Citizen's Council for Health Freedom: "The Truth about Electronic Health Records"

The Citizen's Council for Health Freedom (CCHF) is an independent 501(c)3 non-profit organization with a mission "to protect health care choices and patient privacy" (<a href="http://www.cchfreedom.org/about.php">www.cchfreedom.org/about.php</a>).<br /><br />Its president, Twila Brase, wrote this piece about Electronic Health Records in the CCHF newsletter of June 18, 2014, observing some "inconvenient truths" and highlighting one of the most asinine statements I've ever seen about computers made by (of course) a venture capital official who happened to play a significant role in formulating the Affordable Care Act a.k.a. "Obamacare":<br /><br /><blockquote class="tr_bq"><a href="http://healthenews.cchfreedom.org/newsletter.php/148">http://healthenews.cchfreedom.org/newsletter.php/148</a><br /><br />The Truth about Electronic Health Records<br /><br />Propaganda only works for so long. Pretty soon truth catches up to it. This is exactly what's happening with electronic health records.<br /><br />If you're a doctor you know how bad the government-mandated electronic health record (EHR) is. <b>But if you're a patient, you may not realize that EHRs are endangering your life</b> and jeopardizing medical excellence.<br /><br />The EHR is nothing like what Big Government, Big Data, and Big Health said it would be. They promised convenience, coordinated care, fewer medical errors, more efficient medical practice, and portable medical records. <b>They never meant it and it hasn't happened. These data systems were created for billing, data collection and government control of doctors, not patient care.</b></blockquote><br />From all I have seen over the years, I must agree with the last two sentences above. The pioneers who explored this technology back to the 1950's warned against the nightmare that exists today, but I don't think they believed we would ever get to where we are in 2014.<br /><br />Further, while Politico did not explicitly mention risk to life and limb caused by these systems, Twila Brase did.  <b>"EHRs are endangering your life" </b>is the elephant in the living room that the industry and its well-captured (and perhaps lubricated?) "regulators"<b> simply will not address in a serious manner.</b><br /><br />It has been my belief this reflects self-serving willful blindness, gross negligence and/or pecuniary motives, but I also believe that a fundamental malevolence on the part of people and organizations who know better increasingly needs to be considered as a contributor to the recklessness in the health IT sector.  These are experimental technologies of admittedly (by the regulators) definite but unknown risk, due to impediments to that knowledge.  Demanding their rapid diffusion under threat of penalty while knowing about the risks, and the uncertainty about magnitude, certainly does not reflect a benevolent disposition.<b> </b><br /><br />For more on the above points see my April 9, 2014 post <b>"FDA on health IT risk: reckless, or another GM-like political coverup?"</b> (<a href="http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html">http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html</a>) and its 11 points and hyperlinks.  This post and its linked brethren represents an indictment of sorts against the health IT hyperenthusiast culture and the unprecedented regulatory accommodation enjoyed by this sector.<b><br /></b><br /><br /><blockquote class="tr_bq">Arthur Allen at POLITICO Pro eHealth (<a href="http://www.politico.com/story/2014/06/health-care-electronic-records-107881.html">http://www.politico.com/story/2014/06/health-care-electronic-records-107881.html</a>) says government-imposed EHRs are:<br /><ul><li>Driving doctors to distraction </li></ul><ul><li>Igniting nurse protests </li></ul><ul><li>Crushing hospitals under debt</li></ul>"In short," he writes, "<b>the current generation of electronic health records has about as many fans in medicine as Barack Obama at a tea party convention.</b>"</blockquote><br />I guess that's  Politco's way of saying "not very many at all."<br /><br /><blockquote class="tr_bq">Doctors forced to use these EHRs say: </blockquote><blockquote class="tr_bq"><ul><li>"They slow us down and distract us from taking care of patients."</li></ul><ul><li>"We're basically key-punch operators, transcriptionists having to input the data ourselves. It has essentially tripled the time to complete a medical record."</li></ul><ul><li>"That's why I'm retiring."</li></ul><ul><li>"Before I took notes, wrote what I wanted to say. Now I write and I click. If you just click, the person who reads the record gets no idea of what the patient was going through, your thought process."</li></ul><ul><li>"Anything that in a normal world would take at most two clicks, here it takes four or five."</li></ul></blockquote><br />In fact, doctors and nurses forced to use this technology say far worse (e.g., see my posts on candid clinician feedback at <a href="http://hcrenewal.blogspot.com/2010/01/honest-physician-survey-on-ehrs.html">http://hcrenewal.blogspot.com/2010/01/honest-physician-survey-on-ehrs.html</a> , <a href="http://hcrenewal.blogspot.com/2013/11/another-survey-on-ehrs-affinity-medical.html">http://hcrenewal.blogspot.com/2013/11/another-survey-on-ehrs-affinity-medical.html</a> , <a href="http://hcrenewal.blogspot.com/2014/02/ehrs-real-story-sobering-assessment.html">http://hcrenewal.blogspot.com/2014/02/ehrs-real-story-sobering-assessment.html</a> , and <a href="http://hcrenewal.blogspot.com/2013/07/candid-nurse-opinions-on-ehrs-at.html">http://hcrenewal.blogspot.com/2013/07/candid-nurse-opinions-on-ehrs-at.html</a>).<br /><blockquote class="tr_bq"><br />Proponents falsely promised privacy. The real goal of Big Government, Big Data and Big Health was NO privacy. Data is valued <b>as a tool of control and a means to profit. </b>And today, 2.2 million entities today have legal access to your medical records without your consent because of the so-called HIPAA "privacy rule" and the 2009 HITECH Act. In addition, untold numbers of computer thieves, identity thieves and hackers have illegal access.</blockquote><br />Not only that, but our data is sold in, in essence, data broker "back alleys" (e.g., see <b>"Health IT Vendors Trafficking in Patient Data?"</b> at <a href="http://hcrenewal.blogspot.com/2009/10/health-it-vendors-trafficking-in.html">http://hcrenewal.blogspot.com/2009/10/health-it-vendors-trafficking-in.html</a> ).<br /><br />Worse, the phenomenon of mismanagement of the "sales" is international in scope (e.g., see "<b>NHS slammed for MAJOR data blunders as scale of patient info sell-off is revealed"</b> at <a href="http://www.theregister.co.uk/2014/06/17/nhs_blamed_for_major_data_blunders_with_sale_of_patient_info_to_private_outfits/">http://www.theregister.co.uk/2014/06/17/nhs_blamed_for_major_data_blunders_with_sale_of_patient_info_to_private_outfits/</a>).<br /><br /><blockquote class="tr_bq">Every doctor and hospital must use EHRs by January 1, 2015 or face financial penalties. This was part of Obama's 2009 Recovery Act, and the foundation of Obamacare. The sheer cost of the mandate has forced many doctors to shut down private clinics and become health system employees, susceptible to being told by outsiders how to practice medicine.</blockquote><br />Regarding "crushing hospitals under debt", the EHR "mania" has led medical centers such as the University of Arizona Health System, about to undergo the stresses of mass immigration of South American children no less, to sink $30 million into the red in large part in <i>trying to fix EHR bugs</i> (see my June 2, 2014 post <b>"In Fixing Those 9,553 EHR "Issues", Southern Arizona’s Largest Health Network is $28.5 Million In The Red"</b> at <a href="http://hcrenewal.blogspot.com/2014/06/in-fixing-those-9553-ehr-issues.html">http://hcrenewal.blogspot.com/2014/06/in-fixing-those-9553-ehr-issues.html</a>).<br /><br />As another example of madness, the mania -- plus bad health IT -- led a  medical system based in Rhode Island to spend $100 million to replace Siemens health IT that caused <i><b>thousands of potentially harmful prescription errors </b></i>(<a href="http://hcrenewal.blogspot.com/2011/11/lifespan-rhode-island-yet-another.html">http://hcrenewal.blogspot.com/2011/11/lifespan-rhode-island-yet-another.html</a>) with Epic, and in doing so, eroding the cash flow and bond rating of the state's largest health system (<a href="http://www.modernhealthcare.com/article/20140606/NEWS/306069948">http://www.modernhealthcare.com/article/20140606/NEWS/306069948</a>).<br /><br />Next Ms. Brase reveals a stunning fact about one of the architects of that 2009 Economic Recovery Act:<br /><br /><blockquote class="tr_bq">The arrogance of some EHR supporters is unpardonable. <b>Bob Kocher helped write Obamacare</b>, was trained as a doctor and <b>is employed as a Venrock venture capitalist in health IT</b>, but his credentials are those of a bureaucrat and profiteer (<a href="http://www.venrock.com/teammember/bob-kocher/">http://www.venrock.com/teammember/bob-kocher/</a>). </blockquote><br />Unpardonable arrogance indeed.  <br /><br />In other words, a speculator and profiteer in the health IT sector helped in the formulation of laws that pushed the technology onto physicians, nurses and hospitals with CMS penalties for non-adopters of "certified" systems.   It would be interesting to know just how far such a potential conflict of interest went in the crafting of the ACA and HITECH itself.<br /><br />Beyond that issue, this venture cap issues the following perverse statement, as cited by Politico and CCHF:<br /><br /><blockquote class="tr_bq">Per Politico pro eHealth, he says, <b>"The reason so many [computers] are inefficient is that doctors are inefficient. If they redesigned their workflows, computers would work better."</b></blockquote><br />Readers of this blog are familiar with perversity in health IT, but that statement is literally stunning.  It would make for a funny Saturday Night Live or Rowan and Martin's Laugh-In (to us 60's folks) skit if the topic were not so serious.<br /><br /><b>If they [doctors] redesigned their workflows, computers would work better?</b><br /><br />Where, exactly, is the evidence for that assertion? <b>  Exactly how should doctors "redesign" their workflows, </b>considering the poorly bounded, conflicted, highly variable, uncertain, and high-tempo nature of the field? [1]<br /><br />How can one even have a well-defined and unvarying "workflow" in such a domain that would "make computers work better?" <br /><br />Answer:  it's impossible.<br /><br />(Perhaps<span data-ft="{"tn":"K"}" data-reactid=".u.1:3:1:$comment10203787041178410_10203787453188710:0.0.$right.0.$left.0.0.1:$comment-body"><span class="UFICommentBody" data-reactid=".u.1:3:1:$comment10203787041178410_10203787453188710:0.0.$right.0.$left.0.0.1:$comment-body.0"><span data-reactid=".u.1:3:1:$comment10203787041178410_10203787453188710:0.0.$right.0.$left.0.0.1:$comment-body.0.$text0:0:$0:0"> patients should adjust the unpredictable nature of their illnesses and symptoms to make the computers work better, too?)</span></span></span><br /><br />What Dr. Kocher seems to turn on its head is the recognition that:<b> </b><br /><br /><b>"The reason so many [computers in healthcare] are inefficient is that they are grossly misdesigned for a domain like medicine.  They are unfit for purpose.  If they [the IT companies] redesigned their entire process in HIT production (from conception, design, implementation, marketing, and support) to be consistent with the needs of the field of clinical medicine and of clinicians, computers would work better." </b>- Silverstein<br /><br />The reality is that if the healthcare IT industry actually <i>fired its ossified business-IT-oriented leaders</i> (since business computing and clinical computing are two highly different fields, e.g., see <a href="http://hcrenewal.blogspot.com/2008/06/business-v-clinical-computing.html">http://hcrenewal.blogspot.com/2008/06/business-v-clinical-computing.html</a>), or relegated them to managing accounting systems, and embraced the teaching of 50+ years of Medical Informatics in building good health IT (see definitions of good and bad health IT at <a href="http://cci.drexel.edu/faculty/ssilverstein/cases/">http://cci.drexel.edu/faculty/ssilverstein/cases/</a>), then we might actually get significant value and better safety from the technology.<br /><br />Mr. Kocher, that's an idea to consider.  <br /><br />As I wrote at that 2008 post on business v. clinical computing:<br /><br /><blockquote class="tr_bq"><span style="font-family: inherit;"><span style="font-size: small;">... The prevalent belief in MIS [management information systems a.k.a. business computing] seems to be that <b>medicine is another area of transactional business subject to conventional modeling by generalists</b>, to be followed by "business process re-engineering" and traditional information systems development processes and methodologies.<br /><br />However, the belief that one could employ conventional business-oriented "analysis" in the clinical world always seemed to me to be oversimplistic, overoptimistic, and in fact not infrequently harmful to medical practice as a result of the simplistic assumptions. It is a belief that does not perform well even in the conventional business world where significant cost overruns, project difficulties, and project failures are commonplace, let alone in the unforgiving environments of medicine. </span></span></blockquote><br />My fear is that many in business computing may lack the mental flexibility and capability to understand issues like that, that conflict directly with their linear-flow, business-oriented worldview.<br /><br /><blockquote class="tr_bq">In other words, Mr. Kocher <b>wants doctors to practice according to the computer systems he helped impose, not the doctor's patients</b>. We must never let his agenda for medical practice prevail. State legislatures must act now to restore patient privacy rights and use Tenth Amendment powers to undo the EHR mandate.</blockquote><br />Exactly.  It's certainly the simple way to big profits, and injured and dead patients be damned.  Building good health IT is far more resource intensive.<br /><blockquote class="tr_bq"><br /><b>Working to sustain an ethical patient-doctor relationship,</b><br /><br />Twila Brase<br />President and Co-founder</blockquote><br />Thank heaven someone is working towards those ends.<br /><br />Notes: <br /><br /><span style="font-size: x-small;">[1]  Per Medical Informatics researchers Nemeth and Cook's "<b>Hiding in plain sight: What Koppel et al. tell us about healthcare IT"</b>, Journal of Biomedical Informatics 38 (2005) 262–263 available at <a href="http://www.ctlab.org/documents/Hiding%20in%20plain%20sight.pdf">http://www.ctlab.org/documents/Hiding%20in%20plain%20sight.pdf</a>)  </span><b><br /></b>

Citizen's Council for Health Freedom: "The Truth about Electronic Health Records"

The Citizen's Council for Health Freedom (CCHF) is an independent 501(c)3 non-profit organization with a mission "to protect health...

