healthy4u: and Cosmetic Act

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 ...

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