healthy4u: IOM

More Perversity on Health IT Risks, and ... EHR Sense from Nurses on "Nurse Talk", a Syndicated Radio Show

As I mentioned on July 2 <a href="http://hcrenewal.blogspot.com/2013/07/is-oncs-definition-of-significant-ehr.html">at this post</a>, in a June 25, 2013 Bloomberg News article "<a href="http://www.bloomberg.com/news/2013-06-25/digital-health-records-risks-emerge-as-deaths-blamed-on-systems.html">Digital Health Records’ Risks Emerge as Deaths Blamed on Systems</a>" by technology reporter Jordan Robertson an EHR-harms case in which I am (unfortunately) intimately involved as substitute plaintiff is mentioned: that of the death of my mother. I'd previously written about EHR-related electronic encounters with truly perverse individuals at my Jan. 2010 post "More on Perversity in the Healthcare IT World: Is Meditech Employing Sockpuppets?" at <a href="http://hcrenewal.blogspot.com/2010/01/more-on-perversity-in-hit-world.html">http://hcrenewal.blogspot.com/2010/01/more-on-perversity-in-hit-world.html</a>. There were quite a few thoughtful comments in the reader comments of the June 25, 2013 Bloomberg article, but also the typical callous, incompetent and/or bizarre comments that an anonymous forum invites (really, semi-anonymous, as the website tracks IP's of commenters).  The anonymous comment below stood out from the rest as a worst-case example of perverse defense of health IT (it may have been removed by now): <blockquote class="tr_bq">Pharm Aid 1 week ago I'm surprised at the poor quality of reporting in this article.  First, Scot Silverstein has been on jihad against electronic medical records LONG before his dear mother passed away in 2011.  According to Silverstein's own website, he opposed EMRs back as far as 2009. Second, the article fails to mention Silverstein's conflict of interest here - he works in this space.  Essentially, Silverstein contacts a vendor of EMRs, offers his "consulting" services.  This totally smacks of a shakedown to me.  If they don't hire him, he criticizes them and claims they are killing people.  Don't take my word for it, check out his website and blog. Third, the number of medical errors from paper-based records is staggering.  According to a study from 7 years ago, a staggering number - 23% - of patients at one health system had medication errors attributed to illegible paper-based charts.  This is roughly consistent with other studies, including the epic IOM report on errors in medicine.</blockquote> Let me point out the perversities.  I am assuming the comment was not simply deliberately false character assassination and that the writer believed what he/she was writing - which if not, would show the industry's cheerleaders in an even worse light than if the assumption is the poster believes what he/she wrote: <ul><li>No expression of sympathy or remorse at my mother's death, whatever the cause.</li></ul><ul><li>Gross and almost humorously silly caricature of my "consulting" (which is as expert witness) and defamatory comments.</li></ul><ul><li>Gross mischaracterization of this blog and my Drexel Univ. healthcare informatics teaching site at <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases">http://www.ischool.drexel.edu/faculty/ssilverstein/cases</a>.</li></ul><ul><li>A mysterious invocation of some unnamed article on paper records at one health system.   I note that N=1 for both the mysterious unnamed study and its subject institution, representing the absolute worst regarding drawing conclusions, especially conclusions that we need to spend hundreds of billions of healthcare dollars on what today is largely bad health IT (see definitions of good and bad health IT at the aforementioned Drexel site).</li></ul><ul><li>An apparent mischaracterization of the "epic" 1999 IOM report "To Err is Human"on errors in medicine (<a href="http://www.iom.edu/~/media/Files/Report%20Files/1999/To-Err-is-Human/To%20Err%20is%20Human%201999%20%20report%20brief.pdf">http://www.iom.edu/~/media/Files/Report%20Files/1999/To-Err-is-Human/To%20Err%20is%20Human%201999%20%20report%20brief.pdf</a>).  It's clear that many if not most medical errors have nothing whatsoever to do with documentation, either paper or electronic (I made that point at my Dec. 2010 post "Is health IT the solution to the wrong problem?" at <a href="http://hcrenewal.blogspot.com/2010/12/is-healthcare-it-solution-to-wrong.html">http://hcrenewal.blogspot.com/2010/12/is-healthcare-it-solution-to-wrong.html</a>).  From that 1999 IOM report's summary:</li></ul><blockquote class="tr_bq">... Among the problems that commonly occur during the course of providing health care are adverse drug events and improper transfusions, surgical injuries and wrong-site surgery, suicides, restraint-related injuries or death, falls, burns, pressure ulcers, and mistaken patient identities. </blockquote><ul><li> As to "[my] claims that EHRs are [injuring and] killing people", I merely report what others find - that still others deliberately dismiss (e.g., as "anecdotal") - or ignore. Just the latest example is the ECRI Deep Dive study (<a href="http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html">http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html</a>).  171 health information technology-related problems voluntarily reported during a nine-week period to the ECRI Institute PSO from just 36 hospitals.  Eight of the incidents reported involved patient harm, and three may have contributed to patient deaths, said the institute.  Other examples appear at HC Renewal.</li></ul> In summary, there is someone out there who reads Bloomberg and who either 1) supports health IT, but lacks empathy, lacks judgment, and lacks scientific and critical thinking skills or 2) is simply a confabulator and liar. Perversity regarding health IT needs sunlight - lots of it. ----------------------- Here's some of that sunlight in a talk program on "Nurse Talk", a nationally syndicated radio show by and for nurses. <blockquote class="tr_bq"><a href="http://nursetalksite.com/">Nurse Talk</a> is heard on the air in major metropolitan areas on both the West and East Coasts, and worldwide on the Internet, and has partnerships with the largest groups of nurses in the country. </blockquote> Listen to the July 3, 2013 program "RNs DeAnn McEwen and Michelle Mahon on Electronic Medical Records" at <a href="http://nursetalksite.com/2013/07/03/rns-deann-mcewen-and-michelle-mahon/">http://nursetalksite.com/2013/07/03/rns-deann-mcewen-and-michelle-mahon/</a>. -- SS

More Perversity on Health IT Risks, and ... EHR Sense from Nurses on "Nurse Talk", a Syndicated Radio Show

As I mentioned on July 2 at this post , in a June 25, 2013 Bloomberg News article " Digital Health Records’ Risks Emerge as Deaths Blam...

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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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Bipartisan Policy Center's Health Innovation Initiative: Health IT Industry Officials Lying to Regulators With Impunity?

