technical but revealing summary from Part 2: <blockquote> Discussions were held with the Directors of 7 Emergency Departments in New South Wales (NSW) public hospitals assessing the impact of the introduction of the FirstNet information system into their Departments. All but one of the Directors has found that the system has had a deleterious impact on their department’s clinical work. The range of problems reported indicate that whilst the software is not fit-for-purpose, many of the problems are created or exacerbated by attitudes of the NSW Health IT support, Health Support Services (HSS). In most departments it was reported that staff have developed significant strategies for minimising and circumventing the use of the system. The Directors are frustrated by the lack of a reporting functionality that disables their ability to monitor their own department’s performance. Most Directors report an increase in the time required to deal with patients and therefore a deterioration in access block times. This has been masked by changes in the way this time has been redefined by NSW Health. Overall, most perceive that in moving from their previous information system EDIS to FirstNet they and their patients have suffered. Most Directors are resigned to the fact that no improvements will be made to the current performance of the system due to its inherent inadequacies and the attitude of HSS. A consequence of the ED Directors critique leads inevitably to the debate on the merits of enterprise wide systems versus best-of-breed systems. Emerging from these issues are criteria for a new technology for creating clinical information systems.</blockquote> I will have more to say on this study later. I have to take an injured relative to the doctor. (Note - the culpable system was not by this vendor). -- SS

"A Study of an Enterprise Health information System" - Finally, an Informatics Scientist Does A Rigorous Review of a Commercial EHR System, by Cerner

Australian professor Jon Patrick, who I wrote about at this blog in the past such as at my Nov. 2009 post " Academic Freedom and ED EHR...

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HIMSS and Healthcare IT: We Don't Need A "Usability Maturity Model." We Need - USABILITY - and Less of Cold-Blooded Calculus

