healthy4u: Dr. Scott Monteith

At Risk in the Computerized Hospital: The HITECH Act as Social Policy Malpractice, and Passivity of Medical Professionals

I am revisiting the issue of HITECH in light of recent reports on health IT drawbacks and/or failure to achieve long-claimed advantages. The <a href="http://waysandmeans.house.gov/media/pdf/111/hitech.pdf" target="_blank">HITECH Act</a>, a multi-billion dollar EHR incentive/penalty measure inserted into the 2009 American Recovery and Reinvestment Act legislation (<a href="http://en.wikipedia.org/wiki/American_Recovery_and_Reinvestment_Act_of_2009" target="_blank">ARRA</a> or 'economic recovery' act), is proving to be an example of what should be called "Social Policy Malpractice." The HITECH Act was largely a consequence of intense industry lobbying on behalf of the IT industry (as in the Washington Post at "<a href="http://www.washingtonpost.com/wp-dyn/content/article/2009/05/15/AR2009051503667.html?hpid=topnews">The Machinery Behind Health-Care Reform: How an Industry Lobby Scored a Swift, Unexpected Victory by Channeling Billions to Electronic Records</a>", May 16, 2009). It is in fact not based on science or reliable evidence, and has led to increased patient endangerment and a worsening national debt picture. The recent revelations of reports from diverse sources including but not by any means limited to the following indicate that HITECH and its expenditures of billions of dollars on experimental, unregulated, unproven technology represents social policy malpractice:   <div></div><div><ul><li>ABC News (<a href="http://abcnews.go.com/Health/medical-records-private-abc-news-investigation/story?id=17228986" target="_blank">Your Medical Records May Not Be Private: ABC News Investigation</a>" - privacy of electronic health data is very poor, in ways that paper would and could never have permitted); </li></ul></div><div><ul><li>The Center for Public Integrity "<a href="http://www.publicintegrity.org/2012/09/19/10812/growth-electronic-medical-records-eases-path-inflated-bills" target="_blank">Growth of electronic medical records eases path to inflated bills</a>", on how EHRs lead to increased, not decreased healthcare costs; </li></ul></div><div><ul><li>Experts at Penn and Harvard -"<a href="http://online.wsj.com/article/SB10000872396390443847404577627041964831020.html?mod=googlenews_wsj" target="_blank">A Major Glitch for Digitized Health-Care Records</a>" - savings from EHRs are illusory;</li></ul><ul><li>Budget reports - in view of the deficit spending reported by OMB and others that is causing national debt to spiral out of control, jeopardizing the economic well being of the United States, and with upcoding as a side-effect and no cost savings, HITECH is an unaffordable extravagance.  </li></ul><ul><li>Recent revelations of outright EHR-induced mass chaos largely due to outspoken clinicians who've had enough - "<a href="http://hcrenewal.blogspot.com/2012/09/in-addition-to-nurses-doctors-now-air.html" target="_blank">Contra Costa County health doctors air complaints about county's new $45 million computer system</a>", "<a href="http://hcrenewal.blogspot.com/2012/09/the-extremes-to-which-faith-based.html" target="_blank">Lake County (IL) Health Department - Depression era soup lines at the clinic</a>";</li></ul><ul><li>Abuses of NPRM Public Comment periods on followup health IT incentive regulations via industry ghostwriting (stealth lobbying), reducing EHR effectiveness while further enriching the industry - "<a href="http://hcrenewal.blogspot.com/2012/08/health-it-vendor-epic-uses-clients-as.html">Health IT Vendor EPIC Caught Red-Handed: Ghostwriting And Using Customers as Stealth Lobbyists - Did ONC Ignore This?"</a>;</li></ul> Of course, I'd already cited these reports in past posts but they bear repeating: <ul></ul><ul></ul></div><div><ul><li>The IOM report on HIT safety ("There's risk, but we don't even know the magnitude because there are major systemic impediments to diffusion of that information"), <a href="http://hcrenewal.blogspot.com/2011/11/iom-report-on-health-it-safety-nix-fda.html" target="_blank">http://hcrenewal.blogspot.com/2011/11/iom-report-on-health-it-safety-nix-fda.html</a>;</li></ul></div><div><ul><li>FDA (known injuries and deaths are likely the "tip of the iceberg" because of the impediments, and EHRs are medical devices that should fall under the FD&C Act, but FDA has largely refrained from enforcing our regulatory requirements with respect to HIT devices because they're a political hot potato - Jeff Shuren MD JD, CDRH), <a href="http://hcrenewal.blogspot.com/2011/04/fda-decides-regulating-implantable.html" target="_blank">http://hcrenewal.blogspot.com/2011/04/fda-decides-regulating-implantable.html</a>;</li></ul></div><div><ul><li>NIST (health IT usability is poor, major remediation is needed) - <a href="http://hcrenewal.blogspot.com/2011/10/nist-on-ehr-mission-hostile-user.html" target="_blank">http://hcrenewal.blogspot.com/2011/10/nist-on-ehr-mission-hostile-user.html</a></li></ul></div><div></div><div> I'd called for a moratorium on ambitious EHR plans for similar reasons as far back as 2008, at posts <a href="http://hcrenewal.blogspot.com/2008/11/should-us-call-moratorium-on-ambitious.html" target="_blank">here</a> and <a href="http://hcrenewal.blogspot.com/2009/01/i-ask-again-should-us-call-moratorium.html" target="_blank">here</a>.