healthy4u: AHRQ

Regulation of HIT by federal independent agency vs. federal executive agency / Open criminal probe of GM recall

In the FY2014 HHS budget-in-brief document (PDF at <a href="http://www.hhs.gov/budget/fy2014/fy-2014-budget-in-brief.pdf">http://www.hhs.gov/budget/fy2014/fy-2014-budget-in-brief.pdf</a>) on page 115, there's this: <div class="gmail_extra"> <div style="margin-left: 40px;">Patient Safety and Health IT Usability Patient safety and usability continue to be a focus for ONC. Working with federal partners AHRQ and FDA, ONC will create the foundation for a patient safety program that will be launched in FY 2014called “The Patient Safety Plan”. The Plan seeks to ensure that health IT is safely designed and implemented, medical staff are properly informed and trained to use their health IT systems, and a surveillance system is established to monitor health IT related patient safety events and ensure that unsafe conditions are corrected.</div></div> I believe the health IT industry now realizes some form of regulation is inevitable after, for example, revelations from medical malpractice insurers that a significant number of lawsuits involve the effects of health IT (see for instance my post "Malpractice Claims Analysis Confirms Risks in EHRs" at <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 also believe that industry and its pundits have pushed for the most favorable regulation possible.  This involves pushing for regulation by agencies with the least agency independence as possible, as I bring out below.  HHS along with its member branches FDA, AHRQ and ONC are executive departments of the US government  The legislation that governs the way such departments and agencies may propose and establish regulations is the Administrative Procedure Act of 1946 (<a href="http://en.wikipedia.org/wiki/Administrative_Procedure_Act">http://en.wikipedia.org/wiki/Administrative_Procedure_Act</a>). First, it seems the executive branch is attempting to concentrate more power within itself over health IT through proposals like in the FY2014 HHS document. I also point out that that HHS (and its offices such as ONC, FDA etc.) are federal executive departments.  <a href="http://en.wikipedia.org/wiki/United_States_federal_executive_departments" target="_blank">http://en.wikipedia.org/wiki/United_States_federal_executive_departments</a>. These are not entirely independent of presidential control: <blockquote>"The heads of the federal executive departments, known as secretaries of their respective department, form the traditional Cabinet of the United States, an executive organ that serves at the disposal of the president and normally act as an advisory body to the presidency."</blockquote> In other words, the leaders serve at the pleasure of the President. This is as opposed to the executive department cousin, the federal independent agency, such as the NRC (Nuclear regulatory commission) and NTSB (national transportation safety board) that are independent agencies (<a href="http://en.wikipedia.org/wiki/Independent_agencies_of_the_United_States_government" target="_blank">http://en.wikipedia.org/wiki/Independent_agencies_of_the_United_States_government</a>): <blockquote>Independent agencies of the United States federal government are those agencies that exist outside of the federal executive departments (those headed by a Cabinet secretary). More specifically, the term may be used to describe agencies that, while constitutionally part of the executive branch, are independent of presidential control, usually because the president's power to dismiss the agency head or a member is limited.</blockquote> It is no secret the administration is determined to push as rapid as possible rollout of health IT, come hell or high water, via HITECH, its coming penalties and other measures.  Its predecessor administration was a bit more genteel and circumspect in this regard. It is clear to me that, in the current political environment, regulation by a federal executive agency is minimalist and will likely be politically ineffective, due to fear of its leadership of being dismissed if they upset the upper echelons.   I note that Jeffrey Shuren, a physician and attorney, director of FDA CDRH already stated in 2010 that "health IT is a political hot potato" as a reason that FDA "has largely refrained from enforcing our regulatory requirements."  