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The Bloat Continues: More Tales of Non-Profit Hospital Executive Compensation

While unemployment remains high, and mortgage foreclosures continue in the US, nothing seems to stop the rise of health care costs, lead by compensation for top health care leaders. So, it is time once again for a round-up of inflated executive compensation at non-profit and government hospital systems.  We will describe the bloat in order of the appearance of the information in public. Cincinnati The December, 2011, the Cincinnati Business Courier <a href="http://www.bizjournals.com/cincinnati/feature/datacenter-hospital-executive.html">tabulated </a>the pay of the best compensated hospital employees, and discussed the results in an <a href="http://www.bizjournals.com/cincinnati/blog/2011/12/in-hospitals-its-not-just-ceos.html">accompanying article</a>.  By my count, 19 local hospital employees made more than $1 million in 2010.  These included 6 system CEO, 4 division CEOs, 5 chief level executives or vice presidents, 1 clinical department chair, and 3 doctors.  The top compensation went to Kenneth Hanover, CEO of Health Alliance/ UC Health, $2,799,338. Three others made more than $2 million. Western New York In January, 2012, Buffalo Business First <a href="http://www.bizjournals.com/buffalo/news/2012/01/23/four-hospital-execs-earn-more-than-1.html">reported</a>: <blockquote>The top hospital administrators in Western New York took home more than $53 million in compensation during 2010, with four executives earning $1 million-plus paydays. Hospital presidents and chief executives at the region’s two largest health systems were among the top earners, with James Kaskie, president and CEO of Kaleida Health , earning $2.36 million; and Joseph McDonald, president and CEO at Catholic Health , earning nearly $1.1 million. Kaskie’s compensation, as well as Kaleida executives Connie Vari, Robert Nolan and Margaret Paroski, included a deferred retirement plan payout. All four were among the top five earners for 2010, the most recent year for which complete data is available.</blockquote> The life of a top hospital executive near Buffalo was not quite as plush as in Cincinnati. Only 4 made more than $1 million, including the CEO, Chief Medical Officer/ Executive Vice President, and Chief Operating Officer of Kaleida Health, and the CEO of Catholic Health System. Eleven more executives got more than $500,000. North Carolina It was a very good year for executives from some of the state's biggest health care systems, per a February, 2012 <a href="http://www.charlotteobserver.com/2012/02/01/2974848/chs-paid-its-ceo-42m.html">article in the Charlotte Observer</a>. <blockquote>Carolinas HealthCare System paid its CEO $4.2 million in 2011, $523,000 more than the year before, as the system celebrated a profitable year and met all of its systemwide goals, according to hospital officials. Chief Executive Officer Michael Tarwater, 58, who has led the $6 billion public hospital system for 10 years, received a base salary of about $1 million, two bonuses totaling $2.5 million, and other compensation, including retirement and health benefits, of about $700,000. That represents a 9 percent increase in base salary and a 14 percent overall increase compared to 2010, when Tarwater's salary was $986,172 and total compensation was $3.7 million.</blockquote> Meanwhile, at Novant Health, <blockquote>The most recent compensation figures for Novant executives are from 2010. In that year, Novant's CEO Paul Wiles, 64, received total compensation of $3.2 million, including his salary of $1 million, a bonus of about $837,000, and $1.37 million in other income, including retirement and health benefits. Wiles retired at the end of 2011 and was succeeded by Carl Armato, who was previously chief operating officer for Novant.</blockquote> A data table within the article showed that there were 10 employees, all executives, at Carolinas Healthcare System in 2011, and 6, again all executives, at Novant Health in 2010, who got more than $1 million in compensation. Why did the Carolinas CEO warrant a multi-million dollar pay package? One of his employees endeavored to explain, <blockquote>'We've had extremely good performance,' said Debra Plousha Moore, the system's chief of human resources. 'All performance goals this year were either met or exceeded.'</blockquote>Why the credit for that performance should not be spread amongst more hospital employees, especially those who actually took care of patients, she did not explain. Northern New York City Suburbs In February, 2012, LoHud.com <a href="http://www.lohud.com/article/20120212/NEWS02/302120060/Business-Medicine-Part-2-Eight-local-hospital-officials-got-1M-2010">reported</a>: <blockquote>Eight executives from 15 Lower Hudson Valley hospitals received more than $1 million in salary, bonuses, benefits and other pay in 2010 at a time when the state struggled to control health-care costs.</blockquote> The details included: <blockquote>Three executives received more in total compensation than Westchester Medical Center CEO Michael Israel, who earned $1.3 million and oversees a hospital that’s more than twice the size of other facilities in the region.</blockquote> Also, <blockquote>The highest-paid hospital employees include White Plains Hospital CEO Jon Schandler with $1.6 million in total compensation, Dr. Edward Lundy at Good Samaritan Hospital in Suffern with $1.48 million and Edward Dinan, CEO of Lawrence Hospital in Bronxville, with $1.41 million. Others in the million-dollar range include John Federspiel, president of Hudson Valley Hospital Center in Cortlandt; Joel Seligman, CEO of Northern Westchester Hospital in Mount Kisco; and Keith Safian, CEO of Phelps Memorial Hospital Center in Sleepy Hollow. A year earlier, Federspiel received a compensation package of nearly $2 million due partly to an $800,000 deferred compensation payout. The average CEO compensation rose 13 percent from 2009, to $939,751. Ten hospitals paid $7.7 million in bonuses to top executives, an increase of 15 percent over 2009. White Plains Hospital alone distributed $2.1 million in bonuses, including $650,000 to Dr. Jesus Jaile-Marti, chief of neonatology, and $575,000 to Schandler.</blockquote> This article highlighted the contrast between compensation for executives and for employees who provide front line care: <blockquote>The high salaries also come as hospitals pressure many employees for wage freezes, rising insurance costs and watered-down pensions, said Deborah Elliott, a nurse and deputy executive officer of the New York State Nurses Association, a statewide union representing nurses at Sound Shore, Mount Vernon, St. John’s Riverside, St. Joseph’s and Nyack hospitals as well as Westchester Medical Center. 'It never ceases to amaze me that we sit at the bargaining table with these executives who are making $1 million and they give us such a hard time about a half-percent increase for a nurse who is making $63,000,' Elliott said. 'It’s galling.'</blockquote>Again, contrast that one half percent with the average chief executive increase of 13%. While it is a rare hospital that would disparage the performance of its dedicated nurses and physicians, somehow executive talent seems to matter more. For example, here is how Hudson Valley Hospital Center president John Federspiel's compensation was justified by his board chair: <blockquote>Edward B. MacDonald Jr., chairman of Hudson Valley Hospital Center’s board of directors, said Federspiel deserves his paycheck. The hospital has earned a profit for 22 of the 25 years that Federspiel has been at the helm and has expanded both its services and payroll in that time, he said. 'He’s the best administrator, planner and motivator I have ever had the privilege to work with,' MacDonald said. 'I wish I could pay him more.'</blockquote>Again, why the CEO, but not the nurses and doctors deserves the credit for the hospital's performance was not stated. Summary It all gets so tedious, doesn't it? CEOs of all but the smallest non-profit hospitals now seem entitled to at least $1 million a year. At larger systems, multiple executives per system seem entitled to that level of compensation, and CEOs may get multiple millions a year. Yet these are ostensibly non-profit organizations dedicated or providing care to their communities, and often to serving the poor. Thus the health care bubble continues to inflate, and executives are ever more distracted by money, and seem less focused on mission. Note that reporting of this ever rising compensation seems to be becoming more perfunctory as the results seem more routine (and tedious). Two of the four articles noted above did not provide any justifications for the high pay, while two only trotted out brief versions of the "our CEO is so brilliant" meme. As I <a href="http://hcrenewal.blogspot.com/2011/12/more-tales-of-hospital-ceo-compensation.html">said in December</a>, in a health care system with ever rising costs, declining access, and stagnant quality, we no longer can tolerate the perverse incentives generated by unaccountably high compensation to top executives. As long as top executives continue their sense of "self-entitlement," and can continue their current management practices reinforced by ever rising pay checks, expect poor leadership to undermine any attempts to improve health care. Tired repetitions of the usual rationales, that the CEOs are brilliant and hard-working, and that their compensation is mandated by the market do not make these rationales true. We need health care leadership that has compassion for the increasing hardships that their patients have to endure, and that puts doing the right thing for patients' and the public's health ahead of self-interest.