On Wednesday, February 13, 2013, The <a href="https://bipartisanpolicy.org/" target="_blank">Bipartisan Policy Center's</a> Health Innovation Initiative held a discussion on its new report: An Oversight Framework for Assuring Patient Safety in Health Information Technology.  The announcement is here:  <a href="https://bipartisanpolicy.org/news/press-releases/2013/02/bipartisan-policy-center-releases-recommendations-oversight-framework-pa">https://bipartisanpolicy.org/news/press-releases/2013/02/bipartisan-policy-center-releases-recommendations-oversight-framework-pa</a> The report is here (PDF):  "<a href="http://bipartisanpolicy.org/sites/default/files/Patient%20Safety%20Health%20IT_0.pdf" target="_blank">An Oversight Framework for Assuring Patient Safety in Health Information Technology.</a>" The "who's" of the<a href="https://bipartisanpolicy.org/" target="_blank"> Bipartisan Policy Center's</a> Health Innovation Initiative included these people: <ul><li>Senator Tom Daschle, Former U.S. Senate Majority Leader; Co-founder, Bipartisan Policy Center (BPC); and Co-leader BPC Health Project Carolyn M. Clancy, M.D., Director, Agency for Healthcare Research and Quality, Department of Health and Human Services</li><li>Farzad Mostashari, M.D., ScM, National Coordinator for Health Information Technology, Department of Health and Human Services </li><li>Peter Angood, M.D., Chief Executive Officer, American College of Physician Executives</li><li>Russ Branzell, Chief Executive Officer, Colorado Health Medical Group, University of Colorado Health</li><li>John Glaser, Ph.D., Chief Executive Officer, Siemens Health Services </li><li>Douglas E. Henley, M.D., FAAFP, Executive Vice President and Chief Executive Officer, American Academy of Family Physicians</li><li>Jeffrey C. Lerner, Ph.D., President and Chief Executive Officer, ECRI Institute</li><li>Ed Park, Executive Vice President and Chief Operating Officer, athenahealth</li><li>Emad Rizk, M.D., President, McKesson Health Solutions</li><li>Janet Marchibroda, Moderator; Director, BPC Health Innovation Initiative </li></ul> Unfortunately, I was unable to attend.  I was at the <a href="http://www.justicewinterconvention.org/" target="_blank">2013 Annual Winter Convention of the American Association for Justice</a> (Trial Lawyer's Association) in Florida, as an invited speaker on health IT risk, its use in evidence tampering, and other legal issues. <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/AVvXsEh1kTtcFaa9AlR4ehFZ2saSVQIFGGXDXX0oj-i8Ak1HQVCSfth5AWUu_Z2XZr0dLHOklLh0MpDCA_dcNT35QiGkJfroeHJDohpj7zLVKul8fjan3Ob9p4DSsotj8f0vdTceuobxQiizwqFv/s1600/aaj.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="192" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh1kTtcFaa9AlR4ehFZ2saSVQIFGGXDXX0oj-i8Ak1HQVCSfth5AWUu_Z2XZr0dLHOklLh0MpDCA_dcNT35QiGkJfroeHJDohpj7zLVKul8fjan3Ob9p4DSsotj8f0vdTceuobxQiizwqFv/s400/aaj.jpg" width="400" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">"United for Justice" - click to enlarge</td><td class="tr-caption" style="text-align: center;"> </td><td class="tr-caption" style="text-align: center;"> </td><td class="tr-caption" style="text-align: center;"> </td></tr></tbody></table><div class="separator" style="clear: both; text-align: center;"></div> I found the following statement from the Bipartisan Policy Center's Health Innovation Initiative <a href="http://bipartisanpolicy.org/sites/default/files/Patient%20Safety%20Health%20IT_0.pdf" target="_blank">report</a> remarkable as a "framework for health IT safety": <blockquote class="tr_bq">The Bipartisan Policy Center today proposed an oversight framework for assuring patient safety in health information technology. Among other guiding principles, the framework should be risk-based, flexible and assure patient safety is a shared responsibility, the authors said. “Assuring safety in clinical software in particular is a shared responsibility among developers, implementers, and users across the various stages of the health IT life cycle, which include design and development; implementation and customization; upgrades, maintenance and operations; and risk identification, mitigation and remediation,” the report states. Among other recommendations, the center said clinical software such as electronic health records and software used to inform clinical decision making should be subject to a new oversight framework, rather than traditional regulatory approaches [e.g.,  FDA - ed.] applied to medical devices given its lower risk profile.</blockquote> I find it remarkable that the health IT industry and its supporters now feel they can lie to our government and regulatory agencies with impunity.  Stating that health IT has a "lower risk profile" is an example. One cannot know what is acknowledged to be unknown. From the Institute of Medicine in its 2012 report on health IT safety: <blockquote class="tr_bq">Institute of Medicine. 2012. <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/Patient%20Safety%20and%20Health%20IT%20prepub.pdf" target="_blank">Health IT and Patient Safety: Building Safer Systems for Better Care</a> .  Washington, DC: The National Academies Press. ... While some studies suggest improvements in patient safety can be made, others have found no effect. Instances of health IT–associated harm have been reported. However, little published evidence could be found quantifying the magnitude of the risk. Several reasons health IT–related safety data are lacking include the absence of measures and a central repository (or linkages among decentralized repositories) to collect, analyze, and act on information related to safety of this technology. Another impediment to gathering safety data is contractual barriers (e.g., nondisclosure, confidentiality clauses) that can prevent users from sharing information about health IT–related adverse events. These barriers limit users’ abilities to share knowledge of risk-prone user interfaces, for instance through screenshots and descriptions of potentially unsafe processes. In addition, some vendors include language in their sales contracts and escape responsibility for errors or defects in their software (i.e., “hold harmless clauses”). The committee believes these types of contractual restrictions limit transparency, which significantly contributes to the gaps in knowledge of health IT–related patient safety risks. These barriers to generating evidence pose unacceptable risks to safety. ... More worrisome, some case reports suggest that poorly designed health IT can create new hazards in the already complex delivery of care. Although the magnitude of the risk associated with health IT is not known, some examples illustrate the concerns. Dosing errors, failure to detect life-threatening illnesses, and delaying treatment due to poor human–computer interactions or loss of data have led to serious injury and death.”  </blockquote> Even to those with particularly thick skulls, this statement seems easy to comprehend: "The magnitude of the risk associated with health IT is not known." I repeat once again: One cannot know what is acknowledged to be unknown. A statement that health IT has a "lower risk profile" compared to other regulated healthcare sectors such as devices or drugs, in order to seek continued and extraordinary regulatory accommodations, is remarkable.  It is either reckless regarding something that the statement's makers should know, or should have made it their business to know - or a deliberate prevarication with forethought. The report did attempt to shroud the declarative "lower risk profile" in a sugar coating through misdirection, citing the need to take into account "several factors" including: <blockquote class="tr_bq">"the level of risk of potential patient harm, the degree of direct clinical action on patients, the opportunity for clinician involvement, the nature and pace of its development, and the number of factors beyond the development stage that impact its level of safety in implementation and use." </blockquote> These "factors" speak to a higher level of potential risk, not lower, and are a justification for stronger regulatory oversight, not weaker.  I would opine that there is a possibility that health IT. through which almost all transactions of care need to pass (e.g., orders, results reporting, recording and review of observations, finding, diagnoses, prognoses, treatment plans, etc.), could have a higher risk profile than one-off devices or drugs.  Health IT affects every patient, not just those under a specific therapy or using a specific device or drug. Partial taxonomies developed from limited data themselves speak to the issue of a potentially huge risk profile of health IT, e.g., the FDA Internal Memo on HIT Risks (<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/Internal-FDA-Report-on-Adverse-Events-Involving-Health-Information-IT.pdf" target="_blank">link</a>), the AHRQ Hazards Manager taxonomy (<a href="http://healthit.ahrq.gov/HealthITHazardManagerFinalReport" target="_blank">link</a>), and the sometimes hair-raising voluntary defects reports (largely from one vendor) in the FDA MAUDE database (<a href="http://hcrenewal.blogspot.com/2011/01/maude-and-hit-risk-mother-mary-what-in.html" target="_blank">link</a>).  Further, health IT can and does affect thousands or tens of thousands of patients en masse even due to one simple defect, such as happened in Rhode Island at Lifespan (<a href="http://hcrenewal.blogspot.com/2011/11/lifespan-rhode-island-yet-another.html" target="_blank">link</a>), or due to overall design and implementation problems such as at Contra Costa County, CA (<a href="http://hcrenewal.blogspot.com/2012/09/in-addition-to-nurses-doctors-now-air.html" target="_blank">link</a>) and San Francisco's Dept. of Public Health (<a href="http://hcrenewal.blogspot.com/2010/11/avatar-fails-no-not-cameron-movie-but.html" target="_blank">link</a>). We don't know the true levels of risk and harm - but we need to, and rapidly.  Industry self-policing is not the answer; it didn't work in drugs and devices, and even with regulation there are still significant problems in those sectors.  (Imagine how it would be if those sectors received the special accommodations that health IT receives, and wishes to continue to receive.) My other issue is with the "shared responsibility" including "users." The user's responsibility is patient care, not being a beta tester for bug-laden or grossly defective health IT products.  Their responsibility ends at reporting problems without retaliation, and ensuring patient safety. Their responsibility is to avoid carelessness - as it is when they drive their cars. In other words, the inclusion of "users" in the statement is superfluous. It is not a responsibility to be omniscient and be held accountable when bad health IT promotes "use error" (the NIST definition of "use error" I will not repeat again here; search the blog) -- as opposed to and as distinct from "user error" - note the final "r" - i.e., carelessness. Bad health IT (see <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/" target="_blank">here</a>): <blockquote class="tr_bq">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> One special accommodation that the health IT industry has been afforded for far too long is to be able to "blame the user." "Blaming the victim" of bad health IT is a more appropriate description. -- SS

