A War on Patients: Panel Says EHRs Should Not Be Vetted Before Marketing and Deployment

<div style="text-align: center;"><i><span style="font-size: small;">"First, do harm - it's a learning experience, and injured or dead patients are just a bump in the road, anyway" - the apparent creed of the healthcare computing hyperenthusiasts </span></i></div><br />Joe Conn and Modern Healthcare published the following article:<br /><br /><blockquote class="tr_bq"><b>Work group says OK to some HIT safety regs</b> (<a href="http://www.modernhealthcare.com/article/20130807/BLOG/308079998?AllowView=VW8xUmo5Q21TcWJOb1gzb0tNN3RLZ0h0MWg5SVgra3NZRzROR3l0WWRMWGJYUDBHRWxyd01qUzMyWmVqNTNzWUpiV3A=">link</a>), Joe Conn, Modern Healthcare, Aug. 7, 2013</blockquote><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><br /></div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">What is important is what safety regs the Workgroup said "no" to.  It comes as no surprise:</div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"></div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><blockquote>A federally chartered special work group with representatives from three federal agencies has submitted its draft recommendations on establishing a regulatory framework for health information <b>technology. Chief among those recommendations is that <a href="http://www.modernhealthcare.com/section/articles?tagID=66">health IT</a> should not be subjected to pre-market federal regulation, </b>but there were a few exceptions.</blockquote><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><br />The exceptions are narrow, and are likely already covered as Class III medical devices by FDA (see <a href="http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/">http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/</a>):</div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><br /></div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><blockquote class="tr_bq">The exceptions under which there should be <a href="http://www.modernhealthcare.com/section/articles?tagID=1136"> FDA</a> regulation, according to the work group, include medical device accessories to be defined as such by the FDA; certain forms of “high risk” clinical decision support systems, such as “computer aided diagnostics,” also to be defined by the FDA; and some “higher risk software” use cases to be defined by the committee's own safety work group.</blockquote><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"></div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"></div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><br />They did acknowledge the need for postmarket surveillance:</div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"></div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><blockquote class="tr_bq">... The group also recommended: developing a federally supported, <b>post-market surveillance system for health IT products “to ensure safety-related decision support is in place,”</b> creating a process for gathering information on safety issues, aggregated at the federal level and establishing a public process for “customer rating of HIT to enhance transparency.”<br /><br />Dr. David Bates [a professor at Harvard Medical School], chairman of the Food and Drug Administration Safety Innovation Act work group, presented the preliminary findings Wednesday at a meeting of HHS' Health Information Technology Policy Committee. </blockquote><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><br />Let me translate this to plain English:  the health IT systems that go in (and their upgrades and patches) are recommended to be free from pre-marketing regulation and regulatory vetting.  <b>Patients are to be the guinea pigs for testing of the software.  </b></div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><br /><b>If patients are harmed or killed, they get the honor of being named as "postmarket surveillance learning cases" who gave their all for the betterment of healthcare information technology.  </b><br /><br />(Without their consent, but who needs consent to test experimental and unvetted devices on guinea pigs?)<b></b><br /><b><br /></b>Bates did express some liability concerns:<br /><br /><blockquote class="tr_bq">Asked during a question and answer period following his presentation whether the committee <b>had considered the liability implications of its recommendations</b>, Bates said, “<b>It's not something we discussed at length</b>, but it's something we can discuss over the next month.”</blockquote><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><br />I, on the other hand, as a legal consultant on health IT-related medical errors and evidence tampering, <b>am</b> considering liability issues.<br /><br />Unfortunately, patients would rather be whole than in lawsuits (or dead).  Also, sadly, it's physicians and nurses who will bear the brunt, if not all, of the liability for bad outcomes due to defective IT such as at these two recent posts, with vendor alerts regarding serious flaws of medication and other orders not being retained:</div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"></div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><ul><li><a href="http://hcrenewal.blogspot.com/2013/08/another-health-it-glitch-can.html">Another Health IT "Glitch" - Can Digital Disappearing Ink Kill Patients? - Siemens Safety Advisory Notification #1</a> </li></ul><ul><li><a href="http://hcrenewal.blogspot.com/2013/08/can-digital-disappearing-ink-ehr-glitch.html">Can Digital Disappearing Ink (An EHR "Glitch") Kill Patients? Part 2 - Siemens Safety Advisory Notification #2</a></li></ul><ul><li>and the others posted at this blog at query link: <a href="http://hcrenewal.blogspot.com/search/label/glitch">http://hcrenewal.blogspot.com/search/label/glitch</a></li></ul></div></div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><br />A clarification for all those proletarians who lack Harvard educations, and for the Workgroup members as well. Allow me to point out that the above manufacturer safety alerts of life-threatening fundamental flaws (involving entered text that "disappears", apparently found in live-patient scenarios, and the other "glitches" that did cause life-threatening errors sometimes <i>en masse</i> involving <i><b>thousands</b></i> of patients such as another apparent Siemens debacle at <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>) <b>would likely not have occurred if the systems had been vetted <i>before</i> being turned loose</b> on patients.<br /><br /></div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">Finally:  David and panel members, my mother and I thank you profusely.  <br /><br />Oh wait...my mother can't thank you, she's dead from the toxic effects of un-premarket-vetted health IT on simple care processes at the very hospital where I performed my residency two decades ago.</div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"></div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><br />She might have died a few times before she actually did thanks to other IT "glitches" that cropped up during her recovery from the first one, but I was able to (in one case, by sheer happenstance of showing up at  the right time) discover or provide staff with information to work around additional unvetted-health-IT flaws before those did her in.</div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"></div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><br /></div><div class="separator" style="clear: both; text-align: center;"></div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"></div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">It's taken more than a decade for critical-thinking, unconflicted writers and researchers ("<a href="http://hcrenewal.blogspot.com/2013/02/modern-healthcare-health-it-iconoclasts.html">iconoclasts</a>") to force cybernetics-over-all hyperenthusasts (see <a href="http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html">here</a>) like Bates and his panel members to own up the risks of health IT at all, e.g. via sites like this blog and <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/">this teaching site</a>. These panel members IMO have their heads buried in sand.<br /><br />Dr. Bates and his panel are, in my opinion, healthcare IT extremists, which is in part the apparent holding of the belief that computers have more rights than patients - and the other beliefs mentioned in this post:  <b>"Another Health IT 'Glitch' - Can Digital Disappearing Ink Kill Patients?"</b> at <a href="http://hcrenewal.blogspot.com/2013/08/another-health-it-glitch-can.html">http://hcrenewal.blogspot.com/2013/08/another-health-it-glitch-can.html</a>.</div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><br /></div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">-- SS</div></div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><br /></div></div></div>

A War on Patients: Panel Says EHRs Should Not Be Vetted Before Marketing and Deployment

"First, do harm - it's a learning experience, and injured or dead patients are just a bump in the road, anyway" - the apparent...

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

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

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

As I observed at my Aug. 15, 2012 post " Contra Costa's $45 million computer health care system endangering lives, nurses say "...

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