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

<div style="text-align: center;">(Addendum: the AHRQ hazards manager taxonomy report can see seen at <a href="http://healthit.ahrq.gov/sites/default/files/docs/citation/HealthITHazardManagerFinalReport.pdf.">http://healthit.ahrq.gov/sites/default/files/docs/citation/HealthITHazardManagerFinalReport.pdf.</a>)</div> In a July 2010 post "<a href="http://hcrenewal.blogspot.com/2010/07/meaningful-use-final-rule-have.html" target="_blank">Meaningful Use Final Rule: Have the Administration and ONC Put the Cart Before the Horse on Health IT?</a>" and an Oct . 2010 post "<a href="http://hcrenewal.blogspot.com/2010/10/cart-before-horse-again-institute-of.html" target="_blank">Cart before the horse, again: IOM to study HIT patient safety for ONC; should HITECH be repealed?</a>" I wrote about the postmodern "ready, fire, aim" approach to health IT: In the first post, I wrote: <blockquote class="tr_bq">... These "usability" problems require long term solutions. There are no quick fix, plug and play solutions. Years of research are needed, and years of system migrations as well for existing installations. Yet we now have an HHS Final Rule on "meaningful use" regarding experimental, unregulated medical devices the industry itself admits have major usability problems, along with a growing body of literature on the <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=2009">risks entailed</a>. <div dir="ltr"></div><div dir="ltr">For crying out loud, talk about putting the cart before the horse... </div> <div dir="ltr" style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhbxjl-AlGATfarPayjaUYkCOG4sUrulp4D88Nk7_z-eEbaWRl-xi1g0neGKWDhEL1w6-_-FCu4iBoJx9AUlU-bccaAmEcMfmGI1uoa4gTohjch5gzcx5tA9Ru-uMB0Mip6NE0PuUsfDXJ5/s1600/horse-cart.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5493460657310735298" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhbxjl-AlGATfarPayjaUYkCOG4sUrulp4D88Nk7_z-eEbaWRl-xi1g0neGKWDhEL1w6-_-FCu4iBoJx9AUlU-bccaAmEcMfmGI1uoa4gTohjch5gzcx5tA9Ru-uMB0Mip6NE0PuUsfDXJ5/s320/horse-cart.jpg" style="cursor: pointer; display: block; height: 168px; margin: 0px auto 10px; text-align: center; width: 253px;" /></a>Something's very wrong here...</div> However, this situation is anything but humorous. How more "cart before the horse" can government get?</blockquote> In the second post, I wrote: <blockquote class="tr_bq">... So, in the midst of a National Program for Health IT in the United States (NPfIT in the U.S.), with tens of billions of dollars earmarked for health IT already (money we don't really have, but it can be printed quickly, or borrowed from China) the IOM is going to study health IT safety, prevention of health IT-related errors, etc. ... only now?</blockquote> Here we go yet again. The problem with the AHRQ (<a href="http://www.ahrq.gov/" target="_blank">Agency for Healthcare Research and Quality</a>, a division of HHS) announcement below of a webinar about a new tool for identifying, categorizing, and resolving health IT hazards, as I have written before, is putting the "cart before the horse" and throwing medical ethics to the wind. If we've just developed a tool "for identifying, categorizing, and resolving health IT hazards", the magnitude of which others such as IOM admit are unknown to our detriment (e.g., <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/Patient%20Safety%20and%20Health%20IT%20prepub.pdf">Health IT and Patient Safety: Building Safer Systems for Better Care</a>, pg. S-2), then health IT is, it follows, an experimental technology. If it is an experimental technology, AHRQ and others in HHS should probably be raising the issue of a slow down or moratorium on widespread rollout under HITECH until risk management and remediation is better understood.  At the very least they should be calling for patient informed consent that a device that will largely regulate their care is experimental, that a competency "gap" exists among healthcare practitioners within the "health IT environment" (meaning patients are at risk), and that patients should be offered the opportunity for informed consent with opt-out provisions.  The principals should not just be announcing a webinar: <blockquote class="tr_bq">Sent: Tuesday, June 05, 2012 12:23 PM To: OHITQUSERS@LIST.NIH.GOV Subject: Register Now! AHRQ Health IT Webinar "Purpose and Demonstration of the Health IT Hazard Manager and Next Steps" June 11, 2:30 PM ET Agency for Healthcare Research and Quality Purpose and Demonstration of the Health IT Hazard Manager and Next Steps June 11, 2012 — 2:30-4 p.m., EST The Agency for Healthcare Research and Quality (AHRQ) has identified a gap in a health care/public health practitioner’s competency within the health IT environment. This webinar is designed to increase practitioners’ competencies in several areas: improving health care decision making; supporting patient-centered care; and enhancing the quality and safety of medication management by improving the ability to identify, categorize, and resolve health IT hazards. The Webinar will explore the Health IT Hazard Manager—a tool for identifying, categorizing, and resolving health IT hazards. When implemented, the tool allows health care organizations and software vendors alike to learn about potential hazards and work to resolve them, including the use of data to communicate potential and actual adverse effects. The session will discuss how the Health IT Hazard Manager was tested and refined as well as strategies and implications for deploying it. The target audience includes AHRQ grantees/researchers; health care providers, including physicians and nurses; consumers/patients; and health care policymakers. ... Webinar learning objectives include: 1. Describe the rationale for developing the Health IT Hazard Manager and how it evolved through alpha and beta testing. 2. Explain the process for identifying and categorizing health IT-related hazards. 3. Demonstrate how the Health IT Hazard Manager would be used [i.e., it's not yet in use, despite mandates for HIT rollout with penalties for non-adopters - ed.] within and across care delivery organizations and health IT software vendors. 4. Discuss policy and process implications for deploying the Health IT Hazard Manager via different organizations (i.e., AHRQ; Office of the National Coordinator for Health IT; Patient Safety Organization(s); Accrediting bodies; IT entities). </blockquote> In effect, HHS seems to be saying "we're working on the HIT risk problem, but roll it out anyway; if you get harmed or killed, tough luck."  This seems a form of negligence. Have we thrown out all we know about <a href="http://grants.nih.gov/grants/policy/hs/ethical_guidelines.htm" target="_blank">medical research and human subjects protections</a> in face of the magical powers and profits of computers in medicine? -- SS

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

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

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More Electronic Medical Record Breaches: You Could Not Do This With Paper

