healthy4u: David Blumenthal

On EHR's: See No Evil, Hear No Evil, Speak No Evil: Part 2

Part 1 is <a href="http://hcrenewal.blogspot.com/2013/03/on-ehrs-see-no-evil-hear-no-evil-speak.html" target="_blank">here</a>. This is the second a series of posts I plan on the issue of "See No Evil, Hear No Evil, Speak No Evil" regarding EHR's. Frequent reminders are needed by all stakeholders, I believe, to think critically about, and take with a big grain of salt, effusive praise by key opinion leaders, politicians, etc. about health IT, and accompanying attempts to deride those critical of the technology, to counterbalance ongoing HIT hyperenthusiasm. The following quote comes from a May 2010 post "<a href="http://hcrenewal.blogspot.com/2010/05/david-blumenthal-on-health-it-safety.html" target="_blank">David Blumenthal on health IT safety: nothing to see here, move along</a>": Blumenthal, at the time Director of ONC at HHS had reportedly stated that: <blockquote><a href="http://www.massdevice.com/news/blumenthal-evidence-adverse-events-with-emrs-anecdotal-and-fragmented">http://www.massdevice.com/news/blumenthal-evidence-adverse-events-with-emrs-anecdotal-and-fragmented</a> ... [Blumenthal's] department is confident that its mission remains unchanged in trying to push all healthcare establishments to adopt EMRs as a standard practice. "The [ONC] committee [investigating FDA reports of HIT endangement] said that nothing it had found would give them any pause that a policy of introducing EMR's [rapidly and on a national scale - ed.] could impede patient safety," he said.</blockquote> The "nothing" includes 44 injuries voluntarily reported to FDA and 6 reported deaths in an enviroment where few know where to report such things and where no reporting requirements exist, and a statement from the head of <a href="http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/default.htm" target="_blank">CDRH</a> at FDA that due to systematic impediments to accurate knowledge the known figures likely are a small fraction ("tip if the iceberg") of the actual occurrence. The FDA internal memo on HIT risk brought to the forefront by investigative reporter Fred Schulte and <a href="http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html" target="_blank">downloadable here</a> spells out the FDA impediments in some detail.  It is not reasonable to believe the head of ONC and an entire ONC committee would have been entirely unaware of the issues.  (Later studies are even more concerning, e.g., by IOM and ECRI, as at this blog.) Yet an ONC committee under his leadership recommended "full steam ahead" anyway. In the corporate world that is known as <a href="http://legal-dictionary.thefreedictionary.com/gross+Negligence" target="_blank">gross negligence</a>: <blockquote class="tr_bq"> Gross negligence is a conscious and voluntary disregard of the need to use reasonable care, which is likely to cause foreseeable grave injury or harm to persons, property, or both. It is conduct that is extreme when compared with ordinary <a href="http://legal-dictionary.thefreedictionary.com/Negligence">Negligence</a>, which is a mere failure to exercise reasonable care.</blockquote> There is nothing to discuss, nothing to debate about that. <table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjbHE2UNfxaELR3Yk4qQCUvMAOu4J5axEZ67udtvYVvnEu4Vcu_fXZd0Q_YkkCBFoIlqTOz5y6kt1vzC7rs70R_6UAtHl3rCPmjxlsZtYX1kkZrPmEdxnlwe4uLE7celn0yQKHvK0x06tAT/s1600/SEM-article_html_d8fed9d.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="232" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjbHE2UNfxaELR3Yk4qQCUvMAOu4J5axEZ67udtvYVvnEu4Vcu_fXZd0Q_YkkCBFoIlqTOz5y6kt1vzC7rs70R_6UAtHl3rCPmjxlsZtYX1kkZrPmEdxnlwe4uLE7celn0yQKHvK0x06tAT/s320/SEM-article_html_d8fed9d.jpg" width="320" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">Claims about HIT beneficence this need to be taken with a big grain of this.</td></tr></tbody></table> The ongoing "what? me worry?" attitude of the pundits needs to be counterbalanced.  This series is a small effort (the industry has a lot more control of the channel than I) to catalog the words and call out the pundits in a readily-found format. More to come in this series. -- SS

On EHR's: See No Evil, Hear No Evil, Speak No Evil: Part 2

Part 1 is here . This is the second a series of posts I plan on the issue of "See No Evil, Hear No Evil, Speak No Evil" regarding...

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Kaiser Health News/Philadelphia Inquirer on InformaticsMD: "The flaws of electronic records"