Bipartisan Policy Center's Health Innovation Initiative: Health IT Industry Officials Lying to Regulators With Impunity?

On Wednesday, February 13, 2013, The Bipartisan Policy Center's Health Innovation Initiative held a discussion on its new report: An Ov...

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HIMSS Senior Vice President on Medical Ethics: Ignore Health IT Downsides for the Greater Good

The Health Information Management Systems Society (<a href="http://www.himss.org/" target="_blank">HIMSS</a>) is the large health IT vendor trade group in the U.S.  At a Sept. 21, 2012 <a href="http://blog.himss.org/2012/09/21/will-health-it-increase-fraud-and-abuse/" target="_blank">HIMSS blog post</a>, <a href="http://blog.himss.org/author/jcasillas2/" target="_blank">John Casillas</a>, Senior Vice President of HIMSS Financial-Centered Systems and HIMSS Medical Banking Project dismisses concerns about health IT with the refrain: <blockquote class="tr_bq">... To argue that the existence of something good for healthcare in many other ways, such as having the right information at the point of care when it’s needed, is actually bad because outliers use it to misrepresent claims activity is deeply flawed. Through the best use of health IT and management systems, we have the opportunity to improve the quality of care, reduce medical errors and increase patient safety. Don’t let the arguments of some cast a cloud over the critical importance and achievement of digitizing patient health records. Surely, no one can argue paper records are the path forward. Name one other industry where this is the case. I can’t. Let’s not let the errors of a few become the enemy of good.</blockquote> The ethics of these statements from a non-clinician are particularly perverse. The statement "Don’t let the arguments of some cast a cloud over the critical importance and achievement of digitizing patient health records" is particularly troubling. When those "some" include organizations such as FDA (see FDA Internal 2010 memo on HIT risks, <a href="http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html" target="_blank">link</a>) and IOM's Committee on Patient Safety and Health Information Technology (see 2012 report on health IT safety, <a href="http://hcrenewal.blogspot.com/2011/11/iom-report-on-health-it-safety-nix-fda.html" target="_blank">link</a>) both stating that harms are definite but magnitude unknown due to systematic impediments to collecting the data, and the ECRI Institute having had health IT in its "top ten healthcare technology risks" for several years running, <a href="http://hcrenewal.blogspot.com/2012/03/ecri-institutes-top-health-technology.html" target="_blank">link</a>, the dismissal of "clouds" is unethical on its face. These reports indicate that nobody knows if today's EHRs improve or worsen outcomes over good paper record systems or not.  The evidence is certainly conflicting (see <a href="http://hcrenewal.blogspot.com/2011/02/updated-reading-list-on-health-it.html" target="_blank">here</a>). It also means that the current hyper-enthusiasm to roll out this software nationwide in its present state could very likely be at the expense of the unfortunate patients who find themselves as roadkill on the way to the unregulated health IT utopia. That's not medicine, that's perverse human subjects experimentation without safeguards or consent. As a HC Renewal reader noted: <blockquote class="tr_bq">Astounding hubris, although it does seem to be effective.  Such is PC hubris.  Who could ever call for reducing the budget of the NIH that is intended to improve health.  Has health improved?  No. So why does a group with spotty successes if not outright failure never get cut?  It’s not the results, it’s the mission that deserves the funding.  So it’s not the reality of HIT, it’s the promise, the mission, that gets the support.  Never mind the outcome, it’s bound to improve with the continued support of the mission.</blockquote> Is this HIMSS VP aware of these reports?  Does he even care? Does he believe patients harmed or killed as a result of bad health IT (and I know of a number of cases personally through my advocacy work, including, horribly, infants and the elderly) are gladly sacrificing themselves for the greater good of IT progress? It's difficult to draw any other conclusion from health IT excuses such as proffered, other than he and HIMSS simply don't care about unintended consequences of health IT. Regarding "Surely, no one can argue paper records are the path forward" - well, yes, I can.  (Not the path 'forward', but the path for now, at least, until health IT is debugged and its adoption and effects better understood).  And I did so argue, at my recent posts "<a href="http://hcrenewal.blogspot.com/2012/09/good-health-it-v-bad-health-it-paper-is.html" target="_blank">Good Health IT v. Bad Health IT: Paper is Better Than The Latter</a>" and "<a href="http://hcrenewal.blogspot.com/2012/09/a-reason-to-refuse-use-of-ehrs-in-your.html" target="_blank">A Good Reason to Refuse Use of Today's EHR's in Your Health Care, and Demand Paper</a>".  I wrote: <blockquote class="tr_bq">I opine that the elephant in the living room of health IT discussions is that bad health IT is infrequently, if ever, made a major issue in healthcare policy discussions. I also opine that bad health IT is far worse, in terms of diluting and decreasing the quality and privacy of healthcare, than a very good or even average paper-based record-keeping and ordering system.   This is a simple concept, but I believe it needs to be stated explicitly.  </blockquote> A "path forward" that does not take into account these issues is the path forward of the <a href="http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html" target="_blank">hyper-enthusiastic technophile</a> who either deliberately ignores or is blinded to technology's downsides, ethical issues, and repeated local and mass failures. If today's health IT is not ready for national rollout, e.g., causes harms of unknown magnitude (e.g., see <a href="http://hcrenewal.blogspot.com/search/label/glitch" target="_blank">this query link</a>), results in massive breaches of security as the "Good Reason" post above, and mayhem such as <a href="http://hcrenewal.blogspot.com/2012/09/in-addition-to-nurses-doctors-now-air.html" target="_blank">at this link</a>, then: The best - and most ethical - option is to slow down HIT implementation and allow paper-based organizations and clinicians to continue to resort to paper until these issues are resolved.  Resolution needs to occur in lab or experimental clinical settings without putting patients at risk - and with their informed consent. Anything else is akin to the medical experimentation abuses of the past that led to current research subjects protections such as the "<a href="http://grants.nih.gov/grants/policy/hs/ethical_guidelines.htm" target="_blank">Ethical Guidelines & Regulations</a>" used by NIH. -- SS

