healthy4u

Hedging the Future of the FDA?

A little while ago, we discussed the Obama administration's nomination for Commissioner of the US Food and Drug Administration (FDA), Dr Margaret Hamburg, focused on her current position as a director of Henry Schein Inc, a large distributor of medical products, including drugs and devices. There is another aspect of her nomination worthy of discussion, but which has not been publicly discussed. It has appeared almost as a footnote in a few reports of her nomination. For example, at the end of an <a href="http://www.chicagotribune.com/news/nationworld/chi-090311-margaret-hamburg-fda,0,4751083.story">article in the Chicago Tribune</a>, <blockquote>Hamburg is married to Peter Fitzhugh Brown, an artificial intelligence expert who is executive vice president and director of Renaissance Technologies, a privately owned hedge fund. </blockquote> In this time of financial meltdown, hedge funds are more frequently mentioned in the press. Hedge funds are a relatively new, and generally opaque presence in the financial world. Hedge funds apparently buy and sell stocks, bonds, commodities, financial instruments, and use a variety of investment strategies. Since health care accounts for over $2 trillion of the US economy, it seems possible that hedge funds might be involved in stocks, bonds, and the finances in general of health care corporations. We therefore wondered Mr Brown's position at the hedge fund management company Renaissance Technologies might have something to do with health care, particularly with health care corporations that make products regulated by the FDA. It turns out that this question has no simple answer. Hedge funds are often described as secretive and lightly regulated. This seems accurate, as it is not easy to find out much about their operations, strategy, holdings, or leadership. My usual Google searching tricks did not turn up much useful about Renaissance Technologies. Most helpful was a <a href="http://www.bloomberg.com/news/marketsmag/mm_0108_story1.html">2008 article in Bloomberg News</a>, which labeled the company as "the world's largest hedge fund manager." It was managing $35.4 billion in assets in September, 2007. The Bloomberg reporter's attempt to find out something about the company's strategies was a failure, summarized by his conclusion, "nobody knows precisely how the firm makes its millions." When the funds founder, Jim Simons, was asked what he can say about his trading strategy, he answered, "not much." The instruments he trades? - "everything." The strategies he uses? - "a lot." The only publicly available information about the company's holdings is in its 13F filings with the US Securities and Exchange Commission (SEC). The 2009 filing, covering 2008, is <a href="http://xml.10kwizard.com/filing_raw.php?repo=tenk&ipage=6134654">here</a>. The filing only covers long stock holdings at the end of the year. Lacking a research staff, I have not been able to go through the voluminous report in detail, but do note that the company at times invested in health care corporations from A ([Abbott Laboratories, valued at $88,909,000) to Z (Zimmer Holdings, $7,858,000). I had little luck finding out the role of Mr Brown within the company, and whether he has any personal responsibility for making decisions about investments in any health care corporations. But I did find that a prominent Renaissance Technologies fund, the Medallion Fund, worth $6 billion in July, 2007, is owned mostly by Renaissance Technologies employees, presumably including Mr Brown, not outside investors, "Medallion stopped taking new money from outside investors in 1993 and returned pretty much the last of their capital 12 years later. Today, the fund is run almost exclusively for the benefit of the Renaissance staff." Furthermore, most of Renaissance Technologies is now owned by its founder and a few top officers, including in particular, Peter Fitzhugh Brown, who the Bloomberg article reported as owning "5-10 percent." So, does Mr Brown's position in and partial ownership of Renaissance Technologies amount to a conflict of interest with respect to his wife's proposed position as Commissioner of the FDA? It is not clear. Mr Brown works for a company that manages billions of dollars, and likely a good chunk of that money is invested in instruments related to health care corporations. Mr Brown now presumably a goodly number of shares of the company's premier fund, and owns a substantial minority interest in the company as a whole. Hence he indirectly probably owns a substantial amount of such instruments. Whether he has any direct decision making responsibility for the buying and selling of such instruments is unclear. Therefore, it seems that Dr Hamburg actually has a "potential conflict of interest" arising out of her husband's role in Renaissance Technologies. In academic conflict of interest policies, that phrase often appears without a definition, perhaps to soften the words so often applied now to medical academics. But this seems to be a real instance in which it should be used. The shadows cast by the increasing opacity of the world of finance, now dominated as never before by organizations such as hedge funds that control large pools of investment about which regulations compel little disclosure, now seem to be darkening health care. In my humble opinion, the Senate hearings on Dr Hamburg's confirmation ought to determine whether this potential conflict is more than that. Furthermore, we need a broader dialogue about how to dispel the shadows and secrecy that the dark arts of finance have spread to health care.

Hedging the Future of the FDA?

A little while ago, we discussed the Obama administration's nomination for Commissioner of the US Food and Drug Administration (FDA), Dr...