Health IT industry consortium HIMSS has followed up its Master of the Obvious, 50-years-too-late paper "Defining and Testing EMR Usability: Principles and Proposed Methods of EMR Usability Evaluation and Rating" (June 2009) that I wrote about in a Dec. 2010 post "<a href="http://hcrenewal.blogspot.com/2010/12/unintended-errors-with-ehr-based-result.html">Unintended errors with EHR-based result management: a case series, and a special pleading for health IT</a>" with a new report: <a href="http://www.himss.org/ASP/ContentRedirector.asp?ContentID=76349"></a><blockquote><a style="font-weight: bold;" href="http://www.himss.org/ASP/ContentRedirector.asp?ContentID=76349">Promoting Usability in Health Organizations: Usability Maturity Model</a> (PDF, Feb. 2011)</blockquote> I knew I was in for a heaping helping of gobbledygook after reading the title itself: “Promoting Usability in Health Organizations: Initial Steps and Progress Toward a Healthcare Usability Maturity Model” A “Healthcare Usability Maturity Model” is a clue that what follows will take simplicity, and expend considerable ink to tangle it into a mess of process mysticism, buzzwords, paradigms, very pretty charts, and other Master-of-the-Obvious-made-to-look-sophisticated, destined-for-the-dusty-shelf consultant report. That is largely what follows. See for yourself.This passage in the Executive Summary is pathognomonic of the amoral, money-over-blood, patients-as-guinea-pigs mentality that inhabits the commercial health IT sector. I find it particularly revealing and revolting: <blockquote> ... Leaders may be reluctant to incorporate usability principles and practices [in a safety-critical technology increasingly mediating all aspects of medical care delivery - ed.] because of perceptions that these methods may slow development and product fielding. However, data exist on usability return on investment (ROI), outlining the value of adopting usability in health organizations. </blockquote> Excuse me? It takes proof of "ROI" to convince these companies to produce usable (which subsumes the concept of "safe") health IT? This is as cold-blooded a calculus as it gets. This is <a href="http://en.wikipedia.org/wiki/Ford_Pinto">Ford Pinto</a> material:<blockquote>... Critics alleged that the vehicle's lack of reinforcing structure between the rear panel and the tank meant the tank would be pushed forward and punctured by the protruding bolts of the <a href="http://en.wikipedia.org/wiki/Differential_%28mechanics%29" title="Differential (mechanics)" class="mw-redirect">differential</a><a href="http://en.wikipedia.org/wiki/Ford_Pinto#cite_note-fordpintocase-14">[15]</a> [by a rear end collision of only 20 mph/32 km/h, causing a fire - ed.]— making the car less safe than its contemporaries.According to a 1977 <a href="http://en.wikipedia.org/wiki/Mother_Jones_%28magazine%29" title="Mother Jones (magazine)">Mother Jones</a> article, Ford allegedly was aware of the design flaw, refused to pay for a redesign, and decided it would be cheaper to pay off possible lawsuits for resulting deaths. The magazine obtained a <a href="http://en.wikipedia.org/wiki/Cost-benefit_analysis">cost-benefit analysis</a> that it said Ford had used to compare the cost of an $11 repair against the monetary value of a human life—what became known as the Ford Pinto Memo.<a href="http://en.wikipedia.org/wiki/Ford_Pinto#cite_note-50worst-12">[13]</a><a href="http://en.wikipedia.org/wiki/Ford_Pinto#cite_note-mother-15">[16]</a><a href="http://en.wikipedia.org/wiki/Ford_Pinto#cite_note-16">[17]</a> An example of a Pinto rear-end accident that led to a lawsuit was the 1972 accident that killed Lilly Gray and severely burned 13-year old Richard Grimshaw. The accident resulted in the court case <a href="http://en.wikipedia.org/wiki/Grimshaw_v._Ford_Motor_Co.">Grimshaw v. Ford Motor Co.</a>,<a href="http://en.wikipedia.org/wiki/Ford_Pinto#cite_note-17">[18]</a> in which the California Court of Appeal for the Fourth Appellate District upheld compensatory <a href="http://en.wikipedia.org/wiki/Damages">damages</a> of $2.5 million and <a href="http://en.wikipedia.org/wiki/Punitive_damages">punitive damages</a> of $3.5 million against Ford, partially because Ford had been aware of the design defects before production but had decided against changing the design. [In more recent years, others said the Ford Pinto scandal was not clear-cut, but health IT unusability increasing odds for medical errors is clear-cut - ed.] </blockquote> <blockquote> </blockquote> Why are these companies and their leadership getting to play God - in a field such as Medicine? <a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhtYbO9i2jbJhyyQoyesX24vy99i7HmbRi1kxfdWEEBWLpTmLP96_JrM5JI86qwUPQj1Ty9do51aSnNSRNA8dohgaxoRq-xqmtV_BNVjW4U6Bq42Yw3K2gnwf5tK7_mxnnVqOj9KN9r1y6W/s1600/cp.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5579924020893002882" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhtYbO9i2jbJhyyQoyesX24vy99i7HmbRi1kxfdWEEBWLpTmLP96_JrM5JI86qwUPQj1Ty9do51aSnNSRNA8dohgaxoRq-xqmtV_BNVjW4U6Bq42Yw3K2gnwf5tK7_mxnnVqOj9KN9r1y6W/s320/cp.jpg" style="display: block; margin: 0px auto 10px; text-align: center; cursor: pointer; width: 128px; height: 181px;" /></a>Usability? Those Luddite doctors and crummy patients will get usability over my - er, their - dead bodies, if I don't profit handsomely from it. Finally, I have several meta-observations about this new report: <ul><li>We don't need a "usability maturity model." We need USABILITY. We need the common and longstanding knowledge of software usability in other mission critical sectors to be applied on the development whiteboard and usability testing labs (if any!) at HIT vendors. </li></ul><ul><li>Why is it that health IT usability has to be written about, basically as if from the grade school level, in 2011 - some sixty years into the “computer revolution?” Do we still write treatises on why it’s wise to use sterile technique and good lighting in operating rooms? What is the major malfunction in this industry? </li></ul><ul><li>Why is this treatise not entitled “Promoting Usability in Health IT Vendor Development Shops: A Vendor Responsibility Model”?</li></ul><ul><li>The frequent use of the terminology "user experience" as applied to healthcare IT in this report struck my eye. It has been adopted in this report, but was uncommon regarding health IT until recently, as in my posts about the health IT <a href="http://www.tinyurl.com/hostileuserexper">mission hostile user experience.</a> </li></ul>The terminology is conspicuously absent in the aforementioned earlier 2009 HIMSS report. It would not take Sherlock Holmes to theorize that I might be an <a href="http://www.google.com/search?client=firefox-a&rls=org.mozilla%3Aen-US%3Aofficial&channel=s&hl=en&source=hp&biw=1024&bih=578&q=healthcare+IT+user+experience&btnG=Google+Search#sclient=psy&hl=en&client=firefox-a&hs=q9q&rls=org.mozilla:en-US%3Aofficial&channel=s&biw=1024&bih=578&tbs=ww:1&q=%22mission+hostile+user+experience%22&aq=f&aqi=&aql=&oq=&pbx=1&bav=on.2,or.&fp=6c13b9433fbb516b">unattributed contributor</a> to the new 2011 HIMSS report. If anyone knows differently, I'd be interested to hear about it.-- SS <blockquote> </blockquote>

HIMSS and Healthcare IT: We Don't Need A "Usability Maturity Model." We Need - USABILITY - and Less of Cold-Blooded Calculus

Health IT industry consortium HIMSS has followed up its Master of the Obvious, 50-years-too-late paper " Defining and Testing EMR Usabi...

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Vladimir Putin and Common Sense on IT