I have written repeatedly on the dangers posed by poorly managed health IT regarding information breaches.  See "<a href="http://hcrenewal.blogspot.com/2012/01/2011-closes-on-note-of-electronic.html" target="_blank">2011 Closes on a Note of Electronic Medical Record Privacy Breach Shame</a>" and other posts at this query link:   <a href="http://hcrenewal.blogspot.com/search/label/medical%20record%20confidentiality">http://hcrenewal.blogspot.com/search/label/medical%20record%20confidentiality</a> Now this, from Kaiser Health News and The Washington Post: <blockquote class="tr_bq"><a href="http://www.kaiserhealthnews.org/Stories/2012/June/04/electronic-health-records-theft-hacking.aspx" target="_blank">As Patients' Records Go Digital, Theft And Hacking Problems Grow </a> <div class="byline">By David Schultz</div><div class="timestamp">Jun 03, 2012</div> As more doctors and hospitals go digital with medical records, the size and frequency of data breaches are alarming privacy advocates and public health officials. <div class="nosyndication"><div class="inlineImage300"> </div></div>Keeping records secure is a challenge that doctors, public health officials and federal regulators are just beginning to grasp. And, as two recent incidents at Howard University Hospital show, inadequate data security can affect huge numbers of people.  </blockquote> With paper, you'd need a stream of trucks to accomplish this magnitude of theft: <blockquote class="tr_bq">On May 14, federal prosecutors <a href="http://dl.dropbox.com/u/37285095/Napper%20Information.pdf" shape="rect" target="_blank">charged</a> one of the hospital's medical technicians with violating the Health Insurance Portability and Accountability Act, or HIPAA. Prosecutors say that over a 17-month period Laurie Napper used her position at the hospital to gain access to patients' names, addresses and Medicare numbers in order to sell their information. A plea hearing has been set for June 12; Napper's attorney declined comment. Just a few weeks earlier, the hospital <a href="http://huhealthcare.com/healthcare/hospital/data-breach/FAQ" shape="rect" target="_blank">notified</a> more than 34,000 patients that their medical data had been compromised. A contractor working with the hospital had downloaded the patients' files onto a personal laptop, which was stolen from the contractor's car. The data on the laptop was password-protected but unencrypted, which means anyone who guessed the password could have accessed the patient files without a randomly generated key. According to a hospital press release, those files included names, addresses, and Social Security numbers -- and, in a few cases, "diagnosis-related information."</blockquote> I add that they could also probably have booted the laptop from alternate media, and/or removed the hard drive and inserted into another computer, to access the contents. <blockquote class="tr_bq">Ronald J. Harris, Howard University's top spokesman, said in an e-mail that the two incidents are unrelated, but declined to answer further questions. In its press release about the stolen laptop, the hospital said it will set new requirements for all laptops used by contractors and those issued to hospital personnel to help protect data. Still it could have been worse. Much worse. Just days after Howard University contacted its patients about the stolen laptop, the Utah Department of Health <a href="http://www.health.utah.gov/databreach/" shape="rect" target="_blank">announced</a> that hackers based in Eastern Europe had broken into one of its servers and stolen personal medical information for almost 800,000 people -- more than one of every four residents of the state.</blockquote> How many trucks (and Stargate SG-1 style invisibility cloaks) would it take to inconspicuously steal 800,000 paper charts, I ask? <blockquote class="tr_bq">And last November, TRICARE, which handles health insurance for the military, <a href="http://www.tricare.mil/breach/old.htm" shape="rect" target="_blank">announced</a> that a trove of its backup computer tapes had been stolen from one of its contractors in Virginia. The tapes contained names, Social Security numbers, home addresses and, in some cases, clinical notes and lab test results for nearly 5 million patients, making it the largest medical data breach since the Department of Health and Human Services began tracking incidents two and a half years ago.</blockquote> Five million charts in a country of 300 million people... <blockquote class="tr_bq">As recently as five years ago, it's possible no one outside Howard University would have known about the incidents there. But, <a href="http://www.hhs.gov/ocr/privacy/hipaa/administrative/breachnotificationrule/index.html" shape="rect" target="_blank">new reporting rules</a> adopted as part of the 2009 stimulus act insure the public knows far more about medical data breaches than in the past. When a breach occurs that affects 500 or more patients, health care providers now must notify not only HHS, but also the media.</blockquote> Meaning there were breaches the public does not know about. <blockquote class="tr_bq">Deven McGraw, director of the health privacy project at the <a href="https://www.cdt.org/" shape="rect" target="_blank">Center for Democracy & Technology</a>, a Washington-based Internet advocacy group, said the number of incidents is growing with the increased use of digital health records. The health care industry, she added, has been slow to respond.</blockquote> A problem is not enough "motivation." <blockquote class="tr_bq">"Many financial companies have used encryption for years and they probably wonder what the heck is going on with the health care industry," McGraw said. "It's much cheaper to deploy safeguards than to suffer a breach."</blockquote> I offer a one word answer:  complacency. Now for the "spin control": <blockquote class="tr_bq">This growing problem puts HHS in a tough spot. It is pushing hospitals and doctors to adopt electronic health records, but it's also responsible for punishing health care providers who fail to properly secure their patients' records. "Mistakes happen, incidents happen, corners get cut from time to time," said Susan McAndrew, deputy director for health information policy at HHS's Office of Civil Rights. "That's where we come in."</blockquote> "From time to time" is a rather modest description of the millions of breaches mentioned in just this posting.  But as I've written before, don't worry, your records are safe. Just don't tell the doctor about that "incident" at that seedy club the other night, and find some other excuse to get the antibiotics you need, and that information will be safe, too. -- SS

More Electronic Medical Record Breaches: You Could Not Do This With Paper

I have written repeatedly on the dangers posed by poorly managed health IT regarding information breaches. See " 2011 Closes on a Note...

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WSJ "There's a Medical App for That—Or Not" - Misinformation on Health IT Safety Regulation?