At my Dec. 2012 post "<a href="http://hcrenewal.blogspot.com/2012/12/upcoming-profile-of-informaticsmd-in.html" target="_blank">How an interview for Kaiser Health News rekindled memories of health IT dysfunction in the 90's that persist in the 10's</a>" I mentioned an interview by a reporter from the Kaiser Health Foundation regarding health IT flaws. His article appeared in both the <a href="http://www.philly.com/philly/entertainment/20130218_The_flaws_of_electronic_records.html" target="_blank">Philadelphia Inquirer</a> and <a href="http://www.kaiserhealthnews.org/Stories/2013/February/18/Scot-Silverstein-health-information-technology.aspx" target="_blank">Kaiser Health News</a> today under the title "The flaws of electronic records": <blockquote class="tr_bq">Philadelphia Inquirer / Kaiser Health News Feb. 18, 2013 <h5 class="byline">Jay Hancock, KAISER HEALTH NEWS</h5><a href="http://www.philly.com/philly/entertainment/20130218_The_flaws_of_electronic_records.html" target="_blank">The flaws of electronic records</a> Drexel University's Scot Silverstein is a leading critic of the rapid switch to computerized medical charts, saying the notion that they prevent more mistakes than they cause is not proven.   <div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEi_8NHZXfqJrMOagNsDryhPIBfqkCL6Fpg0AV_7cXGpvSysrGf5LNS4vuXZ7bHr0FvlxiN9_8QDMVh7JtYnhDxeQ9XkUACF_VE4yC5XetVqe3I7aWif1W7wxpor32l3xF1SPfZxrg-mSG9S/s1600/silverstein_fixing_computer.JPG" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="205" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEi_8NHZXfqJrMOagNsDryhPIBfqkCL6Fpg0AV_7cXGpvSysrGf5LNS4vuXZ7bHr0FvlxiN9_8QDMVh7JtYnhDxeQ9XkUACF_VE4yC5XetVqe3I7aWif1W7wxpor32l3xF1SPfZxrg-mSG9S/s1600/silverstein_fixing_computer.JPG" width="320" /></a></div> Scot Silverstein of Lansdale, one of the most ardent critics of electronic medical records, works on an antique computer. A growing collection of evidence suggests poorly designed medical software can obscure clinical data, generate incorrect treatment orders, and cause other problems. <div class="photo_area" style="width: 600px;"><div class="photocaption"> RON TARVER /Staff Photogapher </div></div> Jay Hancock, KAISER HEALTH NEWS Posted: Monday, February 18, 2013, 3:01 AM Computer mistakes like the one that produced incorrect prescriptions for thousands of Rhode Island patients are probably far more common and dangerous than proponents of electronic medical records believe, says Drexel University's Scot Silverstein. Flawed software at Lifespan hospital group printed orders for low-dose, short-acting pills when patients should have been taking stronger, time-release ones, the Providence-based system disclosed in 2011. Lifespan says nobody was harmed. But Silverstein, a physician and adjunct professor of health-care informatics who is making a name for himself as a strident critic of electronic health records, says the Lifespan breakdown is part of a much larger problem. "We're in the midst of a mania right now" as traditional patient charts are switched to computers, he said in an interview in his Lansdale home. "We know it causes harm, and we don't even know the level of magnitude. That statement alone should be the basis for the greatest of caution and slowing down."</blockquote> In an ethical world, it would be.  Medicine, though, is in the throes of a loss of ethics, as many stories at this site and many others attest to. <blockquote class="tr_bq">Use of electronic medical records is speeding up, thanks to $10 billion and counting in bounties the federal government is paying to caregivers who adopt them. The consensus among government officials and researchers is that computers will cut mistakes and promote efficiency. So 4,000 hospitals have installed or are installing digital records, the Department of Health and Human Services said last month. Seventy percent of doctors surveyed in September by research firm CapSite said they had switched to digital data. But the notion that electronic charts prevent more mistakes than they cause just isn't proven, Silverstein says. Government doesn't require caregivers to report problems, he points out, so many computer-induced mistakes may never surface.</blockquote> The recent ECRI "deep dive" study of "EHR events" (<a href="http://hcrenewal.blogspot.com/2013/02/ecri-institute-pso-uncovers-health.html" target="_blank">link</a>) is just the latest to raise red flags on that point. Even Dr. David Blumenthal, former chair of the Office of the National Health IT Coordinator (ONC) in HHS seems to have <a href="http://hcrenewal.blogspot.com/2010/05/david-blumenthal-on-health-it-safety.html" target="_blank">changed his message</a> about reporting of medical problems. From a Feb. 16, 2013 New York Times article "<a href="http://www.nytimes.com/2013/02/17/sunday-review/the-hip-replacement-case-shows-why-doctors-often-remain-silent.html?_r=0" target="_blank">Doctors Who Don’t Speak Out</a>": <blockquote class="tr_bq">....  TRADITIONALLY, doctors have brought problems to the attention of colleagues by conducting research and publishing their findings in a medical journal. The advantage of that system helps ensure the credibility of study data and protects a researcher from random attack, said Dr. David Blumenthal, the president of the Commonwealth Fund, a group that studies health policy issues. But getting a study published can take a year or two; some Johnson & Johnson consultants did publish studies about the hip’s flaws, but they largely appeared after it had been recalled. Dr. Blumenthal said there was probably a need for more immediate ways for doctors to share their concerns, like forums supported by professional medical organizations. </blockquote> Back to the Inquirer article: <blockquote class="tr_bq">He doesn't discount the potential of digital records to eliminate duplicate scans and alert doctors to drug interactions and unsuspected dangers. But the rush to implementation has produced badly designed products that may be more likely to confound doctors than enlighten them, he says. Electronic health records, Silverstein believes, should be rigorously tested under government supervision before being used in life-and-death situations, much like medical hardware or airplanes.</blockquote> In fact, arguments otherwise are specious.  "Harm to innovation" is the one I've heard most often.  Yet, those proffering such claims cannot point out what aspect of regulation - adherence to GMP's (good manufacturing processes), pre-market safety and quality testing, post-market surveillance, etc. - will "harm innovation."  Indeed, they opine as if innovation in medicine without objective safety and quality checks is a virtue, rather than a potential vice. <blockquote class="tr_bq">Silverstein "is an essential critic of the field," said physician George Lundberg, editor at large for MedPage Today and former editor of the Journal of the American Medical Association. "It's too easy for those of us in medicine to get excessively enthusiastic about things that look like they're going to work out really well. Sometimes we go too far and don't see the downside of things."</blockquote> (Dr. Lundberg mentioned me in Nov. 2011 at MedPage today in a piece entitled "Health IT: Garbage In, Garbage Out" as <a href="http://hcrenewal.blogspot.com/2011/11/george-lundberg-promise-of-health-it.html" target="_blank">here</a>.) The patients - including ourselves and our own family members, I might add - are the ones who pay the price of our hyper-enthusiasm. <blockquote class="tr_bq">... The FDA's Jeffrey Shuren, a neurologist, has said such cases "likely reflect a small percentage of the actual events that do occur."</blockquote> "Tip of the iceberg" were his exact words (<a href="http://hcrenewal.blogspot.com/2010/02/fda-on-health-it-adverse-consequences.html" target="_blank">link</a>). <blockquote class="tr_bq">... At conferences and working from home on the "Health Care Renewal" blog, Silverstein chronicles digital failures and criticizes hospitals in the same dogged way he applied himself to building the 1970s-era Heathkit computers [and amateur radio equipment - ed.] he still keeps in his home, say people who know him. "His message has been consistent": Health IT "provides far less benefit than is claimed by its proponents and opens new, sometimes potent, routes to failure," said Richard I. Cook, a medical error expert at the University of Chicago who sat on a panel examining electronic record safety at the authoritative Institute of Medicine. "No one wants him to be visible. But his message and tone have not wavered."</blockquote> Dr. Cook wrote the lone dissent to milquetoast IOM recommendations on health IT risk - the magnitude of which IOM itself admitted is unknown - in their 2012 report "Health IT and Patient Safety: Building Safer Systems for Better Care" available <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/Patient%20Safety%20and%20Health%20IT%20prepub.pdf" target="_blank">here</a>.  See Appendix E. The last scientific conference at which I chronicled these failures was at the Health Informatics Society of Australia's HIC2012, as a keynote speaker on health IT trust (<a href="http://hcrenewal.blogspot.com/2012/08/my-presentation-to-health-informatics.html" target="_blank">link</a>).  I would have been at HIC2011, to which I had been originally invited, but was helping care for a relative injured by bad health IT at that time.  Her death freed me to travel Down Under in 2012. I have presented at a number of plaintiff attorney's meetings since then, however, such as the American Association for Justice Winter Convention (AAJ, formerly the Trial Lawyer's Association) just last week (<a href="http://www.justicewinterconvention.org/" target="_blank">link</a>).  Trial lawyers don't seem to mind a very direct approach to the issues, unlike many so-called scientists who, as author Michael Crichton once warned (<a href="http://www.goodreads.com/quotes/344539-i-want-to-pause-here-and-talk-about-this-notion" target="_blank">link</a>), seem to believe in "consensus" rather than science. <blockquote class="tr_bq"> The HIMSS Electronic Health Record Association, an industry group, declined to comment on Silverstein. A spokesman for the Office of the National Coordinator for Health Information Technology, the administration's proponent of digital records, said: "It's important to listen to all the voices" in the discussion of the subject.  </blockquote> Some voices, unfortunately, are louder than others and backed by lobbyists and big money.  See, for instance, the May 2009 Washington Post article by Robert O'Harrow Jr. "The Machinery Behind Health-Care Reform: How an Industry Lobby Scored a Swift, Unexpected Victory by Channeling Billions to Electronic Records" (link to the article and my essay about it is <a href="http://hcrenewal.blogspot.com/2009/05/machinery-behind-healthcare-reform-how.html" target="_blank">here</a>). I do point out, however, for the benefit of those at HIMSS and ONC, that knowing of risks, while doing nothing substantive while "listening to all voices in the discussion" can be seen as gross negligence. <blockquote class="tr_bq">Trained as an internist and in medical information technology [Medical Informatics- ed.] as a Yale University postdoc, Silverstein, 55, served as Merck & Co.'s director of scientific information in the early 2000s and then as a full-time Drexel professor, shifting in recent years to part-time teaching and working on medical liability cases for plaintiff attorneys. His insistent warnings about digital health risks over more than a decade have effectively barred him from a lucrative career at a hospital or software vendor.