Vladimir Putin may be known for showing off his pectorals riding horses bare chested, but he also seems to have a substantial amount of gray matter between the ears. Our country, including the healthcare IT sector, could probably learn something from him: <blockquote><a href="http://online.wsj.com/article/SB10001424052748704415104576065641376054226.html"> A Walled Wide Web for Nervous Autocrats </a> Wall Street Journal Jan. 8, 2011 By EVGENY MOROZOV At the end of 2010, the "open-source" software movement, whose activists tend to be fringe academics and ponytailed computer geeks, found an unusual ally: the Russian government. Vladimir Putin signed a 20-page executive order requiring all public institutions in Russia to replace proprietary software, developed by companies like Microsoft and Adobe, with free open-source alternatives by 2015. The move will save billions of dollars in licensing fees, but Mr. Putin's motives are not strictly economic. In all likelihood, his real fear is that Russia's growing dependence on proprietary software, especially programs sold by foreign vendors, has immense implications for the country's national security. Free open-source software, by its nature, is unlikely to feature secret back doors that lead directly to Langley, Va. </blockquote>It's also less likely to feature a backdoor to a hacker's basement, or a lot of bugs ("glitches") that some health IT vendors and customer organizations allow to accumulate into the thousands before lifting a finger. This brings to mind the adage that "if you want something done right, do it yourself." <blockquote> ... For ordinary Internet users, there is one silver lining: The embrace of open-source technology by governments may result in more intuitive software applications, written by a more diverse set of developers. [Read the whole article at the link above - ed.] </blockquote>More intuitive IT applications could solve a lot of the current health IT problems, such as the <a href="http://www.tinyurl.com/hostileuserexper">mission hostile user experience</a> of many closed-source products from major vendors. Afrer major IT debacles including the <a href="http://www.huffingtonpost.com/stephen-soumerai/dont-repeat-the-uks-elect_b_790470.html">£13 billion abyss</a> of the National Programme for IT in the NHS (NPfIT), the UK also seems to be learning: <blockquote><a href="http://www.ehi.co.uk/news/EHI/6687/new_approach_urged_for_government_it">New approach urged for government IT</a> E-Health Insider <div style="padding-bottom: 10px;font-size:0.9em;">2 March 2011 Lyn Whitfield </div> <div style="margin-top: 3px; margin-bottom: 10px; float: right; margin-left: 15px;"> </div> A new report into government IT failures has warned that previous inquiries may have embedded problems by focusing on inappropriate ‘best practice’ instead of looking for alternative approaches. The report, from the Institute for Government, says “existing ‘best practice’ project models do not deal with the fundamental issues at the heart of government IT.”[As I've stated <a style="font-style: italic;" href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/">here</a>, one has to consider the "worst practices" as well, the "thou shall not's." Typical Milquetoast, touchy-feely "best practices" models and their "sanitized accounts of successful projects" (cf. <a href="http://hcrenewal.blogspot.com/2009/12/healthcare-it-as-cybernetic-miracle.html">Greenhalgh</a><a href="http://hcrenewal.blogspot.com/2009/12/healthcare-it-as-cybernetic-miracle.html"> et al.</a>) avoid such inconvenient realities like the plague - ed.] It also argues that: “By implementing these same, flawed project techniques in an increasingly rigid fashion, these traditional solutions can act to exacerbate the problems further.” [This sounds familiar, typical of the inflexible, dogmatic business IT culture, descended from the punched-card programmable tabulator culture of the 1920's - see <a href="http://hcrenewal.blogspot.com/2008/05/seedie-society-for-exorbitantly.html">this link</a> - ed.] Instead, it calls for a new that focuses on using government’s huge buying power to get better deals for what it calls ‘platform' technologies – such as server capacity and PCs – while encouraging departments to adopt ‘agile’ methodologies to deliver systems to meet the particular challenges they face.... Andrew Adonis, Director of the Institute for Government said: “The billions spent on cancelled IT projects, such as ID cards and National Programme for IT in the NHS, demonstrate precisely why we need a much more flexible approach to government IT. ... The report cites the national programme as one ‘symptom of failure’ in government IT; the tendency for projects to run late and for departments to struggle to keep suppliers on board or hold them to their original delivery requirements as a result. </blockquote> <a href="http://en.wikipedia.org/wiki/Agile_software_development">Agile software development methodologies</a> have traditionally been anathema to the culture of IS departments involved in mercantile, manufacturing and management varieties of business computing. As I've written many times, however, those methodologies are essential in healthcare IT, such as <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=Cardiology%20story">here</a> and <a href="http://hcrenewal.blogspot.com/2010/09/health-it-danger.html">here</a>. At the latter link I observed: <blockquote>... In fact, in my observations IT personnel are the true Luddites [as opposed to clinicians who are often accused of that reactionary characteristic- ed.], clinging to inappropriate, rigid business-IT views on the healthcare IT development and implementation process (vs. more appropriate and modern <a href="http://en.wikipedia.org/wiki/Extreme_Programming">agile methodologies</a>), holding unshakable, stereotypical views about physicians, and remaining unreasonably obstinate on clinician complaints about "clunky" health IT user experiences.</blockquote> Perhaps Mr. Putin and Mr. Adonis deserve a copy of the book "<a href="http://www.amazon.com/Medical-Informatics-Electronic-Collaboration-Innovation/dp/0763739251">Medical Informatics 20/20: Quality And Electronic Health Records Through Collaboration, Open Solutions, And Innovation</a>", Jan. 2007, by the <a href="http://www.ehealth.va.gov/EHEALTH/CPRS_Demo.asp">VistA</a> (open-source EMR) pioneers. The "Open Solutions" part of that title says it all. -- SS

Vladimir Putin and Common Sense on IT

Vladimir Putin may be known for showing off his pectorals riding horses bare chested, but he also seems to have a substantial amount of gray...

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IOM Committee on Patient Safety and Health IT, Meeting Two: Institute of Medicine, or of Mediocrity?

