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IOM Report - "Health IT and Patient Safety: Building Safer Systems for Better Care" - Nix the FDA; Create a New Toothless Agency

<div style="text-align: center;">[Authors' note: This major part of this post was written before I had the actual IOM report itself. Having now read that report, available <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/Patient%20Safety%20and%20Health%20IT%20prepub.pdf">here</a> in PDF, my opinions are unchanged.]</div> The <a href="http://www.iwatchnews.org/">Center for Public Integrity</a> has published a story ahead of the Thursday release of the Institute of Medicine's report on health IT safety. This was a panel, by the way, that rejected my testifying, live, about my own relative's IT-<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=diary"></a> related harm, despite my Medical Informatics credentials and explicit requests [see note below]. The IOM report apparently recommends that an extraordinary special accommodation be afforded to the healthcare IT industry regarding regulation of health IT software devices. Excerpts from the Center for Public Integrity's article: <a href="http://www.iwatchnews.org/2011/11/07/7325/panel-recommends-new-agency-regulate-safety-health-information-technology" itemprop="url"></a> <blockquote><div class="field field-name-body field-type-text-with-summary field-label-hidden clearfix" itemprop="description"><div class="field-items"><div class="field-item"><div style="font-weight: bold;"> <a href="http://www.iwatchnews.org/2011/11/07/7325/panel-recommends-new-agency-regulate-safety-health-information-technology" itemprop="url">Panel recommends new agency to investigate safety of health information technology</a></div>Health information technology has been touted as crucial to better health care, but a new report says an entirely new regulatory agency is needed to oversee this largely unregulated sector, which can also injure or kill patients if it’s not operating properly. </div></div></div></blockquote><div class="field field-name-body field-type-text-with-summary field-label-hidden clearfix" itemprop="description"><div class="field-items"><div class="field-item"><div style="color: black;"> </div><div style="color: black;">We would never have known that if not for the efforts of a small group of specialists with a conscience writing on this issue over the past decade; the industry long emphasized only the beneficence of the technology.</div> <blockquote>In pushing for a new oversight body, the respected Institute of Medicine, an independent research and advisory organization, is explicitly advising that the Food and Drug Administration (FDA) not be tasked with the job — a recommendation that is bound to be controversial. [Indeed - ed.]  The eagerly anticipated report, titled “Health IT and Patient Safety: Building Safer Systems for Better Care,” will be publicly released Thursday. A copy was obtained by iWatch News. The study details nine other recommendations for how to ensure patient safety when doctors and other health care providers use health information technology, or health IT. The findings from the report were presented October 28 to the Department of Health and Human Services (HHS) and its agencies.</blockquote> I do not consider the IOM's rationale for excluding the FDA to be reasonable...more below. <blockquote>... the push [by the Administration] is occurring so far without any agency really ‘watch dogging’ the safety of health IT — the software, hardware and systems that record and manage patients’ health information. These expensive devices by and large have not gone through any regulatory checks for safety in the way that food, drugs and other medical technology must; most of that oversight is handled by the FDA. But at the moment, no one is required to report instances of harm caused by health information devices and no government agency currently monitors their safety.</blockquote> This is a scandal of major proportions, considering the government has taken the approach "ready, shoot, aim" in putting in place penalties for non-adopters on a fantastically rushed timeline, via the HITECH Act within ARRA, while ignoring the risks. <blockquote>“With all of that money, marketing and public outreach, most simply affirm the value of health IT as an article of faith, rather than investigate it via careful evaluation,” said Ross Koppel, adjunct professor of sociology at the University of Pennsylvania and its School of Medicine, and investigator for RAND Corporation. He is listed as one of the reviewers of the report. </blockquote>"Faith" (e.g., irrational exuberance) in a technology has no place in science or medicine. Addendum:  from the report itself: <blockquote class="tr_bq">... While some studies suggest improvements in patient safety can be made, others have found no effect. Instances of health IT–associated harm have been reported. However, little published evidence could be found quantifying the magnitude of the risk. Several reasons health IT–related safety data are lacking include the absence of measures and a central repository (or linkages among decentralized repositories) to collect, analyze, and act on information related to safety of this technology. Another impediment to gathering safety data is contractual barriers (e.g., nondisclosure, confidentiality clauses) that can prevent users from sharing information about health IT–related adverse events. These barriers limit users’ abilities to share knowledge of risk-prone user interfaces, for instance through screenshots and descriptions of potentially unsafe processes. In addition, some vendors include language in their sales contracts and escape responsibility for errors or defects in their software (i.e., “hold harmless clauses”). The committee believes these types of contractual restrictions limit transparency, which significantly contributes to the gaps in knowledge of health IT–related patient safety risks. These barriers to generating evidence pose unacceptable risks to safety. </blockquote><blockquote class="tr_bq">[IOM (Institute of Medicine). 2012. <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> (PDF). Washington, DC: The National Academies Press, pg. S-2.] </blockquote> Also in the IOM report: <blockquote class="tr_bq">… “For example, the number of patients who receive the correct medication in hospitals increases when these hospitals implement well-planned, robust computerized prescribing mechanisms and use barcoding systems. But even in these instances, the ability to generalize the results across the health care system may be limited. For other products— including electronic health records, which are being employed with more and more frequency— some studies find improvements in patient safety, while other studies find no effect. More worrisome, some case reports suggest that poorly designed health IT can create new hazards in the already complex delivery of care. Although the magnitude of the risk associated with health IT is not known, some examples illustrate the concerns. Dosing errors, failure to detect life-threatening illnesses, and delaying treatment due to poor human–computer interactions or loss of data have led to serious injury and death.”</blockquote> In other words, nobody has any real idea of the magnitude of harms, which also implies nobody knows if the magnitude of harms exceeds the magnitude of benefits.  National rollout under these conditions is a horribly unethical situation on first principles. <blockquote>Though a variety of studies have concluded that the use of health IT may improve patient safety, mistakes made in the systems or difficulty using the technology can lead to serious injury or death, according to the report. </blockquote> Other studies actually show little or no benefit or cost savings. See <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=readinglist">this reading list</a> for examples. So, it has been article of faith that the technology in its present form is of benefit, and is not a risk. <blockquote>An allergy might be omitted from a computer record, for example, or an incorrect medication dosage might be recorded. In Rhode Island, a Lifespan <a href="http://hcrenewal.blogspot.com/2011/11/lifespan-rhode-island-yet-another.html">computer glitch</a> [5] caused about 2,000 patients to receive the wrong types of medications. In <a href="http://www.huffingtonpost.com/2010/04/20/electronic-medical-record_n_545441.html">another instance</a> [6] in March 2009, an unattended patient suffered multiple seizures for hours after a computer failed to alert doctors the patient was moved from the intensive care into their ward.</blockquote> And people die needlessly (a few examples are at <a href="http://hcrenewal.blogspot.com/2010/07/maude-database-patient-outcome-death.html">link</a>, <a href="http://hcrenewal.blogspot.com/2011/06/babys-death-spotlights-safety-risks.html">link</a>, <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=diary">link</a>). <blockquote> As reports of patient harm began to emerge, the federal Office of the National Coordinator (ONC) for health IT asked the Institute of Medicine (IOM) a year ago to establish a Committee on Patient Safety and Health Information Technology to make recommendations to the government about how to maximize health IT safety.</blockquote> I would rephrase that to: as reports on patient harm were no longer able to be<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=koppel_kreda"> suppressed by the industry</a>... <blockquote> In its report, the IOM committee says the FDA would likely restrict market innovation in health IT, which could also jeopardize patient safety.</blockquote> There has been little to no real "innovation" in health IT in well over a decade; if anything, the usability and quality has deteriorated. Further, there is no data supporting the contention that FDA regulation of IT harms innovation. Pharma IT (regulated) is far more innovative than the IT in healthcare delivery (unregulated). <blockquote>Stringent regulations “can negatively impact the development of new technology by limiting implementation choices and restricting manufacturers’ flexibility to address complex issues,” the report says. </blockquote> Bull. It will keep the companies honest and "encourage" them to adhere to good software engineering and usability principles (unlike <a href="http://sydney.edu.au/engineering/it/%7Ehitru/index.php?option=com_content&task=view&id=91&Itemid=146">here</a>), which will save lives. It's unfortunate such "encouragement" is needed, I note. <blockquote>The FDA currently <a href="http://www.iwatchnews.org/2010/02/23/7047/fda-considers-regulating-safety-electronic-health-systems">receives voluntary reports</a> [7] of health IT-related incidents, but has no resources or protocols through which to take action; the agency <a href="http://www.vuvox.com/collage/detail/02b26ea6c3">has long fought a losing battle</a> [8] with health IT vendors over trying to monitor the technology. The report also notes the agency does not have the investigative capabilities, funding or manpower to regulate devices such as electronic health records, personal health records or health information exchanges. </blockquote>Then give them the resources, not develop an entire new agency. The FDA has the talent and experience. [Note: I have no connections to FDA whatsoever - ed.] <blockquote>... To adequately oversee health IT safety, the committee recommends that the secretary of health and human services create and fund a new independent watchdog agency, along the lines of the National Transportation Safety Board. Like NTSB, the new agency would conduct investigations and make recommendations for all stakeholders, including the secretary of the health and human services, vendors and health care organizations. Vendors of the technology would be required to report adverse events, while reporting would be voluntary for clinicians. Like NTSB, though, the new agency would also have no enforcement power. </blockquote> That is to say, it will be toothless and ignored, leaving a cavalier industry that should have gotten its act together twenty years ago to continue on with its nihilistic ways. <blockquote>The panel also recommends that the HHS secretary publicly report on the progress of health IT safety each year, beginning in 2012. If the secretary determines at any time that adequate safety progress has not been made, only then should the FDA take the regulatory lead and be given the resources to do so, the report recommends, adding that the agency should be developing a framework now to be prepared.