</div><div>  </div><div></div><div>The path that ethical medical centers and clinicians should take is to delay computerization in 2012 and push for slowdown or retraction of HITECH and its penalties for non-adopters.  Yet instead, what is usually seen is excuses and cheerleading by healthcare organization leaders, and passive physician and nurse acceptance of deficient information technology.  </div><div></div><div> This stunning passivity and acceptance by physicians and nurses of a deeply flawed technology of unknown risk seems largely due to physician learned helplessness and the Stockholm Syndrome.  See the posts on "physician learned helplessness" at <a href="http://hcrenewal.blogspot.com/2007/10/physicians-learned-helplessness.html" target="_blank">http://hcrenewal.blogspot.com/2007/10/physicians-learned-helplessness.html</a> (commenting on observations in MedScape written by a lawyer), as well as on the "Stckholm Syndrome"  at <a href="http://en.wikipedia.org/wiki/Stockholm_syndrome" target="_blank">http://en.wikipedia.org/wiki/Stockholm_syndrome</a>.  Per a psychiatrist/informatics specialist Dr. Scott Monteith who has <a href="http://hcrenewal.blogspot.com/search/label/Dr.%20Scott%20Monteith" target="_blank">commented on this blog</a>, the compliance of clinicians may also be a manifestation of the inherent human psychopathology reflected in the <a href="http://en.wikipedia.org/wiki/Milgram_experiment" target="_blank">Milgram Experiment</a> (and elsewhere):</div><div></div> <blockquote class="tr_bq"><div>The Milgram experiment on obedience to authority figures was a series of notable social psychology experiments conducted by Yale University psychologist Stanley Milgram, which measured the willingness of study participants to obey an authority figure who instructed them to perform acts that conflicted with their personal conscience. Milgram first described his research in 1963 in an article published in the Journal of Abnormal and Social Psychology, and later discussed his findings in greater depth in his 1974 book, Obedience to Authority: An Experimental View. </div></blockquote><div> As to the consequences of physician "acceptance" of this technology in 2012 in its present condition, physicians are: <div><ul><li>Acting, in effect, 'in loco parentis' for their patients, not in the latter's best interests, who are not even afforded opportunity for informed consent.  This is in violation of long-accepted norms of human subjects experimentation and research such as the <a href="http://www.hhs.gov/ohrp/archive/index2.html" target="_blank">Belmont Report, Nuremberg Code</a> and <a href="http://www.hhs.gov/ohrp/humansubjects/index.html" target="_blank">HHS human subject protection</a> regulations at <a href="http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html">45 CFR part 46</a> themselves;</li></ul></div><div><ul><li>Giving free provision of their expertise and labor at improvisation and workarounds, in effect providing free alpha and beta testing to an entirely unregulated IT sector;</li></ul></div><div><ul><li>Engaging in passive acceptance of the entire liability and their hospital executives' breach of fiduciary responsibility to protect them from same due to Hold Harmless clauses, and breach of Joint Commission safety standards through signing "gag" clauses on defects and harms (see <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=koppel_kreda" target="_blank">http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=koppel_kreda</a>). </li></ul></div> </div><div>National health IT leaders have proven to be hyperenthusiasts about health IT benefits as well:</div><div></div><div> <blockquote class="tr_bq">... This from Robert Kolodner, former head of the Office of the National Coordinator for Health IT (ONC) at HHS: <blockquote class="tr_bq">Dr. Robert Kolodner, a physician who headed the federal push for electronic medical records in 2007, acknowledged that billing abuse took a backseat to steps likely to entice the medical community to embrace the new technology. Kolodner said officials were certain the savings achieved by computerizing medicine would be so great that billing abuse, “while needing to be monitored, was not something that should be put as the primary issue at that time.”</blockquote> In other words, sideline (ignore) health IT-based billing abuse (and safety risks to the live patients subjected to this experimental technology without informed consent) because "we believe" the savings will be greater based on "our faith in the technology."</blockquote>  </div><div>Such individuals contributed materially to the social policy malpractice represented by the HITECH ACT.</div><div> </div><div>Considering all of the above, I call once again for a moratorium on further economic incentives for EHR adoption, and investment in the very measures recommended by the National Research Council in its Jan. 2009 report "<a href="http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=12572" target="_blank">Computational Technology for Effective Health Care: Immediate Steps and Strategic Directions</a>" that:</div><div> <blockquote class="tr_bq">In the long term, success will depend upon accelerating interdisciplinary research in biomedical informatics, computer science, social science, and health care engineering. </blockquote></div><div></div><div></div><div> This research must be conducted, of course, with full human subjects protections in place.</div><div> </div><div>-- SS</div>