The Bloat Continues: More Tales of Non-Profit Hospital Executive Compensation

While unemployment remains high, and mortgage foreclosures continue in the US, nothing seems to stop the rise of health care costs, lead by ...

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Generic Leadership Fine for EHR Implementation in High Acuity, High Risk Areas Such as an Emergency Department?

At my Feb. 16, 2012 post "<a href="http://hcrenewal.blogspot.com/2012/02/hospitals-and-doctors-use-health-it-at.html">Hospitals and Doctors Use Health IT at Their Own Risk - Even if 'Certified'</a>" I established that buyers and users of EHR systems do so at their own risk with regard to implementation problems or outright defects resulting in patient harm. As I've also written at my April 2011 post "<a href="http://hcrenewal.blogspot.com/2011/04/fda-decides-regulating-implantable.html">FDA Decides Regulating Implantable Defibrillator Medical Devices a Political Hot Potato; Demurs</a>", FDA has admitted health IT is a medical device that they shy away from regulating because it's politically expedient not to do so. (The area is a "hot potato" per the Director of FDA's <a href="http://www.fda.gov/MedicalDevices/default.htm">CDRH</a>, the Center for Devices and Radiological Health, so FDA stays away.) Yet FDA knows of the stakes. As I observed at my Aug. 2010 post "<a href="http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html">Internal FDA memorandum of Feb. 23, 2010 to Jeffrey Shuren on HIT risks</a>" and elsewhere, patient harm is occurring due to these devices and FDA is aware. Due to admitted impediments to information diffusion, however, even FDA, IOM, The Joint Commission (due to a "dearth of data" as in their 2008 <a href="http://hcrenewal.blogspot.com/2008/12/joint-commission-sentinel-events-alert.html">Sentinel Events Alert On Healthcare IT</a>) and others do not know the true magnitude of the problem. From the FDA internal memo at the preceding FDA memorandum link: <blockquote> Limitations of the MAUDE [<a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.CFM" style="font-weight: bold;">Manufacturer and User Facility Device Experience database</a>] search and final subset of Medical Device Reports (MDRs) include the following: 1. Not all H-IT safety issue MDRs can be captured due to limitations of reporting practices including ... (a) Vast number of H-IT systems that interface with multiple medical devices currently assigned to multiple procodes making it difficult to identify specific procodes for H-IT safety issues; ... (b) Procode assignments are also affected by the ability of the reporter/contractor to correctly identify the event as a H-IT safety issue; ... (c) Correct identification by the reporter of the suspect device brand name is challenged by difficulties discerning the actual H-IT system versus the device it supports. 2. Due to incomplete information in the MDRs, it is difficult to unduplicate similar reports, potentially resulting in a higher number of reports than actual events. 3. Reported death and injury events may only be associated with the reported device but not necessarily attributed to the device. 4 Correct identification by the reporter of the manufacturer name is convoluted by the inability to discern the manufacturer of the actual H-IT system versus the device it supports. 5 The volume of MDR reporting to MAUDE may be impacted by a lack of understanding the reportability of H-IT safety issues and enforcement of such reporting. ... The results of this data review suggest significant clinical implications and public safety issues surrounding Health Information Technology. The most commonly reported H-IT safety issues included wrong patient/wrong data, medication administration issues, clinical data loss/miscalculation, and unforeseen software design issues; all of which have varying impact on the patient’s clinical care and outcome, which included 6 death and 43 injuries. The absence of mandatory reporting enforcement of H-IT safety issues limits the number of relevant MDRs and impedes a more comprehensive understanding of the actual problems and implications. </blockquote> Finally, as I pointed out in my Dec. 2009 post "<a href="http://hcrenewal.blogspot.com/2009/12/onc-defines-taxonomy-of-health-it.html">ONC Defines a Taxonomy of Robust Healthcare IT Leadership</a>", the Office of the National Coordinator for Health IT at HHS (ONC) had published the following with regard to the qualification of those who could "lead the successful deployment and use of health IT to achieve transformational improvement in the quality, safety, outcomes, and thus in the value, of health services in the United States": <blockquote>Clinician/Public Health Leader: By combining formal clinical or public health training with training in health IT, individuals in this role will be able to lead the successful deployment and use of health IT to achieve transformational improvement in the quality, safety, outcomes, and thus in the value, of health services in the United States. In the health care provider settings, this role may be currently expressed through job titles such as Chief Medical Information Officer (CMIO), Chief Nursing Informatics Officer (CNIO). In public health agencies, this role may be currently expressed through job titles such as Chief Information or Chief Informatics Officer. Training appropriate to this role will require at least one year of study leading to a university-issued certificate or master’s degree in health informatics or health IT, as a complement to the individual’s prior clinical or public health academic training. For this role, the entering trainees may be physicians or other clinical professionals (e.g. advanced-practice nurses, physician assistants) or hold a master’s or doctoral degree(s) in public health or related health field. Individuals could also enter this training while enrolled in programs leading directly to degrees qualifying them to practice as physicians or other clinical professionals, or to master’s or doctoral degrees in public health or related fields (such as epidemiology). Thus, individuals could be supported for training if they already hold or if they are currently enrolled in courses of study leading to physician, other clinical professional, or public-health professional degrees.