</blockquote> This makes little sense. In fact, it's an extraordinary special accommodation to the health IT industry (or should I say lobby) relative to other healthcare medicine/device sectors, and is bizarre. It continues health IT as a <a href="http://hcrenewal.blogspot.com/2010/01/meaningfully-experimental-protocols-and.html">human subjects research experiment</a> without informed consent and opt-out. With catastrophe-inviting events like <a href="http://hcrenewal.blogspot.com/2011/11/lifespan-rhode-island-yet-another.html">this one</a> becoming more commonplace, just how many patients will have been maimed or died in the meantime while the HHS Secretary's 'determination of adequate safety progress' is being made? (What, exactly, will be deemed 'adequate', I also ask?) <blockquote>Creating a new independent agency would, of course, require resources; the current budget for NTSB is set at $559 million over the 2010 to 2014 period. In the current climate of fiscal restraint, convincing Congress to appropriate that sort of cash for a new government body might be a tall order.</blockquote> I note that it's a waste of taxpayer money to create a new agency to maintain/increase health IT industry profits at the expense of patients - not a wise choice IMO. <a href="http://www.grassley.senate.gov/"></a> <blockquote><a href="http://www.grassley.senate.gov/">... Republican Sen. Chuck Grassley</a> [11] of Iowa, senior member of the Senate Finance Committee, said the new report “adds more to the list of unresolved questions, including which government agency, if any, should regulate health care information technology.” Grassley, who <a href="http://media.washingtonpost.com/wp-srv/politics/documents/erecords102409.pdf">wrote</a> [12] HHS and health IT vendors two years ago asking what was being done to ensure the safety of the devices, said “the approach seemed to be, write checks first, solve the problems later, instead of the other way around.” </blockquote> Having spoken extensively with Sen. Grassley's staff on these issues, I agree - except for the "seemed to be" disclaimer. Replace "seemed to be" with "was." <blockquote>The Institute of Medicine committee does have one dissenter. Dr. <a href="http://news.uchicago.edu/profile/richard-cook">Richard Cook</a> [13] from the University of Chicago feels the FDA is indeed the proper agency to oversee health IT safety. Cook writes that health IT is considered a “Class III medical device,” that is to say, a device that performs integral medical functions, which the FDA already has the jurisdiction to regulate.</blockquote> Dr. Cook is a co-author of the short 2005 paper "<a href="http://www.ctlab.org/documents/Hiding%20in%20plain%20sight.pdf" style="font-weight: bold;">Hiding in plain sight: What Koppel et al. tell us about healthcare IT</a>" which I consider seminal in understanding why health IT as it exists today is so poorly done. <blockquote>In its report, the IOM panel also recommended that another study be done to quantify health IT-related deaths, serious injuries or unsafe conditions so that the safety concerns can be properly addressed. “You can only improve what you measure,” says the report.</blockquote> As I wrote in Oct. 2010, that is <a href="http://hcrenewal.blogspot.com/2010/10/cart-before-horse-again-institute-of.html">putting the cart before the horse again</a>. We study these issues while a national rollout under threat of penalty is underway? That's simply crazy. <blockquote>Other recommendations in the report: establishing and enforcing criteria for the safety of electronic health records, funding a new Health IT Safety Council to set standards for safety, and requiring all health IT vendors to publicly register and list their products with the Office of the National Coordinator.</blockquote></div></div></div> No issues there, except these efforts should have occurred over a decade ago, at the latest. Finally, while I disagree with the action agenda, I do thank the IOM for bringing the issues of health IT risks out into the sunlight. Perhaps now these issues will start to be addressed, and ultimately patient safety and human rights safeguarded. From the report's introduction: <blockquote>... Caught in the middle are the patients—the ultimate recipients of care. Stories of patient injuries and deaths associated with health information technologies (health IT) frequently appear in the news, juxtaposed with stories of how health professionals are being provided monetary incentives to adopt the very products that may be causing harm. These stories are frightening, but they shed light on a very important problem and a realization that, as a nation, we must do better to keep patients safe ... the entire committee believes the current state of safety of health IT must not be permitted to continue.</blockquote> I've been writing words like that for over a decade. -- SS Addendum Nov. 8, 2011: The IOM has issued this press release: <blockquote><div class="MsoNormal"> From: National Academies News <InternetMailforONPI@nas.edu> Date: November 8, 2011 8:25:43 AM PST To: National Academies News <InternetMailforONPI@nas.edu> Subject: Health Information Technology and Patient Safety - For Immediate Release Health Information Technology and Patient Safety – For Immediate Release</div><div class="MsoNormal"> </div>Health IT and Patient Safety: Building Safer Systems for Better Care, a new report from the Institute of Medicine, is available for IMMEDIATE RELEASE. The report examines a broad range of health information technologies and recommends actions that the government, health care providers, and technology vendors should take to improve patient safety. Contrary to some early news accounts, the report does not recommend that a new agency be established to regulate these technologies. Reporters can obtain a copy of the report by contacting the National Academies' Office of News and Public Information; tel. <a href="http://www.blogger.com/blogger.g?blogID=9551150" value="+12023342138">202-334-2138</a> or e-mail <a href="mailto:news@nas.edu" title="mailto:news@nas.edu">news@nas.edu</a>. In addition, members from the committee that wrote the report will discuss their recommendations and take questions at a one-hour public briefing starting at 10:30 a.m. EST Thursday, Nov. 10, in Room 100 of the National Academies’ Keck Center, 500 Fifth St. N.W., Washington, D.C. Those who cannot attend may participate through a live audio webcast accessible at <a href="http://www.nationalacademies.org/" target="_blank" title="http://www.nationalacademies.org/">http://www.nationalacademies.org</a>. </blockquote> I am not sure why they state "Contrary to some early news accounts, the report does not recommend that a new agency be established to regulate these technologies." From the report prepub, page 6-28 to 6-29: <blockquote> ... To truly improve patient safety, a new approach is needed. The committee believed that the experiences of other industries such as transportation and nuclear energy in creating the NTSB and the NRC were instructive, and concluded that the development of an independent, federal entity was best suited to performing the needed above-described analytic and investigative functions for health IT–related adverse events in a transparent, nonpunitive manner. The committee envisions an entity that would be similar in structure to the NTSB or the NRC, which are both independent federal agencies created by and reporting directly to Congress. Among other responsibilities, these entities conduct investigations, for the purpose of ensuring safety. NTSB is a nonregulatory agency that does not establish fault or liability in the legal sense but investigates incidents. The NRC is a regulatory body that has the ability to issue fines and fees. The committee considered both agencies and concluded the NTSB to be most similar to the needs of health IT–assisted care. An independent, federal entity analogous in form and function to the NTSB is needed. This entity would not have enforcement power and would be nonpunitive. Instead, it would have the authority to conduct investigations and, upon their completion, make recommendations. </blockquote>This recommendation followed: <blockquote style="font-weight: bold;"> ... Recommendation 8: The Secretary of HHS should recommend that Congress establish an independent federal entity for investigating patient safety deaths, serious injuries, or potentially unsafe conditions associated with health IT. This entity should also monitor and analyze data and publicly report results of these activities.</blockquote> Hopefully this issue will we clarified when the final report is generally available and the public briefing occurs. I hope it's not an issue over the word "entity" vs. "agency", a difference that in practice would probably make no difference, economically speaking. Addendum #2, Nov. 8, 2011: After re-reading all of this, it seems the issue at question in the National Academies press release above is "regulation" vs. "investigating and monitoring." That apparently being the case, let me state again that I have problems with the fact that the recommendations seem to preclude true regulation that should start ASAP, not at the whim of the Secretary of HHS when he/she decides that "adequate safety progress has not been made." That represents, in my opinion, a special accommodation to the healthcare IT industry as previously mentioned. In fact, Dr. Cook had a dissenting recommendation in Appendix E of the report that I agree with: <blockquote> Recommendation 9: The Secretary of Health and Human Services should direct the FDA to exercise its authority to regulate health IT, including all EHRs and associated components, and health information exchanges, as Class III medical devices. [Under the 1976 Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act - ed.]</blockquote> -- SS [Note] Regarding the IOM, my presenting in person the events that led to my relative's travails was rejected on the basis of 'protocol.' Despite the remarkable aspect of a physician/Medical Informatics specialist's relative (in fact, a specialist writing on health IT risks for over a decade) being gravely injured as a result of health IT-related disruption of care continuity, despite support for my personal attestation by internal members of the study group, my live testimony was rejected. Considering the issues were not just relevant to the IOM study, but at its heart, the rejection on procedural grounds brings to mind the <a href="http://en.wikipedia.org/wiki/Three_wise_monkeys">simian adage</a> "see no evil, hear no evil, speak no evil." The Institute of Medicine, on matters of life and death, acted more as an "Institute of Protocol" (or perhaps "Institute of Politics") in my opinion than an institute of science. I believe this lessens the credibility of their action agenda.

