Patient Safety & Quality Healthcare: "Malpractice Claims Analysis Confirms Risks in EHRs"

Two "<i>EHR beneficence is not exactly as advertised</i>" stories in one day.  It's hard to keep up:<br /><br />After my earlier post today <a href="http://hcrenewal.blogspot.com/2014/02/ehrs-real-story-sobering-assessment.html">"EHRs: The Real Story" - Sobering assessment from Medical Economics</a>, now there's this.<br /><br />From the journal "Patient Safety & Quality Healthcare" (<a href="http://www.psqh.com/%E2%80%8E">PSQH</a>):<br /><br /><b>Malpractice Claims Analysis Confirms Risks in EHRs</b><br /><b>Jan/Feb 2014 </b><br /><br />Article available at <a href="http://www.cci.drexel.edu/faculty/ssilverstein/PSQH_MalpractClaimsAnalyConfirRisksEHR.pdf">this link</a>.<br /><br /><blockquote class="tr_bq">[Short header on several EHR-related care foul ups]<br /><br />... Distressing situations like those described above are happening around the country as healthcare organizations adopt electronic health records (EHRs) in growing numbers. Although these systems promise to reduce costs and improve quality and safety, they’ve also ushered in unintended consequences as a result of human error, design flaws, and technology glitches.<br /><br />Recognizing these emerging risks, CRICO—the patient safety and medical malpractice insurer for the Harvard medical community— is taking action. The Massachusetts-based company has expanded its proprietary coding system to capture EHR-related problems that have contributed to patient harm, and to guide the hospitals, physicians, and other providers it serves toward addressing vulnerabilities in their systems. </blockquote><br />I had previously written about another Med Mal insurer who had noted these problems at <a href="http://cci.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=norcal">http://cci.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=norcal</a>.<br /><br /><blockquote class="tr_bq">... CRICO recently analyzed a year’s worth of medical malpractice claims in its comparative database and found <b>147 cases in which EHRs were a contributing factor</b>. Computer systems that don’t “talk” to each other, test results that aren’t routed properly, and mistakes caused by faulty data entry or copying and pasting <b>were among the EHR-related problems found in the claims, which represented $61 million in direct payments and legal expenses.</b></blockquote><br />The article notes this:<br /><blockquote class="tr_bq"><br />... Half of the 147 cases resulted in severe injury.</blockquote><br /><b>Patient deaths were a likely result, too, </b>I note.<br /><br />Note that this is just one insurer's data and assuming a good number of them were local to Massachusetts, could represent a significant percentage of the annual medical malpractice lawsuits in the state (Pennsylvania, a much larger state, has about 1500 med mal lawsuits filed annually).  <br /><br />Note also that most cases of harm <b>never make it to litigation</b> due to the harsh economics of medical malpractice.<br /><br />Numbers such as this will be going up as implementation, driven by HITECH incentives and penalties, accelerates in coming years.  This is especially true as medical centers and physician practices with far less clinical IT expertise and savvy than Harvard's become HIT users, and as the ability to capture such events increases.<br /><br />The ECRI Institute "Deep Dive" study of health IT risk also speaks to a rise in numbers, with its finding of <b>171 health IT "events" in just 36 hospitals over 9 weeks</b> voluntarily reported (i.e., just a fraction of the total), with <b>8 injuries and 3 possible deaths as a result</b> (<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>).<br /><br /><blockquote class="tr_bq">... The team asked its CRICO and Strategies members, “What vulnerabilities are you seeing? What are your risk managers worried about? What are your doctors complaining about?”<br /><br />It used that feedback to draft a set of EHR-specific codes and then tested them in three datasets: CRICO (Harvard users) and two of Strategies’ larger clients, !e Doctors Company and Princeton Insurance. Based on those results, CRICO revised and approved 15 new EHR codes that went “live” in January 2013.<br /><br />That means CRICO’s cadre of nurse coders can now identify EHR as a contributing factor to a malpractice claim, instead of using one of the less specific factors available in the past. <span style="color: red;"><i><b>[It's about time for a dose of transparency in the health IT sector - ed.]</b></i></span>  And they can flag whether the problem involved user issues, system/technology issues, or both. “In some cases,” Sato points out, “<b>the system design sets up humans to make errors.”<i> </i></b></blockquote><br />This should all be no surprise to any reader of this blog.  Read the whole article.<b> </b><br /><br />A more comprehensive list of "EHR harm modes" are at my posts "<b>Internal FDA memorandum of Feb. 23, 2010 to Jeffrey Shuren on HIT risks. Smoking gun? I report, you decide</b>" (<a href="http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html">http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html</a>) and "<b>Cart Before the Horse, Part 3: AHRQ's Health IT Hazard Manager</b>" (<a href="http://hcrenewal.blogspot.com/2012/06/cart-before-horse-part-3-ahrqs-health.html">http://hcrenewal.blogspot.com/2012/06/cart-before-horse-part-3-ahrqs-health.html</a>).<br /><br />The actual Hazards Manager report is at <span style="font-size: small;"><a href="https://www.blogger.com/null"></a><a href="http://healthit.ahrq.gov/sites/default/files/docs/citation/HealthITHazardManagerFinalReport.pdf">http://healthit.ahrq.gov/sites/default/files/docs/citation/HealthITHazardManagerFinalReport.pdf</a>. It contains this summary of known hazards:</span><br /><span style="font-size: small;"><br /></span><br /><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/AVvXsEjBfqMe89ZhrHPmZk_4tCcymGkvz0t0XEm8VSOMumbHa-U2WrdKJeZaZDUb8iQMEr5Y2ZwleIsSrYDanYk9nGbP9UOERnVYtIDNu0dhTodoua_1sfR6nHyVk_98F0eyq2xOjnBa_bjUejjX/s1600/hazman.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="247" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjBfqMe89ZhrHPmZk_4tCcymGkvz0t0XEm8VSOMumbHa-U2WrdKJeZaZDUb8iQMEr5Y2ZwleIsSrYDanYk9nGbP9UOERnVYtIDNu0dhTodoua_1sfR6nHyVk_98F0eyq2xOjnBa_bjUejjX/s1600/hazman.jpg" width="400" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">AHRQ's taxonomy of health IT hazards.  <b>Click to enlarge.</b></td></tr></tbody></table><br />------------------- <br /><br />Having written on these issues since 1998 as a "health IT iconoclast" (<a href="http://rtg.cis.upenn.edu/MDCPS/Posters/IT%20Iconoclasts.pdf">http://rtg.cis.upenn.edu/MDCPS/Posters/IT%20Iconoclasts.pdf</a>) and having been largely ignored by the <i>cognoscenti</i>, can I now say <b>"I told you so?"</b><br /><br /><span style="font-size: small;">-- SS</span>

Patient Safety & Quality Healthcare: "Malpractice Claims Analysis Confirms Risks in EHRs"

Two "EHR beneficence is not exactly as advertised" stories in one day.  It's hard to keep up:After my earlier post today "EHRs: The Real Story" - Sobering assessment from Medical Economics, now there'…

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Should "Diagnosing While Texting" Be Illegal?

I saw an interesting comment at Medscape in the comment thread of the article "<a href="http://www.medscape.com/viewarticle/809237">Do Your EHR Manners Turn Patients Off?</a>" (MedScape subscription required).<br /><br /><div style="margin-left: 40px;">Dr. [redacted] | Neurology<br /><br />I live in a town that has passed legislation criminalizing texting and driving. A driver is more impaired and distracted when texting than when intoxicated.  EHR's and the practice of medicine should be no different. <b>Do you really believe that your physician is actually concentrating on the patient in front of them while their attention is primarily focused on entering data on a computer?</b> The reality is that EHR's true value is data collection for statistical analysis by our government and there is an obvious deficiency for enhancing the physician-patient collaborative experience. </div><div><br /></div><div><br /></div><div>Medicine, like driving, is a very cognition, thinking and concentration-intense activity.   Failures lead to injury and death (although not quite as dramatically in the former compared to the latter).</div><div></div><div><br />I think the point about distraction the commenter makes is valid, or at least worthy of healthy consideration.<br /><br />Unless you're a health IT hyperenthusiast, that is (see <a href="http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html">http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html</a>).</div><div></div><div><br />-- SS </div>

Should "Diagnosing While Texting" Be Illegal?

I saw an interesting comment at Medscape in the comment thread of the article "Do Your EHR Manners Turn Patients Off?" (MedScape subscription required).Dr. [redacted] | NeurologyI live in a town that …

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Solutionism: are all healthcare issues transparent and self-evident processes that can be easily optimized, if only the right algorithms are in place?

I've ordered this book:  <span id="btAsinTitle">"<b><a href="http://www.amazon.com/Save-Everything-Click-Here-Technological/dp/1610391381" target="_blank">To Save Everything, Click Here: The Folly of Technological Solutionism</a></b></span>" by <a href="http://www.amazon.com/s/ref=ntt_athr_dp_sr_1?_encoding=UTF8&field-author=Evgeny%20Morozov&search-alias=books&sort=relevancerank">Evgeny Morozov</a>.<br /><br />I've read some excerpts prior to its delivery and find them fascinating.  Emphases mine:<br /><br /><blockquote>... Alas, all too often, this never-ending quest to ameliorate—or what the Canadian anthropologist Tania Murray Li, writing in a very different context, has called “the will to improve”—is shortsighted and only perfunctorily interested in the activity for which improvement is sought. <b>Recasting all complex social situations either as neatly defined problems with definite, computable solutions or as transparent and self-evident processes that can be easily optimized—if only the right algorithms are in place!—this quest is likely to have <i>unexpected consequences that could eventually cause more damage than the problems they seek to address.</i></b><br /><br /><b>I call the ideology that legitimizes and sanctions such aspirations “solutionism.”</b> I borrow this unabashedly pejorative term from the world of architecture and urban planning, where it has come to refer to an <b>unhealthy preoccupation with sexy, monumental, and narrow-minded solutions</b>—the kind of stuff that wows audiences at <a href="http://www.ted.com/pages/registration" target="_blank">TED Conferences</a>—to problems that are <b>extremely complex, fluid, and contentious.</b> These are the kinds of problems that, on careful examination, do not have to be defined in the singular and all-encompassing ways that “solutionists” have defined them; what’s contentious, then, <b>is not their proposed solution but their very definition of the problem itself. </b>Design theorist Michael Dobbins has it right: solutionism <b>presumes rather than investigates the problems that it is trying to solve</b>, reaching “for the answer <b>before the questions have been fully asked</b>.” <span style="color: red;"><i><b>[Such as, how risk-prone are paper records, exactly, and how might the risks be ameloriated without spending hundreds of billions of dollars on healthcare IT? - ed.]</b></i></span> How problems are composed matters every bit as much as how problems are resolved.<br /><br />Solutionism, thus, is not just a fancy way of saying that for someone with a hammer, everything looks like a nail; it’s not just another riff on the inapplicability of “technological fixes” to “wicked problems” (a subject I address at length in The Net Delusion). It’s not only that many problems are not suited to the quick-and-easy solutionist tool kit. It’s also that what many solutionists presume to be “problems” in need of solving are not problems at all; a deeper investigation into the very nature of these “problems” would reveal that the <b>inefficiency, ambiguity, and opacity</b>—whether in politics or everyday life—that the newly empowered geeks and solutionists are rallying against <b>are not in any sense problematic. Quite the opposite: these vices are often virtues in disguise</b>. <span style="color: red;"><i><b>[Such as - paper charts t<span style="color: red;">hat are rapid to produce and brow<span style="color: red;">se</span></span>, redundancies in healthcare processes that can help prevent errors of omission, a<span style="color: red;">mbiguities in decision making that take into account that<span style="color: red;"> n<span style="color: red;">ot everyone fits a guideline</span></span></span>, etc.? - ed.]</b></i></span> That, thanks to innovative technologies, the modern-day solutionist has an easy way to eliminate them does not make them any less virtuous.</blockquote><br />It occurs to me that what I've been calling "<a href="http://www.jpands.org/vol14no2/silverstein.pdf" target="_blank">the syndrome of inappropriate overconfidence in computing</a>" or <a href="http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html" target="_blank">"healthcare IT hyper-enthusiasm that ignores the downsides</a>" -- or that which authors such as Nemeth/Cook might call a blindness to complexity that is "<a href="http://www.ctlab.org/documents/Hiding%20in%20plain%20sight.pdf" target="_blank">hiding in plain sight</a>" and "<a href="http://hcrenewal.blogspot.com/2013/03/dr-richard-cook-on-health-it-sectors.html" target="_blank">HIT techno-fantasies</a>" -- and similar ideas, <i><b>may all be the same thing.</b></i><br /><br />"Solutionism" may be a good umbrella label for these ideas.   Thus, those who challenge these ideas in healthcare and call for caution and restraint are not anti-health IT, not anti-technology, but anti-Solutionism, or maybe 'temperate solutionists' as opposed to 'extremist solutionists' or 'radical solutionists.'<br /><br />And the reason the pushback is so vicious at times may be that we are attacking not just an industry but a broad philosophy or ideology - "<span class="ssens">a systematic body of concepts especially about human life or culture."<br /><br />The current culture promotes solutionism - the belief that there's a <b>technocratic</b> (technological & bureaucratic, i.e., </span><span class="ssens"><span class="ssens">management of society by technical 'expert</span>s') solution to every problem as "solutionism" is defined elsewhere.  I think a vast majority of people, including the 'intellectuals', have bought into it.  </span><br /><br /><span class="ssens">It doesn't help that "radical solutionism" is exceptionally profitable for its proponents....<br /><br />Solutionism may be applicable to, say, domains where numbers or logistical matters predominate (e.g., banking and FedEx), but not to "messy" domains such as medicine.  Or at least not to all of medicine's component parts, such as the parts that clinicians perform using hard-earned expertise, judgement and ethics.</span><br /><span class="ssens"><br />Finally, I ask:<br /><br />Why can't be cure mental illness, or ensure perfect outcomes in cardiac surgery, or prevent wars, with the appropriate computer apps?</span><br /><br /><span class="ssens">After all, with the appropriate tools, why can't we easily perform nuclear fission on our kitchen tables?</span><br /><br /><span class="ssens">More after I read the book.</span><br /><br /><span class="ssens">-- SS </span>

