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Justice Delayed - Two Device Companies Still Settling Cases from 10 Plus Years Ago

Here we go again.  After a hiatus during which the US media and perhaps parts of the government were preoccupied with such issues as the ongoing controversy over health care reform, and a government shutdown apparently arising out of this controversy, the <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">march of legal settlements</a> involving big health care organizations has resumed. In alphabetical order,... Boston Scientific <a href="http://www.startribune.com/business/228211891.html">From</a> the Minneapolis Star-Tribune on 17 October, 2013, an account of a settlement arising from alleged misbehavior that started in 2002, <blockquote class="tr_bq">A $30 million settlement between the U.S. Department of Justice and Boston Scientific will likely end a case involving the sale of defective heart devices from 2002 through 2005 by subsidiaries Guidant, Guidant Sales and Cardiac Pacemakers.</blockquote> Note that the allegations were particularly egregious since they involved a company selling products they knew to be defective in ways that could prove fatal as if they were quite safe, <blockquote class="tr_bq">The settlement closes a fraudulent-claims lawsuit that alleged Guidant knowingly sold defective implantable defibrillators to health care facilities that implanted them into thousands of Medicare patients. </blockquote> In particular, <blockquote class="tr_bq">The government’s complaint said that Guidant knew as early as April 2002 that its Prizm 2 line of devices was defective and knew in November 2003 that its Renewal 1 and 2 devices were capable of short-circuiting and delivering an electric shock that 'arcs' back onto the device instead of being directed to an irregularly beating heart. According to Boston Scientific’s website, 83 malfunctions and nine reported deaths have been connected with the Renewal devices and 40 confirmed malfunctions and five patient deaths have been associated with the Prizm devices. About 500 Renewal devices remain implanted worldwide; about 1,400 Prizm devices remain in patients, according to the website. Although Guidant took action to fix the defects, the government alleged that the company continued to sell its remaining stock of the old, defective versions of the devices. In fact, federal officials say that as Guidant learned about the cause of the defect, it took steps to hide the problem from patients, doctors and the Food and Drug Administration. According to the government, Guidant did not fully disclose the problem until May 2005, when two Minneapolis doctors publicly aired their concerns about one of the defibrillators after it failed to revive a 21-year-old Grand Rapids, Minn., patient. Guidant later admitted it had known for three years that the device could short-circuit, but chose not to alert doctors or the public.</blockquote> This is only the latest settlement made by Boston Scientific since 2005, <blockquote class="tr_bq">Boston Scientific paid $27.5 billion to acquire Guidant in 2006. It has been paying quite a bit since in relation to Guidant’s defective defibrillators. In 2007, Boston Scientific paid $240 million to settle claims with thousands of patients who had sued Guidant after the defective devices were recalled. Later, in February 2010, Guidant pleaded guilty to misleading the FDA about problems with the devices and paid a fine of $296 million.</blockquote> In fact, the then case of the allegedly concealed implantable cardiac defibrillators (ICD) was one of the first cases of apparently unethical health care corporate management behavior leading to bad patient outcomes we <a href="http://hcrenewal.blogspot.com/2005/05/guideants-short-circuit.html">discussed</a> on Health Care Renewal.  (Look <a href="http://hcrenewal.blogspot.com/2011/01/guidant-boston-scientific-gets.html">here</a> for a more recent summary of this case.) Yet despite the fact that this apparently deeply unethical conduct lead to patient deaths, no individual who authorized, directed or implemented the bad behavior has suffered any negative consequences for it over the eight years since the details first became public. One physician who helped bring this case to light was also apparently concerned about the impunity of those responsible, <blockquote class="tr_bq"> Dr. Robert Hauser, one of the doctors who went public back in 2005, criticized the settlement on Thursday. 'The $30 million should have little impact on their business,' Hauser said in an e-mail. 'I find it very disturbing that such a small settlement was accepted by the DOJ in view of the magnitude of wrongdoing by Guidant management.' </blockquote> Stryker Corp This week, MLive.com <a href="http://www.mlive.com/business/west-michigan/index.ssf/2013/10/stryker_to_pay_132_million_to.html">reported</a> on another settlement involving allegations of unethical behavior by a device company dating back to 2003, <blockquote class="tr_bq"> An investigation by federal authorities found that Stryker Corp. subsidiaries in five foreign countries made illicit payments and tried for several years to bribe doctors, health care professionals and government-employed officials in order to obtain or retain business. Stryker <a href="http://topics.mlive.com/tag/Stryker/index.html"> </a>has agreed to pay more than $13.2 million to settle the charges. The SEC charged the Kalamazoo-based medical technologies company with violating the Foreign Corrupt Practices Act,  alleging that its subsidiaries in Argentina, Greece, Mexico, Poland and Romania made illicit payments totaling approximately $2.2 million 'that were incorrectly described as legitimate expenses in the company’s books and records.' The SEC said descriptions of the payments varied from a charitable donation to consulting and service contracts, travel expenses, and commissions. The SEC states that Stryker made about $7.5 million in illicit profits as a result of the improper payments. It did not specify during what year all of the events occurred, but indicated some as far back as 2003.</blockquote> Note that the payments seemed deliberately designed to corrupt health care professionals and managers, for example, <blockquote class="tr_bq">According to the SEC’s order, Stryker’s subsidiary in Greece made a purported 'donation' of nearly $200,000 in 2007 to a public university in Greece to fund a laboratory that was a pet project of a public hospital doctor. In exchange for the payment, the doctor agreed to provide business to Stryker.</blockquote> Also, <blockquote class="tr_bq">The SEC stated that its investigation also found that Stryker subsidiaries bribed foreign officials by paying their expenses for trips that lacked any legitimate business purpose. 'For example, in exchange for the promise of future business from the director of a public hospital in Poland, Stryker paid travel costs for the director and her husband in May 2004,' according to the SEC. 'This included a six-night stay at a New York City hotel, attendance at two Broadway shows, and a five-day trip to Aruba.'</blockquote> As in the case above, it appears that no individual who authorized, directed or implemented the questionable payments will suffer any negative consequences.  In fact, as is usual in such cases, <blockquote class="tr_bq"> The settlement does not not require Stryker to admit or deny the allegations,...</blockquote> However, an SEC official did say, <blockquote class="tr_bq"> Stryker’s misconduct involved hundreds of improper payments over a number of years during which the company’s internal controls were fatally flawed. Companies that allow corruption to occur by failing to implement robust compliance programs will not be allowed to profit from their misconduct.</blockquote> While Health Care Renewal has not discussed this particular case before, it is hardly the first case of bad conduct by Stryker that we have discussed.  In the past we noted -  In 2012, a Stryker subsidiary pleaded guilty to misbranding in response to allegations that its marketers conspired to defraud physicians in order to sell a product to promote bone growth that proved harmful to patients (look <a href="http://hcrenewal.blogspot.com/2012/01/unequal-justice-under-law-comparing.html">here</a>). -  In 2010, Stryker settled a case alleging unfair and deceptive sales practices again used for bone growth accelerators (look <a href="http://hcrenewal.blogspot.com/2010/09/at-end-of-summer-everybody-well-nearly.html">here</a>).   -  In 2009, some apparently low-level Stryker employees pleaded guilty to promoting off-label use of these same products (look <a href="http://hcrenewal.blogspot.com/2009/02/three-troubled-device-companies.html">here</a>).  - In 2007, Stryker made an agreement allowing federal supervision after charges one of its units had violated anti-kickback laws when making supposed "royalty" payments, often huge, to orthopedic surgeons in connection with its production of prosthetic hips and knees.  Several other device companies signed deferred prosecution agreements, and as a result, for a time all had to make public their payments to doctors and various non-profit organizations.  (See summary <a href="http://hcrenewal.blogspot.com/2007/11/more-about-surgeons-who-received-large.html">here</a>.)  Summary  This recent crop of settlements has some features in common.  The settlements involved multinational device companies.  The settlements occurred at least a decade after the alleged bad behavior started.  The settlements required only small payments - at least on a corporate scale -from the companies involved, but no negative consequences for anyone who authorized, directed, or implemented the bad behavior.  Finally, the settlements were made by companies who had striking past records of previous settlements of bad behavior. The <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">march of legal settlements</a> demonstrates the pervasiveness of unethical behavior, often involving harm to patients or sullying of health care professionals, involving large, rich health care corporations.  It also demonstrates the impunity of the top leaders of such corporations who often make huge amounts of money despite, or perhaps because of their companies' misconduct.  Despite intermittent threats by US government officials to get tough with unethical behavior by health care corporations, this pattern has continued for years, as we have documented.  True health care reform would hold leaders of health care organizations accountable for their organizations' behavior, and its effects on patients and health care professionals.