There's a health IT meme that just won't die (patients may, but not the meme). It's the meme that health IT "certification" is a certification of safety. I expressed concern about the term "certification" being misunderstood even before the meme formally appeared, when the term was adopted by HHS with regard to evaluation of health IT for adherence to the "meaningful use" pre-flight features checklist.  See my mid-2009 post "<a href="http://hcrenewal.blogspot.com/2009/08/cchit-has-company.html" target="_blank">CCHIT Has Company</a>" where I observed: <blockquote class="tr_bq">HIT "certification." ... is a term I put in quotes since it really is "features qualification" at this point, not certification such as a physician receives after passing Specialty Boards.</blockquote> The "features qualification" is an assurance that the EHR functions in way that could enable an eligible provider or eligible hospital to meet the Center for Medicare & Medicaid Services' (CMS) requirements of "Meaningful Use."  No rigorous safety testing in any meaningful sense is done, and no testing under real-world conditions is done at all. I've seen the meme in various publications and venues.  I've even seen it in legal documents in medical malpractice cases where EHR's were involved, as an attempted defense. Now the WSJ has fallen for the health IT Certification meme. An article "<a href="http://online.wsj.com/article/SB10001424052702303674004577432742562311810.html" target="_blank">There's a Medical App for That—Or Not</a>" was published on May 29, 2012.  Its theme is special regulatory accommodation for health IT in the form of opposition to FDA regulation of devices such as "portable health records and programs that let doctors and patients keep track of data on iPads." In the article, this assertion about health IT "certification" is made: <blockquote class="tr_bq">... The FDA's approach to health-information technology risks snuffing out activity at a critical frontier of health care. Poor, slow regulation would encourage programmers to move on, leaving health care to roil away for yet another generation, fragmented, disconnected and choking on paperwork. The process already exists for safeguarding the public for computers in health care. It's not FDA premarket review but the health information technology certification program, established under President George W. Bush and still working fine under the Obama Health and Human Services Department. The government sets the standards and an independent nonprofit [ATCB, i.e., ONC Authorized Testing and Certification Bodies - ed.] ensures that apps meet those standards. It's a regulatory process as nimble as the breakout industry it's meant to monitor. That is where and how these apps should be regulated.</blockquote> It's a wonderful meme.  Unfortunately, it's wrong.  Dead wrong. Certification by an ATCB does not "safeguard the public."   Two ONC Authorized Testing and Certification Bodies (ATCB's) admitted this in email, as in my Feb. 2012 post "<a href="http://hcrenewal.blogspot.com/2012/02/hospitals-and-doctors-use-health-it-at.html" target="_blank">Hospitals and Doctors Use Health IT at Their Own Risk - Even if Certified</a>".  I had asked them, point-blank: <blockquote>"Is EHR certification by an ATCB a certification of EHR safety, effectiveness, and a legal indemnification, i.e., certifying freedom from liability for EHR use of clinical users or organizations? Or does it signify less than that?"</blockquote> I received two replies from major ONC ATCB's indicating that "certification" is merely assurance that HIT meets a minimal set of "meaningful use" guidelines, not that it's been vetted for safety.  For instance: <blockquote class="tr_bq">From: Joani Hughes (Drummond Group) Sent: Monday, March 05, 2012 1:06 PM To: Scot Silverstein Subject: RE: EHR certification question Per our testing team: It is less than that. It does not address indemnification although a certification could be used as a conditional part of some other form of indemnification function, such as a waiver or TOA, but that is ultimately out of the scope of the certification itself. Certification in this sense is an assurance that the EHR functions in way that could enable an eligible provider or eligible hospital to meet the CMS requirements of Meaningful Use Stage 1. Or to restate it more directly, CMS is expecting eligible providers or eligible hospitals to use their EHR in “meaningful way” quantified by various quantitative measure metrics and eligible providers or eligible hospitals can only be assured they can do this if they obtain a certified EHR technology. Please let me know if you have any questions. Thank you, Joani. Joani Hughes Client Services Coordinator Drummond Group Inc.</blockquote> The other ATCB, ICSA Labs, stated that: <blockquote class="tr_bq">... Certification by an ATCB signifies that the product or system tested has the capabilities to meet specific criteria published by NIST and approved by the Office of the National Coordinator. In this case the criteria are designed to support providers and hospitals achieve "Meaningful Use." A subset of the criteria deal with the security and patient privacy capabilities of the system. Here is a list of the specific criteria involved in our testing: <a href="http://healthcare.nist.gov/use_testing/effective_requirements.html" target="_blank">http://healthcare.nist.gov/use_testing/effective_requirements.html</a> In a nutshell, ONC-ATCB Certification deals with testing the capabilities of a system, some of them relate to patient safety, privacy and security functions (audit logging, encryption, emergency access, etc.). What was suggested in the email below (freedom from liability for users of the system, etc.) would be out of scope for ONC-ATCB testing based on the given criteria. [I.e., certification criteria - ed.] I hope that helps to answer your question.</blockquote> I had noted that: <blockquote class="tr_bq">... My question was certainly answered [by the ATCB responses]. ONC certification is not a safety validation, such as in a document from NASA on aerospace software safety certification, "<a href="http://ntrs.nasa.gov/archive/nasa/casi.ntrs.nasa.gov/20040014965_2004000657.pdf">Certification Processes for Safety-Critical and Mission-Critical Aerospace Software</a>" (PDF) which specifies at pg. 6-7:</blockquote><blockquote><blockquote>In order to meet most regulatory guidelines, developers must build a safety case as a means of documenting the safety justification of a system. The safety case is a record of all safety activities associated with a system throughout its life. Items contained in a safety case include the following: • Description of the system/software • Evidence of competence of personnel involved in development of safety-critical software and any safety activity • Specification of safety requirements • Results of hazard and risk analysis • Details of risk reduction techniques employed • Results of design analysis showing that the system design meets all required safety targets • Verification and validation strategy • Results of all verification and validation activities • Records of safety reviews • Records of any incidents which occur throughout the life of the system • Records of all changes to the system and justification of its continued safety</blockquote></blockquote> A CCHIT ATCB juror, a physician informatics specialist, has also done a guest post in Jan. 2012 on HC Renewal about the certification process, reproducing his testimony to HHS on the issue.  That post is "<a href="http://hcrenewal.blogspot.com/2011/01/dr-monteith-hit-testimony-to-hhs.html" target="_blank">Interesting HIT Testimony to HHS Standards Committee, Jan. 11, 2011, by Dr. Monteith</a>."  Dr. Monteith testified (emphases mine): <blockquote class="tr_bq"><div class="MsoNormal">... I’m “pro-HIT.” For all intents and purposes, I haven’t handwritten a prescription since 1999.</div><div class="MsoNormal"> </div><div class="MsoNormal">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:</div><div class="MsoNormal"> </div><div class="MsoNormal">ONC’s strategy has put the cart before the horse. HIT is not ready for widespread implementation. </div><div class="MsoNormal"> </div><div class="MsoNormal">... ONC has promoted HIT as if there are clear evidence-based products and processes supporting widespread HIT implementation.</div><div class="MsoNormal"> </div><div class="MsoNormal">But what’s clear is that we are experimenting…with lives, privacy and careers.</div> ... 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. <div class="MsoNormal">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.</div><div class="MsoNormal"> </div><div class="MsoNormal">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.  [Which can contribute to mistakes and "use error" - ed.] Certification is an “open book” test. How can so many do so poorly?</div><div class="MsoNormal"> </div><div class="MsoNormal">For example, our EHR is certified, even though it cannot generate eRxs from within the EHR, as required by MU.</div><div class="MsoNormal"> </div><div class="MsoNormal">To CCHIT’s credit, our EHR vendor did not pass certification. Sadly, our vendor went to another certification body, and now they’re certified.</div><div class="MsoNormal"> </div><div class="MsoNormal">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)?</div><div class="MsoNormal">  </div><div class="MsoNormal">The concept of “unintended consequences” comes to mind.</div><div class="MsoNormal"> </div><div class="MsoNormal">All that said, the problem really isn’t MU and its gross shortcomings, it is ONC trying to do the impossible:</div><div class="MsoNormal"> </div><div class="MsoNormal">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.</div></blockquote><div class="MsoNormal"> </div><div class="MsoNormal">Needless to say, as was learned at great cost in past decades, a "disciplined process" in medicine includes meaningful safety regulation by objective outside experts. </div><div class="MsoNormal"> </div>Further, the certifiers have no authority to do important things such as forcibly remove dangerous software from the market.  An example is the forced Class 1 recall of a defective system as I wrote about in my Dec. 2011 post "<a href="http://hcrenewal.blogspot.com/2011/12/fda-recalls-health-it-software-because.html" target="_blank">FDA Recalls Draeger Health IT Device Because This Product May Cause Serious Adverse Health Consequences, Including Death</a>".   Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death. In that situation, the producer had been simply advising users (in critical care environments, no less) to "work around the defects" that could indicate incorrect recommended dosage values of critical meds, including a drug dosage up to ten times the indicated dosage, as well as corrupt critical cardiovascular monitoring data.  As I observed: <blockquote class="tr_bq">... I find a software company advising clinicians to make sure to "work around" blatant IT defects in "acute care environments" the height of arrogance and contempt for patient safety. </blockquote> Without formal regulatory authority to take actions such as this FDA recall, "safeguarding the public" is a meaningless platitude. It's also likely the ATCB's, which are private businesses, would not want the responsibility of "safeguarding the public."  That responsibility would open them up to litigation when patient injuries or death were caused, or were contributed to, by "certified" health IT. I have in the past also noted that the use of the term "certification" might have been deliberate, to mislead potential buyers exactly into thinking that "certification" is akin to a UL certification of an electrical appliance for safety, or an FAA approval of a new aircraft's flight-worthiness. The WSJ needs to clarify and/or retract its statement, as the statement is misinformation. At my Feb. 2012 post "<a href="http://hcrenewal.blogspot.com/2012/02/health-it-ddulites-and-disregard-for.html" target="_blank">Health IT Ddulites and Disregard for the Rights of Others</a>" I observed: <blockquote class="tr_bq">Ddulites [HIT hyper-enthusiasts - ed.] ... ignore the downsides (patient harms) of health IT. This is despite being already aware of, or informed of patient harms, even by reputable sources such as <a href="http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html">FDA</a> (Internal FDA memo on H-IT risks), <a href="http://hcrenewal.blogspot.com/2008/12/joint-commission-sentinel-events-alert.html">The Joint Commission</a> (Sentinel Events Alert on health IT), the <a href="http://www.isb.nhs.uk/documents/isb-0160/dscn-18-2009/0160182009specification.pdf">NHS</a> (Examples of potential harm presented by health software - Annex A starting at p. 38), and the <a href="http://hcrenewal.blogspot.com/2010/12/ecri-healthcare-it-in-top-ten-health.html">ECRI Institute</a> (Top ten healthcare technology risks), to name just a <a href="http://hcrenewal.blogspot.com/2011/02/updated-reading-list-on-health-it.html">few</a>. In fact, the hyper-enthusiastic health IT technophiles will go out of their way to incorrectly dismiss risk management-valuable case reports as "anecdotes" not worthy of consideration (see "Anecdotes and medicine" essay <a href="http://hcrenewal.blogspot.com/2011/08/from-senior-clinician-down-under.html">at this link</a>). They will also make unsubstantiated, often hysterical-sounding claims that health IT systems are necessary to, or simply will "transform" (into what, exactly, is usually left a mystery) or even "revolutionize" medicine (whatever that means). </blockquote> Health IT is a potentially dangerous technology.   It requires meaningful regulation to "safeguard the public."  How many incidents like <a href="http://hcrenewal.blogspot.com/2011/11/lifespan-rhode-island-yet-another.html" target="_blank">this</a> and <a href="http://hcrenewal.blogspot.com/2011/12/yet-another-glitch-affecting-thousands.html" target="_blank">this</a> will it take before that is understood by the hyper-enthusiasts? I've emailed the ATCB's that had responded to my aforementioned query for clarification on the WSJ assertion about their role, being that the statement is in contradiction to their earlier replies to me.  I also advised them of the potential liability issues. However, if it turns out to be true that the ONC-ATCB's do intend themselves as the ultimate watchdog and assurer of public safety related to EHR's, that needs to be known by the public and their representatives. -- SS