At Risk in the Computerized Hospital: The HITECH Act as Social Policy Malpractice, and Passivity of Medical Professionals

I am revisiting the issue of HITECH in light of recent reports on health IT drawbacks and/or failure to achieve long-claimed advantages.The HITECH Act, a multi-billion dollar EHR incentive/penalty mea…

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20 Sep 2012

Bad health IT and its effects on willingness of patients to share sensitive information

I call your attention to this video from the 2nd International Summit on the Future of Health Privacy where HC Renewal occasional contributor Dr. Scott Monteith, a psychiatrist, presents on how health IT damages the physician-patient relationship, the bedrock of good medicine, in one case via an inexcusable health IT defect. The defect nearly cost a woman her good reputation - and her child - by "transforming" coffee drinking into solvent sniffing. The video is here:  <a href="http://www.healthprivacysummit.org/events/2012-health-privacy-summit/custom-129-ec40d08a35f947e487f68a5f534a9e82.aspx">http://www.healthprivacysummit.org/events/2012-health-privacy-summit/custom-129-ec40d08a35f947e487f68a5f534a9e82.aspx</a> <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="http://www.healthprivacysummit.org/events/2012-health-privacy-summit/custom-129-ec40d08a35f947e487f68a5f534a9e82.aspx" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="178" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgS2ctf3aR4Od2Bas-tSrdYlO963ONIhluMMnfJ4PqF6gnU2QE8aefxAY08YzO3AgjN8hxWUT18SOKNirUmulqLb1Zbg7mzNbET9VfcD6g8SM1xA5JVVOCFhfXt3iPPs-E4za0PXHd0Vv76/s320/monteith.jpg" width="320" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">Dr. Monteith on how bad health IT damages trust.  See video <a href="http://www.healthprivacysummit.org/events/2012-health-privacy-summit/custom-129-ec40d08a35f947e487f68a5f534a9e82.aspx" target="_blank">at this link</a> starting at 4:40.</td></tr></tbody></table> Dr. Monteith starts at 4:40 when he is asked <blockquote class="tr_bq">"Do you feel HIT affects the willingness of patients to share sensitive information with providers?"</blockquote> His answer is a definite "yes", and the video should be seen to understand his reasons, the largest one being the trust that is injured by this technology as currently (mal)implemented, failing to maintain privacy, data integrity, affecting doctor-patient interaction (e.g., due to poor usability), etc. His two examples where HIT has injured trust, resulting in decreased willingness of patients to share sensitive information: <ul><li>A patient feared compromised privacy regarding psychiatric information (a fear that was certainly well-justified in view of ABC's recent expose of health IT breaches as I wrote about at my Sep. 14, 2012 post "<a href="http://hcrenewal.blogspot.com/2012/09/a-reason-to-refuse-use-of-ehrs-in-your.html">A Reason to Refuse Use of EHR's in Your Health Care, and Demand Paper</a>.")</li></ul><ul><li>An error in EHR-generated record affecting a child custody battle, with a husband alleging unfitness of the mother due to substance abuse.  The EHR incorrectly showed a damaging diagnosis due to both a data mapping flaw (lumping multiple diagnoses under the same code) and a user interface flaw (permitting all of the diagnoses lumped under that code to not be seen, only the worst one) that transformed caffeine (i.e., coffee) overuse to "inhalant abuse."  </li></ul> Stunningly, Dr. Monteith reported the error was not remediated even after several years. As seen by the voluntary reports submitted by one of many HIT sellers (<a href="http://hcrenewal.blogspot.com/2011/01/maude-and-hit-risk-mother-mary-what-in.html" target="_blank">link</a>), the only one that seems to do so, and some involuntary ones such as at <a href="http://google2.fda.gov/search?q=pulsecheck&client=FDAgov&site=FDAgov&lr=&proxystylesheet=FDAgov&output=xml_no_dtd&getfields=*&ie=UTF-8&ip=98.114.36.41&access=p&sort=date:D:L:d1&entqr=3&entqrm=0&oe=UTF-8&ud=1&filter=0" target="_blank">this link</a>, these issues are just the "tip of the iceberg." That exact phrase was uttered by a senior FDA official himself, reflecting known severe impediments to information diffusion on harms, as I reported <a href="http://hcrenewal.blogspot.com/2010/02/fda-on-health-it-adverse-consequences.html" target="_blank">at this link</a>. Yet the government (e.g., HHS's <a href="http://healthit.hhs.gov/portal/server.pt/community/healthit_hhs_gov__onc/1200" target="_blank">Office of the National Coordinator for Health Information Technology</a>, ONC) and IT industry push this technology like candy, emphasizing largely unproven benefits and completely ignoring downsides such as damaged trust, damaged reputations that could have cost a woman custody of her child, and damaged bodies. A video of an attorney personally affected by these issues is at this link:   <a href="http://www.healthprivacysummit.org/events/2012-health-privacy-summit/custom-137-ec40d08a35f947e487f68a5f534a9e82.aspx">http://www.healthprivacysummit.org/events/2012-health-privacy-summit/custom-137-ec40d08a35f947e487f68a5f534a9e82.aspx</a> -- SS

Bad health IT and its effects on willingness of patients to share sensitive information

I call your attention to this video from the 2nd International Summit on the Future of Health Privacy where HC Renewal occasional contributor Dr. Scott Monteith, a psychiatrist, presents on how health…