</blockquote> Perverse as that reality may be, it's also the reverse:  I would not want to work for a hospital or software vendor in 2013, where effecting change to protect patients from bad health IT is hard if not impossible, e.g., as at <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=lawsuit" target="_blank">link</a>, <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=clinical%20computing%20problems%20in%20ICU" target="_blank">link</a>, and <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=Cardiology%20story" target="_blank">link</a>, and at the other case examples at that site.  I find it a far more effective use of my time to help enact change from the outside - and avoiding the pathological individuals who make such scenarios possible. <blockquote class="tr_bq">"I'm sure Scot would be better off by keeping his mouth shut and getting a job with a hospital that's just put in a big . . . system," said Matthew Holt, a Silverstein critic and cochairman of Health 2.0, which organizes health technology conferences.</blockquote> I note that the raison d'être for this blog is the impact of many people doing just that sort of thing - "keeping their mouth shut" and making money, no matter what the ethical implications.  (The patients killed by such behaviors are, unfortunately, unavailable for comment.) <blockquote class="tr_bq"> Many say he comes on too strong. Even admirers cringed when he began blogging about the 2011 death of his mother, which he blames in a lawsuit on a computer error that allegedly caused Abington Memorial Hospital to overlook a key medication. (Both he and the hospital said they couldn't comment on a pending suit.) Personalizing his campaign, some thought, made him seem less objective.</blockquote> I'm at a loss here.  "Too strong" - on matters of life and death that affect everyone?  A proficient writer, who had been writing about health IT problems since 1998, should have kept silent about a first hand story of HIT harm in 2010 of potential great relevance towards public safety?  Writing about the incident 'lessens objectivity'?  That makes little sense, and is perverse.  Those who opined as such have their priorities in serious disarray. Such personalized accounts are common and have caused great change.  <a href="http://en.wikipedia.org/wiki/Libby_Zion_law" target="_blank">Libby Zion's death</a> due to hospital neglect, and her father's making the issues quite public, comes to mind, as do the many laws enacted that are named after people who've gone public after personal tragedy: <blockquote class="tr_bq">... Grieving the loss of their child, Zion's parents became convinced that their daughter's death was due to inadequate staffing at the teaching hospital.  Sidney Zion questioned the staff's competence for two reasons. The first was the administration of meperidine, known to cause fatal interactions with phenelzine, the antidepressant that Libby Zion was taking. The second issue was the use of restraints and emergency psychiatric medication. Sidney's aggrieved words were: "They gave her a drug that was destined to kill her, then ignored her except to tie her down like a dog." To the distress of the doctors, Zion began to refer to his daughter's death as a "murder." Sidney also questioned the long hours that residents worked at the time. In a New York Times op-ed piece he wrote: "You don't need kindergarten to know that a resident working a 36-hour shift is in no condition to make any kind of judgment call—forget about life-and-death." The case eventually became a protracted high-profile legal battle, with multiple abrupt reversals; case reports about it appeared in major medical journals.</blockquote> An alternate explanation is that, lacking other credible means, this is an ad hominem reaction (of those "some") seeking an angle to attack the message ... and the messenger ... or is simply a reaction of, to put it bluntly, castrati who are more at home in a country club than in the world of ideas. For a bona fide example of "coming on too strong", there's this: <div class="PlainText">In the NEJM article "The 'Meaningful Use' Regulation for Electronic Health Records", David Blumenthal, M.D., M.P.P. (ONC Chair) and Marilyn Tavenner, R.N., M.H.A. (10.1056/NEJMp1006114, July 13, 2010) available <a href="http://healthcarereform.nejm.org/?p=3732&query=home">at this link</a>, the opening statement is (emphases mine): </div><blockquote dir="ltr" style="margin-right: 0px;"><div class="PlainText">The widespread use of electronic health records (EHRs) in the United States is inevitable. EHRs will improve caregivers’ decisions and patients’ outcomes. Once patients experience the benefits of this technology, they will demand nothing less from their providers. Hundreds of thousands of physicians have already seen these benefits in their clinical practice.</div></blockquote><div class="PlainText"> I think it fair to say those are grandiose statements and predictions presented with a tone of utmost certainty in one of the world's most respected scientific medical journals.  Even though it is a "perspectives" article, I once long ago learned that in writing in esteemed scientific journals of worldwide impact, statements of certainty were at best avoided, or if made should be exceptionally well referenced. I note the lack of footnotes showing the source(s) of these statements. Another bona fide example of "coming on too strong": <blockquote class="tr_bq">“We have the capacity to transform health with one thunderous click of a mouse after another,” said (former) HHS Secretary Michael Leavitt - <a href="http://www.himss.org/ASP/ContentRedirector.asp?ContentId=65039&type=HIMSSNewsItem">2005 HIMSS Summit</a> </blockquote> <table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEi81rMzS-WFiPrb91_Guccc9_kcbOUplIvRl6eAqyOYRwvsQoibE1PA5rhERJ-q54ZC1TCcdeuJH1o7Ecm_5F5wI4yqIzw4j7xvllLz7pS9-fYIc6we-mJokTLmpLZsggAjGOMJS-veYpb3/s1600/lightning.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEi81rMzS-WFiPrb91_Guccc9_kcbOUplIvRl6eAqyOYRwvsQoibE1PA5rhERJ-q54ZC1TCcdeuJH1o7Ecm_5F5wI4yqIzw4j7xvllLz7pS9-fYIc6we-mJokTLmpLZsggAjGOMJS-veYpb3/s1600/lightning.jpg" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">We shall transform health (into what, exactly, is not specified) one thunderous mouse click after another!</td></tr></tbody></table></div> It doesn't get any stronger than that, unless, perhaps, the thunderous wrath of God is invoked. Back to the Inquirer once again: <blockquote class="tr_bq">"His refusal to temper his message makes it sometimes difficult to hear," said Ross Koppel, a University of Pennsylvania sociologist and digital health record skeptic.</blockquote> As per a recent article by Joe Conn in Modern Healthcare entitled "Health IT Iconoclasts" (<a href="http://hcrenewal.blogspot.com/2013/02/modern-healthcare-health-it-iconoclasts.html" target="_blank">link</a>), which wrote of Dr. Koppel, Deborah Peel, Lawrence Weed and me, Dr. Koppel has firsthand experience at his message being found "difficult to hear" by the hyper-enthusiasts: <blockquote class="tr_bq">... Researcher Ross Koppel started an uproar in 2005 when he and a colleague coauthored an article in the Journal of the American Medical Association that found a first-generation computerized physician order entry system (CPOE) at the Hospital of the University of Pennsylvania was simultaneously creating new errors even as it reduced others. Koppel’s bombshell—he’s now an adjunct professor of sociology at the University of Pennsylvania— brought down the wrath of information technology boosters. The Healthcare Information and Management Systems Society, a health IT trade group, challenged the study’s “methodology and its subsequent outcomes,” and criticized its authors for their “limited view” and not “looking at the big picture.”  [Others wrote that his work was 'disingenuous', although it had similar findings to my own observation of the very same CPOE system at Yale-New Haven Hospital ... in 1992 - ed.] ... In 2009, he revealed in another JAMA article that health IT vendors’ contracts included “hold harmless” clauses that shielded software developers from legal liability for medical errors their systems caused, even if the developers had been warned about the defects. “That got me major upheaval,” the worst of his career, Koppel recalls.</blockquote> Koppel, a sociologist, has probably done more for health IT transparency and safety than the physicians of the entire academic medical and medical informatics community combined. <blockquote class="tr_bq">... But Silverstein says his position today is the same as it has always been. He believes in the potential power of electronic records for good, he says. But any doctor who feels bound by the Hippocratic oath's injunction to "first, do no harm," he adds, should balk at what's going on. "Patients are being harmed and killed as a result of disruptions to care caused by bad health IT," he said. "I'm skeptical of the manner and pace" of implementation, "not of the technology itself. . . . My only bias is against bad medicine. And my bias is against people with complacent attitudes about bad medicine."</blockquote> The issues are actually relatively simple, using terminology coined by <a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhGiHKiF08nosKVU7uTAYFAuZg0tzy09D_tVjFrfb2sJmv6LrJlm_Pv-vazJeH5joFN8HbBEAGFJRgS9EIIr5grSxultREvX8Uycje6Tgf0cYzN6BfLqgbHbKFxor9o14guSy_qimQdUwou/s1600/jon_IMG_1038a.jpg" target="_blank">Dr. Jon Patrick of U. Sydney</a> at the aforementioned HIC2012 meeting in Australia during our discussions.  Bad health IT must be removed from the market, and good health IT must replace it. <blockquote class="tr_bq">Good Health IT ("GHIT") is defined as IT that provides a good user experience, enhances cognitive function, puts essential information as effortlessly as possible into the physician’s hands, keeps eHealth information secure, protects patient privacy and facilitates better practice of medicine and better outcomes. Bad Health IT ("BHIT") is defined as IT that is ill-suited to purpose, hard to use, unreliable, loses data or provides incorrect data, causes cognitive overload, slows rather than facilitates users, lacks appropriate alerts, creates the need for hypervigilance (i.e., towards avoiding IT-related mishaps) that increases stress, is lacking in security, compromises patient privacy or otherwise demonstrates suboptimal design and/or implementation.   </blockquote>   It is this author's opinion that this change will not happen by "going along to get along" or "listening to all the voices in the discussion of the subject" (especially those with Big Money and Big Lobbyists behind them) while doing nothing. I also note that "complacent attitudes about bad medicine" are not the sole province of IT personnel or healthcare management.  Physicians and nurses who acquiesce to bad health IT are part of the problem. -- SS