Justice Delayed - Two Device Companies Still Settling Cases from 10 Plus Years Ago

Here we go again. After a hiatus during which the US media and perhaps parts of the government were preoccupied with such issues as the on...

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Former FDA Commissioner, CMS Administrator McClellan adds Johnson and Johnson Board Membership to Positions with General Atlantic LLC, Capital Royalty, Castlight Health, and AvivReit

Our latest example of the interchangeability of top insiders within corporate health care and the government agencies that are supposed to regulate corporate health care comes via an <a href="http://www.investor.jnj.com/releaseDetail.cfm?ReleaseID=796836&year=2013">announcement</a> from Johnson and Johnson, <blockquote class="tr_bq">Johnson & Johnson (NYSE: JNJ) announced today that Mark B. McClellan, M.D., Ph.D., Senior Fellow in Economic Studies, and Director of the Initiative on Value and Innovation in Health Care, Brookings Institution, will join the Board of Directors on October 15, 2013.  Dr. McClellan will serve on the Regulatory, Compliance & Government Affairs Committee and the Science, Technology & Sustainability Committee of the Board. As former commissioner of the U.S. Food and Drug Administration (FDA) from 2002 to 2004, and as the former administrator of the Centers for Medicare & Medicaid Services for the U.S. Department of Health and Human Services from 2004 to 2006, Dr. McClellan has more than two decades of public service and academic research experience. From 2001 to 2002, he served as a member of the President's Council of Economic Advisers and senior director for health care policy at the White House. During President William J. Clinton's administration, Dr. McClellan held the position of deputy assistant secretary of the Treasury for economic policy.</blockquote> So Dr McClellan has gone from running the US Food and Drug Administration, the primary government regulator of the pharmaceutical industry, to stewardship of one of the biggest pharmaceutical (and biotechnology and device) companies. Not noted in that announcement was that Dr McClellan has been collecting positions in health care corporations since at least 2009.  The examples I found included in chronological order: 2009 - General Atlantic LLC This appears to be a private equity firm which <a href="http://www.generalatlantic.com/about-us/a-proud-legacy/">claims</a> to be a "leading global investment firm." From a 2010 a Mergers & Acquisitions <a href="http://www.themiddlemarket.com/news/General-Atlantic-Adds-Healthcare-Vet-201877-1.html">article</a>, <blockquote class="tr_bq">A year ago, the firm hired Dr Mark McClellan, previously a commissioner of the Food & Drug Administration, to its healthcare practice as a special advisor.</blockquote> According to the firm's <a href="http://www.generalatlantic.com/people/special-advisors/">current website</a>, he is still a special advisor.   2010 - Capital Royalty LP In a 2010 <a href="http://www.capitalroyalty.com/news/item/firm-news/capital-royalty-establishes-strategic-advisory-committee/">press release</a>, this apparently private equity firm claimed to be <blockquote class="tr_bq">a market pioneer and innovator in healthcare investing with a focus on intellectual property investments in FDA-approved biopharmaceutical assets</blockquote> In that release, it announced the creation of a Strategic Advisory Committee that included Dr Mark McClellan.  He <a href="http://www.capitalroyalty.com/about-us/strategic-advisory-committee/dr.-mark-mcclellan-md-phd/">still sits</a> on that committee.  2012 - Castlight Health In a 2012 <a href="http://www.castlighthealth.com/2012/mark-mcclellan-joins-castlight-health%E2%80%99s-advisory-board/">press release</a>, this firm claimed to be <blockquote class="tr_bq">developer of a personalized health care shopping portal offering unbiased information about health care cost and quality</blockquote> That press release announced the addition of Dr McClellan to the firm's Advisory Board, <a href="http://www.castlighthealth.com/company/advisory-board/">on which</a> he still sits.  2013 - AvivReit This firm "specializes in the ownership and triple-net leasing of post-acute and long-term care skilled nursing facilities (SNFs)" per its <a href="http://www.avivreit.com/about-aviv/">website</a>. Dr McClellan is currently on its <a href="http://ir.avivreit.com/od.aspx?iid=4328838">board of directors</a>.  He apparently was appointed in 2013.  Notably, I did not see anything in any of these firms' announcements about Dr McClellan or their biographies of him that noted his board or advisory committee positions with other firms. Summary Dr Mark McClellan rose through the ranks in the US executive branch ending with positions as FDA commissioner and administrator of the Center for Medicare and Medicaid Services (CMS) within the Department of Health and Human Services (DHHS).  He served under two presidents, Clinton and George W Bush.  Within 3 years of exiting DHHS, he picked up his first important commercial position, at General Atlantic LLC, and then added other positions with Capital Royalty, Castlight Health, AvivReit, and now the biggest of all, Johnson and Johnson.  Meanwhile he apparently continues at the Brookings Institution.  He must be one very busy man. This case could be lumped with those of another former FDA commissioner and Secretary of Health and Human Services who ended up as a Director of Medtronic (see <a href="http://hcrenewal.blogspot.com/2011/10/former-us-secretary-of-health-and-human.html">this post</a>),  another Secretary of DHHS who ended up on the boards of multiple health care corporations (see <a href="http://hcrenewal.blogspot.com/2011/06/embedded-networks-of-influence-in.html">this post</a>), a director of the National Institutes of Health (NIH) who became a Sanofi executive, etc, etc (see <a href="http://hcrenewal.blogspot.com/2010/12/former-nih-director-spins-trhough.html">this post</a>). While some might argue whether his acquisition of a leading advisory position with a private equity firm three years after he left DHHS technically constituted a spin through the <a href="http://hcrenewal.blogspot.com/search/label/revolving%20doors">revolving door</a>, Dr McClellan's cumulative acquisition of four more such positions within the following four years certainly demonstrates how our corporate dominated health care system and the government agencies which are supposed to be regulating it to assure the health and safety of patients, and the maintenance of the public health seem to be run by an interchangeable cast of insiders.  We have asked before whether we can trust federal regulators to put patients' and the public's health first when they know they could easily become  candidates for lucrative private positions in the companies they regulate, or which are affected by their regulations, presumably assuming they have not done too much during their time in government to offend the leaders of such companies. We have noted that the system in which government and big corporations largely overlap in terms of their leadership and presumably goals is called <a href="http://hcrenewal.blogspot.com/search/label/corporatism">corporatism</a>.  One can argue that such systems end up being run primarily for the benefit of corporate and government insiders.  Until we dispel the fog of corporatism that has spread over the government that was once supposed to be of the people, by the people, and for the people, expect no real health care reform, and expect continuing rising costs, declining access, and worsening patient care. Obviously, true health care reform would start with the government and its officials putting patients' and the public's health first, way ahead of the financial comfort of corporate leaders. I would note that neither the currently controversial and now operational Affordable Care Act, nor any of its opponents schemes for alternatives addresses this issue. by Roy M. Poses MD for Health Care Renewal

