healthy4u

National Programme for Health IT Declared Dead Due to 'Luddite Doctors' and Lousy IT, But Mostly Lousy IT

And poor leadership. From the NHS Department of Health (also see "<a href="http://www.e-health-insider.com/news/6227/end_of_npfit_to_be_announced_today">End of NPfIT to be announced today</a>" at eHealth Insider.com): <blockquote>9 Sept. 2010 <a href="http://www.dh.gov.uk/en/MediaCentre/Pressreleases/DH_119293">The future of the National Programme for IT</a> A Department of Health review of the National Programme for IT has concluded that a centralised, national approach is no longer required, and that a more locally-led plural system of procurement should operate, whilst continuing with national applications already procured. A new approach to implementation will take a modular approach, allowing NHS organisations to introduce smaller, more manageable change, in line with their business requirements and capacity. NHS services will be the customers of a more plural system of IT embodying the core assumption of ‘connect all’, rather than ‘replace all’ systems. This reflects the coalition government’s commitment to ending top-down government and enabling localised decision-making. The review of the National Programme for IT has also concluded that retaining a national infrastructure will deliver best value for taxpayers. Applications such as Choose and Book, Electronic Prescription Service and PACS have been delivered and are now integrated with the running of current health services. Now there is a level of maturity in these applications they no longer need to be managed as projects but as IT services under the control of the NHS. Consequently, in line with the broader NHS reforms, the National Programme for IT will no longer be run as a centralised national programme and decision making and responsibility will be localised. Health Minister, Simon Burns, said: “Improving IT is essential to delivering a patient-centred NHS. But the nationally imposed system is neither necessary nor appropriate to deliver this. We will allow hospitals to use and develop the IT they already have and add to their environment either by integrating systems purchased through the existing national contracts or elsewhere. “This makes practical sense. It also makes financial sense. Moving IT systems closer to the frontline will release £700 million extra in savings. Every penny saved through productivity gains will be reinvested to improve patient care.” Director General for [Medical] Informatics Christine Connelly [former CIO of Cadbury Schweppes, the candy-and-soft drink company, and before that Chief of Staff for Gas, Power and Renewables, and Head of IT at British Petroleum - ed.] said: “It is clear that the National Programme for IT has delivered important changes for the NHS including an infrastructure which the NHS today depends on for providing safe and responsive health care. Now the NHS is changing [ostensibly away from central bureaucratic control and towards more physician autonomy - ed.], we need to change the way IT supports those changes, bringing decisions closer to the front line and ensuring that change is manageable and holds less risk for NHS organisations.” </blockquote> The U.S. will painfully learn these lessons in years to come, it being clear that to date we've learned nothing from the UK's experiences. Worse, our own government is ignoring the downside risks of the technology, bypassing science (and patient safety) for political expedience. At the same time, the EU is heading in the reverse direction, with the Swedish Medical Products Agency leading the way for consideration of HIT in the EU as a medical device to be regulated (see "<a href="http://hcrenewal.blogspot.com/2009/06/improving-patient-safety-in-eu-hit.html">Improving Patient Safety In The EU: HIT Should Be Classified As Medical Devices</a>"). On ignoring science, see my July 2010 post <a href="http://hcrenewal.blogspot.com/2010/07/new-england-journal-on-meaningful-use.html">"Science or Politics? The New England Journal and "The 'Meaningful Use' Regulation for Electronic Health Records"</a>. Also see my prior calls for US restraint such as at "<a href="http://hcrenewal.blogspot.com/2008/11/should-us-call-moratorium-on-ambitious.html">Should The U.S. Call A Moratorium On Ambitious National Electronic Health Records Plans</a>?" and "<a href="http://hcrenewal.blogspot.com/2008/12/open-letter-to-president-barack-obama.html">Open Letter to President Barack Obama on Healthcare Information Technology</a>". In fact, a major American health IT vendor (e.g., <a href="http://www.publications.parliament.uk/pa/cm200809/cmselect/cmpubacc/153/15304.htm">at this link</a>, items 5 and 6, Cerner Millenium) was explicitly blamed by the UK's government for many of the National Programme's travails. The key experience of the NHS is reflected in this passage: <blockquote>A new approach to implementation will take a modular approach, allowing NHS organisations to introduce smaller, more manageable change, in line with their business requirements and capacity. </blockquote> The "meaningful use" requirements in the U.S. alone ignore local "business requierments and capacity" over the centralized diktats of bureaucrats. -- SS Sept. 10 addendum, from <a href="http://histalk2.com/2010/09/09/news-91010/">here</a>: <blockquote>... Said the co-director of the Royal College of Physicians Health Informatics Unit, “One of the dirty secrets of the NHS is the regrettable state of medical record keeping. Earlier reports have shown that this compromises patient safety and clinical care. If IT in the health service is going to regain the confidence of the medical profession, then more emphasis has to be placed by the Department of Health on making sure that the new systems accurately capture the dialogue between doctor and patient. Everything else flows from getting that right.” </blockquote> Earlier reports ["earlier" with respect to...what? - ed.] "have shown that [poor electronic medical record keeping] compromises patient safety and clinical care? You don't say? -- SS

National Programme for Health IT Declared Dead Due to 'Luddite Doctors' and Lousy IT, But Mostly Lousy IT

And poor leadership. From the NHS Department of Health (also see " End of NPfIT to be announced today " at eHealth Insider.com): 9...

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Projecting Competence ...

Projecting competence ... used to be important. No longer. Today I received a mailing about a surgical educational conference at a local hospital, Jefferson. The envelope, pre-printed stationery used by the department, had the following logo: <div style="text-align: center;"><a onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}" href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhvllq0zIUlTXeu_2HP0HkqQ178gNReMcf3LQi5fGdIRkGm0pB1jLdLqcfbdY7cmqVrgeLjwKvaXv_Qo1nfxcCtx31Lhg4R-c_ibXzmf80viFfKcklQMf6MJrrzPuJ-MbXtsla39d7P8eiZ/s1600/sugery1.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5514679740966751026" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhvllq0zIUlTXeu_2HP0HkqQ178gNReMcf3LQi5fGdIRkGm0pB1jLdLqcfbdY7cmqVrgeLjwKvaXv_Qo1nfxcCtx31Lhg4R-c_ibXzmf80viFfKcklQMf6MJrrzPuJ-MbXtsla39d7P8eiZ/s320/sugery1.jpg" style="display: block; margin: 0px auto 10px; text-align: center; cursor: pointer; width: 395px; height: 167px;" /></a>(click to enlarge) </div> This envelope certainly does not inspire my confidence. We are in a bad time in medicine when hospitals cannot spell. I cannot imagine how this was missed, other than via the hiring of the cheapest help possible. -- SS

Projecting Competence ...

Projecting competence ... used to be important. No longer. Today I received a mailing about a surgical educational conference at a local hos...