See my April 2011 post "FDA Decides Regulating Implantable Defibrillator Medical Devices a 'Political Hot Potato'; Demurs" at <a href="http://hcrenewal.blogspot.com/2011/04/fda-decides-regulating-implantable.html">http://hcrenewal.blogspot.com/2011/04/fda-decides-regulating-implantable.html</a> for links to source. I believe it would be better to place the authority for health IT regulation under the aegis of a federal independent agency, whether an existing one or one created for that purpose, so that its leaders are more independent of executive branch control. ----- I predict that without meaningful regulation, this is where the health IT industry will find itself in a few years. <blockquote class="tr_bq"><a href="http://www.reuters.com/article/2014/03/11/us-autos-gm-recall-probe-idUSBREA2A1RZ20140311" target="_blank">http://www.reuters.com/article/2014/03/11/us-autos-gm-recall-probe-idUSBREA2A1RZ20140311</a> Reuters - Federal prosecutors are examining whether General Motors is criminally liable for failing to properly disclose problems with some of its vehicles that were linked to 13 deaths and led to a recall last month, according to a source familiar with the investigation. The New York-based probe is in its early stages, and the source did not elaborate on the legal theory behind the potential criminal liability. .. Federal investigators are reviewing information about how GM handled reports of problems with ignition switches that first came to light 10 years ago, according to the source. The federal probe by the U.S. attorney in Manhattan adds to a growing list of U.S. authorities examining the recall, which GM announced in February. The National Highway Traffic Safety Administration (NHTSA) previously opened an investigation into whether GM reacted swiftly enough in its recall. Earlier on Tuesday, Reuters reported that a U.S. Senate committee chairman is seeking a hearing on the issue. The U.S. House Energy and Commerce Committee also ordered GM and NHTSA to turn over information about GM's ignition switch problems. The problems in some instances allowed the engine and other components, including front airbags, to turn off while the vehicle was traveling at high speed. More than 1.6 million older vehicles are affected. The failure is believed to be caused when weight on the ignition key, road conditions or some other jarring event causes the ignition switch to move out of the "run" position, turning off the engine and most of the car's electrical components mid-drive, with sometimes catastrophic results. GM has recommended that owners use only the ignition key with nothing else on the key ring. .. The House committee examining the GM issue, led by Michigan Republican Fred Upton, gave the company and NHTSA until March 25 to turn over information about their responses to consumers' complaints about the problem. The committee has asked GM officials to provide a briefing no later than March 18 on how GM has responded to reports of incidents since 2003 and its interaction with NHTSA since then on problems related to the ignition defect. Upton led the 2000 investigation into Firestone tire failures on Ford Motor Co vehicles, resulting in the TREAD Act that requires automakers to report complaints of defects to the NHTSA. That law also makes it a crime to intentionally mislead the agency about defects that lead to serious accidents. ... The person familiar with the criminal probe declined to discuss whether prosecutors were considering liability under the TREAD Act.</blockquote>  In fact, there is no good reason the health IT sector has been excluded from such actions, through an unprecedented regulatory accommodation this single healthcare sector has enjoyed for decades - namely, that of no true regulation at all.   <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/AVvXsEjAREJP0qSqoHqaCCq9y3x81HIJTzS6-HLSU3as_BIzCDOfNAHgX2WAaVEFDLHSYhUMaJFX_l6DHv-RxT00pyP3RJcFQfgbCqBsXJG_-xohfHQYOYO1jqYyqUUObqd3ro9ymPy1cI1ivlXh/s1600/dilbert.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="150" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjAREJP0qSqoHqaCCq9y3x81HIJTzS6-HLSU3as_BIzCDOfNAHgX2WAaVEFDLHSYhUMaJFX_l6DHv-RxT00pyP3RJcFQfgbCqBsXJG_-xohfHQYOYO1jqYyqUUObqd3ro9ymPy1cI1ivlXh/s1600/dilbert.jpg" width="200" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;"> <div class="MsoNormal">Sure, let's regulate a <s>potentially</s> proven dangerous healthcare technology, health IT (a glamor child of this administration) by a federal executive agency that serves "at the disposal" of the President ... instead of a federal independent agency, with ... uh ...better independence.  Great idea!</div></td></tr></tbody></table> -- SS 3/12/14 Addendum: Note this report of possible delays by the Department of Transportation on disclosure of GM ignition defects, by its National Highway Traffic Safety Administration branch, that caused fatalities and where disclosure could have (and finally now has) resulted in huge legal problems for GM.  