healthy4u

Are the health IT hyper-enthusiasts inept, or merely insane?

From a psychiatrist, partially in response to the <a href="http://www.kaiserhealthnews.org/Stories/2013/February/18/Scot-Silverstein-health-information-technology.aspx" target="_blank">article about me in Kaiser Health News</a>, on the travails of health IT. They write: <blockquote class="tr_bq">... In psychiatry we screen for certain medication side effects using a tool called "DISCUS."  [Dyskinesia Identification System Condensed User Scale - ed.] In a paper and pen world, we (1) reviewed a single page; (2) circled a score; (3) signed and (4) dated. In [redacted] EHR, we need to do the following to complete one DISCUS…      DISCUS Completion in [redacted] EHR: <ul><li>1.  Log in;</li><li>2.  Acknowledge to do items by choosing “ok”;</li><li>3.  Go to “my to do list.”</li></ul>Then: <ul><li>4.  Double click specific date of to do items to complete (this reveals the specific to do items)</li><li>5.  Right click specific patient’s name</li><li>6.  Choose “enter option”</li><li>7.  Review all 3 pages under “assessment” tab (click through each page)</li><li>8.  Then choose “evaluation” tab</li><li>9.  Review “evaluation” (keeping in mind the total score from last page of “assessment”)</li><li>10.  Choose your “conclusion” in item 5</li><li>11.  Add “comments” as indicated (item 6)</li><li>12.  Under “name/ID number” type in the first characters of your last name (or your ID number)</li><li>13.  Select your name</li><li>14.  Go to the bottom under “select physician to notify” and UNcheck your name</li><li>15.  Click “yes” under “is evaluation section complete and ready to be locked?”</li><li>16.  Confirm above choice by choosing “ok”</li><li>17.  Press “submit” button across the top</li><li>18.  Now go back to “my to do list” and you’ll see that the item you just processed above is still there -- double click the same to do item that you just finalized (and processed in item 5 above)</li><li>19.  Then check “reviewed”</li><li>20.  Then press “submit”</li><li>21.  Then press “refresh” and the item will be completed (refresh does not need to be done after each DISCUS)</li></ul>Finally: <ul><li>22.  For processing of additional DISCUS for a given “sign on," go back to step 3, 4 or 5 (as needed), and repeat. </li></ul></blockquote> And this is just the easy stuff. I'm not a psychiatrist, but I can opine with confidence that anyone who expects human-computer interaction such as this to "revolutionize medicine" is insane. Perhaps this helps explain city-wide debacles such as <a href="http://hcrenewal.blogspot.com/2010/11/avatar-fails-no-not-cameron-movie-but.html" target="_blank">this</a> in San Francisco. -- SS

Are the health IT hyper-enthusiasts inept, or merely insane?

From a psychiatrist, partially in response to the article about me in Kaiser Health News , on the travails of health IT. They write: ... In ...

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Another Revolving Door Variant: From Academia with Millions in Medtronic Royalties, to the White House, to the Health Care Service Corp