Kaiser Health News/Philadelphia Inquirer on InformaticsMD: "The flaws of electronic records"

At my Dec. 2012 post " How an interview for Kaiser Health News rekindled memories of health IT dysfunction in the 90's that persist...

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Making a Stat Less Significant: Common Sense on "Side Effects" Lacking in Healthcare IT Sector

At my Mar. 27, 2011 post "<a href="http://hcrenewal.blogspot.com/2011/03/those-who-dismiss-heathcare-and-healht.html">Those Who Dismiss Healthcare (and Healthcare IT) Adverse Events Reports as Mere "Anecdotes" Have Lost - Supreme Court-Style</a>" I wrote that the SCOTUS decided in MATRIXX INITIATIVES, INC., ET AL. v. SIRACUSANO ET AL. (<a href="http://www.supremecourt.gov/opinions/10pdf/09-1156.pdf">link to PDF</a>) that: <blockquote>... We conclude that the materiality of adverse event reports cannot be reduced to a bright-line rule ... Because adverse reports can take many forms, assessing their materiality is a fact-specific inquiry, requiring consideration of their source, content, and context. </blockquote> Wall Street Journal author and "Numbers Guy" Carl Bialik adds to that point in an article today "<a style="font-weight: bold;" href="http://online.wsj.com/article/SB10001424052748703712504576235683249040812.html">Making a Stat Less Significant</a>" where he writes: <blockquote>To determine whether a medical side effect is significant in an experiment requires knowing that every incidence of that side effect is being reported. Researchers can feel confident that is happening in a controlled clinical trial of a drug, but they can't be sure when a drug is being sold to the general public, as was the case with Zicam.</blockquote> In other words, when one is not sure that every incident of a side effect is being reported, one should not cavalierly dismiss "anecdotal" reports of side effects, especially from reliable reporters. The practictioners of Medical Informatics, along with the HIT Industry and its customers, appear to have failed in that regard with respect to clinical IT (electronic medical records, CPOE etc.) For years they have argued that these medical devices should not be regulated because that would "stifle innovation" and that reports of device adverse events were "anecdotal." Many in the field still make these arguments. This view extends all the way up to the Director of the Office of the National Coordinator for Health IT, who glibly stated per the Aug. 2010 Huffington Post Investigative Fund article <a href="http://huffpostfund.org/stories/2010/08/fda-obama-digital-medical-records-team-odds-over-safety-oversight">FDA, Obama Digital Medical Records Team at Odds over Safety Oversight</a> that FDA's own reports of health IT related injuries and deaths were “anecdotal": <blockquote>ONC director Blumenthal, the point man for the administration, has called the FDA’s injury findings “anecdotal and fragmentary.” He told the Investigative Fund that he believed nothing in the report indicated a need for regulation. </blockquote> Those "injury findings" appear in an FDA Internal Memo made available by the aforementioned Huffington Post Investigative Fund and archived at the following link: <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/Internal-FDA-Report-on-Adverse-Events-Involving-Health-Information-IT.pdf"></a><blockquote><a href="http://www.ischool.drexel.edu/faculty/ssilverstein/Internal-FDA-Report-on-Adverse-Events-Involving-Health-Information-IT.pdf">Internal FDA memorandum on HIT risks</a> (PDF) to Jeffrey Shuren MD JD (Director, Center for Devices and Radiological Health). Health Information Technology (H-IT) Safety Issues. "This is an Internal Document Not Intended for Public Use." Feb. 23, 2010. (My description/summary of the memorandum is at my Aug. 2010 post "<a href="http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html">Internal FDA memorandum of Feb. 23, 2010 to Jeffrey Shuren on HIT risks. Smoking gun?</a>")</blockquote> That memorandum itself emphasizes how FDA's own knowledge of these events is partial due to reporting impediments and lack of knowledge of resources such as FDA's MAUDE database. The known reports were likely "<a href="http://hcrenewal.blogspot.com/2010/02/fda-on-health-it-adverse-consequences.html">the tip of the iceberg</a>" according to the Director of FDA’s Center for Devices and Radiological Health (CDRH) <a href="http://www.healthimaging.com/index.php?option=com_articles&view=article&id=20311:jeffrey-e-shuren-named-as-fda-cdrh-director">Jeffrey Shuren, MD, who also happens to be a lawyer</a>. As at the aforementioned "<a href="http://hcrenewal.blogspot.com/2010/02/fda-on-health-it-adverse-consequences.html">tip of the iceberg</a>" link, at an HHS meeting of the HIT Policy Committee's Adoption/Certification Workgroup on February 25, 2010, Shuren testified: <blockquote>... In the past two years, we have received 260 reports of HIT-related malfunctions with the potential for patient harm – including 44 reported injuries and 6 reported deaths. Because these reports are purely voluntary, they may represent only the tip of the iceberg in terms of the HIT-related problems that exist. Even within this limited sample, several serious safety concerns have come to light. The reported adverse events have largely fallen into four major categories: (1) errors of commission, such as accessing the wrong patient’s record or overwriting one patient’s information with another’s; (2) errors of omission or transmission, such as the loss or corruption of vital patient data; (3) errors in data analysis, including medication dosing errors of several orders of magnitude; and (4) incompatibility between multi-vendor software applications and systems, which can lead to any of the above.</blockquote> The problem with ignoring testimony and reports of health IT-related difficulties and dismissing them as "anecdotal" goes back to the issue of "knowing that every incidence of that side effect is being reported." While FDA itself admits significant doubt about completeness of reporting in its memo, what's worse is that Koppel and Kreda at University of Pennsylvania wrote a paper from which one might conclude that the healthcare and health IT industries are themselves aligned to conceal health IT adverse events reports. In their remarkable article <a href="http://jama.ama-assn.org/content/301/12/1276.extract">Health Care Information Technology Vendors' "Hold Harmless" Clause - Implications for Patients and Clinicians</a>, Journal of the American Medical Association, 2009;301(12):1276-1278, we learn that there is little motivation for device safety in the health IT industry: <blockquote>Healthcare information technology (HIT) vendors enjoy a contractual and legal structure that renders them virtually liability-free—“held harmless” is the term-of-art—even when their proprietary products may be implicated in adverse events involving patients. This contractual and legal device shifts liability and remedial burdens to physicians, nurses, hospitals, and clinics, even when these HIT users are strictly following vendor instructions...HIT vendors are not responsible for errors their systems introduce in patient treatment because physicians, nurses, pharmacists, and healthcare technicians should be able to identify—and correct—any errors generated by software faults. [In other words, they are expected to be clairvoyant when presented with erroneous or missing data - ed.] </blockquote> We additionally learn that: <blockquote>The significant disparity between buyers and sellers in knowledge and resources [about healthcare IT problems] is profound and consequential. Vendors retain company confidential knowledge about designs, faults, software-operations, and glitches. Their counsel have crafted contractual terms that absolve them of liability and other punitive strictures while compelling users’ non-disclosure of their systems’ problematic, or even disastrous, software faults. </blockquote>In other words, health IT customers and users have a gag order imposed on them regarding software faults and defects. I think any reasonable person would conclude there is great doubt as to whether "every incidence of [HIT side effects] is being reported." I also pointed out in JAMA (<a href="http://jama.ama-assn.org/content/302/4/382.1.extract">link</a>) and on my Drexel website (<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=koppel_kreda">link</a>) how agreeing to these terms caused hospital executives to violate both their fiduciary duties to their organization's workers as well as Joint Commission safety standards obligations. (I've personally reported health IT defects I'd observed in hospitals where my relatives were patients to FDA's MAUDE database, discovering that the institution itself, whose officials I alerted to the problems, did not. An example is <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1729552">here</a>.) The above is all common sense. Thus, the dismissal of reports of health IT-related patient injury, deaths, and "near misses" represents a failure of common sense, as well as a massive abrogation of fiduciary responsibilities and legal and ethical obligations among the Medical Informatics, health IT vendor, healthcare delivery, and healthcare regulatory sectors. One end result is that it permits software <a href="http://sydney.edu.au/engineering/it/%7Ehitru/index.php?option=com_content&task=view&id=120&Itemid=116">like this</a> to be mandated by state governments on hundreds of hospitals. One can only imagine the public, press and legal reactions if mission-critical software issues of this magnitude were brought forth after an aviation or nuclear power plant disaster. The cavalier dismissals of HIT mishap reports clearly fall into the "knew, or should have known" category of negligence. Plaintiff attorneys for patients injured or killed via HIT-related mishaps should take note. -- SS Note: my WSJ comment on this issue appears <a href="http://online.wsj.com/article/SB10001424052748703712504576235683249040812.html#articleTabs%3Dcomments%26commentId%3D2294618">here</a>.