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15 Sep 2012

Dr. Scott Monteith: On a New Wonder "Drug" on the Market

I've posted several guest posts by Dr. Scott Monteith, a psychiatrist/informaticist, at Healthcare Renewal. These include the Mar. 2011 post "<a href="http://hcrenewal.blogspot.com/2011/03/dr-scot-monteith-on-best-compromise-on.html">On 'The Best Compromise' on Physicians and Use of Troublesome Health IT</a>", the Jan. 2011 post "<a href="http://hcrenewal.blogspot.com/2011/01/dr-monteith-hit-testimony-to-hhs.html">Interesting HIT Testimony to HHS Standards Committee, Jan. 11, 2011, by Dr. Monteith</a>" and the Dec. 2010 post "<a href="http://hcrenewal.blogspot.com/2010/12/meaningful-use-and-devil-in-details.html">Meaningful Use and the Devil in the Details: A Reader's View</a>". Here's a new guest post from Dr. Monteith regarding a new "Wonder Drug" on the market: <blockquote>New Drug on the market! This new drug claims to be incredibly effective. It’s very expensive, but the sellers assure us that it’s worth it! Using the drug is complicated, and the health care team will likely experience side effects including frustration, reduced efficiency, fatigue, lack of attention, confusion, and cognitive dissonance (as the drug often “appears” not to work -- but it really does work and we know because the manufacturers consistently tell us it does). By the way, the sellers of this new drug say that side effects are the fault of the people who use the drug, not the drug itself. The drug isn’t proven to work, but its investors view it as promising and tell us that this small detail can be ignored. Besides, it would be costly to prove that it’s effective (remember, it’s already a very expensive drug). And there are case studies showing that it appears to work. Some people reportedly really like it (these people, in fact, often become drug salesmen). Never mind that there are also large numbers of case studies indicating that it’s ineffective and dangerous, and can even kill people. [Of course, cases of success are scientifically robust and universally valid; cases of adverse events are <a href="http://hcrenewal.blogspot.com/2011/08/from-senior-clinician-down-under.html">merely anecdotal (link)</a> - ed.] Nor do we have clear best practices related to correct dosages and when to take it, but the drug’s producers tell us that more of the drug is generally better than less. Everyone will have to figure out these minor details on their own. It’s recommended that you hire experts to help you with this detail. No problem – there are experts around every corner (they’re called “consultants”). Please join the manufacturers in their campaign to use and promote this new drug – the government has! Uncle Sam will pay you an incentive to use this new experimental drug over the next few years. If you refuse to use it, however, beware! Uncle Sam will penalize caregivers who refuse to use the drug by reducing their payments by 1% in the first year, and then accelerating these reductions in years 2-5. We also need to work hard to keep groups of citizens from regulating it, or asking inconvenient questions like “can you please prove that it works before we take it and risk side effects and spend large amounts of money on it?” (You know, the same kind of nasty questions that we ask of other health care interventions.) Almost forgot…once you start the drug, it’s very hard to quit to using it. No, it’s not heroin. Don’t be silly! Finally, we’re working hard to keep the manufacturers safe from any liability associated with the drug. Yes, yes, I know – they claim it’s safe and works and all problems are related to the people who take it. But these “safe harbors” (whether through government intervention or strong user agreements) are necessary ... just in case ... By now I’m sure that you want to run out to your pharmacy to buy this wonderful new drug. You may also want to invest in its maker as well. So here are the details… The generic name is “HIT.” The trade name is “EHR.” It’s stock symbol is ONC. </blockquote> I think the point is very well made. -- SS

Dr. Scott Monteith: On a New Wonder "Drug" on the Market

I've posted several guest posts by Dr. Scott Monteith, a psychiatrist/informaticist, at Healthcare Renewal.These include the Mar. 2011 post "On 'The Best Compromise' on Physicians and Use of Troubleso…

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31 Oct 2011

Dr. Scott Monteith on "The Best Compromise" on Physicians and Use of Troublesome Health IT