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Full Moon Friday the 13th: Computers down at Vermont's largest hospital

A health IT "glitch" hit in Vermont on Full Moon Friday the 13th (have some werewolf with your bad luck!)<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/AVvXsEjV_zdKebiTKhfRJ6uNpkvPKcEBO6KdRLFaX9I2jr_774V1kxcEclGioScEsgplQzaD5ewqWC5zNQeqq2L4uEd62Qt4Hth98npdNSWR5lBv7f_BXtr0hnEZim77eHA10BZwaHDmZ8JjPTaU/s1600/werewolf.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="160" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjV_zdKebiTKhfRJ6uNpkvPKcEBO6KdRLFaX9I2jr_774V1kxcEclGioScEsgplQzaD5ewqWC5zNQeqq2L4uEd62Qt4Hth98npdNSWR5lBv7f_BXtr0hnEZim77eHA10BZwaHDmZ8JjPTaU/s1600/werewolf.jpg" width="200" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">Dark Shadows' Quentin Collins (David Selby) in a foul full-moon mood.</td></tr></tbody></table><br />Note, however, that "bad luck" has little or nothing to do with mission-critical healthcare IT mass outages.  Mismanagement often does:<br /><br /><blockquote class="tr_bq"><a href="http://www.wcax.com/story/25773022/computers-down-at-vermonts-largest-hospital">http://www.wcax.com/story/25773022/computers-down-at-vermonts-largest-hospital</a><br /><div id="WNStoryHeader"><h3 class="">Computers down at Vermont's largest hospital</h3><i class="wnDate">Posted: Jun 13, 2014 4:12 PM EST </i><i class="wnDate">Updated: Jun 13, 2014 4:12 PM EST </i><br /><div id="WNStoryByline"><div class="byline">By WCAX News</div></div></div></blockquote><div class=" withRelated right" id="WNStoryBody"><blockquote><span id="WNStoryDateline">BURLINGTON, Vt. - </span><br />A major, systemwide computer problem at Fletcher Allen Health Care in Burlington Friday.<br /><br />The hospital says the computer system went down at 9:45 a.m. <b>The glitch</b> means doctors and nurses could not enter patient information into computers.</blockquote><br /><b>"Glitch"</b> is an unfortunate euphemism for potentially harmful or deadly computer malfunctions, often due to mismanagement of that technology. See query link <a href="http://hcrenewal.blogspot.com/search/label/glitch">http://hcrenewal.blogspot.com/search/label/glitch</a>.<br /><br /><blockquote class="tr_bq">Hospital spokesperson Mike Noble says information is now being recorded manually <span style="color: red;"><i><b>[i.e., on paper - ed.] </b></i></span>Noble says the staff continues to provide the same care as normal and no surgeries were canceled because of the computer issue.<br /><br />Noble says the issue appears to be an internal problem and not something from an outside computer provider.<br /><br /><b>It’s not known when the problem will be corrected.</b></blockquote><br />This is yet another "the systems that revolutionize healthcare against all of paper's ills have all gone down, we don't know when they will be fixed, but patient care has not been compromised because we are resorting to paper" story (more at query link <a href="http://hcrenewal.blogspot.com/search/label/Patient%20care%20has%20not%20been%20compromised">http://hcrenewal.blogspot.com/search/label/Patient%20care%20has%20not%20been%20compromised</a>).  <br /><br />-- SS</div>

Full Moon Friday the 13th: Computers down at Vermont's largest hospital

A health IT "glitch" hit in Vermont on Full Moon Friday the 13th (have some werewolf with your bad luck!) Dark Shadows' Quenti...

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Masters of the Obvious at Athens Regional Medical Center: Lack of clinician input, training, common sense created problems with Athens Regional electronic records system - but mostly lack of common sense

<div style="text-align: center;"><span style="font-size: x-small;">(Note: also see my earlier May 26, 2014 post at <a href="http://hcrenewal.blogspot.com/2014/05/i-could-not-make-this-up-if-i-tried.html">http://hcrenewal.blogspot.com/2014/05/i-could-not-make-this-up-if-i-tried.html</a>)</span></div><br />My early medical mentor, Dr. Victor P. Satinsky, had disdain for those whom he called "<b>Masters of the Obvious</b>", who proffered profound words of wisdom that were in fact common-sensical or well-accepted, as if they'd invented those words personally.<br /><br />I think it's fair to say that after countless publications dating back decades, pointing out the essential role of <b>clinical leadership</b> in the development of clinical tools such as healthcare information technology systems, that such involvement is now a<b> </b>standard of care that reasonable hospital leadership would mandate when spending tens of millions of dollars on potentially injurious or lethal systems.<br /><br />Yet the physician revolt at Athens Regional Medical Center appears to be a result of its most senior leadership not keeping IT leadership on an appropriately short leash (a phenomenon that falls under the topical heading of "severe mismanagement"):<br /><br /><blockquote class="tr_bq"><a href="http://onlineathens.com/local-news/2014-06-14/lack-input-training-created-problems-athens-regional-electronic-records-system">http://onlineathens.com/local-news/2014-06-14/lack-input-training-created-problems-athens-regional-electronic-records-system</a><b> </b><br /><br /><b>Lack of input, training created problems with Athens Regional electronic records system</b><br /><br />By Kelsey Cochran<br />Athens Banner-Herald<br />Updated Sunday, June 15, 2014<b> </b><br /><br /><b>More input in the way Athens Regional Health Systems’ electronic health records system was implemented should have come from the clinicians who use it every day, and fewer decisions should have been made by the hospital’s information technology department</b>, a top hospital administrator and two vice presidents of system vendor Cerner Corp. said this week, in the wake of criticism of the system by a number of physicians.<br /><br />... Although some daily users of the system were involved in the planning and design process from the beginning, Cerner Vice President Michael Robin, who has worked closely with ARMC since the deal was first made, said his team noticed midway through its implementation that <b>the hospital system’s IT team was leading the project,</b> <b>which is "atypical" of Cerner clients</b> like ARMC, he said. </blockquote><br />First, I don't think that IT team control of health IT projects is all that unusual.   Clinicians, even medical informaticists with cross-disciplinary expertise, rarely are more than "internal consultants" who may be ignored, as opposed to true leaders with executive presence and authority (e.g., control of budgets, grants of authority, and IT staff performance evaluation, hire and fire authority).<br /><br />Second, where was the Board of Directors?  They were ultimately responsible for allowing the IT leadership in at a level beyond their collective heads. <br /><br />Third, it's just a bit odd that the leader of the (failed) $20 billion National Programme for IT in the NHS, Richard Granger, said almost exactly the same thing about listening to end-users ca. 2007 (see <a href="http://hcrenewal.blogspot.com/2007/07/clinical-it-mayhem-is-good-for-it.html">http://hcrenewal.blogspot.com/2007/07/clinical-it-mayhem-is-good-for-it.html</a>).  I as well as numerous other authors had similar observations, in some cases dating to the 1960's.  For example,  see my essays, some dating to the late 1990s at <a href="http://cci.drexel.edu/faculty/ssilverstein/cases/?loc=cases">http://cci.drexel.edu/faculty/ssilverstein/cases/?loc=cases</a>, and Dr. Donald Lindberg's quotes from 1969 at the page below from Morris Collen's book "A History of Medical Informatics in the United States 1950-1990."<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/AVvXsEgcn4aLX1NGS_wG4FsSop81xaYmy9OeDKeiW-6qndwAvRWTmR6Sa4pwXyBuG02j4jKhifXdjSbcCcLcFngrkv6lYcip-V6DQvXzAsPCHdqMity4UopLN1lptK4OjgvBQIMUurTDLVb4l7Jr/s1600/collen168.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="320" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgcn4aLX1NGS_wG4FsSop81xaYmy9OeDKeiW-6qndwAvRWTmR6Sa4pwXyBuG02j4jKhifXdjSbcCcLcFngrkv6lYcip-V6DQvXzAsPCHdqMity4UopLN1lptK4OjgvBQIMUurTDLVb4l7Jr/s1600/collen168.jpg" width="210" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">EHR pioneer Dr. Donald A.B. Lindberg (<a href="http://www.nlm.nih.gov/od/roster/lindberg.html">http://www.nlm.nih.gov/od/roster/lindberg.html</a>), 1969:  "Computer engineering experts per se have virtually no idea of the real problems of medical or even of hospital practice, and furthermore have consistently underestimated the complexity of the problems ... in no cases can these jobs be done, simply because they have not been defined with a physician as the continuing major contributor and user of the information." (Click to enlarge)</td></tr></tbody></table><br />The essential nature of clinicians actually having input (and at a leadership level) into the design and implementation of clinical tools such as health IT is patently obvious.  <b>Only in the perverse control-mentality of business information technology</b> (a.k.a. MIS or management information systems, see <a href="http://hcrenewal.blogspot.com/2008/05/seedie-society-for-exorbitantly.html">http://hcrenewal.blogspot.com/2008/05/seedie-society-for-exorbitantly.html</a> for the possible pre-electronic computer, tabulator-based roots of that culture)<b> could such a precept even be questioned, let alone ignored.</b><br /><blockquote class="tr_bq"><br />... Moore, who took over as administrative lead on the electronic health record system after Thaw resigned, said some of the issues outlined in the physicians’ letter were real, and some were “theoretical.”</blockquote><br />Translation: some of the complaints were accidents waiting to happen.<br /><br /><blockquote class="tr_bq"><i>..."To the best of our knowledge, there was not patient harm or patient death.” </i></blockquote><br />In other words, this is yet another story where the common, feel-good and ignorant refrain "but patient care has not been compromised" has reared its ugly head.  (I've made this type of claim a topical header at this blog.  See query link <a href="http://hcrenewal.blogspot.com/search/label/Patient%20care%20has%20not%20been%20compromised">http://hcrenewal.blogspot.com/search/label/Patient%20care%20has%20not%20been%20compromised</a> for others.) <br /><br />Assuming that's true - note that the impact of bad health IT can be delayed due to delayed effects of bad or missing information - this statement is, let me be impolite, vacuous on its face.<br /><div class="headword" id="headword"><blockquote class="tr_bq"><h2><span style="font-size: small;">vac·u·ous (<a href="http://www.merriam-webster.com/dictionary/vacuous">http://www.merriam-webster.com/dictionary/vacuous</a><b><span style="font-weight: normal;">)</span></b></span></h2><span class="main-fl"><i>adjective</i></span> <span class="pr">\<span class="unicode">ˈ</span>va-kyə-wəs\</span> </blockquote><div class="ld_on_collegiate"><blockquote><div class="bottom_entry">: having or showing a lack of intelligence or serious thought : lacking meaning, importance, or substance</div></blockquote></div></div><br />It seems some simple facts apparently need to be explained to these geniuses.   I'll put it in caps just to make sure they understand some basic issues:<br /><br /><ul><li>A HOSPITAL IS NOT A PLACE FOR RISKY INFORMATION TECHNOLOGY EXPERIMENTATION.   UNNECESSARY RISK IN HEALTHCARE IS A VERY, VERY BAD THING.<b> </b></li></ul><ul><li><b>THE GOAL OF HOSPITALS IS NOT TO SUBJECT PATIENTS TO RISK VIA MISMANAGEMENT OF HEALTHCARE IT</b>, AND THEN PROCLAIM "NOBODY WAS INJURED OR KILLED" AFTER THE PERPETRATORS OF THE MISMANAGEMENT ARE UPROOTED. </li></ul><ul><li>CLINICIANS DO NOT TOIL IN HOSPITALS TAKING CARE OF SICK PATIENTS SO THAT INFORMATION TECHNOLOGY PERSONNEL CAN HAVE COMFY JOBS AND COOL COMPUTERS.</li></ul><br />One wonders if these points might be above the intellectual pay grade of those running hospitals - including boards - in 2014. <br /><br />If nobody was injured or killed, it was due to<i><b> happenstance</b></i>, not due to appropriate due diligence and adherence to the standards of care essential in this healthcare sector - that is, healthcare information technology.<br /><br />Depending on happenstance is not a good healthcare management strategy. <br /><br />-- SS<br /><br />

Masters of the Obvious at Athens Regional Medical Center: Lack of clinician input, training, common sense created problems with Athens Regional electronic records system - but mostly lack of common sense

(Note: also see my earlier May 26, 2014 post at http://hcrenewal.blogspot.com/2014/05/i-could-not-make-this-up-if-i-tried.html ) My early me...