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The 2009 Spelman College CS Olympiad

We've just sponsored the Seventh Annual <a href="http://www.spelman.edu/%7Esccso/">Spelman College Computer Science Olympiad</a> for the third consecutive year — something we were proud to do as part of our commitment to supporting computer science education and encouraging talented students from diverse backgrounds. This year, 22 teams from 12 Historically Black Colleges & Universities (HBCUs) or Association of Computer/Information Sciences and Engineering Departments at Minority Institutions (ADMI) participated in the Olympiad. One of the five events was the programming challenge, which for the second time was a <a href="http://www.google.com/webmasters/gadgets/">Google Gadgets</a> competition. Their task? To build an interactive, useful, and creative Google Gadget. Teams worked on their gadget concept and design prior to the Olympiad, and then brought their gadgets to a Friday night hack session, where Googlers and students worked together to debug the gadgets and make last-minute adjustments. At the conclusion of the workshop, teams presented their gadgets to a panel of three Googler judges, demonstrating gadget functionalities, discussing design challenges, and providing suggestions for how they would further refine their gadgets. Our judges were then faced with the tough task of deciding upon the winners: <ul><li>First Place: Hampton University "2011"</li><li>Second Place: University of the District of Columbia "Firebirds"</li><li>Third Place: Norfolk State University "Green"</li></ul>Here's a look at Hampton University's first place gadget, a rendering of a game akin to tic-tac-toe called "Do Not Want." <a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEj4wE2fi5qPrMD8PI9anV0ENOELhNuxbrXWTU2NAZbyVkkxsXoladO3r105UNyy9OdD6ImxWRnLSHVkG7rfeRvWgkHG2F3OhH1_NeAOOGKMSyL3PVxomm4Vqpyrlmpc1LdAH563sX7WPhXL/s1600-h/donotwant.JPG" onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5317935508080993570" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEj4wE2fi5qPrMD8PI9anV0ENOELhNuxbrXWTU2NAZbyVkkxsXoladO3r105UNyy9OdD6ImxWRnLSHVkG7rfeRvWgkHG2F3OhH1_NeAOOGKMSyL3PVxomm4Vqpyrlmpc1LdAH563sX7WPhXL/s400/donotwant.JPG" style="display:block; margin:0px auto 10px; text-align:center;cursor:pointer; cursor:hand;width: 400px; height: 352px;" /></a> Congratulations to all 22 teams! Posted by Anna Davda, University Programs Specialist

The 2009 Spelman College CS Olympiad

We've just sponsored the Seventh Annual Spelman College Computer Science Olympiad for the third consecutive year — something we were pr...

