healthy4u: nuremberg code

Good HIT, Bad HIT, HIMSS And Reckless Technology Advocacy: Will This Hurt President Obama?

HIMSS, the <a href="http://www.himss.org/" target="_blank">Health Information Systems Management Society</a>, is the large vendor trade group representing healthcare IT sellers. At the HIMSS blog entitled "Health IT is an essential element to transform the Nation’s healthcare system" (<a href="http://blog.himss.org/2012/10/05/health-it-is-an-essential-element-to-transform-the-nations-healthcare-system/" target="_blank">link</a>), <a class="url fn n" href="http://blog.himss.org/author/carlamsmith/" rel="author" title="View all posts by Carla M Smith, MA, CNM, FHIMSS">Carla M Smith, MA, CNM, FHIMSS</a> writes this with regard to the House  <a href="http://waysandmeans.house.gov/news/documentsingle.aspx?DocumentID=310498">letter</a> to HHS Secretary Sebelius asking her to suspend payments for the EHR Incentive Payments authorized in the American Recovery & Reinvestment Act of 2009: <blockquote class="tr_bq">HIMSS opposes halting the Meaningful Use EHR Incentive Program. Health IT is an essential, foundational element of any meaningful transformation of the Nation’s healthcare delivery system.  </blockquote> (Of course, not mentioned is "transformed" into what, exactly; this utopian ideation is a topic for another time.) A chart is then presented as to "how US civilian hospitals have, since the first incentive payments were made in second quarter, 2011, matured in their use of health IT."  Then this statement is made: <blockquote class="tr_bq">Healthcare providers are adopting certified EHRs and using them for meaningful purposes; thus, achieving Congressional intent to improve the quality, safety, and cost-effectiveness of care in U.S. </blockquote> Really?  (See my Feb. 2012 post "<a href="http://hcrenewal.blogspot.com/2012/02/hospitals-and-doctors-use-health-it-at.html" target="_blank">Hospitals and Doctors Use Health IT at Their Own Risk - Even if Certified</a>.") This non-evidence based, amoral advocacy by HIMSS for health IT may cost the President the November election.  HIMSS has beguiled the president into similar unquestioning advocacy for the technology in its present form, which his opponents are now (rightfully) seizing upon as in the House letter. The reckless mistakes made by HIMSS and their advocates include these two: 1.   The unquestioned belief that this expensive technology would save billions of dollars in healthcare costs, instead of depleting precious healthcare resources better spent on, say, improvement of healthcare services for the poor. 2.  More importantly, the appallingly naïve belief that any health IT is good health IT, and that any health IT is only capable of good, not bad. HIMSS has thus failed to recognize - or perhaps worse, recognized but recklessly ignored - the profound difference between good health IT (GHIT) and bad health IT (BHIT). As I defined at my <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/" target="_blank">teaching site on Medical Informatics</a>: <blockquote class="tr_bq">Good Health IT ("GHIT") is defined as IT that provides a good user experience, enhances cognitive function, puts essential information as effortlessly as possible into the physician’s hands, keeps eHealth information secure, protects patient privacy and facilitates better practice of medicine and better outcomes. Bad Health IT ("BHIT") is defined as IT that is ill-suited to purpose, hard to use, unreliable, loses data or provides incorrect data, causes cognitive overload, slows rather than facilitates users, lacks appropriate alerts, creates the need for hypervigilance (i.e., towards avoiding IT-related mishaps) that increases stress, is lacking in security, compromises patient privacy or otherwise demonstrates suboptimal design and/or implementation.   </blockquote> I am an advocate of the former, and an opponent of the latter. Bad health IT is prevalent in 2012 due to lack of meaningful quality control, software validation, usability standards and testing, and regulation of any type - a situation HIMSS long favored.   (The failed National Programme for HIT [NPfIT] in the NHS <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=granger_speaks_out" target="_blank">learned this the hard way</a>, as will Australians <a href="http://sydney.edu.au/engineering/it/~hitru/index.php?option=com_content&task=view&id=91&Itemid=146" target="_blank">needing emergency care</a>, I predict.) Put bluntly, in the end BHIT maims and kills patients, squanders precious healthcare resources, and drains the treasury into IT industry pockets (see my Oct. 3, 2012 post "<a href="http://hcrenewal.blogspot.com/2012/10/honesty-and-good-sense-on-electronic.html">Honesty and Good Sense on Electronic Medical Records From Down Under"</a> and this query link on <a href="http://hcrenewal.blogspot.com/search/label/healthcare%20IT%20risks" target="_blank">health IT risks</a>).  