Making a Stat Less Significant: Common Sense on "Side Effects" Lacking in Healthcare IT Sector

At my Mar. 27, 2011 post " Those Who Dismiss Healthcare (and Healthcare IT) Adverse Events Reports as Mere "Anecdotes" Have L...

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David Blumenthal to Resign as Director of the Office of the National Coordinator of HIT (ONC)

From NextGov.com - TECHNOLOGY AND THE BUSINESS OF GOVERNMENT <blockquote><a href="http://healthitupdate.nextgov.com/2011/02/dr_david_blumenthal_who_has.php?oref=latest_posts">Blumenthal Calls It Quits</a><div class="lingo_nolink"> By John Pulley, March 3, 2011 </div> Dr. David Blumenthal, who has pushed the country's health care providers to give up paper files in favor of electronic medical records, announced Thursday that he is stepping down as the country's de facto <a style="cursor: pointer; display: inline; font-family: "Times New Roman",Times,serif; font-size: 15px; font-weight: 400; font-style: normal;" class=" lingo_link" href="http://topics.nextgov.com/Health+IT/" rel="nofollow">health IT</a> czar after almost two years on the job. He will return to Harvard University, according to news reports. Blumenthal served as National Coordinator for Health IT during a period of tremendous change. In 2009, Congress allocated billions of dollars to expand the Office of the National Coordinator's authority and to make available incentive funds intended to encourage mass adoption of electronic medical records. The first of those incentives payments were disbursed recently. ... Health and Human Services Secretary Kathleen Sebelius, writing in a memo obtained by Kaiser Health News, said that "David will leave his post having built a strong foundation, created real momentum for [<a style="cursor: pointer; display: inline; font-family: "Times New Roman",Times,serif; font-size: 15px; font-weight: 400; font-style: normal;" class=" lingo_link" href="http://topics.nextgov.com/health+information+technology/" rel="nofollow">health information technology</a>] adoption, charted a course for the meaningful use of [electronic health records] and launched a new phase of cooperative and supportive work with the health care community, states and cities across the nation." Despite that progress, however, there has been no shortage of impediments to large-scale adoption, including the dearth of qualified health IT specialists, a lack of certified health IT products [which by the way is an artificial, government and industry lobby-created impediment; "certification" does not equal safe or effective; it's merely a hastily-evaluated features check - ed.], disruptions in work flow caused by the switch to electronic health records [which in large part remain <a href="http://www.tinyurl.com/hostileuserexper">mission hostile</a> to clinical work - ed.] and the challenge of meeting "meaningful use" standards that trigger incentive payments. </blockquote> I wish Dr. Blumenthal well. ONC Chair is not an easy role, as I'm sure his predecessors would confirm. My final comment is that the last paragraph might be rearranged as follows: <blockquote>... Despite the impediments to large scale adoption, however, there has been no shortage of irrational exuberance in the technology, nor progress in taking seriously the <a href="http://hcrenewal.blogspot.com/2011/01/maude-and-hit-risk-mother-mary-what-in.html">risks to patients</a>. Many of the "impediments" are probably not surmountable at our present dearth of understanding of this experimental technology and its sociotechnical complexities, with many in government, medicine and the IT industry dismissing a growing body of "inconvenient" literature (such as <a href="http://hcrenewal.blogspot.com/2011/02/updated-reading-list-on-health-it.html">here</a>), and these same people and IT merchants ignoring those who do understand those issues (or worse, such as <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=lawsuit">here</a>). </blockquote>-- SS

David Blumenthal to Resign as Director of the Office of the National Coordinator of HIT (ONC)

From NextGov.com - TECHNOLOGY AND THE BUSINESS OF GOVERNMENT Blumenthal Calls It Quits By John Pulley , March 3, 2011 Dr....

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Health IT: On Anecdotalism and Totalitarianism

<div dir="ltr" style="font-family:arial;">At the article Blumenthal on EMRs: Debate "raging" over competition vs. standards (<a href="http://www.massdevice.com/news/blumenthal-emrs-debate-raging-over-competition-vs-standards" target="_blank">http://www.massdevice.com/news/blumenthal-emrs-debate-raging-over-competition-vs-standards</a>), ONC czar David Blumenthal is cited as saying several interesting things: </div> <div dir="ltr" style="font-family:arial;"> </div> <blockquote dir="ltr" style="margin-right: 0px;font-family:arial;"> <div dir="ltr">... EMRs make him a better physician, he said, recounting personal anecdotes of discovering patients' allergies through automated EMR alerts and using stored image date to more quickly get a diagnosis for a patient without subjecting them to more radiation and toxic radiation agents ... </div></blockquote> <div dir="ltr" style="font-family:arial;"> </div> <div dir="ltr" style="font-family:arial;"> It's the EMR "anecdotalists" (as opposed to the "<a href="http://en.wikipedia.org/wiki/Harry_Markopolos" target="_blank">Markopolists</a>") who say that "anecdotes" of HIT-related injury are meaningless. They deem reports of safety issues and HIT-related misadventures and risk as simply "anecdotal", and that "anecdotes don't make evidence" (or "anecdotes don't make data"). </div> <div dir="ltr" style="font-family:arial;"> </div> <div dir="ltr" style="font-family:arial;"> Yet anecdotal reports of EMR "saves" are used by a czar to justify tens of billions of dollars of expenditures?</div> <div dir="ltr" style="font-family:arial;"> </div> <div dir="ltr" face="arial"> To the anecdotalists, I say: you can't have it both ways. </div> <div dir="ltr" face="arial"> </div> <div dir="ltr" style="font-family: arial;">That same article concludes with this concerning statement: </div> <div dir="ltr" style="font-family: arial;"> </div> <blockquote dir="ltr" style="margin-right: 0px;font-family:arial;"> <div dir="ltr">... Blumenthal, adamantly pro-EMR, said there is a move afoot to add technical fluency into certification for healthcare providers. "Boards of certification, all the primary care boards of medicine have adopted principles that will lead them to create requirements for the use of electronic health systems as a research requirement, and even the medical licensing boards are beginning to think about whether the maintenance of licensure should be dependent, to some degree, on using electronic health systems," he said. "Information is the lifeblood of medicine, and unless physicians and other healthcare professionals are capable of using the most modern technology available for managing information, I think they will have trouble claiming, in the 21st century, the unique competence that entitles them to being licensed and board certified. I think they'll have trouble holding up their heads as professionals and claiming that they are at the top of their game and capable of providing the best care that technology allows."</div></blockquote> <div style="font-family: arial;" dir="ltr"> It appears that my observation ten years ago of a cross-occupational invasion on Medicine by the IT domain (and its purveyors) was prescient. They've continued the march, and now they're now literally at the castle gates. I commented on this issue in more detail a few weeks ago at my post "<a href="http://hcrenewal.blogspot.com/2010/09/american-board-of-medical-specialties.html">American Board of Medical Specialties to "incorporate tools to promote meaningful use of health IT into its maintenance-of-certification program"</a>. I have two questions: </div> <div style="font-family: arial;" dir="ltr"> </div> <div style="font-family: arial;" dir="ltr">1) Was it the intention of the Medical Informatics pioneers to prohibit physicians from being licensed and/or board certified on the basis of using health IT? If such a seemingly totalitarian intention existed, that's fine, I just want to hear it debated. </div> <div style="font-family: arial;" dir="ltr"> </div> <div dir="ltr">2) Is the mere consideration (let alone enactment) of such a restriction, for all specialties, truly evidence based? (Note some merely skimming-the-surface "evidence" at my 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>.) -- SS </div>

Health IT: On Anecdotalism and Totalitarianism

At the article Blumenthal on EMRs: Debate "raging" over competition vs. standards ( http://www.massdevice.com/news/blumenthal-emr...