GM is a company that was a centerpiece of the administration's economic interventions in recent years: <blockquote class="tr_bq">Did the Obama White House Protect GM? Liz Peek The Fiscal Times March 12, 2014</blockquote><blockquote><a href="http://www.thefiscaltimes.com/Columns/2014/03/12/Did-Obama-White-House-Protect-GM">http://www.thefiscaltimes.com/Columns/2014/03/12/Did-Obama-White-House-Protect-GM</a> Did the Obama administration purposefully hide problems with GM cars? Were they panicked that a massive recall of GM products would undermine one of President Obama’s most self-congratulatory campaign themes – that he “saved” Detroit’s auto industry? This is a tale of two car companies: GM, shining star in President Obama’s reelection galaxy, and Toyota, which became political fodder. The House Energy and Commerce Committee announced two days ago that it would undertake an investigation into why it took GM until quite recently to address a decade of complaints about stalling problems with several car models, and why the National Highway Traffic Safety Administration did not demand a recall of the troubled lines earlier on.  [Because they were afraid to? - ed.]  Reports of unexpected stalling in Chevy Cobalts began to trickle in as early as 2003 when 7 incidents were relayed to NHTSA, according to The New York Times ... </blockquote> Read the whole article. The Department of Transportation is ... you guessed it ... a <a href="http://en.wikipedia.org/wiki/United_States_federal_executive_departments">federal executive agency</a>, not a federal independent agency. -- SS <div id="stcpDiv" style="left: -1988px; position: absolute; top: -1999px;"><div class="field field-name-field-author-ref field-type-entityreference field-label-hidden"><div class="field-items"><div class="field-item odd"><a href="http://www.thefiscaltimes.com/Authors/P/Liz-Peek" rel="author">Liz Peek</a></div></div></div>The Fiscal Times <div class="field field-name-field-release-date field-type-datetime field-label-hidden"><div class="field-items"><div class="field-item odd">March 12, 2014</div></div></div><div class="field field-name-body field-type-text-with-summary field-label-hidden"><div class="field-items"><div class="field-item odd">Did the Obama administration purposefully hide problems with GM cars? Were they panicked that a massive recall of GM products would undermine one of President Obama’s most self-congratulatory campaign themes – that he “saved” Detroit’s auto industry? This is a tale of two car companies: GM, shining star in President Obama’s reelection galaxy, and Toyota, which became political fodder. The House Energy and Commerce Committee announced two days ago that it would undertake an investigation into why it took GM until quite recently to address a decade of complaints about stalling problems with several car models, and why the National Highway Traffic Safety Administration did not demand a recall of the troubled lines earlier on.  Reports of unexpected stalling in Chevy Cobalts began to trickle in as early as 2003 when 7 incidents were relayed to NHTSA, <a href="http://www.nytimes.com/2014/03/09/business/auto-regulators-dismissed-defect-tied-to-13-deaths.html?_r=0">according to The New York Times</a>.</div></div></div>- See more at: http://www.thefiscaltimes.com/Columns/2014/03/12/Did-Obama-White-House-Protect-GM#sthash.Ed9FH0ZD.dpuf</div><div id="stcpDiv" style="left: -1988px; position: absolute; top: -1999px;">National Highway Traffic Safety Administrationsuspected of causing many deaths:  "Did the Obama White House Protect GM?", The Fiscal TimesMarch 12, 2014, <a href="http://www.thefiscaltimes.com/Columns/2014/03/12/Did-Obama-White-House-Protect-GM">http://www.thefiscaltimes.com/Columns/2014/03/12/Did-Obama-White-House-Protect-GM</a>.Note that the Department of Transportation is ... you guessed it ... a <a href="http://en.wikipedia.org/wiki/United_States_federal_executive_departments">federal executive department</a>.</div><div id="stcpDiv" style="left: -1988px; position: absolute; top: -1999px;">Did the Obama White House Protect GM?</div><div id="stcpDiv" style="left: -1988px; position: absolute; top: -1999px;">Did the Obama White House Protect GM?</div>

Regulation of HIT by federal independent agency vs. federal executive agency / Open criminal probe of GM recall

In the FY2014 HHS budget-in-brief document (PDF at http://www.hhs.gov/budget/fy2014/fy-2014-budget-in-brief.pdf ) on page 115, there's t...