Solutionism: are all healthcare issues transparent and self-evident processes that can be easily optimized, if only the right algorithms are in place?

I've ordered this book:  "To Save Everything, Click Here: The Folly of Technological Solutionism" by Evgeny Morozov.I've read some excerpts prior to its delivery and find them fascinating.  Emphases m…

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Some Real-World Lessons for the Health IT Hyper-Enthusiasts

An article was published in Health Leaders Media yesterday by Scott Mace, senior technology editor entitled <b>"Scot Silverstein's Good Health IT and Bad Health IT"</b> <a href="http://www.healthleadersmedia.com/content/TEC-288116/Scot-Silversteins-Good-Health-IT-and-Bad-Health-IT" target="_blank">at this link</a>.<br /><br />(Actually, the terms "good health IT" and "bad health IT" themselves came from <a href="http://sydney.edu.au/engineering/it/~jonpat/CV/CV_brief.html" target="_blank">Prof. Jon Patrick</a> as a result of my discussions with him in Australia about my conviction, presented to the Health Informatics Society of Australia in my Aug. 2012 talk "<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/HISA2012_Final.ppt" target="_blank">Critical Thinking on Building Trusted, Transformative Medical Information:  Improving Health IT as the First Step</a>", that to be trusted and do no harm, health IT must be “done well".)<br /><br />Scott Mace observes:<br /><br /><blockquote class="tr_bq">Inevitably, when the subject turns to the pitfalls of bad health IT, you will find Scot Silverstein, MD, ready to comment. He has been writing about health IT difficulties since 1998.<br /><br />Silverstein is an adjunct professor at Drexel University who I recently interviewed for an upcoming <i>HealthLeaders</i> magazine story on physician resistance to health IT.<br /><br />A <a href="http://hcrenewal.blogspot.com/2012/09/in-addition-to-nurses-doctors-now-air.html" target="_blank">recent Silverstein blog post</a> caught my eye for the following statement: "It is impossible for people, especially medical professionals, to be 'ready' for a system that 'is not ready for them.'"<br /><br />I wanted to learn about the good doctor's thinking and so I gave him a call. We spoke for two hours and it felt like scratching the surface of issues that healthcare will be facing for a good while to come. </blockquote><br />Indeed, the issues we discussed were just scratching the surface.  The real world is ever so complex.<br /><br />Also noted was my observation that:<br /><br /><blockquote class="tr_bq">... Silverstein says it is wrong to think of the tension in healthcare as being IT modernists versus Luddites ... [he says] "I believe the proper framing of this tension between technologists and physicians is that of technology hyper-enthusiasts, who either are unaware of or deliberately ignore the downsides and ethical issues of healthcare information technology in its present state, versus pragmatist physicians who just want to get a job done."</blockquote><br />The hyper-enthusiasts largely ignore the real world.<b> </b><br /><br /><b>Two recent "real world" posts on other blogs by practicing physicians caught my eye,</b> that help illustrate the concepts of health IT's disruption of clinicians and of clinical care.  These disruptions increase risk of error (even under normal circumstances; in an emergency scenario, I fear the disruptions will become far more destructive).<br /><br />These disruptions need to be thrust in the face of the hyper-enthusiasts as characteristic of a very flawed approach to healthcare improvement. <br /><br />The real-world observations, courtesy <a href="http://www.kevinmd.com/blog/category/tech" target="_blank">KevinMD blog</a> (who reposted them from the source bloggers), with my comments are in <span style="color: red;"><i><b>[red italics]:</b></i></span><br /><br /><blockquote class="tr_bq"><a href="http://www.kevinmd.com/blog/2013/01/information-overload-doctors-increases-malpractice-risk.html" target="_blank">Information overload for doctors increases malpractice risk</a><br />Wes Fisher, MD<br />January 1, 2013<br /><br />I have used the electronic medical record (specifically EPIC) since 2004.  I have grown accustomed to its nuances, benefits and quirks.  There are parts about it I really like.  There are parts of it I’d like to do without but accept that they are necessary evils in our current health care climate.  I know that there will always be parts of any modified computer system that will suffer growing pains.  For any new and adapting technology this is understandable.<br /><br />But there is a little-appreciated issue that I see brewing: doctors (and maybe even patients) are quietly being buried by electronic information overload.  As a result, I believe doctors are being placed at an increased liability risk. <span style="color: red;"><i><b>[Not just doctors, but all clinicians, and the acquirers and implementers of the technology, and those who force the use of it on the clinicians - ed.]</b></i></span><br /><br />Let me explain.<br /><br />In the past era of medicine, nothing happened without a doctor’s order.  Nothing.  If you wanted a medication, lab test, invasive procedure, opportunity to participate in rehab classes – anything – you needed a doctor’s order.   For the years of paper records and independent doctors offices, this work flow assured that doctors (1) knew what was happening with their patients, (2) saw their patients, (3) prescribed the proper therapy, and (4) assumed the risk for the intervention or treatment prescribed.  Information proceeded in a logical linear fashion and the doctor was always at the head of the information line.<br /><br />But we are no longer in the old days in medicine.  We are in the era of near-instantaneous information flow, multi-directional electronic communication, and geographically disparate order entry by “caregivers,” (think nurses, nurse practitioners, advanced practice nurses, clinic operators, registrars, etc.) who help us take messages, continue care, and order things.  In this electronic process, messages are no longer passed from just one individual to another, but rather are passed to two, three, four, or more individuals simultaneously from any one of several different clinical locations – some of which might be many miles apart.  <b>There is an incredible amplifying effect of all of these messages, orders, and notifications — so much so that even the most tech-savvy doctors are struggling to keep up.</b> <span style="color: red;"><i><b>[This observation about an "amplifying effect" gives life to my own observation that the terms "EHR" and "EMR" are anachronistic and suggest to the layperson an innocuous file cabinet, when in reality today's "EHR" is an enterprise healthcare resource and clinician control system, with all that implies in terms of potential adverse unintended consequences - ed.]</b></i></span><br /><br />In fact, it is not uncommon for a doctor these days to work for two hours on a procedure and return to the computer to find twenty or thirty new notifications, e-mails, or orders have been deposited there.  Head back in for the next case and then another thirty items appear.  Pretty soon, it’s an avalanche of items.  Worse: doctors must click on each one of these notifications individually to “verify” he or she has looked at each and every single one.  <span style="color: red;"><i><b>[Looking at the computer has likely become a source of dread to many clinicians; I used to get the same feeling when facing up to a day's emails in Pharma, sometimes more than a hundred - ed.]</b></i></span><br /><br />Doctors understand that the reason we have to click on all these orders is because (a) no one gets paid in our system unless a doctor orders whatever-it-is <span style="color: red;"><i><b>[not the best motivation - ed.]</b></i></span> and (b) someone has to be the fall guy if there’s a problem with a nurse, medical assistant, or lab technician that “orders” something on behalf of the physician.  <span style="color: red;"><i><b>[Ditto; the "social issues" of health IT include factors like these  - ed.] </b></i></span> There is even a trend to auto-order things (like a pneumovax vaccine, for instance) that assure the hospital maintains excellent public reporting metrics whether the doctor ordered them or not with the order later appearing in our inbox to be clicked. <span style="color: red;"><i><b> [This observation gives life to my own that the computer is increasingly becoming the intermediary between doctor and patient - ed.]</b></i></span><br /><br />But worst of all are the <b>silent notifications sent from fellow physician colleagues buried amongst the other notifications.</b> They tell of an important story, one that needs fairly urgent attention, but because people no longer pick up the phone, are not immediately noticed or highlighted. <b>It’s like a landmine sitting in a doctor’s inbox waiting to be stumbled upon.</b><br /><br />* Click* *Click* *Click* * Click* *Click* <b>*Boom* </b> <span style="color: red;"><i><b>[The "silent silo" syndrome, as I called it, also affects lab results reporting.  It should be clear that health IT does not "automagically" improve communications over Alexander Graham Bell's invention - ed.]</b></i></span><br /><br />With all these people and devices ordering and sending, the limited number of doctors out there are<b> being bombarded from multiple directions</b>.   It is getting harder to keep up these days.  Orders and notices come to us on names we don’t recognize or have been long forgotten.  (Computers don’t forget that you saw the patient eight years ago).  <span style="color: red;"><i><b>[These observations should put an end, once and for all, to the oversimplifications of comparing health IT to, say, mercantile or banking IT - ed.] </b></i></span>And once an order is placed and acted upon without our knowledge these days, we click on the order to clear our notices and thereby assume all the legal risk for the care. The legal buck still ultimately stops with us. <br /><br /><b>Doctors need to speak up about this problem.</b> <span style="color: red;"><i><b> [I could not agree more - ed.]</b></i></span> We are not in the old days any longer.  We are in the fast-paced, electronic medical record era where things happen (literally) at the speed of light.  We need the electronic medical record companies, payors, hospitals and legal community to come together to help us find a solution to this current information overload crisis that maintains patient safety and improves efficiencies while limiting legal risks to the doctors who are doing their very best just to keep up.