</blockquote> Here, though, is a more typical reality in today's hospitals, the background of an EHR deployment leader in one of the most risk-prone and difficult environments in healthcare, the Emergency Department (ED) in a large hospital of which I am aware: <div dir="ltr"></div><blockquote><div style="font-weight: bold;" dir="ltr">Clinical Systems Analyst </div> <div style="font-weight: bold;" dir="ltr">January 2004 – Present</div> <div dir="ltr">Project manager for implementation of an ED EHR [vendor name redacted] Responsible for all aspects of implementation including build and process design, report build, testing, training, and go-live support. Extensive knowledge ADT processes, HL7, and CPOE. Manage software patches and upgrades. Experience in HTML, SQL and SAP. </div> <div dir="ltr"> </div> <div dir="ltr">Financial Systems Analyst November 2001 – January 2004 </div> <div dir="ltr">Project Team Lead for implementation of Patient Accounting system. Responsible for system development and system build, training, testing, and reporting. </div> <div dir="ltr"> </div> <div dir="ltr"> </div> <div dir="ltr"> Education </div> <div dir="ltr"> [Regional university in the lower 50% of US News rankings in the region, name redacted] B.S., Management Information Systems 2000 – 2003 </div> <div dir="ltr"> </div> <div dir="ltr"> [Name redacted] Community College </div> <div dir="ltr">Associates Degree, Business Administration</div> </blockquote><div dir="ltr"></div> <div dir="ltr"> So, ED physicians (with many years of doctoral and post-doctoral training and experience, boards testing their competence, etc.) may be placing the lives of patients and their careers in the hands of: <ul><li> An experimental medical device, </li><li>unregulated by anyone, </li><li>in a field whose qualifications for leadership are unregulated by anyone, </li><li>devices known to be risky, </li><li>but without anyone knowing the magnitude of that risk, </li><li>whose implementation is led by a generic 'clinical' systems analyst "responsible for all aspects of implementation" with a Bachelor's degree in MIS from a second-tier institution, an Associates degree from a community college, and no medical or Medical Informatics education or experience whatsoever.</li></ul> Further, that project lead jumped from financial systems analyst to 'clinical' analyst/leader of an ED EHR implementation. One should also ask <ul><li>Who was the hiring manager who hired such a person and put them in the role?</li><li>On what credentials and experience was the decision based? </li><li>What were the hiring manager's own credentials? </li></ul> I leave it to the reader to decide if this is an appropriate arrangement, and if they would place their trust in an ED whose activities center around a cybernetic system implemented in this manner. -- SS Feb. 17, 2012 Addendum: At least in this case the person has degrees. Per several prominent healthcare IT recruiters in the past in the article "Who's Growing CIO's" in the journal Healthcare Informatics, as mentioned at my Sept. 2009 post "<a href="http://hcrenewal.blogspot.com/2008/09/correcting-historical-misinformation.html">Correcting historical information from the recruiter component of the Health IT Ecosystem</a>", the School of Hard Knocks was plenty good for health IT leadership roles: <blockquote>I don't think a degree gets you anything," says healthcare recruiter Lion Goodman, president of the Goodman Group in San Rafael, California about CIO's and other healthcare MIS staffers. Healthcare MIS recruiter Betsy Hersher of Hersher Associates, Northbrook, Illinois, agreed, stating "There's nothing like the school of hard knocks." In seeking out CIO talent, recruiter Lion Goodman "doesn't think clinical experience yields [hospital] IT people who have broad enough perspective. Physicians in particular make poor choices for CIOs. They don't think of the business issues at hand because they're consumed with patient care issues," according to Goodman.</blockquote> -- SS </div>

Generic Leadership Fine for EHR Implementation in High Acuity, High Risk Areas Such as an Emergency Department?

At my Feb. 16, 2012 post " Hospitals and Doctors Use Health IT at Their Own Risk - Even if 'Certified' " I established tha...

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Hospitals and Doctors Use Health IT at Their Own Risk - Even if "Certified"

Due to my observations of confusion about health IT certification [1], and due to vague or incomplete seller language that could be misinterpreted by buyers (perhaps by design), I recently asked several ONC-ATCBs (HHS's Office of the National Coordinator for Health IT-Authorized Testing and Certification Bodies) the following. I sent this question via email to their "questions" email addresses: <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> One ONC-ATCB provided the following in response to my request for information. <div style="margin-left: 40px;">From: Trivedi, Amit V (ICSA Labs) Sent: Thursday, February 16, 2012 11:22 AM To: Scot Silverstein Subject: RE: Form submission from: Contact Us Hello Scot, Thanks for your email. 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. Thanks, Amit Amit Trivedi Program Manager - Healthcare ICSA Labs, an Independent Division of Verizon Business</div> Mar. 5, 2012 Addendum:  I also received a response from another ONC-ATCB, the Drummond Group: <blockquote>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> These are direct and clear statements. My question was certainly answered. ONC cerification 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>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> Health IT testing conspicuously lacks attention to most of the aerospace software safety points above. I note that there appears to be no reasonable excuse for such omissions. IOM has recently studied the issue of HIT safety. IOM states in a Nov. 2011 report that HIT safety and safety testing is unsatisfactory, and has recommended HHS study it as well. IOM recommends HHS annually re-evaluate whether regulation is needed to improve safety, although IOM favors industry self-policing [2]. Thus, buyers and users of even "ONC certified" health IT are not indemnified from liability due to medical errors or problems caused by the health IT. Sellers who exaggerate the value of certification or imply its meaning is akin to FDA device approval, likewise, could be faulted for making false representations about their products. It would appear the sellers could potentially be sued for doing so by purchasers/users who themselves get into legal hot water due to EHR defects or other problems. -- SS Note: [1] I believe confusion about EHR "certification" is in part due to the term itself. I raised objections to this term when it was first proposed based on my experience in pharma, suggesting what I felt was the more accurate expression "features qualification" instead. [2] "Health IT and Patient Safety: Building Safer Systems for Better Care", Institute of Medicine of the National Academies, Nov. 2011, <a href="http://www.iom.edu/Reports/2011/Health-IT-and-Patient-Safety-Building-Safer-Systems-for-Better-Care.aspx">http://www.iom.edu/Reports/2011/Health-IT-and-Patient-Safety-Building-Safer-Systems-for-Better-Care.aspx</a>

Hospitals and Doctors Use Health IT at Their Own Risk - Even if "Certified"

Due to my observations of confusion about health IT certification [1] , and due to vague or incomplete seller language that could be misint...