I have posted two guest posts by Dr. Scott Monteith, a psychiatrist/informaticist, at the Jan. 2011 post "<a href="http://hcrenewal.blogspot.com/2011/01/dr-monteith-hit-testimony-to-hhs.html">Interesting HIT Testimony to HHS Standards Committee, Jan. 11, 2011, by Dr. Monteith</a>" and the Dec. 2010 post "<a href="http://hcrenewal.blogspot.com/2010/12/meaningful-use-and-devil-in-details.html">Meaningful Use and the Devil in the Details: A Reader's View</a>". Here is another, with his permission. He is responding to a talking point from a health IT commentary website that was distributed among the AMIA evaluations special interest group readership. Dr. Monteith asks some very probing questions. He writes: <blockquote>I would like to respond to what I see as being one of the most important and challenging “real-life” issues confronting clinicians, and is captured in this excerpt [below, from the multi-vendor sponsored site HISTalk - ed.]: <blockquote> HisTALK: ... Somewhere between “we vendors are doing the best we can given a fiercely competitive market, economic realities, and slow and often illogical provide procurement processes that don’t reflect what those providers claim they really want” and “we armchair quarterbacks critics think vendors are evil and the answer is free, open source applications written by non-experts willing to work for free under the direct supervision of the FDA” is the best compromise.</blockquote> That is, this excerpt performs the helpful task of framing “the best compromise” somewhere between two extreme viewpoints. It would be helpful (at least for me) if this group could discuss what “the best compromise” actually ‘looks like’ in practice. How does one actually understand and live within “the best compromise”? Let’s start with a relatively simple scenario: What should clinicians do when they are working with EHRs that have known “problems” that are putting patients at risk, and the problems are not being immediately addressed, either directly or indirectly through, for example, an acceptable “work around,” or other adjustments to the EHR or local business processes? Should the clinician continue to use the EHR and… <ul><li> assume that others (e.g., vendor, IT department, administration, etc.) will fix the problem(s)?</li></ul><ul><li> report the problem(s)? Once? Twice? Three or more times? (How many?) To whom?</li></ul><ul><li> inform the patient of the known problem(s) (if the problem(s) apply to the patient)?</li></ul><ul><li>inform the patient that we do not have a good understanding of how to balance or even understand the risks posed by the EHR, given the dearth of peer-reviewed literature and algorithms? (What is “acceptable risk” for a given EHR problem? Does the EHR-related problem’s risk/benefit analysis change if the patient is in the hospital for a simple, nonlife-threatening problem vs. a complex, life-threatening problem)?</li></ul><ul><li> give the patient the option to NOT use the EHR? (Note that we almost always give patients the choice to refuse other “risky ventures” such as diagnostic procedures and treatments.)</li></ul><ul><li> inform their medical malpractice insurance company of the EHR-related problems?</li></ul><ul><li> submit the problem(s) to the organization’s ethics committee, if there is one?</li></ul><ul><li> report the problem(s) to the organization’s risk management staff?</li></ul><ul><li> report the problem(s) in writing or verbally?</li></ul><ul><li> stop using the EHR?</li></ul> Etc. (including some combination of things). Can providers (especially physicians) legitimately rationalize, given our ethical (to patients and our colleagues) and legal obligations (to patients and the state where we are licensed), the use of tools that are posing risks to patients and providers, when those risks are not spelled-out, not well understood, not peer-reviewed, etc.? (Obviously everything we do has risks, but we are obligated to revel and discuss those risks as noted above. Further, the risks/benefits of a given diagnostic or treatment intervention are the product of peer-reviewed algorithms. Are patient’s aware of the risks associated with their doctor’s or hospital’s EHR?) Again, the above excerpt suggests that there is a “ best compromise.” But what is/are “the best compromise(s)”? I joke with friends that I am a “radical moderate” – that is, I usually find myself committed to the “middle ground” in most complex and thoughtful discussions. But when it comes to EHRs, I am finding it difficult to define or understand what a “moderate” or an acceptable “best compromise” looks like. Given the current EHR exuberance driven by ONC’s incentive dollars and vendor profits (or hoped-for profits), we all know that the “politically correct” approach is to “go along” and be an “early adopter” (without too many protests). But is the politically correct approach really the “best compromise,” especially in light of our ethical and legal obligations? I am anxious to hear what other people think about this matter. I am sincerely seeking help in better understanding a sensible, real-life “best compromise” for those of us in the trenches. Note that if we cannot define “the best compromise,” then what does that say about us? How can we justify “getting on board” with patient care tools (e.g., EHRs, eRx’ing, etc.) that are posing risks (known and unknown), with no clear processes for informing patients, not giving patients their choice to use these e-tools, no clear evidence-based risk/benefit analyses, etc.?</blockquote> My own pithy, initial responses are as follows: <blockquote>Re: Given the current EHR exuberance driven by ONC’s incentive dollars and vendor profits (or hoped-for profits), we all know that the “politically correct” approach is to “go along” and be an “early adopter” (without too many protests). But is the politically correct approach [i.e, "go along to get along" - ed.] really the “best compromise,” especially in light of our ethical and legal obligations?</blockquote> No, for the reasons after your comma. [i.e., in light of our ethical & legal obligation - ed.] One should look to the past for lessons in what the "compromises" might be. How about the <a href="http://en.wikipedia.org/wiki/Flexner_Report">Flexner Report of 1910</a> as a start? The treatises on human research protections penned largely after the <a href="http://en.wikipedia.org/wiki/Tuskegee_syphilis_experiment">Tuskegee experiments</a> and the horrors of WW2, such as these as listed on an NIH web page "<a href="http://ohsr.od.nih.gov/guidelines/index.html">Office of Human Subjects Research, Regulations and Ethical Guidelines</a>" might also shed some light: <ul><li><a href="http://ohsr.od.nih.gov/guidelines/45cfr46.html">45 CFR 46</a> Protection Of Human Subjects</li></ul> <ul><li><a href="http://ohsr.od.nih.gov/guidelines/GrayBooklet82404.pdf">Guidelines for Conduct of Research Involving Human Subjects at NIH (Gray Booklet) (pdf file)</a></li></ul> <ul><li><a href="http://ohsr.od.nih.gov/guidelines/belmont.html">The Belmont Report</a> Ethical Principles and Guidelines for the Protection of Human Subjects of Research</li></ul> <ul><li><a href="http://ohsr.od.nih.gov/guidelines/nuremberg.html">Nuremberg Code</a> Directives for Human Experimentation</li></ul> <ul><li><a href="http://ohsr.od.nih.gov/guidelines/helsinki.html">World Medical Association Declaration Of Helsinki</a></li></ul>I further opine:<blockquote>Re: How can we justify “getting on board” with patient care tools (e.g., EHRs, eRx’ing, etc.) that are posing risks (known and unknown), with no clear processes for informing patients, not giving patients their choice to use these e-tools, no clear evidence-based risk/benefit analyses, etc.?</blockquote> Perhaps with the line that "I never make mistakes ... everything I do is an experiment." The technology is experimental. Perhaps the best way forward is to treat it as such. In medicine I think there's a rich history of how to conduct proper (and improper) experimental research. Again, Dr. Monteith raises some critical questions that need to be answered. Or, more correctly, needed to be answered a long time ago, and long before planned national rollouts of healthcare information technology. -- SS