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Logical Fallacies in Defense of Million Dollar Babies

We recently posted about the latest example of generously paid health care leaders, million dollar plus hospital CEOs in the Baltimore area (<a href="http://hcrenewal.blogspot.com/2010/08/more-hospital-ceos-join-millionaires.html">here</a>).  Such stories are appearing more often in the media, and increasingly generating skeptical, anguished, or angry responses.  Defending Millionaire Hospital CEOs So it should be no surprise that the defenders of rich hospital CEOs are starting to rally.  The Baltimore Sun published two letters defending the million dollar plus compensation received by many local hospital CEOs.  But what arguments they made. First, let us examine in detail  <a href="http://articles.baltimoresun.com/2010-09-02/news/bs-ed-hospital-assn-letter-20100902_1_hospital-ceo-hospital-leaders-maryland-hospital-association">the arguments made</a> by Carmela Coyle, "president and CEO of the Maryland Hospital Association."  She opened with this description of hospitals as organizations: <blockquote>Famed management expert Peter Drucker said that health care is the most difficult, chaotic, and complex industry to manage today, and that the hospital is "altogether the most complex human organization ever devised." Indeed, hospitals are not your typical business. Hospitals are places where lives are saved. They ease pain and suffering. Hospitals are open every minute of every day, driven by a mission of caring and rooted in their communities. Hospitals do not close up and move on when economic times get tough. This requires extraordinary dedication, commitment, talent, and leadership. And hospitals are governed by trustees--independent leaders from the communities hospitals serve. </blockquote> She then briefly described her version of how hospital CEO compensation is set: <blockquote>The compensation for hospital executives is determined by those boards and compensation committees who follow nationally recommended practices for setting contract terms, evaluating CEO performance, reviewing salary comparability data, setting and approving compensation, and ensuring the process is free from conflict of interest.</blockquote> Then she provided this extraordinary description of what hospital CEOs do: <blockquote>Perhaps the more important look is at what these hospital leaders do day in and day out for Marylanders: •Provide more than 88,000 Maryland jobs; most hospitals are the largest employers in their communities and they employ your friends and neighbors; •Make health care available 24 hours a day, every day of the year, regardless of a recession, blizzards, physician and nurse shortages, or other obstacles; •Bring you the latest technology and facilities so you, your family, and your neighbors can get the care they need, when they need it; •Manage the uncertainties and vast change that health care reform will bring; •Preserve your local hospital as the cornerstone of care in your community. Hospitals are unique places, and it takes unique people to run them. Maryland is fortunate to have such leaders.</blockquote>. "Famed management expert Peter Drucker said...." - Appeal to Authority Mr Drucker may be a management expert, but what expertise does he have in health care, medicine, or the health care environment?  I actually agree that the hospital environment is "difficult, chaotic, and complex" in many senses, but would assert that it is the health care professionals in hospitals (doctors, nurses, other clinicians, therapists, technicians, etc) who are most expert at and primarily tasked with responding to these complexities (see below).  I submit that the opening citation of Drucker is an example of an <a href="http://www.nizkor.org/features/fallacies/appeal-to-authority.html">appeal to authority</a> (chosen not because of his specific expertise in the relevant context.) "Hospitals are places where lives are saved...." - Appeal to Emotion Of course they are, and the general description of the hospital is true.  However, who is it who (rarely) save lives, (hopefully often) relieve pain and suffering, and provide continuous service "every minute of every day?"  It is, glaringly obviously, the health care professionals listed above, admittedly assisted by a variety of staff who keep the lights on, make the food, clean the operating rooms, etc, etc.  The most removed from the actual clinical care are the managers.  The higher the managers are in the food chain, the less likely they are to have any contact with actual clinical care.  I submit that most CEOs deal mainly with C-level officers and vice presidents, and interact mainly with them, spread sheets, PowerPoints, and emails.  Given that hospitals do al these wonderful things, should not the support, credit, and frankly, pay go to those who actually do wonderful things, not sit in meetings and play with spread sheets? I believe that this wonderful description of the hospital mission is mainly an <a href="http://www.nizkor.org/features/fallacies/appeal-to-emotion.html">appeal to emotion</a>, designed to generate warm and fuzzy opinions about hospitals that make paying their detached top managers much more than the people who actually provide patient care more emotionally, but not logically palatable. "And hospitals are governed by trustees...." "The compensation for hospital executives is determined by those boards...." - Begging the Questions and an Appeal to Common Practice The description of how CEO pay is set merely describes a process, but does not explain why this process is likely to come up with the right result.  It <a href="http://www.nizkor.org/features/fallacies/begging-the-question.html">begs questions</a> about hospital leadership and governance that we have discussed often, including whether <a href="http://hcrenewal.blogspot.com/search/label/boards%20of%20trustees">boards</a> populated by people with little understanding of health care, sometimes including leaders of <a href="http://hcrenewal.blogspot.com/search/label/finance">financial firms</a> who helped usher in the great recession, and sometimes including individuals with obvious <a href="http://hcrenewal.blogspot.com/search/label/conflicts%20of%20interest">conflicts of interest</a> are likely to make decisions about executive compensation that ultimately support the hospitals' missions.  It begs questions about the standards to which <a href="http://hcrenewal.blogspot.com/search/label/executive%20compensation">executive pay</a> is compared, especially the phenomenon that all executives are above average (see this <a href="http://hcrenewal.blogspot.com/2010/07/where-no-hospital-ceos-are-below.html">post</a>).  The implication that because a process is in place that follows the usual practice, the outcome must be good amounts to an <a href="http://www.nizkor.org/features/fallacies/appeal-to-common-practice.html">appeal to common practice</a>.  "what these hospital leaders do day in and day out...." -Appeal to Emotion and the Questionable Cause Fallacy In one sense, this is just a more extreme version of the <a href="http://www.nizkor.org/features/fallacies/appeal-to-emotion.html">appeal to emotion</a> used above.  Furthermore, the bullet points are really about what hospitals and their health care professionals and support staff, not what their leaders do.  It is the hospitals as organizations that provide jobs.  It is the professionals and support staff who make the health care available every hour of every day.  (Have you ever seen the CEO of a hospital caring for an acute patient at 2 AM?  LOL.)  It is the hospital that provides the technology and facilities.  It is largely the health care professionals who manage uncertainties.  Suggesting that the few CEOs, sitting in their meetings and reading their spread-sheets, rarely directly interacting with health professionals, and virtually never actually involved in patient care, should get most of the credit for these good works insults the thousands of health care professionals who actually do the health care.  It also amounts to an example of the <a href="http://www.nizkor.org/features/fallacies/questionable-cause.html">questionable cause fallacy</a>: the fallacy is that because the managers are somehow associated with actual health care, they cause the health care to happen.  (Think how long a hospital could provide services if the health care professionals and support staff were to vanish.  Think how long a hospital could provide services if the managers vanished.) The <a href="http://articles.baltimoresun.com/2010-09-03/news/bs-ed-hancock-ceo-pay-letter-20100903_1_hospital-ceo-hospital-boards-board-compensation-committee">second letter</a> to the Baltimore Sun was by the chairman and CEO of Yaffe & Company, Inc, apparently a firm that consults on executive pay.  This letter was even less to the point than that above.  I invite our readers to discover its logical fallacies. Summary For a while we have been writing an informal series of posts about how logical fallacies may be deployed to advocate questionable health policy arguments, usually in a highly self-serving manner.  Our most recent example was <a href="http://hcrenewal.blogspot.com/2010/04/everybodys-doing-it-health-care-leaders.html">here</a>.  Most of the <a href="http://hcrenewal.blogspot.com/search/label/logical%20fallacies">examples</a> seemed to involve defenses of financial relationships among doctors and medical academics and drug and device companies, often written by people who themselves have financial relationships with such companies.  The question of huge compensation given to leaders of health care organizations, and related questions about the effects of their <a href="http://hcrenewal.blogspot.com/search/label/perverse%20incentives">perverse incentives</a>, <a href="http://hcrenewal.blogspot.com/search/label/impunity">impunity</a> from negative consequences of their actions, status as a new aristocracy, etc on health care dysfunction are getting more attention in the media.  So it should be no surprise that the defenders of the pay and power of these leaders are appearing.  It probably, but regrettably should also be no surprise that the defenses are mostly illogical, and made by people with financial interests in continuing excess compensation for health care leaders. Physicians, other health care professionals, those interested in health policy, and the public at large need to be continuously skeptical about health policy advocacy appearing in the media, especially by those who stand to personally gain from the results of the advocacy. My just slightly tongue-in-cheek suggestion for a policy position that could address this issue would be mandatory training in logical and evidence-based thinking, specifically to include recognition of logical fallacies, beginning at least at the middle-school level for all Americans (and around the globe), reinforced for those in health care.  (See the <a href="http://www.nizkor.org/features/fallacies/">Nizkor Project site</a> for a useful catalog of logical fallacies.)