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Logical Fallacies in Defense of Conflicts of Interest Employed by a Leader of Academic Medicine

We have repeatedly discussed the adverse effects of conflicts of interest on health care.  Recently, I <a href="http://hcrenewal.blogspot.com/2012/02/texas-tmap-trials-as-illustration-of.html">argued</a> that the most pernicious are conflicts of interest created as an incentive for trusted health care leaders, usually respected health care professionals or academics, to promote the vested interests of those who pay them, in the guise of the leaders' professional roles.  In this capacity, the leaders are often dubbed "key opinion leaders" by those who employ them, but may be regarded as mere "salesmen" by the corporate personnel who recruit them. (See posts <a href="http://hcrenewal.blogspot.com/2008/06/key-opinion-leaders-were-sales-people.html">here</a> and <a href="http://hcrenewal.blogspot.com/2010/10/not-best-and-brightest-drug-marketers.html">here</a>)  These relationships may be hidden, often behind confidentiality agreements, unless revealed by litigation.  Documents revealed by discovery in legal actions showed how companies planned other organized stealth marketing efforts for drugs that included activities by KOLs (e.g., see post <a href="http://hcrenewal.blogspot.com/2009/09/lexapro-marketing-plan-was-meant-to.html">here</a> about marketing of Lexapro, and <a href="http://hcrenewal.blogspot.com/2006/08/stealth-marketing-of-neurontin.html">here</a> about Neurontin). However, defenses of conflicts of interest continue to appear regularly.  The latest example, which incorporates an important twist, appeared <a href="http://online.wsj.com/article/SB10001424052970203686204577116374283814362.html">in yesterday's Wall Street Journal</a>.  It was in the form of a "Boss Talk"  interview with a leader of a major health care organization (whose identity we will discuss later.) The title of the interview indicated that the interviewee was not "worried about industry ties" of academia or of health care professionals.  Conflicts of interest were clearly its main focus.  For example, it began, <blockquote>Many universities are wringing their hands over the increasing coziness of medical schools and their corporate partners.</blockquote> Then it stated that the interviewee: <blockquote>has no such qualms.</blockquote> The defense of this lack of qualms was heavily based on logical fallacies. Biased Sample or Hasty Generalization The main reason for this lack of concern appeared to be complete disregard of the more serious kinds of conflict of interest briefly described above. The interviewer asked: <blockquote>What are the trickiest conflicts of interest to navigate?</blockquote> The answer was: <blockquote>Surgery is particularly challenging. Let's say you're a physician and you come up with a new hip replacement. You invented it so you're going to make a lot of money. But if you're going to do my surgery, I want you to put in the device you think is best. How do you separate that, when the person is the inventor and the great technician?</blockquote>This may be tricky, but is arguably not the most tricky kind of conflict of interest. The trickier example of the key opinion leader hired as a salesman was not raised by the interviewer or the interviewee. Such a case was graphically revealed by testimony of the aborted TMAP trial which implicated the former state mental health director as hired by Johnson and Johnson subsidiary Janssen to "promote Risperdal as a safe and effective medication." (See <a href="http://hcrenewal.blogspot.com/2012/02/texas-tmap-trials-as-illustration-of.html">this post</a>.) Industry spokespeople and key opinion leaders themselves tout KOLs as clinical, educational, and/or scientific experts chosen for their expertise to advance medicine, science and public health.  There have been  documented instances (e.g., see posts <a href="http://hcrenewal.blogspot.com/2008/06/key-opinion-leaders-were-sales-people.html">here</a> and <a href="http://hcrenewal.blogspot.com/2010/10/not-best-and-brightest-drug-marketers.html">here</a>) in which defectors from marketing departments of commercial health care corporations described KOLs as salespeople who could be more influential hidden within their professional or academic cloaks.  Even some physicians paid to be speakers on behalf of pharmaceutical corporations have acknowledged their role as salespeople in fancy dress (see post <a href="http://hcrenewal.blogspot.com/2010/11/of-drug-talks-deception-and-denial.html">here</a>).  There are cases of documents revealed by discovery in legal actions that show how companies planned organized stealth marketing efforts for drugs that included activities by KOLs (e.g., see post <a href="http://hcrenewal.blogspot.com/2009/09/lexapro-marketing-plan-was-meant-to.html">here</a> about marketing of Lexapro, and <a href="http://hcrenewal.blogspot.com/2006/08/stealth-marketing-of-neurontin.html">here</a> about Neurontin). Perhaps the interviewee was unaware of these issues.  Whether due to ignorance or deliberate avoidance, failing to consider the full spectrum of conflicts of interest, and specifically ignoring those with the greatest likelihood of adverse effects, appears to be a logical fallacy in this instance.  If deliberate, it appears to be reasoning from an (intentionally) <a href="http://www.nizkor.org/features/fallacies/biased-sample.html">biased sample</a>, if not, it appears to be a <a href="http://www.nizkor.org/features/fallacies/hasty-generalization.html">hasty generalization</a>. The interview also included a few other choice logical fallacies that went unchallenged by the interviewer. False Dilemma The interviewer asked: <blockquote>What do you tell professors who won't work with drug or biotech companies?</blockquote> The response was: <blockquote>I think that's a huge mistake. If you're a professor now, and you want to get your discovery to society, you either need to start a company or work with a company to commercialize a product.</blockquote> Of course, in the "good old days," academic researchers got their "discoveries to society" simply by publishing them. Developing and marketing products based on their discoveries, while worthwhile undertakings in their own rights, were not considered part of the academic mission. Professors could still do this, if their goal was not to get rich. Yet the Bayh-Dole act allowed academic institutions to make money from their professors' discoveries, and the rush to commercialize the university has been on ever since. So while professors and academic institutions who are motivated mainly by money might not consider just putting the knowledge they discover in the public domain, that course remains possible, just not so lucrative. The assertion that the only way to get a "discovery to society" is to start or work with a company is simply false, and using this assertion in an argument appears to be an example of a <a href="http://www.nizkor.org/features/fallacies/false-dilemma.html">false dilemma</a>. Straw Man The interviewee worked another argument into the same paragraph: <blockquote>When professors have told me they won't work with companies anymore because they feel they'll have this scarlet letter, I think: 'Wouldn't that be sad if all the best scientists and clinicians won't work with companies because the public has said they're evil?'