HIMSS Senior Vice President on Medical Ethics: Ignore Health IT Downsides for the Greater Good

The Health Information Management Systems Society ( HIMSS ) is the large health IT vendor trade group in the U.S. At a Sept. 21, 2012 HIMSS...

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

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

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

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

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Doctors and EHRs: Reframing the "Modernists v. Luddites" Canard to The Accurate "Ardent Technophiles vs. Pragmatists" Reality

One manner by which Healthcare's core values are usurped is via distortions and slander about physicians and other clinicians. At "<a href="http://hcrenewal.blogspot.com/2012/02/health-it-ddulites-and-irrational.html">Health IT: Ddulites and Irrational Exuberance</a>" and related posts (<a href="http://hcrenewal.blogspot.com/search/label/Ddulite">query link</a>) I've described the phenomenon of the: <blockquote>'Hyper-enthusiastic technophile who either deliberately ignores or is blinded to technology's downsides, ethical issues, and repeated local and mass failures.'</blockquote> I have called this personality type the "Ddulite", which is "Luddite" with the first four letter reversed. I have also pointed out that the two are not exact opposites, as the Luddites did not endanger anyone in trying to preserve their textile jobs, whereas the Ddulites in healthcare IT do endanger patients. Yet, in the 20 years I've been professionally involved in health IT, I have frequently heard the refrain, usually from IT personnel and their management, that "Doctors resists EHRs because they are [backwards, technophobic, reactionary, dinosaurs, unable/unwilling to change, think they are Gods, ..... insert other slanderous/libelous comment]. I've heard this at Informatics meetings, at medical meetings, at commercial health IT meetings (e.g., Microsoft's Health Users Group, and at <a href="http://www.himss.org/ASP/index.asp">HIMSS</a>), at government meetings (e.g., <a href="http://www.gs1.org/healthcare/about">GS1 healthcare</a>), and others. The summary catchphrase I've heard and seen (even in the comments on this blog) is that doctors are "Luddites" while IT personnel are forward-thinking, know better than doctors, and are "Modernists." This slander and libel of physicians and other clinicians needs to stop, and the entire issue needs to be reframed. Doctors are pragmatists. When a new technology is rigorously shown to be beneficial to patients, and (perhaps more importantly) rigorously shown not to be of little benefit or worse, significantly harmful, doctors will embrace it. There are countless examples of this that I need not go into. They also have responsibilities, obligations, ethical considerations, liabilities, and other factors to consider in their decisions: <blockquote><a href="http://www.merriam-webster.com/dictionary/pragmatism">Pragmatism</a> (Merriam-Webster): : a practical approach to problems and affairs <tried a="" and="" balance="" between="" pragmatism="" principles="" strike="" to=""> </tried></blockquote> The reality is not: <blockquote>Luddite doctors <---- are in tension with ----> Modernist IT personnel</blockquote> but is: <blockquote>Pragmatist doctors <---- are in tension with ----> Ardent technophiles (Ddulites) </blockquote> The technophiles' views may be due, on the one hand, to ignorance of medicine's true complexities and "innocent" overconfidence in technology. Unfortunately, it is a gargantuan leap of logic to go from "well, computers work in tracking FedEx packages and allowing me to withdraw money from my U.S. bank when I'm abroad, to "therefore with just a little work they will transform medicine." Anyone familiar with even the most fundamental issues in Medical Informatics is aware of this. (This is the problem with "generic management" of healthcare IT - healthcare amateurs are unfamiliar with these issues.) Due to the complex, messy social, scientific, informational, ethical, cultural, emotional and other issues relatively unique to medicine, that leap from banking/widget tracking/mercantile computing --> medicine is probably more naive than the leap in logic, for instance, that would have a person believe since a hot air balloon can go high in the sky, it can take a person to the moon, as I observed <a href="http://hcrenewal.blogspot.com/2009/01/wsj-waste-feared-in-digitizing-patient.html">here</a>. On the other hand the technophile's expressed views can also be a territorial ploy with full awareness of, and reckless disregard for, the consequences of technology's downsides. (The CIO where I was a CMIO was well-known to be an aficionado of Sun Tzu's "<a href="http://en.wikipedia.org/wiki/The_Art_of_War">Art of War</a>" in his corporate politics - the polar opposite of a 'team player.' I might add that the doctors were fully expected to be 'team players'.) Part of the struggle between the health IT industry and medical professionals has also been control of information flow about HIT. This has been brought to the fore by my observation of the almost uniformly negative comments on today's HIT at the physician-only site <a href="http://www.sermo.com/">Sermo.com</a>. Sermo is populated, I might add, not by computerphobes but by physicians in a wide variety of specialties using computers for social networking. These comments will hopefully soon be published. (They are not dissimilar to the many comments I reported in my Jan. 2010 post "<a href="http://hcrenewal.blogspot.com/2010/01/honest-physician-survey-on-ehrs.html">An Honest Physician Survey on EHR's</a>", although some might call the sponsor of the latter survey, <a href="http://www.aapsonline.org/">AAPS</a>, biased. I do not think the same can be said of Sermo.com, an open site for all physicians.) I have mentioned on this blog the numerous impediments to flow of information about health IT's downsides, and these impediments are well described, for example, in the Joint Commission Sentinel Events Alert on Health IT (<a href="http://www.jointcommission.org/assets/1/18/SEA_42.PDF">link</a>), the FDA Internal Memorandum on H-IT Safety (<a href="http://www.scribd.com/huffpostfund/d/33754943-Internal-FDA-Report-on-Adverse-Events-Involving-Health-Information-Technology">link</a>) and elsewhere (such as at <a href="http://hcrenewal.blogspot.com/2011/02/updated-reading-list-on-health-it.html">link</a>, <a href="http://hcrenewal.blogspot.com/search/label/healthcare%20IT%20safety">link</a>). The Institute of Medicine of the National Academies noted this in their <a href="http://hcrenewal.blogspot.com/2011/11/iom-report-on-health-it-safety-nix-fda.html">late 2011 study on EHR safety</a>: <blockquote>... While some studies suggest improvements in patient safety can be made, others have found no effect. Instances of health IT–associated harm have been reported. However, little published evidence could be found quantifying the magnitude of the risk. Several reasons health IT–related safety data are lacking include the absence of measures and a central repository (or linkages among decentralized repositories) to collect, analyze, and act on information related to safety of this technology. Another impediment to gathering safety data is contractual barriers (e.g., nondisclosure, confidentiality clauses) that can prevent users from sharing information about health IT–related adverse events. These barriers limit users’ abilities to share knowledge of risk-prone user interfaces, for instance through screenshots and descriptions of potentially unsafe processes. In addition, some vendors include language in their sales contracts and escape responsibility for errors or defects in their software (i.e., “hold harmless clauses”). The committee believes these types of contractual restrictions limit transparency, which significantly contributes to the gaps in knowledge of health IT–related patient safety risks. These barriers to generating evidence pose unacceptable risks to safety.[IOM (Institute of Medicine). 