The revolving door spins, and where it will stop, nobody knows... In October, 2010, we noted questions about how Dr Stephen Ondra got to be a <a href="https://www.va.gov/opa/bios/docs/ondra.pdf">Senior Policy Adviser for the US Department of Veterans Affairs</a>. A veteran who was a neurosurgery professor at Northwestern University, Dr Ondra had received millions of dollars in royalties from device manufacturer Medtronic, whose CEO supported his appointment to the government position  (see this <a href="http://hcrenewal.blogspot.com/2010/10/toxic-and-dangerous-watchdog-vs.html">post</a>).  As soon as he was appointed, he publicly opposed a nominee for US Surgeon General who had been critical of the medical device industry, and its financial ties to doctors. After going to Washington, Dr Ondra apparently also served in the Executive Office of the President, in the White House, but <a href="http://triblocal.com/lake-forest/community/stories/2012/04/northwestern-memorial-hospital-names-stephen-l-ondra-chief-medical-officer/">returned</a> to Northwestern University in 2012.  However, he did not stay there for long. This month, a <a href="http://www.forbes.com/sites/brucejapsen/2013/02/07/obama-advisor-ondra-hired-as-top-doc-at-blue-cross-plan/">post</a> on Forbes indicated he is moving on again, and back to the corporate side of health care. <blockquote class="tr_bq">the nation’s fourth-largest health insurance company is naming a key former health advisor to President Obama as its top doctor. Dr. Stephen Ondra, will become senior vice president and chief medical officer at Health Care Service Corp., the Chicago-based parent company of Blue Cross plans in Illinois, Texas, Oklahoma and New Mexico. The plan has more than 13 million health plan members and is looking to grow even more, announcing last year a proposed partnership with the Blue Cross plan in Montana.</blockquote> Health Care Service Corp is a mutual insurance company, that is, a company owned by its policy-holders rather than stock holders.  However, that does apparently not make it any more ascetic than a typical for-profit insurance company, at least in terms of generosity towards its top hired executives.  As Crain's Chicago Business <a href="http://www.chicagobusiness.com/article/20120515/NEWS03/120519922/blue-cross-parents-ceo-pay-climbs-to-12-9-million">reported</a> in 2012, <blockquote class="tr_bq">New federal regulations intended to force health insurers to spend less on administration didn't keep the parent of Blue Cross & Blue Shield of Illinois from paying CEO Patricia Hemingway Hall more than $12.9 million in 2011, a 61 percent raise. The Health Care Service Corp. chief executive's total compensation last year dwarfed the $8 million she received in 2010, according to a filing with the Illinois Department of Insurance. The 2011 increase was fueled by an $11.8 million bonus, which was 69 percent above her 2010 bonus of $7 million. Ms. Hall wasn't alone in getting a big raise at Health Care Service, whose insurance business booked net income of more than $1 billion in 2011, for the second straight year. The 10 highest-paid executives at the Chicago-based mutual company — which operates Blue Cross plans in Illinois and three other states — earned a collective $41.7 million, 65 percent more than the $25.3 million they were paid in 2010.</blockquote>  If Dr Ondra's new position puts him among the latter group of executives, he too stands to make millions a year.  So to recap Dr Ondra's career so far, in 2010 he was a medical school professor who had earned millions in royalties from Medtronic.  He then went to top leadership positions in the US Veterans Department and Executive Office of the President.  He returned briefly to Northwestern University, only to leave again for a top executive position in for-profit insurance company Health Care Service Corp, where he is likely to make millions more. Thus Dr Ondra is our latest interesting example of the "<a href="http://hcrenewal.blogspot.com/search/label/revolving%20doors">revolving door</a>" phenomenon in health care.  He started as an erstwhile academic physician but with a very major financial relationship with a medical device company.  He then went through the door the first time into the US government, and then a second time from the government to a for-profit insurance company, with just a brief stop-over in academia. By the way, it appears that all of this is quite legal.  It does again raise questions about whether health care leaders in government with previous relationships with industry might still feel undue sympathy to the interests of industry, as might government leaders who can expect future jobs in industry. Moreover, this case, like previous cases we have discussed,  indicates how leadership in academic health care, corporate health care, and the government tend to blend together.  Leaders of one type of organization have more and more in common with leaders of the other types of organizations than they do with their lesser ranked colleagues, and certainly than with other health care constituencies.  So the more the revolving door revolves, the more we wonder about the <a href="http://hcrenewal.blogspot.com/search/label/corporatism">corporatism</a> of health care, about how health care seems to be increasingly run by an amorphous group of academic/ corporate/ government leaders whose loyalties may be more to each other than to academic and professional values, patients' and the public's health, and government of, by and for the people.

Another Revolving Door Variant: From Academia with Millions in Medtronic Royalties, to the White House, to the Health Care Service Corp

The revolving door spins, and where it will stop, nobody knows... In October, 2010, we noted questions about how Dr Stephen Ondra got to be ...