</blockquote> I doubt that any of even the most vociferous critics of the conflicts of interest that now befog health care have claimed that those involved are evil, much less that they are have successfully convinced the whole public at large that anyone who "works with companies" is evil. Implying that this would be the result of criticism of conflicts of interest does not appear to be supported by evidence, and is probably flat wrong. Asserting it here appears to be an example of the <a href="http://www.nizkor.org/features/fallacies/straw-man.html">straw man fallacy</a>. Summary So the Wall Street Journal has added to our collection of defenses of conflicts of interest that seem mainly to be based on logical fallacies.  We have noted that logical fallacies are increasingly deployed to defend the status quo in health care, and particularly to defend the interests of those who are profiting the most from the current dysfunctional system.  We have noted that several defenses of the conflicts of interest generated by financial relationships between physicians and medical academics on one hand and commercial health care firms on the other, were based on logical fallacies.  (See examples <a href="http://hcrenewal.blogspot.com/2011/03/once-more-with-feeling-another-defense.html">here</a>, <a href="http://hcrenewal.blogspot.com/2010/11/there-you-go-again-richard-epstein-says.html">here</a>,  <a href="http://hcrenewal.blogspot.com/2009/09/latest-version-of-argument-that-we-are.html">here</a>, and <a href="http://hcrenewal.blogspot.com/2011/09/using-logical-fallacies-to-scold.html">here</a>.)  I have yet to see a coherent, logical, fact-based argument that the benefits for patients' and the public's health of physicians and medical academics working part-time as consultants, advisers, speakers, and directors of health care corporations outweigh the obvious risks of biasing medical decision making, education and research in favor of vested interests. In 2011, I <a href="http://hcrenewal.blogspot.com/2011/09/using-logical-fallacies-to-scold.html">noted</a>, "I have also yet to see an argument in favor of conflicts of interest made by anyone who does not have such conflicts."At least, however, up to that point I had not noted any such arguments made by people who had much power to enforce their views, as opposed to the ability to just express them.  The interview discussed above, however, was a person who has such power. The interview was with Dr Susan Desmond-Hellmann, the relatively new Chancellor of the University of California- San Francisco, who was just <a href="http://www.fiercebiotech.com/special-reports/25-most-influential-people-biopharma-today/susan-desmond-hellmann-25-most-influentia">named</a> one of the "25 most influential people in biopharma."  She has recently been advocating a change of direction towards commercialization for her campus, one of the most prestigious health care oriented universities/ academic medical centers in the country.  She previously justified this redirection again using logical fallacies (look <a href="http://hcrenewal.blogspot.com/2011/10/logical-fallacies-to-support-putting.html">here</a>).  She also appears to yet another advocate for conflicts of interest who has her own conflicts.  As we noted <a href="http://hcrenewal.blogspot.com/2009/05/bio-tech-u.html">here</a>, Dr Desmond-Hellmann had little academic experience before she became Chancellor, but had worked her way up in the corporate pharmaceutical world, leaving her position as President for drug development at Genentech after it was taken over by Roche.  As we <a href="http://hcrenewal.blogspot.com/2011/10/logical-fallacies-to-support-putting.html">noted previously</a>, even after that, Dr Desmond-Hellmann apparently has not completely left the corporate world. - A <a href="http://www.athletepromotions.com/celebrity/Susan-Desmond-Hellmann-appearance-booking-agent.php">web-site</a> for a speakers' bureau in which she apparently still participates lists her as a current "Advisor of Genentech since April 2009." - In 2010, Dr Desmond-Hellmann joined the board of directors of Procter and Gamble, a company which makes many health related products, although it sold its global pharmaceutical business. Last year, the company made an agreement with Teva to market over-the counter medications (see<a href="http://www.reuters.com/article/2011/11/03/teva-pg-idUSN1E7A20BZ20111103"> this Reuters article</a>). Note that she got this position despite apparently not having any prior personal investment in P&G stock. However, per the company's <a href="http://www.pg.com/en_US/downloads/investors/annual_reports/2011/PG_2011_Proxy.pdf">2011 proxy statement</a>, she appears to be in line to collect over $250,000 a year in compensation for this position. It does not seem impossible that these ongoing commercial interests may influence how she acts in her role as Chancellor.  Yet while it may be unsurprising, it is very disappointing that conflicts of interest are now being uncritically and illogically publicly defended by people in positions to exert so much influence on health care. The noted cognitive psychologists George Loewenstein, Sunita Sah, and Daylian Cain just asserted in JAMA [Loewenstein G, Sah S, Cain DM. The unintended consequences of conflict of interest disclosure. JAMA 2012; 307: 669-670. Link <a href="http://jama.ama-assn.org/cgi/content/extract/307/7/669?etoc">here</a>.] <blockquote>Conflicts of interest, including fee-for-service arrangements, are at the heart of the astronomical increases in health care costs in the United States, and transparency is not substitute for more substantive reform.</blockquote> True health care reform requires such substantive reform of the financial arrangements among corporations that sell health care services or products and health care professionals and others who make decisions about patients' or the public's health. To decide how to accomplish such reform, we need a better discussion informed by logic and evidence, sans logical fallacies. Those who lead health care ought to be able to participate in this discussion under these conditions.

Logical Fallacies in Defense of Conflicts of Interest Employed by a Leader of Academic Medicine

We have repeatedly discussed the adverse effects of conflicts of interest on health care. Recently, I argued that the most pernicious are ...