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More on Huffington Post Investigative Fund: "FDA, Obama Digital Medical Records Team at Odds over Safety Oversight"

Re: today's Huffington Post Investigative Fund article "<a href="http://huffpostfund.org/stories/2010/08/fda-obama-digital-medical-records-team-odds-over-safety-oversight">FDA, Obama Digital Medical Records Team at Odds over Safety Oversight</a>." (I'd written some preliminary comments at an earlier post entitled "<a style="font-style: italic;" href="http://hcrenewal.blogspot.com/2010/08/huffington-post-investigative-fund-fda.html">Huffington Post Investigative Fund: FDA, Obama Digital Medical Records Team at Odds over Safety Oversight</a>.") First, some relatively obvious questions about the Cerner health IT crashes at the <a href="http://www.trinity-health.org/index.htm">Trinity Health System</a> chain of hospitals featured in the story: <ul><li>How many patients were affected? Is the number actually known?</li><li>Were affected patient charts corrected? </li><li>What restrictions, if any, have been placed on physicians, other clinicians, employees, contractors, staff, etc. about speaking to the press on the Trinity Health HIT malfunctions?</li><li>If any restrictions were placed, are they in violation of Joint Commission Safety Standards as in my July 22, 2009 JAMA letter to the editor "Health Care Information Technology, Hospital Responsibilities, and Joint Commission Standards" <a href="http://jama.ama-assn.org/cgi/content/extract/302/4/382">at this link</a>?</li><li>Did this healthcare system sign "hold harmless" clauses with Cerner, as per Koppel and Kreda's 2009 JAMA article "Health Care Information Technology Vendors' Hold Harmless Clause - Implications for Patients and Clinicians, JAMA 2009;301(12):1276-1278, at <a href="http://jama.ama-assn.org/cgi/content/extract/301/12/1276">this link</a>? </li><li>Did this healthcare system sign a gag clause with Cerner, the vendor of their affected systems according to the Huffington Post article?</li><li>Medical adverse events from medical record errors can occur quickly, or be more delayed. If patient harm comes of the IT errors that occurred, will the healthcare system file a public report?</li></ul> Now, on to some specific comments and observations on the Huffington Post Investigative Fund article. The Huffington Post article begins: <blockquote>Computers at a major Midwest hospital chain went awry on June 29, posting some doctors’ orders to the wrong medical charts in a few cases and possibly putting patients in harm’s way. The digital records system “would switch to another patient record without the user directing it to do so,” said Stephen Shivinsky, vice-president for corporate communications at Trinity Health System. Trinity operates 46 hospitals, most in Michigan, Iowa and Ohio.</blockquote> The bolded passage sounds like obfuscatory PR language, as if the EMR system changed the window focus to another patient's window (people do this all the time when they have multiple windows open in a GUI). If so, that would not be a major problem - the user would just switch back via clicking on the desired window. Let's state what it sounds like the problem really was with crystal clarity: Data a clinician entered into the window of primary focus (say, on Mary Jones) would end up in the electronic record of a window that was not the window of primary focus and in the background (say, that of Tom Smith). The clinician would be unaware this had occurred, and two errors would then occur. The first error was that appropriate data would be missing for Mary. The second is that inappropriate data would be present for Tom. These events put both patients at risk of medical error. <blockquote>Less than two weeks later, an unrelated glitch caused Trinity to shut down its $400 million system for four hours at 10 hospitals in the network because electronic pharmacy orders weren’t being delivered to nurses for dispensing to patients, he said.</blockquote> Was this 'glitch' [a code word for "we are not in control of our system, it is in control of us" - ed.] related to the problem above? If so, that would suggest major system problems deep within its code. If not, it suggests lax overall quality control of this IT. <blockquote> “As soon as it was brought to our attention, we moved to fix the problem,” Shivinsky said of Trinity’s system </blockquote> This statement says nothing. One would not expect them to wait to fix a potentially dangerous problem. <blockquote>He said nobody was injured in either event, ...</blockquote> As in my prior post, the correct statement would be: <blockquote>Nobody was injured, yet, due to the errors. </blockquote> ... the Cerner Corp. system now works properly, Does that mean all the problems are fixed? The article implies not via its ending where Shivinsky is quoted that: <blockquote>... Meanwhile technicians are still trying to figure out the root cause. “We’ll get to the bottom of it and fix it,” he said. </blockquote>By the way, I note the following employee reporting site on Cerner's environment: <a href="http://www.jobvent.com/cerner-corp--job-reviews-C1174">link</a>. Could this be a factor in Richard Granger, the former head of the UK's NHS national IT programme <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=granger_speaks_out">saying that</a>: <blockquote> "Sometimes we put in stuff that I'm just ashamed of ... Some of the stuff that Cerner has put in recently is appalling ... Cerner and prime contractor Fujitsu had not listened to end users ... Failed marriages and co-dependency with subcontractors ... A string of problems ranging from missing appointment records, to inability to report on wait times ... Almost a dozen cancelled go-live dates ... Stupid or evil people ... Stockholm syndrome -identifying with suppliers' interests rather than your own ... A little coterie of people out there who are "alleged experts" who were dismissed for reasons of non-performance."</blockquote> I can only wonder. <blockquote>... and the hospital chain determined that “technician error” led to the system shutdown and that the mixing up of patients was the result of a “Cerner coding issue” involving software that occurred after an upgrade.</blockquote> What was the "technician" doing that led to the shutdown, what was the technician's background and qualifications to be doing it to a mission critical medical device? Further, what, exactly, was the "Cerner coding issue?" Was it Cerner's fault? Trinity's? Both? Were other organizations using the same software similarly affected? How will other healthcare organizations learn if the cause of the problems is not revealed? <blockquote>Even absent any harm to patients, such incidents underscore possible risks faced by even large health organizations that have eagerly embraced new medical software to track patient records and treatment. As the Obama administration ramps up plans to create a digital medical file for every American by 2014 – at an anticipated tab to taxpayers of up to $27 billion – technology’s boosters tend to tout its potential benefits to patients and ability to slow runaway medical costs.</blockquote> That's not been my observation. Look at the UK for instance: <blockquote>The <st1:place st="on"><st1:country-region st="on">UK</st1:country-region></st1:place> Public Accounts Committee report on disastrous problems in their £12.7 billion national EMR program is <a href="http://www.publications.parliament.uk/pa/cm200809/cmselect/cmpubacc/153/15304.htm">here</a>. <o:p></o:p> Gateway reviews of the UK National Programme for IT from the Office of Government Commerce (OGC) are <a href="http://www.connectingforhealth.nhs.uk/about/foi">here</a> (released under the UK’s Freedom of Information Act), and a summary of 16 key points is <a href="http://www.computerweekly.com/blogs/tony_collins/2009/06/16-key-points-in-gateway-revie.html">here</a>.</blockquote> I wish there were strong documentary evidence on the latter point about major savings, and that there wasn't evidence to the contrary. The healthcare system doesn't have enough spare capital to throw away on the hopes some touted technology (from which an industry stands to make billions) is a panacea. <blockquote> Yet despite the high political and financial stakes, the administration has established no national mandatory monitoring procedure for the new devices and software. That no process exists to report and track errors, pinpoint their causes and prevent them from recurring is largely the result of two decades of resistance by the technology industry, a review of government records and interviews by the Huffington Post Investigative Fund shows. The industry argues that even with flaws, digital systems are an improvement over current paper records.</blockquote> That is no excuse for decades of toleration of the flaws. It is an amoral position. As at my July 28 post <a href="http://hcrenewal.blogspot.com/2010/07/open-question-on-moral-authority-and.html">"An Open Question on Moral Authority and Healthcare IT"</a>, it is playing God. The HuffPo article continues: <blockquote> “There’s an assumption that just because you have an electronic system, it’s going to be safer, so people let down their guards,” said Vimla Patel, who directs research on the topic at the University of Texas Health Science Center in Houston.</blockquote> It's not an "assumption." This meme has been pushed so long by the HIT industry and its irrationally exuberant, uncritical supporters, it's become an accepted statement of fact - as per my July 14 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> where the Chairman of ONC states it as fact in the New England Journal of Medicine, with nary a footnote to back it up: <blockquote>Blumenthal - The widespread use of electronic health records (EHRs) in the United States is inevitable. EHRs will improve caregivers’ decisions and patients’ outcomes. Once patients experience the benefits of this technology, they will demand nothing less from their providers. Hundreds of thousands of physicians have already seen these benefits in their clinical practice.</blockquote> That's pretty definitive. If there's a trace of doubt, I don't see it. <blockquote>Monitoring could help others learn from problems faced by early users of the technology, which is being sold nationally, or how they were remedied. Shivinsky said he wasn’t sure if federal officials had been notified of the difficulties at Trinity — or would be. No rule requires it.</blockquote> Why is there no rule? What if this were a medical device such as a CT scanner, or heart defibrillator? Why does health IT get special accommodation when it is now a regulator and governor of clinician communications and actions, placed in between clinician and patient? <blockquote>Almost a month after the first event at Trinity, David Blumenthal, the government’s top medical health information technology official, didn’t know about it. “First I’ve heard about it,” Blumenthal said when told by a reporter July 20, as he left a Capitol Hill hearing. Since then, Blumenthal has declined to discuss the incident or its implications. </blockquote> That's perhaps because it conflicts with his other assertions on health IT technological determinism, noted above. How many other "events" is he aware of? <blockquote>Kelli Christman, a spokesman for Cerner, the manufacturer of the software used at Trinity, did not respond to repeated emails and phone calls over the past week seeking comment.</blockquote> What are they hiding? Perhaps other affected healthcare systems? <blockquote>... Many industry groups contend that FDA regulation would “stifle innovation” and stall the national drive to wire up American medicine. That view resonates among the dozens of health information technology experts serving as consultants to Blumenthal’s office and on advisory groups. Blumenthal also has been skeptical of the need for regulation and argued that even if some miscues occur, digital systems are far less prone to error than paper ones.</blockquote> In an industry with contractual gag clauses and clinician fear of speaking about HIT problems (e.g., of retaliation by hospital officials), how can anyone be sure of this? Is this a scientific statement, or a marketing position? See may paper <a href="http://www.scribd.com/doc/28747771/Remediating-an-Unintended-Consequence-of-Healthcare-IT-A-Dearth-of-Data-on-Unintended-Consequences-of-Healthcare-IT" class="title">"Remediating an Unintended Consequence of Healthcare IT: A Dearth of Data on Unintended Consequences of Healthcare IT</a>" for more on this issue. <blockquote> “We know that every study and every professional consensus process has concluded that electronic health systems strongly and materially improve patient safety. And we believe that in spreading electronic health records we are going to avoid many types of errors that currently plague the healthcare system,” Blumenthal said when unveiling new regulations in Washington on July 13.</blockquote> This statement is without merit, as per my prior post "<a href="http://hcrenewal.blogspot.com/2010/08/huffington-post-investigative-fund-fda.html">Huffington Post Investigative Fund: FDA, Obama Digital Medical Records Team at Odds over Safety Oversight</a>." Further: note to Dr. Blumenthal: <a href="http://www.s8int.com/crichton.html">Consensus is not science</a>: <blockquote> [Chrichton, Caltech Michelin Lecture, 2003] ... I want to pause here and talk about this notion of consensus, and the rise of what has been called consensus science. I regard consensus science as an extremely pernicious development that ought to be stopped cold in its tracks. Historically, the claim of consensus has been the first refuge of scoundrels; it is a way to avoid debate by claiming that the matter is already settled. Whenever you hear the consensus of scientists agrees on something or other, reach for your wallet, because you're being had. Let's be clear: the work of science has nothing whatever to do with consensus. Consensus is the business of politics. Science, on the contrary, requires only one investigator who happens to be right, which means that he or she has results that are verifiable by reference to the real world. In science consensus is irrelevant. What is relevant is reproducible results. The greatest scientists in history are great precisely because they broke with the consensus. There is no such thing as consensus science. If it's consensus, it isn't science. If it's science, it isn't consensus. Period</blockquote> Blumenthal goes on: <blockquote>In public remarks that day, Blumenthal said he “expects” an eventual certification process for the digital systems to “collect information about the problems that occur with the implementation of electronic health records, if any.” He did not say when that would happen. </blockquote> Eventual? Why not NOW, considering that the HIT industry has been in business for decades? The infrastructure for such reporting already exists, such as the <a href="http://www.fda.gov/Safety/MedWatch/default.htm">FDA MedWatch</a> system and <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm">Manufacturer and User Facility Device Experience</a> (MAUDE) database - where, by the way, an HIT-related death was reported (<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=maude_death">link</a>). Imagine the aviation, nuclear energy industry or pharma making such outrageous statements about getting around to collecting information on potentially hazardous flaws "eventually." <blockquote>In a later interview, Blumenthal said “safety concerns are not being ignored,” but wouldn’t comment further.</blockquote> Yes, they are being ignored. Worse, they're being suppressed as in this case example, <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=lawsuit">"A Lawsuit Over Healthcare IT Whistleblowing and Wrongful Discharge: Malin v. Siemens Healthcare</a>." <blockquote> ... Dozens of other health information technology insiders, from academics to front-line users who believe digital medical records can promote better and cheaper health care, told the Investigative Fund in interviews that they nonetheless fear safety issues will mount as doctors and hospitals move quickly to install the systems and collect stimulus checks.</blockquote> Just anecdotal, according to ONC and others. <blockquote>“People just assume that computers will make things safer,” said Nancy Leveson, a safety engineering expert at Massachusetts Institute of Technology. “While they can be designed to eliminate certain kinds of hazards, they increase others and sometimes they introduce new types of hazards.”</blockquote> This is a principle direct from the discipline of <a href="http://rkcsi.indiana.edu/archive/SI/Arts/SI_report_Aug_14.doc">Social Informatics</a>. Social Informatics (SI) refers to the body of research and study (e.g,, as collected <a href="http://rkcsi.indiana.edu/">here</a>) that examines social aspects of computerization, including the roles of information technology in social and organizational change, the uses of information technologies in social contexts, and the ways that the social organization of information technologies is influenced by social forces and social practices. <blockquote>Some experts are calling for closer government monitoring of the systems to protect the public. “We need to have some scrutiny at the front end and have an approval process to make sure they are safe before they’re deployed,” said Sharona Hoffman, a law professor at Case Western Reserve University, who has written about the issue in academic journals.</blockquote> I am one of those experts, and I agree. <blockquote>... In 2004, digital record keeping got a boost when President George Bush signed an executive order to create a digital medical file for every American within a decade, a goal officials said at the time they could reach “without substantial regulation.” “The time wasn’t right at that time to move forward or the support wasn’t there (for safety regulations),” said Robert Kolodner, who ran the national coordinator’s office during some of the Bush years.</blockquote> Again, I ask - why the hell not? When is a good time to discuss healthcare and HIT safety? Would such attitudes be tolerated in other industries? I dare say, hell no. <blockquote>Edward H. Shortliffe, president of the American Medical Informatics Association and a longtime industry figure, agreed that safety issues weren’t a “primary concern” as tech companies began to expand their offerings.</blockquote> That is a startling revelation - it could be the basis for medical malpractice plaintiff lawsuits on the basis of negligence, all the way to <a href="http://www.answers.com/topic/criminal-negligence">criminally negligent homicide</a> if a patient dies of an HIT-related event. <blockquote><a style="font-weight: bold;" href="http://www.answers.com/topic/criminal-negligence">Criminal negligence</a>: The failure to use reasonable care to avoid consequences that threaten or harm the safety of the public and that are the foreseeable outcome of acting in a particular manner.</blockquote> The HuffPo article further observes: <blockquote> Earlier this year, the [health IT] trade group convened an expert panel to study the issues for the first time, but its findings have yet to be made public. Shortliffe said he didn’t think the organization would take a stand on government regulation of the industry, but said: “We recognize that there are significant challenges that the field as a whole is facing.”</blockquote> The "first time" in an industry messing with people's medical care for decades? How is this possible? <blockquote>... ONC director Blumenthal, the point man for the administration, has called the FDA’s injury findings “anecdotal and fragmentary.” </blockquote> Just how many "anecdotes" do we need in an industry that places gag clauses on health IT users? [March 2011 addendum - see thoughts on health IT "anecdotes" at this posting: <a href="http://hcrenewal.blogspot.com/2011/03/those-who-dismiss-heathcare-and-healht.html">Those Who Dismiss Healthcare (and Healthcare IT) Adverse Events Reports as Mere "Anecdotes" Have Lost, Supreme Court-Style</a> - ed.] <blockquote> He told the Investigative Fund that he believed nothing in the report indicated a need for regulation [i.e., absence of evidence in a tight-lipped industry as evidence of absence - ed.] Yet others see anecdotes as a starting point for a more methodical look at problems that arise.</blockquote> Who is more attuned to risk mitigation when they see red flags? Who are the clinician scientists, and who are the "see no evil, hear no evil, speak no evil" politicians? <blockquote>The same day that Blumenthal, Sebelius and other federal health officials unveiled their digital records plan in Washington, an obscure government agency held a conference less than 20 miles away in suburban Maryland to discuss the state of quality controls. Ben-Tzion Karsh, an engineering professor at the University of Wisconsin in Madison who attended the National Institute of Standards and Technology conference said he heard a “broad consensus” among experts that electronic medical records need to function better and safer. “The truth is that we do not at this time know what would make an EHR (electronic health record) safe,” he said. Others said that despite the rosy view taken by many political figures in Washington, many systems on the market today aren’t designed in ways that prevent and limit new errors—and that nobody is holding the industry accountable.</blockquote><div style="overflow: hidden; color: rgb(0, 0, 0); background-color: transparent; text-align: left; text-decoration: none; border: medium none;"> </div>Again I ask: how is this possible after decades of this industry's selling of products to hospitals for use on actual patients? Also, the simple question arises: is this technology truly ready for the ambitious national roll out plans of the past two administrations? I've touched on many of these issues in past years on this blog and at my <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases">academic website on HIT problems</a>. I see a clear runaway train and train wreck headed down the tracks. The next few years in health IT should prove interesting indeed. -- SS

More on Huffington Post Investigative Fund: "FDA, Obama Digital Medical Records Team at Odds over Safety Oversight"

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Huffington Post Investigative Fund: FDA, Obama Digital Medical Records Team at Odds over Safety Oversight