2012. <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/Patient%20Safety%20and%20Health%20IT%20prepub.pdf">Health IT and Patient Safety: Building Safer Systems for Better Care</a> (PDF). Washington, DC: The National Academies Press, pg. S-2.] </blockquote> Also in the IOM report: <blockquote class="tr_bq">… “For example, the number of patients who receive the correct medication in hospitals increases when these hospitals implement well-planned, robust computerized prescribing mechanisms and use barcoding systems. But even in these instances, the ability to generalize the results across the health care system may be limited. For other products— including electronic health records, which are being employed with more and more frequency— some studies find improvements in patient safety, while other studies find no effect. More worrisome, some case reports suggest that poorly designed health IT can create new hazards in the already complex delivery of care. Although the magnitude of the risk associated with health IT is not known, some examples illustrate the concerns. Dosing errors, failure to detect life-threatening illnesses, and delaying treatment due to poor human–computer interactions or loss of data have led to serious injury and death.”</blockquote> I note that the 'impediments to generating evidence' effectively rise to the level of legalized censorship, as observed by Koppel and Kreda regarding gag and hold-harmless clauses in their JAMA 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>", JAMA 2009;301(12):1276-1278. doi: 10.1001/jama.2009.398. Pragmatist physicians are quite rightly very wary of the technology as it now exists. Ultimately, even when information on HIT risks or defects does surface, it is highly inappropriately labeled as "anecdotal" (see <a href="http://hcrenewal.blogspot.com/2011/08/from-senior-clinician-down-under.html">this post on anecdotes</a> for why this behavior is inappropriate). This "anecdotalist" phenomenon occurs right up to the HHS Office of the National Coordinator for Health IT (ONC), as I described in my post "<a href="http://hcrenewal.blogspot.com/2011/04/common-sense-on-side-effects-lacking-in.html">Making a Stat Less Significant: Common Sense on 'Side Effects' Lacking in Healthcare IT Sector</a>" and elsewhere. Therefore, another part of reframing the pragmatism vs. technophilia issue is for clinicians to put an end to censorship of HIT adverse experiences. I have the following practical suggestions, used myself, to start to accomplish the latter goal. These suggestions are in the interest of protecting public health and safety: When a physician or other clinician observes health IT problems, defects, malfunctions, <a href="http://www.tinyurl.com/hostileuserexper">mission hostility</a> (e.g., poor user interfaces), significant downtimes, lost data, erroneous data, misidentified data, and so forth ... and most certainly, patient 'close calls' or actual injuries ... they should (anonymously if necessary if in a hostile management setting): (DISCLAIMER:  I am not responsible for any adverse outcomes if any organizational policies or existing laws are broken in doing any of the following.) <ul><li>Inform their facility's senior management, if deemed safe and not likely to result in retaliation such as being slandered as a "<a href="http://www.jpands.org/vol9no3/huntoon.pdf">disruptive physician</a>" and/or or being subjected to sham peer review (<a href="http://www.aapsonline.org/index.php/article/sham_peer_review_resources_physicians/">link</a>).</li></ul><ul><li>Inform their personal and organizational insurance carriers, in writing. Insurance carriers do not enjoy paying out for preventable IT-related medical mistakes. They have begun to become aware of HIT risks. See, for example, the essay on Norcal Mutual Insurance Company's newsletter on HIT risks<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=norcal"> at this link</a>. (Note - many medical malpractice insurance policies can be interpreted as requiring this reporting, observed occasional guest blogger <a href="http://hcrenewal.blogspot.com/search/label/Dr.%20Scott%20Monteith">Dr. Scott Monteith</a> in a comment to me about this post.)</li></ul><ul><li>Inform the Joint Commission (or similar national accreditor of hospital safety if not in the U.S.) via their complaint site at <a href="http://www.jointcommission.org/report_a_complaint.aspx">http://www.jointcommission.org/report_a_complaint.aspx</a> . Also consider writing the JC senior officers (<a href="http://www.jointcommission.org/about_us/joint_commission_officers.aspx">link to officer's list</a>), whose awareness of HIT issues I can personally attest to via our correspondences.</li></ul><ul><li>Inform the FDA (or similar healthcare regulator if not in the U.S.) via the FDA Medwatch Form 3500 reporting site at <a href="https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm">https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm</a>. An example of such an adverse event report I filed myself (when the involved hospital refused) is <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/Detail.CFM?MDRFOI__ID=1729552">at this link</a> in the FDA MAUDE (Manufacturer and User Facility Device Experience) database.</li></ul><ul><li>Inform the State Medical Society and local Medical Society of your locale.</li></ul><ul><li>Inform the appropriate Board of Health for your locale.</li></ul><ul><li>If applicable (and it often is), inform the Medicare Quality Improvement Organization (QIO) of your state or region. Example: in Pennsylvania, the QIO is "<a href="http://www.qipa.org/Home.aspx">Quality Insights of PA</a>."</li></ul><ul><li>Inform a personal attorney.</li></ul><ul><li>Inform local, state and national representatives such as congressional representatives. Sen. Grassley of Iowa is aware of these issues, for example.</li></ul><ul><li>As clinicians are often forced to use health IT, at their own risk even when "certified" (<a href="http://hcrenewal.blogspot.com/2012/02/hospitals-and-doctors-use-health-it-at.html">link</a>), if a healthcare organization or HIT seller is sluggish or resistant in taking corrective actions, consider taking another risk (perhaps this is for the very daring or those near the end of their clinical career). Present your organization's management with a statement for them to sign to the effect of:</li></ul><blockquote>"We, the undersigned, do hereby acknowledge the concerns of [Dr. Jones] about care quality issues at [Mount St. Elsewhere Hospital] regarding EHR difficulties that were reported, namely [event A, event B, event C ... etc.] We hereby indemnify [Dr. Jones] for malpractice liability regarding patient care errors that occur due to EHR issues beyond his/her control, but within the control of hospital management, including but not limited to: [system downtimes, lost orders, missing or erroneous data, etc.] that are known to pose risk to patients. We assume responsibility for any such malpractice. With regard to health IT and its potential negative effects on care, Dr. Jones has provided us with the Joint Commission Sentinel Events Alert on Health IT at <a href="http://www.jointcommission.org/assets/1/18/SEA_42.PDF" style="font-style: italic;">http://www.jointcommission.org/assets/1/18/SEA_42.PDF</a>, the IOM report on HIT safety at <a href="http://www.modernhealthcare.com/Assets/pdf/CH76254118.PDF" style="font-style: italic;">http://www.modernhealthcare.com/Assets/pdf/CH76254118.PDF</a>, and the FDA Internal Memorandum on H-IT Safety Issues at <a href="http://www.scribd.com/huffpostfund/d/33754943-Internal-FDA-Report-on-Adverse-Events-Involving-Health-Information-Technology" style="font-style: italic;">http://www.scribd.com/huffpostfund/d/33754943-Internal-FDA-Report-on-Adverse-Events-Involving-Health-Information-Technology</a>. CMO __________ (date, time) CIO ___________ (date, time) CMIO _________ (date, time) General Counsel ___________ (date, time) etc."</blockquote><ul><li>If the hospital or organizational management refuses to sign such a waiver (and they likely will!), note the refusal, with date and time of refusal, and file away with your attorney. It could come in handy if EHR-related med mal does occur.</li></ul><ul><li>As EHRs remain experimental, I note that indemnifications such as the above probably belong in medical staff contracts and bylaws when EHR use is coerced.</li></ul> These measures can help "light a fire" under the decision makers, and "get the lead out" of efforts to improve this technology to the point where it is usable, efficacious and safe. -- SS