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Congressman Darrell Issa: FDA's email monitoring of "whistleblowers" communicating with Congress was illegal

In followup to my post of Jan. 30, 2012 "<a href="http://hcrenewal.blogspot.com/2012/01/can-you-sue-government-fda.html">Can You Sue the Government? FDA Whistleblowers Sue Over Surveillance of Personal e-Mail</a>" I provide a link to a probing letter from Darrell Issa, Chairman, US House of Representatives Committee on Oversight and Government Reform to Margaret Hamburg MD, Commissioner of the FDA. The letter raises the issue that FDA's email monitoring of "whistleblowers" communicating with Congress was illegal ("unlawful, and will not be tolerated"), and the illegality was further compounded by harassment and retaliation against the "whistleblowers." Many probing "who? why? when?" questions are asked of FDA. I do not have free text of this letter, just a link to images of the letter. I cannot post the text (no access to OCR of a PDF at the moment), but the letter images are here: <a href="http://www.whistleblowers.org/storage/whistleblowers/documents/FDAComplaint/issaletter.fdaspying.pdf">http://www.whistleblowers.org/storage/whistleblowers/documents/FDAComplaint/issaletter.fdaspying.pdf</a> Worth reading in its entirety. -- SS

Congressman Darrell Issa: FDA's email monitoring of "whistleblowers" communicating with Congress was illegal

In followup to my post of Jan. 30, 2012 " Can You Sue the Government? FDA Whistleblowers Sue Over Surveillance of Personal e-Mail ...

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Death at Birth: A Tragedy Caused by Overwork and Undertraining - and Technology

As a result of my recent post "<a href="http://hcrenewal.blogspot.com/2012/02/those-goddamn-trial-lawyers-are-to.html">Plaintiff's Trial Lawyers Are to Blame for EHRs That 'Tattle' on Doctors - And Harm Patients</a>", a malpractice attorney, Patrick Malone in Washington, D.C., sent me a link to a tragic summary of a case his firm handled. The story illustrates the toxic effects that health IT and other technology, especially when not "done well", can have on patient care. I present it below with just a bit of comment, with permission of attorney Malone. Emphases also mine: <div class="bodytext"> <h3></h3></div><blockquote><div class="bodytext"> <div class="description"> <a href="http://www.patrickmalonelaw.com/lawyer-attorney-1838178.html">Death at Birth: A Tragedy Caused by Overwork and Undertraining</a>The Patrick Malone firm represented the family of Keren Kipoliongo, a baby girl who died in her mother’s womb just minutes before the successful Cesarean section delivery of her twin sister Gabrielle.This tragedy occurred at Virginia Hospital Center in Arlington, Virginia in July 2008. At midnight one evening, Mrs. Kipoliongo and her husband presented to the labor and delivery unit at the hospital, as scheduled per their obstetrician’s instructions. The plan was to induce labor with the drug Pitocin (oxytocin) and monitor both babies during the labor with fetal heart monitors, to make sure they could withstand the contractions and be safely delivered by the normal vaginal route.This was the first pregnancy for the couple, and they were excited about the prospects of having twins. They had set up their home in northern Virginia with a nursery with two cribs and two of everything else they would need.The obstetrician whom Mrs. Kipoliongo had seen regularly throughout her pregnancy checked them into the L&D unit and then went to sleep in the doctors’ lounge. He instructed the nurse and a resident physician (doctor in training) to call him if needed.Mrs. Kipoliongo was left alone for large stretches through the night. It wasn’t until a nursing shift change at 7 a.m. that she started to get close attention from the nurses. By that time, baby Keren was in bad shape as shown by fetal monitor patterns in which her heart beat was slowing ominously with the mother’s contractions. She had already shown throughout the overnight period a flattening or lack of variability from beat to beat. (The flattening of the heart rate often means the baby is not getting enough oxygen.) [Why was this not noted and acted upon promptly? Read on - ed.] They finally brought the obstetrician in, and he decided around 8:15 a.m. to do a Cesarean section. Baby Keren was still alive at that point. Unfortunately she died some time over the next hour, because when the doctor finally cut into the mother’s womb after 9 a.m., he found that she was dead, with the umbilical cord wrapped tightly around her neck.When our law firm investigated what had happened on behalf of the family, we found several disturbing facts. These included:<ul><li>Despite the lack of reassuring signs on baby Keren’s heartbeat, the nurses failed to do any of a number of standard things that can improve the baby’s condition, such as turning the mother, giving the mother oxygen, and giving extra fluids.</li><li>The hospital overworked the nurse assigned to Mrs. Kipoliongo’s labor, giving her a second patient for whom she was also primarily responsible. Standards require one-on-one nursing during a labor that is as involved as hers was. The stimulating drug Pitocin requires close monitoring. In addition, Keren was under-sized (a condition called “intrauterine growth restriction”), and that is why they were proceeding with a scheduled birth rather than wait for labor to start on its own. (At autopsy, Keren was found to have completely normal body organs; her only issue was being small.) [I note that the overwork might have included having to interact with an EHR presenting a <a href="http://www.tinyurl.com/hostileuserexper" style="font-weight: bold; font-style: italic;">mission hostile user experience</a>, as I've seen in critical care environments and have worked to specifically avoid when I was in charge <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=Cardiology%20story">as here</a> - ed.] </li><li>Inspection of the computerized hospital record showed that this nurse, Julie Bates Gilpin, made most of her entries in the record hours after the purported observation time, including a whole series of entries after her shift ended. [I have seen this phenomenon myself; some EHR's allow entries even without a time stamp, and the only way to ascertain when entries were made is via discovery of metadata (automatically generated audit trails and other data that shows who manipulated data, and when. Hospitals often resist providing full metadata, despite Federal Rules of Civil Procedure (FRCP) governing e-discovery enacted almost 6 years ago - ed.] </li><li>We asked the nurse at a deposition why her entries showed such regular times of observation, at exactly 15 minutes after the hour, 30 minutes, 45 minutes, etc. She told us that was because she “rounded” on her patients every 15 minutes. But later we discovered – after winning a “motion to compel” in which the judge required the hospital to turn over records of the other patients Ms. Gilpin was monitoring that night (with names blacked out) – that she was also recording the same exact pattern of observations on her other patient, at 15 past the hour, 30, 45, and so on. So when we compared our client’s record with the other patient, it was clear that Nurse Gilpin was making computer entries showing that she was in two places at once. Again, most of these entries were made hours later and back-timed. [I also wonder, during the actual clinical encounter time was the nurse treating the actual patients or the e-Patient, i.e., the 'virtual patient' represented by the computer screens? - ed.] </li><li>We also wanted to know why the alarm on the fetal monitor went off 12 times during the night but was answered only one of those times by Nurse Gilpin. We discovered that these monitors have alarm reset buttons like a snooze button on an alarm clock. You can hit the button and turn off the alarm without doing anything else for the patient. Most of the time, the “snooze button” was hit by a nurse at the nurse’s station. What did this mean? The monitor was supposed to be tracking two separate twin babies. [Not exactly what I would call a "state of the art" alert design - ed.] The alarm would go off when the signal was lost for one baby. The nurses are supposed to reposition the patient so they can pick up the signal again. They didn’t do that for most of the times that the signal was lost. So it turned out that hours went by during the night when nothing was tracked on baby Keren’s heartbeat.</li><li>Even worse, we found out that when we took Nurse Gilpin’s testimony, she no longer remembered how to do her job on the labor and delivery unit even though she had worked there up until a few months before the time of her deposition. We asked her how a nurse reads the fetal monitor and what are bad signs for the baby, and she said she didn’t know.</li><li>And even worse than that (the wrongdoing kept piling up in this case as we continued our investigation), the resident doctor, whose name was Dr. Sahardat Nurudeen, and who was the only physician monitoring our client’s labor progress for nearly eight hours, also claimed at her deposition that she couldn’t read a fetal monitor tracing even though she was in training to become an obstetrician. (In fact, she had completed her full obstetric residency and was preparing for her board certification test at the time of her deposition.) We say “claimed,” because it could be that she just wanted to avoid answering tough questions at the deposition about individual segments of Keren’s monitor strips. Either way, it wasn’t good for high quality, accountable patient care.</li></ul>We finally concluded that there were many chances during that night to save Keren’s life, but the understaffing and overwork and apparently poor training (how could a nurse or a young doctor forget how to read a fetal monitor, a basic part of their training?) [and the toxic effects of ill-conceived and ill-implemented technology - ed.] led to an unnecessary tragedy. </div> </div></blockquote> This story should give pause to technophiles in medicine who ignore technology's possible downsides, and the clinicians who are compelled to center their clinical lives around such technology (while the purveyors of that technology are often <a href="http://jama.ama-assn.org/content/301/12/1276.extract">held harmless</a> by hospital executives <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=koppel_kreda">in violation of the latter's fiduciary responsibilities</a>). -- SS