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CMS does not have any information that supports or refutes claims that a broader adoption of EHRs can save lives?

If this is true, the EHR hyper-enthusiasm problem is even worse than I believed.<br /><br />From the April 2014 newsletter of the American Association for Physicians and Surgeons (<a href="http://www.aapsonline.org/index.php/about_us/">http://www.aapsonline.org/index.php/about_us/</a>), an organization that is dedicated "to preserving the sanctity of the patient-physician relationship and the practice of private medicine":<br /><br /><blockquote class="tr_bq"><b>CMS Claims to Have No Information on EHRs</b><br /><br />On Mar. 14, 2014, the Office of Strategic Operations and Regulatory Affairs of the Centers for Medicare and Medicaid Services replied to a Freedom of Information Act (FOIA) request sent Apr. 4, 2012:  The American Recovery and Reinvestment Act of 2009 (ARRA) created the Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs.  While our Office of E-Health Standards and Services works to implement the provisions of the ARRA, <b>we do not have any information that supports or refutes claims that a broader adoption of EHRs can save lives."</b></blockquote><br />However, that doesn't stop our government from spending billions of taxpayer dollars on them, when, in fact, we <i>do know</i> of harms they cause.  One can reasonably assume their primary interest is in bookkeeping.<br /><br />With FDA, it's even worse.  Rather than stopping at admitting they simply don't know due to admitted impediments to knowing, they simply leap to a conclusion that the technology is of 'sufficiently low risk' not to warrant their regulatory attention, even if such systems meet the statutory requirements to be a medical device and thus fall under the Food, Drug & Cosmetic Act.<br /><br />See my Apr. 9, 2014 post <b>"FDA on health IT risk: We don't know the magnitude of the risk, and what we do know is the tip of the iceberg, but health IT is of 'sufficiently low risk' that we don't need to regulate it"</b> and its ten-point (and non-comprehensive) summary of risks: <a href="http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html">http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html</a>.  Another FOIA request is surely needed...<br /><br />More generally, I know from personal development and implementation experience that when "done well",<span style="font-size: small;"> that is, when</span> <b>good health IT </b>and good implementation practices are offered and with patient safety as a priority, health IT can save lives and improve care.  It's just that the commercial for-profit health IT sector does not meet those expectations, due largely to its leadership model from the merchant-computing culture.  Instead, bad health IT is the norm.  From my academic site at <a href="http://cci.drexel.edu/faculty/ssilverstein/cases/">http://cci.drexel.edu/faculty/ssilverstein/cases/</a>:<br /><br /><blockquote class="tr_bq"><span style="font-size: small;"><b>Good Health IT</b> is IT that provides a good user experience, enhances cognitive function, puts essential information as effortlessly as possible into the physician’s hands, can be easily, substantively and cost-effectively customized to the needs of medical specialists and subspecialists, keeps eHealth information secure, protects patient privacy and facilitates better practice of medicine and better outcomes. <br /><br /><b>Bad Health IT </b>is IT that is ill-suited to purpose, hard to use, unreliable, loses data or provides incorrect data, is difficult and/or prohibitively expensive to customize to the needs of different medical specialists and subspecialists, causes cognitive overload, slows rather than facilitates users, lacks appropriate alerts, creates the need for hypervigilance (i.e., towards avoiding IT-related mishaps) that increases stress, is lacking in security, compromises patient privacy or otherwise demonstrates suboptimal design and/or implementation. </span></blockquote><br /> I am seeking source material from the AAPS and will post it.<br /><br />-- SS<br /><br /><b>April 26, 2014 Addendum:</b><br /><br />Below is the letter to AAPS from CMS.  Click to enlarge.<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/AVvXsEiSrd8gxZN0QHQd4cLK_aeA3uDI-a9I__6VVZfa32Gz6iCAm8Y-r2APJEzYw_Mav9oJSOWtFXXJYCz3iIELuUPqiJtPt_xtwa1k4hzcXTmEwYOhHSHKmfx6bGUSrXInxG2ax_nK15KLDeDV/s1600/CMS_Letter.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="400" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiSrd8gxZN0QHQd4cLK_aeA3uDI-a9I__6VVZfa32Gz6iCAm8Y-r2APJEzYw_Mav9oJSOWtFXXJYCz3iIELuUPqiJtPt_xtwa1k4hzcXTmEwYOhHSHKmfx6bGUSrXInxG2ax_nK15KLDeDV/s1600/CMS_Letter.jpg" width="308" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">CMS:  "we do not have any information that supports or refutes claims that a broader adoption of EHRs can save lives."  [But let's spend hundreds of billions of dollars anyway.]  Click to enlarge.<b><br /></b></td></tr></tbody></table><br /><b><u>An additional thought</u>:</b><br /><br />While CMS may "not have any information that supports or refutes claims that a broader adoption of EHRs can save lives", they <b>do have</b> (or should have made it their business to have) information <b><u>that EHRs cause harm and take lives</u></b> (e.g., via FDA at <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> , ECRI at <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> and others).<br /><br />-- SS<br /><br />

CMS does not have any information that supports or refutes claims that a broader adoption of EHRs can save lives?

If this is true, the EHR hyper-enthusiasm problem is even worse than I believed. From the April 2014 newsletter of the American Association ...

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FDA on health IT risk: reckless, or another GM-like political coverup? "We don't know the magnitude of the risk, and what we do know is the tip of the iceberg, but health IT is of 'sufficiently low risk' that we don't need to regulate it."