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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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A Right Royal Mess: EHRs and Royal Berkshire NHS Foundation Trust

Almost every theme I've written about for the past 15 years, at this blog and at my teaching site (<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/" target="_blank">link</a>) regarding health IT mismanagement is present here: <blockquote class="tr_bq"><a href="http://www.ehi.co.uk/insight/analysis/1033/a-right-royal-mess" target="_blank">A Right Royal Mess</a>      ehealth INSIDER 12 February 2013 Newly released reports on Royal Berkshire NHS Foundation Trust’s implementation of Cerner Millennium show that many crucial issues were not addressed prior to go-live; and that the trust is continuing to face considerable operational and financial issues because of the system. Rebecca Todd reports.</blockquote> Read it at the link above. I feel this scenario is being repeated in many countries, including the U.S., with many different vendor products.  The industry's pathologies and self-serving memes are difficult to overcome. As Orwell said:  "To see what is in front of one's nose needs a constant struggle." But don't worry...you're perfectly safe.  Computers, after all, improve healthcare and are entirely beneficent, according to the pundits.  Every untoward event is a mere "anecdote." -- SS Addendum 2/15/13:  just to illustrate my point, there's also this: <blockquote class="tr_bq"><a href="http://www.ehi.co.uk/news/EHI/8392/monitor-blasts-rotherham%27s-epr-programme" target="_blank">Monitor blasts Rotherham's EPR programme</a> ehealth INSIDER 15 February 2013 Lis Evenstad  The Rotherham NHS Foundation Trust has been found in significant breach of its terms of authorisation by Monitor, with its electronic patient record implementation identified as a key issue. The trust this month admitted it was facing "persistant serious issues" with the deployment of its Meditech EPR including "clinician and staff acceptance and usability" ... “The trust has not managed EPR implementation in an effective way and significant operational and financial risks will remain until the trust has a robust and operationally effective EPR system." ... “It is unclear whether the trust has sufficient visibility over operational performance and quality issues, including incidents of patient harm,” it adds.</blockquote> -- SS

A Right Royal Mess: EHRs and Royal Berkshire NHS Foundation Trust

Almost every theme I've written about for the past 15 years, at this blog and at my teaching site ( link ) regarding health IT mismanage...

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A Sewage-Laden Cruise Ship, Burning Aircraft Batteries, Neo-Nazi Factory Security - Will Jaw Dropping Cases Prompt the Public to Demand Better Leadership?