<br /><br /><i>Wes Fisher is a cardiologist who blogs at </i><a href="http://drwes.blogspot.com/" rel="nofollow" target="_blank">Dr. Wes</a><i>.</i></blockquote><br />The above "anecdote" (I use that term somewhat satirically, see <a href="http://hcrenewal.blogspot.com/2011/08/from-senior-clinician-down-under.html" target="_blank">here</a>) is likely characteristic of the lives now lived by most clinicians using today's health IT.  Hyperenthusiasts, take note.<br /><br />The second real-world illustration of the naivete of the hyper-enthusiasts is as below.  I'd observed most of the points made in my own writings after my CMIO period in the late 1990's, which I highlight.   It is quite interesting to see these same points come from others without Informatics expertise, directly from the clinic:<br /><br /><blockquote class="tr_bq"><a href="http://www.kevinmd.com/blog/2012/12/explaining-epic-failure-emrs.html" target="_blank">Explaining the epic failure of EMRs</a><br />Kiran Raj Pandey, MD<br />December 19, 2012<br /><br />It is no news a lot of doctors like to stick up a rather snotty nose to EMR. The defenders of the EMR tend to label such doctors as archetypal Luddites, sticking to their archaic ways and unbecoming of change and the new times.<i><b> <span style="color: red;">[</span></b><b><span style="color: red;">In reality, the tension is </span><a href="http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html" target="_blank">between the hyper-enthusiasts or 'Ddulites' vs. pragmatist clinicians</a></b> <b><span style="color: red;">with real-world patient care responsibilities and obligations - ed.]</span></b><span style="color: red;"><b> </b></span></i>But as is usually the case with any two heated but opposite arguments, the truth likely lies somewhere between the two extremes.<br /><br />On an objective basis, there is no denying that automatisation of medical record keeping is the new way forward. In theory, if the machine could keep records for you and give it back to you when and where you want it, thus freeing up valuable time for the patient encounter, that should be winsome for everyone. That alas, is a vision of the EMR utopia <span style="color: red;"><i><b>[the path to Utopia usually has very bad unintended consequences, and Utopia never reached - ed.]</b></i></span>, and let alone being anywhere close to such utopia,<b> it is difficult to ascertain if we are even set in the road leading us there</b>. <span style="color: red;"><i><b>[As I've opined, we're on a speeding bullet train on a quarter-mile track - ed.] </b></i></span><br /><br />Sometime ago, exasperated at the<b> sheer waste of time</b> that the clunky new discharge module was causing <b>because it would not work the way it is supposed to</b> (my hospital is means challenged, so they are building a patchwork of cheapskate EMR suite on top of their legacy system from the 90s, just to placate the gods of CMS <i><b><span style="color: red;">[and the </span><a href="http://hcrenewal.blogspot.com/2013/01/when-sociologists-uphold-hippocratic.html" target="_blank">Lords of Kobol</a> <span style="color: red;">- ed.]</span></b></i>), I complained to the IT guy that the thing barely works! The guy was sympathetic and said, “look I know the discharge module sucks, just bear with it until the end of the year when we should be able to weed out the bugs.” <span style="color: red;"><i><b>[Hospitals and clinics, as I've written, are NOT the proper place for software alpha and beta-testing - ed.]</b></i></span><br /><br />But that’s not all, I said, even if it were working just the way it is supposed to, the discharge still takes me longer than what it used to with paper. “That’s something you will have to learn to live with,” he retorted. <b>“Computer records do take a longer time than paper, and there is nothing I can do to change that.” <span style="color: red;"><i>[This reflects healthcare IT culture's of arrogant acceptance of bad health IT, largely ignoring ways to ease human-computer interaction - ed.]</i></span></b><br /><br />Right there, I think is where EMR loses a lot of ground against paper records. At any practice, <b>time is the most valuable resource</b>, and anything that doesn’t offer a straight off benefit to save time will have a hard time being adapted. <span style="color: #cc0000;"><i><b>[The reverse is also true - ed.] </b></i></span>Add to that the inertia people have about their old ways and you have a deal breaker right there.<br /><br />That’s not all. Driven by the constant government whip to adopt EMR, and a<b>n EMR industry that is hell bent upon imposing itself on healthcare</b> <span style="color: red;"><i><b>[long ago I began writing of a territorial invasion of healthcare by the IT industry - ed.]</b></i></span>, a lot of makeshift EMR adoption has taken place. So you have hospitals where one part is using one system while the other is using a completely different one. At one clinic I recently worked at, we had to switch between 3 different EMR systems, just to get the patients records. And there still was the paper records not to mention the dictation.<b>The constant juggling not only made the patient encounters time consuming and cumbersome</b> <span style="color: red;"><i><b>[and surely tiring - ed.]</b></i></span>, it literally made us curse at the computers and ruin an otherwise perfectly normal day at work. <span style="color: red;"><i><b>[And increase risk of cognitive overload and error substantially - ed.]</b></i></span> Patient volumes have gone down from 15-16 patients per day to a half of that after EMR adoption.<br /><br />What’s wrong with the current adoption of EMR? Why are even the converted like me questioning EMR? <span style="color: red;"><i><b>[Converted to what? - ed.]</b></i></span><br /><br />I think there are two reasons for such seemingly epic failure. First, how we interface with an EMR. <b>Second how the EMR tries to impose its will on to us instead of the other way around. <span style="color: red;"><i>[I've written that HIT should work like the clinicians work, not the other way around.  Again, the IT has become the cybernetic 'governor' or 'regulator' of care, and is not just an innocuous records system - ed.] </i></span></b> A keyboard and a point and click device may well have worked for many other interactions with the computer, but with an EMR it doesn’t always appear to be nifty. <br /><br />... On the same note, no EMR is going to be see a faster adoption if something like writing a prescription takes a minute when in paper it barely takes 10 seconds. Right now doing something as simple as writing a prescription feels like running through a bunch of fire breathing hoops. Someone may argue, you can at least read it better <i><b><span style="color: red;">[when <span style="color: black;"><span style="color: red;">bugs and </span><a href="http://hcrenewal.blogspot.com/search/label/glitch" target="_blank"><span style="color: black;">'</span>glitches'</a> </span>d<span style="color: #b00000;">ue to sloppy </span>industry practices don't cause faulty output such as occurred</span> <a href="http://hcrenewal.blogspot.com/2011/11/lifespan-rhode-island-yet-another.html" target="_blank">here</a> <span style="color: red;">- ed.] </span></b></i>, but don’t get me started on how the EMR can come up with its own ludicrous set of errors, something that would never be possible with paper.<i><b> <span style="color: red;">["</span><a href="http://hcrenewal.blogspot.com/2012/09/good-health-it-v-bad-health-it-paper-is.html" target="_blank">not possible with paper</a>" <span style="color: red;">is a theme I've written about as well - ed.]</span></b></i><br /><br />Trying to impose a ready made architecture on to health care will not work. <b>“It works for retail and banking,”</b> some people seem to offer cluelessly<i><b> [<span style="color: red;">Business/mercantile computing and clinical computing </span></b><span style="color: red;"><b>are two different subspecialties of computing, I've long observed - ed.]</b></span></i>. But a patient encounter is no visit to your bank cashier. And human body is not your bank account, it is way more complicated and it is bound to generate way more complex information that is difficult to straight jacket into the rigid and rudimentary pipeline of set information pathways. An ideal EMR is supposed to be a seamless body-glove; today they feel like the hangman’s cloak, not only are they cumbersome, dark and dreary and suffocating, under their apparition, they <b>force things you to do things you wouldn’t otherwise do.</b> <span style="color: red;"><i><b>[Hyper-enthusiasts don't really seem to care<span style="color: black;">;<span style="color: red;"> if it's a computer, it must be better </span></span>- ed.]</b></i></span><br /><br />Such forced behavior modification may make the administrator, the insurance company, and the government happy <span style="color: red;"><i><b>[it does - ed.]</b></i></span> but I can’t understand how selecting a dozen pesky radio buttons while doing the discharge makes the patient lead a healthy life or make his doctor particularly enamored with the EMR, <b>just because the government said so, or that it made the IT companies a few million dollars richer</b>.<i><b> <span style="color: red;">[Doctors are just supposed to obediently accept this technology by the hyper-enthusiasts and profiteers - ed.]</span></b></i><br /><br /><i>Kiran Raj Pandey is an internal medicine resident who blogs at </i><a href="http://page59.wordpress.com/" rel="nofollow" target="_blank">page59</a><i>.</i></blockquote><br />I feel "<a href="http://hcrenewal.blogspot.com/2011/08/from-senior-clinician-down-under.html" target="_blank">anecdote</a>" #2 is also quite common, and the sentiments shared by a large number of clinicians forced into using this technology in its present state.<br /><br />Hyper-enthusiasts and other health IT promoters and grandstanders need to read the above accounts well.  They need to understand that the real-world effects of the technology, recklessly pushed, can be toxic, and not result in the utopia of better care and cost-savings they naively believe will deterministically occur.  <br /><br />-- SS

Some Real-World Lessons for the Health IT Hyper-Enthusiasts

An article was published in Health Leaders Media yesterday by Scott Mace, senior technology editor entitled "Scot Silverstein's Good Health IT and Bad Health IT" at this link.(Actually, the terms "goo…

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WSJ, Koppel and Soumerai: A Major Glitch for Digitized Health-Care Records - Cost Savings Illusory