Death at Birth: A Tragedy Caused by Overwork and Undertraining - and Technology

As a result of my recent post " Plaintiff's Trial Lawyers Are to Blame for EHRs That 'Tattle' on Doctors - And Harm Patient...

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Those Goddamn Plaintiff's Trial Lawyers Are to Blame for EHRs That 'Tattle' on Doctors - And Harm Patients

It seems the EHR technophiles are starting to notice one of the side effects of EHR technology: the liabilities EHRs impose on users. Interestingly, those liabilities are presented below as the fault not of a cavalier industry receiving extraordinary governmental and regulatory accommodation compared to other healthcare sectors that, among other issues, have allowed it to (see hyperlinks for more information): <ul><li>Disregard practices of <a href="http://sydney.edu.au/engineering/it/%7Ehitru/essays/Pt%206%20-%20Comparison%20between%20ERD%20and%20Relational%20Schemata.pdf">good software engineering</a>, <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/Patient%20Safety%20and%20Health%20IT%20prepub.pdf">product safety</a> and <a href="http://hcrenewal.blogspot.com/2011/10/nist-on-ehr-mission-hostile-user.html">human factors issues</a> (usability), </li><li>Ignore tenets of good information presentation yielding literal <a href="http://hcrenewal.blogspot.com/2011/02/electronic-medical-records-two-weeks.html">reams of 'legible gibberish'</a> masquerading as medical records that confuse attorneys on both sides of the Bar as well as clinicians, </li><li>Flout proper conduct of <a href="http://ohsr.od.nih.gov/guidelines/index.html">human subjects experimentation</a> e.g. without <a href="http://hcrenewal.blogspot.com/2009/03/draft-patient-rights-statement-and.html">informed consent</a>,</li><li>Avoid appropriate methodologies for <a href="http://en.wikipedia.org/wiki/Randomized_controlled_trial">medical device trials</a> (all the while promoting the data these devices generate as 'revolutionizing healthcare'),</li><li>and more as covered on this site and at my Drexel University educational site <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/">at this link</a>. </li></ul> Instead, the liabilities are presented as the fault of plaintiff trial lawyers, who need to be disempowered through yet another special accommodation for health IT. My comments are interspersed in [red italics]: <blockquote>Feb. 8, 2012 The Wall Street Journal MarketWatch <a href="http://www.marketwatch.com/story/healthcare-it-expert-exposes-hidden-risks-of-lawsuits-due-to-electronic-health-record-2012-02-08" style="font-weight: bold;">Healthcare IT Expert Exposes Hidden Risks of Lawsuits Due to Electronic Health Record </a> Spokesperson Says Electronic Health Records May Give Crippling Access to Physician's Actions and Increase the Need for Defensive Medicine [Crippling access to physician's actions? That is an odd combination of terms - ed.] DELRAY BEACH, Fla., Feb 8, 2012 (GlobeNewswire via COMTEX) -- Since the American Recovery and Reinvestment Act (ARRA) passed in February 2009 and caused a digital tsunami in the healthcare industry, physicians have been scrambling to comply with the requirement to switch to electronic health record systems. (EHRs) While many in the healthcare industry laud the use of EHRs to improve quality of care and analyzing patient outcomes, Dr. Sam Bierstock, founder of Champions In Healthcare, points out significant concerns regarding increased vulnerability to medical legal claims that may result from the use of EHRs without major tort reform that would relieve physicians of an onslaught of malpractice suits. "EHRs unquestionably have the potential to improve patient safety and the quality of care delivered, but what few people realize is that using an EHR exposes physicians to an Orwellian level of analysis of every single act while doing their job," said Bierstock, who has advocated and pioneered the use and benefits of EHRs for more than 30 years." EHRs, however, can also be audited to examine how long it took them to act after an abnormal lab result came in, if the doctor checked on on-line references before making a clinical decision, what was said in every email and how long the doctor took to respond, and even how long the doctor looked at a screen or scrolled down to read an entire document. [Why, exactly, this is a bad thing, I do not understand; it seems hypocritical. After all, any data collected that can help improve healthcare has been deemed golden - up to now - ed.] Physicians are exposing themselves to an unacceptable level of scrutiny and analysis of their use of computers that may serve to encourage malpractice suits. ["Unacceptable level of scrutiny" is largely a code phrase for <a href="http://library.ahima.org/xpedio/groups/public/documents/ahima/bok1_036537.hcsp?dDocName=bok1_036537">audit trails and other 'metadata'</a>, i.e., automatically generated computer data that shows who accessed or modified a document or other data, when, from where, etc. I ask - access to this data is unacceptable to whom? Injured patients? - ed.] Meaningful tort reform is essential to getting the maximal benefit from these wonderful systems. [Wonderful systems, when even the IOM admits we don't know the level of harm they cause, the NIST indicates they are poorly usable, and so forth <a href="http://hcrenewal.blogspot.com/2011/02/updated-reading-list-on-health-it.html">as here</a>? - ed.] According to Bierstock, the problem runs even deeper because during his career as an industry consultant with Champions in Healthcare, and as a speaker at healthcare events he has noticed that the vast majority of physicians are still not aware of the complex requirements imposed upon them by the Health Information Technology for Economic and Clinical Health (HITECH) Act even though it has been a law for more than two years. [I agree with the statement "imposed upon them", but this imposition was largely at the hands of the HIT pundits, the 'Ddulites' (technophiles who ignore technology's downsides, the opposite of 'Luddites', <a