<div style="text-align: center;">(Note: also see my followup post "<a href="http://hcrenewal.blogspot.com/2010/08/more-on-huffington-post-investigative.html">More on Huffington Post Investigative Fund: "FDA, Obama Digital Medical Records Team at Odds over Safety Oversight"</a>) </div> The Huffington Post Investigative Fund has published a remarkable expose of health IT difficulties and the Big Politics that surround them regarding safety and efficacy: <a href="http://huffpostfund.org/stories/2010/08/fda-obama-digital-medical-records-team-odds-over-safety-oversight"></a><blockquote><a href="http://huffpostfund.org/stories/2010/08/fda-obama-digital-medical-records-team-odds-over-safety-oversight">FDA, Obama Digital Medical Records Team at Odds over Safety Oversight</a> Aug. 3, 2010 By <a title="View user profile." href="http://huffpostfund.org/users/fredschulte" jquery1280932414984="124">Fred Schulte</a> and <a title="View user profile." href="http://huffpostfund.org/users/eschwartz" jquery1280932414984="125">Emma Schwartz</a> Computers at a major Midwest hospital chain went awry on June 29 [after an 'upgrade' - ed.], posting some doctors’ orders to the wrong medical charts in a few cases and possibly putting patients in harm’s way. The digital records system “would switch to another patient record without the user directing it to do so,” said Stephen Shivinsky, vice-president for corporate communications at Trinity Health System. Trinity operates 46 hospitals, most in Michigan, Iowa and Ohio. [In other words, data entered by clinicians was going into the wrong charts. How many charts were involved? Does the hospital system even know, I wonder? - ed.] Less than two weeks later, an unrelated glitch caused Trinity to shut down its $400 million system for four hours at 10 hospitals in the network because electronic pharmacy orders weren’t being delivered to nurses for dispensing to patients, he said. ... Even absent any harm to patients, such incidents underscore possible risks faced by even large health organizations that have eagerly embraced new medical software to track patient records and treatment. As the Obama administration ramps up plans to create a digital medical file for every American by 2014 – at an anticipated tab to taxpayers of up to $27 billion – technology’s boosters tend to tout its potential benefits to patients and ability to slow runaway medical costs. Yet despite the high [actually, potentially catastrophic - ed.] political and financial [and clinical -ed.] stakes, the administration has established no national mandatory monitoring procedure for the new devices and software. That no process exists to report and track errors, pinpoint their causes and prevent them from recurring is largely the result of two decades of resistance by the technology industry, a review of government records and interviews by the Huffington Post Investigative Fund shows. The industry argues that even with flaws, digital systems are an improvement over current paper records.</blockquote> I began to document some of the problems and the resistance of what Washington Post reporter Robert O'Harrow Jr. in May 2009 called the "<a href="http://www.washingtonpost.com/wp-dyn/content/article/2009/05/15/AR2009051503667.html?hpid=topnews">Healthcare IT lobby</a>" a decade ago in a website. That website, now hosted at Drexel University, is entitled "<a style="font-weight: bold;" href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/">Contemporary Issues in Medical Informatics: Common Examples of Healthcare Information Technology Difficulties</a>." Few in government and industry were apparently listening, despite <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/content/documents/FINAL_Healthcare%20IT%20Failure_Oct_19_2006.ppt">ongoing worldwide interest in the topic</a> (PPT). Read the Huffington Post report in its entirety. It includes a slide-show timeline of the health IT industry's sidestepping of government oversight and safety concerns. As I am currently busy helping out my ill mother, I will offer more commentary later. However, one quote really stuck out. Is the Chairman of the Office of the National Coordinator for Health IT (ONC) <a href="http://healthit.hhs.gov/portal/server.pt?open=514&objID=15930&&PageID=15653&mode=2&in_hi_userid=10731&cached=true&utm_source=National+eHealth+Collaborative&utm_campaign=e1871fd68c-CONNECT_09_announcement_061209&utm_medium=email">Dr. David Blumentha</a>l lying, or simply misinformed? Judging by the quality of academic discourse these days, I'd hope the latter (an alarming situation in and of itself), but the former is also possible. He is quoted as stating: <blockquote> “We know that every study and every professional consensus process has concluded that electronic health systems strongly and materially improve patient safety. And we believe that in spreading electronic health records we are going to avoid many types of errors that currently plague the healthcare system,” Blumenthal said when unveiling new regulations in Washington on July 13.</blockquote> As at my July 14, 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> , however, I pointed out some examples that contradict this meme. This list is just for starters: (Hyperlinks to these and others can be found at my Medical Informatics teaching site <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=other">here</a> and <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=2009">here</a>:) <div class="PlainText" style="font-family:arial;"></div> <blockquote style="margin-right: 0px;font-family:arial;" dir="ltr"><div class="PlainText" style="font-family:arial;"></div><div class="PlainText" style="font-family:arial;">1. Health IT Project Success and Failure: Recommendations from Literature and an AMIA Workshop by Bonnie Kaplan and Kimberly D. Harris-Salamone. From the May/June 2009 issue of JAMIA. 2. "E-Health Hazards: Provider Liability and Electronic Health Record Systems.” Hoffman and Podgurski’s followup paper on EHR medical and legal risks 3. Role of Computerized Physician Order Entry Systems in Facilitating Medication Errors. Ross Koppel, PhD, et al, Journal of the American Medical Association, 2005;293:1197-1203 4. Electronic Health Record Use and the Quality of Ambulatory Care in the United States. Arch Intern Med. 2007;167:1400-1405. The authors examined electronic health records (EHR) use throughout the U.S. and the association of EHR use with 17 basic quality indicators. They concluded that “as implemented, EHRs were not associated with better quality ambulatory care.” 5. Pessimism, Computer Failure, and Information Systems Development in the Public Sector. (Public Administration Review 67;5:917-929, Sept/Oct. 2007, Shaun Goldfinch, University of Otago, New Zealand) 6. <a href="http://www.blogger.com/redir.aspx?C=cd79bb9ef239435c91597828510ff401&URL=http%3a%2f%2fiig.umit.at%2fefmi%2fbadinformatics.htm" target="_blank"></a>Bad Health Informatics Can Kill. his site contains summaries of a number of reported incidents in healthcare where IT was the cause or a significant factor. It comes from the Working Group for Assessment of Health Information Systems of the European Federation for Medical Informatics (EFMI). </div><div class="PlainText" style="font-family:arial;"></div><div class="PlainText">7. The U.S. National Research Council’s "Current Approaches to U.S. Health Care Information Technology are Insufficient." 8. The UK Public Accounts Committee report on disastrous problems in their £12.7 billion national EMR program. 9. Gateway reviews of the UK National Programme for IT from the Office of Government Commerce (OGC) (released under the UK’s Freedom of Information Act). 10. A report on the serious problems with the Department of Defense’s AHLTA system, Electronic Records System Unreliable, Difficult to Use, Service Officials Tell Congress. (This system, as I <a href="http://hcrenewal.blogspot.com/2010/07/4-billion-military-emr-ahlta-to-be-put.html">wrote here</a>, is slated for abandonment. I cannot imagine it was greatly improving outcomes). 11. A New York Times report “Little Benefit Seen, So Far, in Electronic Patient Records” on Jha’s research at the Harvard School of Public Health, that compared 3,000 hospitals at various stages in the adoption of computerized health records and found little difference in the cost and quality of care. 12. An American Journal of Medicine paper “Hospital Computing and the Costs and Quality of Care: A National Study” by Himmelstein and Woolhandler at Harvard Medical School, that also concluded “as currently implemented, hospital computing might [very] modestly improve process measures of quality but not administrative or overall costs." 13. A Milbank Quarterly article “Tensions and Paradoxes in Electronic Patient Record Research: A Systematic Literature Review Using the Meta-narrative Method" by Greenhalgh, Potts, Wong, Bark and Swinglehurst at University College London. 14. Health Affairs, 29, no. 4 (2010): 639-646 Electronic Health Records’ Limited Successes Suggest More Targeted Uses, Catherine M. DesRoches et al. 15. NORCAL Mutual Insurance Company: "Electronic Health Records: Recognizing and Managing the Risks" (PDF <a href="http://www.norcalmutual.com/publications/claimsrx/oct_09.pdf">here</a>) </div></blockquote> My healthcare informatics graduate students are well aware of studies such as these. [Feb. 2011 addendum: see a much longer list at this link - <a href="http://hcrenewal.blogspot.com/2011/02/updated-reading-list-on-health-it.html">An Updated Reading List on Health IT</a> - ed.] Why isn't ONC Chairman Dr. Blumenthal? Perhaps equally as remarkable is this from <a href="http://www.trinity-health.org/index.htm">Trinity Health</a>, the healthcare system whose health IT crashed: <blockquote>We are not aware of any patient safety or quality of care issues caused by this event,” he said. </blockquote> Many of the "safety and quality" issues due to erroneous data in charts can come out weeks, months or even years later. The issue that the health IT cheerleaders seem to ignore is risk. Has the erroneous data been identified and corrected, I wonder? Probably not. According to the Huffington Post Investigative Fund article, they don't even know what caused the problem: <blockquote>... While doctors were concerned about the problems, ... [well, yes, I'd be quite frightened myself, especially considering who <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=koppel_kreda">holds the liabilities</a> for health IT defects - ed.] ... Shivinsky said that most are happy with the system and would “never go back to paper.” [That sounds very nice. Is it true? - ed.] Meanwhile technicians are still trying to figure out the root cause. “We’ll get to the bottom of it and fix it,” he said.</blockquote> Eventually, I would hope, since the kludged "correction" I heard about is that clinicians can now only open one electronic patient chart at a time, potentially slowing and impairing their work. I've emailed Mr. Shrivinsky asking if they'd truly identified and remediated the problem yet. -- SS

Huffington Post Investigative Fund: FDA, Obama Digital Medical Records Team at Odds over Safety Oversight