Former FDA Commissioner, CMS Administrator McClellan adds Johnson and Johnson Board Membership to Positions with General Atlantic LLC, Capital Royalty, Castlight Health, and AvivReit

Our latest example of the interchangeability of top insiders within corporate health care and the government agencies that are supposed to r...

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A new and very interesting EMR "glitch" - no warnings on stopping a medicine that diminishes the effects of a second medication

A new and very interesting EMR "glitch" from a report I received recently: <blockquote class="tr_bq">... I found a glitch with my [name redacted] EMR. It probably happens with all EMRs. I had a patient on primidone (<a href="http://en.wikipedia.org/wiki/Primidone">http://en.wikipedia.org/wiki/Primidone</a>) for essential tremor. Later, his primary care put her on warfarin [a "blood thinner" - ed.] for atrial fibrillation. Some time after that, I took her off of primidone.  Her INR jumped to 7 or 8. [High - ed.] What happens is that the EMRs warn a physician pretty well if you START a medicine that interacts with warfarin, but fails to warn if you STOP a medicine that interacts with warfarin. If you are used to relying on your EMR to warn you about drug interactions, you can fall into this trap easily, as I found out. Luckily, the patient was not harmed. </blockquote> In other words, if a medication that interacts with another medication by suppressing the latter's effects to some degree is discontinued, EMRs may not warn of it.  Stopping the former can accentuate the effects of the latter, and disaster can result.  A primidone metabolite, phenobarbital, decreases INR and the anticoagulant effects of warfarin (<a href="http://www.medscape.com/viewarticle/745645_3">http://www.medscape.com/viewarticle/745645_3</a>).  Stop primidone, but continue warfarin, and ... wham. The alert algorithms were apparently not designed with this eventuality in mind ... probably because the designers never thought of this issue.  Medicine is not as easy as it might appear to the outside, non-expert observer. -- SS

A new and very interesting EMR "glitch" - no warnings on stopping a medicine that diminishes the effects of a second medication

A new and very interesting EMR "glitch" from a report I received recently: ... I found a glitch with my [name redacted] EMR. It pr...

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The Mystery of the Fugitive Founder (and Longterm President of an Offshore Medical School for US Students)