IOM Report - "Health IT and Patient Safety: Building Safer Systems for Better Care" - Nix the FDA; Create a New Toothless Agency

[Authors' note: This major part of this post was written before I had the actual IOM report itself. Having now read that report, avail...

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Lifespan (Rhode Island): Yet another health IT "glitch" affecting thousands - that, of course, caused no patient harm that they know of - yet

There's been yet another health IT "glitch" that, of course, caused no patients to be harmed. See other "glitches" <a href="http://hcrenewal.blogspot.com/2011/05/twelve-hour-health-it-glitch-at.html" style="font-weight: bold;">here</a>, <a href="http://hcrenewal.blogspot.com/2011/01/orderless-in-seattle-software-glitch.html" style="font-weight: bold;">here</a>, <a href="http://hcrenewal.blogspot.com/2010/03/will-it-take-luminosity-of-dozen.html" style="font-weight: bold;">here</a> and at other posts which can be found by searching this blog on the banal term 'glitch'. I note that when a clinician makes a mistake, it's called "malpractice." When health IT causes errors that can injure or kill, it's commonly referred with the banal, now-standard euphemism for computing malpractice: <div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjivTnAMIjZskLX87kQCR-LOWelEzDEUzupVGbOaKKCNKfoQe3kVzfxxERhVQOn9TIenOfKan-gR82Ogh9aqBulFgBlwHxLj2qCFmPiVm2j7sRFcyZRcO8vEFZfhsbqSGkn4802s3h9mfDF/s1600/glitch-mmo.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5671179020595590226" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjivTnAMIjZskLX87kQCR-LOWelEzDEUzupVGbOaKKCNKfoQe3kVzfxxERhVQOn9TIenOfKan-gR82Ogh9aqBulFgBlwHxLj2qCFmPiVm2j7sRFcyZRcO8vEFZfhsbqSGkn4802s3h9mfDF/s320/glitch-mmo.jpg" style="cursor: pointer; display: block; height: 90px; margin: 0px auto 10px; text-align: center; width: 180px;" /></a></div> Presenting the latest healthcare IT "glitch", affecting thousands: <blockquote><a href="http://www.wpri.com/dpp/news/local_news/providence/providence-rhode-island-state-senator-jamie-daniels-calls-for-review-of-lifespan-after-medical-errors">Computer glitch led patients to receive wrong meds</a> Senator calls for review of Lifespan WPRI.com (Providence, RI) Updated: Thursday, 03 Nov 2011, 5:47 AM EDT Published : Wednesday, 02 Nov 2011, 11:56 PM EDT Reported by Steve Nielsen PROVIDENCE, R.I. (WPRI) - Rhode Island State Senator Jamie Doyle says he is shocked to hear a <a href="http://www.lifespan.org/">Lifespan</a> computer glitch caused thousands of patients to receive the wrong types of medication. [Appx. 2,000 across five Lifespan hospitals according to the Providence Journal, see below, and the <a href="http://www.washingtonpost.com/business/ri-senator-wants-investigation-after-up-to-2000-hospital-patients-got-wrong-form-of-medicine/2011/11/03/gIQAufcviM_story.html">WaPo</a> - ed.] Doyle is now calling for an independent review of all the hospitals Lifespan runs, and a review of the Rhode Island Department of Health. The DOH is investigating after learning patients who were supposed to receive medications taken once a day instead received medications meant to be taken more than once per day.</blockquote> Health IT, of course, is unregulated by FDA or anyone, and vetted for safety only so far as the seller wishes to spend money on such tasks - which cuts their margins.  Ultimately, debugging is on live patients. <blockquote>[11/5/2011 note: As an anonymous commenter pointed out, the 2,000 or so errors at Lifespan should probably be multiplied by the number of organizations using the same software ---> "The entire country may have suffered 25,000-50,000 errors from this one glitch alone", the commenter astutely notes - ed.]</blockquote> Of course, the customary "we did feel lucky today, and the gun was empty" disclaimer follows: <blockquote>"Lifespan has not reported any adverse events or situations where patients required additional medications, but the information gathering and investigation is still ongoing," said DOH spokeswoman Annemarie Beardsworth.</blockquote> In other words, there could have been adverse events, we just at the Dept. of Health don't know yet with certainty, because none have been reported yet. <blockquote>In addition, some patients who were meant to get a medication with a coating did not receive a coating. The coating can help with stomach pains of other problems. "I just don't feel comfortable right now with some of the things that are coming out of there," Doyle said, "I really don't want to point fingers in any direction. but what we need to do is we need answers." Senator Doyle wants to have the review started in the next two to three weeks. </blockquote> Mr. Doyle, see my academic site on HIT failures <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/">here</a> and an account of repercussions <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=diary">here</a> from an EHR-related medication error. <blockquote> Lifespan released the following statement Wednesday: "Lifespan is actively contacting 2,000 patients affected by this issue to ensure they receive the correct form of their medications. So far, we have reached out to more than 90 percent of the patients, many of whom were already taking the correct medication." Lifespan expects to finish contacting patients by Thursday.</blockquote> It will be interesting to understand the nature of this particular "glitch" and who the software vendor is. All it takes is a single "glitch" to seriously reduce a patient's lifespan. Siemens software may be involved. See this mutually self promoting, marketing-style Siemens document "<a href="http://www.medical.siemens.com/siemens/en_US/gg_hs_FBAs/files/IT_Solutions_And_Consulting/New_2009/09-06-25_NewportHospita_CaseStudy_A9133-9564-C1-4A00.pdf">Newport Hospital - a Lifespan Partner - At the Forefront of EMR Adoption</a>" (PDF), also cached <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/NewportHospital_CaseStudy.pdf">here</a>. (As an aside, one wonders if the hospital and/or its leadership received special financial or other "incentives" in allowing their name to be used in corporate promotions.) Also, Siemens was a company that apparently did not listen to an internal informatics specialist physician's concerns that their health IT for critical care was endangering patients (<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=lawsuit">link</a>). They terminated the whistleblower. Also see my Aug. 2009 post "<a href="http://hcrenewal.blogspot.com/2009/08/why-siemens-healthcare-fails.html">Why Siemens Healthcare Fails"</a> which I had emailed at the time to the Siemens Healthcare CEO Hermann Requardt. -- SS Nov. 4, 2011 addendum: Felice Fryer of the Providence Journal sent me a link to the story of Nov. 3, 2011 she wrote with a few more details, <a href="http://digital.olivesoftware.com/Olive/ODE/ProJo/LandingPage/LandingPage.aspx?href=VFBKLzIwMTEvMTEvMDM.&pageno=MQ..&entity=QXIwMDEwNA..&view=ZW50aXR5">here</a>. Excerpts: <div class="InfoComponentTextHedLine_hl1"></div><blockquote><div class="InfoComponentTextHedLine_hl1">Flaw found in hospitals’ prescriptions </div><div class="InfoComponentTextHedLine_hl2">Some patients discharged from Lifespan hospitals got right drugs in wrong form due to software error </div> <div class="InfoComponentTextByline">By FELICE J. FREYER JOURNAL MEDICAL WRITER </div> Some 2,000 patients of the Lifespan hospital group were discharged with incorrect prescriptions over the past 9 to 15 months because of a software glitch. [It took a year or more to discover these mounting errors? This is beyond the "red flag" warning signs I used to write about. This is crossing the chasm into the territory of "asking for catastrophe" - ed.] The prescriptions listed the right medications, but in the wrong form: people who were supposed to get time-release pills received prescriptions for short-acting ones. The error affected dozens of generic medications for a variety of conditions. Lifespan discovered the problem on Oct. 25 and had fixed the software by Friday, according to Dr. Mary Reich Cooper, Lifespan’s senior vice president and chief quality officer. The hospitals have placed calls to nearly all the affected patients, although not all have called back, Cooper said. Most patients reached had already obtained the correct medication because the error was noticed by someone at the hospital, or a pharmacist or doctor outside, she said. So far, Cooper said, there is no evidence that anyone was harmed. But Dr. Michael D. Fine, state Health Department director, said that the incident is an example of how electronic medical records, which normally help reduce errors, can sometimes amplify them by quickly affecting large numbers of people. “It’s the flip side of what has otherwise been a process that has improved accuracy and reliability,” he said. [I don't notice mention of a "flip side" to health IT in the aforementioned glossy hospital/IT company marketing brochure - ed.] The Health Department is investigating the incident. Fine also plans to examine whether the department should regulate the safety of electronic systems in health care. [Readers of this blog know my opinion on that matter - ed.] Asked whether he was worried there may be other as-yet-unrecognized software glitches, Fine said, “I’m reasonably concerned about the accuracy and integrity of electronic medical records.”... The software in question is not in use at other hospitals in Rhode Island, and the software vendor, Siemens, is notifying hospitals elsewhere in the country, according to Cooper. [In the interests of public health, I believe it incumbent on Siemens to make this "glitch" widely known not just to the hospitals but to the public in areas served by those hospitals, especially with the admission that "the (RI) hospitals have placed calls to nearly all the affected patients, although not all have called back." To not do so reflects negligence in my opinion - ed.] ... The errors arose from the process known as “medication reconciliation,” in which the physician compares the medications a patient was taking before hospitalization with those prescribed during hospitalization, and ensures that the patient goes home with a correct set of prescriptions. The Lifespan hospitals recently adopted an electronic system for this process. Doctors were correctly prescribing medication, and the prescriptions looked right on the computer screen, Cooper explained. But when printing out the prescription list, the software was cutting off a two-letter abbreviation that indicated certain medications should be in long-acting form or coated to protect the stomach. [As at Case 9 from FDA's MAUDE database at the post "<a href="http://hcrenewal.blogspot.com/2009/10/out-policy-is-to-always-have-unabashed.html">Our Policy Is To Always Have Unabashed Faith In The Computer</a>". Do these vendors robustly validate their products? The current errors, in fact, were only peripherally related to medication reconciliation. They were primarily related to computer errors impairing (sabotaging?) the clinicians. It would seem med recon now needs to include comparing what the doctor enters to what is output to the nurses and other healthcare personnel who provide written instructions to patients. Is such a task performable by healthcare personnel when the computer cannot be trusted? Further, do the doctrine of the "learned intermediary" and "hold vendor harmless" clauses seem appropriate here? - ed.] ... Cooper said the risk of harm from taking a short-acting medication instead of a long-acting one was “very, very minimal.” [Cooper misses the point, and IMHO such nihilistic attitudes have no place in healthcare - ed.] But Fine, the health director, said such mistakes “can be scary.” People taking medication for angina or high blood pressure would find their medication wearing off over the course of the day, putting them at risk of heart attack or stroke, he said. </blockquote> Medical errors that might seem innocuous or minor to health IT amateurs can prove catastrophic.  I've seen it happen, leading to injury and death. -- SS