In my Jan. 2011 post "<a href="http://hcrenewal.blogspot.com/2011/01/institute-of-medicine-committee-on.html">Institute of Medicine Committee on Patient Safety and Health Information Technology, and Thoughts on Social Aspects of Health IT Evaluation</a>" I wrote that: <blockquote>The U.S. National Research Council of the <a href="http://www.nationalacademies.org/">National Academy of Sciences</a> issued a report in early 2009 on the state of health IT. That study's report, led in part by pioneers in Medical Informatics G. Octo Barnett and William Stead, was entitled "Computational Technology for Effective Health Care: Immediate Steps and Strategic Directions" (pre-publication PDF available free at <a href="http://www.nlm.nih.gov/pubs/reports/comptech_prepub.pdf">this link</a>). The report was announced under the following header: <a href="http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=12572"> </a><blockquote><a href="http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=12572">CURRENT APPROACHES TO U.S. HEALTH CARE INFORMATION TECHNOLOGY ARE INSUFFICIENT </a></blockquote> The insufficiencies were largely in the areas of difficulties with data sharing and integration, deployment of new IT capabilities, large-scale data management, and lack of cognitive support by health IT for busy clinicians. One might reasonably conclude such deficits could affect patient safety. Recently the <a href="http://www.iom.edu/About-IOM.aspx">Institute of Medicine</a> (the health arm of the National Academy of Sciences) formed a Committee to study health IT safety. It held its first meeting on Dec. 14, 2010 (quite a few years late in my opinion, and only after tens of billions of dollars have been earmarked for health IT, but better late than never): <blockquote> The <a style="font-weight: bold;" href="http://www.iom.edu/Activities/Quality/PatientSafetyHIT.aspx">Institute of Medicine Committee on Patient Safety and Health Information Technology</a> is holding its first meeting on December 14-15, 2010. The first day, December 14, 2010 beginning at 10:30 am, is open to the public to observe the committee proceedings. The committee will hear presentations by the Office of the National Coordinator and other invited guests. There will also be an opportunity for members of the public and representatives of interested organizations to make a brief statement before the committee. Prior registration is requested for attendees and required for those wishing to make a statement.</blockquote></blockquote><blockquote></blockquote> Here are links to the PPT presentations from Meeting 2 of the Committee on Patient Safety and Health IT that took place Feb. 24, 2011: <blockquote> <a href="http://www.iom.edu/%7E/media/Files/Activity%20Files/Quality/Patient%20Safety%20and%20HIT/Meeting%202/Dwork.pdf">http://www.iom.edu/~/media/Files/Activity%20Files/Quality/Patient%20Safety%20and%20HIT/Meeting%202/Dwork.pdf</a> <a href="http://www.iom.edu/%7E/media/Files/Activity%20Files/Quality/Patient%20Safety%20and%20HIT/Meeting%202/WoodsNormanFeb2011.pdf">http://www.iom.edu/~/media/Files/Activity%20Files/Quality/Patient%20Safety%20and%20HIT/Meeting%202/WoodsNormanFeb2011.pdf</a> <a href="http://www.iom.edu/%7E/media/Files/Activity%20Files/Quality/Patient%20Safety%20and%20HIT/Meeting%202/Harper%20IOM%20HIT%20Patient%20Safety.pdf">http://www.iom.edu/~/media/Files/Activity%20Files/Quality/Patient%20Safety%20and%20HIT/Meeting%202/Harper%20IOM%20HIT%20Patient%20Safety.pdf</a> <a href="http://www.iom.edu/%7E/media/Files/Activity%20Files/Quality/Patient%20Safety%20and%20HIT/Meeting%202/Chrisman-.pdf">http://www.iom.edu/~/media/Files/Activity%20Files/Quality/Patient%20Safety%20and%20HIT/Meeting%202/Chrisman-.pdf</a> <a href="http://www.iom.edu/%7E/media/Files/Activity%20Files/Quality/Patient%20Safety%20and%20HIT/Meeting%202/Palmer.pdf"> http://www.iom.edu/~/media/Files/Activity%20Files/Quality/Patient%20Safety%20and%20HIT/Meeting%202/Palmer.pdf</a></blockquote> The PPT's can be downloaded directly from these links. <a href="http://www.blogger.com/redir.aspx?C=6a066a21e02c4884bce66800e5d0abb6&URL=http%3a%2f%2fwww.iom.edu%2f%7e%2fmedia%2fFiles%2fActivity%2520Files%2fQuality%2fPatient%2520Safety%2520and%2520HIT%2fMeeting%25202%2fPalmer.pdf" target="_blank"></a> I note several observations: <ul><li>The overall quality of these presentations appears mediocre; </li></ul><ul><li>Issues of healthcare IT risks - as they exist on the ground in 2011 - are addressed poorly if at all; </li></ul><ul><li>Proposed "solutions" are really nothing novel or new compared to existing literature or recommendations made in earlier studies, including that of the US NRC;</li></ul><ul><li>That these presentations come from the highest scientific body in the United States is, in my opinion, a disappointment and, indeed, an embarrassment.</li></ul> The IOM's rules of engagement, according to the Study Director, preclude my testifying, as a Medical Informatics specialist and former CMIO, about a relative's nearly being killed by poorly designed and implemented health IT. Instead, the linked presentations above are presented. Here's an example of what I consider a somewhat rigorous and critical thinking-based presentation on health IT risks: <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/Clinical_IT_benefits_risks.ppt"></a><blockquote><a href="http://www.ischool.drexel.edu/faculty/ssilverstein/Clinical_IT_benefits_risks.ppt">http://www.ischool.drexel.edu/faculty/ssilverstein/Clinical_IT_benefits_risks.ppt</a></blockquote> I think the IOM should be able to do better than a mere small-university medical informatics adjunct professor. -- SS

IOM Committee on Patient Safety and Health IT, Meeting Two: Institute of Medicine, or of Mediocrity?

In my Jan. 2011 post " Institute of Medicine Committee on Patient Safety and Health Information Technology, and Thoughts on Social As...