Two EHR experts from Ivy-league institutions (which are typically hyperenthusiast-oriented) doubt cost savings from EHR technology.<br /><br /><blockquote class="tr_bq"><b>Wall Street Journal<br />Opinion<br />September 17, 2012<br /><br /><a href="http://online.wsj.com/article/SB10000872396390443847404577627041964831020.html?mod=googlenews_wsj" target="_blank">A Major Glitch for Digitized Health-Care Records</a></b><br /><br />Savings promised by the government and vendors of information technology are little more than hype.<br /><br />By <a href="http://www.populationmedicine.org/content/personnelDetail.asp?PID=164&CID=1&Sub=Y" target="_blank">STEPHEN SOUMERAI</a> And <a href="http://sociology.sas.upenn.edu/r_koppel" target="_blank">ROSS KOPPEL</a><br /><br />In two years, hundreds of thousands of American physicians and thousands of hospitals that fail to buy and install costly health-care information technologies—such as digital records for prescriptions and patient histories—will face penalties through reduced Medicare and Medicaid payments. At the same time, the government expects to pay out tens of billions of dollars in subsidies and incentives to providers who install these technology programs. </blockquote><br />Which, of course, means printing more money for luxuries we cannot afford in the midst of the worst economic downturn since 1929...<br /><br /><blockquote class="tr_bq">The mandate, part of the 2009 stimulus legislation <span style="color: #cc0000;"><i><b>[I think it would be more accurate to say "sneaked into the 2009 stimulus legislation for IT industry benefit" - ed.]</b></i></span>, was a major goal of health-care information technology lobbyists and their allies in Congress and the White House. The lobbyists promised that these technologies would make medical administration more efficient and lower medical costs <b>by up to $100 billion annually. </b></blockquote><br /><b>By up to $100 billion annually?   </b>(Perhaps these lobbyists need lie detector tests - and/or drug tests to see what they may have been smoking?)  I note the lobbying was covered in the Washington Post in "<span style="font-size: 100%;"><a href="http://www.washingtonpost.com/wp-dyn/content/article/2009/05/15/AR2009051503667.html?hpid=topnews">The Machinery Behind Health-Care Reform: How an Industry Lobby Scored a Swift, Unexpected Victory by Channeling Billions to Electronic Records</a>" by Robert O'Harrow Jr., May 16, 2009</span>.<br /><br /><blockquote class="tr_bq">Many doctors and health-care administrators are wary of such claims—a wariness based on their own experience. An extensive new study indicates that the caution is justified: The savings turn out to be chimerical.</blockquote><br />Some still have empirical observational skills and common sense, fortunately.  In my early days of health IT involvement two decades ago as an NIH-sponsored Medical Informatics post doctoral fellow, I believed there was some cost savings possible, but certainly not in the tens or hundreds of billions per year.  The technology was not solving problems that could lead to such savings (see for instance my Dec. 2010 post "<a href="http://hcrenewal.blogspot.com/2010/12/is-healthcare-it-solution-to-wrong.html" target="_blank">Is Healthcare IT a Solution to the Wrong Problem?</a>").  My experiences since my fellowship have only confirmed my own early opinions.<br /><br /><blockquote class="tr_bq">Since 2009, almost a third of health providers, a group that ranges from small private practices to huge hospitals—have installed at least some "health IT" technology. It wasn't cheap. For a major hospital, a full suite of technology products can cost $150 million to $200 million. Implementation—linking and integrating systems, training, data entry and the like—can raise the total bill to $1 billion.</blockquote><br />That's countless billions that could have been spent on actual healthcare delivery itself, especially for underserved populations and the poor.  Instead, that money was funnelled to the IT industry for an experimental, unregulated, unvetted technology to be applied on live patients (and without patient consent, I add).<br /><br /><blockquote class="tr_bq">But the software—sold by hundreds of health IT firms—<b>is generally clunky, frustrating, user-unfriendly and inefficient.</b> For instance, a doctor looking for a patient's current medications might have to click and scroll through many different screens to find that essential information. Depending on where and when information on a patient's prescriptions were entered, the complete list of medications may only be found across five different screens.</blockquote><br />Examples of that from actual systems (sketched to avoid IP problems) is at my ten part series on <b>mission-hostile health IT</b> at this blog, shortened link <a href="http://www.tinyurl.com/hostileuserexper">http://www.tinyurl.com/hostileuserexper</a>.<br /><br /><blockquote class="tr_bq">Now, a comprehensive evaluation of the scientific literature has confirmed what many researchers suspected: The savings claimed by government agencies and vendors of health IT <b>are little more than hype.</b><br /><br />To conduct the study, faculty at McMaster University in Hamilton, Ontario, and its programs for assessment of technology in health—and other research centers, including in the U.S.—sifted through almost 36,000 studies of health IT. The studies included information about highly valued computerized alerts—when drugs are prescribed, for instance—to prevent drug interactions and dosage errors. From among those studies the researchers identified 31 that specifically examined the outcomes in light of the technology's cost-savings claims.<br /><br />With a few isolated exceptions, the preponderance of evidence shows that the systems had not improved health or saved money. </blockquote><br />One must understand this in the context of what these systems really are, what they do, <b>and the problems they can actually address</b> as in my post on 'solution to the wrong problem' mentioned <u>supra</u>.<br /><br /><blockquote class="tr_bq">The authors of "The Economics of Health Information Technology in Medication Management: A Systematic Review of Economic Evaluations" <b>found no evidence from four to five decades of studies that health IT reduces overall health costs.</b> Three studies examined in that McMaster review incorporated the gold standard of evidence: <b>large randomized, controlled trials. </b>They provide the best measure of the effects of health IT systems on total medical costs.</blockquote><br />I point out that<i> randomized controlled trials (RCT's) are notably rare in health IT studies.</i>  Most "confirmatory" studies on health IT benefits are less powerful retrospective/observational studies in specialized settings, with many biases, poor science, etc.  In that sense, such studies can be considered non-generalizable and <b>anecdotal</b> at best (more on the "anecdotes" issue is below).<br /><br />Of course, the pundits and Ddulites ("Luddite" with first four letters reversed; meaning ardent hyperenthusiasts) will likely say "<i>it will all be fixed in version 2.0</i>" despite decades of opportunity to get health IT "right" and demonstrate generalized improved outcomes and cost savings:<br /><blockquote class="tr_bq"><br />... 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:<span style="font-style: italic;"></span><span style="color: red; font-style: italic; font-weight: bold;"> 'Hyper-enthusiastic technophile who either deliberately ignores or is blinded to technology's downsides, ethical issues, and repeated local and mass failures.</span><span style="color: red; font-weight: bold;">'</span></blockquote><br />From Regenstrief Institute, one of the premier and pioneering centers for Medical Informatics research and teaching:<br /><br /><blockquote class="tr_bq">A study from Regenstrief, a leading health IT research center associated with the Indiana University School of Medicine, found that there were no savings, and another from the same center found a significant increase in costs of $2,200 per doctor per year. The third study measured a small and statistically questionable savings of $22 per patient each year.</blockquote><br />That's probably not taking into account <b>increased medical malpractice costs </b>as exemplified <a href="http://hcrenewal.blogspot.com/2011/06/babys-death-spotlights-safety-risks.html" target="_blank">here</a> and <a href="http://hcrenewal.blogspot.com/2011/09/sweet-death-that-wasnt-very-sweet-how_24.html" target="_blank">here</a> and by other settlements I know of but cannot mention due to my consulting role in those cases.<br /><br /><b>A primer on health IT risks,</b> containing a number of key articles and links, is downloadable at <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/HIT_issues_Primer.zip">http://www.ischool.drexel.edu/faculty/ssilverstein/HIT_issues_Primer.zip</a>.  <br /><br /><blockquote class="tr_bq">In short, the most rigorous studies to date contradict the widely broadcast claims that the national investment in health IT—some $1 trillion will be spent, by our estimate—will pay off in reducing medical costs. Those studies that do claim savings rarely include the full cost of installation, training and maintenance—a large chunk of that trillion dollars—for the nation's nearly 6,000 hospitals and more than 600,000 physicians.</blockquote><br />$1 trillion would pay for a tremendous amount of actual healthcare delivery, I note.<br /><br />These system lifecycle costs, known as "total cost of ownership", are due to upgrades and necessary changes as medicine itself, including the science, business and legal components change over time.   The costs are generally underestimated ahead of time.  A good source on these issues is the article "<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/Goldfinch_pessimism_PAR.pdf" target="_blank">Pessimism, Computer Failure, and Information Systems Development in the Public Sector</a>"  (Public Administration Review 67;5:917-929, Sept/Oct. 2007).  This is a cautionary article on IT that recommends much more critical attitudes towards major IT initiatives in all sectors.  <br /><br /><blockquote class="tr_bq">But by the time these health-care providers find out that the promised cost savings are an illusion, it will be too late. Having spent hundreds of millions on the technology, they won't be able to afford to throw it out like a defective toaster.</blockquote><br />There, I disagree.  We may have to "throw it out" as the disruptions to good medical care by bad health IT (BHIT) increase,<b> unless the industry reforms itself very rapidly</b>.  As I state in the introduction to my teaching website "<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/" target="_blank">Contemporary Issues in Medical Informatics: Good IT, Bad IT, and Common Examples of Healthcare Information Technology Difficulties</a>" (started in late 1998 due, in fact, to my observations of inappropriate leadership and poor quality of health IT):<br /><br /><blockquote class="tr_bq"><span style="font-family: Arial;">The site takes a view consistent with medicine’s core values and with patients’ rights that health IT, as a medical apparatus that increasingly forms an enterprise clinical resource management and clinician workflow control mechanism, remains experimental and should be subject to the same ethical considerations, validation processes and regulatory oversight to which almost all other medical technologies and pharmaceuticals are subjected. <b>The site is pro-health IT</b>, but <i><b>only when the health IT is “good IT” - as opposed to “bad IT."</b></i> <br /><b><br />Good Health IT ("GHIT")</b> 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. <br /><b><br />Bad Health IT ("BHIT") </b>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, </span><span style="font-family: Arial;"><span style="font-size: small;"><span style="font-family: inherit;"><span style="color: black;"><span style="color: black; font-family: Arial; mso-bidi-font-weight: bold;"><span style="color: black; font-family: Arial; mso-bidi-font-weight: bold;">compromises</span></span></span></span></span> patient privacy or otherwise demonstrates suboptimal design and/or implementation.