The dysfunction of modern health care likely arises from larger trends within the economy and the society.  We frequently discuss how poor leadership and governance within health care and other organizations exist in a context of <a href="http://hcrenewal.blogspot.com/2012/04/health-care-dysfunction-explained-by.html">focus on short-term revenue</a> above all else (<a href="http://hcrenewal.blogspot.com/search/label/financialization">financialization</a>); <a href="http://hcrenewal.blogspot.com/search/label/perverse%20incentives">perverse incentives,</a> particularly leading to <a href="http://hcrenewal.blogspot.com/search/label/executive%20compensation">excess executive compensation</a> unrelated to leaders' actions or performance; <a href="http://hcrenewal.blogspot.com/search/label/deception">deception</a>, especially in <a href="http://hcrenewal.blogspot.com/search/label/marketing">marketing</a> and <a href="http://hcrenewal.blogspot.com/search/label/public%20relations">public relations</a> coupled to suppression of internal <a href="http://hcrenewal.blogspot.com/search/label/free%20speech">dissent </a>and <a href="http://hcrenewal.blogspot.com/search/label/whistle-blowers">whistle blowing</a>;  <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">lax regulation and law enforcement</a>, in a climate of <a href="http://hcrenewal.blogspot.com/search/label/regulatory%20capture">regulatory capture </a>and by governments afflicted with the <a href="http://hcrenewal.blogspot.com/search/label/revolving%20doors">revolving door</a> allowing <a href="http://hcrenewal.blogspot.com/search/label/conflicts%20of%20interest">conflicts of interest</a> and <a href="http://hcrenewal.blogspot.com/search/label/health%20care%20corruption">corruption</a>, etc, etc. I was thinking of this last weekend while like many Rhode Islanders we were shivering in an unheated house.  A big but not unprecedented snow storm had apparently caused the failure of multiple high-voltage electrical transmission lines and substations, which should be designed to resist such conditions.  (<a href="http://news.providencejournal.com/breaking-news/2013/02/national-grid-says-cause-still-unknown-for-failure-of-high-voltage-lines-se.html">National Grid says cause still unknown for failure of high-voltage lines serving East Bay, Aquidneck Island.</a>) Poor leadership and governance under these circumstances likely lead to threats to public health and safety.  Focus on cost-cutting and current revenue to drive executive compensation may lead to bad design, manufacture, and maintenance of critical systems.  So maybe we should not be surprised at a recent barrage of cases involving threats to health and safety by well-known corporations: <a href="http://www.telegraph.co.uk/finance/newsbysector/retailandconsumer/9821366/Walmart-in-supply-chain-crackdown-after-Bangladesh-factory-fire.html">Walmart in Supply Chain Crackdown after Bangladesh Factory Fire </a> <a href="http://www.dailymail.co.uk/news/article-2268210/Apple-vows-eradicate-child-labour-workforce-increased-audits-following-suicide-report-reveal-problem-persists.html">Apple Vows to Eradicate Child Labour from Workforce</a> <a href="http://www.salon.com/2013/02/14/taibbi_hsbc_got_away_with_murder/singleton/">HSBC Got Away with Murder: the Bank Laundered Money for Drug Traffickers and Terrorist Groups... </a> <a href="http://online.wsj.com/article/SB10001424127887324624404578253010041254492.html">Probe of Boeing 787 Battery Fire Expands</a> <a href="http://www.nydailynews.com/news/world/passengers-crippled-cruise-ship-face-long-bus-rides-article-1.1264072">Sewage-laden Carnival Cruise Ship Docks in Mobile, Alabama: Passengers Finally Disembark from Vacation Vehicle Turned Smelly Nightmare</a> <a href="http://www.belfasttelegraph.co.uk/news/world-news/amazon-used-neonazi-guards-to-keep-immigrant-workforce-under-control-in-germany-29070825.html">Amazon 'used neo-Nazi guards to keep immigrant workforce under control' in Germany</a> Those were just the cases I could easily recall.  Readers are invited to add more to the comments section. At least, I don't think I can blame poor leadership and governance for a huge exploding meteor: <iframe allowfullscreen="" frameborder="0" height="315" src="http://www.youtube.com/embed/90Omh7_I8vI" width="560"></iframe> But maybe a society less dominated by top insiders skimming off more and more money would be better prepared for the next meteor strike. One can only hope that this onslaught of increasingly jaw-dropping cases that threaten health and safety that would have been unimaginable a short time ago might lead the public to demand accountable, transparent, mission-focused, honest leadership of the big organizations, for-profit, non-profit and governmental, that now control our lives.

A Sewage-Laden Cruise Ship, Burning Aircraft Batteries, Neo-Nazi Factory Security - Will Jaw Dropping Cases Prompt the Public to Demand Better Leadership?

The dysfunction of modern health care likely arises from larger trends within the economy and the society. We frequently discuss how poor l...

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Carolinas Healthcare System Pays Executives Even More