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Once More with Feeling: Another Defense of Conflicts of Interest Based on Logical Fallacies

Despite increasing recognition of the adverse effects of <a href="http://hcrenewal.blogspot.com/search/label/conflicts%20of%20interest">health care professionals'</a> and <a href="http://hcrenewal.blogspot.com/search/label/institutional%20conflicts%20of%20interest">health care institutions'</a> conflicts of interest on health care, such financial relationships continue to have their prominent defenders.  The latest example was <a href="http://www.medscape.com/viewarticle/737428">an article</a> in Medscape General Surgery by Frank J Veith MD, entitled "Physicians and Industry: Fix the Relationships, but Keep Them Going."  Dr Veith is a prominent vascular surgeon who "received numerous awards and honors as a leader, outstanding teacher, and innovator in vascular surgery," <a href="http://www.nyuvascular.org/handler.cfm?event=practice,template&cpid=19999">according to New York University</a> We have noted before how defenders of conflicted professionals and professional societies often employ <a href="http://hcrenewal.blogspot.com/search/label/logical%20fallacies">logical fallacies</a> to support their arguments.  Some recent examples were discussed <a href="http://hcrenewal.blogspot.com/2010/11/there-you-go-again-richard-epstein-says.html">here</a>, by a prominent ostensibly libertarian attorney and law professor; <a href="http://hcrenewal.blogspot.com/2009/09/latest-version-of-argument-that-we-are.html">here</a>, published in a well-known medical journal by the former director of "medical communications" for a large pharmaceutical firm; and <a href="http://hcrenewal.blogspot.com/2009/07/again-logical-fallacies-in-defense-of.html">here</a>, by the president of a large medical society, published again in a well-known medical journal. Dr Veith seems to be continuing that tradition. His approach emphasized frequent repetition of the same fallacious argument. Straw Man: "Totally Interrupt All Doctor-Industry Relationships" Dr Veith's main argument seemed to be with attempts to prevent physicians from having any relationships with industry, presumably including not just financial relationships, but professional collaborations or even personal friendships.  For example, he wrote about <blockquote>a recent initiative to completely sever the relationship between industry and doctors has gained traction. This initiative has been supported by several states, including Massachusetts and Vermont, and universities, such as Harvard, Stanford, the University of Massachusetts, and the University of Michigan, which have enacted draconian laws or policies designed to separate doctors and industry and to interrupt any relationship between them.</blockquote> Furthermore, <blockquote>Even many individual physicians have sanctimoniously jumped on the bandwagon and written articles or opinion pieces attacking the evils of any relationship between industry and doctors, suggesting the severance of any such relationships. </blockquote> Then later, Dr Veith wrote, <blockquote>We should establish rules to prevent or minimize the abuses, but we should not totally interrupt all doctor-industry relationships. To do so is wrong-headed and would eliminate the many beneficial effects that accrue to medical care and society from these relationships. It would be throwing the baby out with the bathwater.</blockquote> Finally, he concluded thus, <blockquote>These will be far better solutions than completely eliminating all industry-doctor relationships.... Such safeguards will be better than the present trend for institutions and governments to enact strict measures to separate physicians from industry.</blockquote> Despite making this argument at least four times, the problem is that Dr Veith provided no citations, much less evidence that such "draconian" policies have been enacted or even advocated. There have been new policies on conflicts of interest suggested or adopted by some organizations. None, to my knowledge have been exactly "draconian." For example, Harvard University does have a new policy on conflicts of interest. Maybe Dr Veith was referring to it above when he mentioned Harvard. However, in an interview about the new policy involving university leaders <a href="http://news.harvard.edu/gazette/story/2010/07/conflict-of-interest-policy-adopted/">published</a> in the Harvard Gazette, the Vice Provost of the University said, <blockquote>The University is not designed to be an ivory tower isolated from the world. So the trick is to be able to have a robust system for affording faculty opportunities to engage with the commercial world and at the same time not threaten in any way their own fundamental integrity or that of Harvard.</blockquote>That hardly sounds like a policy that completely severs all relationships between faculty and industry. So Dr Veith's main premise seems to be based on a multiply repeated <a href="http://www.nizkor.org/features/fallacies/straw-man.html">straw-man argument</a>. He argued again and again against a policy that no one seems to be advocating. (And even I, as a hard-liner about conflicts of interest, have never advocated a complete interruption of all relationships of any kind between all physicians and all of industry.) Appeal to Fear: You Will be "Blighted" Perhaps just to spice things up, Dr Veith warned of the dire consequences of the "draconian" policies that no one was advocating: <blockquote>Those institutions that choose such inquisitional approaches will be blighted and suffer competitive disadvantages.