WSJ "There's a Medical App for That—Or Not" - Misinformation on Health IT Safety Regulation?

There's a health IT meme that just won't die (patients may, but not the meme). It's the meme that health IT "certification...

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Dartmouth's Governance and Wall Street

While the money spent on health care in the US continues to increase, care becomes less accessible and its quality becomes more dubious.  Most public health care discourse seems at a loss to explain how we can keep spending more to get less. Of many possible explanations, one that has become more credible is continuing erosion of health care stewardship.  The <a href="http://hcrenewal.blogspot.com/search/label/boards%20of%20trustees">boards of trustees</a> of health care organizations, those charged with their stewardship, seem increasingly preoccupied with self-interest rather than the health care mission.  As more information about how such boards currently operate sneaks into public view, the problems appear more serious and salient. New information about the governance of Dartmouth College, an issue we have <a href="http://hcrenewal.blogspot.com/2007/09/oceania-in-new-hampshire.html">followed since 2007</a>, is illustrative. The Case So Far The problems at Dartmouth were notable because in many ways its governance was superior to that of many US higher educational and health care institutions.  At the time we first <a href="http://hcrenewal.blogspot.com/2007/09/oceania-in-new-hampshire.html">stumbled on</a> these problems, Dartmouth was unusual in that nearly half of its board of trustees were elected by alumni, rather than being self-appointed.  That made its governance both more representative  and more accountable.  In 2007, however, a dispute was ongoing about the extent that the institution's board of trustees ought to represent the alumni at large, or instead, ought to be a self-elected body not clearly accountable to anyone else.  The unelected, or "charter" board members were pushing to increases their numbers.  In 2007, what really got our attention was the stated rationale for this push towards less representative and accountable governance. Mr Charles Haldeman, then the chairman of the board of trustees, announced a smaller proportion of elected trustees would ensure that the board "has the broad range of backgrounds, skills, expertise, and fundraising capabilities needed," and that the board members would possess "even more diverse backgrounds."  However, despite his appeal to diversity, Mr Haldeman seemed most intent on reducing "divisiveness," especially dissent that challenged his own authority.  At the time, we thought his argument for more diversity to reduce dissent and increase his own authority seemed Orwellian. Yet when we examined the backgrounds of the self-appointed trustees, we found that they exhibited little diversity. Furthermore, rather than resembling followers of Ingsoc, they resembled more the group that the radical left traditionally reviled.  Remarkably, three-quarters (6/8) were leaders of the finance sector, of what is popularly called "Wall Street." In 2007, they seemed not very diverse, but why the majority should be in the financial sector, and what implications that had, was then obscure. After the fall of Lehman Brothers and the onset of the global financial collapse/ great recession, the implications of this Wall Street majority on the board of an institution of higher education became more troubling.  Since 2008, growing concerns about the extent that finance is driven by a "greed is good" culture increasingly suggest that domination of university, medical school, or hospital boards by leaders in the finance sector may increasingly divorce boards from the missions which they are supposed to uphold. Yet in 2008, the unelected "charter" members of the Dartmouth board succeeded in increasing their numbers, and hence their proportion of total board seats.  The new board was no more diverse.  Of its 13 charter members, 9 were from finance, and one more was the CEO of a corporation with a major finance subsidiary.  (Look <a href="http://hcrenewal.blogspot.com/2008/11/leadership-of-elite-american-university.html">here</a>.)  By 2009, the charter board members had succeeded in ousting a dissident alumni-elected member, labeling him a member of a "radical cabal," and rewriting a board loyalty oath apparently to discourage further dissent.  (Look <a href="http://hcrenewal.blogspot.com/2009/04/investment-bankers-strike-back.html">here</a>.) All this spoke to the increasing power of the culture of finance among members of the board.  Perhaps, though, there were reasons that the financial majority on the board wanted to suppress dissent other than to make themselves more comfortable with their own dominant culture,  In 2010, as the global financial crisis continued, "<a href="http://www.tellus.org/publications/files/endowmentcrisis.pdf">Educational Endowments and the Financial Crisis: Social Costs and Systemic Risks in the Shadow Banking System</a>," published by the Center for Social Philanthropy, Tellus Institute, focused on how prominent educational institutions, including Dartmouth College, came to invest much of their endowments in risky, illiquid "alternative" investments, the sort provided by the "shadow banking system."  (See this <a href="http://hcrenewal.blogspot.com/2010/05/stewards-of-elite-university-or.html">post</a>.)  The report noted extensive conflicts of interest on the Dartmouth board involving trustees who were also leaders of finance.  Their firms, it turned out, were managing a substantial fraction of the money in the college's endowment.  Half of the charter trustees were also being paid to manage the finances of the institution for whose stewardship they were responsible.  Trustees of non-profit organizations are supposed to exhibit a duty of loyalty, that is, they "must give undivided allegiance when making decisions affecting the organization."  (For a summary of their duties, look <a href="http://www.boardsource.org/Knowledge.asp?ID=3.364">here</a>.)   In 2010, I <a href="http://hcrenewal.blogspot.com/2010/05/stewards-of-elite-university-or.html">noted</a>, "letting a board member's firm manage millions of dollars worth of the institution's endowment portfolio seems an obvious violation of the duty of loyalty."  So, "these sorts of conflicts of interest may be another 'missing link' explaining why the leadership and governance of health care organizations has gone so far astray."  I then posited, "as disclosure continues, maybe enough outrage will ensue so that improved leadership and governance will become possible. The Friends of Eleazar Wheelock Charge Corruption Now there seems to be more outrage.  Last month, the dissident Dartblog <a href="http://www.dartblog.com/data/2012/05/010228.php">broke the story</a> of a <a href="http://www.dartblog.com/AG%20Letter.pdf">letter</a> sent in February, 2012 to the New Hampshire Attorney General by an anonymous group called the "Friends of Eleazar Wheelock."  (Wheelock was the founder of the college.)  To the the letter was appended a report that included an even more extensive list of conflicts of interest affecting Dartmouth trustees, the college's Finance Committee and Investment Committees, and their friends and relatives.  The letter also added <blockquote>The mismanagement extends beyond the investments and endowment. 1) Over a period of seven years The College engaged Lehman Brothers in six 'interest rate swaps' totaling $550 million dollars. The current value of these 'swaps' is now in excess of two hundred million dollars. That is what Dartmouth owes on these bets. These losses are not reported in the College’s financial statements. 2) The College’s 'cash' was invested in six hedge funds. Up to 40% of it was lost. Again, this was not reported. This comprises grant money for research, advances to faculty, and other working capital which should have been invested in the safest of money market instruments. 3) over 50% of the endowment is invested with Trustees, Investment Committee members, or their friends.</blockquote>The report summary stated, <blockquote>The pattern that the Dartmouth trustees and members of the Endowment/Investment committee have engaged in for decades is clear. That pattern is that a donor/investment manager’s pledge to support Dartmouth is reciprocated with an investment of ever increasing proportions in the donor’s firm, lending the credibility of an Ivy League institution to the firm. The investment returns are of little import; most of these alum/donor/investment manager returns are average to poor.</blockquote> It rhetorically asked how the college came into <blockquote>the grip of a club of investment manager alums who have invested almost six hundred million dollars in their very own funds and directed over one billion dollars to their friends? And who have taken almost one hundred million dollars in fees to manage the endowment, often with poor results culminating in the twenty three per cent loss in 2008 and the worst performance of all the Ivies in 2011?</blockquote> The letter charged that there has been a <blockquote>quiet takeover of this great College by a cabal of external, wealthy alumni/ae of the college. They have mortgaged the College’s future through borrowing heavily in the tax exempt marketplace under NH HEFA (Health and Education Facilities Authority). They have simultaneously directed the College’s three billion dollar endowment to themselves, their firms, and their friends. They have furthered their own self-interest at the expense of the College and the Upper Valley. They have abused the non-profit status of Dartmouth College. They have enriched themselves through managing and directing Dartmouth’s three billion dollar endowment. In all cases they have taken gargantuan fund management fees through 'Private Equity', 'Venture Capital', and 'Hedge Funds' investments which they, themselves, manage and are the owners of.</blockquote>Summary A <a href="http://www.americanthinker.com/blog/2012/05/corruption_charges_leveled_at_dartmouth_college_trustees.html">post</a> on the American Thinker blog noted that the letter alleged "corruption." It is impossible to tell whether these expanded allegations will result in any charges, much less convictions. The state Attorney General is currently looking into this (see <a href="http://www.reuters.com/article/2012/05/29/dartmouth-endowment-idUSL1E8GT9CS20120529">Reuters</a>). Certainly, the allegations are at least of ethical corruption as it is defined by Transparency International, "abuse of entrusted power for private gain." The revelations since 2007 (and I could argue beginning with <a href="http://hcrenewal.blogspot.com/2007/09/oceania-in-new-hampshire.html">my finding</a> that the majority of the supposedly "diverse" charter trustees were leaders of finance) first raised questions whether Dartmouth governance's was attentive to the mission, then, whether it was conflicted, and now, whether it is corrupt. That these questions can be credibly raised about one of our most prestigious institutions of higher education and health care demonstrates the depth of our health care crisis. It also demonstrates how the health care crisis seems inextricably linked to the financial crisis, and to a fundamental crisis about our society and its commitment to democracy and fairness. A fair and thorough enquiry about the mess at Dartmouth, resulting in clear actions to uphold the institution's mission and ethics, and, if applicable, the law, would start us down the path of true health care reform. However, if this just gets swept under the rug, we will not have reached the bottom of our descent. ADDENDUM (2 June, 2012) - Note that Dartmouth's most recent President, Jim Yong Kim, who was appointed by and served under the Trustees in question above, is now President of the World Bank (see this LA Times<a href="http://www.washingtonpost.com/business/economy/dartmouths-kim-named-world-bank-president/2012/04/16/gIQArHuiLT_story.html"> article</a>.) See also <a href="http://www.margaretsoltan.com/?p=35969">comments</a> in the University Diaries blog.