</span><br /><br /><span style="font-family: Arial;">This site challenges medically and ethically controversial views that health IT merits special accommodations in terms of freedom from scientific rigor and evidence-based practices, freedom from regulation, and freedom from accountability.  </span></blockquote><br />I  hold little hope of these issues being seriously addressed - let alone solved - any time in the near future due to:<br /><br />1)  the irrational exuberance about this technology, cf: Twitter feeds on hashtags #EHR, #EMR, #HCIT and similar; <br />2)  the industry-promoted myths and fabrications over decades;<br />3)  the FDA-admitted impediments to information diffusion about defects and harms (<a href="http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html" target="_blank">link</a>); <br />4)  IOM-admitted impediments to same (<a href="http://hcrenewal.blogspot.com/2011/11/iom-report-on-health-it-safety-nix-fda.html" target="_blank">link</a>);and<br />5)  the latter's industry-favoring, Milquetoast 2012 recommendations on monitoring, remediation and regulation.<br /><br />These are indicative of an industry that has neatly avoided any meaningful regulation and is, in plain terms, out of control.<br /><br /><blockquote class="tr_bq">Why are we pushing ahead to digitize even more of the health-care system, when the technology record so far is so disappointing? <b>So strong is the belief in health IT that skeptics and their science are not always welcome.</b> Studies published several years ago in the Journal of the American Medical Association and the Annals of Internal Medicine reported that health IT systems evaluated by their own developers were far more likely to be judged "successful" than those assessed by independent evaluators.<br /><br /></blockquote>"Not welcome" is an <i>understatement. </i><br /><br />ONC itself is guilty of bad science, as in its grossly deficient March 2011 Health Affairs paper on health IT benefits. (See my Oct. 2011 post "<a href="http://hcrenewal.blogspot.com/2011/03/benefits-of-health-information.html" target="_blank">ONC: The Benefits Of Health Information Technology: A Review Of The Recent Literature Shows Predominantly Positive Results</a>".  Also see my Aug. 2012 post "<a href="http://hcrenewal.blogspot.com/2012/08/onc-and-irrelevant-comparisons.html" target="_blank">ONC and Misdirection Regarding Mass Healthcare IT Failure</a>".)<br /><br />So bad is the <b>"Health IT critique not welcome"</b> phenomemon that, for example, Medical Informatics leaders such as Bill Hersh of Oregon Health Sciences University (OHSU) openly attack those who are candid on health IT risks (and make fools of themselves via the open attacks), such as the attack I wrote of at my Sept. 2010 post "<a href="http://hcrenewal.blogspot.com/2010/09/dangers-of-critical-thinking-in.html" target="_blank">The Dangers of Critical Thinking in A Politicized, Irrational Culture</a>".<br /><br />Also common in the "Health IT Critique Not Welcome Here" club, and probably deliberately so, is mistaking risk management activities for research observations and calling the former, even when reported by credible witnesses, <b>"anecdotal"</b> while calling at-best weak HIT-positive studies <b>"definitive science."</b>  See "<a href="http://hcrenewal.blogspot.com/2011/08/from-senior-clinician-down-under.html" target="_blank">From a Senior Clinician Down Under: Anecdotes and Medicine, We are Actually Talking About Two Different Things</a>" for the definitive rebuttal of that type of patient-endangering intellectual blindness or dishonesty.<br /><br /><blockquote class="tr_bq">Government agencies like the Office of the National Coordinator of Healthcare Information Technology (an agency of the Department of Health and Human Services) serve as health IT industry boosters. ONC routinely <b>touts stories of the technology's alleged benefits.</b></blockquote><br />But almost never the opposite, which is equally if not more important.  Further, they tout "certification" as a means of HIT safety evaluation and assurance, or do not deny that misconception, despite statements by the very certification bodies or ATCB's they appoint to the contrary.  Yet they need to come clean on this. (I've seen the claim of 'certification equals safety' in actual legal briefs in defense of health IT.)  See my Feb. 2012 post "<a href="http://hcrenewal.blogspot.com/2012/02/hospitals-and-doctors-use-health-it-at.html" target="_blank">Hospitals and Doctors Use Health IT at Their Own Risk - Even if Certified</a>."<br /><br />ONC also seems to turn a blind eye to industry-ghostwriting abuses in the public comments period of Notices of Proposed Rulemaking for "meaningful use" (itself an Orwellian term) rules.  See for instance my Sept. 2012 posts "<a href="http://hcrenewal.blogspot.com/2012/08/health-it-vendor-epic-uses-clients-as.html">Health IT Vendor EPIC Caught Red-Handed: Ghostwriting And Using Customers as Stealth Lobbyists - Did ONC Ignore This?</a>" and "<a href="http://hcrenewal.blogspot.com/2012/09/from-what-i-can-tell-epic-was.html" target="_blank">Was EPIC successful in watering down the Meaningful Use Stage 2 Final Rule?</a>"<br /><br /><blockquote class="tr_bq">We fully share the hope that health IT will achieve the promised cost and quality benefits. As applied researchers and evaluators, we actively work to realize both goals. But this will require an accurate appraisal of the technology's successes and failures, <b>not a mixture of cheerleading and financial pressure by government agencies based on unsubstantiated promises.</b></blockquote><br />I share the same sentiments.  As I've often written, the Achilles heel of the health IT sector<b> is its ignoring the very science and evidence-based approaches </b>of the field - medicine - that health IT is supposed to somehow "revolutionize" and "transform."<br /><br />It is, quite frankly, the utmost in hypocrisy for an industry that demands evidence-based medicine - and touts its expensive products as leading to that change - to itself not practice what I've called "evidence-based computing."<br /><blockquote class="tr_bq"><br />Mr <i>(sic)</i> Soumerai is professor of population medicine at Harvard Medical School and Harvard Pilgrim Health Care Institute. Mr. Koppel is a professor of sociology and medicine at the University of Pennsylvania and principal investigator of its Study of Hospital Workplace Culture. </blockquote><br /><a href="http://www.populationmedicine.org/content/personnelDetail.asp?PID=164&CID=1&Sub=Y" target="_blank">Dr. Soumerai</a> <span style="font-size: 100%;">also co-authored "<a href="http://www.huffingtonpost.com/stephen-soumerai/dont-repeat-the-uks-elect_b_790470.html" id="title_permalink" title="Permalink">Don't Repeat the UK's Electronic Health Records Failure"</a> with </span><span style="font-size: 100%;"><span style="font-size: 100%;">Anthony Avery, Professor of Primary Care at the University of Nottingham Medical School, UK</span>, Huffington Post, Dec. 5, 2010.</span><br /><br />I also expect to hear an "Ivy tower academics - what do they know?" refrain from the industry.  However, this will not hold water, as the Ivory tower inhabitants, as I previously stated, are almost uniformly of the Ddulite-hyperenthusist persuasion and touted when they speak or write in uncritical favor of health IT.<br /><br />-- SS<br /><br /><b>Addendum: </b><br /><br />Penn Wharton professors had a similar opinion on cost-savings in 2009:<br /><br /><blockquote class="tr_bq"><span style="font-size: 100%;"><b><a href="http://knowledge.wharton.upenn.edu/article.cfm?articleid=2260">Information Technology: Not a Cure for the High Cost of Health Care</a>:</b> Knowledge@Wharton, Wharton School of Business, University of Pennsylvania, June 10, 2009. (PDF version available <a href="http://knowledge.wharton.upenn.edu/createpdf.cfm?articleid=2260">at this link</a>)</span> </blockquote><br />As I observed in my June 20, 2009 post "<a href="http://hcrenewal.blogspot.com/2009/06/improving-patient-safety-in-eu-hit.html" target="_blank">Improving Patient Safety In The EU: HIT Should Be Classified As Medical Devices. And, Can We Drop the "Massive Cost Savings" Fable?</a>", in a WSJ article that same day entitled "<a href="http://online.wsj.com/article/SB10001424052970204005504574235751720822322.html">The Myth of Prevention</a>", <b>Abraham Verghese</b>, Professor and Senior Associate Chair for the Theory and Practice of Medicine at Stanford echoed the Wharton professors' doubts about the cost savings and ultimate value of electronic medical records:<br /><br /><blockquote>... I have similar problems with the way President Obama hopes to pay for the huge and costly health reform package he has in mind that will cover all Americans; he is counting on the “savings” that will come as a result of <b>investing in preventive care and investing in the electronic medical record among other things. It’s a dangerous and probably an incorrect projection. </b></blockquote><br />I also had related observations published in a Letter to the Editor in the WSJ in February of that year:<br /><br /><blockquote class="tr_bq"><a href="http://online.wsj.com/article/SB123492035330205101.html" target="_blank">Digitizing Medical Records May Help, but It's Complex</a>, Feb. 18, 2009<br /><br />You observe that the true political goal is socialized medicine facilitated by health care information technology. You note that the public is being deceived, as the rules behind this takeover were stealthily inserted in the stimulus bill.<br /><br />I have a different view on who is deceiving whom. In fact, it is the government that has been deceived by the HIT industry and its pundits. Stated directly, the administration is deluded about the true difficulty of making large-scale health IT work. The beneficiaries will largely be the IT industry and IT management consultants.<br /><br />For £12.7 billion the U.K., which already has socialized medicine, still does not have a working national HIT system, but instead has a major IT quagmire, some of it caused by U.S. HIT vendors.<br /><br />HIT (with a few exceptions) is largely a disaster. I'm far more concerned about a mega-expensive IT misadventure than an IT-empowered takeover of medicine.<br /><br />The stimulus bill, to its credit, recognizes the need for research on improving HIT. However this is a tool to facilitate clinical care, not a cybernetic miracle to revolutionize medicine. <b>The government has bought the IT magic bullet exuberance hook, line and sinker.</b><br /><br />I can only hope patients get something worthwhile for the $20 billion.<br /><br /><i>Scot Silverstein, M.D.</i> <br /><i>Faculty <br />Biomedical Informatics <br />Drexel University Institute for Healthcare Informatics <br />Philadelphia</i></blockquote><br />Next time you hear from some pundit about enormous "cost savings" from clinical IT, remember this post.<br /><br />Let's implement health IT - and do it well, i.e., good health IT (GHIT) instead of bad health IT (BHIT)- to<i><b> facilitate clinicians</b></i>, not to work financial miracles or "revolutionize" anything.<br /><br /><br /><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/AVvXsEhGg0COl5XruSc2M6Tqlbl-KZ69phovYcYzjTceLKGrUR8eAXyQ16-yjmxXJ0OPEbJVRC91slcIJsa4BGJwtZ87D_vM7iBpmTA0awNgSxrNfGGSY42ITYjS6g6SuGfW3SdFDyfur7oq1Ato/s1600/slide1.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="240" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhGg0COl5XruSc2M6Tqlbl-KZ69phovYcYzjTceLKGrUR8eAXyQ16-yjmxXJ0OPEbJVRC91slcIJsa4BGJwtZ87D_vM7iBpmTA0awNgSxrNfGGSY42ITYjS6g6SuGfW3SdFDyfur7oq1Ato/s320/slide1.jpg" width="320" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">A slide from my Aug. 1, 2012 <a href="http://hcrenewal.blogspot.com/2012/08/my-presentation-to-health-informatics.html" target="_blank">presentation</a> to the Health Informatics Society of Australia at HIC2012.  Click to enlarge.</td></tr></tbody></table><br /><br />-- SS