</blockquote> Dr Veith had asserted multiple benefits of continuing relationships among physicians, health care institutions, and commercial firm. He presented no evidence to support his assertions, most of which can be questioned (see below). His warning that institutions will be "blighted" was based on his assertion that the stringent policy no one advocated would eliminate these unproven benefits, hence his warning of  something so severe as "blight" seemed to be an <a href="http://www.nizkor.org/features/fallacies/appeal-to-fear.html">appeal to fear</a>. Ad Hominem: "Sanctimonious" Physicians Leading a "Witch Hunt" As noted above, Dr Veith referred to anonymous physicians who "sanctimoniously jumped on the bandwagon," thus leading to <blockquote>The initiative to separate industry from physicians and surgeons [which] has taken on the trappings of a witch hunt.</blockquote> And again, <blockquote>Their leaders should recognize this and resist the temptation to join the separation witch hunt....</blockquote> My interpretation is that this was an implied set of <a href="http://www.nizkor.org/features/fallacies/ad-hominem.html">ad hominems</a>. Those who supposedly advocated the "draconian" policy were made out to be "sanctimonious" witch hunters. After just having seen "The Crucible," I could also argue that the use of the term "witch hunt," with its current extreme emotional references (apparently to a case in which presumably innocent people were hanged), amounted to an <a href="http://www.nizkor.org/features/fallacies/appeal-to-emotion.html">appeal to emotion</a> and an <a href="http://www.nizkor.org/features/fallacies/appeal-to-fear.html">appeal to fear</a>. Summary I must admit Dr Veith's entire set of arguments was not completely based on logical fallacies.  However, the rest of his arguments hardly appeared even-handed.  He presented a series of assertions about the benefits of such relationships, including that they "foster innovation and development," that "industry-sponsored medical education helps to keep physicians informed about new developments," that industry sponsored education about devices prevents "difficult and dangerous" practices, and helps physicians use devices "better and more safely."  He provided no evidence in favor of these claims, and seemed to ignore arguments about the hazards of payments to physicians biasing their clinical practice, teaching and research. I should also note that these arguments were made by a physician who appears to have his own personal financial relationships with industry.  <a href="javascript:newshowcontent('active','authordisclosures');">In the Medscape article</a>, Dr Veith "disclosed no relevant financial relationships."   However, as a member of the <a href="http://www.medscape.com/public/bios/ed-surgery">editorial board of Medscape General Surgery</a>, Dr Veith "disclosed the following relevant financial relationships: Owns stock, stock options, or bonds from: Vascular Innovations, Inc."  Furthermore, the <a href="http://iconmeeting.org/sites/default/files/file/iCON2011_DISCLOSURE%20SUMMARY_4.pdf">disclosure summary for the iCON2011 conference</a> includes the following for Dr Veith, "Honorarium/Expenses: Cook Medical, Cordis, WL Gore, Medtronic." Finally, Dr Veith apparently runs the Veith Symposium, which <a href="http://www.veithsymposium.org/index.php?pg=acknowledgments">in 2010 acknowledged</a> the following commercial sponsors: Aastrom, Abbott Vascular, Aptus Endosystems Inc, Atrium, Bard Peripheral Vascular, Boston Scientific, Cook Medical, Cordis Cardiac and Vascular Institute, Delcath Systems Inc, Gore, Hansen Medical, Lombard Medical Technologies, Maquet, Medtronic, Organogenesis Inc, Sanofi-Aventis, St. Jude Medical, Tenaxis Medical, Triavascular, Vascutek Terumo. So Dr Veith's article continues the tradition of defenses of physicians' and health care institutions' conflicts of interest based on logical fallacies and unbalanced and unsupported assertions.  Also, note that all the examples of such defenses we have discussed were made by people with their own financial relationships with drug, device, and/or biotechnology companies, although some of them disclosed these relationships.  I have yet to see a defense of such conflicts based on logic and evidence, or a defense of such conflicts made by someone who has absolutely no conflicts of his or her own.  The currently prevalent relationships with health care corporations among academic physicians, researchers, and other decision makers and influencers in health care have been lucrative for them.  I have yet to see a coherent, logical argument that these relationships are good for patients, medical education, biomedical or clinical science, or public health made by anyone, much less someone who does not have such relationships. I will note that the defenses of conflicts of interest begin to seem drearily similar.  Not only do they often use the same logical fallacies, but they repeat the same stale and unsupported arguments about the benefits of financial relationships with industry: that they foster "innovation," and that they provide better educational opportunities than unconflicted programs and educators.  We now know that the managed care industry has engineered stealth health policy advocacy campaigns that furnish talking points to "third parties" which may get caught up in the larger policy discourse (see posts <a href="http://hcrenewal.blogspot.com/2011/02/wendell-potters-deadly-spin.html">here</a> and <a href="http://hcrenewal.blogspot.com/2011/02/health-care-corporate-disinformation.html">here</a>).  I wonder whether some such stealth health policy advocacy campaign by pharmaceutical, device and/or biotechnology companies seeded the discourse about conflicts of interest with some of the logical fallacies and unproven assertions that have become so familiar.  We need to elevate our discourse about health care policy.  People involved in health policy discussions should at least disclose their conflicts of interest when making their points.  We should be very skeptical of  arguments and look carefully for the evidence and logic that supports them.  When we find that evidence and logic is lacking, be even more skeptical about who benefits from them.