In my Sept. 16, 2013 post <b>"An Open Letter to David Bates, MD, Chair, ONC FDASIA Health IT Policy Committee on Recommendations Against Premarket Testing and Validation of Health IT" </b>(<a href="http://hcrenewal.blogspot.com/2013/09/an-open-letter-to-david-bates-md-chair.html">http://hcrenewal.blogspot.com/2013/09/an-open-letter-to-david-bates-md-chair.html</a>) I wrote: <br /><br /><blockquote class="tr_bq">David Bates, Chair, ONC FDASIA Health IT Policy Committee<br />via email<br />    <br />Dear David, I am disappointed (and in fact appalled) at the ONC FDASIA Health IT Policy Committee's recommendations that health IT including typical commercial EHR/CPOE systems not be subjected to a premarket testing and validation process.  I believe this recommendation is, quite frankly, negligent. </blockquote><br />The resultant April 2014 report is out: "<b>FDASIA Health IT Report: Proposed Strategy and Recommendations for a Risk-Based Framework</b>."  It is available at <a href="http://www.healthit.gov/sites/default/files/fdasiahealthitreport_final.pdf">http://www.healthit.gov/sites/default/files/fdasiahealthitreport_final.pdf</a>.<br /><br />The report is an academic idealist's and industry's dream.  It is a patient's nightmare.<br /><br />Instead of regulation, the report recommends the creation of a nebulous <b>"Health IT Safety Center"</b> (pgs. 16 and 25) as a "public-private entity with broad stakeholder engagement, that includes a governance structure for the creation of a sustainable, integrated health IT learning system that avoids regulatory duplication and leverages and complements existing and ongoing efforts.<b><i>"  </i>In other words, a toothless organization without true regulatory authority.</b> <br /><br />The recommendations of the Health IT Policy Committee have apparently been taken seriously by FDA.  <br /><br />This FDA announcement recently appeared (FDA is part of HHS):<br /><br /><blockquote class="tr_bq"><a href="http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm390988.htm">http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm390988.htm</a><br /><br /><b><b>HHS News Release</b></b><br /><b><b>For Immediate Release:</b> April 3, 2014</b><br /><br /><b>Proposed health IT strategy aims to promote innovation, protect patients, and avoid regulatory duplication</b><br /><br /><b>HHS today released a draft report that includes a proposed strategy and recommendations for a health information technology (health IT) framework</b>, which promotes product innovation while maintaining appropriate patient protections and avoiding regulatory duplication. The congressionally mandated report was developed in consultation with health IT experts and consumer representatives and proposes to clarify oversight of health IT products based on a product’s function and the potential risk to patients who use it.<br /><br />... As proposed in the draft report, posted on the ONC, FDA and FCC websites, there would be three health IT categories, based on function and level of risk, that focus on what the product does, not on the platform on which it operates (mobile medical device, PC, or cloud-based, for example).<br /><br />The first category, products with administrative health IT functions, poses little or no risk to patient safety and as such requires no additional oversight. They include software for billing and claims processing, scheduling, and practice and inventory management.<br /><br />The second category, products with health management heath IT functions, <b>includes software for health information and data management, medication management, provider order entry, knowledge management, electronic access to clinical results and most clinical decision support software.</b><br /><br />Products with health management health IT functions are of<b> sufficiently low risk</b> and thus, if they <b>meet the statutory definition of a medical device, FDA does not intend to focus its oversight on them.</b> Instead, the draft report proposes relying primarily on ONC-coordinated activities and private sector capabilities that highlight quality management principles, industry standards and best practices.</blockquote><br />The characterization of these admitted medical devices as <b>"sufficiently low risk"</b> is in my opinion grossly negligent (if not criminal).<br /><br />For instance, GM concealed an ignition flaw that resulted in 13 deaths.<b><i>  Look what's happening now in that sector.  Revelations of corporate wrongdoing and Congressional investigations:</i></b><br /><br /><blockquote class="tr_bq"><a href="http://www.nytimes.com/2014/03/31/business/us-regulators-declined-full-inquiry-into-gm-ignition-flaws-memo-shows.html">http://www.nytimes.com/2014/03/31/business/us-regulators-declined-full-inquiry-into-gm-ignition-flaws-memo-shows.html</a><br /><br />U.S. Agency Knew About G.M. Flaw but Did Not Act<br />By MATTHEW L. WALD<br />MARCH 30, 2014<br /><br />Federal regulators decided not to open an inquiry on the ignitions of Chevrolet Cobalts and other cars even after their own investigators reported in 2007 that they knew of four fatal crashes, 29 complaints and 14 other reports that showed the problem disabled air bags, according to a memo released by a House subcommittee on Sunday.<br /><br />Then in 2010, the safety agency came to the same decision after receiving more reports that air bags were not deploying.<br /><br />The memo also revealed that General Motors approved the faulty design of the switch in 2002 even though the company that made the part, Delphi, warned the automaker that the switch did not meet specifications. This followed a warning the year before — when the Saturn Ion was being developed — but G.M. said that “a design change had solved the problem,” according to the memo.<br />Continue reading the main story<br />Related Coverage<br /><br />The striking new details in the memo bolster the contention that both G.M. and the National Highway Traffic Safety Administration, more than previously acknowledged, <b>ignored or dismissed warnings for more than a decade about a faulty ignition switch that, if bumped, could turn off, shutting the engine and disabling the air bags. General Motors has recalled nearly 2.6 million cars and has linked 13 deaths to the defec</b>t.<b><i> </i></b></blockquote><br />13 deaths, and we get this: <br /><br /><blockquote class="tr_bq"><div class="story-body-text story-content" data-para-count="362" data-total-count="2158" itemprop="articleBody">A House subcommittee, which gathered more than 200,000 pages of documents from G.M. and 6,000 pages from the agency, will hold a hearing on Tuesday. Mary T. Barra, <b>General Motors’ chief executive, and David Friedman, the acting administrator of the safety agency, are scheduled to testify. Both are also scheduled to testify before a Senate panel on Wednesday.</b></div><div class="story-body-text story-content" data-para-count="362" data-total-count="2158" itemprop="articleBody"><br /></div><div class="story-body-text story-content" data-para-count="241" data-total-count="2399" itemprop="articleBody"><b>“The problems persisted over a decade, the red flags were many, and yet those responsible failed to connect the dots</b>,” Fred Upton, a Republican of Michigan and the chairman of the House Energy and Commerce Committee, said in a statement.</div><div class="story-body-text story-content" data-para-count="241" data-total-count="2399" itemprop="articleBody"><br /></div><div class="story-body-text story-content" data-para-count="104" data-total-count="2503" itemprop="articleBody">The most damaging finding in the memo concerned the <b>four fatal crashes that went unheeded by regulators.</b></div><div class="story-body-text story-content" data-para-count="104" data-total-count="2503" itemprop="articleBody"><br /></div><div class="story-body-text story-content" data-para-count="224" data-total-count="2727" id="story-continues-5" itemprop="articleBody">In a presentation dated Nov. 17, 2007, the safety agency’s investigators reported to its Office of Defects Investigation on the fatal crashes, as well as broad range of complaints and other reports about cars shutting off.</div><div class="story-body-text story-content" data-para-count="224" data-total-count="2727" id="story-continues-5" itemprop="articleBody"><br /></div><div class="story-body-text story-content" data-para-count="355" data-total-count="3082" itemprop="articleBody">“The panel did not identify any discernible trend and decided not to pursue a more formal investigation,” the House memo said. The findings <a href="http://www.nytimes.com/2014/03/09/business/auto-regulators-dismissed-defect-tied-to-13-deaths.html" title="The report. ">reinforce an analysis</a> by<b> The New York Times published March 8 that found the agency had received more than 260 complaints about Cobalts, Ions and other cars in the recall, citing potentially dangerous shutdowns<i>.</i></b></div></blockquote><br />While GM is being grilled and raked over the coals, the health IT industry is likely going to get the healthcare industry's most generous and unprecedented special regulatory accommodation<b> </b>by FDA<b> due to its products being deemed of "sufficiently low risk"</b> (?) not to merit attention.<br /><br />--------------------------------------------<br /><div><br /></div><b>The FDA statement is particularly reckless, perhaps criminally so, given the following ten points.</b><br /><br />I add that the following are just highlights off the top of my head, and non-inclusive of all known facts on health IT risk:<br /><br />(1)  FDA's own 2010 "Internal Memo on HIT Risk", "not intended for public use" but exposed by Center for Public Integrity investigative reporter Fred Schulte (<a href="http://www.publicintegrity.org/authors/fred-schulte">http://www.publicintegrity.org/authors/fred-schulte</a>) when he was with the Huffington Post Investigative Fund (as described at <a href="http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html" target="_blank">http://hcrenewal.blogspot.com/<wbr></wbr>2010/08/smoking-gun-internal-<wbr></wbr>fda-memorandum-<span style="font-family: inherit;">of.html</span></a><span style="font-family: inherit;">), stated:</span><br /><span style="font-family: inherit;">  </span><br /><span style="font-family: inherit;"> </span><br /><div style="margin-left: 40px;"><span style="font-family: inherit;"><span style="font-size: 100%;">...In summary, the <b>results of this data review suggest significant clinical implications and public safety issues surrounding Health Information Technology</b>. The most commonly reported H-IT safety issues included wrong patient/wrong data, medication administration issues, clinical data loss/miscalculation, and unforeseen software design issues; all of which have varying impact on the patient’s clinical care and outcome, which included 6 death and 43 injuries. <b>The absence of mandatory reporting enforcement of H-IT safety issues limits the number of relevant MDRs [device reports] and impedes a more comprehensive understanding of the actual problems and implications. </b></span></span> </div><div dir="ltr"><span style="font-family: Arial; font-size: 100%;"></span></div><br />They then go on to categorize the known risk factors and the impediments to knowing about their occurrence:<span style="font-size: x-small;"><span style="font-family: inherit;"><b> </b></span></span><br /><br /><blockquote class="tr_bq"><span style="font-size: x-small;"><span style="font-family: inherit;"><b>Limitations of the MAUDE search and final subset of MDRs include the following:</b> </span></span><br /><br /><span style="font-size: x-small;"><span style="font-family: inherit;">1. Not all H-IT safety issue MDRs can be captured due to limitations of reporting practices including</span></span><br /><span style="font-size: x-small;"><span style="font-family: inherit;">...(a) Vast number of H-IT systems that interface with multiple medical devices currently assigned to multiple procodes making it difficult to identify specific procodes for H-IT safety issues;</span></span><br /><span style="font-size: x-small;"><span style="font-family: inherit;">...(b) Procode assignments are also affected by the ability of the reporter/contractor to correctly identify the event as a H-IT safety issue;</span></span><br /><span style="font-size: x-small;"><span style="font-family: inherit;">...(c) Correct identification by the reporter of the suspect device brand name is challenged by difficulties discerning the actual H-IT system versus the device it supports.<br />2. Due to incomplete information in the MDRs, it is difficult to unduplicate similar reports, potentially resulting in a higher number of reports than actual events.<br />3. Reported death and injury events may only be associated with the reported device but not necessarily attributed to the device.<br />4 Correct identification by the reporter of the manufacturer name is convoluted by the inability to discern the manufacturer of the actual H-IT system versus the device it supports.<br />5 The volume of MDR reporting to MAUDE may be impacted by a lack of understanding the reportability of H-IT safety issues and enforcement of such reporting.</span></span></blockquote><br />In other words, FDA does not know the level of risk due to systematic impediments to information diffusion.<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/AVvXsEiRf0xG1UixoduxWOjXHN0BAMipTO7-63_YQZ4NKtaFyhMvkpdfo7MwpGBU8O0c6XKxBEM4owWvWl0RBV1amw0nVtJlMCMEwEy-o2fovaDZWLYJRc2uY6hS34Kl-lWLwwl9m-iZySg9o4b5/s1600/memo.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="320" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiRf0xG1UixoduxWOjXHN0BAMipTO7-63_YQZ4NKtaFyhMvkpdfo7MwpGBU8O0c6XKxBEM4owWvWl0RBV1amw0nVtJlMCMEwEy-o2fovaDZWLYJRc2uY6hS34Kl-lWLwwl9m-iZySg9o4b5/s1600/memo.jpg" width="243" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;"><span style="font-size: x-small;">Internal FDA Memo ("not intended for public use") on potential dangers of health IT.  <b>Download the full PDF by clicking <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/Internal-FDA-Report-on-Adverse-Events-Involving-Health-Information-IT.pdf">here</a></b>.</span></td></tr></tbody></table><br />I think it axiomatic to state that it is, at best, seriously misleading to now state a technology is of "low risk" while internally having admitted that the risk level is not known due to impediments to that knowledge.  That situation has not changed since this memo's internal FDA dissemination, and its disclosure by Schulte.<br /><br /><i><b>This is inexplicable on its face on scientific grounds.</b></i><br /><br />Further, another HHS agency, the Agency for Healthcare Research and Quality (AHRQ, <a href="http://www.ahrq.gov/">http://www.ahrq.gov/</a>) has also taxonomized in detail a rich tapestry of "how health IT can cause harm."  See "<b>AHRQ Health IT Hazards Manager Report</b>" at <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> and its contained list of harms on pg. 29, reproduced below.<br /><br />AHRQ has no regulatory authority.  These failure modes are expensive to deal with, thus many will likely only be dealt with by the industry (if at all) <i>after</i> patient harms or near-misses.  Patients, however, are not experimental subjects for the debugging and "improvement" of experimental IT systems. <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/AVvXsEjGfJvUqIoCXmUuiiiqJvolkT3Ncg9DoM4VResY7HhOBmbfdZj29hKbwxLRTUbMi7gbaSCfQNdqcKqI6SKWi0JKIyOrHFgBfL3D0-rzEHwfVx6Lm37KilOi8LjiEUBdIzyH9oH47wXprM7H/s1600/ahrq.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="257" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjGfJvUqIoCXmUuiiiqJvolkT3Ncg9DoM4VResY7HhOBmbfdZj29hKbwxLRTUbMi7gbaSCfQNdqcKqI6SKWi0JKIyOrHFgBfL3D0-rzEHwfVx6Lm37KilOi8LjiEUBdIzyH9oH47wXprM7H/s1600/ahrq.jpg" width="400" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">AHRQ Health IT Hazard Manager Report - Hazard Modes of Health IT <b>(click to enlarge)</b></td></tr></tbody></table><br />Surely FDASIA is aware of this.<br /><br /><br /><div>(2)  FDA CDRH Director Jeff Shuren MD, JD's own statement that the known risks are "the tip of an iceberg" <span style="font-size: 100%;">at the<span style="font-weight: bold;"> HIT Policy Committee</span>, <span style="font-weight: bold;">Adoption/Certification Workgroup</span> on February 25, 2010, where the topic was "HIT safety" (The text is available <a href="http://web.archive.org/web/20120320111030/http://healthit.hhs.gov/portal/server.pt/gateway/PTARGS_0_11673_910717_0_0_18/3Shuren_Testimony022510.pdf" target="_blank">at this link</a>):</span><br /><br /><div style="margin-left: 40px;">...... In the past two years, we [FDA] have received <span style="font-weight: bold;">260 reports</span> of HIT-related malfunctions with the potential for patient harm – including <span style="font-weight: bold;">44 reported injuries and 6 reported deaths</span>. Because these reports are purely voluntary, they may represent only the<span style="font-weight: bold;"> tip of the iceberg</span> in terms of the HIT-related problems that exist<span style="font-style: italic;"><span style="font-weight: bold;">.</span></span></div></div><div></div><div></div><div></div><div></div><div></div><div><br />Considering the admitted impediments to information diffusion, it's likely even at this point that FDA knew the number of injuries and deaths was far larger than GM's mere 13 ignition defect-related deaths. </div><div><br /></div><div><div>(3)   FDA's <b>MAUDE (Manufacturer and User Facility Device Experience) databas</b>e is a voluntary medical device defects reporting system, but is not specifically purposed for health IT and is almost unknown to typical health IT users as a resource for reporting flaws.  <br /><br />MAUDE reports show health IT devices are <b>literally festooned with an incredible number of flaws</b>, as if they come from dirt-floor-covered software sweatshops with little oversight.<br /><br />These are defects that have made it into live hospital and caregiver devices, and have led to reported harms and death (see <a href="http://hcrenewal.blogspot.com/2011/01/maude-and-hit-risk-mother-mary-what-in.html" target="_blank">http://hcrenewal.blogspot.com/<wbr></wbr>2011/01/maude-and-hit-risk-<wbr></wbr>mother-mary-what-in.html</a>).<br /><br />The voluntary nature of this MAUDE reporting by just a few HIT sellers, and lack of knowledge of it by health IT users as a resource, cannot fail to lead to the conclusion that the problems are far worse than this limited dataset indicates.<br /><br />(4)  The prestigious U.S. Institute of Medicine of the National Academies (<a href="http://www.iom.edu/">http://www.iom.edu/</a>), perhaps the top scientific authority in this country, also admitted the<b> risk levels of health IT were unknown due to systematic impediments to knowing.