Lifespan (Rhode Island): Yet another health IT "glitch" affecting thousands - that, of course, caused no patient harm that they know of - yet

There's been yet another health IT "glitch" that, of course, caused no patients to be harmed. See other "glitches"...

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Health Care Also Needs to Challenge "Crony Capitalism," the "New Gilded Age, and "the Idolatry of the Market"

The increasing size and scope of the "Occupy Wall Street" movement, and continuing instability in the finance system, most recently due to the threatened default of Greece, and resulting problems with the Euro, and now the bankruptcy of yet another prominent financial firm, MF Global, has lead to renewed discussion of what has gone wrong with the greater political economy. As I have perused some of it, I noted distinct parallels with the some of the discussion we have had about what has gone wrong with health care.  In fact, at the root of health care dysfunction appear to be the dysfunction of the greater political economy. Few in the One Percent Deserved the Money A dominant slogan of the "Occupy" movement is "we are the 99 percent," that is <blockquote>'We are the 99 percent,' is the continuing chant of the protesters, who are now in their seventh week of marching through the streets of Manhattan. And, surprisingly, they have hit upon the crux of America's problems with precisely this sentence. Indeed, they have given shape to a development in the country that has been growing more acute for decades, one that numerous academics and experts have tried to analyze elsewhere in lengthy books and essays. It's a development so profound and revolutionary that it has shaken the world's most powerful nation to its core. Inequality in America is greater than it has been in almost a century. Those fortunate enough to belong to the 1 percent, made up of the super-rich, stand on one side of the divide; the remaining 99 percent on the other. Even for a country that has always accepted opposite extremes as part of its identity, the chasm has simply grown too vast.</blockquote>[Schulz T] The One Percent are Mostly Salaried Corporate Executives Contrary to some propaganda, many in the one percent are not entrepreneurs, but corporate employees, albeit special ones. <blockquote>Also cited as factors contributing to the rapid growth of income at the top were the structure of executive compensation....</blockquote>[Pear R] In Health Care - We have frequently discussed the outsized compensation given to a few top executives. CEOs of for-profit health care corporations may make tens of millions of dollars a year (<a href="http://hcrenewal.blogspot.com/2011/10/peer-benchmarking-lake-wobegone-effect.html">here</a> is a recent example, and many similar stories can be found <a href="http://hcrenewal.blogspot.com/search/label/executive%20compensation">here</a>.) Even CEOs of non-profit hospital systems can make millions of dollars a year. (See <a href="http://hcrenewal.blogspot.com/2011/09/highly-paid-skilled-executives-and.html">this recent example</a>, then go <a href="http://hcrenewal.blogspot.com/search/label/executive%20compensation">here</a> for more.) Thus, a fair number of the one percent are likely to be from health care, and most of those at the top are likely to be current or former top hired executives. The One Percent's Wealth May be More Due to Luck than Skill, Intelligence, or Creativity According to a recent simulation study, <blockquote>by the 'inexorable effect of chance,' and chance alone, 'a small proportion of entrepreneurs come to possess essentially all of the wealth. ... The concentration of wealth occurs merely because some individuals are lucky by randomly receiving a series of high growth rates, and once they are ahead with exponentially growing capital, they tend to stay ahead.' According to Fargione, greater variation in rates of return hastened the concentration of wealth. Inequality grows with time. Wealth concentration continues despite periods of recession and depression.</blockquote>[Breining G] In Health Care-No similar study has been done in health care. However, we have documented many cases in which top health care executives' compensation seemed to have nothing to do with their skill, originality, or ability to uphold the health care mission. How "peer benchmarking," and the "Lake Woebegone Effect" account for immense compensation despite bad results was discussed <a href="http://hcrenewal.blogspot.com/2011/10/peer-benchmarking-lake-wobegone-effect.html">here</a>. A recent series of cases (with links to others) of hospital CEOs who prospered while their institutions' finances decayed was <a href="http://hcrenewal.blogspot.com/2011/08/more-executives-prospering-despite.html">here</a>. The One Percent Gamed the System, and Personally Profited from Perverse Incentives <blockquote>Most fundamentally, what protest groups on the left and the right share with less activist middle-class Americans -- the apolitical voters who often decide elections -- is an abiding sense that the bond between work and reward has been broken. Huge financial rewards are given to executives who fail miserably and get fired. Debt relief programs help not only those who have fallen behind through no fault of their own, but also the profligate who lived beyond their means. The list goes on: What’s inflaming voters isn’t so much inequality per se, though that’s certainly a symptom of the problem. It’s the fact that the rewards in our economic system seem increasingly divorced from American values of hard work, risk taking and innovation. Instead, these benefits are more and more likely to be awarded on the basis of connections and political power. </blockquote>[Klain R] In Health Care-We have seen not merely cases of top health care leaders paid a lot of money for mediocre financial results. We have seen cases in which leaders got outsize pay despite evidence of organizational misconduct, or even crime. For example, see posts <a href="http://hcrenewal.blogspot.com/2011/09/johnson-and-johnson-pleads-guilty.html">here</a>, <a href="http://hcrenewal.blogspot.com/2011/08/why-cultivate-weldons-confidence-ceo.html">here</a> and <a href="http://hcrenewal.blogspot.com/2011/03/despite-recalls-legal-settlements.html">here</a> that contrast one company's multiple legal settlements and guilty pleas and its CEO's eight-figure compensation. The One Percent Deny Accountablity While Blaming Others for the Problems They Produce Based on a as yet unpublished survey of top finance leaders in London, its leader, Rev Andrew Studdert-Kennedy, <blockquote>said he had been 'astonished' by the attitudes of some City workers displayed towards the financial crisis. He said, 'I did speak to many people about morality. I was amazed by how many banking crises there had been and how sanguine people were about them. A number of people said 'this is just what happens - it's the nature of banking, it's the nature of capitalism.' 'It's one thing having historical perspective, but I was astonished that people didn't try to learn a bit more. There is a recognition that there is something wrong, but a reluctance to admit they are part of the problem.'</blockquote>[Brady et al] In addition, <blockquote>Talk to most bank executives and they’ll still place the blame for the 2008 financial crisis on 'irresponsible consumers' who took out mortgages they couldn’t afford; dishonest mortgage brokers; and—at the top of the list—the government, which used Fannie Mae and Freddie Mac to finance mortgage lending to 'people who shouldn’t own homes,' as one senior New York bank executive put it to me recently. All of which is partly true but omits the enthusiasm with which Wall Street feasted on that market, and the fact, as Warren puts it, 'that Wall Street made tens of billions of dollars' from it. In short, there is no remorse, let alone a sense of obligation, because bank executives generally do not believe they were the cause of the financial collapse. As Neil Barofsky, Treasury’s former inspector general charged with oversight of TARP, the $700 billion government bailout of the banks, recalls from his interviews with bankers, the attitude instead was that 'shit happens.' The state of denial has been massive. On Wall Street today, says the vice-chairman of a private-equity firm, 'there is this enormous persecution complex in the banking industry about Dodd-Frank, that everyone is going after the banks.'