Doctors and EHRs: Reframing the "Modernists v. Luddites" Canard to The Accurate "Ardent Technophiles vs. Pragmatists" Reality

One manner by which Healthcare's core values are usurped is via distortions and slander about physicians and other clinicians. At "...

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IOM Report - "Health IT and Patient Safety: Building Safer Systems for Better Care" - Nix the FDA; Create a New Toothless Agency

<div style="text-align: center;">[Authors' note: This major part of this post was written before I had the actual IOM report itself. Having now read that report, available <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/Patient%20Safety%20and%20Health%20IT%20prepub.pdf">here</a> in PDF, my opinions are unchanged.]</div> The <a href="http://www.iwatchnews.org/">Center for Public Integrity</a> has published a story ahead of the Thursday release of the Institute of Medicine's report on health IT safety. This was a panel, by the way, that rejected my testifying, live, about my own relative's IT-<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=diary"></a> related harm, despite my Medical Informatics credentials and explicit requests [see note below]. The IOM report apparently recommends that an extraordinary special accommodation be afforded to the healthcare IT industry regarding regulation of health IT software devices. Excerpts from the Center for Public Integrity's article: <a href="http://www.iwatchnews.org/2011/11/07/7325/panel-recommends-new-agency-regulate-safety-health-information-technology" itemprop="url"></a> <blockquote><div class="field field-name-body field-type-text-with-summary field-label-hidden clearfix" itemprop="description"><div class="field-items"><div class="field-item"><div style="font-weight: bold;"> <a href="http://www.iwatchnews.org/2011/11/07/7325/panel-recommends-new-agency-regulate-safety-health-information-technology" itemprop="url">Panel recommends new agency to investigate safety of health information technology</a></div>Health information technology has been touted as crucial to better health care, but a new report says an entirely new regulatory agency is needed to oversee this largely unregulated sector, which can also injure or kill patients if it’s not operating properly. </div></div></div></blockquote><div class="field field-name-body field-type-text-with-summary field-label-hidden clearfix" itemprop="description"><div class="field-items"><div class="field-item"><div style="color: black;"> </div><div style="color: black;">We would never have known that if not for the efforts of a small group of specialists with a conscience writing on this issue over the past decade; the industry long emphasized only the beneficence of the technology.</div> <blockquote>In pushing for a new oversight body, the respected Institute of Medicine, an independent research and advisory organization, is explicitly advising that the Food and Drug Administration (FDA) not be tasked with the job — a recommendation that is bound to be controversial. [Indeed - ed.]  The eagerly anticipated report, titled “Health IT and Patient Safety: Building Safer Systems for Better Care,” will be publicly released Thursday. A copy was obtained by iWatch News. The study details nine other recommendations for how to ensure patient safety when doctors and other health care providers use health information technology, or health IT. The findings from the report were presented October 28 to the Department of Health and Human Services (HHS) and its agencies.</blockquote> I do not consider the IOM's rationale for excluding the FDA to be reasonable...more below. <blockquote>... the push [by the Administration] is occurring so far without any agency really ‘watch dogging’ the safety of health IT — the software, hardware and systems that record and manage patients’ health information. These expensive devices by and large have not gone through any regulatory checks for safety in the way that food, drugs and other medical technology must; most of that oversight is handled by the FDA. But at the moment, no one is required to report instances of harm caused by health information devices and no government agency currently monitors their safety.</blockquote> This is a scandal of major proportions, considering the government has taken the approach "ready, shoot, aim" in putting in place penalties for non-adopters on a fantastically rushed timeline, via the HITECH Act within ARRA, while ignoring the risks. <blockquote>“With all of that money, marketing and public outreach, most simply affirm the value of health IT as an article of faith, rather than investigate it via careful evaluation,” said Ross Koppel, adjunct professor of sociology at the University of Pennsylvania and its School of Medicine, and investigator for RAND Corporation. He is listed as one of the reviewers of the report. </blockquote>"Faith" (e.g., irrational exuberance) in a technology has no place in science or medicine. Addendum:  from the report itself: <blockquote class="tr_bq">... While some studies suggest improvements in patient safety can be made, others have found no effect. Instances of health IT–associated harm have been reported. However, little published evidence could be found quantifying the magnitude of the risk. Several reasons health IT–related safety data are lacking include the absence of measures and a central repository (or linkages among decentralized repositories) to collect, analyze, and act on information related to safety of this technology. Another impediment to gathering safety data is contractual barriers (e.g., nondisclosure, confidentiality clauses) that can prevent users from sharing information about health IT–related adverse events. These barriers limit users’ abilities to share knowledge of risk-prone user interfaces, for instance through screenshots and descriptions of potentially unsafe processes. In addition, some vendors include language in their sales contracts and escape responsibility for errors or defects in their software (i.e., “hold harmless clauses”). The committee believes these types of contractual restrictions limit transparency, which significantly contributes to the gaps in knowledge of health IT–related patient safety risks. These barriers to generating evidence pose unacceptable risks to safety. </blockquote><blockquote class="tr_bq">[IOM (Institute of Medicine). 2012. <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/Patient%20Safety%20and%20Health%20IT%20prepub.pdf">Health IT and Patient Safety: Building Safer Systems for Better Care</a> (PDF). Washington, DC: The National Academies Press, pg. S-2.] </blockquote> Also in the IOM report: <blockquote class="tr_bq">… “For example, the number of patients who receive the correct medication in hospitals increases when these hospitals implement well-planned, robust computerized prescribing mechanisms and use barcoding systems. But even in these instances, the ability to generalize the results across the health care system may be limited. For other products— including electronic health records, which are being employed with more and more frequency— some studies find improvements in patient safety, while other studies find no effect. More worrisome, some case reports suggest that poorly designed health IT can create new hazards in the already complex delivery of care. Although the magnitude of the risk associated with health IT is not known, some examples illustrate the concerns. Dosing errors, failure to detect life-threatening illnesses, and delaying treatment due to poor human–computer interactions or loss of data have led to serious injury and death.”</blockquote> In other words, nobody has any real idea of the magnitude of harms, which also implies nobody knows if the magnitude of harms exceeds the magnitude of benefits.  