We recently <a href="http://hcrenewal.blogspot.com/2013/09/quality-vs-costs-of-us-corporate-owned.html">wrote</a> about for-profit medical schools located offshore from the US, but catering to American students, not students from the countries in which they operate.  Now some new media reports raise further questions, if not mysteries about another set of such schools.   Two Bloomberg articles on a trial underway focused on the alleged use of offshore accounts to avoid US taxes.  These accounts were connected to the former long-term President and founder of two offshore medical schools, and his spouse, a dean at one of the schools.   The <a href="http://www.bloomberg.com/news/2013-10-08/caribbean-medical-school-founder-faces-trial-over-swiss-accounts.html">first Bloomberg article</a> opened thus: <blockquote class="tr_bq">Patricia Hough, according to her lawyers, is an altruistic psychiatrist who helped her husband build two Caribbean medical schools. To prosecutors, she is a tax cheat who used offshore accounts to avoid paying taxes on millions of dollars from the schools’ sale. Jury selection began today in federal court in Fort Myers, Florida, where Hough, 67, is accused of using accounts at UBS AG, the largest Swiss bank, and elsewhere to hide assets and income from the Internal Revenue Service, including almost $34 million she and her husband made when the schools were sold in 2007. </blockquote> The Bloomberg article asserted, <blockquote class="tr_bq"> At the heart of the case is whether she misused accounts associated with the Saba University School of Medicine Foundation. </blockquote> The main question to me is not whether Dr Hough is guilty or innocent, which I cannot tell.  There are more intriguing  mysteries raised by this case. How Did Non-Profit Medical Schools Become For-Profit?   According to Bloomberg, <blockquote class="tr_bq">  Hough’s lawyers say she helped [her husband, David] Fredrick build Saba University School of Medicine, on the island of Saba in the  Netherland Antilles, and the Medical University of the Americas, or MUA, on Nevis in the West Indies.</blockquote> To do so, <blockquote class="tr_bq"> Through the Saba foundation, which they first funded in 1988, according to a government trial brief filed Oct. 3, the couple opened the Saba University School of Medicine in 1993. Fredrick served as president and a foundation director. Hough was associate dean for clinical medicine. </blockquote> Also, <blockquote class="tr_bq">In 1999, Fredrick and Hough began the Medical University of the Americas, a for-profit school on Nevis in the West Indies, according to the government filing. </blockquote>There seems to be no question that the schools were started by a foundation based in the Netherland Antilles.  A <a href="http://www.mbc.ca.gov/applicant/site_visits_saba.pdf%E2%80%8E">report of a site visit</a> of the Saba University School of Medicine by the Division of Licensing of the Medical Board of California in 2004 summarized this history, <blockquote class="tr_bq">In 1986, the government of the Netherlands Antilles proposed to a group of American educators that a medical school be established on the small island of Saba, N.A.  It was to be relatively small, of high quality and established for the dual ppurpose of benefiting the economy of the island (of only 1500 population) and attracting N.A. citizens to medical careers in the N.A. A committee of Dutch citizens from Curacao, the seat of the N.A. government, approved the preliminary plans and the school was founded as a non-profit foundation under Dutch law....</blockquote> The Saba University <a href="http://www.saba.edu/saba/index.php/about-saba/about-saba-university/accreditations">website</a> still states that the school is accredited in the Netherlands, <blockquote class="tr_bq">Saba University School of Medicine’s Doctor of Medicine (M.D.) program is accredited by the <a href="http://nvao.net/" target="_blank">NVAO</a> (in Dutch: Nederlands-Vlaamse Accreditatieorganisatie). The NVAO is the Accreditation Organization of the Netherlands and Flanders. This organization was established by international treaty and ensures the quality of higher education in the Netherlands and Flanders.</blockquote> So apparently Saba University was started as a non-profit organization meant to focus on medical education for the Netherlands Antilles, and thus accredited there.  But then, somehow,  according to Bloomberg. <blockquote class="tr_bq">Equinox Capital, a private-equity firm based in Greenwich, <a href="http://topics.bloomberg.com/connecticut/">Connecticut</a>, bought the Saba school and MUA for $36 million in 2007. The transaction included $34 million for land held in the name of Fredrick’s daughter from an earlier marriage, according to prosecutors. Hough and Fredrick didn’t tell the IRS about most of the proceeds of the sale and transferred money among various undeclared accounts to buy the plane and real estate, make gifts to family members and pay personal expenses, prosecutors said.</blockquote> There also seems to be no question that Equinox Capital did buy the schools.  The <a href="http://mandasoft.com/1/13007/equinox_capital_inc_acquired_saba_university_school_of_medicine">summary of a 2007 press release</a> from the company stated, <blockquote class="tr_bq"> Equinox Capital III, L.P. announced that it has completed the recapitalization of Saba University School of Medicine B.V. ('Saba'). Founded in 1986, Saba is a leading for-profit university that awards four-year graduate degrees in Doctors of Medicine (M.D.). </blockquote> A <a href="http://www.prairie-capital.com/mobile/funds/r3.html">statement from Prairie Capital,</a> which is now an investor in the schools, noted that now <blockquote class="tr_bq"> R3 Education is a Massachusetts-based holding company that controls The Saba University School of Medicine ('Saba'), The Medical University of the Americas ('MUA') and St. Matthew University ("SMU").</blockquote> After, <blockquote class="tr_bq"> Prairie Capital partnered with Equinox Capital to acquire the three universities. </blockquote> It is enough to cause some dizziness.  Let me recap.  Mr Fredrick and Dr Hough somehow founded two medical schools apparently under the auspices of a foundation, the Saba University School of Medicine Foundation, which the couple ran.  The goal of the foundation was to attract Netherland Antilles citizens to medical careers in the NA.   However, the Saba University school became an off-shore facility for US medical students.  The two schools were later acquired by Prairie Capital and Equinox Capital, and they are now run as for-profit operations by R3 Education. So somehow Saba University transitioned from being a non-profit meant to serve the medical education needs of the Netherlands Antilles to a for-profit owned by US private equity firms (and apparently now focused on serving Americans.) How did that happen?  What was the rationale for the change?  Did any Dutch authorities consider the implications for their country?  Did any American organizations concerned with the quality of education and credentials of US physicians consider the implications? Where Did the Money Go? According to Bloomberg, US prosecutors made some striking allegations, <blockquote class="tr_bq"> Both the foundation and MUA failed to tell the IRS about accounts held at UBS, Liechtenstein Landesbank and other banks, the U.S. charges. Singenberger and Luetolf helped the foundation and MUA move money through British Virgin Islands or Hong Kong entities they controlled called Top Fast Finance Ltd., Ample Dynamic Trading Ltd., New Vanguard Holdings Ltd. and Apex Consultants Ltd., according to prosecutors. 'Hough and Fredrick were the beneficial owners of and had signatory authority over all over these accounts and owned and controlled each of them,' prosecutors said in their brief. </blockquote> The prosecution also alleged that Mr Fredrick and Dr Hough spent the money they allegedly got from selling the two medical schools rather lavishly.  Per the <a href="http://www.bloomberg.com/news/2013-10-08/caribbean-med-school-founder-didn-t-cheat-irs-jury-told.html">second Bloomberg article</a>, <blockquote class="tr_bq">[Prosceutor] Kessler said Hough and her husband used the proceeds of the school sales to buy a $1.6 million airplane, a $1.1 million house in Asheville, North Carolina, a $590,000 house in Greenville, North Carolina, and an $800,000 condominium in Sarasota, Florida. She said they also gave money to relatives. </blockquote> The prosecutors charged that the money the private equity firms paid went to Mr Fredrick and Dr Hough.  But while Mr Fredrick was President of Saba University, and apparently ran the foundation that was supposed to support it, he did not own either.  So why would the money go to him, and his wife?  If the money did not go to them, where did it go? As the trial continued, as documented in a <a href="http://www.businessweek.com/news/2013-10-08/caribbean-med-school-founder-didn-t-cheat-irs-jurors-told">second Bloomberg article</a>, Dr Hough's lawyer denied that she got the money, <blockquote class="tr_bq">Dan Saunders, an attorney for Hough, said his client never believed the money held at UBS AG (UBSN), the largest Swiss bank, and in other offshore banks belonged to her. Rather, he said, she thought it belonged to the foundation that ran the schools. 'It wasn’t her money, and she never believed it was,' Saunders said in his opening statement. </blockquote> If that is true, however, why is money that supposedly belongs to a foundation sitting quietly in a Swiss bank? Dr Hough's lawyer said, <blockquote class="tr_bq"> Saunders said the accounts did serve a business purpose: to protect the assets of their nonprofit foundation from people attempting a hostile takeover.</blockquote> Hostile takeovers of publicly held corporations do occur, of course.  However, how could a hostile takeover of a foundation occur, and who would possibly want or be able to do so? So thus far, no one has offered a rationale explanation for how the schools were sold, why they were sold, and where the money resulting from the sale went. Where in the World is Mr Fredrick? So far, while the defendant is Dr Hough, the role of her husband, Mr Fredrick, apparently the President of Saba University from its founding at least until 2007, seems key.  Yet little of the coverage focused on Mr Fredrick.  The reason for that suggests the next mystery, per  the first Bloomberg article, <blockquote class="tr_bq">Fredrick vanished after the indictment, leaving Hough to face trial alone. U.S. District Judge John Steele, who is overseeing the trial, has declared Fredrick a fugitive.</blockquote> So why did Mr Fredrick flea, and of course, where did he go? Obviously, the fact that Mr Fredrick, who was the President of Saba University for many years, chose not to defend himself against charges that he hid the money he somehow obtained from the sale of that and another medical school, but rather fled, suggests that he may not have had a very good defense against those charges.  What does that say about the leadership of these medical schools?  Summary So the coverage of this intriguing trial, when added to some other publicly available information, suggests a wealth of mysteries about the founding, current nature, and leadership of two Caribbean medical schools which currently are run as for-profit firms and owned by US private equity firms, and whose student bodies come almost exclusively from the US. So the really big mysteries are those about the implications for the medical education these schools provide, the students they attract, the physicians who graduate from their programs, the US patients of such physicians, and the US government which largely provides the loans which paid for these students' education (look <a href="http://www.bloomberg.com/news/2013-09-10/devry-lures-medical-school-rejects-as-taxpayers-fund-debt.html">here</a>). Despite the extraordinary nature of this case (again, involving the longterm president of an offshore medical school that sought to educate a substantial number of US physicians, and who is now a fugitive from justice), the only interest in it so far seems to be its implications for US prosecutions of hidden offshore accounts. This case illustrates why we must reexamine our fascination for "market based" approaches to health care, when almost nothing about any part of health care resembles, or could resemble a free market (see <a href="http://hcrenewal.blogspot.com/2010/08/how-fallacy-of-perfect-health-care.html">this post</a>).  We need to make health care more transparent, and shine more sunshine on the nooks and crannies, like off-shore but US corporate owned medical schools.  We need to facilitate health care leadership and governance that puts patients' and the public's health first, way ahead of the personal enrichment of the participants.   ADDENDUM (29 October, 2013) - Dr Hough was convicted of defrauding the IRS and income tax evasion, see the <a href="http://www.bloomberg.com/news/2013-10-24/caribbean-medical-school-founder-guilty-at-florida-tax-trial-1-.html">Bloomberg article</a>.  So far I see no response, certainly no apology or disavowal, by the current managers and owners of the medical school.