Once More with Feeling: Another Defense of Conflicts of Interest Based on Logical Fallacies

Despite increasing recognition of the adverse effects of health care professionals' and health care institutions' conflicts of int...

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A Brief Primer on Health IT Problems

I have noted that numerous policy makers I've spoken with freely admit their knowledge of healthcare IT is zero, or limited to what they've seen and heard in the press (i.e., mainly marketing messages in disguise). Since most of these officials have little time to study the issues about health IT in depth, I've created a zipped archive of four articles I consider key. The articles can serve as a primer on health IT problems: <blockquote>1. Joint Commission Health IT Sentinel Events Alert, 2009. 2. FDA Internal Report on Adverse Events Involving Health IT. ("Not intended for public use" - but obtained by the press last year, presumably via FOIA), 2010. 3. ECRI Institute Top 10 Health Technology Hazards of 2011 - see hazard #5. 4. Hoffman/Podgurski, Case Western Reserve School of Law: E-HEALTH HAZARDS: PROVIDER LIABILITY AND ELECTRONIC HEALTH RECORD SYSTEMS - comprehensive article, one of a series, 2009. </blockquote> The zipped file can be downloaded from here: <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/HIT_issues_Primer.zip"></a><blockquote><a href="http://www.ischool.drexel.edu/faculty/ssilverstein/HIT_issues_Primer.zip">http://www.ischool.drexel.edu/faculty/ssilverstein/HIT_issues_Primer.zip</a></blockquote> It is 2.7 Mb in length. (A compilation of over fifty articles is at <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/HITreadinglist.doc">http://www.ischool.drexel.edu/faculty/ssilverstein/HITreadinglist.doc</a>, for those with lots of time.) -- SS

A Brief Primer on Health IT Problems

I have noted that numerous policy makers I've spoken with freely admit their knowledge of healthcare IT is zero, or limited to what they...

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More Hospitals Settle, But Not for Much