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Health IT Amateurs, Logical Fallacy and Hospital Leadership: An Inhibitor to Good Health IT

An excellent three-part article on local providers' efforts to "join the electronic medical record/clinical IT movement", including a middle section "<a href="http://www.thonline.com/news/tri-state/article_0db56834-fc4d-5d9d-9ca0-71c7af76117b.html?mode=story" target="_blank">One doctor has reservations about EMR's design, usability</a>", was published yesterday in the <a class="l" href="http://www.thonline.com/">Dubuque (IA) Telegraph Herald</a>. I was cited as that doctor (subscription required). The article began: <blockquote class="tr_bq">Dr. Scot Silverstein travels the country attending conferences [and <a href="http://hcrenewal.blogspot.com/2012/08/my-presentation-to-health-informatics.html" target="_blank">other countries</a> as well - ed.], speaking on panels and voicing concerns about health care's headlong rush into a reliance on electronic medical record systems. </blockquote> "Headlong rush" is an accurate description of my beliefs, as in my "cart before the horse" posts <a href="http://hcrenewal.blogspot.com/2012/06/cart-before-horse-part-3-ahrqs-health.html" target="_blank">here</a>. The newspaper reporter continues: <blockquote class="tr_bq">"Older and younger physicians alike are increasingly concerned about the poor design and poor usability of clinical IT," Silverstein said.  </blockquote> Not only that, but so is ONC, the Institute of Medicine and the National Institute for Standards and Technology, among others, who I indicated were the source of my quotes. <blockquote class="tr_bq">The Drexel University College of Information Science and Technology faculty member calls "EMR" an anachronistic term from a time when the systems were merely storage tools for records.  "What is meant in 2012 is not just an innocuous 'filing cabinet,' but an enterprise clinical resource management and workflow control system - not just storing records, but regulating and governing all clinical behavior and action," Silverstein said.</blockquote> That is, indeed, my own observation. <blockquote class="tr_bq">Silverstein contends such systems are inappropriate for some health-care environments, such as emergency rooms and intensive-care units.  "They slow down and distract clinicians due to their generally poor user interfaces, in the worst possible setting, and disrupt clinician cognition," he said.</blockquote> Again, not only me.  As I had written to the reporter: <blockquote class="tr_bq">... These devices are not appropriate for high-risk, high-intensity environments such as ED's, ICU's etc.  They slow down and distract clinicians due to their generally poor user interfaces, in the worst possible setting, and disrupt clinician cognition.  But don't take my word for it.  See the 2012 report from the Institute of Medicine on healthcare IT safety (I wrote about it at <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>), the National Institute of Standards and Technology report on clinical IT usability (<a href="http://hcrenewal.blogspot.com/2011/10/nist-on-ehr-mission-hostile-user.html">http://hcrenewal.blogspot.com/2011/10/nist-on-ehr-mission-hostile-user.html</a>) and the literature I collated at <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=readinglist">http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=readinglist</a>. </blockquote> In fact, document image management systems and human data abstractors are a good tradeoff to meet the needs of the most time-pressed clinicians whose time is a hospital's most valuable asset, and to make patient charts available when and where needed.  This is as opposed to "digital data field and form-based" (i.e., conventional) EMR's that force the clinicians to waste their time in clerical functions and distract them from pressing clinical matters and informational accuracy.  He then reports: <blockquote class="tr_bq">Silverstein defines such cognition as the decision making and problem solving necessary to provide quality health care.</blockquote> Precisely. <blockquote class="tr_bq">... Silverstein thinks current clinical IT programs focus too much on raw data and not enough on supporting a physician's decision-making abilities. "As a result, valuable time and energy is spent managing data as opposed to understanding the patient," he said. "Ideally, IT systems would place raw data into context with current medical knowledge to provide clinicians with computer models that depict the health status of the patient, including information on how different organ systems are interacting, epidemiological insight into the local prevalence of disease and potential patient-specific treatment regimens." </blockquote>  Actually, it's not just that I think and said these things.  