WSJ, Koppel and Soumerai: A Major Glitch for Digitized Health-Care Records - Cost Savings Illusory

Two EHR experts from Ivy-league institutions (which are typically hyperenthusiast-oriented) doubt cost savings from EHR technology.Wall Street JournalOpinionSeptember 17, 2012A Major Glitch for Digiti…

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A Message for Xerox: Americans Not 'Resistant to Change'; They Are Resistant to Reckless Change That Endangers Them

A press release from Xerox Healthcare Provider Solutions:<br /><br /><blockquote class="tr_bq"><span class="articleDate">Jul 31, 2012</span><br /><span class="articleDate"></span><a href="http://news.xerox.com/pr/xerox/Xerox-Surveys-Americans-Electronic-Health-Records.aspx" target="_blank">Only 26 Percent of Americans Want Electronic Medical Records, Says Xerox Survey</a></blockquote><div class="MsoNormal"><br /></div><div class="MsoNormal">The subtitle is a rhetorical question: </div><div class="MsoNormal"><b><br /></b></div><blockquote class="tr_bq"><div class="MsoNormal"><b>When it comes to healthcare, are Americans resistant to change?</b></div></blockquote><div class="MsoNormal"><b><span style="color: #1f497d;"> </span></b></div><div class="MsoNormal"><br /></div><div class="MsoNormal"><span class="articledate">This is analogous to the refrain of calling physicians and nurses "Luddites" regarding their not happily and passively accepting today's clinical IT.  I addressed that issue at my post on pragmatist clinicians v. health IT hyper-enthusiasts <a href="http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html" target="_blank">at this link.</a></span></div><div class="MsoNormal"><br /></div><blockquote class="tr_bq"><div class="MsoNormal"><span class="articledate">Jul 31, 2012</span></div><div class="MsoNormal"><br /></div><div class="MsoNormal"><span style="color: #1f497d;"> </span></div><div class="MsoNormal">ROCHESTER, N.Y. – Americans routinely use electronic files to manage their finances, communicate with friends and family and even take college courses – but when it comes to medical records – <b>only 26 percent want them digital</b>. The findings come from the third annual Electronic Health Records (EHR) online survey of 2,147 U.S. adults, conducted for Xerox (NYSE: XRX) by Harris Interactive in May 2012. </div><div class="MsoNormal"><br /></div><div class="MsoNormal"></div><div class="MsoNormal">According to the survey, <b>only 40 percent of respondents believe digital records will deliver better, more efficient care</b>. That response fell two percent from last year’s survey, and matches the response reported in 2010. <b>Overall, 85 percent of respondents this year expressed concern about digital medical records.</b></div></blockquote><div class="MsoNormal"><br /></div><div class="MsoNormal">Americans have a healthy skepticism of putting their private information online to be <a href="http://hcrenewal.blogspot.com/search/label/medical%20record%20privacy" target="_blank">hacked</a>, of the <a href="http://www.tinyurl.com/hostileuserexper" target="_blank">disruptive effects</a> of today's commercial health IT on their clinicians, and the costs of doing so.  This likely comes from common sense, reading and observation.<br /><br />As one reader of this blog wrote: <br /><br /><blockquote class="tr_bq">Xerox kindly shared all three years of their annual Electronic Health Records (EHR) online surveys by Harris Interactive. The media, industry and government unrelentingly promote health technology as the latest, greatest best stuff. But the public ain’t buying it. They want smart phones, but they don’t want <b>EHRs</b>. </blockquote></div><div class="MsoNormal"><br />The Xerox article paternalistically continues:<br /><br /></div><div class="MsoNormal"></div><blockquote class="tr_bq"><div class="MsoNormal">“We continue to see a<b> resistance to change</b> from <b>consumers</b> – meaning providers need to continue to educate Americans on the value of EHRs,” said <a href="http://www.blogger.com/redir.aspx?C=128f7c1b39b042a884df5a17e3807ff8&URL=http%3a%2f%2fwww.acs-inc.com%2fthot_chadharris.aspx" target="_blank">Chad Harris</a>, group president, Xerox Healthcare Provider Solutions.</div></blockquote><div class="MsoNormal"><br /><span style="color: black;">(Note the use of the 'EHR' acronym.  As I've written, the acronyms 'EHR' and 'EMR' are anachronisms used to describe what are no longer innocuous filing systems, but greatly intrusive <b>enterprise clinical resource and workflow control systems</b>.  I think the public increasingly understands that.)</span><br /><br /></div><div class="MsoNormal">This patriarchal statement by Chad Harris about "resistance to change" by "healthcare consumers" needing re-education is, in a word, <i>depraved</i>, because I think the person uttering the sentence knows better.  Let's define depraved:</div><div class="MsoNormal"><br /></div><blockquote class="tr_bq"><div class="MsoNormal"><a href="http://www.thefreedictionary.com/depraved" target="_blank">Depraved</a> (adj.):  morally bad or debased; corrupt; perverted</div></blockquote><div class="MsoNormal"><br /></div><div class="MsoNormal">This statement implies is that health IT is a perfected technology without significant flaws, whose benefits are well-proven and whose drawbacks and risks are well understood.</div><div class="MsoNormal"><br /></div><div class="MsoNormal">Unfortunately, none of those are true.  From my May 2012 post on ONC's embarrassing "<a href="http://hcrenewal.blogspot.com/2012/05/oncs-health-data-palooza-title-of.html" target="_blank">Health Data Palooza</a>", worth repeating here, with hyperlinks:</div><div class="MsoNormal"><br /></div><div style="font-family: inherit;"><ul><li><span style="font-size: small;">There is a markedly unscientific "irrational exuberance" pushing clinical IT into wide use at a dangerously rapid pace. This exuberance is contradicted by a growing body of literature that shows the benefits are likely far less than stated, e.g., by way of example, the ad-hoc set at </span><span style="font-size: small;"><a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=readinglist">http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=readinglist;</a></span><span style="font-size: small;"></span> </li><li><span style="font-size: small;">The technology remains experimental, its rollout is a human subjects experiment on a massive scale lacking nearly all the protections of other human subjects experimentation and for IT in mission critical settings (e.g., informed consent, formal quality control/validation/regulation, formal postmarket surveillance and reporting) due to extraordinary legal and regulatory special accommodations afforded the technology and its purveyors; </span></li><li><span style="font-size: small;">Defects of in-use systems are rampant, inappropriately turning patients and clinicians into software alpha and beta testers (e.g., as in the voluntary FDA MAUDE database, <a href="http://hcrenewal.blogspot.com/2011/01/maude-and-hit-risk-mother-mary-what-in.html">http://hcrenewal.blogspot.com/2011/01/maude-and-hit-risk-mother-mary-what-in.html</a> which contains information for just one HIT vendor, Cerner, who voluntarily reports such issues);</span> </li><li><span style="font-size: small;">The technology is unsupportive of clinician cognitive needs (2009 National Research Council study, which also stated that accelerating interdisciplinary research in biomedical informatics, computer science, social science, and health care engineering will be essential to perfect this technology);</span> </li><li><span style="font-size: small;">The roles of <a href="http://hcrenewal.blogspot.com/2011/08/from-senior-clinician-down-under.html" target="_blank">scientific discovery and anecdote</a> have been turned on their heads. RCT's of clinical IT are nearly non-existent and lower-level evidence (e.g., weak observational, pre-post, </span><span style="font-size: small;">qualitative</span><span style="font-size: small;">, and other study types) are cited as "scientific proof" of efficacy and safety justifying hundreds of billions of dollars of taxpayer (or is it Chinese loan?) expenditures.  Yet, risk management-relevant case reports of harmful events and near misses, crucial to help organizations and regulatory agencies understand risks are dismissed as "anecdotal" (e.g., Blumenthal: "The [ONC] committee [investigating FDA reports of HIT endangement] said that nothing it had found would give them any pause that a policy of introducing EMR's could impede patient safety," he said, while ONC issued an article based on questionable research methods entitled </span><span style="font-size: small;">"<a href="http://content.healthaffairs.org/content/30/3/464.full.html">The Benefits Of Health Information Technology: A Review Of The Recent Literature Shows Predominantly Positive Results</a>" </span><span style="font-size: small;">extolling the virtues of HIT, written about at <a href="http://hcrenewal.blogspot.com/2011/03/benefits-of-health-information.html">http://hcrenewal.blogspot.com/2011/03/benefits-of-health-information.html</a>).</span> </li><li><span style="font-size: small;">Risks are definite, with known patient injury and death, but the magnitude is admittedly unknown as admitted by JC (2008 Sentinel Event Alert), FDA (2010 Internal memo on HIT risks and statements of Jeffrey Shuren MD JD about known harms likely being "the tip of the iceberg"), IOM (2011 report on HIT risk), ECRI Institute (Top ten healthcare technology hazards for 2011 and 2012), NORCAL Mutual Insurance Company 2009 report on EHR risks, others;</span> </li><li><span style="font-size: small;">Existence of severe impediments to information diffusion about risks explicitly admitted by FDA (2010 memo), IOM (2011 report), others; </span></li><li><span style="font-size: small;">Usability of commercial products in real world settings is often poor (e.g., NIST 2011 study on usability), promoting "use error" (user interface designs that engender users to make errors of commission or omission, where many errors are due not to user error per se but due to designs that are flawed, e.g., poorly written messaging, misuse of color-coding conventions, omission of information, etc.) </span></li><li><span style="font-size: small;">These systems promote capture and display of clinically irrelevant information in the interest of charge capture, and result in <a href="http://hcrenewal.blogspot.com/2011/02/electronic-medical-records-two-weeks.html" target="_blank">reams of "legible gibberish"</a> with many negative characteristics that make it difficult for other clinicians and reviewers to establish a cohesive, definitive narrative of clinical events and timelines.</span></li></ul></div><div class="MsoNormal"><br /></div><div class="MsoNormal"></div><div class="MsoNormal">The article continues: </div><div class="MsoNormal"><br /></div><blockquote class="tr_bq"><div class="MsoNormal">Despite consumers’ misgivings of the value of EHRs, caregivers <i style="color: red;"><b>[largely hospitals and healthcare systems who force it on their staffs and owned physician practices - ed.]</b></i> are quick to adopt digital technology.  <i style="color: red;"><b>[Thanks to incentives and looming penalties - ed.]</b></i> When asked how their healthcare provider recorded medical information during their last visit to a doctor or hospital, 60 percent of respondents – who have visited a doctor or hospital – reported that the information was entered directly into a tablet, laptop or in-room computer station versus 28 percent who reported the information was taken via handwritten notes. </div></blockquote><div class="MsoNormal"><br /></div><div class="MsoNormal">As the numbers don't justify the practice, even if the numbers as stated are valid, my response is:<br /><br /><i>So what? </i></div><div class="MsoNormal"><br /></div><div class="MsoNormal"></div><blockquote class="tr_bq"><div class="MsoNormal">To help caregivers do more with this patient information, Xerox is working with researchers at PARC, A Xerox Company, to explore EHRs as a gateway to a variety of healthcare innovation <b>possibilities</b>. The resulting technology tools <b>will </b>simplify back-office and front-line processes, reduce errors, and free up caregivers to spend more time and attention on day-to-day patient care.</div></blockquote><div class="MsoNormal"><br /></div><div class="MsoNormal">The "possibilities" <b>will</b><b> </b>accomplish all these things?   </div><div class="MsoNormal"><br /></div><div class="MsoNormal">Not only does that not follow logically, but where's the data, or is this simply wishful thinking? </div><div class="MsoNormal"><br /></div><div class="MsoNormal">The latter "possibility that <b>will </b>come true" - "free up caregivers to spend more time and attention on day-to-day patient care" - is the most laughable.   These systems do anything but, as for example <a href="http://hcrenewal.blogspot.com/2012/09/realizing-ehr-potential-or-avoiding.html" target="_blank">here</a> regarding the the time costs of data acquisition and the time costs of data input.  I have yet to see serious studies that consistently demonstrate any time savings at all for clinicians.  Quite the reverse, actually.<br /><br />Of course, the mandatory marketing puffery: </div><blockquote class="tr_bq"><div class="MsoNormal"><br /></div><div class="MsoNormal"></div><div class="MsoNormal">“A big part of PARC’s healthcare work for Xerox is using <a href="http://www.blogger.com/redir.aspx?C=128f7c1b39b042a884df5a17e3807ff8&URL=http%3a%2f%2fwww.parc.com%2fservices%2ffocus-area%2fethnographyservices%2f" target="_blank">ethnography</a> and other social science methods to observe and analyze actual work practices – not just what people say they do,” said <a href="http://www.blogger.com/redir.aspx?C=128f7c1b39b042a884df5a17e3807ff8&URL=http%3a%2f%2fnews.xerox.com%2fpr%2fxerox%2felectronic.aspx%3ffid%3d181957%26id%3dE0C30430" target="_blank">Steve Hoover</a>, CEO, PARC, A Xerox Company. “If there’s one thing that this survey tells us, coupled with our own experiences, it’s that you should never develop or deploy technology outside of the human context.”</div></blockquote><div class="MsoNormal"><br /></div><div class="MsoNormal">Precisely what is being done now, and on a national scale in the 'National Program for IT in the HHS.'</div><div class="MsoNormal"><br /></div><div class="MsoNormal">Xerox, either you're part of the solution or part of the problem.</div><div class="MsoNormal"><br />Which is it? </div><div class="MsoNormal"><br /></div><div class="MsoNormal"><b><span style="font-family: 'Calibri','sans-serif';"> </span></b></div>-- SS

A Message for Xerox: Americans Not 'Resistant to Change'; They Are Resistant to Reckless Change That Endangers Them

A press release from Xerox Healthcare Provider Solutions:Jul 31, 2012Only 26 Percent of Americans Want Electronic Medical Records, Says Xerox SurveyThe subtitle is a rhetorical question: When it comes…

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Health IT difficulties and controversial excuses from health IT hyperenthusiasts and extremists