Dartmouth's Governance and Wall Street

While the money spent on health care in the US continues to increase, care becomes less accessible and its quality becomes more dubious. Mo...

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Upcoming Keynote Presentation to Health Informatics Society of Australia: Health IT Must First Do No Harm

Pulse+IT Magazine (<a href="http://www.pulseitmagazine.com.au/">http://www.pulseitmagazine.com.au/</a>) is Australasia's first, and they claim only, eHealth and Health IT periodical. In a May 30, 2012 article entitled "Patient and safety advocates a highlight at HIC2012" at <a href="http://www.pulseitmagazine.com.au/index.php?option=com_content&view=article&id=1014:patient-and-safety-advocates-a-highlight-at-hic2012&catid=16:australian-ehealth&Itemid=327" target="_blank">this link</a>, writer Kate McDonald describes my upcoming panel participation and Keynote Presentation at the annual Health Informatics Conference (HIC) of the <a href="http://www.hisa.org.au/" target="_blank">Health Informatics Society of Australia</a> (HISA) in Sydney. The focus of the HIC2012 meeting is "Building a Healthcare Future through Trusted Information." Ms. McDonald had called me from Down Under to discuss my upcoming talk.  She writes: <blockquote class="tr_bq"> ... Also on the panel [one of the conference's annual Q&A panels - ed.] will be NEHTA CEO Peter Fleming, HISA board director and well-known consultant David Rowlands, and Scot Silverstein, an adjunct professor of health informatics at Drexel University in the US. Dr Silverstein also has a personal story to tell that brings home the importance of what exactly is 'trusted' information. A qualified medical doctor and medical informatics researcher, Dr Silverstein is a strong advocate for safety in health IT systems, having been personally involved in what he believes was a case of medical misadventure caused by an electronic health record that resulted in harm to a close relative. He will also deliver a keynote speech on the topic of improving health IT systems as a first step towards evidence-based medicine and better clinical outcomes. Dr Silverstein told Pulse+IT that there is a “syndrome of over-confidence” in computer output that he finds puzzling. “In other fields people, when they start getting incorrect bills or they keep coming and they can't stop them, it is always blamed on a computer system,” he said. “And yet in medicine, it seems to have evolved a culture around computing that machines in healthcare must deterministically create improvement and are purely beneficent and can't be capable of creating harm. “It is a strange philosophy because in the same breath, people say healthcare information technology is capable of great benefit, that is a very powerful technology and when it is done well, it is. [As I've written before, "doing HIT well" is a challenge of 'wicked' complexity - ed.]  But anything that is a potential source for great good can also have a downside. There seems to be a cognitive gap in connecting computing in healthcare to its possible risk.”</blockquote> She summarizes the views expressed in our phone conversation well.  My theme will be that health IT and the information it generates cannot be trusted until the technology itself is trustworthy, and earns our trust, through better engineering and implementation practices. Ironically, I was invited to 2011's meeting.  I would have attended, but was tending to the injuries of my relative caused by the aforementioned medical misadventure. That relative is no longer with us and is hopefully resting in peace. HISA was kind enough to re-invite me for 2012, for which I am grateful. I will also be spending some time with several Medical Informatics professors in Australian universities, which should provide an excellent opportunity for sharing of views. <table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgvFU828jpijB3bF46WY9PhM5RgJ5aGKmOSLdR7Q4MKlOxfKX_DbjWnOLJDlfu8MRCWAhWl_cW3PY0VJvD1VdW-OHXdPLdl5tBGm4d6-KvRZ3AM1X_pAQzhk8Dc2NSZ-jhC3zFIYEl7-rb9/s1600/sydney.jpg" style="margin-left: auto; margin-right: auto;"><img border="0" height="213" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgvFU828jpijB3bF46WY9PhM5RgJ5aGKmOSLdR7Q4MKlOxfKX_DbjWnOLJDlfu8MRCWAhWl_cW3PY0VJvD1VdW-OHXdPLdl5tBGm4d6-KvRZ3AM1X_pAQzhk8Dc2NSZ-jhC3zFIYEl7-rb9/s320/sydney.jpg" width="320" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">Sydney, Australia</td><td class="tr-caption" style="text-align: center;"></td></tr></tbody></table><div style="text-align: center;"></div> I look forward to being in Sydney, never having been physically present in Australia, although being a ham radio operator, my single sideband (voice) and Morse code shortwave signals have been there on many occasions over the years.  This is a mere ~ 10,000-mile path.  No Internet or phone lines needed!  (I hope I get the opportunity to operate an Amateur radio station from "Down Under.") More here after my presentation. -- SS

Upcoming Keynote Presentation to Health Informatics Society of Australia: Health IT Must First Do No Harm

Pulse+IT Magazine ( http://www.pulseitmagazine.com.au/ ) is Australasia's first, and they claim only, eHealth and Health IT periodical...