Dr. Scott Monteith on "The Best Compromise" on Physicians and Use of Troublesome Health IT

I have posted two guest posts by Dr. Scott Monteith, a psychiatrist/informaticist, at the Jan. 2011 post "Interesting HIT Testimony to HHS Standards Committee, Jan. 11, 2011, by Dr. Monteith" and the …

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07 Mar 2011

Dr. Extormity's Testimony at Healthcare IT Hearing

At "<a href="http://hcrenewal.blogspot.com/2011/01/dr-monteith-hit-testimony-to-hhs.html">Interesting HIT Testimony to HHS Standards Committee, Jan. 11, 2011, by Dr. Monteith</a>" I reproduced a physician's testimony on "Meaningful Use" of Health IT. I thought his testimony illustrated the issues quite well. However, Dr. Monteith's been outdone, this time by Dr. Extormity. Click to play: <div style="text-align: center;"><a href="http://www.youtube.com/watch?v=mYZwbtNekS8&feature=player_embedded"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5564684296131576562" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgxJvdDACxop8Np7td9Y-Btuj-LVcTu1DFXN8N8OomDi77jtHUotPuYaqk7MWSbMsOOWnRg8xdoa_yoQdrQ_x2JrMWGEaqg2yDbOFIKwJ76zBln3Om_gHEuF7diYgzfkPBE7z7BvQhEfQnI/s320/drextormity.jpg" style="cursor: pointer; display: block; height: 196px; margin: 0px auto 10px; text-align: center; width: 320px;" /></a>Dr. Extormity's Testimony at Healthcare IT Hearing - click to play. </div> Also see my May 2008 post "<a href="http://hcrenewal.blogspot.com/2008/05/seedie-society-for-exorbitantly.html">SEEDIE, the Society for Exorbitantly Expensive and Difficult to Implement EHR’s</a>" for more on Dr. Extormity's fine work. Note: this was a "medical humor break" of the kind Residents need to stay sane on the battlefield. (Hat tip to <a href="http://ducknetweb.blogspot.com/2011/01/extormity-ehr-testimony-at-health-it.html">ducknetweb.blogspot.com</a>). -- SS

Dr. Extormity's Testimony at Healthcare IT Hearing

At "Interesting HIT Testimony to HHS Standards Committee, Jan. 11, 2011, by Dr. Monteith" I reproduced a physician's testimony on "Meaningful Use" of Health IT.I thought his testimony illustrated the …

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21 Jan 2011

Interesting HIT Testimony to HHS Standards Committee, Jan. 11, 2011, by Dr. Monteith

Psychiatrist-medical informaticist Dr. Scott Monteith was a guest blogger on the complications of "Meaningful Use of EHR's" in the Dec. 21, 2010 post "<a href="http://hcrenewal.blogspot.com/2010/12/meaningful-use-and-devil-in-details.html">Meaningful Use and the Devil in the Details: A Reader's View</a>." He also testified at the Office of the National Coordinator's Health IT Standards Committee Implementation Workgroup which recently had a meeting, Jan. 10-11, 2010, as I wrote about <a href="http://hcrenewal.blogspot.com/2011/01/onc-workgroup-document.html">here</a>. With his permission I am reproducing his testimony to the Committee (which is supposed to also be posted to the <a href="http://healthit.hhs.gov/portal/server.pt?open=512&objID=1482&&PageID=17128&mode=2">meeting website</a>) without further comment. None is needed. Emphases in the original:  <a name="_GoBack"></a><blockquote>HIT Testimony in DC January 11, 2011 My name is Scott Monteith, a board-certified psychiatrist and Fellow of the APA from Michigan. I work in private practice and with Community Mental Health (CMH). I also teach in MSU’s medical school. My 21 year interest in HIT includes: <ul><li>being a CCHIT Juror; </li></ul> <ul><li>appointed by our Governor to three terms on the Controlled Substances Advisory Commission, which has a role overseeing Michigan’s Automated Prescription System; </li></ul> <ul><li>a member of the Business Operations Workgroup for Michigan’s Health Information Network;</li></ul> <ul><li>working with malpractice insurance companies to manage growing risks from EHRs;</li></ul> <ul><li> and more.</li></ul> I’m “pro-HIT.” For all intents and purposes, I haven’t handwritten a prescription since 1999. That said and with all due respect to the capable people who have worked hard to try to improve health care through HIT, here’s my frank message: ONC’s strategy has put the cart before the horse. HIT is not ready for widespread implementation. The problem isn’t Luddite doctors not adopting; the problem is that HIT isn’t ready, especially if we want safe and efficacious bells and whistles like CDS, interoperability, etc. To describe ONC’s handling of HIT promotion, let me use an analogy: It’s as if policy makers said, “Let’s promote a cure for cancer. By curing cancer, we can save money and improve the quality of people’s lives.” Like our collective fantasy for the benefits of widespread HIT use, which I share, who can argue with the dream of curing cancer, or the good intentions behind it? The problem is that finding a cure for cancer isn’t as simple as declaring a cure, and then merely getting resistant doctors to start using it. Continuing the analogy, ARRA dollars are incenting doctors to use Laetrile, the supposed cancer cure that was not evidence-based and didn’t work. ONC has promoted HIT as if there are clear evidence-based products and processes supporting widespread HIT implementation. But what’s clear is that we are experimenting…with lives, privacy and careers. As a clinician, I’m here to report that certified EHRs are not necessarily producing better documentation or improved care. Yes, EHR-generated documentation is usually more legible, but it’s often “legible gibberish.” And there’s a lot of it, including meaningless data, burying relevant information. Example: A colleague requested records for his mother’s nearly two-week hospital stay; this particular hospital is an early adopter of EHRs. He received almost 2,900 pages. Finding relevant data in the midst of 2,900 pages can be like finding a needle in a haystack. Here’s another example of EHRs degrading documentation: In our CMH, administration inserted language into the doctors' treatment plans. The problem is that the language is patently false and untrue. Unfortunately, administration controls the EHR, and physicians cannot change the untrue language. “Ghost writing” clinical notes – often incorrectly – is increasingly common, whether through fixed fields, no or limited free text, inserted language that cannot be changed, multi-authored documents, or other means. I have documented scores of error types with our certified EHR, and literally hundreds of EHR-generated errors, including consistently incorrect diagnoses, ambiguous eRxs, etc. As a CCHIT Juror, I’ve seen an inadequate process. Don’t get me wrong, the problem is not CCHIT. The problem stems from MU. EHRs are being certified even though they take 20 minutes to do a simple task that should take about 20 seconds to do in the field. Certification is an “open book” test. How can so many do so poorly? For example, our EHR is certified, even though it cannot generate eRxs from within the EHR, as required by MU. To CCHIT’s credit, our EHR vendor did not pass certification. Sadly, our vendor went to another certification body, and now they’re certified. MU does not address many important issues. Usability has received little more than lip-service. What about safety problems and reporting safety problems? What about computer generated alerts, almost all of which are known to be ignored or overridden (usually for good reason)? The concept of “unintended consequences” comes to mind. All that said, the problem really isn’t MU and its gross shortcomings, it is ONC trying to do the impossible: ONC is trying to artificially force a cure for cancer, basically trying to promote one into being, when in fact we need to let one evolve through an evidence-based, disciplined process of scientific discovery and the marketplace. Thank you for the opportunity to be a part of this process.</blockquote> Actually, I will make one comment: In the current climate of "cybernetics over all" in healthcare, this is not the type of testimony that will get the good Dr. any dinner invitations. -- SS