Further, the failure to recognize that the technology's downsides need to be understood and remediated before national deployment occurs and under controlled conditions, not after (which uses patients as non-consenting experimental subjects for software debugging), speaks to gross corporate negligence on the part of HIMSS.  It's not as if they did not have advance warning of all of healthcare IT's deficiencies.  BHIT also permits record alterations after the fact that may be to <a href="http://hcrenewal.blogspot.com/2011/09/sweet-death-that-wasnt-very-sweet-how_24.html" target="_blank">conceal medical error</a>.  I am aware of numerous instances of such alterations, fortunately caught by critical-thinking, detail-minded attorneys.  However, like health IT harms, the incidences of known alteration attempts likely reflect the "tip of the iceberg." HIMSS and its fellow travelers have thus led this administration down the Garden Path of health IT perdition. I warned of this in a Feb. 18, 2009 Wall Street Journal <a href="http://online.wsj.com/article/SB123492035330205101.html">letter to the editor:</a> <blockquote class="tr_bq">Dear Wall Street Journal: You observe that the true political goal is socialized medicine facilitated by health care information technology. You note that the public is being deceived, as the rules behind this takeover were stealthily inserted in the stimulus bill. I have a different view on who is deceiving whom. In fact, it is the government that has been deceived by the HIT industry and its pundits. Stated directly, the administration is deluded about the true difficulty of making large-scale health IT work. The beneficiaries will largely be the IT industry and IT management consultants. For £12.7 billion the U.K., which already has socialized medicine, still does not have a working national HIT system, but instead has a major IT quagmire, some of it caused by U.S. HIT vendors. [That project, the NPfIT in the NHS, has now been abandoned - ed.] HIT (with a few exceptions) is largely a disaster. I'm far more concerned about a mega-expensive IT misadventure than an IT-empowered takeover of medicine. The stimulus bill, to its credit, recognizes the need for research on improving HIT. However this is a tool to facilitate clinical care, not a cybernetic miracle to revolutionize medicine. The government has bought the IT magic bullet exuberance hook, line and sinker. I can only hope patients get something worthwhile for the $20 billion. Scot Silverstein, MD </blockquote> Mr. President, again, quite bluntly, the health IT industry took you for a ride, and the damage is done and is continuing due to lack of any meaningful health IT post market surveillance.   (As I wrote <a href="http://hcrenewal.blogspot.com/2012/10/house-ways-and-means-notes-ehrs-not.html" target="_blank">here</a>, the untoward results have already been used against the current administration, with more perhaps to follow.) In the U.S. we have the 1938 <a href="http://www.fda.gov/regulatoryinformation/legislation/federalfooddrugandcosmeticactfdcact/default.htm" target="_blank">Federal Food, Drug, and Cosmetic Act</a> (FD&C Act) in place: <blockquote class="tr_bq">The introduction of this act was influenced by the death of more than 100 patients due to a <a href="http://en.wikipedia.org/wiki/Sulfanilamide" title="Sulfanilamide">sulfanilamide</a> medication where <a href="http://en.wikipedia.org/wiki/Diethylene_glycol" title="Diethylene glycol">diethylene glycol</a> was used to dissolve the drug and make a liquid form.<a href="http://en.wikipedia.org/wiki/Federal_Food,_Drug,_and_Cosmetic_Act#cite_note-3">  </a>See <a class="mw-redirect" href="http://en.wikipedia.org/wiki/Elixir_Sulfanilamide_disaster" title="Elixir Sulfanilamide disaster">Elixir Sulfanilamide disaster</a>. It replaced the earlier <a href="http://en.wikipedia.org/wiki/Pure_Food_and_Drug_Act" title="Pure Food and Drug Act">Pure Food and Drug Act</a> of 1906. </blockquote> It should be honored, not ignored via special accommodation to the health IT industry and its trade group. HITECH also needs to be put in dormancy until the problems with these <a href="http://hcrenewal.blogspot.com/2011/04/fda-decides-regulating-implantable.html" target="_blank">unregulated medical devices</a> get worked out in relatively small, controlled settings to minimize risk, with patient informed consent.  This is in accord with human rights documents dating at least to the <a href="http://en.wikipedia.org/wiki/Nuremberg_Code" target="_blank">Nuremberg Code</a>, as in any new, experimental or partly-experimental medical device, pharmaceutical, or therapy. -- SS