</blockquote>[Andrews S] In Health Care-Health care leaders and their apologists sometimes cite their awesome responsibility as a rationale for their outrageous compensation. Yet while health care leaders often decry the state of the health care system, I have yet to hear one take any responsibility for what has gone wrong. Meanwhile, Wendell Potter has described how the leaders of one part of health care, health insurance and managed care, set up elaborate but stealthy public relations campaigns to blame the problems of health care mainly on patients and doctors, but certainly not the health insurance or managed care (see post <a href="http://hcrenewal.blogspot.com/2011/03/millions-to-health-insurance-ceos-but.html">here</a>). This echoes how top finance leaders blame their industry's problems on feckless consumers. The One Percent are Not Held Accountable, and Have De Facto Impunity <blockquote>So, yes, we face a threat to our capitalist system. But it’s not coming from half-naked anarchists manning the barricades at Occupy Wall Street protests. Rather, it comes from pinstriped apologists for a financial system that glides along without enough of the discipline of failure and that produces soaring inequality, socialist bank bailouts and unaccountable executives. </blockquote>[Kristof ND] <blockquote>In our article in the last issue,1 we showed that, contrary to the claims of some analysts, the federally regulated mortgage agencies, Fannie Mae and Freddie Mac, were not central causes of the crisis. Rather, private financial firms on Wall Street and around the country unambiguously and overwhelmingly created the conditions that led to catastrophe. The risk of losses from the loans and mortgages these firms routinely bought and sold, particularly the subprime mortgages sold to low-income borrowers with poor credit, was significantly greater than regulators realized and was often hidden from investors. Wall Street bankers made personal fortunes all the while, in substantial part based on profits from selling the same subprime mortgages in repackaged securities to investors throughout the world. Yet thus far, federal agencies have launched few serious lawsuits against the major financial firms that participated in the collapse, and not a single criminal charge has been filed against anyone at a major bank. The federal government has been far more active in rescuing bankers than prosecuting them.</blockquote>[Madrick J et al] In Health Care-We have gone on endlessly how despite numerous examples of unethical or even criminal behavior by health care organizations, almost never has any individual who authorized, directed or implemented the bad behavior suffered any negative consequences. (Look <a href="http://hcrenewal.blogspot.com/search/label/crime">here</a> and <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">here</a>.) The One Percent Have Captured Government The most important reason for the unaccountability of the one percent is regulatory capture, leading to corporatism: <blockquote>much as the economic giants of the Gilded Age developed such enormous influence that they could dictate basic political conditions, today's Wall Street bosses and CEOs have successfully arranged extensive deregulation for their industries. Indeed, he argues that this is the only thing that can explain how hedge fund managers suddenly started making billions of dollars a year. Former Citigroup CEO Sanford Weill, for example, kept a framed pen in his office as a symbol of his influence. It was the pen President Bill Clinton -- at Weill's instigation -- used in 1999 to sign into law legislation repealing the provisions in the Glass-Steagall Act of 1933 that separated the transactions of investment and commercial banks. At the same time, Bartels writes, the wealthy receive enormous tax breaks worth hundreds of billions of dollars. </blockquote>[Schulz T] In Health Care- We have discussed <a href="http://hcrenewal.blogspot.com/search/label/regulatory%20capture">regulatory capture</a>, <a href="http://hcrenewal.blogspot.com/search/label/embedded%20networks%20of%20influence">embedded networks of influence</a>, and <a href="http://hcrenewal.blogspot.com/search/label/corporatism">corporatism</a> in health care. Summary The articles I summarized above called for the need to "save capitalism from crony capitalists," [Kristof ND], and to seize "the high political ground" by "reform that lessens the influence of money in politics and government," and to strengthen "the bonds between work and reward," [Klain], and to end the impunity of the wealthy [Madrick et al]. A Vatican Council has <a href="http://www.zenit.org/article-33718?l=english">called</a> for the end of the "idolatry of the market," the "ethic of solidarity," and the "primacy of the spiritual and the ethical," and of "politics - which is responsible for the common good - over the economy and finance." This has also been supported by the Archbishop Of Canterbury. In parallel, as we have said again and again, true health care reform requires competent, ethical leadership that upholds health care's core values within a governance structure of accountability, integrity, transparency, and honesty. Tackling the deep problems in health care will require tackling the deeper problems in the global political economy which helped to generate them. References Andrews S. The woman who knew too much. Vanity Fair, November, 2011. Link <a href="http://www.vanityfair.com/politics/features/2011/11/elizabeth-warren-201111">here</a>. Brady B, Merrick J. Exclusive: cover-up at St Paul's. The Independent, Oct 30, 2011. Link <a href="http://www.independent.co.uk/news/uk/home-news/exclusive-coverup-at-st-pauls-2377923.html">here</a>. Breining G. The 1 percent: how lucy they are. Minneapolis Star-Tribune, Oct 29, 2011. Link <a href="http://www.startribune.com/opinion/132819963.html">here</a>. Klain R. Americans want a government that ties rewards to work. Bloomberg, Oct 31, 2011. Link <a href="http://www.bloomberg.com/news/2011-10-31/americans-want-a-government-that-ties-rewards-to-work-ron-klain.html">here</a>. Kristof ND. Crony capitalism comes home. NY Times, Oct 28, 2011. Link <a href="http://www.nytimes.com/2011/10/27/opinion/kristof-crony-capitalism-comes-homes.html">here</a>. Madrick J, Portnoy F. Should some bankers be prosecuted? NY Review of Books, November 10, 2011. Link <a href="http://www.nybooks.com/articles/archives/2011/nov/10/should-some-bankers-be-prosecuted/">here</a>. Pear R. Top earners doubled share of nation's income, study finds. NY Times, Oct 25, 2011. Link <a href="http://www.nytimes.com/2011/10/26/us/politics/top-earners-doubled-share-of-nations-income-cbo-says.html">here</a>. Schulz T. The second gilded age: has America become an oligarchy? Spiegel Online, Oct 28, 2011. Link <a href="http://www.spiegel.de/international/spiegel/0,1518,793896,00.html">here</a>.

Health Care Also Needs to Challenge "Crony Capitalism," the "New Gilded Age, and "the Idolatry of the Market"

The increasing size and scope of the "Occupy Wall Street" movement, and continuing instability in the finance system, most recentl...

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If a Medical School is Just Part of the "Biomedical Industry," Who Will Do Medical Education?