The Mystery of the Fugitive Founder (and Longterm President of an Offshore Medical School for US Students)

We recently wrote about for-profit medical schools located offshore from the US, but catering to American students, not students from the c...

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Louise Schaper, PhD, CEO, Health Informatics Society of Australia: "What's Missing From the Health IT Investment? - Health Informatics"

Louise Schaper, PhD, CEO of the Health Informatics Society of Australia (HISA, <a href="http://www.hisa.org.au/">http://www.hisa.org.au/</a>), graciously extended an invitation in 2011 that I could not attend, and again in 2012 (that I accepted) to give a keynote presentation at HISA's annual convention, Healthcare Informatics Conference (HIC).  A writeup of my HIC2012 presentation in Sydney is at <a href="http://hcrenewal.blogspot.com/2012/08/my-presentation-to-health-informatics.html">http://hcrenewal.blogspot.com/2012/08/my-presentation-to-health-informatics.html</a>. I unfortunately could not make it Down Under for HIC2013 in Adelaide.  However, HISA has posted videos of a number of presenters. One of the presenters is Dr. Schaper.  Her presentation "Health Informatics: A megatrend driving investment, careers & delivering the future of healthcare" is at <a href="http://www.hisa.org.au/page/hic2014videos">http://www.hisa.org.au/page/hic2014videos</a> (bottom video).  It is well worth watching. <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/AVvXsEgtb74lZXAe1diMqwSJ8Nh11TljYQA3a9eG0zcSSZCmTvUsW1j3QWjHr4C_R07npu3SqbGa7olG-QMFLGFBygsO6e4l5ucGzyT6ACyIe7tEg4Ia3AulBRshz-tCBQvjME5Rlso_X65vobWD/s1600/schaper_louise.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="200" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgtb74lZXAe1diMqwSJ8Nh11TljYQA3a9eG0zcSSZCmTvUsW1j3QWjHr4C_R07npu3SqbGa7olG-QMFLGFBygsO6e4l5ucGzyT6ACyIe7tEg4Ia3AulBRshz-tCBQvjME5Rlso_X65vobWD/s200/schaper_louise.jpg" width="152" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">Louise Schaper PhD, CEO, Health Informatics Society of Australia</td></tr></tbody></table> After reviewing the potential benefits of heathcare IT, Dr. Schaper asks what I consider the most critical question of all. At 08:20 she asks:  "What's missing from this [multi-billion dollar] investment?" <div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiYPjXC9te_7YpCosQhbRBYckorMvRZTXeCMvtJaYGopDXMrFiQYw5w0Hsa_gF8HnVoqqR9vETX6fPwgfqP9WXx0Nn3RF9Mr-_rmBYDwFkSHv6GYoMykqKJDHWEXot7lPb074Q01cgNH8Ab/s1600/whats_missing1.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="286" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiYPjXC9te_7YpCosQhbRBYckorMvRZTXeCMvtJaYGopDXMrFiQYw5w0Hsa_gF8HnVoqqR9vETX6fPwgfqP9WXx0Nn3RF9Mr-_rmBYDwFkSHv6GYoMykqKJDHWEXot7lPb074Q01cgNH8Ab/s400/whats_missing1.jpg" width="400" /></a></div> The answer is "Health Informatics." Dr. Schaper then indicates the real-world implications of the field of commercial health IT largely missing its critical founding scientific discipline: <div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEie2q-fIpGGRJYOnqjN5GOjMKeoiJJqLjSYpFBKR23egeQoA0H0Y85IpcpMgAeNkzgfsO4eVk4soHm7GLy5dJc5OO3_ZBJYxyd191_hGmPRpCqiSH7ZO39f0jsWjLtifGkEnm9bivs4ZyfN/s1600/whats_missing2.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="290" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEie2q-fIpGGRJYOnqjN5GOjMKeoiJJqLjSYpFBKR23egeQoA0H0Y85IpcpMgAeNkzgfsO4eVk4soHm7GLy5dJc5OO3_ZBJYxyd191_hGmPRpCqiSH7ZO39f0jsWjLtifGkEnm9bivs4ZyfN/s400/whats_missing2.jpg" width="400" /></a></div> At 13:00 she amplifies the point further:  We are not learning our lessons!  The themes of that slide are familiar to readers of this blog, and to current health IT users: <div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEg6WEbveq_WErWzYy8pmfhKxv-6HHyQCMdwqb_pfPM2hSuHyYbxOa4wBtFzI_PDqj8GZMhRao2_0sDEhcVqqpPWUhuLddFuR3sqfkhRHFR0IA94ZC4hGX9TnezRPoFMHTQYmwQdq8d6nFNv/s1600/whats_missing3.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="275" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEg6WEbveq_WErWzYy8pmfhKxv-6HHyQCMdwqb_pfPM2hSuHyYbxOa4wBtFzI_PDqj8GZMhRao2_0sDEhcVqqpPWUhuLddFuR3sqfkhRHFR0IA94ZC4hGX9TnezRPoFMHTQYmwQdq8d6nFNv/s400/whats_missing3.jpg" width="400" /></a></div> Dr, Schaper then goes on to cover some real-world issues related to impediments to meaningful health informatician engagement in health IT design, implementation and other aspects of leadership. The presentation is worth watching in its entirety.  The issues in health IT of meaningful involvement and leadership by those with expertise in healthcare informatics (as compared to, for example, those in manufacturing, mercantile, and management computing whose experience is often ill-suited for high-level roles in healthcare projects) are truly international. Finally, for those in the U.S. not used to Australian accents, Dr. Schaper's is quite enjoyable to listen to. -- SS