Logical Fallacies in Defense of Million Dollar Babies

We recently posted about the latest example of generously paid health care leaders, million dollar plus hospital CEOs in the Baltimore area ...

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Health IT: "Danger"

In an article simply entitled "Danger", Health Data Management author Elizabeth Gardner spells out some "inconvenient truths" about health IT. Many of the contributors have opined on the risks associated with health IT; several are newly contrite about this issue: <blockquote><a href="http://www.healthdatamanagement.com/issues/18_8/danger-ehr-safety-errors-40754-1.html">Danger</a> By Elizabeth Gardner Health Data Management Magazine, 08/01/2010 Even to Ross Koppel, electronic health records are better than paper ones, "or cuneiform tablets, smoke signals, or carrier pigeons," he adds. He prefers to use hospitals and doctors that have EHRs. But the University of Pennsylvania sociologist specializes in analyzing interactions between medical computer systems and the people who use them, and he's found enough problems to turn him into an industry gadfly on the potential dangers of EHRs. "A resident will get an alert at 50 [milligrams of a certain drug] at one hospital, 60 at a second hospital, and no alert at a third hospital because they turned it off," Koppel says. "So he thinks the 70 milligrams he's ordered there are safe. The residents don't know whether the alerts are on or off. They're not familiar with many medications and they start a new rotation every thirty days. They use these alerts as safety bumpers and that's not safe." ... Koppel has found plenty of other glitches, from outright programming errors to user interfaces that make life difficult for clinicians. Numerical values appear in an order that makes sense to the computer but looks random to a human; positive test results aren't always flagged for review; weights aren't consistently labeled as pounds or kilograms (which can lead to babies, for example, being given twice, or half, the medication they need). "Everyone focuses on why physicians are resistant to computers, but I would rather focus on how difficult the systems are to use," Koppel says. "Most physicians are the smartest guys in the room. Their resistance to technology as such is zero, but they resist software that has a clunky structure."</blockquote> Dr. Koppel, a sociologist, is a well recognized name in health IT critical thinking circles. He will not win any favors from the health IT vendors and CIO's for that comment about physicians and smartness, but he is quite correct. Physicians are not Luddites. They readily adapt new technology proven as good for patients. In fact, in my observations IT personnel are the true Luddites, 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>Every year the ECRI Institute, Plymouth Meeting, Pa., a not-for-profit organization that evaluates health technology, issues a top 10 list of technology hazards in medical care. "Problems with computerized equipment and systems" ranked seventh this year, right behind "needlesticks and other sharps injuries" and ahead of "surgical stapler hazards." Most of the incidents reported to ECRI by its 5,000 members (hospitals, health systems, payers, and other interested parties) were due to convergence of computers and medical devices in areas like medication management and the routing of device alarms to clinicians' cell phones and pagers. (ECRI Institute points out that such problems are "most certainly underreported.")</blockquote> Under-reporting of health IT hazards is a familiar theme to this author, as in a 2009 paper entitled "<a style="font-weight: bold;" href="http://www.scribd.com/doc/28747771/Remediating-an-Unintended-Consequence-of-Healthcare-IT-A-Dearth-of-Data-on-Unintended-Consequences-of-Healthcare-IT">Remediating an Unintended Consequence of Healthcare IT: A Dearth of Data on Unintended Consequences of Healthcare IT</a>" that was not published due to first-round reviews. Some of those reviews were legitimate and constructive regarding revision, but others appeared to suggest the topic was verboten (for example, "nothing is in this paper that could not be read in any big city newspaper", rather the oxymoron considering the paper's topic). I did not bother with a revision, simply making the paper public and bypassing the peer review censorship I saw coming. <blockquote>But EHRs can easily cause errors, too. Plenty of experts believe that too many systems are being installed too fast into environments too complex to be easily computerized. In the frenzy to be eligible for federal EHR meaningful use incentive payments, and avoid reimbursement penalties starting in 2015, institutions may be setting themselves up for disastrous computer-induced medical errors.</blockquote> The theme of "too fast" has been present in my writings for awhile now; see for example my 2008 posts "<a href="http://hcrenewal.blogspot.com/2008/11/should-us-call-moratorium-on-ambitious.html">Should The U.S. Call A Moratorium On Ambitious National Electronic Health Records Plans</a>?" and "<a href="http://hcrenewal.blogspot.com/2008/12/open-letter-to-president-barack-obama.html">Open Letter to President Barack Obama on Healthcare Information Technology</a>". <blockquote>"I'm one of the biggest believers [in EHRs], but there's tremendous pressure to implement these systems so fast," says medical informaticist Dean Sittig, associate professor at the University of Texas Health Science Center at Houston and a leading researcher on successes and failures of EHR implementations. "It worries me that people won't have adequate time to come to grips with what they're doing and test their systems properly."</blockquote> Dr. Sittig did write some excellent, pioneering articles on the <a href="http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2579195/pdf/procascamc00009-0785.pdf">indispensibility of the CMIO role ("information architect" - PDF)</a> back in the mid-1990's that I use in my teaching. However, a few years ago he told a former student of mine (he was unaware of that relationship) who listed me as a reference on her CV to not do so, as I was not a "real medical informaticist" or words to that effect. Seems at the time he may have taken issue with my realist views on the problems with health IT. <blockquote>The medical environment is more complex than other fields like aircraft navigation, which is already hard enough to computerize, notes Nancy Leveson, professor of aeronautics and astronautics at the Massachusetts Institute of Technology. She's a pioneer in software safety ... "We're talking about a professional environment of doctors, and changing the way they do business," Leveson says. "Most other kinds of automation aren't doing that. </blockquote> This issue is critical and at the root of health IT dysfunction. No other profession is being asked to use IT in the manner in which clinicians have been asked. No other profession may have an information model as complex that they're asked to record in painstaking, granular detail, either. <blockquote> Because software engineers aren't taught about usability and the impact of their systems on the world, they think they'll just automate it the way they want and make people do it their way. There's a lot of stuff out there [in health care] that's very difficult to use. The industry is naive about introducing software and the change it requires and the potential hazards it introduces, and they think it's going to be all right."