A little while ago, we <a href="http://hcrenewal.blogspot.com/2011/09/director-of-bristol-myers-squibb-to-run.html">discussed</a> questions raised by the pre-existing financial relationships of Dr Laurie Glimcher, the new incoming Dean of Weill Cornell Medical School. Dr Glimcher is also the longest serving director of Bristol-Myers-Squibb, and has a number of other financial relationships with drug and device companies. A new interview with Dr Glimcher suggested that what is most interesting about the coverage of her ascension to the Cornell Deanship is what it did not mention, especially whether she has any goals other than promote relationships with and do product development for corporate health care. So let me review what has been made public about the interests and goals of Weill Cornell Medical College's new Dean. The New York Times: To Develop "Research Capacity" and a "New High-Tech Campus" The New York Times <a href="http://www.nytimes.com/2011/09/08/nyregion/laurie-h-glimcher-named-dean-of-weill-cornell-medical-college.html">article</a> focused on the new Dean's conflicts of interests, but found no doubts about these conflicts among the university leadership to whom the new Dean would report. Instead, <blockquote>Cornell University’s president, Dr. David J. Skorton, said he believed Dr. Glimcher had the skills to carry out the medical school’s plan to double its research capacity and to help the university compete to develop a new high-tech campus proposed by the Bloomberg administration.</blockquote> However, while it emphasized how university leaders defended Dr Glimcher's conflicts of interest, the New York Times article said nothing about the university leadership's educational or clinical expectations for Dr Glimcher. The Cornell Sun: To "Strengthen its Relationship with Biotechnology and Pharmaceutical Companies" Similarly, <a href="http://cornellsun.com/section/news/content/2011/09/08/glimcher-chosen-new-dean-cornell-medical-college">according to </a>the Cornell Daily Sun, the university leadership regarded the new Dean's relationships with industry as strengths, not weaknesses, <blockquote>As the longest-standing member of the corporate board of biopharmaceutical company Bristol-Myers Squibb, [Dr Laurie] Glimcher has 'extensive experience' in corporate finance, governance and management, according to a University press release. </blockquote> So, <blockquote>Under Glimcher’s leadership, Weill hopes to strengthen its relationship with biotechnology and pharmaceutical companies, develop innovative cures and bolster research, the University stated.</blockquote> The Sun did briefly note, <blockquote>In a press release, [Cornell University President David J] Skorton said he was 'honored and delighted' that Glimcher accepted the position. 'Her passion for accomplishment and her many research and clinical strengths make her ideally suited to build on Tony Gotto’s strong foundation and lead Weill Cornell’s bright future in clinical care, education and translational research,' Skorton said.</blockquote> However, there were no further details about what Dr Glimcher would do for clinical care or education. The Cornell Press Release: To Achieve "Preeminence in the Biomedical Sciences" This <a href="http://www.pressoffice.cornell.edu/presskits/New-WCMC-dean.cfm">press release </a>emphasized Dr Glimcher's corporate skills even more than did the Times or Sun articles, <blockquote>Her service with the biopharmaceutical company Bristol-Myers Squibb, where she is the longest-standing member of the corporate board of directors and of its audit committee, has afforded her extensive experience in management oversight, corporate governance, corporate finance, accountability, leadership and the practical aspects of running a business and bringing therapeutics to the marketplace. 'This is great news for the medical school and for the city,' said Sanford I. Weill, chairman of the medical college's board of overseers and a member of the board of trustees of Cornell University. 'With her thorough appreciation of the management and financial challenges of complex organizations, I am confident she will lead the college with the same creativity and acumen she demonstrated when she pioneered the establishment of Bristol-Myers' science and technology committee, which is widely credited for transforming its stake in research. With a state-of-the-art biomedical research facility under construction and Dr. Glimcher at the helm, Weill Cornell and New York are on course to achieve a preeminence in the biomedical sciences that has already been achieved in clinical medicine and first-rate medical education.' </blockquote> However, it said nothing substantive about Dr Glimcher's educational or clinical goals or interests. (Perhaps, because Mr Weill thought that the school had already achieved preeminence in these areas, he also thought no further goals in these areas are needed.) Crain's New York Business: "Critical that the Pharmaceutical Industry has Input from the Biomedical Industry" Now Crain's New York Business just published <a href="http://www.crainsnewyork.com/article/20111030/SUB/310309989">an interview</a> with Dr Laurie Glimcher, the Dean to be of the Weill Cornell Medical College with a singular emphasis.  It introduced Dr Glimcher thus, <blockquote>She is the longest-serving member of the board at Bristol-Myers Squibb and has been a big earner from her work with drug companies. Snaring Dr. Glimcher is a coup for Cornell University, which is using her status to bolster its proposal to build a science and engineering campus on Roosevelt Island.</blockquote> The interviewer asked, can New York become "a more competitive research hub?"  Dr Glimcher opined, <blockquote>I think New York City is going to be the next greatest center for biomedical research.</blockquote> Then, with an instructive tilt, why are you so comfortable taking research funding from drug makers?  Her answer included the usual rationale, but with a twist: <blockquote>I think it's critical that the pharmaceutical industry has input from the biomedical industry. I believe it is essential to have partnerships to accomplish our goals.</blockquote>The implication, and the twist is that she apparently sees herself as leading not a medical college, but an entity within the "biomedical industry." The next question was, does this mean that more collaboration with drug companies are ahead for Weill Cornell?  Her answer was no surprise, <blockquote>Harvard probably has more ties to pharmaceutical companies than Weill Cornell, but Weill Cornell definitely has connections that I hope we can leverage.</blockquote> At this point, it should be no surprise that this interview of this erstwhile leader of "biomedical industry" mentioned nothing substantive about clinical care or medical education. Summary: Education and Patient Care Disappear into the Maw of the "Biomedical Industry" In summary, so far, all the hoopla about the new Dean of Weill Cornell Medical College has been about her anticipated ability to align the school with the pharmaceutical and biotechnology industry. Amidst the hoopla, neither the new Dean nor anyone within the Cornell leadership has said anything about her interests, goals, or positions relevant to education or clinical care. Yet education is the most fundamental mission of a medical school and of academic medicine. Instead, on one occasion, the new Dean suggested that she would be leading not a medical school, but part of the "biomedical industry." So it appears that the brave new version of the Weill Cornell Medical College is not merely more focused on doing product development for industry than on its traditional mission of education, research more broadly defined, (e.g., which also may include basic biomedical research, clinical research, and epidemiological and public health research), and patient care. It appears that applied research for product development has become its only important goal. How else should one interpret what the new Dean and her supervisors have said? Not one of them has said anything about education or patient care other than to acknowledge that these endeavors exist.  (Also, not one of them discussed the other kinds of research that medical schools and academic medical centers have traditionally done.) If Cornell's Board Chairman, President, and Medical College Dean are only interested in being part of the "biomedical industry," why should anyone want to attend what is still called their "Medical College?" Why should anyone want to serve as a house officer in one of the "Medical College's" hospitals? Why should anyone want to attend one of the "Medical College's" continuing medical education courses? If Cornell's Board Chairman, President, and Medical College Dean are only interested in being part of the "biomedical industry," that is, doing applied research for product development, why would any patient want to go to their hospital,s clinics, and other facilities? We now see not merely academic medical leadership chosen because of, not despite their conflicts of interest with health care corporations. We now also see academic medical leadership who appear only interested in corporate product development, and not even interested in talking about education or patient care (or traditional biomedical, clinical, and epidemiological research.) Of course, all this discussion is based only what has been published so far about the new leadership of Weill Cornell. Maybe the publications have been woefully incomplete and full of errors. I eagerly hope that to be the case (nooffense intended to the journalists involved.) But I fear that we are seeing the final common pathway for the corporate academic medical center, its transformation into the "Biomedical Industry." If academic medical leaders no longer care about education or patient care, the downward spiral of our health care system has only just begun.

If a Medical School is Just Part of the "Biomedical Industry," Who Will Do Medical Education?

A little while ago, we discussed questions raised by the pre-existing financial relationships of Dr Laurie Glimcher, the new incoming Dean ...

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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 ...

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Cybernetik Über Alles: Computers Have More Rights Than Patients?