href="http://hcrenewal.blogspot.com/2012/02/health-it-ddulites-and-irrational.html" style="font-weight: bold;">link</a>), and various species of non-medical profiteers - ed.] "I talk to many physicians who have no idea they can suffer financial, civil and even criminal penalties (i.e. jail) for non-compliance.," said Bierstock. "I have been asked to speak about this topic many times, but beyond HITECH, it's my opinion that similarly, doctors and hospitals don't yet fully realize their medical legal vulnerability associated with the use of EHRs. [They will learn, fast, with Medical Informatics specialists such as myself on patients' side instead of on the side of the health IT industry - ed.] This will be the case until there is major tort reform, which has unfortunately been thwarted by the influence of American Trial Attorneys and their associations." [You see, it's all the fault of the evil Plaintiff's Bar - ed.] Bierstock noted that in an effort to stimulate physicians and hospitals to install and use EHRs, The American Reinvestment and Recovery Act of 2009 also authorized the Centers for Medicare and Medicaid Services (CMS) to issue guidelines which define what is "Meaningful Use" of an EHR - guidelines which must be met in order for hospitals and doctors to receive financial incentive payments for using EHRs, or be penalized by having Medicare or Medicaid payments reduced for failure to meet the guidelines. [Unfortunately, they did not formulate guidelines for safety. Thus, as Sharona Hoffman, JD notes in <a href="http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1697587" style="font-weight: bold; font-style: italic;">MEANINGFUL USE AND CERTIFICATION OF HEALTH INFORMATION TECHNOLOGY: WHAT ABOUT SAFETY?</a>, "General system safety is a property that is attainable only through rigorous processes for development and evaluation. However, the regulations do not address certification of EHR vendors’ software development processes or even require vendors to analyze and mitigate potential safety hazards. Furthermore, ATCBs will use testing requirements developed by the National Institute of Standards and Technology (NIST) that are apparently intended only to determine whether systems include certain features. Passing such tests is not sufficient to ensure that those features function properly in the long term and under varied operating conditions." - ed.] Bierstock believes that if physicians are expected to embrace EHRS, they should be allowed to do so in a manner that maximizes the benefits of these systems to the delivery of care and to the benefit of their patients without worrying about giving unlimited ammunition to trial lawyers. [Perhaps the EHR pundits should have foreseen this eventuality before pushing the current administration to mandate national EHR rollout. It didn't take a rocket scientist to do so - ed.] "Quite simply, physicians may be in a situation that leaves them vulnerable to litigation and threatens loss of their professional standing and personal assets -- all because an external evaluator [e.g., a trial lawyer, judge or jury -ed.] may not think the physician lived up to arguable standards in the digital age," said Bierstock. "Overall, EHRs are the litigator's proverbial golden goose. They are to malpractice attorneys what the electron microscope is to microbiology." [In other words, EHRs deserve yet another special accommodation, this time regarding legal Discovery, in addition to the many other special accommodations this industry has received. In fact, EHRs make available only that which they are designed to, and discoverability of that information is a Federal matter under the <a href="http://www.fiosinc.com/case-law-rules/e-discovery-federal-rules-civil-procedure-frcp.aspx" style="font-weight: normal;">Federal Rules of Civil Procedure (FRCP) governing e-discovery </a>- "On December 1, 2006 the Federal Rules of Civil Procedure were revised to address numerous e-discovery issues. Rules 16,26,33,34,37 and 45 require attorneys to pay specific attention to electronic discovery issues. E-Discovery practices and strategies need to be reviewed and aligned with the updated rules to ensure compliance." - ed.] </blockquote> I find requests for additional special accommodations for EHR's over other medical devices and IT in other industries (e.g., airplane black boxes and cockpit recorders that monitor the every move of pilots) to be illustrative of the concept "be careful, you may get what you wish for." That plaintiff trial lawyers are blamed for quite properly using the Federal Rules of Civil Procedure to assure justice for victims of medical malpractice, including EHR-related medical malpractice, is outrageous. It seems the pundits might be starting to panic, after realizing the "data utopia" that is going to "revolutionize medicine" has a downside. -- <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/biography.htm">S. Silverstein, MD</a> Feb. 14, 2012 Addendum: It seems the clinical data itself generated by today's health IT - garnered while putting patients at risk and costing many billions of dollars - might not be anywhere near as trustworthy as advertised by the technophiles. See "<a href="http://aushealthit.blogspot.com/2012/02/it-seems-we-are-not-only-ones-bumping.html">It Seems We Are Not The Only Ones Bumping Up Against EHR Data Quality Issues. PCEHR Implications Are Worth Considering</a>" at the Australian Health Information Technology blog by Dr. David More, MB PhD FACHI, and the <a href="http://jamia.bmj.com/">JAMIA</a> articles he references. Dr. More observes: <blockquote>... If ever there was an example of “garbage in, garbage out” in operation this has to be it. There has to be a great deal of care taken as we move from the most simplest data sharing to more complex efforts.</blockquote> -- SS

Those Goddamn Plaintiff's Trial Lawyers Are to Blame for EHRs That 'Tattle' on Doctors - And Harm Patients

It seems the EHR technophiles are starting to notice one of the side effects of EHR technology: the liabilities EHRs impose on users. Inter...

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