National rollout under these conditions is a horribly unethical situation on first principles. <blockquote>Though a variety of studies have concluded that the use of health IT may improve patient safety, mistakes made in the systems or difficulty using the technology can lead to serious injury or death, according to the report. </blockquote> Other studies actually show little or no benefit or cost savings. See <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=readinglist">this reading list</a> for examples. So, it has been article of faith that the technology in its present form is of benefit, and is not a risk. <blockquote>An allergy might be omitted from a computer record, for example, or an incorrect medication dosage might be recorded. In Rhode Island, a Lifespan <a href="http://hcrenewal.blogspot.com/2011/11/lifespan-rhode-island-yet-another.html">computer glitch</a> [5] caused about 2,000 patients to receive the wrong types of medications. In <a href="http://www.huffingtonpost.com/2010/04/20/electronic-medical-record_n_545441.html">another instance</a> [6] in March 2009, an unattended patient suffered multiple seizures for hours after a computer failed to alert doctors the patient was moved from the intensive care into their ward.</blockquote> And people die needlessly (a few examples are at <a href="http://hcrenewal.blogspot.com/2010/07/maude-database-patient-outcome-death.html">link</a>, <a href="http://hcrenewal.blogspot.com/2011/06/babys-death-spotlights-safety-risks.html">link</a>, <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=diary">link</a>). <blockquote> As reports of patient harm began to emerge, the federal Office of the National Coordinator (ONC) for health IT asked the Institute of Medicine (IOM) a year ago to establish a Committee on Patient Safety and Health Information Technology to make recommendations to the government about how to maximize health IT safety.</blockquote> I would rephrase that to: as reports on patient harm were no longer able to be<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=koppel_kreda"> suppressed by the industry</a>... <blockquote> In its report, the IOM committee says the FDA would likely restrict market innovation in health IT, which could also jeopardize patient safety.</blockquote> There has been little to no real "innovation" in health IT in well over a decade; if anything, the usability and quality has deteriorated. Further, there is no data supporting the contention that FDA regulation of IT harms innovation. Pharma IT (regulated) is far more innovative than the IT in healthcare delivery (unregulated). <blockquote>Stringent regulations “can negatively impact the development of new technology by limiting implementation choices and restricting manufacturers’ flexibility to address complex issues,” the report says. </blockquote> Bull. It will keep the companies honest and "encourage" them to adhere to good software engineering and usability principles (unlike <a href="http://sydney.edu.au/engineering/it/%7Ehitru/index.php?option=com_content&task=view&id=91&Itemid=146">here</a>), which will save lives. It's unfortunate such "encouragement" is needed, I note. <blockquote>The FDA currently <a href="http://www.iwatchnews.org/2010/02/23/7047/fda-considers-regulating-safety-electronic-health-systems">receives voluntary reports</a> [7] of health IT-related incidents, but has no resources or protocols through which to take action; the agency <a href="http://www.vuvox.com/collage/detail/02b26ea6c3">has long fought a losing battle</a> [8] with health IT vendors over trying to monitor the technology. The report also notes the agency does not have the investigative capabilities, funding or manpower to regulate devices such as electronic health records, personal health records or health information exchanges. </blockquote>Then give them the resources, not develop an entire new agency. The FDA has the talent and experience. [Note: I have no connections to FDA whatsoever - ed.] <blockquote>... To adequately oversee health IT safety, the committee recommends that the secretary of health and human services create and fund a new independent watchdog agency, along the lines of the National Transportation Safety Board. Like NTSB, the new agency would conduct investigations and make recommendations for all stakeholders, including the secretary of the health and human services, vendors and health care organizations. Vendors of the technology would be required to report adverse events, while reporting would be voluntary for clinicians. Like NTSB, though, the new agency would also have no enforcement power. </blockquote> That is to say, it will be toothless and ignored, leaving a cavalier industry that should have gotten its act together twenty years ago to continue on with its nihilistic ways. <blockquote>The panel also recommends that the HHS secretary publicly report on the progress of health IT safety each year, beginning in 2012. If the secretary determines at any time that adequate safety progress has not been made, only then should the FDA take the regulatory lead and be given the resources to do so, the report recommends, adding that the agency should be developing a framework now to be prepared.</blockquote> This makes little sense. In fact, it's an extraordinary special accommodation to the health IT industry (or should I say lobby) relative to other healthcare medicine/device sectors, and is bizarre. It continues health IT as a <a href="http://hcrenewal.blogspot.com/2010/01/meaningfully-experimental-protocols-and.html">human subjects research experiment</a> without informed consent and opt-out. With catastrophe-inviting events like <a href="http://hcrenewal.blogspot.com/2011/11/lifespan-rhode-island-yet-another.html">this one</a> becoming more commonplace, just how many patients will have been maimed or died in the meantime while the HHS Secretary's 'determination of adequate safety progress' is being made? (What, exactly, will be deemed 'adequate', I also ask?) <blockquote>Creating a new independent agency would, of course, require resources; the current budget for NTSB is set at $559 million over the 2010 to 2014 period. In the current climate of fiscal restraint, convincing Congress to appropriate that sort of cash for a new government body might be a tall order.</blockquote> I note that it's a waste of taxpayer money to create a new agency to maintain/increase health IT industry profits at the expense of patients - not a wise choice IMO. <a href="http://www.grassley.senate.gov/"></a> <blockquote><a href="http://www.grassley.senate.gov/">... Republican Sen. Chuck Grassley</a> [11] of Iowa, senior member of the Senate Finance Committee, said the new report “adds more to the list of unresolved questions, including which government agency, if any, should regulate health care information technology.” Grassley, who <a href="http://media.washingtonpost.com/wp-srv/politics/documents/erecords102409.pdf">wrote</a> [12] HHS and health IT vendors two years ago asking what was being done to ensure the safety of the devices, said “the approach seemed to be, write checks first, solve the problems later, instead of the other way around.” </blockquote> Having spoken extensively with Sen. Grassley's staff on these issues, I agree - except for the "seemed to be" disclaimer. Replace "seemed to be" with "was." <blockquote>The Institute of Medicine committee does have one dissenter. Dr. <a href="http://news.uchicago.edu/profile/richard-cook">Richard Cook</a> [13] from the University of Chicago feels the FDA is indeed the proper agency to oversee health IT safety. Cook writes that health IT is considered a “Class III medical device,” that is to say, a device that performs integral medical functions, which the FDA already has the jurisdiction to regulate.</blockquote> Dr. Cook is a co-author of the short 2005 paper "<a href="http://www.ctlab.org/documents/Hiding%20in%20plain%20sight.pdf" style="font-weight: bold;">Hiding in plain sight: What Koppel et al. tell us about healthcare IT</a>" which I consider seminal in understanding why health IT as it exists today is so poorly done. <blockquote>In its report, the IOM panel also recommended that another study be done to quantify health IT-related deaths, serious injuries or unsafe conditions so that the safety concerns can be properly addressed. “You can only improve what you measure,” says the report.