</blockquote> I would replace the word "naive" with "willfully ignorant, complacent and negligent." There are simply no acceptable excuses for a field that has been in existence for decades to be as toddlers on the impact of their work. <blockquote>... Clinicians who already have extensive experience with EHRs are under no illusions that everything works smoothly. "It's inevitable that some new errors will be introduced [with EHRs]," says David Bates, M.D., chief of general medicine at Brigham and Women's Hospital, Boston, a patient safety expert, and a member of the information technology executive committee of Partners HealthCare, Brigham's parent. </blockquote> Considering the ice-cold reception by most of those clinician experts (e.g., in the medical informatics community) to my writings on HIT problems that began in 1999 and now reside at my Drexel site <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/">here</a>, and to the similar writings of others, I disagree with Bates' assessment. I think the experts have now painted themselves into a corner and have been forced by reality and their own willful blindness into admitting the truth about this experimental technology. (A <a href="http://www.ncbi.nlm.nih.gov/sites/entrez">PubMed</a> search on "Bates DW" is not generally revealing of papers on health IT risks until relatively recently.) <blockquote>"The key thing is to devote enough resources and attention to fixing them [errors] after they happen. Your EHR may prevent 10 errors for every new one it causes [not sure where these figures come from or if they're generalizable at all - ed.], but you have to have an approach for dealing with the new ones."</blockquote> Again, I would differ. The key thing is to prevent them from happening as much as possible. The pharma and medical device industries do this through RCT's, post market studies, and strong regulatory requirements for their products' manufacture and use. Bates is not an advocate of regulation of health IT. As in my post "<a href="http://hcrenewal.blogspot.com/2009/07/health-care-information-technology.html">JAMA letter: Health Care Information Technology, Hospital Responsibilities, and Joint Commission Standards"</a>, in 2009 Bates signed on to an unpublished letter to JAMA (archived <a href="http://www.evernote.com/pub/poikonen/PublicPharmacoinformatics#n=582cbf46-d342-46bc-a39e-3d57e3a31388">here</a>) in response to Koppel and Kreda's article on "hold harmless" clauses that stated "... the belief that the best approach to increase the safety and effectiveness of EHR systems is by legal regulation of system vendors is misplaced." (Incidentally, the letter that JAMA did publish was <a href="http://jama.ama-assn.org/cgi/content/extract/302/4/382">mine</a>.) <div></div> <blockquote>... Partners has been developing its own in-house EHR for several decades, and still encounters things that need fixing. For example, when physician order entry was introduced, the system made it possible to order fatally large doses of intravenous potassium, because the initial order choices hadn't been properly vetted by the internal team responsible. The nurses who executed the orders knew enough to catch the error before it harmed a patient, but Bates says it took a year and a half to get the screen corrected in the order entry system.</blockquote> I can add that taking a year and a half to correct a potential fatality-causing screen in a home-built clinical IT application is not just a technological issue, but also an organizational, political and leadership issue. <blockquote> ... "Emergency care is by definition nonlinear and unpredictable, and information technology tends to enforce a certain amount of linearity: you can't do step 5 until you've done steps 1 through 4," says Wears. Emergency room personnel often care for multiple patients simultaneously and have to do things "out of order" so they can be more efficient. If an EHR enforces a linear pattern, it will just get in their way, and they'll compensate by running a parallel system on paper and putting information into the EHR later. "That subverts one of the fundamental things you wanted the system to do-give you real-time feedback on good and bad ideas," Wears says.</blockquote> The realities of the ED cannot be neatly dealt with as if a calm, solitary office environment . <blockquote>There's plenty of blame to go around. Koppel and Leveson say software design, or lack of it, is a common culprit, and they take vendors to task for not focusing on usability.</blockquote> Again, there is no reasonable excuse for IT intractability in a mission critical sector. <blockquote> Leveson says part of the problem is a lack of regulatory standards. "The FDA doesn't want to oversee anything and that's a mistake," she says. "So it's become this free-for-all in the industry."</blockquote> I've used that same language. In my 2009 post <a href="http://hcrenewal.blogspot.com/2009/08/e-health-hazards-provider-liability-and.html">E-Health Hazards: Provider Liability and Electronic Health Record Systems</a> I wrote "the unregulated free-for-all that has been the health IT marketplace, with dangerous and even <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=clinical%20computing%20problems%20in%20ICU">outrageous practices</a> I noted starting a decade ago, must come to an end as the market matures and as diffusion of this technology massively increases per the government mandates now in effect." <blockquote>Though experts say EHRs clearly fall under the category of medical devices, the FDA has steered clear of directly regulating them. Its ill-starred policy of requiring pre-market approval for blood-bank software, begun back in the 1990s, resulted in major vendors pulling out of the market altogether and stifling innovation ... "That kind of regulation provides a huge economic disincentive and there hasn't been any substantial improvement in blood bank software in 10 years," says Geisinger's Walker. "If the FDA required it for EHRs, it would harm patients more than help."</blockquote> I disagree with Walker and especially disagree with the latter statement, based on one anecdotal case of IT regulation (ironically, it's HIT proponents who most often claim that 'anecdotes' of patient harm don't make data). Further, the FDA was called in initially because of IT dangers in existing blood banking software. Also, the "innovation" referred to could more accurately be referred to as "lifecycle adaptation and enhancement", not true innovation. In other words, there was not enough profit to be made in maintaining mature software under regulation. The effect might be to push the quick-buck profiteers out of the industry, and thus improve quality and innovation. The Swedish Medical Products Agency is leading the way for consideration of HIT in the EU as a medical device to be regulated as in my post "<a href="http://hcrenewal.blogspot.com/2009/06/improving-patient-safety-in-eu-hit.html">Improving Patient Safety In The EU: HIT Should Be Classified As Medical Devices</a>". Yet, that didn't seem to impact Swedish innovation; in the UK, Wrightington, Wigan and Leigh NHS Foundation Trust has recently awarded its hospital information system contract to Swedish healthcare systems provider, Cambio (<a href="http://www.e-health-insider.com/news/6214/cambio_for_wrightington_wigan_and_leigh">link</a>). Albeit in another anecdote, FDA's regulation did not harm pharma IT as far as I could tell, while a Group Director in Merck Research Labs' Research Information Systems Division. Truth is, there is no good data one way or the other regarding regulation, but after thirty or more years of an unfettered HIT industry, I believe it reasonable to say that the presence of harmful HIT speaks more for regulation than for a continued industry "free-for-all." <blockquote>The Agency for Healthcare Research and Quality is currently working with the FDA, VA and other federal agencies to develop a common format for reporting I.T.-related patient safety events and unsafe conditions. </blockquote> "What took so long" is my question. Read the whole article. The myth of health IT beneficence continues to be eroded. One can only hope the tens of billions earmarked for the technology in the recent economic "recovery" legislation will become similarly eroded in years to come, to allow the technology to be safely improved - that is, in vitro, not in vivo. -- SS