As I observed at my Aug. 15, 2012 post "<a href="http://hcrenewal.blogspot.com/2012/08/contra-costas-45-million-computer.html">Contra Costa's $45 million computer health care system endangering lives, nurses say</a>" and other posts, common in case reports of health IT difficulties is the refrain (usually from a seller, healthcare executive or health IT pundit) that:<br /><br /><ul><li>It's a rare event, it's just a 'glitch',  it's teething problems, it's a learning experience, we have to work the 'kinks' out, it's growing pains, etc.</li></ul><br />Or perhaps worse:<br /><ul><li>Patient safety was not compromised (stated long before the speaker or writer could possibly know that).</li></ul><br />What these statements translate to:  any patient harm that may have resulted is for the "greater good" in perfecting the technology.<br /><br />Here is the problem with that:<br /><br />These statements, while seemingly banal, are actually highly controversial and amoral. and reflect what can be called "faith-based informatics beliefs" (i.e., enthusiasm not driven by evidence).<br /><b><br /></b>They are amoral<b> because they significantly deviate from accepted medical ethics and patient rights</b>, especially regarding experimentation or research such as the plain language of the <a href="http://history.nih.gov/research/downloads/nuremberg.pdf" target="_blank">Nuremberg code</a>, the <a href="http://videocast.nih.gov/pdf/ohrp_belmont_report.pdf" target="_blank">Belmont Report</a>, World Medical Association <a href="http://history.nih.gov/research/downloads/helsinki.pdf" target="_blank">Declaration of Helsinki</a>, <a href="http://www.nccamwatch.org/research/human_guidelines.pdf" target="_blank">Guidelines for Conduct of Research Involving Human Subjects at NIH</a>, and <a href="http://bioethics.od.nih.gov/IRB.html" target="_blank">other documents</a> that originated out of medical abuses of the past.<br /><br />Semantic or legal arguments on the term "research", "experimentation" etc. are, at best, misdirection away the substantive issues.  Indeed, for all practical purposes the use of unfinished software (or software with newly-minted modifications) that has not been extensively tested and validated and that is suspected to or known to cause harm, without explicit informed consent, <b>is contrary to the spirit of the aforementioned patients' rights documents.</b><br /><br />They are excuses from health IT hyper-enthusiasts ("<a href="http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html" target="_blank">Ddulites</a>"), who in fact have become so hyper-enthusiastic as to ignore the ethical issues and downsides.  The attitude gives more rights to the cybernetic device and its creators than to the patients who are subject to the device's effects.<br /><br />These excuses are, in effect, from people who it would not be unreasonable to refer to as <i>technophile extremists.</i><br /><br />-- SS <b></b><br /><b><br /></b><b>Addendum:</b><br /><br />The <a href="http://videocast.nih.gov/pdf/ohrp_belmont_report.pdf" target="_blank">Belmont Report</a> of the mid to late 1970's, long before health IT became at all common, actually starts out with a section discussing "BOUNDARIES BETWEEN PRACTICE AND RESEARCH."  I have updated one of the observations in that section to modern times<b>:</b><br /><br /><blockquote class="tr_bq"> ... It is important to distinguish between biomedical and behavioral research, on the one hand, and the practice of accepted therapy on the other, <b>in order to know what activities ought to undergo review for the protection of human subjects of research</b>. <br /><br />... When a clinician <i style="color: red;"><b>[or entire healthcare delivery system - ed.]</b></i> departs in a significant way from standard or accepted practice, the innovation does not, in and of itself, constitute research. The fact that a procedure is "experimental," in the sense of new, untested or different, does not automatically place it in the category of research.<br /><br />Radically new procedures of this description <i style="color: red;"><b>[such as use of cybernetic intermediaries to regulate and govern care - ed.]</b></i> should, however, <b>be made the object of formal research at an early stage in order to determine whether they are safe and effective.</b> Thus, it is the responsibility of medical practice committees, for example, to insist that a major innovation <i style="color: red;"><b>[such as health IT - ed.]</b></i> be incorporated into a formal research project. </blockquote><br />Health IT appears to have been "graduated" from experimental to tried-and-true without the formal safety research called for in the Belmont report.<br /><br />The Belmont report continues: <br /><br /><blockquote class="tr_bq">Research and practice may be carried on together when research is designed to evaluate the safety and efficacy of a therapy. This need not cause any confusion regarding whether or not the activity requires review; <b>the general rule is that if there is any element of research in an activity, that activity should undergo review for the protection of human subjects. </b></blockquote><br />Instead, what we have for the most part are excuses and special accommodations for health IT, on which the <a href="http://hcrenewal.blogspot.com/2011/02/updated-reading-list-on-health-it.html" target="_blank">literature is conflicting</a> regarding safety and efficacy, all the way up to the <a href="http://hcrenewal.blogspot.com/2011/11/iom-report-on-health-it-safety-nix-fda.html" target="_blank">Institute of Medicine</a>.<br /><br />-- SS

Health IT difficulties and controversial excuses from health IT hyperenthusiasts and extremists

As I observed at my Aug. 15, 2012 post "Contra Costa's $45 million computer health care system endangering lives, nurses say" and other posts, common in case reports of health IT difficulties is the r…

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ONC's "Health Data Palooza" - A Title of Exceptionally Bad Taste, For a "See No Evil" Meeting

The Office of the National Coordinator of Health IT has sent out this announcement:<br /><span style="font-size: small;"><br /></span><div style="color: #16588b; font-family: Arial, Helvetica, sans-serif; font-size: 20px;"><span style="font-size: small;">Subject: HEALTH DATA PALOOZA III: Unleashing the Power of Data to Improve Health<br />From:    ONC Health IT <onchealthit .="." service.govdelivery.com="service.govdelivery.com"><br />Date:    Thu, May 10, 2012 10:36 am </onchealthit></span></div><div style="color: #16588b; font-family: Arial,Helvetica,sans-serif; font-size: 20px;"><br /></div><div style="color: #16588b; font-family: Arial,Helvetica,sans-serif; font-size: 20px;">HEALTH DATA PALOOZA III: Unleashing the Power of Data to Improve Health</div><div style="text-align: center;"><br /><span style="font-size: small;">June 5-6th, Washington DC<br />Health Data and Innovation Week<br /><a href="http://links.govdelivery.com/track?type=click&enid=ZWFzPTEmbWFpbGluZ2lkPTIwMTIwNTEwLjc0NDU0MDEmbWVzc2FnZWlkPU1EQi1QUkQtQlVMLTIwMTIwNTEwLjc0NDU0MDEmZGF0YWJhc2VpZD0xMDAxJnNlcmlhbD0xNjk4NDczMyZlbWFpbGlkPXNjb3RzaWx2QGFvbC5jb20mdXNlcmlkPXNjb3RzaWx2QGFvbC5jb20mZmw9JmV4dHJhPU11bHRpdmFyaWF0ZUlkPSYmJg==&&&101&&&http://www.hdiforum.org" target="_blank">www.hdiforum.org</a> | #healthdata<br /><br /><b>CONFIRMED SPEAKERS</b><br /><b>Kathleen Sebelius</b>, Secretary of Health and Human Services<br /><b>Marc Bertolini</b>, CEO Aetna<br /><b>Thomas Goetz</b>, Execuitve Editor of WIRED<br /><b>Atul Gawande</b>, surgeon and author<br /><b>Bill Frist</b>, former Republican Majority Leader<br /><b>Dominique Dawes</b>, two time gold medal winner<br /><b>Todd Park</b>, US Chief Technology Officer<br /><br /><br />Hear from <b>Farzad Mostashari</b>, National Coordinator for Health IT on <b>data liberation</b><br />ONC will host breakout sessions on Consumer e-Health, HealthData.gov, <br />and Uses of Data by ACOs<br />ONC will release nine challenges during this year’s event! </span></div><div style="text-align: center;"><br /></div><div style="text-align: left;"><br /></div><div style="text-align: left;"><span style="font-size: small;">This title for a government-sponsored meeting is bizarre and tasteless in my opinion.  What is deemed by ONC to be the major source of this data?  Health IT.</span></div><div style="text-align: left;"><br /></div><div style="text-align: left;"><span style="font-size: small;"><b>"Palooza?"</b></span></div><div style="text-align: left;"><span style="font-size: small;"><br /></span></div><div style="text-align: left;"><span style="font-size: small;">From Urban Dictionary:</span></div><div style="text-align: left;"><span style="font-size: small;"><br /></span></div><blockquote dir="ltr" style="margin-right: 0px;"><div><b>Palooza - <a href="http://www.urbandictionary.com/define.php?term=palooza">http://www.urbandictionary.com/define.php?term=palooza</a></b></div><div class="definition"><b></b></div></blockquote><blockquote dir="ltr" style="margin-right: 0px;"><div class="definition"><b>An all-out crazy party; partying at one place with a ton of people like there's no tomorrow; The art of throwing a very drunken extravagant party with a plethora of friends</b></div></blockquote><div></div><div></div><div><br /><span style="font-size: small;"><b>"Data Liberation?"    </b></span></div><div></div><div><br /><span style="font-size: small;">What about "patient liberation" -- from risk? </span></div><div></div><div><br />Considering it unlikely that issues in the bulleted points below, commented on in detail in past posts on this blog, will be discussed at this meeting, the title of the meeting is especially tasteless:</div><div></div><div style="font-family: Arial,Helvetica,sans-serif;"><ul><li><span style="font-size: small;">There is a markedly unscientific "irrational exuberance" pushing clinical IT into wide use at a dangerously rapid pace. This exuberance is contradicted by a growing body of literature that shows the benefits are likely far less than stated, e.g., by way of example, the ad-hoc set at </span><span style="font-size: small;"><a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=readinglist">http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=readinglist</a></span><span style="font-size: small;"> </span> </li><li><span style="font-size: small;">The technology remains experimental, its rollout is a human subjects experiment on a massive scale lacking nearly all the protections of other human subjects experimentation and for IT in mission critical settings (e.g., informed consent, formal quality control/validation/regulation, formal postmarket surveillance and reporting) due to extraordinary legal and regulatory special accommodations afforded the technology and its purveyors; </span></li><li><span style="font-size: small;">Defects of in-use systems are rampant, inappropriately turning patients and clinicians into software alpha and beta testers (e.g., as in the voluntary FDA MAUDE database, <a href="http://hcrenewal.blogspot.com/2011/01/maude-and-hit-risk-mother-mary-what-in.html">http://hcrenewal.blogspot.com/2011/01/maude-and-hit-risk-mother-mary-what-in.html</a> which contains information for just one HIT vendor, Cerner, who voluntarily reports such issues);</span> </li><li><span style="font-size: small;">The technology is unsupportive of clinician cognitive needs (2009 National Research Council study, which also stated that accelerating interdisciplinary research in biomedical informatics, computer science, social science, and health care engineering will be essential to perfect this technology);</span> </li><li><span style="font-size: small;">The roles of <a href="http://hcrenewal.blogspot.com/2011/08/from-senior-clinician-down-under.html" target="_blank">scientific discovery and anecdote</a> have been turned on their heads. RCT's of clinical IT are nearly non-existent and lower-level evidence (e.g., weak observational, pre-post, </span><span style="font-size: small;">qualitative</span><span style="font-size: small;">, and other study types) are cited as "scientific proof" of efficacy and safety justifying hundreds of billions of dollars of taxpayer (or is it Chinese loan?) expenditures.  Yet, risk management-relevant case reports of harmful events and near misses, crucial to help organizations and regulatory agencies understand risks are dismissed as "anecdotal" (e.g., Blumenthal: "The [ONC] committee [investigating FDA reports of HIT endangement] said that nothing it had found would give them any pause that a policy of introducing EMR's could impede patient safety," he said, while ONC issued an article based on questionable research methods entitled </span><span style="font-size: small;">"<a href="http://content.healthaffairs.org/content/30/3/464.full.html">The Benefits Of Health Information Technology: A Review Of The Recent Literature Shows Predominantly Positive Results</a>" </span><span style="font-size: small;">extolling the virtues of HIT, written about at <a href="http://hcrenewal.blogspot.com/2011/03/benefits-of-health-information.html">http://hcrenewal.blogspot.com/2011/03/benefits-of-health-information.html</a>).</span> </li><li><span style="font-size: small;">Risks are definite, with known patient injury and death, but the magnitude is admittedly unknown by JC (2008 Sentinel Event Alert), FDA (2010 Internal memo on HIT risks and statements of Jeffrey Shuren MD JD about known harms likely being "the tip of the iceberg"), IOM (2011 report on HIT risk), ECRI Institute (Top ten healthcare technology hazards for 2011 and 2012), NORCAL Mutual Insurance Company 2009 report on EHR risks, others;</span> </li><li><span style="font-size: small;">Existence of severe impediments to information diffusion about risks explicitly admitted by FDA (2010 memo), IOM (2011 report), others; </span></li><li><span style="font-size: small;">Usability of commercial products in real world settings is often poor (e.g., NIST 2011 study on usability), promoting "use error" (user interface designs that engender users to make errors of commission or omission, where many errors are due not to user error per se but due to designs that are flawed, e.g., poorly written messaging, misuse of color-coding conventions, omission of information, etc.) </span></li><li><span style="font-size: small;">These systems promote capture and display of clinically irrelevant information in the interest of charge capture, and result in <a href="http://hcrenewal.blogspot.com/2011/02/electronic-medical-records-two-weeks.html" target="_blank">reams of "legible gibberish"</a> with many negative characteristics that make it difficult for other clinicians and reviewers to establish a cohesive, definitive narrative of clinical events and timelines.</span></li></ul></div><div></div><div><br />Health IT and health data issues are not 'partying' affairs. An un-seriousness about anything related to health IT seems in vogue of late.<span style="color: black; font-family: 'Arial','sans-serif'; font-size: 10pt;"></span><br /><br />Finally, I ask:  does this "Health Data Palooza" bring my <a href="http://hcrenewal.blogspot.com/2012/02/health-it-ddulites-and-disregard-for.html" target="_blank">Ddulite</a> term to life?</div><div></div><div><br /><blockquote><span style="font-weight: bold;"><span style="color: red; font-style: italic;">Ddulite: Hyper-enthusiastic technophiles who </span></span><span style="color: red; font-style: italic; font-weight: bold;">either deliberately ignore or are blinded to technology's downsides</span><span style="font-weight: bold;"><span style="color: red; font-style: italic;">, ethical issues, and repeated local and mass failures. </span></span></blockquote><br />A Ddulite Palooza.  How charming.<br /><br />Like the recent extravagances of other government agencies such as <a href="http://www.cnn.com/2012/04/16/politics/gsa-hearing/index.html" target="_blank">GSA in Las Vegas</a> and the <a href="http://worldnews.msnbc.msn.com/_news/2012/05/07/11575731-prostitute-at-center-of-secret-service-scandal-agents-were-stupid-brutes?lite" target="_blank">Secret Service in Colombia</a>, let's hope this Data Palooza is a Palooza in name only.<br /><br />In light of those recent scandals, calling a government sponsored meeting a "Palooza" seems inappropriate on that basis as well. <br /><br />-- SS<br /><br />5/13/12  Addendum:<br /><br />A commenter pointed this flyer out:<br /><br /><br /><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiTPbMy_j7ie4KaNq3KWvaVvz0U-dCbEJ6UFSqTSyAmbRjMgptx5t_RbH8VRoBEsC_HQnKX-0E0NlppsCpdARzpzgLCAXPfRFN5WhNbiifkKQBMqONs_ORtXBGiny-6_XxVVycRVkTM8CG1/s1600/Health_Datapalooza_Poster_4.25_large.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="320" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiTPbMy_j7ie4KaNq3KWvaVvz0U-dCbEJ6UFSqTSyAmbRjMgptx5t_RbH8VRoBEsC_HQnKX-0E0NlppsCpdARzpzgLCAXPfRFN5WhNbiifkKQBMqONs_ORtXBGiny-6_XxVVycRVkTM8CG1/s320/Health_Datapalooza_Poster_4.25_large.jpg" width="247" /></a></div><div style="text-align: center;"><span style="font-size: x-small;">(click to enlarge)</span></div><div style="text-align: center;"><br /></div><div style="text-align: left;">I post it here with no additional comments.</div><div style="text-align: left;"><br /></div><div style="text-align: left;">-- SS</div></div>