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Know-Nothing, or Industry Shill? You Be The Judge.

I have not been writing much the past few weeks due to other concerns, and will probably not write much this summer. However, I have been commenting on various posts on other blogs.  One resultant thread stands out as yet another example of a likely industry shill or sockpuppet defending the state of health IT, oddly at a blog on pharma (same blog as was the topic of tmy post "<a href="http://hcrenewal.blogspot.com/2012/04/more-youre-too-negtive-and-you-dont.html" target="_blank">More 'You're Too Negative, And You Don't Provide The Solution To The Problems You Critique', This Time re: Pharma</a>"). Industry-sponsored sockpuppetry is a form of stealth marketing or lobbying, through discreditation of detractors, although in a perverse form. The following exchanges meet the sockpuppetry criteria once pointed out by business professional and HC Renewal reader Steve Lucas in 2010 in a post about an industry sockpuppet caught red-handed through IP forensics <a href="http://hcrenewal.blogspot.com/2010/01/more-on-perversity-in-hit-world.html" target="_blank">here</a>: <blockquote class="tr_bq">... In reading this thread of comments I have to believe [anonymous commenter moniker] "IT Guy" is a salesperson. My only question is: Were you assigned this blog or did you choose it? We had this problem a number of years ago where a salesperson was assigned a number of blogs with the intent of using up valuable time in trying to discredit the postings. In my very first sales class we learned to focus on irrelevant points, constantly shift the discussion, and generally try to distract criticism. I would say that HCR is creating heat for IT Guy’s employer and the industry in general. I find it sad that a company would allow an employee to attack anyone in an open forum. IT Guy needs to check with his superiors to find out if they approve of this use of his time, and I hope he is not using a company computer, unless once again this attack is company sanctioned. </blockquote> In the hopes that continued exposure of this nonsense can educate and thus help immunize against its effects, I present this: At "In the Pipeline", a blog on medicinal chemistry (the science of drug making) and other pharma topics, a rebuttal to a claim that over 500,000 people (not 50K) might have died due to VIOXX was posted entitled "<a href="http://pipeline.corante.com/archives/2012/05/30/500000_excess_deaths_from_vioxx_where.php" target="_blank">500,000 Excess Deaths From Vioxx? Where?</a>" That 500K possibility appeared on a UK site 'THE WEEK With the FirstPost' at "<a href="http://www.theweek.co.uk/us/46535/when-half-million-americans-died-and-nobody-noticed" target="_blank">When half a million Americans died and nobody noticed</a>."  The author of the FirstPost piece started out by raising the point made by publisher Ron Unz that life in China might be more valued than that in the U.S., where major pharma problems and scandals generally meet what this blog calls "<a href="http://hcrenewal.blogspot.com/search/label/anechoic%20effect" target="_blank">the anechoic effect</a>."  (In China, Unz noted, perpetrators of scandalous drug practices actually get arrested and suffer career repercussions.) FirstPost notes: <blockquote class="tr_bq">ARE American lives cheaper than those of the Chinese? It's a question raised by Ron Unz, publisher of <a href="http://www.theamericanconservative.com/blog/chinese-melamine-and-american-vioxx-a-comparison/%20" target="_blank">The American Conservative</a>, who has produced a compelling comparison between the way the Chinese dealt with one of their drug scandals – melamine in baby formula - and how the US handled the Vioxx aspirin-substitute disaster ... (Unz) "The inescapable conclusion is that in today's world and in the opinion of our own media, American lives are quite cheap, unlike those in China."  </blockquote><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"> Not to argue to merits of the order of magnitude-expanded VIOXX claim, which I disagree with, but having concern for the general state of ethics in biomedicine in the U.S., I posted the following comment at the comment thread of the rebuttal post at "In the Pipeline" <a href="http://pipeline.corante.com/archives/2012/05/30/500000_excess_deaths_from_vioxx_where.php#973935" target="_blank">at this link</a>: </div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"></div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><blockquote class="tr_bq"><div class="commentsbody"><a href="http://pipeline.corante.com/archives/2012/05/30/500000_excess_deaths_from_vioxx_where.php#973935">6. </a>MIMD on May 30, 2012 11:38 AM writes...</div> While I agree the VIOXX numbers here are likely erroneous, the point of the cheapening of the value of American life is depressingly accurate. For instance, look how readily companies lay people off, ruining them, and perhaps forcing them out of the workforce forever. Also, currently being pushed by HHS is a medical device for rapid national implementation known to cause injury and death. The government is partially financing it to the tune of tens of billions of dollars, probably with Chinese money no less.  [Either that, or with freshly-printed money adding to the trillions of $ in our deficit - ed.] There are financial penalties for medical refuseniks (non-adopters). However, FDA, the Institute of Medicine and others readily admit in publication thay have no idea of the magnitude of the harm because of lack of data collection, impediments to information diffusion and even legal censorship of the harms data. In effect, we don't even know if the benefits exceed the harms, and FDA and IOM admit it. FDA in fact refers to the known injuries and deaths from this device as "likely the tip of the iceberg." Perhaps to some it's no longer a big deal if people are injured and/or die in data gathering for this medical enterprise. E.g., see "<a href="http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html">FDA Internal Memo on H-IT Risks</a>", and the Inst. of Medicine report in the same issues <a href="http://hcrenewal.blogspot.com/2011/11/iom-report-on-health-it-safety-nix-fda.html">here</a>. </blockquote><blockquote class="tr_bq">It's all for the greater social good, they might say.</blockquote>  </div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">The following anonymous reply ensued:</div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"></div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><blockquote class="tr_bq"><div class="commentsbody"><a href="http://pipeline.corante.com/archives/2012/05/30/500000_excess_deaths_from_vioxx_where.php#974103">10. </a>Watson on May 30, 2012 1:47 PM writes...</div> @6 You keep using that word - "device" - I do not think it means what you think it means</blockquote>  </div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"></div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">I replied:</div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"> </div><blockquote class="tr_bq"><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><a href="http://pipeline.corante.com/archives/2012/05/30/500000_excess_deaths_from_vioxx_where.php#974232">11. </a>MIMD on May 30, 2012 3:48 PM writes...</div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"> #10 'medical device' is the term chosen by FDA and SMPA (EU). But that's a distraction from the points I raise in the linked post about the experiment.</div></blockquote> To which this confused misdirection came forth from the ether: <blockquote class="tr_bq"><div class="commentsbody"><a href="http://pipeline.corante.com/archives/2012/05/30/500000_excess_deaths_from_vioxx_where.php#974290">12. </a>Watson on May 30, 2012 4:46 PM writes...</div><div class="commentsbody"> </div>The linked article is discussing the poor state of "medical device records" because of a lack of uniform specifications with respect to Health Information Technology, i.e. how these technologies code data and the challenges of making the data obtained uniform across a wide variety of implementations and vendors. [Erroneous, incomplete misdirection - ed.] It seems that the concern, far from being that Health Information Technology is "killing" people, is that the Medical Device Records may contain duplicate reports for adverse health events because of health care providers encoding the data more than once for each event.  [What in the world? - ed.] This problem with replication exists because there are different health record systems where this data needs to be input, and perhaps the same patient uses different physicians who have different systems, but all of which are required to report adverse events. [I have little idea what this even means - ed.] </blockquote><blockquote class="tr_bq">In other words, "Health Information Technology" is not some monolithic "device", and your conflation of "HIT" which is more properly an abstract term with the "devices" which are used to generate some forms of patient data is in my view the real distraction. [The "real" distraction from the ethical issues of the HIT experiment is terminology about medical devices?  Misdirection again from the ethical issue, and of a perverse nature - ed.] Yes, some of the "devices" (a blood pressure monitor for example) may have underlying issues, which the FDA regulations for "medical device records" are designed to identify. The FDA, as a governmental entity has no constitutional power to mandate certain devices or implementations are to be used.  [Now we're in la-la land of misinformation and distraction- ed.] The power that the FDA does have is to inspect that the manufacturer of a device keeps appropriate medical device records (e.g. a lot of syringes, or a batch of formulated drug) and addresses any complaints about the device to the satisfaction of the FDA.</blockquote> My replies: <blockquote class="tr_bq"><a href="http://pipeline.corante.com/archives/2012/05/30/500000_excess_deaths_from_vioxx_where.php#976431">17. </a>MIMD on May 31, 2012 8:51 PM writes... #12 It seems that the concern, far from being that Health Information Technology is "killing" people, is that the Medical Device Records may contain duplicate reports for adverse health events because of health care providers encoding the data more than once for each event Yes, fix just that little problem and then the problems with clinical IT are solved! (Actually,I'm not even sure what you're referring to, but the evidence is that fixing it as you suggest is the cure.)  [Sarcasm - ed.] The FDA, as a governmental entity has no constitutional power to mandate certain devices or implementations are to be used. You are also right about FDA. They were completely toothless even <a href="http://hcrenewal.blogspot.com/2011/12/fda-recalls-health-it-software-because.html" rel="nofollow">in this situation</a>.  [Sarcasm again - ed.] <a href="http://pipeline.corante.com/archives/2012/05/30/500000_excess_deaths_from_vioxx_where.php#976453">18. </a>MIMD on May 31, 2012 9:10 PM writes... #12 In other words, "Health Information Technology" is not some monolithic "device", and your conflation of "HIT" which is more properly an abstract term with the "devices" which are used to generate some forms of patient data is in my view the real distraction. Those who conducted the Tuskegee experiments probably felt the same way. It's all about definitions, not ethics, and not data - which FDA as well as IOM or the National Academies, our highest scientific body, among others, admits, as in the linked posts in #6, is quantitatively and structurally lacking on risks and harms. I don't really mean to laugh at you, not knowing how little you really know about the Medical Informatics domain, but you bring to mind this Scott Adams adage on logical fallacy: FAILURE TO RECOGNIZE WHAT’S IMPORTANT Example: My house is on fire! Quick, call the post office and tell them to hold my mail! And with that, I move on, letting others enjoy the risible comments from surely to follow! :-)</blockquote> <div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">I could not have been more correct. In typical industry shill/sockpuppet fashion comes this, with clear evidence of a not-so-clever liar which I've bolded:</div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"> </div><blockquote class="tr_bq"><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><a href="http://pipeline.corante.com/archives/2012/05/30/500000_excess_deaths_from_vioxx_where.php#976731">19. </a>Watson on June 1, 2012 12:35 AM writes... @18 I read the articles you originally linked to, and my comments were based upon trying to interpret your meaning from those selections. I worked in the industry and had to deal with GMP, and had to make sure to follow all of the guidelines with respect to medical device manufacturing and electronic records. I understand the terminology very well. Luckily, I never had to deal with "health IT", but I did have to pore over enough pages of Federal Register legalese to know that what is sufficient is not necessarily what is best.  [Right.  See below - ed.] Is that risible enough for you? The link that you provided in @17 was a much more concrete example, and if you had referenced it in your original post, would have cleared up much of the confusion that I (and I assume @9) faced in understanding what it was you were trying to convey. It would have been useful if you had explained which device or devices you were talking about. If you had more than conjecture to back up the Chinese money trail, and if you had provided an example of a company that has been damaged by being a refusenik, those would have supported your argument as well. [Continuing haphazardly with the irrelevant as a distraction in an attempt to shift the focus from the ethical issue of nationally implementing HIT in a relative risk-information vacuum, having weakly conceded the main argument's been lost - ed.] Straw man and ad hominem fallacies are pretty transparent around here, and I wish you the best with both. [Another attempt at diversion - ed.] I assure you that I recognize what's important, that I have ethics, and that I care about people having reliable healthcare. [This seems a form of post-argument-lost attempt to seize the moral high ground - ed.]</div></blockquote><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><table border="0" cellpadding="0" cellspacing="0" id="content"><tbody><tr><td valign="top" width="100%"> I then point out the nature of what is likely a bold-faced lie.  Someone who's read the Federal Register in depth would likely know FDA's authority is not a "Constitutional power", as bolded below: <blockquote class="tr_bq"><a href="http://pipeline.corante.com/archives/2012/05/30/500000_excess_deaths_from_vioxx_where.php#977304">20. </a>MIMD on June 1, 2012 6:44 AM writes... @19 The FDA taxonomy of HIT safety issues in the leaked Feb. 2010 "for internal use only" document "H-IT Safety Issues" available at the link in my post #6 is quite clear: - errors of commission - errors of omission or transmission - errors in data analysis - incompatibility between multi-vendor software applications or systems This is further broken down in Appendices B and C, with actual examples. Both this FDA internal report and the public IOM report of 2011 (as well as Joint Commission Sentinel Events Alert on health IT of a few years ago, and others) make it abundantly clear there is a dearth of data on the harms, due to multiple cultural, structural and legal impediments to information diffusion. Yes, it's in the linked IOM report at #6 entitled "Health IT and Patient Safety: Building Safer Systems for Better Care". See for instance the summary pg. S-2 where IOM states about limited[ed] transparency on H-IT risk that "these barriers to generating evidence pose unacceptable risks to safety." Argue with them, not me. Back to my original point: national rollout of this medical device (whatever you call it is irrelevant to my point, but see Jeff Shuren's statement to that effect <a href="http://hcrenewal.blogspot.com/2011/04/fda-decides-regulating-implantable.html" rel="nofollow">here</a>) under admitted conditions of informational scarcity regarding risks and harms represents a cheapening of the value of patient's lives. Cybernetics Over All. As to your other misdirection, spare me the lecture. It's not ad hominem to call statements like "The FDA, as a governmental entity has no constitutional power to mandate certain devices or implementations are to be used" for what they are - laughable (and I am being generous). FDA's authority is statutory, not written in the Constitution. Same with their parent, HHS. To get quite specific, on human subjects experimentation, which the H-IT national experiment is, the statutory authority for HHS research subject protections regulations derives from 5 U.S.C. 301; 42 U.S.C. 300v-1(b); and 42 U.S.C. 28. [The USC or United States Code is the codification by subject matter of the general and permanent laws of the United States.  HHS revised and expanded its regulations for the protection of human subjects in the late 1970s and early 1980s. The HHS regulations on human research subjects protections themselves are codified at 45 CFR (Code of Federal Regulations, aka Federal Register) part 46, subparts A through D. See <a href="http://www.hhs.gov/ohrp/humansubjects/guidance/">http://www.hhs.gov/ohrp/humansubjects/guidance/</a>. - ed.] A real scientist would have known things like this before posting, or have made it their business to know. </blockquote><blockquote class="tr_bq">Tell me: are you in sales? Not to point fingers, but with your dubious evasion of the ethical issue that was the sole purpose of my post, and your other postings using misdirection and logical fallacy to distract, you fit that mindset. You certainly don't sound like a scientist. Any med chemist worth their salt (pun intendend) would have absorbed the linked reports and ethical issues accurately, the first time.</blockquote> I then pointed out I've moved this 'discussion' to the HC Renewal Blog, as it is not relevant per se to pharma, the major concern of In the Pipeline. Industry shill/sockpuppet (as in the perverse example at <a href="http://hcrenewal.blogspot.com/2010/01/more-on-perversity-in-hit-world.html" target="_blank">this link</a>) or just a dull, ill-informed but opinionated person who happens to read blogs for medicinal chemists, where layoffs have been rampant in recent years, takes issue with my attacks on those practices, and defends health IT like a shill? You be the judge. Whether a shill or know-nothing contributed the cited comments, it is my hope this post contributes to an understanding of pro-industry sockpuppetry. -- SS </td><td valign="top" width="100%"> </td><td valign="top" width="100%"> </td><td valign="top" width="100%"> </td><td valign="top" width="100%"> </td><td valign="top" width="100%"> </td><td valign="top" width="100%"> </td><td valign="top" width="100%"> </td><td valign="top" width="100%"> </td><td valign="top" width="100%"> </td><td valign="top" width="100%"> </td></tr></tbody></table></div><a href="http://pipeline.corante.com/archives/2012/05/30/500000_excess_deaths_from_vioxx_where.php#zemail"></a>