Health IT: "Danger"

In an article simply entitled "Danger", Health Data Management author Elizabeth Gardner spells out some "inconvenient truths...

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The Ultimate Workaround To Mission Hostile Health IT: Humans (a.k.a. "Scribes")

<div style="text-align: center;">"Gentlemen, we can rebuild him. We have the technology. We have the capability to build the world's first bionic doctor. Dr. Data will be that doctor; <s style="font-style: italic;">better</s> worse than he was before. <s style="font-style: italic;">Better, stronger, faster</s> Worse, weaker, slower." -- parody of Oscar Goldman from the 1970's scifi series <a href="http://www.youtube.com/watch?v=HofoK_QQxGc">The Six Million Dollar Man</a>. </div><div style="text-align: center;"> <a onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}" href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgqzasoTiRKrqW917SPMiqTdjbdN5HIlHCXgUfbNIfBWTD4XeQkZfy9lf5N9Xco8sPERtjLya5T8uhctdg9j4zFlVjiuCkMzFzon9ihChnpVyKp66kif_i3xYmzW8DByUScF3aAEaJy6w61/s1600/sixmillion.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5513937992318855618" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgqzasoTiRKrqW917SPMiqTdjbdN5HIlHCXgUfbNIfBWTD4XeQkZfy9lf5N9Xco8sPERtjLya5T8uhctdg9j4zFlVjiuCkMzFzon9ihChnpVyKp66kif_i3xYmzW8DByUScF3aAEaJy6w61/s320/sixmillion.jpg" style="display: block; margin: 0px auto 10px; text-align: center; cursor: pointer; width: 187px; height: 121px;" /></a>"Gentlemen, we can rebuild him." </div><div style="text-align: center;"> <div style="text-align: left;">The EMR is a technology that was supposed to improve clinical medicine (revolutionize it, some say). It was supposed to facilitate clinical medicine. It was not supposed to slow physicians and others down to the point of impairing their ability to practice medicine. However, the rosy predictions are not proving to be the case. Instead, we have the ultimate workaround to the health IT <a href="http://www.tinyurl.com/hostileuserexper">mission hostile user experience</a>: <blockquote>Los Angeles Times September 6, 2010 <div class="byline"> Harris Meyer <a style="font-weight: bold;" href="http://www.latimes.com/health/la-he-medical-scribes-20100906,0,2694959.story">Scribes are doctors' tech support</a> Melissa Genove has dreamed of becoming a physician since childhood. To help her prepare, she spends as many as 35 hours each week shadowing emergency room doctors at Loma Linda University Medical Center. The 23-year-old listens intently as they examine patients, records their treatment plans in a laptop computer, and follows up on prescriptions, lab tests, consultations with specialists and anything else the doctors order. Genove is not an intern, or even a medical student. She is the chief medical scribe in the hospital's emergency department — and one of several thousand young people pioneering a new healthcare field. Scribes are filling a necessary niche as doctors make the wrenching transition from old-fashioned paper charts to 21st century electronic medical records. The computerized system is supposed to make doctors more efficient and ensure better care for patients. Congress has such faith in the value of electronic medical records that it provided as much as $27 billion over 10 years to encourage doctors to use them, and the Centers for <a class="taxInlineTagLink" id="HEPRG00002" title="Medicare" href="http://www.latimes.com/topic/health/government-health-care/medicare-HEPRG00002.topic">Medicare</a> and Medicaid Services will penalize those who don't by cutting their reimbursement rates as much as 5%. But while the conversion is underway, doctors estimate that their productivity plummets by about 30% as they learn to cope with a complicated new system. [And what clinical IT in 2010 isn't complicated, I ask? - ed.] That's where scribes come in.</div></blockquote><div class="byline"> </div> This brings real meaning to the observation that "you should not have to work around something that is not in the way." <div style="text-align: center;"><a onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}" href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhuU_k88RnHpQsZuxQqubBBxqzCSNIcPnx0vkTOwPc2fQZxA4JcqMshHV21HrzV-cTje_k_iXnqkA02yE6mz7d2M8_kEremGFdfSsMI17KQ5JIGnJMd6FrVyDWXlLDdUHRzVI-DTq72Aeen/s1600/labyrinth.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5514150356466381106" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhuU_k88RnHpQsZuxQqubBBxqzCSNIcPnx0vkTOwPc2fQZxA4JcqMshHV21HrzV-cTje_k_iXnqkA02yE6mz7d2M8_kEremGFdfSsMI17KQ5JIGnJMd6FrVyDWXlLDdUHRzVI-DTq72Aeen/s320/labyrinth.jpg" style="display: block; margin: 0px auto 10px; text-align: center; cursor: pointer; width: 320px; height: 237px;" /></a>Just one screen from a Cerner product (from a presentation touting recent addition of a simple database "<a href="http://www.screencast.com/users/kkoche1/folders/Jing/media/5d3aa28f-2312-4a40-8e0d-47c15dcaee90">search</a>" feature that should/could have been present eons ago). Each menu item leads to even more screens, subscreens, menus and pick lists, in labyrinthine fashion. Click to enlarge. </div> In a domain as complex as medicine, ever-increasing demands for fine grained data on clinical encounters now outstrip the 2010-style human-computer interface's abilities to allow capture of the data without massive interference in the process of medicine itself. This mismatch is due largely to the limitations of the GUI as the primary user interface (UI) metaphor, especially the widget-centric UI currently in vogue, characterized by massive numbers of screens and <a href="http://en.wikipedia.org/wiki/GUI_widget">GUI widgets</a>, labyrinthine navigation, and forced data entry of artificially and needlessly "atomized" data through interaction with multiple widgets. CPOE as an example has become a <a href="http://en.wikipedia.org/wiki/Rube_Goldberg_machine">Rube Goldberg</a> contraption (def: "deliberately over-engineered machine that performs a very simple task in a very complex fashion"), the furthest thing from a straightforward "typewriter for orders" as can be. For instance, a simple order requires interaction with search boxes, multiple drop down lists, scroll bars, check boxes, and other widgets to capture each micro-component of the order, wasting much time compared to writing "Sotalol hydrochloride 120 mg PO BID, first dose now." There are alternatives to "data atomization" and "widget-centricity" in the health IT user interface, apart from simply cleaning up the current interaction disorganization and other weaknesses, but the health IT industry seems largely oblivious to alternatives. <div style="text-align: center;"><a onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}" href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh21K_FklxQqTMcml0C6D5UHN3L7VF4tMXNK6_X6XNKFF0BSXZG3ClJ_iM5IDHpuWCnJgFW_rnArDAlIoBui_M_utv0-WOQXQM7rNzuKpRkbNAj3mmSoIMRhE2jd0SpRFXvkgB15CQOyl1N/s1600/Rubenvent.