Good HIT, Bad HIT, HIMSS And Reckless Technology Advocacy: Will This Hurt President Obama?

HIMSS, the Health Information Systems Management Society, is the large vendor trade group representing healthcare IT sellers.At the HIMSS blog entitled "Health IT is an essential element to transform …

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06 Oct 2012

Human Subjects Experimentation Directives Ignored in the Grand Health IT Experiment?

The following represents some very inconvenient truths that have long been ignored.Health IT is an experimental technology. The literature in 2012 remains conflicting on benefits and risks (the latter which is acknowledged, but whose magnitude is uncertain). At NIH study sections, for example, research proposals that involve health IT (even modifications to existing applications) are subjected to far more scrutiny around human subjects protections, of both patients and investigators, than the typical wide-scale hospital implementation of enterprise health IT systems. The latter are validated and approved by - nobody. How many of these directives are ignored in the Grand Health IT Experiment? I've bolded the issues that I believe are ignored. See "<a href="http://hcrenewal.blogspot.com/2011/02/updated-reading-list-on-health-it.html">Reading list on health IT</a>" for more information on conflicts in the literature: --------------------------------------------- Directives for Human Experimentation <a href="http://ohsr.od.nih.gov/guidelines/nuremberg.html">NUREMBERG CODE</a> <ol><li>The voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice [that is, to opt-out - ed.], without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision. This latter element requires that before the acceptance of an affirmative decision by the experimental subject there should be made known to him the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonable to be expected; and the effects upon his health or person [information on HIT risk exists, such as on this blog - ed.] which may possibly come from his participation in the experiment. The duty and responsibility for ascertaining the quality of the consent rests upon each individual who initiates, directs or engages in the experiment. It is a personal duty and responsibility which may not be delegated to another with impunity.</li><li>The experiment should be such as to yield fruitful results for the good of society, unprocurable by other methods or means of study [such as small scale controlled clinical trials with full informed consent and opt-out provisions- ed.], and not random and unnecessary in nature.</li><li>The experiment should be so designed and based on the results of animal experimentation and a knowledge of the natural history of the disease or other problem under study that the anticipated results will justify the performance of the experiment.</li><li>The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury.</li><li>No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur; except, perhaps, in those experiments where the experimental physicians also serve as subjects.</li><li>The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment. [The magnitude of HIT risks are unknown - ed.] </li><li>Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death.</li><li>The experiment should be conducted only by scientifically qualified persons. [Yet the HIT field is filled with amateurs - ed.] The highest degree of skill and care should be required through all stages of the experiment of those who conduct or engage in the experiment.</li><li>During the course of the experiment the human subject should be at liberty to bring the experiment to an end [go back to paper - ed.] if he has reached the physical or mental state where continuation of the experiment seems to him to be impossible.</li><li>During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage [go back to paper - ed.], if he has probable cause to believe, in the exercise of the good faith, superior skill and careful judgment required of him that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject.</li></ol> Reprinted from Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10, Vol. 2, pp. 181-182.. Washington, D.C.: U.S. Government Printing Office, 1949.I'd thought these issues were settled after WW2, but apparently not.-- SS

Human Subjects Experimentation Directives Ignored in the Grand Health IT Experiment?

The following represents some very inconvenient truths that have long been ignored.Health IT is an experimental technology. The literature in 2012 remains conflicting on benefits and risks (the latte…

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20 Mar 2012