</b>  IOM noted this in their <a href="http://hcrenewal.blogspot.com/2011/11/iom-report-on-health-it-safety-nix-fda.html">late 2011 study on EHR safety</a>:</div></div><div><br /><blockquote>... While some studies suggest improvements in patient safety can be made, others have found no effect. Instances of health IT–associated harm have been reported. However, <b><u>little published evidence could be found </u></b><span style="font-weight: bold;"><u>quantifying the magnitude of the risk</u>. </span><br /><br />Several reasons health IT–related safety data are lacking include the <span style="font-weight: bold;">absence of measures and a central repository</span> (or<span style="font-weight: bold;"> linkages</span> among decentralized repositories) to collect, analyze, and act on information related to safety of this technology. Another impediment to gathering safety data is <span style="font-weight: bold;">contractual barriers (e.g., nondisclosure, confidentiality clauses)</span> that can prevent users from sharing information about health IT–related adverse events. These barriers limit users’ abilities to share knowledge of risk-prone user interfaces, for instance through screenshots and descriptions of potentially unsafe processes. In addition, some vendors include language in their sales contracts and escape responsibility for errors or defects in their software (i.e., “<span style="font-weight: bold;">hold harmless clauses</span>”). The committee believes these types of contractual restrictions <span style="font-weight: bold;">limit transparency, <u>which significantly contributes to the gaps in knowledge of health IT–related patient safety risks</u>. </span></blockquote><br />The IOM did note, contrary to FDA's current finding that these systems are of "<b>sufficiently low risk</b>", that: <br /><br /><blockquote><span style="font-weight: bold;">These barriers to generating evidence pose unacceptable risks to safety.</span><span style="font-style: italic;">[IOM (Institute of Medicine). 2012. <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/Patient%20Safety%20and%20Health%20IT%20prepub.pdf">Health IT and Patient Safety: Building Safer Systems for Better Care</a> (PDF). Washington, DC: The National Academies Press, pg. S-2.]</span><span style="font-weight: bold;"><br /></span></blockquote><br />Also in the IOM report:<br /><br /><blockquote class="tr_bq">… “For example, the number of patients who receive the correct medication in hospitals increases when these hospitals implement well-planned, robust computerized prescribing mechanisms and use barcoding systems. But even in these instances, the<span style="font-weight: bold;"> ability to generalize the results across the health care system may be limited</span>. For other products— including electronic health records, which are being employed with more and more frequency— some studies find improvements in patient safety, while other studies find no effect.<br /><br /><b>More worrisome, some case reports suggest that poorly designed health IT can create new hazards</b> in the already complex delivery of care. <u><b>Although the magnitude of the risk associated with health IT is not known</b></u>, some examples illustrate the concerns. Dosing errors, failure to detect life-threatening illnesses, and delaying treatment due to poor human–computer interactions or loss of data have led to serious injury and death.”</blockquote></div><div></div><div><br />IOM could not have stated the reality more explicitly than via their statement "<u><b>the magnitude of the risk associated with health IT is not known."</b></u> </div><div><br />(5)   Surely FDA (and the FDASIA committees responsible for the new Report) are aware of  the ECRI Institute's Deep Dive study results from a study they carried out within their PSO-member hospitals (<a href="http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html" target="_blank">http://hcrenewal.blogspot.com/<wbr></wbr>2013/02/peering-underneath-<wbr></wbr>icebergs-water-level.html</a>).  I would call 171 voluntarily-reported health IT-related mishaps in 36 hospitals over 9 weeks, with 8 injuries and 3 possible deaths, an alarming study.<br /><br />In fact, in 2014 based on their PSO data, the ECRI Institute identified health IT as #1 of the "Top Ten Technology Risks in Healthcare" (<a href="http://hcrenewal.blogspot.com/2014/04/in-ecri-institutes-new-2014-top-10.html">http://hcrenewal.blogspot.com/2014/04/in-ecri-institutes-new-2014-top-10.html</a>):<br /><br /><blockquote class="tr_bq"><span style="font-family: inherit;"><span style="font-size: small;">CONCERN #1: <b>Data integrity failures with health information technology systems</b></span></span><span style="font-family: inherit;"><span style="font-size: small;"> </span></span><br /><br /><span style="font-family: inherit;"><span style="font-size: small;">With the federal government offering financial incentives for hospitals and physician practices to adopt EHR systems, use of these systems more than tripled from 2009 through 2012. “Health IT systems are very complex,” says James P. Keller, M.S., vice president, technology evaluation and safety, ECRI Institute. <b>“They are managing a lot of</b><b> information, and it’s easy to get something wrong” if the systems are not designed and </b><b>implemented well.</b> While appropriately designed and implemented systems can provide complete, current, and accurate patient care information so that the clinician can make appropriate treatment decisions,<b> the presence of incorrect data can lead to incorrect</b> treatment, potentially leading to patient harm.</span></span></blockquote><span style="font-family: inherit;"><span style="font-size: x-small;"></span></span></div><div></div><div><br />I certainly would NOT aver that this technology's risk level is of "<b>sufficiently low risk</b>" to not warrant formal regulation by a body skilled in software regulation, as is FDA., e.g., for medical devices and for IT used in pharmaceutical clinical trials data management and drug manufacturing.<br /><br />See for example <b>"General Principles of Software Validation; Final Guidance for Industry and FDA Staff" </b>at <a href="http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm085281.htm">http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm085281.htm</a>.<br /><br />(I would <i><b>really</b></i> not enjoy being in a position to have to make such an averment about "<b>sufficiently low risk</b>" under GM ignition investigation-like conditions... )</div><div><br /></div>(6)  Surely FDA (and the FDASIA committees responsible for the new Report) are aware of the data reported by the medical malpractice insurer CRICO, that insures the Harvard medical community (see <a href="http://hcrenewal.blogspot.com/2014/02/patient-safety-quality-healthcare.html" target="_blank">http://hcrenewal.blogspot.com/<wbr></wbr>2014/02/patient-safety-<wbr></wbr>quality-healthcare.html</a>):<br /><br /><blockquote class="tr_bq">... CRICO recently analyzed a year’s worth of medical malpractice claims in its comparative database [from numerous sources] 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>  ... <b>Half of the 147 cases resulted in severe injury.</b> <span style="color: red;"><b><i> [Death numbers are unstated - ed.] </i></b></span></blockquote><br />Note that these numbers were an examination of lawsuits filed; most medical malpractice never gets to the point of an actual filed lawsuit due to the unfavorable economics of the medical malpractice industry.  Perhaps 5% of actual events ever get filed, thus CRICO's data is also a "tip of an iceberg."<br /><br />(7)  Surely FDA (and the FDASIA committees responsible for the new Report) are aware of mass risk introduced by faulty systems such as in the incident in Rhode Island, at Lifespan Healthcare (<a href="http://hcrenewal.blogspot.com/2011/11/lifespan-rhode-island-yet-another.html">http://hcrenewal.blogspot.com/2011/11/lifespan-rhode-island-yet-another.html</a>), where thousands of prescriptions were altered by faulty HIT without physician knowledge.  Suffixes for the long acting version of a drug (e.g., "XL" or "XR") were dropped:<br /><br /><blockquote class="tr_bq">PROVIDENCE, R.I. (WPRI) - Rhode Island State Senator Jamie Doyle says he is <span style="font-weight: bold;">shocked to hear a <a href="http://www.lifespan.org/">Lifespan</a> computer glitch caused thousands of patients to receive the wrong types of medication. </span><span style="font-weight: bold;"><span style="color: red;">[Appx. 2,000 across five Lifespan hospitals according to the Providence Journal, see below, and </span></span><span style="font-weight: bold;"><span style="color: red;">the</span> <a href="http://www.washingtonpost.com/business/ri-senator-wants-investigation-after-up-to-2000-hospital-patients-got-wrong-form-of-medicine/2011/11/03/gIQAufcviM_story.html">WaPo</a></span><span style="font-weight: bold;"><span style="color: red;"> - ed.]</span></span><br /><br />Doyle is now calling for an independent review of all the hospitals Lifespan runs, and a review of the Rhode Island Department of Health.<br /><br />The DOH is investigating after learning patients who were supposed to receive medications taken once a day <b>instead received medications meant to be taken more than once per day.  <span style="color: red;">[In other words, they were taking short acting drugs on a long-acting once a day schedule, thus being massively under-dosed - ed.]</span></b></blockquote><br />(8)  The FDA (and the FDASIA committees responsible for the new Report) surely cannot be unaware of all of the "glitches" reported on in-situ health IT systems, as cataloged at this blog under the tag "glitch" and as of this writing numbering 25 posts, some including patient deaths.  See the results of the query link: <a href="http://hcrenewal.blogspot.com/search/label/glitch">http://hcrenewal.blogspot.com/search/label/glitch</a>.<br /><br />(9) Surely FDA (and the FDASIA committees responsible for the new Report) cannot be unaware that FDA itself had to recall health IT with flaws "serious enough to cause patient death":<br /><br /><blockquote class="tr_bq"><b>FDA recall.  McKesson Anesthesia Care – Patient Case Data May Not Match Patient Data</b>:  <b>Use of this affected product may cause serious adverse health consequences, including death. </b><br /><a href="http://hcrenewal.blogspot.com/2014/03/ehr-recall-use-of-this-affected-product.html">http://hcrenewal.blogspot.com/2014/03/ehr-recall-use-of-this-affected-product.html</a><br /><br /><b>FDA Recalls Draeger Health IT Device Because "This Product May Cause Serious Adverse Health Consequences, Including Death"</b> <br /><a href="http://hcrenewal.blogspot.com/2011/12/fda-recalls-health-it-software-because.html">http://hcrenewal.blogspot.com/2011/12/fda-recalls-health-it-software-because.html</a><br /><br /><b>FDA Recall: Philips Xcelera Connect - Incomplete Information Arriving From Other Systems </b><br /><a href="http://hcrenewal.blogspot.com/2012/07/health-it-fda-recall-philips-xcelera.html">http://hcrenewal.blogspot.com/2012/07/health-it-fda-recall-philips-xcelera.html</a><br /><br /><b>FDA recall:  An ED EHR "Glitch" That Mangles Prescriptions </b><br /><a href="http://hcrenewal.blogspot.com/2013/08/a-good-way-to-cynernetically-harm-or.html" target="_blank">http://hcrenewal.blogspot.com/<wbr></wbr>2013/08/a-good-way-to-<wbr></wbr>cynernetically-harm-or.html</a> </blockquote><br />(10)  FDA (and the FDASIA committees responsible for the new Report) are surely not unaware of my own report to its MAUDE database (because the hospital denied my request to issue the report itself) of a fundamental defect in a widely used health IT system, Eclipsys Sunrise, that nearly caused the death of my mother... AFTER she was seriously injured due to a flaw in an ED's EHR that did lead a year later to her death:<br /><br /><blockquote class="tr_bq"><a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=172955">http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=172955</a>2 <br /><br />ECLIPSYS SUNRISE CLINICAL MANAGER       <br />Event Date 06/12/2010<br />Event Type  Injury   Patient Outcome  Hospitalization,Other,Life Threatening,Required Intervention<br />Event Description<br /><br />The eclipsys sunrise clinical manager emr/cpoe is in use at (b) (6) hospital. This system appears to have a serious deficiency: <b>an apparent lack of date constraint validity checking when users are seeking information on prior medication orders and administration. </b>(b) (6), (b) (6) was admitted (b) (6) 2010, for cerebrovascular problems. Famotidine iv was started prophylactically to prevent gastric problems, but was discontinued and changed to protonix a few days later due to suspicion of causing severe agitation and confusion, causing her to pull her lines. Around (b) (6) 2010, patient was transferred to physical therapy floor in the hospital. Hospital considers such a transfer to be a "discharge" and "readmission. " however, patient did poorly, had to be sent back to med-surg floor several days later. Due to having pulled a percutaneous endoscopic gastrostomy tube -peg tube-, she was started on TPN on (b) (6) 2010. In the first bag of tpn solution was 40 mg. Famotidine. Patient's mental status began deteriorating and she began to get very, very agitated and confused once again. Eclipsys sunrise problem/bug was noted when son, a physician informaticist -and author of this report- noted the 40 mg famotidine in the tpn bag, and reported to the floor rn that this was contraindicated. The rn pulled up the medication order and administration records on the eclipsys sunrise clinical manager system to confirm famotidine had been administered previously. Famotidine was shown only as being ordered for tpn on (b) (6), but not prior. The rn selected a date constraint entry box, at which time a calendar widget popped up. The rn set the date constraint back to (b) (6), then (b) (6), then (b) (6) 2010, but the use of the famotidine at that time did not appear. Son of patient demanded the famotidine be stopped anyway, which it was, and that an allergy entry be entered. However, it was fortunate son was a physician and remembered the name of the medicine. In tracing this error today, it was found that the data from admission on (b) (6) to "discharge" to physical therapy floor (b) (6) 2010, was unavailable since it was considered a "prior admission" although the patient had never left the hospital physically. The sunrise system, however, failed to flag the (b) (6) 2010 date constraint entries as 'out of bounds' for the current admission. <b>The validity of the date constraints was not checked, preventing the rn user from realizing he should have called up the prior admissions records. If son of patient had not been a physician, famotidine might have been continued and patient might have suffered more severe consequences than she did after the 40 mg was given in the first tpn bag</b>. As it was, she spent the next three days in a severe delirium and is only slowly recovering. That the eclipsys sunrise ehr did not alert its user that the date constraints they set for seeking medication ordering and administration data were out of bounds -beyond the range of the current "admission" <b>-is a significant and severe oversight and/or bg, and a danger to patients not fortunate enough to have a physician informaticist son closely monitoring their care. </b></blockquote><br />Addendum May 4, 2014:<br /><br />(11)   CMS: "we do not have any information that supports or refutes claims that a broader adoption of EHRs can save lives."  (But let's spend hundreds of billions of dollars anyway.) <br /><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/AVvXsEgKNTHRZ65twX8W-4VKJyyfOxz-EKIMmIfoipBwryewkc-IKs_JkusXtcujYkfmjqkzRE_1FyX0m7GAS3X-MTb0rq0yeup3rRxjRKLk2xmnWlO6BLlwHE0rJOqULoHziPGyOKQnO3Jkb2La/s1600/CMS_Letter.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="400" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgKNTHRZ65twX8W-4VKJyyfOxz-EKIMmIfoipBwryewkc-IKs_JkusXtcujYkfmjqkzRE_1FyX0m7GAS3X-MTb0rq0yeup3rRxjRKLk2xmnWlO6BLlwHE0rJOqULoHziPGyOKQnO3Jkb2La/s1600/CMS_Letter.jpg" width="308" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">CMS: "we do not have any information that supports or refutes claims that a broader adoption of EHRs can save lives."  [But let's spend hundreds of billions of dollars anyway.]  <b>Click to enlarge.</b></td></tr></tbody></table><br />--------------------------------------------<br /><br />Note that these ten points themselves, all I had time to write about this morning, themselves represent a "tip of the iceberg" regarding health IT risks.<br /><br />In my opinion it's immensely reckless for FDA to make a statement that "products with health management heath IT functions, includes software for health information and data management, medication management, provider order entry, knowledge management, electronic access to clinical results and most clinical decision support software<b> ...</b> are of <b>sufficiently low ri</b>sk" so as to not warrant formal regulation that is already in place for other healthcare software sectors.<br /><br />Fortunately, the public gets to comment via this announcement:<br /><br />Proposed Risk-Based Regulatory Framework and Strategy for Health Information Technology Report; Notice to Public of Availability of the Report and Web Site Location; Request for Comments<br /><a href="http://www.regulations.gov/#!documentDetail;D=FDA_FRDOC_0001-4678">http://www.regulations.gov/#!documentDetail;D=FDA_FRDOC_0001-4678</a><br /><br />I feel, however, that the decision is a given, and that the health IT industry has such regulatory capture that public comments will be ignored.  (Not that I won't try.)<br /><br />Finally:<br /><br />I ponder what ever happened to the inquiry responses about health IT defects and harm sought by the Senate Finance Committee, as reported in the Washington Post:<br /><br /><blockquote class="tr_bq"><b>Electronic medical records draw frequent criticisms</b><br />By Alexi Mostrous<br />Washington Post Staff Writer<br />Sunday, October 25, 2009 <br /><br /><a href="http://www.washingtonpost.com/wp-dyn/content/article/2009/10/24/AR2009102400967.html?hpid%3Dtopnews&sub=AR">http://www.washingtonpost.com/wp-dyn/content/article/2009/10/24/AR2009102400967.html?hpid%3Dtopnews&sub=AR</a><br /><br />... the Senate Finance Committee has amassed a thick file of testimony alleging serious computer flaws from doctors, patients and engineers unhappy with current systems.<br /><br /><b>On Oct. 16, the panel wrote to 10 major sellers of electronic record systems, demanding to know, for example, what steps they had taken to safeguard patients.</b> "Every accountability measure ought to be used to track the stimulus money invested in health information technology," said <a href="http://projects.washingtonpost.com/congress/members/g000386/" target="">Sen. Charles E. Grassley</a> (Iowa), the panel's ranking Republican. </blockquote><br />The results of that request seem to have gone to the recycle bin.<br /><br />-- SS<br /><br />