In May, 2012, we <a href="http://hcrenewal.blogspot.com/2012/05/from-serving-poor-to-pay-executives.html">discussed</a> the contrast between the outsize compensation given to top executives of Carolinas Healthcare System, a large tax-exempt public hospital authority, and the apparent failure of the system to fulfill it promise to provide community care.  Now we can update that story. 2012 Executive Compensation The Charlotte Observer <a href="http://www.charlotteobserver.com/2013/02/06/3835851/charlotte-hospital-pay.html">reported </a>on the compensation given to top executives at the Carolinas Health Care System in 2012: <blockquote class="tr_bq">The top executive at Carolinas HealthCare System received $4.76 million in 2012 compensation, a 12 percent increase over 2011, as the system celebrated a profitable year and met all of its systemwide performance goals, the system announced. CEO Michael Tarwater, 59, who has led the $7.5 billion nonprofit system for more than 10 years, received a salary of $1.1 million, two bonuses totaling $2.8 million, and other compensation, including retirement and health benefits, of $795,724. The top 10 executives at Carolinas HealthCare each received more than $1 million in total compensation. Most received increases of more than 8 percent.</blockquote> A more detailed list, which included the rate of increase since 2011:: <blockquote class="tr_bq">Michael Tarwater, CEO: $4,760,026 – 12.36 percent increase Joseph Piemont, president and chief operating officer: $2,880,926 – 13.57 percent increase Greg Gombar, chief financial officer: $1,898,027 – 8.35 percent increase Laurence Hinsdale, executive vice president: $1,844,413 – 8.92 percent increase Paul Franz, executive vice president: $1,704,671 – 8.17 percent increase Dennis Phillips, executive vice president: $1,420,521 – 5.14 percent increase Dr. Roger Ray, chief medical officer: $1,315,148 – 21.76 percent increase John Knox, chief administrative officer: $1,296,185 – 8.24 percent increase Debra Plousha Moore, executive vice president: $1.145,357 – increase not available Russell Guerin, executive vice president: $1,141,171 million – 7.56 percent increase </blockquote><div style="color: black; font: 10pt sans-serif; height: 1px; overflow: hidden; text-align: left; text-transform: none; width: 1px;"> Read more here: http://www.charlotteobserver.com/2013/02/06/3835851/charlotte-hospital-pay.html#storylink=cpy</div><div style="color: black; font: 10pt sans-serif; height: 1px; overflow: hidden; text-align: left; text-transform: none; width: 1px;"> Read more here: http://www.charlotteobserver.com/2013/02/06/3835851/charlotte-hospital-pay.html#storylink=cpy</div> Also here were the compensation figures for some leaders of individual hospitals within the system: <blockquote class="tr_bq">Others in Carolinas HealthCare System - 2012 • Spencer Lilly, president, Carolinas Medical Center: $633,326 • Robert Larrison, president, Carolinas Rehabilitation: $348,976 • Douglas Roush, president, CMC-Mercy: $262,745 • Christopher Hummer, president, CMC-Pineville: $549,616 • William Leonard, president, CMC-University: $378,369 • Phyllis Wingate-Jones, president, CMC-NorthEast: $761,160 • Peter Acker, president, CMC-Lincoln: $385,847 • Michael Lutes, president, CMC-Union: $488,427 </blockquote><div style="color: black; font: 10pt sans-serif; height: 1px; overflow: hidden; text-align: left; text-transform: none; width: 1px;"> Read more here: http://www.charlotteobserver.com/2013/02/06/3835851/charlotte-hospital-pay.html#storylink=cpy</div> The Context The context is that Carolinas Healthcare is a large tax-exempt public hospital system that claims that it "works to improve and enhance the overall health and wellbeing of its communities" according to <a href="http://www.carolinashealthcare.org/about-chs">its web-site</a>.  However, there have been accusations, for example here by "Jessica Curtis, director of the Hospital Accountability Project for Community Catalyst in Boston," that is has been <blockquote class="tr_bq">'...sending very low income patients to collections and suing them as well.' The Observer and The News & Observer reported last year that during the five years ending in 2010, North Carolina hospitals filed more than 40,000 lawsuits. Most of the suits were filed by Carolinas HealthCare.</blockquote> Note that we discussed the contrast between this hospital system's public nature and aspirational statements about serving the community on one had, and its oversize executive compensation on the other hand <a href="http://hcrenewal.blogspot.com/2012/05/from-serving-poor-to-pay-executives.html">here</a>.  Since then, executive compensation has only gone up. The Usual Talking Points for Justification Of course, when asked, defenders of the hospital system gave the stock justifications.  