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5514195533630289058" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh21K_FklxQqTMcml0C6D5UHN3L7VF4tMXNK6_X6XNKFF0BSXZG3ClJ_iM5IDHpuWCnJgFW_rnArDAlIoBui_M_utv0-WOQXQM7rNzuKpRkbNAj3mmSoIMRhE2jd0SpRFXvkgB15CQOyl1N/s320/Rubenvent.jpg" style="display: block; margin: 0px auto 10px; text-align: center; cursor: pointer; width: 320px; height: 129px;" /></a>Professor Butts and the Self-Operating Napkin: EMR's have become machines that perform simple tasks in a very complex fashion </div> Unfortunately, it's difficult to show this complexity using actual EMR images, as most health IT vendors avoid posting screen images and user manuals online, and forbid customers from doing so. They are excessively secretive about their products. Try a Google image search on 'Cerner Millenium' as an example (click <a href="http://www.google.com/images?hl=en&client=firefox-a&hs=FKy&rls=org.mozilla:en-US:official&channel=s&q=cerner%20millenium&um=1&ie=UTF-8&source=og&sa=N&tab=wi&biw=1680&bih=861">here</a>), then compare to an image search on, say, Microsoft Word (click <a href="http://www.google.com/images?um=1&hl=en&client=firefox-a&hs=q3I&rls=org.mozilla%3Aen-US%3Aofficial&channel=s&biw=1680&bih=861&tbs=isch%3A1&sa=1&q=microsoft+word&aq=f&aqi=g10&aql=&oq=&gs_rfai=">here</a>). The inappropriate-for-medicine, management information systems (MIS)-derived business model of the healthcare IT vendors and <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=ecosystem">HIT ecosystem</a> also contributes to the, at best, stuck-in-the-1980's health IT user interface. (As an example of these issues, the industry wouldn't even listen to aforementioned UI alternatives even if I served them up on a silver platter, because using the advice would require significant investments on their part to incorporate alternative UI approaches into their products, meaning lower short and medium term profits. Unlike pharma and tangible medical devices, interest in advanced R&D in the health IT industry seems nil. Instead, complacency rules.) An important question to ponder is whether the dream of the health IT pioneers back in the 1950's and 1960's was too idealistic and indeed unrealistic to begin with. Was it based on "2001, A Space Odyssey"-style overoptimism, and the lack of foreknowledge of how little true progress would be made in the commercial IT market in human computer interaction, artificial intelligence, natural language processing, voice recognition, and other innovations by the 21st century? <blockquote>Doctors have embraced the scribes as well. "The physicians were spending too much time documenting and not enough time with the patient," said Dr. Robert Steele, chief of Loma Linda's emergency department, which began using scribes in November. "The solution was to take the doctors off the computer, put them at the bedside, and let the scribe do the transcription. It's been a huge success. The physicians love it.</blockquote> It is not hard to understand why physicians, with their years of training and expertise, would welcome relief from extremely tedious clerical tasks. <blockquote>Leaders of the three biggest companies providing scribes estimate that about 200 emergency departments in community hospitals and academic medical centers currently use them. More scribes are on the way. Ronald Reagan UCLA Medical Center, Emory University Hospital in Atlanta and Beth Israel Medical Center in New York City said they are exploring the idea. Physicians in other specialties, including urology and family practice, also are starting to adopt scribes. Still, some physicians question whether college students are equipped to handle the complicated task of charting patients after only two to four months of training. Others wonder why it's necessary to hire additional staff to fill out computerized records that were supposed to be simpler and more efficient than paper.</blockquote> The key phrase is "were supposed to be simpler and more efficient" than paper. I'd likely be hard-pressed to find robust research supporting that assertion in the scientific literature. I'd be more likely find the origins of this meme in vendor marketing materials. <blockquote> "It will be interesting to watch whether the need for scribes goes away as the next generation of physicians who grew up with computers and electronic medical records comes in," said Dr. Ann O'Malley, a senior researcher at the Center for Studying Health System Change in Washington, D.C.</blockquote> This passage implies the bottleneck is those physicians who need to "get used to the IT", whereas a major component of the problem is the health IT user interface itself. Scribes might "go away" if the health IT user experience was vastly improved. The IT needs to become more physician and medicine-friendly. <blockquote> At Loma Linda [Hospital], Steele said doctors used to spend two minutes with a patient, then take four minutes typing the information into a computer. Now the doctor talks to the patient with the scribe present and summarizes the encounter to the scribe in 30 seconds. While the scribe spends three minutes entering the information into an ever-present laptop, the doctor can spend extra time with the patient. Afterward, the doctor checks the accuracy of the scribe's chart, makes any necessary additions or corrections, and signs off. Although novice scribes sometimes need the doctor's help in understanding terminology, those with several months' experience usually are spot-on, Steele said. </blockquote> Again, clerical work is a very poor use of a physician's time. Scribes are a good idea considering 2010's EMR technology, at least from the time/skills perspective. <blockquote>... [Dr. Michael] Murphy of ScribeAmerica estimates that doctors can see eight additional patients over a 10-hour shift, hiking Medicare revenues alone by $91 an hour. The companies that develop and sell electronic medical records systems are "in total denial" about how complicated they are for doctors to use, [Dr. David] Strumpf said. "They know these systems need scribes," he said. "They work with us to train our scribes on their systems, but they don't want to be public about it."</blockquote> (One wonders how much in "denial" the companies are and just who is truly in denial; after all, purchase of these systems just became a governmental priority.) Here, of course, is the major drawback to scribes: money. Scribes "typically cost $20 to $26 an hour" today, and that number is likely to rise. While the article's contributors maintain that physicians can boost their revenues by "$50 to $60 an hour" using scribes, I wonder if the overall economic impact of the generalized use of tens or hundreds of thousands of EMR scribes would be in the "wrong" direction (i.e., from the payor and government perspective). The billions spent on EMR's were supposed to reduce the costs of healthcare, not increase the expenses associated with it. I also wonder what could happen when a scribe is not available. <blockquote>At the University of Virginia Medical Center in Charlottesville, Va., emergency room physicians can complete electronic charts just as fast as scribes, most of whom are pre-med students at UVA. But doctors would rebel if the scribes disappeared, said Dr. Robert Reiser, medical director of the scribe program, which the university runs itself. </blockquote> Sept. 10 Addendum: See an interesting financial analysis by Doug Perednia <a href="http://www.kevinmd.com/blog/2010/11/scribes-lead-unintended-consequences-electronic-medical-records.html">here</a>. -- SS </div></div>