<div style="text-align: center;">[Note: this essay contains many hyperlinks. They can be right-clicked and opened in a separate tab or window.]</div> What medical devices are shielded from liability? Are there other examples of legislation seeking legal protections for wide-scale use of medical devices that even the device's trade group leadership admits are <a href="http://hcrenewal.blogspot.com/2010/07/barry-chaiken-md-mph-lets-be-patient.html">not ready, and are experimental</a>? Here we have a proposal from a member of the U.S. Congress to shield health IT software, a medical device (per <a href="http://hcrenewal.blogspot.com/2011/04/fda-decides-regulating-implantable.html">FDA's Director of CDRH - the Center for Device and Radiological Health</a> and <a href="http://hcrenewal.blogspot.com/2009/06/improving-patient-safety-in-eu-hit.html">others</a>), and its users from liability through an apparently unique special accommodation. This from iHealthBeat.org: <div class="date"></div><blockquote><div class="date">Thursday, October 27, 2011 </div><div class="date"><a href="http://www.ihealthbeat.org/articles/2011/10/27/bill-would-establish-new-legal-protections-for-ehr-adopters.aspx">Bill Would Establish New Legal Protections for EHR Adopter</a><a href="http://www.ihealthbeat.org/articles/2011/10/27/bill-would-establish-new-legal-protections-for-ehr-adopters.aspx">s</a></div>On Wednesday, Rep. Tom Marino (R-Penn.) introduced legislation (<a href="http://thomas.loc.gov/cgi-bin/bdquery/z?d112:h.r.3239:" target="_blank">HR 3239</a>) that would create certain legal protections for Medicare and Medicaid providers who have implemented electronic health record systems, the <a href="http://www.timesleader.com/news/Marino__Bill_offers_safeguards_for_electronic_records_10-26-2011.html" target="_blank">Wilkes-Barre Times Leader</a> reports. The bill -- called the Safeguarding Access for Every Medicare Patient Act -- would create a system for reporting potential medical errors that occur when using EHRs, but it would not allow such information to be used as legal admission of wrongdoing. The bill would cover certain physicians and hospitals that serve Medicare and Medicaid beneficiaries. It also would cover participants and users of health information exchanges. Marino, who is a member of the House Judiciary Committee, said that offering the new legal protections to health care providers would promote greater use of EHRs and encourage Medicare and Medicaid providers to continue serving beneficiaries. [As if they could not do so without EHR's? - ed.] He said, "Many providers are reluctant to use [EHRs] because they believe the practice will make them more vulnerable to unnecessary legal action," [unnecessary? How about real and necessary, as per the White Paper <a href="http://www.acgroup.org/images/2011_White_Paper_-_Do_EHRs_Increase_Liability.pdf">Do EHR's Increase Liability</a><a href="http://www.acgroup.org/images/2011_White_Paper_-_Do_EHRs_Increase_Liability.pdf">?</a> - ed] adding, "This [bill] protects access for seniors in the Medicare and Medicaid programs" (Riskind, Wilkes-Barre Times Leader, 10/27). <div id="articlebody"></div></blockquote><div id="articlebody"></div> From Rep. Marino's <a href="http://marino.house.gov/press-release/bill-would-protect-access-medicare">website</a> (my comments are in [bracketed red italics]): <blockquote><div align="center">Marino Introduces Safeguarding Access For Every Medicare Patient Act</div><div align="center">FOR IMMEDIATE RELEASE Oct. 26, 2011 </div>WASHINGTON -- U.S. Rep. Tom Marino, PA-10, has introduced legislation that offers limited legal protection to Medicare and Medicaid providers who use electronic records. [Which, I fear, could effectively act as, or mutate into, absolute protection in the environs of the legal system - ed.] HR3239, the Safeguarding Access For Every Medicare Patient Act, would ensure patient access to Medicare and Medicaid providers; reduce health care costs [really? That's not what <a href="http://hcrenewal.blogspot.com/2009/06/wharton-on-healthcare-it-can-i-go-home.html">Wharton</a> and <a href="http://hcrenewal.blogspot.com/2010/03/hospitals-under-knife-sacrificing.html">others</a> write - ed.]; guarantee incentives to providers to remain in the Medicare and Medicaid programs; and promote participation in health information technology. Providers will eventually be required to participate in electronic recordkeeping or face a reduction in payments. Marino said the bill offers incentive in the form of legal protection to providers who may be reluctant to remain in the Medicare and Medicaid programs due to low reimbursement rates which are constantly being targeted for further reductions. [I imagine the known risks of health IT such as these at "<a href="http://hcrenewal.blogspot.com/2011/01/maude-and-hit-risk-mother-mary-what-in.html">MAUDE and HIT Risks: What in God's Name is Going on Here?</a>" are a minor consideration if you receive legal immunity - ed.] HR3239 would create a system for reporting potential errors that occur when using electronic records without the threat of that information being used as an admission of guilt. [Even if the physician or nurse is guilty of EHR-caused or aggravated, i.e., "<a href="http://hcrenewal.blogspot.com/2011/10/nist-on-ehr-mission-hostile-user.html">use error</a>" per NIST, malpractice - ed.] It also prevents electronic records from being used as an easy source for “fishing expeditions,’’ [like <a href="http://hcrenewal.blogspot.com/2011/09/sweet-death-that-wasnt-very-sweet-how_24.html">this case</a>, <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=diary">this case</a>, <a href="http://hcrenewal.blogspot.com/2010/07/maude-database-patient-outcome-death.html">this case</a> and <a href="http://hcrenewal.blogspot.com/2011/03/thanks-to-wonders-of-ehr-this-premature.html">this case</a> where patients died? - ed.] while making sure that parties responsible for errors are held accountable [how? -ed]. The proposal allows for providers who use electronic records to take remedial measures without having those actions be used to establish guilt [even though remediation may be very relevant to malpractice, patient injury and death prior to the remediation, and the remediation is informed by the error - ed.]; places time limits on the filing of lawsuits; and offers protection against libel and slander lawsuits. [If this provision were to allow clinicians to speak publicly about HIT flaws without legal retaliation or <a href="http://www.aapsonline.org/peerreview/epidemic.php">sham peer review</a>, I'd be all for it - ed.] “Many providers are reluctant to use electronic records because they believe the practice will make them more vulnerable to unnecessary legal action,” Marino said. [I think it's much more likely they are reluctant to use them due to the aforementioned hair-raising MAUDE reports and literature such as <a href="http://hcrenewal.blogspot.com/2011/02/updated-reading-list-on-health-it.html">here</a>, <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=2009">here</a> and <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=other">here</a> - ed.] and “Every time a doctor or hospital chooses not to participate because of these fears, our seniors lose another provider. This protects access for seniors in the Medicare and Medicaid programs.” Marino said HR3239 is a two-pronged attack against rising health care costs: It provides legal protection to providers while encouraging the use of health information technology which has been shown to reduce costs. [See above links on that issue - ed.] “Best of all, passage of this bill would require no new spending,” Marino said. [Besides the hundreds of billions to be spent on the IT itself - ed.]</blockquote> This sounds like a healthcare IT vendor marketing piece, with claims refuted repeatedly here at HC Renewal, usually via the biomedical literature. It's slick, purporting to "protect Medicare access" while actually promoting health IT sales. Did Rep. Marino get snowed by the health IT lobby? (See "<a href="http://www.washingtonpost.com/wp-dyn/content/article/2009/05/15/AR2009051503667.html?hpid=topnews">The Machinery Behind Healthcare Reform</a>" in the Washington Post.) A major question is: What are the patients and their rights to redress for injuries that occur due to EHR's? Chopped liver? Isn't this bill really saying that patients are experimental subjects with limited rights? In other words, that improving EHR's should be at the expense of the unfortunate patients treated under its auspices? That the computers have more rights than the patients? That line of thinking about what in reality is unconsented medical experimentation (i.e., "First, let's experiment" as opposed to "First, do no harm") has led to some very dark places in medicine, and not just in ancient history (e.g., see "<a href="http://hcrenewal.blogspot.com/2011/09/bioethics-panel-blasts-late-u.html">Bioethics panel blasts late U. Pittsburgh professor</a>"). See <a href="http://hcrenewal.blogspot.com/2011/02/updated-reading-list-on-health-it.html">this reading list</a> for more on these issues. Also see the many other posts on this blog about health IT quality, usability, efficacy, risk (and that the levels of that risk are admittedly unknown), lack of informed consent, and other issues via query links such as <a href="http://hcrenewal.blogspot.com/search/label/healthcare%20IT%20dangers" style="font-weight: bold;">here</a>, <a href="http://hcrenewal.blogspot.com/search/label/Healthcare%20IT%20experiment" style="font-weight: bold;">here</a>, <a href="http://hcrenewal.blogspot.com/search/label/Healthcare%20IT%20failure" style="font-weight: bold;">here</a> and <a href="http://hcrenewal.blogspot.com/search/label/healthcare%20IT%20defects" style="font-weight: bold;">here</a> - and the hyperlinks within those lists of posts - to more fully understand this perspective. The text of the proposed legislation is <a href="http://thomas.loc.gov/cgi-bin/query/z?c112:H.R.3239:">here</a>. While not all bad, it raises a number of concerns. Excerpts are as follows: <h3></h3><blockquote><h3 style="font-weight: normal;">H. R. 3239</h3><h3 style="font-weight: normal;">To provide certain legal safe harbors to Medicare and Medicaid providers who participate in the EHR meaningful use program or otherwise demonstrate use of certified health information technology.