Louise Schaper, PhD, CEO, Health Informatics Society of Australia: "What's Missing From the Health IT Investment? - Health Informatics"

Louise Schaper, PhD, CEO of the Health Informatics Society of Australia (HISA, http://www.hisa.org.au/ ), graciously extended an invitation...

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Drudge Report, Oct. 10, 2013, 9 AM EST: All that needs to be said about government, computing and healthcare

Per <a href="http://www.drudgereport.com/">Drudge Report</a>. Oct. 10, 2013, 9 AM EST: From the same people who brought us HITECH, the stimulus bill for rapid rollout of commercial electronic medical records, order entry, results reporting and other components of enterprise clinical "command and control" software for hospitals through which every transaction of care must pass. More IT malpractice.  The Drudge links, as they appear on the page: <blockquote class="tr_bq"><a href="http://www.digitaltrends.com/opinion/obamacare-healthcare-gov-website-cost/">Obamacare website cost more than FACEBOOK, TWITTER, LINKEDIN, INSTAGRAM...</a> <a href="http://thehill.com/video/house/327489-boehner-obamacare-threatens-fines-but-fails-to-deliver-care">'How can we tax people for not buying a product from a website that doesn't work?'</a> <a href="http://www.elpasotimes.com/politics-national/?third_party=many-tried-to-warn-officials-of-obamacare-website-jam"> Major insurers, Dem allies repeatedly warned Obama admin...</a> <a href="http://www.foxnews.com/tech/2013/10/09/3-million-obamacare-website-may-face-months-glitches-experts-warn/">REPORT: WH knew site might not be ready...</a> <a href="http://bigstory.ap.org/article/poll-rollout-health-exchanges-gets-thumbs-down#overlay-context=article/anti-government-protesters-dog-taiwan-national-day">POLL: Just 1 in 10 report success...</a> <a href="http://www.mediaite.com/tv/debbie-wasserman-schultzs-shocking-insufficient-rambling-response-to-msnbc-on-obamacare-enrollees/">DNC head says site designed for 50,000 max...</a> <a href="http://www.infowars.com/once-you-get-into-the-obamacare-website-you-cant-get-out/">Once you get in, you can't get out...</a> <a href="https://www.healthcare.gov/marketplace/global/en_US/registration.js">Crazzzzzzzy code...</a> <a href="http://www.cbsnews.com/8301-505269_162-57606633/obamacare-website-looks-like-nobody-tested-it-programmer-says/">'It looks like nobody tested it'...</a> <a href="http://www.washingtonpost.com/business/technology/some-say-health-care-sites-problems-highlight-flawed-federal-it-policies/2013/10/09/d558da42-30fe-11e3-8627-c5d7de0a046b_story.html?hpid=z3">WASHPOST: Not code, but 'outdated, costly, buggy technology'...</a> <a href="http://washington.cbslocal.com/2013/10/09/carney-i-dont-know-if-obama-has-used-health-care-website/">CARNEY: 'I Don’t Know' If Obama Has Tried Website...</a> <a href="http://washington.cbslocal.com/2013/10/10/hawaii-relaunching-obamacare-exchange-after-not-selling-any-health-insurance-due-to-software-problems/">Hawaii forced to relaunch after zero sign-ups...</a></blockquote> I won't comment any further; I don't think I need to. <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/AVvXsEioxvlYhb12vWVBwgfbAaRyFwgypKV8y0E58B8ndx9GQ10QJ2Z_aOyJsdVFRsFs6jv8GM3TsIVJ06wIU3ADiSUO8Kh8uOVTzEVjheehWDk6xSre92w_Rlew0e-EPt9MY09j06M1CL-ekt02/s1600/drudge_computers.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="260" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEioxvlYhb12vWVBwgfbAaRyFwgypKV8y0E58B8ndx9GQ10QJ2Z_aOyJsdVFRsFs6jv8GM3TsIVJ06wIU3ADiSUO8Kh8uOVTzEVjheehWDk6xSre92w_Rlew0e-EPt9MY09j06M1CL-ekt02/s400/drudge_computers.jpg" width="400" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">Drudge Report, Oct. 10, 2013, 9 AM EST.  Click to enlarge.</td></tr></tbody></table> Of course, the Anecdotalists [1] and Denialists [2] will probably say this is all a "glitch" and that things will be great in ver. 2.0. Fools all. Oh, and the cost, via Drudge, per the linked story.  A mere: <div style="text-align: center;"><tt><tt><a href="http://weaselzippers.us/2013/10/09/gross-u-s-taxpayers-shelled-out-634320919-to-build-obamacare-website/">$634,320,919</a></tt></tt> </div> -- SS [1]  See "Health IT: On Anecdotalism and Totalitarianism" at  <a href="http://hcrenewal.blogspot.com/2010/09/health-it-on-anecdotalism-and.html">http://hcrenewal.blogspot.com/2010/09/health-it-on-anecdotalism-and.html</a>) [2]  See "The Denialists' Deck of Cards: An Illustrated Taxonomy of Rhetoric Used to Frustrate Consumer Protection Efforts" by Chris Jay Hoofnagle, available at <a href="http://papers.ssrn.com/sol3/papers.cfm?abstract_id=962462">http://papers.ssrn.com/sol3/papers.cfm?abstract_id=962462</a>) Oct. 10, 2013 addendum: Also see "Analysis: IT experts question architecture of Obamacare website" at <a href="http://uk.reuters.com/article/2013/10/05/us-usa-healthcare-technology-analysis-idUKBRE99407T20131005">http://uk.reuters.com/article/2013/10/05/us-usa-healthcare-technology-analysis-idUKBRE99407T20131005</a>.  If the allegations here are even partially true, every programmer and manager who ever worked on this system should be summarily fired and never permitted to touch another computer involved in healthcare - ever. -- SS

Drudge Report, Oct. 10, 2013, 9 AM EST: All that needs to be said about government, computing and healthcare

Per Drudge Report . Oct. 10, 2013, 9 AM EST: From the same people who brought us HITECH, the stimulus bill for rapid rollout of commercial e...