The quote came verbatim, as I had indicated, from the prestigious <a href="http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=12572" target="_blank">National Research Council of the United States and their 2009 study on health IT,</a> led by healthcare IT pioneers Drs. Octo Barnett and William Stead. Any time logically consistent, ethics-based, common sense observations and opinions are expressed about health IT, however, one can always rely on a pundit or hospital executive for a misdirecting, illogical, and/or impertinent comment. The expected came from Kay Takes, vice president of patient care services at Mercy Medical Center-Dubuque: <blockquote class="tr_bq"> ... Kay Takes, vice president of patient care services at Mercy Medical Center-Dubuque, said the hospital finds electronic medical records a help in the critical environment of the ICU. "Specifically in the ICU, in the last 13 months we've gotten enhancements that allow us to download values from the medical equipment - it's automatically pulled into the medical record," she said "It's been fantastic. The availability of the information is enormously valuable. It's been a lot more of a benefit than a hindrance."</blockquote> I speak from experience, in having been involved in developing those exact same capabilities in the mid 1990's (or, most accurately, <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=clinical%20computing%20problems%20in%20ICU" target="_blank">protecting patients from the dangers created by the IT department in the project</a>), that they are a convenience to those who formerly had to collect the data manually and write it on the ICU flowsheet. The capabilities are also a mild convenience to clinicians who view the data, although the surface area of a paper flowsheet is a great advantage in seeing more data in one's field of view at one time than the usual small computer screen (to illustrate see my Feb. 2012 post EHR Workstation Designed by Amateurs <a href="http://hcrenewal.blogspot.com/2012/02/ehr-workstation-designed-by-amateurs.html" target="_blank">at this link</a> and my Jan. 2012 post An 'Anecdotal Complaint' About An ICU EHR <a href="http://hcrenewal.blogspot.com/2012/01/anecdotal-complaint-about-icu-ehr.html" target="_blank">at this link</a>). From the latter post: <blockquote class="tr_bq">... And we do still talk to each other – but even that doesn’t always “work out”, because we’ve lost our operational minds (collectively) – the shared-by-all compact, visually all data in one place, and temporally arranged – i.e., the shared nurse/doc/resp flowsheet [traditionally in an ICU, a long tabular scroll of paper for "at a glance" patient status overview - ed.] – where everybody was looking at the same page, which we no longer are – as the team is slowly discovering. And which required no logon for sign-over bedside rounding (~40 minutes for 20-30 babies was the allotted time). The flowsheet needed only a 10-15 second glance to spot developing problems; “the computer” is effectively inaccessible in the time allotted for the twice daily sign-n-out “rounds”. </blockquote> Ultimately, though, Ms. Takes, if quoted accurately, commits the logical fallacy of <a href="http://en.wikipedia.org/wiki/Ignoratio_elenchi" title="Ignoratio elenchi">ignoratio elenchi</a> ("ignorance of refutation", missing the point) – an argument that may in itself be valid, but does not address the issue in question. For this convenience does not at all justify the downsides of EHRs, especially in an ICU:  increased time for task completion, increased risk of errors of commission or omission, and the other risks as outlined in sources such as <a href="http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html" target="_blank">FDA's 2010 Internal Memo on H-IT Risks</a>, and recently by AHRQ in their <a href="http://healthit.ahrq.gov/HealthITHazardManagerFinalReport" target="_blank">IT Hazards Manager project</a> (Appendix B). Let's review those risks and failure modes from the AHRQ report, all observed empirically in the real world.  From the report: <blockquote class="tr_bq">A health IT hazard is a characteristic of any health IT application or its interactions with any other health care system (e.g., the people, equipment and work spaces of an ICU) that increases the risk that care processes will be compromised and patients harmed.