</blockquote> As I wrote in Oct. 2010, that is <a href="http://hcrenewal.blogspot.com/2010/10/cart-before-horse-again-institute-of.html">putting the cart before the horse again</a>. We study these issues while a national rollout under threat of penalty is underway? That's simply crazy. <blockquote>Other recommendations in the report: establishing and enforcing criteria for the safety of electronic health records, funding a new Health IT Safety Council to set standards for safety, and requiring all health IT vendors to publicly register and list their products with the Office of the National Coordinator.</blockquote></div></div></div> No issues there, except these efforts should have occurred over a decade ago, at the latest. Finally, while I disagree with the action agenda, I do thank the IOM for bringing the issues of health IT risks out into the sunlight. Perhaps now these issues will start to be addressed, and ultimately patient safety and human rights safeguarded. From the report's introduction: <blockquote>... Caught in the middle are the patients—the ultimate recipients of care. Stories of patient injuries and deaths associated with health information technologies (health IT) frequently appear in the news, juxtaposed with stories of how health professionals are being provided monetary incentives to adopt the very products that may be causing harm. These stories are frightening, but they shed light on a very important problem and a realization that, as a nation, we must do better to keep patients safe ... the entire committee believes the current state of safety of health IT must not be permitted to continue.</blockquote> I've been writing words like that for over a decade. -- SS Addendum Nov. 8, 2011: The IOM has issued this press release: <blockquote><div class="MsoNormal"> From: National Academies News <InternetMailforONPI@nas.edu> Date: November 8, 2011 8:25:43 AM PST To: National Academies News <InternetMailforONPI@nas.edu> Subject: Health Information Technology and Patient Safety - For Immediate Release Health Information Technology and Patient Safety – For Immediate Release</div><div class="MsoNormal"> </div>Health IT and Patient Safety: Building Safer Systems for Better Care, a new report from the Institute of Medicine, is available for IMMEDIATE RELEASE. The report examines a broad range of health information technologies and recommends actions that the government, health care providers, and technology vendors should take to improve patient safety. Contrary to some early news accounts, the report does not recommend that a new agency be established to regulate these technologies. Reporters can obtain a copy of the report by contacting the National Academies' Office of News and Public Information; tel. <a href="http://www.blogger.com/blogger.g?blogID=9551150" value="+12023342138">202-334-2138</a> or e-mail <a href="mailto:news@nas.edu" title="mailto:news@nas.edu">news@nas.edu</a>. In addition, members from the committee that wrote the report will discuss their recommendations and take questions at a one-hour public briefing starting at 10:30 a.m. EST Thursday, Nov. 10, in Room 100 of the National Academies’ Keck Center, 500 Fifth St. N.W., Washington, D.C. Those who cannot attend may participate through a live audio webcast accessible at <a href="http://www.nationalacademies.org/" target="_blank" title="http://www.nationalacademies.org/">http://www.nationalacademies.org</a>. </blockquote> I am not sure why they state "Contrary to some early news accounts, the report does not recommend that a new agency be established to regulate these technologies." From the report prepub, page 6-28 to 6-29: <blockquote> ... To truly improve patient safety, a new approach is needed. The committee believed that the experiences of other industries such as transportation and nuclear energy in creating the NTSB and the NRC were instructive, and concluded that the development of an independent, federal entity was best suited to performing the needed above-described analytic and investigative functions for health IT–related adverse events in a transparent, nonpunitive manner. The committee envisions an entity that would be similar in structure to the NTSB or the NRC, which are both independent federal agencies created by and reporting directly to Congress. Among other responsibilities, these entities conduct investigations, for the purpose of ensuring safety. NTSB is a nonregulatory agency that does not establish fault or liability in the legal sense but investigates incidents. The NRC is a regulatory body that has the ability to issue fines and fees. The committee considered both agencies and concluded the NTSB to be most similar to the needs of health IT–assisted care. An independent, federal entity analogous in form and function to the NTSB is needed. This entity would not have enforcement power and would be nonpunitive. Instead, it would have the authority to conduct investigations and, upon their completion, make recommendations. </blockquote>This recommendation followed: <blockquote style="font-weight: bold;"> ... Recommendation 8: The Secretary of HHS should recommend that Congress establish an independent federal entity for investigating patient safety deaths, serious injuries, or potentially unsafe conditions associated with health IT. This entity should also monitor and analyze data and publicly report results of these activities.</blockquote> Hopefully this issue will we clarified when the final report is generally available and the public briefing occurs. I hope it's not an issue over the word "entity" vs. "agency", a difference that in practice would probably make no difference, economically speaking. Addendum #2, Nov. 8, 2011: After re-reading all of this, it seems the issue at question in the National Academies press release above is "regulation" vs. "investigating and monitoring." That apparently being the case, let me state again that I have problems with the fact that the recommendations seem to preclude true regulation that should start ASAP, not at the whim of the Secretary of HHS when he/she decides that "adequate safety progress has not been made." That represents, in my opinion, a special accommodation to the healthcare IT industry as previously mentioned. In fact, Dr. Cook had a dissenting recommendation in Appendix E of the report that I agree with: <blockquote> Recommendation 9: The Secretary of Health and Human Services should direct the FDA to exercise its authority to regulate health IT, including all EHRs and associated components, and health information exchanges, as Class III medical devices. [Under the 1976 Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act - ed.]</blockquote> -- SS [Note] Regarding the IOM, my presenting in person the events that led to my relative's travails was rejected on the basis of 'protocol.' Despite the remarkable aspect of a physician/Medical Informatics specialist's relative (in fact, a specialist writing on health IT risks for over a decade) being gravely injured as a result of health IT-related disruption of care continuity, despite support for my personal attestation by internal members of the study group, my live testimony was rejected. Considering the issues were not just relevant to the IOM study, but at its heart, the rejection on procedural grounds brings to mind the <a href="http://en.wikipedia.org/wiki/Three_wise_monkeys">simian adage</a> "see no evil, hear no evil, speak no evil." The Institute of Medicine, on matters of life and death, acted more as an "Institute of Protocol" (or perhaps "Institute of Politics") in my opinion than an institute of science. I believe this lessens the credibility of their action agenda.

IOM Report - "Health IT and Patient Safety: Building Safer Systems for Better Care" - Nix the FDA; Create a New Toothless Agency

[Authors' note: This major part of this post was written before I had the actual IOM report itself. Having now read that report, avail...

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