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Science or Politics? The New England Journal and "The 'Meaningful Use' Regulation for Electronic Health Records"

<div class="PlainText" style="font-family:arial;">In the NEJM article "The 'Meaningful Use' Regulation for Electronic Health Records", David Blumenthal, M.D., M.P.P. (ONC Chair) and Marilyn Tavenner, R.N., M.H.A. (10.1056/NEJMp1006114, July 13, 2010) available <a href="http://healthcarereform.nejm.org/?p=3732&query=home">at this link</a>, the opening statement is (emphases mine): </div><blockquote dir="ltr" style="margin-right: 0px;font-family:arial;"><div class="PlainText">The widespread use of electronic health records (EHRs) in the United States is inevitable. EHRs will improve caregivers’ decisions and patients’ outcomes. Once patients experience the benefits of this technology, they will demand nothing less from their providers. Hundreds of thousands of physicians have already seen these benefits in their clinical practice.</div></blockquote><div class="PlainText" style="font-family:arial;"> I think it fair to say those are grandiose statements and predictions presented with a tone of utmost certainty in one of the world's most respected scientific medical journals. </div><div class="PlainText" style="font-family:arial;"></div><div class="PlainText" style="font-family:arial;"> Even though it is a "perspectives" article, I once long ago learned that in writing in esteemed scientific journals of worldwide impact, statements of certainty were at best avoided, or if made should be exceptionally well referenced. </div><div class="PlainText" style="font-family:arial;"></div><div class="PlainText" style="font-family:arial;">I note the lack of footnotes showing the source(s) of these statements. </div><div class="PlainText" style="font-family:arial;"></div><div class="PlainText" style="font-family:arial;">I also note the lack of mention of literature refuting or potentially refuting these statements of certainty. I can think of more than a few examples of the latter just off the top of my head [ref. 1-15 below, certainly not a comprehensive list but merely skimming the surface]. </div><div class="PlainText" style="font-family:arial;"></div><div class="PlainText" style="font-family:arial;">In politics, however, no such sourcing is necessary. It's easy for a politician <a href="http://www.powerlineblog.com/archives/2010/07/026720.php" target="_blank">to say</a> "Free markets will not give us the healthcare system we want" or, conversely, "I <a href="http://www.powerlineblog.com/archives/2010/07/026746.php" target="_blank">never heard about</a> the DOJ's selective dismissal of charges against people intimidating voters at a voting site in Philadelphia." </div><div class="PlainText" style="font-family:arial;"></div><div class="PlainText" style="font-family:arial;">So, did the NEJM publish fact, or political platitude? </div><div class="PlainText" style="font-family:arial;"></div><div class="PlainText" style="font-family:arial;">Can someone provide a list of peer reviewed, rigorous studies that back the assertions of certainty in 10.1056/NEJMp1006114, and override the body of literature that could cast doubt on these assertions of certainty? Since it's people's lives at stake, not an inventory of widgets, I've promoted the idea of holding off on national roll outs until we: <ul style="font-family:arial;"><li>learn sufficiently from failures such as the UK's <a href="http://www.publications.parliament.uk/pa/cm200809/cmselect/cmpubacc/153/15304.htm">NPfIT</a> (National Programme for IT) in the NHS and our own military's <a href="http://hcrenewal.blogspot.com/2010/07/4-billion-military-emr-ahlta-to-be-put.html">AHLTA debacle</a> on how to avoid same, which can injure and kill patients and wastes massive money and resources healthcare can ill afford, and more importantly that can be better used elsewhere - such as care of the poor;</li></ul><ul style="font-family:arial;"><li>improve the technology's usability, safety and efficacy through the years of Medical Informatics and other disciplinary research needed, that was short circuited through the invention of the ONC office by Bush (although national HIT then remained a goal, not a mandate), and the 'militarization' of ONC under Obama whereby HIT was unilaterally declared a proven technology and mandated for national rollout;</li></ul><ul style="font-family:arial;"><li>end the contractual "hold vendor harmless clauses" (see Koppel and Kreda's 2009 JAMA article <a href="http://jama.ama-assn.org/cgi/content/extract/301/12/1276">here</a>), and fear-based censorship of information on health IT problems, patient injuries and deaths related to the devices; and</li></ul><ul><li>meaningfully regulate these devices that have increasingly become governors of care delivery. </li></ul> I have written extensively on these topics at this blog, at my <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/">academic website on health IT failure</a>, and other sources (see list at end of my <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/biography.htm">bio</a>). When there are significant doubts about a medication or medical device, we ought not push for national rollout. Health IT devices have gotten special accommodation, and it's not on the basis of any rigorous science I am familiar with. <style title="owaParaStyle">P { MARGIN-TOP: 0px; MARGIN-BOTTOM: 0px } BODY { SCROLLBAR-HIGHLIGHT-COLOR: #cecfce; SCROLLBAR-ARROW-COLOR: #3f52b8; SCROLLBAR-TRACK-COLOR: #fffbff; SCROLLBAR-DARKSHADOW-COLOR: #fafafa; SCROLLBAR-BASE-COLOR:-- S</style>-- SS </div> References: (hyperlinks to these and others can be found at my medical informatics teaching sites <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=other">here</a> and <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=2009">here</a>): <div class="PlainText" style="font-family:arial;"></div> <blockquote dir="ltr" style="margin-right: 0px;font-family:arial;"><div class="PlainText" style="font-family:arial;"></div><div class="PlainText" style="font-family:arial;">1. Health IT Project Success and Failure: Recommendations from Literature and an AMIA Workshop by Bonnie Kaplan and Kimberly D. Harris-Salamone. From the May/June 2009 issue of JAMIA. 2. "E-Health Hazards: Provider Liability and Electronic Health Record Systems.” Hoffman and Podgurski’s followup paper on EHR medical and legal risks 3. Role of Computerized Physician Order Entry Systems in Facilitating Medication Errors. Ross Koppel, PhD, et al, Journal of the American Medical Association, 2005;293:1197-1203 4. Electronic Health Record Use and the Quality of Ambulatory Care in the United States. Arch Intern Med. 2007;167:1400-1405. The authors examined electronic health records (EHR) use throughout the U.S. and the association of EHR use with 17 basic quality indicators. They concluded that “as implemented, EHRs were not associated with better quality ambulatory care.” 5. Pessimism, Computer Failure, and Information Systems Development in the Public Sector. (Public Administration Review 67;5:917-929, Sept/Oct. 2007, Shaun Goldfinch, University of Otago, New Zealand) 6. <a href="http://www.blogger.com/redir.aspx?C=cd79bb9ef239435c91597828510ff401&URL=http%3a%2f%2fiig.umit.at%2fefmi%2fbadinformatics.htm" target="_blank"></a>Bad Health Informatics Can Kill. his site contains summaries of a number of reported incidents in healthcare where IT was the cause or a significant factor. It comes from the Working Group for Assessment of Health Information Systems of the European Federation for Medical Informatics (EFMI). </div><div class="PlainText" style="font-family:arial;"></div><div class="PlainText">7. The U.S. National Research Council’s "Current Approaches to U.S. Health Care Information Technology are Insufficient." 8. The UK Public Accounts Committee report on disastrous problems in their £12.7 billion national EMR program. 9. Gateway reviews of the UK National Programme for IT from the Office of Government Commerce (OGC) (released under the UK’s Freedom of Information Act). 10. A report on the serious problems with the Department of Defense’s AHLTA system, Electronic Records System Unreliable, Difficult to Use, Service Officials Tell Congress. (This system, as I <a href="http://hcrenewal.blogspot.com/2010/07/4-billion-military-emr-ahlta-to-be-put.html">wrote here</a>, is slated for abandonment. I cannot imagine it was greatly improving outcomes). 11. A New York Times report “Little Benefit Seen, So Far, in Electronic Patient Records” on Jha’s research at the Harvard School of Public Health, that compared 3,000 hospitals at various stages in the adoption of computerized health records and found little difference in the cost and quality of care. 12. An American Journal of Medicine paper “Hospital Computing and the Costs and Quality of Care: A National Study” by Himmelstein and Woolhandler at Harvard Medical School, that also concluded “as currently implemented, hospital computing might [very] modestly improve process measures of quality but not administrative or overall costs." 13. A Milbank Quarterly article “Tensions and Paradoxes in Electronic Patient Record Research: A Systematic Literature Review Using the Meta-narrative Method" by Greenhalgh, Potts, Wong, Bark and Swinglehurst at University College London. 14. Health Affairs, 29, no. 4 (2010): 639-646 Electronic Health Records’ Limited Successes Suggest More Targeted Uses, Catherine M. DesRoches et al. 15. NORCAL Mutual Insurance Company: "Electronic Health Records: Recognizing and Managing the Risks" (PDF <a href="http://www.norcalmutual.com/publications/claimsrx/oct_09.pdf">here</a>) </div></blockquote><blockquote dir="ltr" style="margin-right: 0px;font-family:arial;"><div class="PlainText"> </div><div class="PlainText"> </div><div class="PlainText"></div></blockquote> Addendum 7/14: I think this statement at "The Road to Hellth" blog in a post entitled "<a href="http://roadtohellth.com/index.php?option=com_content&view=article&id=146:meaningful-ruse&catid=37:dapblog&Itemid=175">Meaningful Ruse</a>" that cites my posts is apropos: <blockquote>... Meaningful use entered our vocabulary in early 2009 as part of a $20+ billion gift from doctors, hospitals and the taxpayers to the needy folks at Cerner, GE, Siemens, Allscripts, Epic and other purveyors of complex, expensive and difficult-to-use and potentially even dangerous medical software products. </blockquote> -- SS

Science or Politics? The New England Journal and "The 'Meaningful Use' Regulation for Electronic Health Records"

In the NEJM article " The 'Meaningful Use' Regulation for Electronic Health Records ", David Blumenthal, M.D., M.P.P. (ONC...

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