For example, <blockquote class="tr_bq">Carolinas HealthCare officials said executive compensation is 'performance based' and reflects the system’s growth. </blockquote> The Observer found a health care executive compensation consultant to make the usual arguments about the need to pay market rates to prevent supposedly talented executives from being recruited elsewhere: <blockquote class="tr_bq"> Consultants who assist hospitals in setting executive compensation say they compare peers at hospital systems of comparable size, complexity and performance. 'If , he’s going to get paid higher in the range. That individual is very vulnerable to being recruited away' said Bob Erra, president of Integrated Healthcare Strategies. 'The last thing a compensation committee wants to do is to lose a leader over pay,' said Erra, whose Minneapolis-based firm works with Novant Health but not Carolinas HealthCare.</blockquote>  Just as we mentioned in our <a href="http://hcrenewal.blogspot.com/2013/02/non-profit-hospital-executive-salaries.html">most recent post</a>, whenever anyone bothers to try to justify extravagant executive compensation at hospitals, and for that matter, most other health care organizations throughout the US, they seem to repeat the same set of talking points.    We first listed the talking points <a href="http://hcrenewal.blogspot.com/2011/09/talking-points-sans-original-thought-to.html">here</a>, and then provided additional examples of their use <a href="http://hcrenewal.blogspot.com/2011/09/more-repeats-of-talking-points.html">here</a>, <a href="http://hcrenewal.blogspot.com/2012/03/example-of-how-complex-takes-control.html">here</a> and <a href="http://hcrenewal.blogspot.com/2012/12/health-care-hired-managers-not-playing.html">here</a>.   The talking points are: -  we pay what everyone else pays -  CEOs work hard and are brilliant, and so deserve high pay -  high pay is needed to attract and retain competent, if not brilliant people. Note that without specific evidence to back them up, the first two talking points at least are logical fallacies.  The first is an <a href="http://www.nizkor.org/features/fallacies/appeal-to-common-practice.html">appeal to common practice</a>.  The second is an <a href="http://www.nizkor.org/features/fallacies/appeal-to-authority.html">appeal to authority</a>. None of the examples of these talking points we have seen so far explain why these apply to CEOs and other top hired managers, but not to other kinds of employees. So it should be no surprise that the justifications for the largess to hospital executives at Carolinas follow the talking points yet again. -  We Pay What Everyone Else Pays => "they compare peers at hospital systems of comparable size, complexity and performance."  Note further that it is hard to believe the comparisons were only to other public hospital systems, that is, hospital systems run by local government - CEOs Work Hard and Are Brilliant => "(the CEO) is a high performer...."  Note further that as usual no evidence of the CEO's specific performance was offered. - High Pay Needed for Retention => "That individual is very vulnerable to being recruited away."  Note that as we wrote recently, most CEOs are recruited from within the organization, and no specific evidence that this specific CEO was particularly likely to be recruited away was offered.  So as is usual, underlying these talking points there was no evidence, nor arguments that would make them more logical. Summary: the More Things Change The more they stay the same.  Thus this seems to be yet another example of how top managers almost always now seem able to personally profit from their positions of trust.  In this particular example, however, these were managers of a public organization, so it may be possible that public pressure could make them more accountable and hold them to more reasonable pay.   So to repeat my conclusions from 2012....  The governance of this organization, like that of many others we have discussed, needs to regain accountability, transparency, integrity, and ethics. It must insist that the leaders it hires uphold the mission ahead of other concerns, particularly personal enrichment. It must provide these leaders with realistic incentives based on how well they uphold this mission, not on revenue or operating margin. Until such changes are accomplished, expect this hospital system, like many other health care organizations, to contribute only to our ever rising prices, declining access, and stagnating health care quality.

Carolinas Healthcare System Pays Executives Even More

In May, 2012, we discussed the contrast between the outsize compensation given to top executives of Carolinas Healthcare System, a large ta...

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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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