</h3><h3>... SEC. 4. RULES RELATING TO E-DISCOVERY.</h3><ul> In any health care lawsuit against a covered entity that is related to an EHR-related adverse event, with respect to certified EHR technology used or provided by the covered entity, electronic discovery shall be limited to--</ul> <ul><ul>[I'm not sure what "certification" has to do with litigation, since "certification" of health IT has nothing to do with safety or usability; see note below - ed.] (1) information that is related to [what does that mean? - ed.] such EHR-related adverse event; and</ul></ul><ul><ul> (2) information from the period in which such EHR-related adverse event occurred. [eDiscovery related to EHR-related adverse events is already difficult, e.g., obtaining complete metadata. What these provisions would do is likely to increase the complications through legal maneuvers on terms such as"related to", "period" etc. - ed.]</ul></ul><h3>SEC. 5. LEGAL PROTECTIONS FOR COVERED ENTITIES.</h3><ul> (a) General- For a covered entity described in section 2, the following protections apply:</ul><ul><ul> (1) ENCOURAGING SPEEDY RESOLUTION OF CLAIMS-</ul></ul><ul><ul><ul> (A) GENERAL- A claimant may not commence a health care lawsuit against a covered entity on any date that is 3 years after the date of manifestation of injury or 1 year after the claimant discovers, or through the use of reasonable diligence should have discovered, the injury, whichever occurs first. This limitation shall be tolled to the extent that the claimant is able to prove--</ul></ul></ul><ul><ul><ul><ul> (i) fraud;</ul></ul></ul></ul><ul><ul><ul><ul> (ii) intentional concealment; or</ul></ul></ul></ul><ul><ul><ul><ul> (iii) the presence of a foreign body, which has no therapeutic or diagnostic purpose or effect, in the person of the injured person.</ul></ul></ul></ul><ul><ul> ... (2) EQUITABLE ASSIGNMENT OF RESPONSIBILITY- In any health care lawsuit against a covered entity--</ul></ul><ul><ul><ul> (A) each party to the lawsuit other than the claimant that is such a covered entity shall be liable for that party's several share of any damages only and not for the share of any other person and such several share shall be in direct proportion to that party's proportion of responsibility for the injury, as determined under clause (iii);</ul></ul></ul><ul><ul><ul> (B) whenever a judgment of liability is rendered as to any such party, a separate judgment shall be rendered against each such party for the amount allocated to such party [does that include the IT vendor? - ed.] ; and</ul></ul></ul><ul><ul><ul> (C) for purposes of this paragraph, the trier of fact shall determine the proportion of responsibility of each such party for the claimant's harm.</ul></ul></ul><ul><ul> (3) SUBSEQUENT REMEDIAL MEASURES- Evidence of subsequent remedial measures to an EHR-related adverse event with respect to certified EHR technology used or provided by the covered entity (including changes to the certified EHR system, additional training requirements, or changes to standard operating procedures) by a covered entity shall not be admissible in health care lawsuits. [This in and of itself seems to give special accommodation to health IT, since remediation helps make the case for the presence of problems to begin with - ed.]</ul></ul><ul><ul> (4) INCREASED BURDEN OF PROOF PROTECTION FOR COVERED ENTITIES- Punitive damages may, if otherwise permitted by applicable State or Federal law, be awarded against any covered entity in a health care lawsuit only if it is proven by clear and convincing evidence that such entity acted with reckless disregard for the health or safety of the claimant. In any such health care lawsuit where no judgment for compensatory damages is rendered against such entity, no punitive damages may be awarded with respect to the claim in such lawsuit. [Would that apply to a case such as <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=clinical%20computing%20problems%20in%20ICU">this?</a> Does it apply to the health IT vendors and their often cavalier software development and quality practices, if patients become injured, such as <a href="http://sydney.edu.au/engineering/it/%7Ehitru/index.php?option=com_content&task=view&id=91&Itemid=146">here</a>, "A Study of an Enterprise Health Information System?" How about to <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=lawsuit">this case</a>, "A Lawsuit Over Healthcare IT Whistleblowing?" - ed.]</ul></ul> <ul><ul> (5) PROTECTION FROM LIBEL OR SLANDER- Covered entities and employees, agents and representatives of covered entities are immune from civil action for libel or slander arising from information or entries made in certified EHR technology and for the transfer of such information to another eligible provider, hospital or health information exchange, if the information, transfer of information, or entries were made in good faith and without malice. [Does that include defects reports? - ed.]</ul></ul></blockquote><ul><ul></ul></ul> From an ethical perspective, when you know a technology can be unsafe, but you don't know the levels of risk it creates, and the literature is conflicting on the benefits (prima facie evidence the technology is still experimental), you do not promote its wide-scale use in medicine and offer special accommodations to the technology's producers and users. Period. This is especially true without explicit patient informed consent and opportunity for opt-out. To promote such technology is not ethical. Note: I believe the misunderstanding of "certification" of health IT contributes to the problems with such proposals. "Certification" of HIT has little if anything to do with safety, reliability, usability, etc. (e.g,, see <a href="http://hcrenewal.blogspot.com/2010/03/on-oncs-proposed-establishment-of.html" rel="nofollow">http://hcrenewal.blogspot.com/2010/03/on-oncs-proposed-establishment-of.html</a>). "Certification" of health IT is not validation of safety, usability, efficacy, etc., but a pre-flight checklist of features, interoperability, security and the like. The certifiers admit this explicitly. See the <a href="http://www.cchit.org/about">CCHIT web pages</a> for example. ("CCHIT Certified®, an independently developed certification that includes a rigorous inspection of an EHR’s integrated functionality, interoperability and security.") Health IT "certification" is not like <a href="http://www.ul.com/global/eng/pages/">Underwriters Laboratories (UL) certification of appliances</a>. ("Independent, not-for-profit product safety testing and certification organization ... With more than a 116-year proven track record, UL has been defining safety from the public adoption of electricity to new breakthroughs that help protect our future. UL employees are committed to safeguarding people, places and products in new and innovative ways for today’s borderless world.") -- SS 10/28/11 Addendum: This Representative seems to represent <a href="http://marino.house.gov/our-district">districts in Pennsylvania served by the Geisinger </a>healthcare system, including <a href="http://maps.google.com/maps?client=firefox-a&rls=org.mozilla:en-US:official&channel=s&hl=en&biw=1920&bih=887&q=danville+pa&um=1&ie=UTF-8&hq=&hnear=0x89cf6538e03a582d:0xceea3df3d7837f38,Danville,+PA&gl=us&ei=TiarToSNGMrs0gG29oWCDw&sa=X&oi=geocode_result&ct=image&resnum=2&ved=0CD0Q8gEwAQ">Danville, PA</a> where their <a href="http://www.geisinger.org/locations/index.html">main campus</a> is located. His legislative assistant on healthcare represented Geisinger to me in a conversation today in glowing terms. However, I suggest that Geisinger does not have a perfect track record, e.g., see the post "<a href="http://hcrenewal.blogspot.com/2011/08/safe-technology-factors-contributing-to.html">A 'safe' technology? Factors contributing to an increase in duplicate medication order errors after CPOE implementation</a>" and its reader comments and links. 10/30/11 Addendum: It occurred to me that in the post "<a href="http://hcrenewal.blogspot.com/2010/12/is-healthcare-it-solution-to-wrong.html">Is Healthcare IT a Solution to the Wrong Problem?</a>" referencing a study published in the Nov. 25, 2010 New England Journal of Medicine entitled "<a href="http://www.nejm.org/doi/full/10.1056/NEJMsa1004404">Temporal Trends in Rates of Patient Harm Resulting from Medical Care</a>" [Landrigan N Engl J Med 363;22] I pointed out that the abilities of health IT to "reduce medical error" may be significantly less than imagined. This is because most medical errors have little to do with record keeping, but instead with human factors. See the post at <a href="http://hcrenewal.blogspot.com/2010/12/is-healthcare-it-solution-to-wrong.html">http://hcrenewal.blogspot.com/2010/12/is-healthcare-it-solution-to-wrong.html</a>. -- SS

Cybernetik Über Alles: Computers Have More Rights Than Patients?

[Note: this essay contains many hyperlinks. They can be right-clicked and opened in a separate tab or window.] What medical devices are sh...

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