Interesting HIT Testimony to HHS Standards Committee, Jan. 11, 2011, by Dr. Monteith

Psychiatrist-medical informaticist Dr. Scott Monteith was a guest blogger on the complications of "Meaningful Use of EHR's" in the Dec. 21, 2010 post "Meaningful Use and the Devil in the Details: A R…

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16 Jan 2011

Meaningful Use and the Devil in the Details: A Reader's View

A reader, Dr. Scott Monteith, a psychiatrist, shared his thoughts on government-mandated 'Meaningful Use' of Electronic Medical Records ('MU') with me after reading a number of my EHR posts, and asked if he could share his thoughts via Healthcare Renewal. Dr Monteith is a graduate of the University of Michigan and Michigan State University where he was chief resident. He is a board certified psychiatrist, clinical assistant professor in the departments of psychiatry and family medicine at Michigan State University, and has worked in the same community health center for 20 years serving people suffering from severe and persistent mental illness. His interest in Health Information Technology goes back over 20 years. He has served as a CCHIT Juror, was appointed by Michigan’s Governor Granholm to the Controlled Substances Advisory Commission which has an oversight role for the Michigan Automated Prescription System, and was a member of the Business Operations group of the Michigan Health Information Network. Dr. Monteith writes:  <blockquote>From Medical Economics:“While 85% of physicians were aware of the financial incentives for implementing an electronic health record (EHR) system, more than 35% did not know that they face government-assessed financial penalties for not complying, according to a survey of more than 500 physicians by Physicians' Reciprocal Insurers, a New York-based medical liability insurance company. The penalties are equal to a 1% reduction of the physician's annual Medicare payments per year up to 5%. However, those penalties do not seem to be having the intended effect, as more than 65% of physicians who were unaware of the financial penalties said this would not cause them to implement system."The above Medical Economics article reflects a reality that is consistent with what we are seeing in the clinical ‘trenches.’Eligible Providers (EPs) are realizing that Meaningful Use (MU) incentives are not as simple as…using a certified EHR + being part of Medicare and/or Medicaid + applying for MU + attesting to MU.Receiving $44k (or $64k) in incentives seems not only increasingly elusive, but of questionable benefit even if some or all of the incentives are realized. The ‘carrot & stick’ of Meaningful Use (MU) seems to increasingly be viewed as ‘meaningless and useless’ by at least some clinicians. Some are asking if ‘MU’ will stand for ‘meaningless and useless’ in the future. There seems to be a long list of reasons why MU is so challenging. From what I have gleaned, there appear to be two main issues: 1. the cost to meet MU may be too high (and, said another way, the ROI might be too low); and 2. there are too many uncertainties associated with MU (largely stemming from the risk of burdensome bureaucratic entanglement – an unknown and potentially huge “cost”). As we know, MU reimbursement flows through two streams: Medicare and Medicaid. And one’s incentive dollars and/or penalties are based on Medicare/Medicaid volume. So small Medicare/Medicaid volume means small incentives/penalties. With the perception of inevitable Medicare and Medicaid cuts, these two funding streams become increasingly irrelevant for more and more providers. Another issue stems from the fact that MU and the associated EHR “certification” are losing credibility because they do not address “usability.” My users simply want EHRs that “work,” and “work” well (like their iPhones). Users ultimately want and expect usability. They hoped that certification would help guide them in this important respect, but they are finding that is not the case. To the extent that certification is not meaningfully addressing ‘usability,’ therefore, MU is viewed as ‘useless’ in guiding purchasing decisions. Further, many are simply not confident that they will meet MU. Other challenges I’ve encountered include: <ul style="font-family:arial;"><li>One big problem with MU is that many people believe that wedding one’s self to MU (ARRA) will open a can of bureaucratic worms (and they might be correct)</li></ul> <ul style="font-family:arial;"><li>MU is 864 pages of details. How many users will read all 864 pages of the government’s final rule for MU? (And of those few who do, how many will understand it?). If one doesn’t know the MU rules, how will one prepare for MU? Hire consultants and IT experts? How much will this cost?