</blockquote> The potential outcomes of these hazards include medical privacy breach/identity theft, medical misadventures such as errors of commission or omission resulting in "close calls" (errors barely averted), or patient injury, or death, stress on clinicians reducing their performance, and documentation errors or data corruption increasing the risk of errors in the short, medium or long term.  In short, nothing you'd likely desire to occur while you or a family member was a patient: <blockquote class="tr_bq">Usability • Information hard to find • Difficult data entry • Excessive demands on human memory • Sub-optimal support of teamwork (situation awareness) • Confusing information display • Inadequate feedback to the user • Mismatch between real workflows and HIT • Mismatch between user mental models/expectations and HIT Data Quality • IT contributed to entry of data in the wrong patient’s record • Organizational policy contributed to entry of data in the wrong patient’s record • Patient information/results routed to the wrong recipient • Discrepancy between database and displayed, printed or exported data • Faulty reference information • Unpredictable elements of the patient’s record available only on paper/scanned documents • Lost data • Inaccurate natural language processing • Virus or other malware Decision Support • Excessive non-specific recommendations/alerts • Faulty recommendation • Missing recommendation or safeguard • Inadequate clinical content • Inappropriate level of automation Vendor Factors • Sub-optimal interfaces between applications and devices • Faulty vendor configuration recommendation • Unusable software implementation tools • Non-configurable software • Inadequate vendor Testing • Inadequate vendor software change control • Inadequate control of user access • Faulty software design (specification) Local Implementation • Faulty local configuration or programming • Inadequate local testing • Inadequate project management • Inadequate software change control • Inadequate control of user access • Suboptimal interface management Other factors • Inadequate training • Excessive workload (including cognitive) • Inadequate organizational change management • Inadequate management of system downtime or slowdown • Unclear policies • Compromised communication among clinicians (i.e., during handoffs) • Interactions with other (non-HIT) care systems • Physical environment (e.g., hardware location, lighting, engineering) • Inadequately secured data • Hardware Failure • Use error in the absence of other factors</blockquote> The convenience of automated data collection through an EMR system comes at, one might say, a slight cost that may not be realized by health IT amateurs.**  Unfortunately, their lack of knowledge of these issues reduces the caution and "pushback" required for good health IT to become the norm, and permits bad HIT to be sold. -- SS ** Amateurs in the sense that I am a <a href="http://www.arrl.org/" target="_blank">radio amateur</a>, not a professional, formally trained telecommunications engineer, and would never take a major role in an enterprise telecommunications project, especially a mission-critical one. 8/27/12  Addendum: A typical, anonymous, irrational response of the type we've seen on this blog before (as for example <a href="http://hcrenewal.blogspot.com/2012/04/allscripts-shares-plunge-on-weak.html?showComment=1335626142332#c3490189922394571931" target="_blank">here</a> and <a href="http://hcrenewal.blogspot.com/2010/01/more-on-perversity-in-hit-world.html" target="_blank">here</a>) has been posted as a comment to the newspaper story: <blockquote class="tr_bq"> "nemesis" posted at 1:19 pm on Mon, Aug 27, 2012.  He travels the country complaining about existing systems? Perhaps the good prof could spend a little time designing the ideal interface/system and see if he can get anyone interested. Surely his design would win them all over.</blockquote> The problem with this type of comment, of course, is that it's logically fallacious (a form of ad hominem and an odd "appeal to perfection") and irrelevant.  It is no way responds to or refutes the issues I raise in the article.    It likely comes from a health IT pundit of some sort, but hopefully not someone in a position of authority.  In medicine, the rule of thumb is simple:  "Critical thinking always, or your patient's dead." -- SS

Health IT Amateurs, Logical Fallacy and Hospital Leadership: An Inhibitor to Good Health IT

An excellent three-part article on local providers' efforts to "join the electronic medical record/clinical IT movement", inc...

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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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