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Quality and Safety Implications of Emergency Department Information Systems: ED EHR Systems Pose Serious Concerns, Report Says

A report "Quality and Safety Implications of Emergency Department Information Systems" appeared in the Oct. 2013 issue of "Annals of Emergency Medicine."  It is available fulltext at <a href="http://www.annemergmed.com/article/S0196-0644%2813%2900506-4/fulltext">http://www.annemergmed.com/article/S0196-0644%2813%2900506-4/fulltext</a>, or in PDF via the tab, free as of this writing. First, a preamble:  I once tried to alert a hospital where I'd trained decades before, Abington Memorial Hospital (<a href="http://www.amh.org/">http://www.amh.org/</a>), of impediments to safe care I'd noted in their EHR's, predominantly their ED EHR.  They did not listen.  In fact, their response to my concerns was characterized by an apparent incompetence regarding conduct of safety investigations.  For instance, to my written concern in an April 2010 letter to the CEO and CMO about the ED EHR that: <blockquote class="tr_bq"> ... I've also had to stop administration [to my mother] of an antibiotic (Levaquin) in the recent past in the ED that she has had an adverse reaction to (torn rotator cuff), despite my having told ED intake she was allergic to it. She relates that administration of Levaquin was then almost repeated on the floor until she herself refused it during that past admission.</blockquote> This was the sworn testimony in May 2013 about the "investigation" that resulted, from the hospital's VP of Risk Management, <a href="http://www.corporationwiki.com/Pennsylvania/Abington/regina-sturgis/81813980.aspx">Regina Sturgis</a>: <blockquote class="tr_bq">A:      Deborah [hospital General Counsel] asked me to investigate the Levaquin issue which I did. Q:      Did you do that on your own or did you delegate some of the -- A:      No.  I did it on my own. Q:      Do you know whether any of the IT folks were ever brought in to look at the -- the EMR issues referenced in this letter? A:     No, I do not.  I know that I was asked to look at the Levaquin because of my clinical background. Q:      Okay.  Did you come up with any conclusions? A:      Yes. Q:      What was your conclusion? A:      That she had been ordered Levaquin in the ETC [Emergency Trauma Center a.k.a. ED], that it had been discontinued about a very short period of time later, under a half an hour, and that she never received it. </blockquote> So, the investigation of a complaint that family and then the patient themselves had to stop the administration of a drug whose staff and EHR had been informed of an allergy consisted of confirming that the medication was never given.  No problem, the ED EHR is safe. (I am not joking; that is the testimony given.  Imagine such an investigation and conclusion about, say, reported aircraft flaws, or, in the industry in which I was once a safety officer, public transit vehicle defects and dangers.) However, when competent people investigate similar issues, the findings are concerning.  From Modern Healthcare (<a href="http://www.modernhealthcare.com/">http://www.modernhealthcare.com/</a>), a publication for healthcare executives, on the new Annals of Emergency Medicine article: <blockquote class="tr_bq"><a href="http://www.modernhealthcare.com/article/20130624/NEWS/306249952/">ED EHR systems pose serious concerns, report says</a> By <a href="mailto:jconn@modernhealthcare.com" target="_blank">Joseph Conn</a> Modern Healthcare <div>June 24, 2013</div></blockquote><blockquote>Electronic health-record systems used in <a href="http://www.modernhealthcare.com/section/articles?tagID=5739" target="_blank">emergency</a> departments are beset with poor data displays, loaded with so many alerts warning of potential <a href="http://www.modernhealthcare.com/section/articles?tagID=51" target="_blank">patient-safety issues</a> that they can lead to user alert fatigue, and may be generating incorrect physician orders, according to a report by two emergency physicians' study groups. Meanwhile, providers wanting to address these <a href="http://www.modernhealthcare.com/section/articles?tagID=975" target="_blank">EHR</a> issues are hampered by a lack of research and solid evidence of the extent of the problem with these systems, and by contract provisions with EHR vendors that stymie the free flow of information about system-linked safety concerns, the report authors say. </blockquote> So, ED's across the country are rolling out technology, often taking advantage of ARRA's HITECH incentives ... but there is a lack of research and solid evidence into the risks.  Allow me to opine - that's simply crazy. <blockquote class="tr_bq">The groups found that “poor data display is a serious problem with many of today's EDISs,” while “the sheer volume” of alerts that range from the “completely irrelevant to life threatening” [or lack of appropriate alerts to relevant, simple issues such as data input errors - ed.] can “dull the senses, leading to a failure to react to a truly important warning.” They also found that “an alarming number of clinicians are anecdotally reporting a substantial increase in the incidence of wrong order/wrong patient errors while using the computerized physician order entry component of information systems.”</blockquote> The word "anecdote", as I have written, is being misused.  The reports are not "anecdotes."  They are risk management-relevant incident reports.  (See "From a Senior Clinician Down Under: Anecdotes and Medicine, We are Actually Talking About Two Different Things" at <a href="http://hcrenewal.blogspot.com/2011/08/from-senior-clinician-down-under.html">http://hcrenewal.blogspot.com/2011/08/from-senior-clinician-down-under.html</a>.) <blockquote class="tr_bq">Two study groups from the American College of Emergency Physicians have recommended a program of systemic vigilance over electronic health-record systems used in emergency departments to improve patient safety and enhance quality of care. ACEP workgroups on informatics and on quality improvement and patient safety published their findings in an article, “<a href="http://www.annemergmed.com/article/S0196-0644%2813%2900506-4/abstract" target="_blank">Quality and Safety Implications of Emergency Department Information Systems</a>,” in the current issue of the Annals of Emergency Medicine. </blockquote> Post marketing surveillance, a standard for decades in other healthcare sectors, has been absent from health IT due to a long-obsolete special regulatory accommodation afforded that industry.  This accommodation was initiated when systems were simple and merely advisory - not the comprehensive enterprise clinical resource and clinician command-and-control systems they are today.  Now, clinician investigators of the technology such as the authors of this study are realizing that continuing this accommodation is a mistake. <blockquote class="tr_bq">It follows in the wake of, and references, an Institute of Medicine report from 2011, “Health IT and Patient Safety: Building Safer Systems for Better Care.” That report concluded that “current market forces are not adequately addressing the potential risks associated with the use of health IT.” It also comes eight months after the New England Journal of Medicine published “<a href="http://www.nejm.org/doi/full/10.1056/NEJMsb1205420" target="_blank">Electronic Health Records and National Patient-Safety Goals</a>,” which warned that recent evidence “has highlighted substantial and often unexpected risks resulting from the use of EHRs and other forms of health information technology.”