FDA on health IT risk: reckless, or another GM-like political coverup? "We don't know the magnitude of the risk, and what we do know is the tip of the iceberg, but health IT is of 'sufficiently low risk' that we don't need to regulate it."

In my Sept. 16, 2013 post "An Open Letter to David Bates, MD, Chair, ONC FDASIA Health IT Policy Committee on Recommendations Against...

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EHR recall: Use of this affected product may cause serious adverse health consequences, including death

Here is another example of a grossly defective health IT product, this from last year but only posted by FDA publicly on 3/14/2014 at <a href="http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm389356.htm">http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm389356.htm</a><a href="http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm389328.htm" target="_blank"></a>:<i> </i><br /><br /><i>"There was an occurrence where the patient case data did not match the patient data when the case was recalled in the Anesthesia Care Record (ACR) in that it included data from another case. <b>Use of this affected product may cause serious adverse health consequences, including death."</b></i><b></b><br /><br />One wonders why problems like this are found in the field when real patients are involved, not in the testing lab...could it have to do with lack of regulatory oversight?<br /><br />Other examples of recalled bad health IT that I know of, including FDA-initiated recalls, are here:  <a href="http://hcrenewal.blogspot.com/2012/07/health-it-fda-recall-philips-xcelera.html" target="_blank">http://hcrenewal.blogspot.com/<wbr></wbr>2012/07/health-it-fda-recall-<wbr></wbr>philips-xcelera.html</a>, <a href="http://hcrenewal.blogspot.com/2011/12/fda-recalls-health-it-software-because.html" target="_blank">http://hcrenewal.blogspot.com/<wbr></wbr>2011/12/fda-recalls-health-it-<wbr></wbr>software-because.html</a> , <a href="http://hcrenewal.blogspot.com/2013/08/a-good-way-to-cynernetically-harm-or.html" target="_blank">http://hcrenewal.blogspot.com/<wbr></wbr>2013/08/a-good-way-to-<wbr></wbr>cynernetically-harm-or.html</a>. <br /><br />Also note the FDA advisory:  <b>Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to <a href="https://www.accessdata.fda.gov/scripts/medwatch/" target="_blank">MedWatch: The FDA Safety Information and Adverse Event Reporting Program</a> either online, by regular mail or by FAX:</b><br /><div><br /><blockquote class="tr_bq"><a href="http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm389328.htm" target="_blank">http://www.fda.gov/<wbr></wbr>MedicalDevices/Safety/<wbr></wbr>ListofRecalls/ucm389328.htm</a><b> </b><br /><br /><b>McKesson Technologies, McKesson Anesthesia Care – Patient Case Data May Not Match Patient Data</b><br /><br /><b>Recall Class:</b> Class I<b> </b><br /><br /><b>Date Recall Initiated</b>: March 15, 2013<b> </b><br /><br /><b>Product:</b> McKesson Anesthesia Care<b> </b><br /><br /><b>Use:</b> The device is a computer-based system which collects, processes, and records data both through manual entry and from monitors which are attached to patients, such as in an operating room environment. The system provides clinical decision support by communicating potential adverse drug event alerts proactively during the pre-anesthesia evaluation and at the point-of-care. The system is generally indicated in the anesthetizing environment when the anesthesia provider decides to perform a patient assessment, to generate a paper and/or electronic record of the administration of anesthesia to a patient, and to document care.<b> </b><br /><br /><b>Recalling Firm:<br /></b>McKesson Technologies, Inc.<br />5995 Windward Parkway<br />Alpharetta, Georgia 30005<b> </b><br /><br /><b>Reason for Recall:</b> There was an occurrence where the patient case data did not match the patient data when the case was recalled in the Anesthesia Care Record (ACR) in that it included data from another case. Use of this affected product may cause serious adverse health consequences, including death<b>.</b><br /><br /><b>Public Contact:</b> Customers with questions may contact McKesson Customer Support at <a href="tel:1-800-442-6767" target="_blank" value="+18004426767">1-800-442-6767</a> (option 3). For questions regarding this recall, call <a href="tel:404-338-3556" target="_blank" value="+14043383556">404-338-3556</a>.<b> </b><br /><br /><b>FDA District:</b> Atlanta District Office<b> </b><br /><br /><b>FDA Comments:<br /></b>On March 15, 2013, the firm initiated a Clinical Alert which was distributed to potentially affected customers. Phone calls were placed to each customer, followed up by an email. The firm provided their customers with written copies of the communication and Clinical Alert; and obtained acknowledgement that they read and understood the issue and preventive action to take.<br /><br />Customers with questions were instructed to contact McKesson Customer Support at <a href="tel:1-800-442-6767" target="_blank" value="+18004426767">1-800-442-6767</a> (option 3). For questions regarding this recall, call <a href="tel:404-338-3556" target="_blank" value="+14043383556">404-338-3556</a>.<br /><br />Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.<b> </b><br /><br /><b>Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to <a href="https://www.accessdata.fda.gov/scripts/medwatch/" target="_blank">MedWatch: The FDA Safety Information and Adverse Event Reporting Program</a> either online, by regular mail or by FAX.</b></blockquote><br />I encourage clinicians to take advantage of MedWatch with regard to bad health IT, anonymously if necessary to avoid internal repercussions or retaliation from executives who've spent hundreds of millions of dollars on the IT, and whose bonuses and promotions might be tied into its "success."<br /><br />-- SS</div>

EHR recall: Use of this affected product may cause serious adverse health consequences, including death

Here is another example of a grossly defective health IT product, this from last year but only posted by FDA publicly on 3/14/2014 at http:/...

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Forbes contributor Nicole Fisher, claimed proponent of healthcare human rights, writes long article on EHRs that neglects to mention patient harm