Know-Nothing, or Industry Shill? You Be The Judge.

I have not been writing much the past few weeks due to other concerns, and will probably not write much this summer. However, I have been co...

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Who Cares if The Patients Die? - Apparently Not Some Hospice Marketers

An <a href="http://www.usatoday.com/money/industries/health/story/2012-06-11/hospice-marketing-Medicare/55120284/1">article</a> in USA Today suggests that marketers for hospices are pushing even more aggressive measures to recruit patients, regardless of the consequences. Marketing Hospice to Prevent Re-Admission Per USA Today, <blockquote>Hospice marketers, exploring possibilities for new revenue to help continue the industry's remarkable growth, are looking to exploit a provision in the 2010 health care law by persuading hospitals to send Medicare patients into end-of-life hospice care instead of readmitting them to the hospital. Such a move, the hospice marketers say, will enable hospitals to avoid paying the Medicare penalties required by the new law when hospitals discharge patients and then have to readmit them within 30 days: Instead of readmitting the patients, hospitals should send them to hospice care, which also is covered by Medicare, according to a USA TODAY analysis of marketing materials. Patients with severe heart problems and pneumonia tend to decline quickly and often move in and out of hospitals, said hospice marketing specialist Rich Chesney, who proposed the idea. It might be better, Chesney said, if a hospital CEO hired people to talk to family members about hospice, instead of a doctor, who is more focused on not losing a patient. Chesney made his proposal recently at a conference sponsored by the National Hospice and Palliative Care Organization, an industry trade group. [Chesney is apparently the <a href="http://www.healthmr.com/information/about-us">President of Healthcare Market Resources,</a> whose slogan is "growing bottom lines with information." - Ed] 'If (hospices) make that part of their business and their revenue stream, that's sound business,' said Stan Massey, <a href="http://www.transcendhospicemarketing.com/main/stan-massey/">chief marketing officer</a> for <a href="http://www.transcendhospicemarketing.com/">Transcend Hospice Marketing</a> in Holland, Ohio. Massey recently wrote a blog recommending hospice marketers talk to hospital CEOs instead of the doctors who usually decide who is eligible for hospice care. Those conversations, he wrote, 'must be framed heavily in terms of financial benefit.'</blockquote> Ignoring the Hospice Mission Lost in the marketers' thinking seems to be any notion of the hospice mission. Hospices are supposed to provide compassionate palliative care to patients at the end of life who do not want any further aggressive intervention. Good hospice care is likely to make the last days of such patients more tolerable. However, generally hospices intentionally do not provide any care beyond palliation, such as, for example, antibiotics for acute infections, transfusions in the case of acute blood loss, or surgery for acute trauma. Should a patient who is not at the end of life be erroneously admitted to hospice, and then suffer some new acute problem, that patient is at risk of bad outcomes, including death because of denial of the sort of care available in acute care settings. Thus, admitting patients to hospice who are not at the end of life or have not given truly informed consent for hospice care may lead to patients dying prematurely, or suffering suffering preventable complications of treatable diseases and injuries. Aggressive marketing of hospice, particularly pushing hospice for patients just because they seem likely to be re-admitted to a hospital, especially by having marketers try to go around patients' own physicians, risks admitting patients to hospice who should not be in hospice. Thus such aggressive hospice marketing may lead to needless, and wrongful deaths of, injuries to, and morbidity for patients who should have received more aggressive treatment. The USA Today article did note: <blockquote>Health care analysts and ethicists, however, say such proposals are contrary to the intent of the health care law, which is to provide better care, not to put more patients into hospice care for which they are not ready. The proposals warp the 'whole idea behind hospice,' said Josh Perry, a business and ethics professor at Indiana University.</blockquote> In addition, <blockquote>Good hospices have been working with hospital CEOs for years, said Carolyn Cassin, president of the National Hospice Work Group, a coalition of the 25 largest not-for-profit hospice organizations. But the goal, she said, was to make sure patients received the care they needed. She said she was surprised to hear it characterized as a marketing approach to cut costs. While hospice care costs less than hospital care, at $151 a day for Medicare patients, it's meant for people who are going to die. In hospice care, patients agree not to seek care to improve their health, such as more surgeries, hospitalizations or chemotherapy. After a doctor certifies that he expects a person to die within six months, Medicare covers hospice care. Experts say they fear patients will be sent to hospice before their time and miss the proper care that could restore their health. Penalties, Perry said, are a 'good thing' to hold hospitals accountable. 'This isn't about extending hospice.'</blockquote> Summary We have previously discussed, most recently <a href="http://hcrenewal.blogspot.com/2012/03/gentivas-odyssey-healthcare-settles.html">here</a>, allegations that specific for-profit hospice corporations were admitting patients who were not at the end of life just to make more money. The current USA Today article suggests that the phenomenon of hospices enrolling inappropriate patients just to enhance revenue could be more widespread than previously appreciated. The more often hospices enroll patients who are not at the end of life, and/or have not given true informed consent for hospice care, the more patients are likely to suffer needless and wrongful morbidity and injuries, and the more patients are likely to needlessly, and wrongfully die prematurely. It seems to me that unexpected morbidity of, injuries to, or premature death of hospice patients who were not obviously already at the end of life could lead to civil litigation, and even criminal investigation. Furthermore, the realization that hospices, once considered the most humane of health care institutions, are more frequently run for profit, and may put profit ahead of their mission should provoke re-examination of our haste to encourage more and more patient care to be given by for-profit organizations in an era of "greed is good." If we really want better health care, we will have to change policies, practices, and laws so that leaders of health care organizations are motivated more by the desire to help patients than by the desire to become rich.

Who Cares if The Patients Die? - Apparently Not Some Hospice Marketers

An article in USA Today suggests that marketers for hospices are pushing even more aggressive measures to recruit patients, regardless of t...

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