</blockquote> I note that if you frequent this blog, you likely read material similar to the bolded red statements above here first, as authored by me, dating to the founding of this blog in 2004. <blockquote class="tr_bq">... “The rush to capitalize on the huge federal investment of $30 billion for the adoption of electronic medical records led to some unfortunate and unintended consequences, particularly in the unique emergency department environment,” said Dr. Heather L. Farley, the lead author of the report, in a news release. “The irreversible drive toward EDIS implementation should be accompanied by a constant focus on improvement and hazard prevention." Farley is assistant chairwoman of the Department of Emergency Medicine at Christiana Care Health System in Newark, Del.</blockquote> Ironically, I note in Dr. Farley's statement some of my own advice, given to ED staff when I was Chief Medical Informatics Officer at Christiana Care 1996-8.   I had in that time period advised <a href="http://www.christianacare.org/bodymod.cfm?id=169&action=detail&ref=1909">Charles Reese IV, MD</a>, Chair of Emergency Medicine, to not implement EHRs or, at best, implement document imaging systems (since ED charts are not that long or complex), not full field-based EHRs, due to the "unfortunate and unintended consequences" of bad health IT in such an environment I recognized even then.  It was only a few years ago that my advice was finally overturned. <blockquote class="tr_bq">The authors also report “(t)here are few consistent data on how commonly these errors occur, and few studies are actually focused on collecting evidence of these errors.” Meanwhile, “there is currently no mechanism in place to systematically allow, let alone encourage, users to provide feedback about ongoing safety issues or concerns” with EHRs in general, and EDISs specifically.</blockquote> On its face, that is not a safety-conscious environment and the rollout and use of such systems seems a fundamental violation of patient's rights, made worse by the fact that there is no informed consent process whatsoever to ED EHR use. <blockquote class="tr_bq">The workgroups came up with seven recommendations: appointing an emergency department “clinician champion,” creating within healthcare delivery organizations an EDIS performance improvement group and an ongoing review process, paying timely attention to EDIS-related patient-safety issues raised by the review process, disseminating to the public lessons learned from performance improvement efforts, distributing vendors' product updates in a timely manner to all EDIS users and removing the “hold harmless” and “learned intermediary clauses” from vendor contracts. </blockquote> Many of these issues have been discussed on this blog. <blockquote class="tr_bq">“The learned intermediary doctrine implies that the end users (clinicians) are the medical experts and should be able to detect and overcome any fallibility or contributing factor of the product,” the authors said.</blockquote> I have also pointed out the absurdity of such a "doctors are clairvoyant" attitude, e.g., at my 2011 post on basic common sense on IT adverse consequences at <a href="http://hcrenewal.blogspot.com/2011/04/common-sense-on-side-effects-lacking-in.html">http://hcrenewal.blogspot.com/2011/04/common-sense-on-side-effects-lacking-in.html</a>. <blockquote class="tr_bq">They conclude that the “lack of accountability for vendors through hold harmless clauses and the shifting of liability to the clinicians through the learned intermediary doctrine are significant and additional impairments to safety improvement. Electronic health records and EDISs are sufficiently complex that the physician and other users cannot be expected to anticipate unpredictable errors.” </blockquote> That aligns with the work of Dr. Jon Patrick in Sydney, whose treatise "A study of an Enterprise Health information System" on the Cerner FirstNet ED EHR is available here: <a href="http://sydney.edu.au/engineering/it/~hitru/index.php?option=com_content&task=view&id=91&Itemid=146">http://sydney.edu.au/engineering/it/~hitru/index.php?option=com_content&task=view&id=91&Itemid=146</a> <blockquote class="tr_bq">Earlier this month, the Electronic Health Record Association, an EHR developers trade group affiliated with the Chicago-based Healthcare Information and Management Systems Society, announced the launch of a voluntary “<a href="http://www.modernhealthcare.com/article/20130611/NEWS/306119952/ehr-trade-group-issues-code-of-conduct-to-improve-patient-safety" target="_blank">code of conduct</a>” in which adherents would agree to drop “gag clauses” in the contracts with their provider customers. </blockquote> Great.  Per the wonderful 2007 article "The Denialists' Deck of Cards: An Illustrated Taxonomy of Rhetoric Used to Frustrate Consumer Protection Efforts" by Chris Jay Hoofnagle, available at <a href="http://papers.ssrn.com/sol3/papers.cfm?abstract_id=962462">http://papers.ssrn.com/sol3/papers.cfm?abstract_id=962462</a>, as of this writing free: <blockquote class="tr_bq"> ... At this point [of losing the argument], the denialist must propose "self regulation" to deal with the problem that doesn't exist. The cool thing about self regulation is that it cannot be enforced, and once the non-existent problem blows over, the denialist can simply scrap it! [20] [20] In the runup to passage of bank privacy legislation, data brokers created a group called the "Individual Reference Services Group" that promptly disappeared after the legislation passed.</blockquote> ("Denialism" is the use of rhetorical techniques and predictable tactics to erect barriers to debate and consideration of any type of reform, regardless of the facts.) IMO 'self regulation' of healthcare is, on its face, a deception.  There are simply too many conflicts of interest. On use of "integrated" big systems: <blockquote class="tr_bq">“These systems do have glitches [indeed - see <a href="http://hcrenewal.blogspot.com/search/label/glitch">http://hcrenewal.blogspot.com/search/label/glitch</a> - ed], but it can be plain and simple bad design that can lead to clinical errors,” Cozzens said.  But ED physicians, he said, are “having the enterprise systems forced upon them. To think you can take one system and adapt it to those different environments is totally wrong. That's why you see low physician satisfaction and the productivity is going down, all for the sacrifice of having an integrated system.”</blockquote> In fact, so-called "best of breed" systems can be bad health IT as well.  See the aforementioned evaluation by Dr. Patrick in Australia. <blockquote class="tr_bq">Bad Health IT ("BHIT") is defined as IT that is ill-suited to purpose, hard to use, hard to customize, unreliable, loses data or provides incorrect data, causes cognitive overload, slows rather than facilitates users, lacks appropriate alerts, creates the need for hypervigilance (i.e., towards avoiding IT-related mishaps) that increases stress, is lacking in security, compromises patient privacy or otherwise demonstrates suboptimal design and/or implementation.  </blockquote> Through my own work, I've seen bad health IT result in patient harm and death.  It's just unfortunate that I got started in this line of work by being, in effect, shot out of a cannon.  That is, my own mother was a victim. -- SS Addendum 10/8/13: From the article: <blockquote class="tr_bq">End-User Recommendation 4: EDIS-related patient safety concerns identified by the review process should be addressed in a timely manner by ED providers, the EDIS vendors, and hospital administration. Each of these processes should be performed in full transparency, specifically with openness, communication, and accountability. </blockquote> I'm not sure the aforementioned levaquin near-accident "investigation" meets these standards. -- SS

Quality and Safety Implications of Emergency Department Information Systems: ED EHR Systems Pose Serious Concerns, Report Says

A report " Quality and Safety Implications of Emergency Department Information Systems " appeared in the Oct. 2013 issue of "...

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