The field of health IT lives a charmed life.<br /><br />Even self-stated human rights advocates in healthcare won't seem to broach the topic of <b>EHR-related harms</b> and<b> lack of informed consent processes</b> regarding their use in a patient's care, even when authors openly state their concerns for patient and human rights.<br /><br />This is despite known harms at potentially alarming levels as indicated by organizations including the IOM, FDA, ECRI Institute, AHRQ, Harvard Med Mal insurer CRICO, The Joint Commission, NHS in the UK, and others.<br /><br />Forbes contributor Nicole Fisher (<a href="http://www.forbes.com/sites/nicolefisher/">http://www.forbes.com/sites/nicolefisher/</a>) published an article in Forbes dated 3/18/2014 and entitled <b>"Electronic Health Records - Expensive, Disruptive And Here To Stay</b>" (<a href="http://www.forbes.com/sites/nicolefisher/2014/03/18/electronic-health-records-expensive-disruptive-and-here-to-stay/">http://www.forbes.com/sites/nicolefisher/2014/03/18/electronic-health-records-expensive-disruptive-and-here-to-stay/</a>).<br /><br />You can read the article at the above link.  It focuses on physician distraction and dissatisfaction, poor usability and usefulness, expense, and related issues.  Of course, quotes from HHS figure prominently.<br /><br />Nowhere, however, is mention of EHR-related harms to patients, such as reported by the aforementioned organizations mentioned - as in this very small sample list of posts, which contain links to source:<br /><br /><blockquote class="tr_bq"><b>Patient Safety & Quality Healthcare: "CRICO Malpractice Claims Analysis Confirms Risks in EHRs"</b><br /><a href="http://hcrenewal.blogspot.com/2014/02/patient-safety-quality-healthcare.html">hcrenewal.blogspot.com/2014/02/patient-safety-quality-healthcare.html</a><br /><br /><b>Peering Underneath the Iceberg's Water Level: ECRI "Deep Dive" Study of Health IT "Events"</b><br /><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 /><b>Internal FDA memorandum on HIT risks</b><br /><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><br /><br /><b>IOM Report - "Health IT and Patient Safety: Building Safer Systems for Better Care"</b><br /><a href="http://hcrenewal.blogspot.com/2011/11/iom-report-on-health-it-safety-nix-fda.html">http://hcrenewal.blogspot.com/2011/11/iom-report-on-health-it-safety-nix-fda.html</a><br /><br /><b>EHRs and Deadly glitches</b><br /><a href="http://hcrenewal.blogspot.com/search/label/glitch">http://hcrenewal.blogspot.com/search/label/glitch</a> (multiple posts)<br /><br /><b>Not to forget issues of breach of privacy:</b>  <br /><a href="http://hcrenewal.blogspot.com/search/label/medical%20record%20privacy">http://hcrenewal.blogspot.com/search/label/medical%20record%20privacy</a> (multiple posts)</blockquote><br />Nor are mentioned the issues of the experimental, unregulated nature of this technology, and the lack of any informed consent process regarding patient's rights to decide whether or not to have these systems used in their care.<br /><br />The only mention of "<b>unintended consequences</b>" links to "<a href="http://www.emrandhipaa.com/guest/2014/03/11/unintended-icd-10-consequences-inadequate-clinical-documentation-can-negatively-impact-physician-profiles-icd-10-tuesdays/">Unintended ICD-10 Consequences: Inadequate Clinical Documentation Can Negatively Impact Physician Profiles</a>." <br /><br />This is in my view disappointing, and seems to be yet another extraordinary healthcare IT industry accommodation, remarkable for an author with the following bio (emphases mine):<br /><br /><blockquote class="tr_bq"><a href="http://www.forbes.com/sites/nicolefisher/">http://www.forbes.com/sites/nicolefisher/</a><br /><br />Nicole Fisher is the Founder and Principal at HHR Strategies, <b>a health care and human rights focused advising firm.</b> Additionally, she is a Senior Policy Advisor and health policy expert on health economic analyses mainly focusing on Medicare, Medicaid and health reform, <b>specifically as they impact women and children</b>. Nicole runs a Health Innovation and Policy page at Forbes.com highlighting and advising companies, ideas and people that are changing the health care landscape. She is also currently pursuing her PhD at the University of North Carolina in the Health Policy and Management Department. Her writing has appeared in other publications such as Health Affairs, Wall Street Journal, Washington Post, Centers for Medicare & Medicaid Services Journal, Wright on Health, The Health Care Blog and Health Services Research. Before pursuing her PhD in health policy, Nicole earned her Master’s degree in Public Policy from the University of Chicago and her undergraduate degree from the University of Missouri. Her health care and policy work at those institutions <b>had an emphasis on underserved populations, women's and children’s issues</b>. She presides on several Boards for domestic and international health organizations and <b>frequently speaks on health reform and human rights.</b></blockquote><br />One might conclude the computer has more rights than the patient and the clinician via this Forbes piece.<br /><br />Finally, although I am a domain specialist (<a href="http://www.kaiserhealthnews.org/stories/2013/february/18/scot-silverstein-health-information-technology.aspx">http://www.kaiserhealthnews.org/stories/2013/february/18/scot-silverstein-health-information-technology.aspx</a>), I am getting rather tired of having to point out the obvious to major media outlets and writers, in essence doing their homework for them.  I'm sure other bloggers feel the same way.  <br /><br />The title of the Forbes piece should have been "<b>Electronic Health Records - Expensive, Disruptive, Deadly."</b><br /><br />To the author of the Forbes piece and other HIT writers, here is the face (and gravestone) of someone injured by this "disruptive" technology.  <b> </b><a href="http://hcrenewal.blogspot.com/2011/06/my-mother-passed-away.html">http://hcrenewal.blogspot.com/2011/06/my-mother-passed-away.html</a><br /><b><br /></b>A few babies too:  <a href="http://hcrenewal.blogspot.com/2011/06/babys-death-spotlights-safety-risks.html">http://hcrenewal.blogspot.com/2011/06/babys-death-spotlights-safety-risks.html</a><b></b><br /><b><br /></b>A family man:  <a href="http://hcrenewal.blogspot.com/2011/09/sweet-death-that-wasnt-very-sweet-how_24.html">http://hcrenewal.blogspot.com/2011/09/sweet-death-that-wasnt-very-sweet-how_24.html</a><br /><br />I know of others from my legal work supporting the EHR-related injured and deceased that I cannot mention.  And I am but one person.<br /><br />If health IT were causing rapes** and child abuse, rather then merely causing mundane severe injuries and equally mundane deaths, would the media would pay more attention? <br /><br />-- SS<br /><br />** I sadly note that EHR's without proper security measures in force actually did enable rape-like behavior in 2011, as at <b>"EHR as Molestation Candidate Selector: What was this Resident looking for in the EHR before 'examining' female patients?"</b> at <a href="http://hcrenewal.blogspot.com/2011/02/what-was-this-medical-resident-looking.html">http://hcrenewal.blogspot.com/2011/02/what-was-this-medical-resident-looking.html</a>.<br /><br />

Forbes contributor Nicole Fisher, claimed proponent of healthcare human rights, writes long article on EHRs that neglects to mention patient harm

The field of health IT lives a charmed life. Even self-stated human rights advocates in healthcare won't seem to broach the topic of EHR...

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Medical Malpractice Insurer CRICO Challenges "EMR Complacency" - Or Do They?

In my Feb. 28, 2014 post "<b>Malpractice Claims Analysis Confirms Risks in EHRs</b>" (<a href="http://hcrenewal.blogspot.com/2014/02/patient-safety-quality-healthcare.html">http://hcrenewal.blogspot.com/2014/02/patient-safety-quality-healthcare.html</a>) I pointed out that the annual medical malpractice claims related to health IT received by the insurer for the Harvard medical community, one of the world's best users of health IT, might represent a significant percentage of the annual med mal claims in the state of Massachusetts.  Many involved serious injury.<br /><br />I also pointed out that the claims themselves represent only a small fraction of total incidents of med mal-related harms (including due to IT), due to the economic realities of med malpractice litigation.<br /><br />In the press release reproduced below, CRICO writes of poor integration and "design deficiencies" - <b>bad health IT</b> - and that "there has been <b>no apparent leader in this field</b> making a concerted effort to design the next generation of EMRs <b>with the physician in mind</b>", and that they hear "<b>significant frustration from physicians related to their experience with EMRs."  </b><br /><br />However, CRICO does not write of the reasons<b> why</b> these issues are as prevalent as they are.<br /><br />Their claim appears to be, in essence, that these problems will be solved through dialog and "conversation" - in other words, appeals to corporate altruism.<br /><br />Why this industry receives special accommodation even from those who have to pay for their mistakes is beyond me: <br /><br /><blockquote class="tr_bq"><b><span style="font-size: small;"><span style="font-family: inherit;">CRICO Challenges EMR Complacency</span></span></b><span style="font-size: small;"><span style="font-family: inherit;"> </span></span><br /><span style="font-size: small;"><span style="font-family: inherit;"><a href="http://www.rmf.harvard.edu/EMR">http://www.rmf.harvard.edu/EMR</a></span></span><span style="font-size: small;"><span style="font-family: inherit;"> </span></span><br /><b><span style="font-size: small;"><span style="font-family: inherit;">February 6, 2013</span></span></b><br /><br />In a recently released video, CRICO offers a vision of how EMRs of the future might improve health care safety for both patient and physician.<b> </b><br /><br /><b>Press Release:  Cambridge, MA —</b> CRICO, the patient safety and medical professional liability company serving the Harvard medical community, has produced a video that puts forth a future vision of how Electronic Medical Records (EMRs) might be embedded into the physician workflow in a manner that would improve health care delivery. CRICO has based the dramatization on real malpractice cases. Through combined analysis of how harm can come to patients from flawed encounters with providers, and conversations with medical and technological visionaries across the country, the video integrates various scenarios into an idealized patient/physician encounter.<b> </b><br /><br /><b>Hearing significant frustration from physicians related to their experience with EMRs</b>, CRICO was inspired to envision a way in which they might be better integrated into  the clinical workflow. This would allow the EMR to offer some relief to physicians and nurses who face seemingly insurmountable challenges of time and data management.<br /><br />Luke Sato, MD, chief medical officer and senior vice president for CRICO said, “The impetus behind this video was to facilitate a dialogue among health care professionals—physicians, IT, hospital administrators—about why we aren’t making better progress in the development of EMRs.  Through analysis of medical malpractice claims, we have line of sight to <b>design deficiencies in the EMR that contribute to claims.</b> The best technological design is one that is integrated seamlessly into one’s workflow. The current EMR is passive—the physician has to actively look for data instead of the technology anticipating what the physician needs to act on.”<br /><br />Opinions within the health care industry are diverse about EMRs but <b>there has been no apparent leader in this field making a concerted effort to design the next generation of EMRs with the physician in mind.</b> In addition to a need for standards across systems, <b>the manual data entry of today’s EMRs adds to the burden of already time-pressed physicians.</b><br /><br />The film was created as a collaborative effort between CRICO’s Luke Sato, MD and David Ting, MD, associate medical director for information systems at Massachusetts General Physicians Organization, who acted as an expert resource for script development and video production. Ting said, “<b>The actual purpose of the video is to ask whether we might intelligently prioritize today’s choices to move our institutions toward improved patient care and improve provider and practice work-life experience.”</b><br /><br />While most of the technology that is used in this dramatization is available today, other elements are further out. CRICO’s future vision, as depicted in the video, is meant as a launching pad <b>to begin the conversation </b>about how new technologies can provide a way to enable EMRs to enhance, streamline, and make safer the patient-physician encounter.<br /><br />Dr. Ting has encouraged his colleagues at MGH to view the video and share their feedback. The physician reaction has elicited a variety of reactions and diverse feedback ranging from “cool, efficient, saves time, and improves outcomes” to “I don’t want voices interfering with my patient interactions.”  The video is available for viewing on the CRICO website, <a href="https://exchangeweb.drexel.edu/owa/redir.aspx?C=boV17iId5ky3j-AH7i-8UbFkSFsPF9EI1dNj1bsYgpqo6Y-wxui_17h2gLlU68Tga7gAZSNP4So.&URL=https%3a%2f%2fwww.rmf.harvard.edu%2fEMR" target="_blank">www.rmf.harvard.edu/EMR</a>.<b> </b><br /><br /><b>ABOUT CRICO</b><br /><br />For more than 30 years, CRICO has been the patient safety and medical professional liability company owned by and serving the Harvard medical community.<br /><br />CRICO is an internationally renowned leader in evidence-based risk management, proudly serving more than 12,000 physicians (including residents and fellows), 22 hospitals, and nearly 209 other health care organizations.</blockquote><br />They see the problems but do not engage the human reasons for the problems, including generic leadership, conflicts of interest, incompetence, territoriality, profit motive, and the other ills that we write of till our faces turn blue at Healthcare Renewal.<br /><br />In other words, their "challenge to EHR complacency" is about as powerful as our challenges have been to Vladimir Putin regarding Crimea and Ukraine. <br /><br />Perhaps when the payouts become even more severe, insurers will think it a good idea to stop 'making nice' with an intrusive and unregulated industry that has invaded clinical affairs <i>like a bull in a china shop.</i><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/AVvXsEgaWP3zIvzuW2hnbvndLEoTuKD54nAHbQjth4Rgxipxag7L7yracMBpy_ofQ_pUn719eiqRvGFanSAjZ8P2B8UrlbYmkLvElRI7-rSujvgY05Q_XCD7ms5qQqwg5w0kCPUB5_MEapO7uGJn/s1600/bull.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="243" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgaWP3zIvzuW2hnbvndLEoTuKD54nAHbQjth4Rgxipxag7L7yracMBpy_ofQ_pUn719eiqRvGFanSAjZ8P2B8UrlbYmkLvElRI7-rSujvgY05Q_XCD7ms5qQqwg5w0kCPUB5_MEapO7uGJn/s1600/bull.jpg" width="320" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">Can we please, pretty please dialog for a bit about your breaking the dishes?</td></tr></tbody></table><br />-- SS

Medical Malpractice Insurer CRICO Challenges "EMR Complacency" - Or Do They?

In my Feb. 28, 2014 post " Malpractice Claims Analysis Confirms Risks in EHRs " ( http://hcrenewal.blogspot.com/2014/02/patient-sa...