The Ultimate Workaround To Mission Hostile Health IT: Humans (a.k.a. "Scribes")

"Gentlemen, we can rebuild him. We have the technology. We have the capability to build the world's first bionic doctor. Dr. Data w...

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At the End of Summer, Everybody, Well, Nearly Everybody (Allergan, CVS Caremark, Stryker, WellStar) Settles

Many US health care organizations announced legal settlements as the dog days of summer drew to a close.  The hit parade included, in order of dollar amount: Stryker Corp As reported <a href="http://www.bloomberg.com/news/2010-08-26/stryker-to-pay-1-35-million-to-settle-massachusetts-marketing-claims.html">by Bloomberg News</a>: <blockquote>Sryker Corp., a maker of artificial hips and knees, will pay $1.35 million to settle claims it marketed items without regulatory approval and misled health care providers about the use of its products, the Massachusetts attorney general said. Stryker’s biotech unit engaged in unfair and deceptive trade practices that boosted sales of products used to strengthen and promote growth of bones, Massachusetts said in a filing in state court in Boston. 'Stryker Biotech subverted review procedures designed to safeguard patients and promoted uses of its products that were not shown to be safe or effective,' Martha Coakley, the attorney general, said today in a statement. </blockquote> Note that this appeared to be one of those rare cases in which allegations were made against individuals, as well as the company as a whole: <blockquote>In October 2009, the biotech unit and former president Mark Philip were indicted by a federal grand jury for misleading the U.S. Food and Drug Administration about the use of the products. Philip, who was president from 2004 to 2008, was accused along with three sales managers of promoting therapeutics in a manner contrary to their FDA-approved use. They pleaded not guilty, according to the case docket. </blockquote>However, the case has not yet gone to trial. As usual, the company denied anybody did anything wrong: <blockquote>As part of the Massachusetts settlement, Kalamazoo, Michigan-based Stryker didn’t admit any liability, the company said in an e-mailed statement. </blockquote> As usual, the penalties were trivial compared to the company's revenues: <blockquote>Under the agreement, Stryker will pay $325,000 in civil penalties, $875,000 to fund efforts to combat unlawful marketing and other programs to benefit health-care consumers, and $150,000 to cover attorney fees and investigative costs. The company reported 2009 revenue of $6.72 billion. </blockquote> CVS Caremark As reported very briefly by the Associated Press <a href="http://www.boston.com/business/articles/2010/08/31/cvs_settles_pricing_case_for_265m">via the Boston Globe</a>, <blockquote>CVS Caremark Corp. has agreed to pay $2.65 million under a settlement with the Massachusetts attorney general’s office, which accused the pharmacy chain of overcharging public entities for prescription drugs. CVS will pay Massachusetts and about 200 cities and towns in the state that were allegedly overcharged under the workers compensation insurance system, Attorney General Martha Coakley said yesterday in a prepared statement.</blockquote> WellStar This story was published <a href="http://www.ajc.com/health/wellstar-agrees-to-2-602802.html">in the Atlanta Journal-Constitution</a>: <blockquote>WellStar Health System has agreed to pay $2.7 million to settle allegations that it improperly billed the state Medicaid system, Attorney General Thurbert Baker announced Monday. The agreement came after a six-month state investigation which found that WellStar mishandled claims involving patients covered by both Medicare and Medicaid. WellStar filed claims that did not properly reflect payments it received from Medicare, allowing it to receive excessive payments from Medicaid.</blockquote> As expected, the hospital system denied it was anything more than a soft-ware glitch: <blockquote>The allegations related to patients served at WellStar’s five hospitals: Cobb, Douglas, Kennestone, Windy Hill and Paulding. 'Upon learning from the state of this potential billing issue, WellStar immediately conducted an internal investigation and fully cooperated with the state,' WellStar said in a statement. The hospital system said a flaw in claims processing software caused the problem. 'The State specifically found no intent to defraud,' WellStar said. WellStar admitted no wrongdoing as part of the settlement , according to the attorney general’s office. </blockquote>It is not entirely clear whether any individuals suffered any negative consequences because of this soft-ware "flaw" which went undiscovered until the state investigated. In <a href="http://www.ajc.com/news/cobb/wellstar-ceo-fired-by-606194.html">another AJC story</a>, which did not directly refer to the one above, published four days later: <blockquote>WellStar Health System’s president and CEO Gregory Simone was fired by the system’s board on Thursday. Board chairman and Marietta attorney Randall Bentley said the decision was a personnel matter and provided no information on the reason for Simone’s termination, which is effective immediately. Earlier this week Bonnie Wilson, WellStar’s executive vice president and general counsel, received notice that her contract would not be renewed. Bentley did not say if the terminations were related.</blockquote> Then, in <a href="http://www.ajc.com/news/cobb/questions-surround-wellstar-dismissals-606572.html">a third story</a>, the hospital denied any relationship among the firings and the legal settlement: <blockquote>WellStar Health System's board this week fired the Gregory Simone, president and chief executive of the non-profit operator of five north metro hospitals and dozens of other facilities. Board chairman Randall Bentley, a Marietta attorney, gave no explanation other than to say Simone's termination was a personnel matter. It was announced Thursday and was effective immediately. His firing follows the Aug. 31 departure of Bonnie Wilson, WellStar’s executive vice president and general counsel. She was told her contract would not be renewed, according to WellStar. Bentley did not say if the Simone's firing and Wilson's departure were related. WellStar and Bentley said Simone's firing was not related to a six-month Medicare and Medicaid investigation. In August, the hospital system agreed to pay $2.7 million to settle allegations that it improperly billed the state Medicaid system, resulting in excessive payments from Medicaid.</blockquote> [sarcasm on] Of course, it was just a soft-ware "flaw," so no one was responsible, just the soft-ware. [sarcasm off] Allergan As reported again <a href="http://www.bloomberg.com/news/2010-09-01/allergan-will-pay-600-million-plead-guilty-to-misdemeanor-in-botox-probe.html">by Bloomberg</a>: <blockquote>Allergan Inc., maker of the wrinkle smoother Botox, agreed to pay $600 million and plead guilty to a misdemeanor in settling a U.S. investigation of its marketing practices. Allergan will pay $375 million to the government as part of a 'misbranding' charge that the marketing of Botox from 2000 to 2005 led to use in treating headache, pain, muscle stiffness and juvenile cerebral palsy, purposes for which the Food and Drug Administration during that time hadn’t approved marketing. Allergan will also pay $225 million to resolve civil claims from the Justice Department, the company said today in a statement. </blockquote> Once again, although the amount this time appears large, it is small compared to the revenues produced by the product in question. The total fines amount to about $100 million per year of sales, but: <blockquote>Botox, [is] Allergan’s top product with $1.3 billion in annual sales,.... </blockquote> Once again, the company denied it did anything all that bad, (even though it did plead guilty to a crime), reported <a href="http://online.wsj.com/article/SB10001424052748703882304575465371767239834.html">by the Wall Street Journal</a>, <blockquote>The company, meanwhile, said the settlement resolves the investigation while avoiding substantial litigation costs and other risks associated with a government enforcement action. Allergan said its plea to the single misdemeanor 'misbranding' charge didn't involve 'false or deceptive conduct.' Specifically, the Botox marketing from 2000 to 2005 resulted in intended Botox use for four unapproved conditions, Allergan said. The drug didn't have directions for these uses, which means it was misbranded, the company said. </blockquote> Got that? On the other hand, <blockquote>Prosecutors alleged Allergan engaged in tactics to promote the drug for unapproved uses, including paying kickbacks to doctors. For example, the government charged that in 2005, Allergan hosted about 100 doctors at an invitation-only program at its corporate headquarters and a Newport Beach, Calif., resort while paying them $1,500 'to listen to off-label marketing presentations.' </blockquote> I did not see anything in any news article that suggested any individual at Allergan would suffer any negative consequences as part of this settlement. Summary So, the parade of<a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements"> legal settlements</a> marches on.  We have now documented a very large number of heretofore respectable health care organizations who have made legal settlements of all sorts of charges of wrong-doing.  As we have repeatedly noted, these settlements have certain characteristics.  The amount of money involved, although it may seem big to those paid less than CEOs, is usually much smaller than the amount of money that could be made by the bad behavior.  The settlement is usually paid by the organization as a whole, and so its effect may be diffused among the employees, the patients or clients, and the stock-holders, if any.  The settlement rarely involves any negative consequences for those who might have authorized, directed, or implemented the bad behavior.  Rarely is the settlement widely reported, and rarely does the organization involved seem to suffer any stain on its reputation. So is it any wonder that the bad behavior that leads to such settlements continues?  Is it any wonder that health care organizational leaders now just seem to think of such settlements as a (relatively negligible) cost of doing business? Inquiring minds may want to know how this state of affairs came to be.  Why are leaders of health care organizations (and other large organizations) able to behave with such relative impunity?  The answer may have to wait for more historical inquiry (although I recently saw what might be a clue, so stay tuned.)  My refrain has been: 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.

At the End of Summer, Everybody, Well, Nearly Everybody (Allergan, CVS Caremark, Stryker, WellStar) Settles

Many US health care organizations announced legal settlements as the dog days of summer drew to a close. The hit parade included, in order ...

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American Board of Medical Specialties to "incorporate tools to promote meaningful use of health IT into its maintenance-of-certification program"

