healthy4u: human experimentation

Cart Before the Horse, Part 3: AHRQ's "Health IT Hazard Manager"

<div style="text-align: center;">(Addendum: the AHRQ hazards manager taxonomy report can see seen 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>)</div> In a July 2010 post "<a href="http://hcrenewal.blogspot.com/2010/07/meaningful-use-final-rule-have.html" target="_blank">Meaningful Use Final Rule: Have the Administration and ONC Put the Cart Before the Horse on Health IT?</a>" and an Oct . 2010 post "<a href="http://hcrenewal.blogspot.com/2010/10/cart-before-horse-again-institute-of.html" target="_blank">Cart before the horse, again: IOM to study HIT patient safety for ONC; should HITECH be repealed?</a>" I wrote about the postmodern "ready, fire, aim" approach to health IT: In the first post, I wrote: <blockquote class="tr_bq">... These "usability" problems require long term solutions. There are no quick fix, plug and play solutions. Years of research are needed, and years of system migrations as well for existing installations. Yet we now have an HHS Final Rule on "meaningful use" regarding experimental, unregulated medical devices the industry itself admits have major usability problems, along with a growing body of literature on the <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=2009">risks entailed</a>. <div dir="ltr"></div><div dir="ltr">For crying out loud, talk about putting the cart before the horse... </div> <div dir="ltr" style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhbxjl-AlGATfarPayjaUYkCOG4sUrulp4D88Nk7_z-eEbaWRl-xi1g0neGKWDhEL1w6-_-FCu4iBoJx9AUlU-bccaAmEcMfmGI1uoa4gTohjch5gzcx5tA9Ru-uMB0Mip6NE0PuUsfDXJ5/s1600/horse-cart.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5493460657310735298" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhbxjl-AlGATfarPayjaUYkCOG4sUrulp4D88Nk7_z-eEbaWRl-xi1g0neGKWDhEL1w6-_-FCu4iBoJx9AUlU-bccaAmEcMfmGI1uoa4gTohjch5gzcx5tA9Ru-uMB0Mip6NE0PuUsfDXJ5/s320/horse-cart.jpg" style="cursor: pointer; display: block; height: 168px; margin: 0px auto 10px; text-align: center; width: 253px;" /></a>Something's very wrong here...</div> However, this situation is anything but humorous. How more "cart before the horse" can government get?</blockquote> In the second post, I wrote: <blockquote class="tr_bq">... So, in the midst of a National Program for Health IT in the United States (NPfIT in the U.S.), with tens of billions of dollars earmarked for health IT already (money we don't really have, but it can be printed quickly, or borrowed from China) the IOM is going to study health IT safety, prevention of health IT-related errors, etc. ... only now?</blockquote> Here we go yet again. The problem with the AHRQ (<a href="http://www.ahrq.gov/" target="_blank">Agency for Healthcare Research and Quality</a>, a division of HHS) announcement below of a webinar about a new tool for identifying, categorizing, and resolving health IT hazards, as I have written before, is putting the "cart before the horse" and throwing medical ethics to the wind. If we've just developed a tool "for identifying, categorizing, and resolving health IT hazards", the magnitude of which others such as IOM admit are unknown to our detriment (e.g., <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>, pg. S-2), then health IT is, it follows, an experimental technology. If it is an experimental technology, AHRQ and others in HHS should probably be raising the issue of a slow down or moratorium on widespread rollout under HITECH until risk management and remediation is better understood.  At the very least they should be calling for patient informed consent that a device that will largely regulate their care is experimental, that a competency "gap" exists among healthcare practitioners within the "health IT environment" (meaning patients are at risk), and that patients should be offered the opportunity for informed consent with opt-out provisions.  The principals should not just be announcing a webinar: <blockquote class="tr_bq">Sent: Tuesday, June 05, 2012 12:23 PM To: OHITQUSERS@LIST.NIH.GOV Subject: Register Now! AHRQ Health IT Webinar "Purpose and Demonstration of the Health IT Hazard Manager and Next Steps" June 11, 2:30 PM ET Agency for Healthcare Research and Quality Purpose and Demonstration of the Health IT Hazard Manager and Next Steps June 11, 2012 — 2:30-4 p.m., EST The Agency for Healthcare Research and Quality (AHRQ) has identified a gap in a health care/public health practitioner’s competency within the health IT environment. This webinar is designed to increase practitioners’ competencies in several areas: improving health care decision making; supporting patient-centered care; and enhancing the quality and safety of medication management by improving the ability to identify, categorize, and resolve health IT hazards. The Webinar will explore the Health IT Hazard Manager—a tool for identifying, categorizing, and resolving health IT hazards. When implemented, the tool allows health care organizations and software vendors alike to learn about potential hazards and work to resolve them, including the use of data to communicate potential and actual adverse effects. The session will discuss how the Health IT Hazard Manager was tested and refined as well as strategies and implications for deploying it. The target audience includes AHRQ grantees/researchers; health care providers, including physicians and nurses; consumers/patients; and health care policymakers. ... Webinar learning objectives include: 1. Describe the rationale for developing the Health IT Hazard Manager and how it evolved through alpha and beta testing. 2. Explain the process for identifying and categorizing health IT-related hazards. 3. Demonstrate how the Health IT Hazard Manager would be used [i.e., it's not yet in use, despite mandates for HIT rollout with penalties for non-adopters - ed.] within and across care delivery organizations and health IT software vendors. 4. Discuss policy and process implications for deploying the Health IT Hazard Manager via different organizations (i.e., AHRQ; Office of the National Coordinator for Health IT; Patient Safety Organization(s); Accrediting bodies; IT entities). </blockquote> In effect, HHS seems to be saying "we're working on the HIT risk problem, but roll it out anyway; if you get harmed or killed, tough luck."  This seems a form of negligence. Have we thrown out all we know about <a href="http://grants.nih.gov/grants/policy/hs/ethical_guidelines.htm" target="_blank">medical research and human subjects protections</a> in face of the magical powers and profits of computers in medicine? -- SS

Cart Before the Horse, Part 3: AHRQ's "Health IT Hazard Manager"

(Addendum: the AHRQ hazards manager taxonomy report can see seen at http://healthit.ahrq.gov/sites/default/files/docs/citation/HealthITHazar...

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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...

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