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We're Sorry ... Our New EMR May Screw Up Your Care, But Don't Worry ... Patient Safety Has Not Been Compromised

A sign seen at a hospital system recently (name redacted):<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/AVvXsEiFv5Vc8MnAwjhlsEA5uP2zO7n0IiSujhj7kGyn2C6ygwzf714UqSrPgQh4-vNNnHBrY1K4NCiRSY3sAOTaeEcP5UL8R0a5dQRr0ILudU-oWkOnTf9uegkc__nrKq6XV-gyuHLGueztsCJC/s1600/we're+sorry+2.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="311" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiFv5Vc8MnAwjhlsEA5uP2zO7n0IiSujhj7kGyn2C6ygwzf714UqSrPgQh4-vNNnHBrY1K4NCiRSY3sAOTaeEcP5UL8R0a5dQRr0ILudU-oWkOnTf9uegkc__nrKq6XV-gyuHLGueztsCJC/s1600/we're+sorry+2.jpg" width="400" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">We're Sorry for any "Delays" as we start using our new EMR system ... But as a patient, you'll notice many benefits.   As to risks, nothing to see here ... move along.   <b>(Click to enlarge)</b></td><td class="tr-caption" style="text-align: center;"><br /></td><td class="tr-caption" style="text-align: center;"><br /></td><td class="tr-caption" style="text-align: center;"><br /></td><td class="tr-caption" style="text-align: center;"><br /></td></tr></tbody></table><br />FirstNet is an EMR system for <b>Emergency Departments. </b><br /><br />What's missing here is this:<br /><br /><ul><li>While "<a href="http://hcrenewal.blogspot.com/search/label/glitch">glitches</a>" that can harm you can happen anytime with these systems, at startup time <a href="http://hcrenewal.blogspot.com/2013/07/rns-say-sutters-new-electronic-system.html">disruptions and malfunctions</a> that could cause injury or death (as reported by <a href="http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html">FDA</a>, <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/Patient%20Safety%20and%20Health%20IT%20prepub.pdf">U.S. Institute of Medicine</a>, ECRI Institute per their <a href="http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html">Deep Dive study of health IT risk</a> and others) are most common;</li></ul><ul><li>Potentially deadly EHR startup "issues" can number in the <b>many thousands</b> (<b><a href="http://hcrenewal.blogspot.com/2013/11/weve-resolved-6036-issues-and-have-3517.html">as at this link</a></b>); </li></ul><ul><li>If you don't want to subject yourself to these delays and/or glitches, you are free to select another hospital for your care. </li></ul><ul><li>(If you are injured or die as a result of the "Delays", then ... we're <i>Extra-Special With Sugar On Top </i>Sorry?)</li></ul><br />In other words, this glib, nonchalant signage is incomplete, and misleading on its face.<br /><br />While I understand its purpose, it ignores patient rights to informed consent and knowledge of a potentially unsafe environment for care, which hospitals have to prevent as an ethical and legal obligation.<br /><br />Of course, "please feel free to ask your caregiver if you have any questions" ... who may in fact be limited by contract or edict to only use <b>"<i>Words That Work</i>"</b> to further soothe unsuspecting patients (<b><a href="http://hcrenewal.blogspot.com/2013/10/words-that-work-singing-only-positive.html">as at this link</a></b>)<b>.</b><br /><br />-- SS

We're Sorry ... Our New EMR May Screw Up Your Care, But Don't Worry ... Patient Safety Has Not Been Compromised

A sign seen at a hospital system recently (name redacted): We're Sorry for any "Delays" as we start using our new EMR system ....

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InformaticsMD on NPR Affiliate KNPR regarding electronic medical record privacy: St. Rose hospital group used patient information to solicit patient lobbying?

<span style="font-family: "Arial","sans-serif"; font-size: 10.0pt;">Radio station <b><a href="http://www.knpr.org/">News 88.9 KNPR</a></b>, the NPR affiliate in Las Vegas</span><span style="font-family: "Arial","sans-serif"; font-size: 10.0pt;"> did </span><span style="font-family: "Arial","sans-serif"; font-size: 10.0pt;">a segment today on the following news story.  The station's Senior Producer had invited me to participate via phone regarding patient privacy issues.</span><br /><div class="MsoNormal"><br /><span style="font-family: "Arial","sans-serif"; font-size: 10.0pt;">Emphases mine: </span></div><div class="MsoNormal"><span style="font-family: "Arial","sans-serif"; font-size: 10.0pt;"> </span></div><blockquote class="tr_bq"><div class="MsoNormal"><a href="http://www.reviewjournal.com/news/federal-complaint-alleges-st-rose-hospitals-violated-patient-privacy"><span style="font-family: "Arial","sans-serif"; font-size: small;">http://www.reviewjournal.com/news/federal-complaint-alleges-st-rose-hospitals-violated-patient-privacy</span></a><br /><br /><span style="font-family: "Arial","sans-serif"; font-size: 10.0pt;">February 10, 2014 - Updated  February 11, 2014 <br /><b>Federal complaint alleges St. Rose Hospitals violated patient privacy</b><br /><br />By STEVEN SLIVKA<br />LAS VEGAS REVIEW-JOURNAL<br /><br />Dignity Health, the owner of St. Rose Dominican Hospitals, is f<b>acing a federal complaint alleging it violated patient privacy by using patient records as leverage in a contract dispute.</b><br />According to a Monday announcement from the Nevada Health Services Coalition, Dignity Health <i><b>used patient records to contact those with coalition member plans after agreements between the two agencies fell through in January</b></i>, something it contends violates the Health Insurance Portability and Accountability Act, or HIPAA. The complaint was filed with the U.S. Department of Health and Human Services Office of Civil Rights.<br /><br />The complaint contends <i><b>St. Rose contacted former patients in an attempt to persuade them to take action with their health plans favorable to St. Rose. </b></i>The complaint also said that St. Rose claimed their actions were simply to be “informative.”<br /><br />“It’s our position that patient data collected in the course of medical treatment should not be used to lobby or gain leverage in contract negotiations,” said Christine Carafelli, executive director of the coalition.<br /><br />The Nevada Health Services Coalition is a nonprofit entity that negotiates hospital contracts for discounted health care service rates for 19 member group organizations, totaling approximately 230,000 Nevada residents.<br /><br />A spokesperson for St. Rose said they would issue a statement on Tuesday.  </span></div></blockquote><div class="MsoNormal"><br /></div><div class="MsoNormal"><span style="font-family: "Arial","sans-serif"; font-size: 10.0pt;"><span style="font-family: "Arial","sans-serif"; font-size: 10.0pt;">The segment has now completed.  It was hosted by Dave Becker of KNPR.</span></span></div><div class="MsoNormal"><br /></div><div class="MsoNormal"><span style="font-family: "Arial","sans-serif"; font-size: 10.0pt;">A representative of the <b>Health Services Coalition</b> (<a href="http://www.lvhsc.org/">http://www.lvhsc.org/</a>), a local organization of union, casino and local government health funds who bargain together for maximum leverage, participated, as did a hospital VP. </span><br /><br /><span style="font-family: "Arial","sans-serif"; font-size: 10.0pt;">The coalition is accusing the St. Rose hospital group (a division of Dignity Health) <i><b>of using patient records to contact patients to urge them to lobby for the hospital in contract negotiations.</b></i></span></div><div class="MsoNormal"><br /></div><div class="MsoNormal"><span style="font-family: "Arial","sans-serif"; font-size: 10.0pt;">I was asked for an opinion on the acceptability of access to patient information in an organization's EHR systems (including PHI such as name, address and other contact information) for purposes of soliciting the patients to lobby the insurers on behalf of the healthcare organization for better terms.</span></div><div class="MsoNormal"><br /></div><div class="MsoNormal"><span style="font-family: "Arial","sans-serif"; font-size: 10.0pt;">My opinion was clear, which I summarize as follows:</span></div><div class="MsoNormal"><br /></div><div class="MsoNormal"><span style="font-family: "Arial","sans-serif"; font-size: 10.0pt;">1.  Hospitals do not "own" patient data to use as they please.  Is is not a simple business asset, like typewriters - or computers.  Any belief that a hospital can treat patient records as such, to be used as they pleased, would reflect arrogance;</span><br /><br /><span style="font-family: "Arial","sans-serif"; font-size: 10.0pt;">2.  The HIPAA privacy rule and its exceptions (viewable at <a href="http://www.hhs.gov/ocr/privacy/hipaa/understanding/summary/">http://www.hhs.gov/ocr/privacy/hipaa/understanding/summary/</a>, section under "</span><span style="font-family: "Arial","sans-serif"; font-size: 10.0pt;"><b>Permitted Uses and Disclosures</b>") would preclude the use of patient's private and protected information in an EHR for selective solicitation for lobbying on behalf of the hospital;</span></div><div class="MsoNormal"><br /></div><div class="MsoNormal"><span style="font-family: "Arial","sans-serif"; font-size: 10.0pt;">3.  Who accessed the patient information, and exactly what they accessed, is not clear, and an electronic audit trail needs to be disclosed as to these issues;</span></div><div class="MsoNormal"><br /></div><div class="MsoNormal"><span style="font-family: "Arial","sans-serif"; font-size: 10.0pt;">4.  Harm could potentially come to patients if someone who accessed the information, who otherwise </span><span style="font-family: "Arial","sans-serif"; font-size: 10.0pt;"><span style="font-family: "Arial","sans-serif"; font-size: 10.0pt;">might not have</span>, used it to advantage for other purposes.  This includes, for example, uses outside of the medical sphere (e.g., personal use by, say, a neighbor or competitor).  I am aware of cases of such abuse, as is HHS and so are hospitals (see my blog query links on medical record privacy and confidentiality at <a href="http://hcrenewal.blogspot.com/search/label/medical%20record%20confidentiality">http://hcrenewal.blogspot.com/search/label/medical%20record%20confidentiality</a> and <a href="http://hcrenewal.blogspot.com/search/label/medical%20record%20privacy">http://hcrenewal.blogspot.com/search/label/medical%20record%20privacy</a>); and:</span></div><div class="MsoNormal"><br /></div><div class="MsoNormal"><span style="font-family: "Arial","sans-serif"; font-size: 10.0pt;">5.  The hospital could have accomplished such goals transparently, safely, and without access to private health information, by putting an ad on the radio (or newspaper etc.), or mailing a general newsletter such as I often receive from area hospitals, even hospitals where I was never a patient.</span></div><div class="MsoNormal"><span style="font-family: "Arial","sans-serif"; font-size: 10.0pt;"><br /></span></div><div class="MsoNormal"><span style="font-family: "Arial","sans-serif"; font-size: 10.0pt;">A hospital VP contributed soothing words that the hospital respects patient privacy, trusts its employees and doesn't wish this matter to become a stumbling block in negotiations.  However, in my opinion the hospital violated the HIPAA privacy rules and potentially put patient privacy at risk. </span><br /><br /><span style="font-family: "Arial","sans-serif"; font-size: 10.0pt;">No amount of soothing, deflecting executive language and shifting of the discussion can change that, and a full disclosure accounting would be proper.  </span><br /><br /><span style="font-family: "Arial","sans-serif"; font-size: 10.0pt;">(I note the HIPAA privacy rules do <b>not</b> state "<i>For informational purposes only.  Use patient information however you want if you trust your employees and you think the risk is low..</i>")</span></div><div class="MsoNormal"><br /></div><div class="MsoNormal"><span style="font-family: "Arial","sans-serif"; font-size: 10.0pt;">That is, assuming an audit trail of sufficient detail is recorded in their EHRs, assuming it is turned on, and assuming it can be trusted in light of the HHS OIG report of Dec. 2013 where many hospitals admitted EHR audit trails can be deleted or edited by a person with appropriate credentials.  (See my Dec. 10, 2013 post <b>"</b></span><b>44% of hospitals reported to HHS that they can delete the contents of their EHR audit logs whenever they'd like" </b>at <a href="http://hcrenewal.blogspot.com/2013/12/44-of-hospitals-reported-to-oig-that.html">http://hcrenewal.blogspot.com/2013/12/44-of-hospitals-reported-to-oig-that.html</a><span style="font-family: "Arial","sans-serif"; font-size: 10.0pt;">).</span></div><div class="MsoNormal"><br />The segment audio is online here: <a href="http://www.knpr.org/son/archive/detail2.cfm?SegmentID=10939">http://www.knpr.org/son/archive/detail2.cfm?SegmentID=10939</a><br /><br /><span style="font-family: "Arial","sans-serif"; font-size: 10.0pt;">-- SS </span><br /><b><br /></b><b><span style="font-family: "Arial","sans-serif"; font-size: 10.0pt;">Feb. 14, 2014 Addendum:</span></b><br /><br /><span style="font-family: "Arial","sans-serif"; font-size: 10.0pt;">A thought experiment demonstrates just how far from propriety, in my opinion, this affair is:</span><br /><br /><span style="font-family: "Arial","sans-serif"; font-size: 10.0pt;">If a hospital can use confidential information in this manner, to enlist patients as de facto lobbyists regarding an insurer, then why could not a hospital use other data - e.g., patients' disease burden, smoking status or even sexual orientation to ask them to lobby, say, a politician to gain some advantage, such as certificate-of-need approval for expansion, or anti-competitive legislation?  Or, to ask patients to participate in political activities for/against some politician or group that might hold views or conduct activities favorable/unfavorable to the hospital's interests?</span><br /><br /><span style="font-family: "Arial","sans-serif"; font-size: 10.0pt;">-- SS </span></div><div class="MsoNormal"><span style="font-family: "Arial","sans-serif"; font-size: 10.0pt;"><br /></span></div>

InformaticsMD on NPR Affiliate KNPR regarding electronic medical record privacy: St. Rose hospital group used patient information to solicit patient lobbying?

Radio station News 88.9 KNPR , the NPR affiliate in Las Vegas did a segment today on the following news story.  The station's Senior Pr...

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