</li></ul> <ul style="font-family:arial;"><li>How will one establish that one is MU-certified? In year one there will be self-attestation. But who/what will certify users as to whether or not users are meeting MU in the other years? How much will it cost (direct costs to pay above certification organization/entity)?</li></ul> <ul style="margin-top: 0in;font-family:arial;" type="disc"><li class="MsoNormal" style="margin-bottom: 6pt;color:black;">How much will it cost users to become certified (indirect costs to prepare for your certification)? </li><li class="MsoNormal" style="margin-bottom: 6pt;color:black;">Currently it appears that one must recertify every year for incentives. But how often will one have to recertify to avoid penalties? What will be the ongoing cost in terms money, time, energy, business flow? Will the ROI be positive or negative (and how positive or negative)?</li></ul> <ul style="font-family:arial;"><li>To what future governmental audits might one be subjected if one gets incentive dollars and/or wants to avoid penalties (especially after the inevitable celebrated cases of abuse)? It is not hard to imagine receiving a letter from the government that says, in essence: “You self attested that you met MU in year one. You are now being audited to substantiate your attestation.”</li></ul> <ul style="margin-top: 0in;font-family:arial;" type="disc"><li class="MsoNormal" style="margin-bottom: 6pt;color:black;">How many people will be audited after receiving ARRA dollars? How much time will the audit take? For how long will you need to keep records? What records? </li><li class="MsoNormal" style="margin-bottom: 6pt;color:black;">What will Congress (and the FBI) do when someone gets ARRA dollars through the “incentives” (or avoids “penalties” in the penalty phase), but they haven’t properly completed the MU certification process, or properly/fully documented it (perhaps no fault of their own)?</li></ul> <ul style="font-family:arial;"><li>What liability does one incur by claiming to meet MU, but then later discovering that someone in the government says that you have not met MU?</li></ul><ul style="font-family:arial;"><li>Given that one needs to do things for MU that establish X percent of a given function (e.g., Rxs) are accomplished through an EHR, one needs both a numerator and denominator to establish the percentage. But how does one capture the data to establish MU percentages for Rxs (and other tasks) that are done on paper?</li></ul> <ul style="font-family:arial;"><li>Are incentive dollars taxable? The answer appears to be “yes.” But many doctors are already “signing over” their dollars to institutions. Unfortunately, neither the doctors nor the institutions are making accommodations for the tax implications. That is, what happens when institutions get the dollars, but because the dollars flow through the clinician, the clinician gets the tax bill?</li></ul> <ul style="margin-top: 0in;font-family:arial;" type="disc"><li class="MsoNormal" style="margin-bottom: 6pt;color:black;">What happens if you change EHRs, for example, due to moving to new practice? Will you have to start all over again? Will you have to reimburse the government? </li><li class="MsoNormal" style="margin-bottom: 6pt;color:black;">Today there are over 400 EHR vendors. In five years, it is expected that at least 350 will ‘go under’ (no longer exist). What then? Recertify? Give back ARRA dollars? </li><li class="MsoNormal" style="margin-bottom: 6pt;color:black;">Will the goal line (either in terms of criteria or time) for MU be moved? (It might move; some say it definitely will move.) How often will this occur? What are the implications for your MU and any ARRA dollars that you have received? </li><li class="MsoNormal" style="margin-bottom: 6pt;color:black;">The Republican “Pledge” is calling for no incentives be spent (including related to HIT).</li></ul> </blockquote>Of course, my own opinion is that setting standards for "meaningful use" implies that use of EHR's can be meaningful to the doctor & patient (rather than to the government and to payors); the literature is conflicting on this point. Further, doing do at a time when HIT is widely acknowledged to be of poor usability (even by HIMSS itself) is putting the cart before the horse, as I wrote at my post "<a href="http://hcrenewal.blogspot.com/2010/10/cart-before-horse-again-institute-of.html">Cart before the horse, again: IOM to study HIT patient safety for ONC; should HITECH be repealed?</a>" We report; you decide. -- SS

Meaningful Use and the Devil in the Details: A Reader's View

A reader, Dr. Scott Monteith, a psychiatrist, shared his thoughts on government-mandated 'Meaningful Use' of Electronic Medical Records ('MU') with me after reading a number of my EHR posts, and asked…

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21 Dec 2010

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