In late February, there have been several notable legal settlements made by more or less prominent hospitals, discussed in rough order of size. United Regional Health Care System <a href="http://www.thecypresstimes.com/article/News/National_News/JUSTICE_DEPARTMENT_REACHES_SETTLEMENT_WITH_TEXAS_HOSPITAL_PROHIBITING_ANTICOMPETITIVE_CONTRACTS_WITH_HEALTH_INSURERS/41050">Per the Cypress Times</a>, <blockquote>The Department of Justice announced today that it has reached a settlement with United Regional Health Care System of Wichita Falls, Texas, that prohibits it from entering into contracts that improperly inhibit commercial health insurers from contracting with United Regional’s competitors. The department said that United Regional unlawfully used these contracts to maintain its monopoly for hospital services in violation of Section 2 of the Sherman Act, causing consumers to pay higher prices for health care services.</blockquote> Note that this appears to be the first settlement involving the Sherman Anti-Trust Act that included a hospital system, or any health care organization which we have discussed. As the Times article mentioned, <blockquote>This is the first case brought by the department since 1999 that challenges a monopolist with engaging in traditional anticompetitive unilateral conduct. </blockquote> Here is more detail about the alleged offenses: <blockquote>According to the complaint, United Regional is by far the largest hospital in Wichita Falls. Its share of general acute-care inpatient hospital services is approximately 90 percent, and its share of outpatient surgical services is more than 65 percent. It is the region’s only provider of certain essential services such as cardiac surgery, obstetrics and high-level trauma care. In Wichita Falls, United Regional’s average per-day rate for inpatient hospital services sold to commercial health insurers is about 70 percent higher than its closest competitor for the services that are offered by both hospitals. The department said that in order to maintain its monopoly in the provision of inpatient hospital and outpatient surgical services, United Regional systematically required most commercial health insurers to enter into contracts that effectively prohibited them from contracting with United Regional’s competitors. United Regional’s contracts required these insurers to pay significantly higher prices if they contracted with a nearby competing facility. Since United Regional is a must-have hospital for any insurer that wants to sell health insurance in the Wichita Falls area, and because the penalty for contracting with United Regional’s rivals was so significant, almost all insurers offering health insurance in Wichita Falls entered into exclusionary contracts with United Regional. As a result, competing hospitals and facilities could not obtain contracts with most insurers and were less able to compete, helping United Regional maintain its monopoly in the relevant markets and raising health-care costs to the detriment of consumers.</blockquote> As far as I could tell, however, for this apparently severe offense there will be no actual penalty. The settlement only appears to provide for a promised change in future behavior by the hospital: <blockquote>The proposed settlement, which if accepted by the court would be in effect for seven years, restores lost competition by prohibiting United Regional from using agreements with commercial health insurers that improperly inhibit insurers from contracting with United Regional’s competitors. In particular, United Regional is prohibited from conditioning the prices or discounts that it offers to commercial health insurers based on whether those insurers contract with other health-care providers and from inhibiting insurers from entering into agreements with United Regional’s rivals. United Regional is also prohibited from taking any retaliatory actions against an insurer that enters into an agreement with a rival provider.</blockquote> So if a hospital engages in actions that restrain competition and results in a de facto monopoly, all the hospital leaders must fear is that at some point it may have to change its monopolistic behavior, according to this settlement. Catholic Healthcare West <a href="http://www.bizjournals.com/sanjose/news/2011/02/22/catholic-healthcare-west-agrees-to.html">Per the San Jose Business Journal</a>, <blockquote>Catholic Healthcare West, parent company to local Mercy hospitals, has agreed to pay $9.1 million to settle allegations that seven of its hospitals submitted false Medicare claims, U.S. Attorney Benjamin Wagner announced late Friday.</blockquote> Here is more detail about the alleged offenses: <blockquote>The hospitals include Community Hospital of San Bernardino, St. Bernadine Medical Center in San Bernardino and St. Elizabeth Community Hospital in Red Bluff. The settlement also included allegations that O’Conner Hospital in San Jose, Seton Medical Center in Daly City and St. Joseph’s Hospital and Medical Center in Phoenix submitted inflated costs for their home health agencies and were overpaid. The agreement also resolves allegations that St. Joseph’s overstated how much was owed in disproportionate share funding for indigent patients. CHW no longer owns O’Conner Hospital or Seton Medical Center. The settlement resolves allegations that St. John’s Regional Medical Center in Oxnard was overpaid for treating a high percentage of patients with end-stage kidney disease for several years, including two when it was not eligible.</blockquote> Note that while the amount of the payment assessed appears substantial, it will be made a very long time after the alleged bad behavior occurred: <blockquote>All of the problems occurred in the 1990s. Federal investigators began looking into the matter in 2001, but it took years to compile evidence and reach a settlement. All of the hospitals had set aside money in a reserve account should they have to pay funds back to the government.</blockquote> So if a hospital submits false claims to the US government, hospital leaders need not fear paying anything back for more than 10 years, according to this settlement. By the way, this was not the first such settlement that Catholic Healthcare West has had to make: <blockquote>In 1998, a whistleblower at Woodland Healthcare disclosed instances of alleged fraud by two medical groups affiliated with local Mercy hospitals, Woodland Clinic Medical Group and Medical Clinic of Sacramento. Following an extensive investigation, former U.S. Attorney John Vincent announced a $10.25 million settlement in May 2001. The allegations included false claims to inflate reimbursement from Medicare, Medi-Cal and military health insurance programs.</blockquote> Massachusetts General Hospital (Partners Healthcare) <a href="http://www.boston.com/news/local/massachusetts/articles/2011/02/25/mgh_to_pay_1m_to_settle_privacy_case/">Per the Boston Globe</a>, <blockquote>Massachusetts General Hospital has agreed to pay the federal government $1 million to settle potential violations of patient privacy laws, which occurred when an employee commuting to work lost patient records on the T’s Red Line two years ago.</blockquote> Here is more detail about the alleged offenses: <blockquote>Health information for 192 patients in Mass General’s Infectious Disease Associates outpatient practice was lost in the incident, including that of patients with HIV/AIDS. The documents included a patient schedule containing names and patient medical record numbers, as well as billing forms containing the name, birth date, medical record number, health insurer and policy number, diagnosis, and name of providers for 66 of those patients.</blockquote> Note that Massachusetts General Hospital is not independent, but part of Partners Healthcare, which reported net patient service revenue of $1.5 billion in the most recent quarter, again <a href="http://www.boston.com/business/healthcare/articles/2011/02/12/partners_healthcare_reports_overall_first_quarter_gain/">per the Boston Globe</a>. So this settlement amounted to about 0.00167% of the system's patient revenue. So if a hospital engages in actions that violate the trust patients have that their information will be kept confidential, all hospital leaders have to fear is that their institution will eventually have to pay something much less than round-up error of their revenue, according to this settlement. Summary Again, the volume of participants in the ongoing <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">march of legal settlements</a> is a reminder of how pervasive bad behavior is in the US health care system. Remember that these settlements are in some sense the tip of the iceberg. They only indicate behavior that inspired legal action which was in turn was publicized. It is likely that for each behavior that eventually leads to a settlement, there are many behaviors that go unreported, or that cause no reaction. It is interesting that sorts of bad behavior that formerly caused no official reaction are now leading to settlements. As noted above, there had been no recent legal actions against <a href="http://hcrenewal.blogspot.com/search/label/concentration%20of%20power">concentration of power</a> in health care up to the United Regional Health Care System settlement. However, like many of the settlements we have previously noted, the latest crop seem to have little deterrent power. The United Regional Health Care System settlement seemingly involved no monetary penalties whatsoever, only a promise of not to do it again. The Catholic Healthcare West settlement's monetary penalties were so delayed, occurring over 10 years after the actions in question, their deterrent power is highly questionable. The Massachusetts General Hospital (really the Partners Healthcare) monetary penalty was infinitesimal compared to the size of the institution's budget. Furthermore, as in nearly every other case we have reported, no person who authorized, directed or implemented the actions in question had to pay any penalty, or suffer any negative consequence, or was even identified. So while there seems to be some increased interest in addressing some kinds of bad behavior, like monopolistic practices, that heretofore generated no official reactions, regulatory authorities still seem loathe to even slap the wrists of the people whose aggregated actions are making our health care so expensive, so inaccessible, and probably of such mediocre quality. Thus, in recent years, health care leaders, like leaders of financial service companies, seem to have impunity,  Up to now, they have been able to preside over all sorts of bad behaviors that help support their exorbitant remuneration without fearing any personal penalties.  As Charles Ferguson, the director of <a href="http://www.sonyclassics.com/insidejob/">Inside Job</a>, said when accepting his Academy Award last night, <a href="http://www.marketwatch.com/story/inside-job-director-slams-wall-street-2011-02-28?reflink=MW_news_stmp">per MarketWatch</a>, <blockquote>Forgive me, I must start by pointing out that three years after a horrific financial crisis caused by fraud, not a single financial executive has gone to jail — and that’s wrong</blockquote> After a slow-motion health care train wreck over the last 30 years, hardly any health care executives have even had to pay a fine, much less go to jail. So I repeat, and repeat, and repeat: we will not deter unethical behavior by health care organizations until the people who authorize, direct or implement bad behavior fear some meaningfully negative consequences. Real health care reform needs to make health care leaders accountable, and especially accountable for the bad behavior that helped make them rich.

More Hospitals Settle, But Not for Much

In late February, there have been several notable legal settlements made by more or less prominent hospitals, discussed in rough order of si...

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