From an Aug. 16 article "<a href="http://www.modernhealthcare.com/article/20100816/MAGAZINE/100819962">Industry pushes meaningful use through incentives</a>" in Modern Healthcare (signup unfortunately required): <blockquote>... Physicians will also be feeling the pressure to be IT savvy in order to maintain their professional certification. The American Board of Medical Specialties said that it would incorporate tools to promote meaningful use of health IT into its maintenance-of-certification program. More than 750,000 U.S. physicians are certified by an American Board of Medical Specialties (<a href="http://www.abms.org/">ABMS</a>) member board, “so it’s readily apparent” [really? - ed.] that building meaningful use of health IT into [Board] certification maintenance will benefit patients, ABMS President and CEO Kevin Weiss, said in a written statement. Additionally, the merging of these two tools “will help to facilitate physicians’ knowledge, skill and use of health IT, and in turn can improve physician performance and patient outcomes,” he said.</blockquote> The bolded statements of certitude from ABMS CEO Kevin Weiss follow the familiar pattern I observed such at my July 2010 post "<a href="http://hcrenewal.blogspot.com/2010/07/new-england-journal-on-meaningful-use.html">Science or Politics? The New England Journal and The 'Meaningful Use' Regulation for Electronic Health Records</a>". These are statements of certitude supported at best by scanty evidence, "estimations" and "projections", while refuted by a growing body of significant research on health IT as it exists now (such as the recent materials <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=2009">here</a>). It is unfortunate that the ABMS has now fallen away from evidence-based medicine and fallen prey to mysticism-based IT practices in medicine. I did, however, see moves like this coming. I believe the ABMS move augurs future, more forceful demands from the <a href="http://www.washingtonpost.com/wp-dyn/content/article/2009/05/15/AR2009051503667.html?hpid=topnews">healthcare IT "Trade Federation"</a> that physicians and hospitals buy and use this technology, a form of totalitarian caprice considering the evidence base. With respect to seeing this coming, here's what I wrote in my post<a href="http://hcrenewal.blogspot.com/2009/04/masochism-medicine-and-clinical-it-how.html"> </a><a href="http://hcrenewal.blogspot.com/2009/04/masochism-medicine-and-clinical-it-how.html">Masochism, Medicine and Clinical IT: How Physicians Can Be Beaten Over and Over, and Still Come Back For More</a> back in April 2009: <blockquote>... Here is a tale about the companies that medicine will be dependent upon for EHR's and other clinical IT - now by force of government (financial at first, but I would not at all rule out punitive licensure and other measures as a possibility in the future for "EHR noncompliers")... </blockquote><style title="owaParaStyle">P { MARGIN-TOP: 0px; MARGIN-BOTTOM: 0px } BODY { SCROLLBAR-ARROW-COLOR: #3f52b8; SCROLLBAR-DARKSHADOW-COLOR: #fafafa; SCROLLBAR-BASE-COLOR: #f7f7f7; SCROLLBAR-HIGHLIGHT-COLOR: #cecfce; SCROLLBAR-TRACK-COLOR: #fff</style>We're not there yet, but I would not be surprised to see moves in that direction in the future. I also consider the ABMS succumbing to IT mysticism as another sign of the degradation of efforts towards true evidence-based medicine in favor of corporate interests. Fortunately, some research organizations have not entirely bought into the irrational exuberance, although whether they can exert enough influence to reform the healthcare IT industry before billions of precious dollars are wasted on today's ill conceived systems is debatable. For example, (and in <a href="http://hcrenewal.blogspot.com/2010/08/health-it-via-observation-and-research.html">another example</a> of research done today affirming conclusions I'd reached years ago using observational skills, knowledge of Medical Informatics, internal medicine thought processes and common sense), McKinsey offers the following. Per the recent McKinsey study "<a href="http://www.mckinseyquarterly.com/Health_Care/Strategy_Analysis/Reforming_hospitals_with_IT_investment_2653">Reforming hospitals with IT Investment</a>": <blockquote>... The realization of the benefits from health care IT investments will require a radically new approach to IT on the part of the CIOs of health care providers, as well as the business leaders and clinicians those CIOs serve. Health care providers will need to use new approaches to achieve an inclusive governance process with streamlined decision-making authority, a radically simplified IT architecture, and a megaproject-management capability.</blockquote> Based on observation alone, I'd <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/scotsilv/invascard.htm">written this in 2002</a> (and probably before as well, somewhere): <blockquote>... From a dual perspective as both a clinician and computer professional, it is evident that critical clinical computing projects benefit greatly from an alternate approach to project preparation, development, implementation, customization and evaluation, as compared to management information systems (business computing) projects. Clinical and business computing appear to be different subspecialties of computing. </blockquote> Instead of naïve, unquestioning IT exuberance, the ABMS and other medical professional organizations should long ago have put their efforts behind moving the health IT vendors and their hospital customers to adopt the 'radical changes' required as in the McKinsey report (and elsewhere, such as in the 2009 <a href="http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=12572">National Research Council's report on health IT</a>). They should have done so before insisting use of the technology be a metric for qualifications to practice medicine. They should be pushing for the approval of health IT as medical devices under the <a href="http://www.fda.gov/regulatoryinformation/legislation/federalfooddrugandcosmeticactfdcact/default.htm">Federal Food, Drug, and Cosmetic Act</a> (FD&C Act), such as the EU is now moving towards; see for example the Swedish Medical Products Agency 2009 report <a href="http://www.lakemedelsverket.se/upload/foretag/medicinteknik/en/Medical-Information-Systems-Report_2009-06-18.pdf">here</a> (PDF). From that report entitled "Proposal for guidelines regarding classification of software based information systems used in health care": <blockquote> A general opinion of the health care providers represented in this Working group is that from a patient safety point of view, it is desirable that stand alone software and systems intended to, directly or indirectly, affect diagnosis, health care and treatment of an individual patient shall be regulated under a Product Safety Regulation. The Working group has not been able to define any other appropriate regulation than the Medical Device directives when it comes to the definition of such systems. ... The Working group believes that software intended for a medical purpose must be regarded as a "device" and expressions such as "project", "service" and similar must be avoided describing a Medical Information System.</blockquote> Further, ABMS should also be pushing for robust post-marketing studies of health IT. If truly representative of ensuring medical practitioners' competence in the interest of patient safety, ABMS should be discouraging specialty societies from blindly buying in to this experimental technology, and instead encouraging them to evaluate health IT critically - as critically as any new medical device or technology - including a complete examination of the literature. The ABMS should hold off on linking clerical capabilities of clinicians to board certification, per Brown University ophthalmologist <a href="http://bms.brown.edu/surgery/ophthalmology/faculty/profiles/migliori.html">Michael Migliori</a> in the above-linked Modern Healthcare story: <blockquote> “I don’t believe achieving meaningful use equates to maintenance of certification,” said Michael Migliori, an ophthalmologist in Providence, R.I. Maintenance of certification is a measurement of clinical knowledge, whereas meaningful use is a clerical designation, he said. “I understand the clinical importance of electronic medical records both in terms of patient safety and quality [although not in today's form IMO - ed.], but we are not at the point where EMR and health information exchange are ready for universal implementation,” Migliori said. “They should not be linked at this time.”</blockquote> In other words, today's health IT is not ready for national roll out, especially with any form of coercion in effect. Here's a major problem in slowing this train. The following chart appeared in the aforementioned McKinsey report on "startup costs" of EMR systems. The figures are presented in the form of dollars per bed: <a onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}" href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhivTP3gNOa-siHY7pXij5OOG-H0-4xs27PnRv26Rctf2LDMG1zAtCgVlo1VCILmcQONUpIyiNCpfDiwDMaPHu6NtyGr6WFpqn_WQBEeJigKPLKPAYTylip4vD0nauv4VJgAFUQHANEaTOH/s1600/mckinsey.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5511958181866088706" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhivTP3gNOa-siHY7pXij5OOG-H0-4xs27PnRv26Rctf2LDMG1zAtCgVlo1VCILmcQONUpIyiNCpfDiwDMaPHu6NtyGr6WFpqn_WQBEeJigKPLKPAYTylip4vD0nauv4VJgAFUQHANEaTOH/s320/mckinsey.jpg" style="display: block; margin: 0px auto 10px; text-align: center; cursor: pointer; width: 396px; height: 227px;" /></a> <div style="text-align: center;">McKinsey on EMR startup costs, estimated at $80,000-$100,000 per bed - click to enlarge. </div><style title="owaParaStyle">P { MARGIN-TOP: 0px; MARGIN-BOTTOM: 0px } BODY { SCROLLBAR-ARROW-COLOR: #3f52b8; SCROLLBAR-DARKSHADOW-COLOR: #fafafa; SCROLLBAR-BASE-COLOR: #f7f7f7; SCROLLBAR-HIGHLIGHT-COLOR: #cecfce; SCROLLBAR-TRACK-COLOR: #ff</style> With these levels of money moving like an overflowing fountain of champagne to the IT industry, with likely tributaries into medicine's regulatory, representation and accreditation organizations, no research seems likely to bring the radical changes needed to ensure this technology is safe and effective. (The McKinsey report also opines that well-done EMR's can recoup the gap between costs and government financial incentives shown in the chart within a few years; that is also highly debatable, even if the HIT is "done well" via radical reform.) I have no answers to these problems other than the many suggestions I've written on these blog pages since 2004, and on my <a href="http://www.tinyurl.com/hitfailurecases">academic site</a> on HIT since 1999. Without those in power willing to consider that health IT today is yet another bubble or mania, then like some diseases, it may only be tincture of time that corrects these problems. That is, when the current Jurassic <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=ecosystem">health IT ecosystem</a> collapses of its own dead weight. What's sad are the expensive IT fossils -- and bodies -- that will be left behind for some future archeologist to discover. -- SS Addendum Sept. 5: EMR use as condition of licensure appears to be heading for reality in at least one state: Massachusetts. See <a href="http://healthblawg.typepad.com/healthblawg/2010/05/hit-incentives-in-massachusetts-less-carrot-more-stick.html">http://healthblawg.typepad.com/healthblawg/2010/05/hit-incentives-in-massachusetts-less-carrot-more-stick.html</a> Hat tip to Al Borges, MD. See his comment in the comments section.

American Board of Medical Specialties to "incorporate tools to promote meaningful use of health IT into its maintenance-of-certification program"

From an Aug. 16 article " Industry pushes meaningful use through incentives " in Modern Healthcare (signup unfortunately required)...

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