ONC's "Health Data Palooza" - A Title of Exceptionally Bad Taste, For a "See No Evil" Meeting

The Office of the National Coordinator of Health IT has sent out this announcement:Subject: HEALTH DATA PALOOZA III: Unleashing the Power of Data to Improve HealthFrom:    ONC Health IT Date:    Thu, …

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Forbes: Obamacare Billionaire: What One Entrepreneur's Rise Says About The Future Of Medicine

An article in Forbes appeared today (4/18/12) entitled "<a href="http://www.forbes.com/sites/matthewherper/2012/04/18/obamacare-billionaire-what-one-entrepreneurs-rise-says-about-the-future-of-medicine/5/">Obamacare Billionaire: What One Entrepreneur's Rise Says About The Future Of Medicine</a>" by Matthew Herper.<br /><br />The article is largely a hagiography of Cerner founder Neal Patterson:<br /><br /><blockquote>North Kansas City is an unlikely place to launch a revolution in American health care. Yet here, amid the dilapidated grain elevators, fast food joints and vast green plains, the dream of using computers to keep you alive at a reasonable cost is battling onward. In a bunkerlike building built to withstand a direct hit by a category five tornado, 22,000 servers handle 150 million health care transactions a day, roughly one-third of the patient data for the entire U.S. Records of your blood pressure, cholesterol, lab test results, that gallbladder surgery last year—and how much you paid for it—may sit there right now. Armed guards stand watch.<br /><br />This is a data center at the headquarters of Cerner, the world’s largest stand-alone maker of health IT systems—and company number 1,621 on FORBES’ Global 2000 list—where the blood-and-guts realities of medicine meet the ­sterile speed and exactitude of the computer revolution. </blockquote><br />Omitted are some pertinent negative accounts, such as Cerner's role in the failed £12.7bn ($20bn U.S.) National Programme for IT in the NHS (NPfIT), as described <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=granger_speaks_out">here</a> and <a href="http://www.blogger.com/hcrenewal.blogspot.com/2010/08/cerners-blitzkrieg-on-london-wheres-raf.html">here</a>.<br /><br />Patterson is quoted with the standard industry bellicose grandiosity and hysterics about computers "revolutionizing" (as opposed to facilitating) medicine:<br /><br /><blockquote>... In 1999 a report from the prestigious Institute of Medicine gave Patterson hope that the rest of medicine was ready to follow in Mayo’s footsteps. Titled “To Err Is Human,” the report detailed how between 44,000 and 98,000 people die every year in hospitals from preventable mistakes, like getting the wrong medicine or the wrong dose of the right one. The ­report specifically prescribed better computer systems as a way to prevent these deadly mistakes. Patterson cites that study as the moment when health IT entered the mainstream. But it was still slow going, and that drove him nuts. His customers at that time were more worried about the Y2K bug than they were about <span style="font-weight: bold;">revolutionizing health care</span>.</blockquote><br />I first heard him and other HIT CEO's uttering the "revolution" line at a Microsoft Healthcare Users Group meeting ca. 1997 and attended largely by IT technicians. I was probably the only Medical Informatics-trained professional in attendance, and perhaps the only physician there.<br /><br />When I then asked those in the room how many had healthcare experience or had even read the Merck Manual, few hands went up. The CEO's could not then satisfactorily explain how medicine would be "revolutionized" by such a crowd. (One of those CEO's, of erstwhile HIT vendor HBOC, was later found to be seriously cooking the books after acquisition by McKesson. See "<a href="http://www.fbi.gov/sanfrancisco/press-releases/2009/sf111909b.htm"><span>Former McKesson HBOC Chairman Convicted of Securities Fraud; Defrauded Investors Lost in Excess of $8 Billion</span></a>" at FBI.gov. <span style="font-weight: bold;">Some revolution...)</span><br /><br />Unfortunately, most medical errors have little to do with documentation, either paper or electronic, as I wrote in Dec. 2010 at<span style="font-weight: bold;"> </span>"<a href="http://hcrenewal.blogspot.com/2010/12/is-healthcare-it-solution-to-wrong.html">Is Healthcare IT a Solution to the Wrong Problem?</a>". The latter, however, has introduced many new <a href="http://hcrenewal.blogspot.com/2011/02/updated-reading-list-on-health-it.html">errors modes and other social-technical problems</a>, permitted <a href="http://hcrenewal.blogspot.com/2012/01/2011-closes-on-note-of-electronic.html">massive security breaches</a> (it's very hard to haul away 10,000 paper charts without being noticed) and opportunities for medical records evidence spoliation simply not possible with paper.<br /><br />There are a few <a href="http://hcrenewal.blogspot.com/2012/02/health-it-ddulites-and-disregard-for.html">Ddulite-ish</a> quotes from Eric Topol and David Bates in an article with a clear tone of exalting health IT.<br /><br />I am quoted in the Forbes article in about the only comment critical of health IT, and the only comment concerning the ethics of human subjects experimentation conducted with this technology, as it exists in 2012:<br /><br /><blockquote>... <span style="font-weight: bold;">the Hippocratic oath says nothing about breaking eggs to make omelets</span>. “We’re kind of headed in the wrong direction,” says Scot Silverstein, a health IT expert at Drexel University who believes that the current systems are too prone to randomly losing data<span style="font-weight: bold; font-style: italic;"> <span style="color: rgb(255, 0, 0);">[I had cited</span> <a href="http://sydney.edu.au/engineering/it/%7Ehitru/index.php?option=com_content&task=view&id=91&Itemid=146">this study</a> <span style="color: rgb(255, 0, 0);">- ed.]</span></span><span style="color: rgb(255, 0, 0);"> </span>and complicating doctors’ lives.</blockquote><br />While the "breaking eggs to make omelets" metaphor was not mine, it reminded me that I just carried out my final earthly duty for my mother, injured in mid 2010 by a health IT-related error and deceased since June 2011. I filed her final IRS tax return yesterday, the due date.<br /><br /><span jsid="text" class="commentBody">I just hope my mother is enjoying her omelet in the Pearly Gates Diner. Scrambled eggs were about all she could eat well after the health IT accident.</span><br /><br />As a result of that experience, my new business card (phone # redacted):<br /><br /><br /><div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgJ816cVuHWs6a6JHRvCv3Eg5mS_dE3ys3CfjSmUwEwZhrc35wFTqN4uJFYSbhZTdfZJGuyzbuJiv_ED8e3BftgodtuvyyQ5-2Oj8vEQCiAozTfs4R0ZXziQYJTc6ITSChhkddVI1ryXP_J/s1600/business_card_nonum.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5732943107289611266" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgJ816cVuHWs6a6JHRvCv3Eg5mS_dE3ys3CfjSmUwEwZhrc35wFTqN4uJFYSbhZTdfZJGuyzbuJiv_ED8e3BftgodtuvyyQ5-2Oj8vEQCiAozTfs4R0ZXziQYJTc6ITSChhkddVI1ryXP_J/s320/business_card_nonum.jpg" style="display: block; margin: 0px auto 10px; text-align: center; cursor: pointer; width: 275px; height: 153px;" /></a><span style="font-size:85%;">(Click to enlarge)</span><br /></div><br /><br />I no longer merely write about health IT risks. I find past involvement with attorneys early in my medical career, as Manager of Medical Programs and Medical Review Officer (drug testing officer) for one of the largest public transit authorities in the United States, quite helpful in this new role.<br /><br />The "eggs that get broken", as in a well known old nursery rhyme from the early 1800's, <a href="http://en.wikipedia.org/wiki/Humpty_Dumpty">cannot be reassembled</a>. Those injured or killed in the unregulated, thoughtless, cavalier journey to some mystical medical cybernetic utopia deserve justice, and the eggheads responsible for their harms have earned the privilege of explaining themselves in the courtroom and being properly penalized where appropriate.<br /><br />The future of medicine - if it is to not become a nightmare <a href="http://bioethics.od.nih.gov/IRB.html#policies">ignoring the lessons of history</a>, repeating the <a href="http://www.npr.org/programs/morning/features/2002/jul/tuskegee/">mistakes of the past</a> - belongs to those willing to take an ethical stand in defense of medicine's core values, and in defense of patients.<br /><br />-- SS

Forbes: Obamacare Billionaire: What One Entrepreneur's Rise Says About The Future Of Medicine

An article in Forbes appeared today (4/18/12) entitled "Obamacare Billionaire: What One Entrepreneur's Rise Says About The Future Of Medicine" by Matthew Herper.The article is largely a hagiography of…

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