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An hour for the Earth

<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEir98md7bwzUMThGcPnwXv04DMCpx0qNbgaI6HUFhMzGAwjL4m2RPuAqdTGJKYzK_MH5lZA81DE66rAMTeK-qoo9_zakPlKdWcproC9PGEI52JNmCSI50buYCDEi7SCyqcpTQTNgZXFNuEJ/s1600-h/light+switch.jpg" onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5317907326443120002" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEir98md7bwzUMThGcPnwXv04DMCpx0qNbgaI6HUFhMzGAwjL4m2RPuAqdTGJKYzK_MH5lZA81DE66rAMTeK-qoo9_zakPlKdWcproC9PGEI52JNmCSI50buYCDEi7SCyqcpTQTNgZXFNuEJ/s400/light+switch.jpg" style="margin: 0pt 0pt 10px 10px; float: right; cursor: pointer; width: 266px; height: 400px;" /></a> Cities around the world will participate in <a href="http://www.earthhour.org/home/">Earth Hour</a> on Saturday, turning off their lights to raise awareness for energy conservation. You might remember that <a href="http://www.google.com/intl/en/earthhour/">last year</a> we “turned the lights out” on the Google.com homepage during Earth Hour to symbolize our own <a href="http://www.google.com/green">commitment to sustainability</a>. We won’t be turning out the lights on our homepage again this year. Our users come first, and while we received lots of enthusiastic feedback last year, some found an all-black Google.com to be a little confusing. (Also, darkened screens don’t actually save energy — modern displays use the same amount of power <a href="http://googleblog.blogspot.com/2007/08/is-black-new-green.html">regardless of what they display</a>.) We are actively supporting this year's <a href="http://www.earthhour.org/home/">Vote Earth</a>, an Earth Hour 2009 initiative to gather one billion words to present at the <a href="http://en.cop15.dk/">United Nations Climate Change Conference</a> in Copenhagen in December of this year. Participants can share their opinions about climate change through the <a href="http://www.earthhour.org/home/#EarthConnect">Earth Connect</a> social platform which incorporates Google tools including <a href="http://maps.google.com/">Google Maps</a>, <a href="http://appengine.google.com/">App Engine</a>, <a href="http://www.google.com/friendconnect/">Friend Connect</a>, <a href="http://translate.google.com/">Google Translate</a>, <a href="http://www.blogger.com/">Blogger</a> and <a href="http://www.feedburner.com/">Feedburner</a>. After all, Earth Hour is about more than dimming lights; it’s about making a commitment to reduce energy consumption throughout the year. At Google, we take this commitment seriously and over the past twelve months we’ve worked hard to reduce Google’s own power use and to help others reduce theirs: <ul><li>We remodeled our San Francisco office to achieve a <a href="http://googleblog.blogspot.com/2009/03/pot-o-leed-gold.html">Gold rating</a> by the <a href="http://www.usgbc.org/">U.S. Green Building Council's</a> LEED Green Building Rating System</li><li>Our engineers are working on a tool called <a href="http://www.google.com/powermeter">Google PowerMeter</a> that will show consumers home energy information almost in real time, right on their computer</li><li>We’ve designed the <a href="http://www.google.com/corporate/green/datacenters/">most efficient data centers</a> possible and are sharing some of our best practices with industry peers</li><li>In the fall we compiled tips and tricks to <a href="http://googleblog.blogspot.com/2008/10/is-your-house-haunted-by-high-energy.html">help our users save energy</a> (and money)</li><li>Our <a href="http://googleblog.blogspot.com/2008/06/plug-ins-converge-on-washington.html">summit on plug-in vehicles</a> in Washington was standing room only, with policy, technology, and energy experts all discussing an electric vehicle future </li></ul>Google will continue to work hard this year to be as green as possible as a company, and we encourage others to take an hour on Saturday and commit to the Earth too. For some great ideas on ways you can save energy every hour of every day through computing efficiency, check out <a href="http://www.climatesaverscomputing.org/">Climate Savers Computing Initiative</a> and their recent video challenge: “<a href="http://www.powerdownfortheplanet.org/video/">Power Down for the Planet</a>.” Posted by Bill Weihl, Green Energy Czar

An hour for the Earth

Cities around the world will participate in Earth Hour on Saturday, turning off their lights to raise awareness for energy conservation. Yo...

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The Political Incorrectness of Discussing Conflicts of Interest in Medical Academia

<a href="http://www.boston.com/news/local/massachusetts/articles/2009/03/26/ethics_event_spawns_a_tussle_at_tufts/">From today's Boston Globe</a>, <blockquote> Tufts University has withdrawn an invitation for a top aide to US Senator Charles E. Grassley to give the keynote speech at a conference on conflicts of interest in medicine and research, leading one conference organizer to pull out and question the university's commitment to academic freedom. The University-wide Committee on Ethics rescinded the invitation on March 13, according to e-mails obtained by the Globe. The messages said top Tufts officials refused to allow other administrators to be panelists at the meeting if Grassley's aide spoke, saying it was inappropriate to do so while Grassley is investigating ties between a Tufts professor and the drug industry. The senator, a Republican from Iowa, sent a letter on Feb. 17 to the president of Tufts, Lawrence S. Bacow, requesting detailed information on the relationship between a 'Dr. Boucher' and the pharmaceutical industry, including the amount and dates of all industry payments between January 2006 and December 2008. Dr. Helen Boucher is an infectious diseases specialist at the Tufts medical school. Spokeswoman Christine Fennelly first said in an e-mail that when Grassley declined the invitation, 'it was decided to refocus the symposium on a smaller scale, where the panelists would be faculty from Tufts University and affiliated faculty from Tufts Medical Center.' Later, when told that Krimsky's e-mails explicitly said the speaking offer was rescinded, she said the invitation to Grassley's aide had been withdrawn. 'Indeed . . . the administration felt it prudent to not engage someone from the Senator's office while we respond to the Senator's inquiry,' she wrote. </blockquote> One only has to browse the FIRE (Foundation for Individual Rights in Education) <a href="http://www.thefire.org/">web-site </a>to see the sad state of free speech and academic freedom in American universities. Most of the cases they discuss seem to involve barriers to presenting politically incorrect viewpoints on campus. FIRE has presented several cases involving dis-invitation of speakers with such views. On the other hand, on Health Care Renewal we have discussed our share of cases involving free speech and academic freedom in academic medicine. Most of these cases seem to involve barriers to presenting research results that turn out unfavorable to vested financial interests, particularly interests served by the promotion of particular health care products, like drugs or devices, or services. This case appears to be something of a hybrid. Like a number of cases discussed on the FIRE web-site, it involves the dis-invitation of a campus speaker whose viewpoint might not fit with that of the powers that be on campus. However, instead of causing offense because of his political positions, Mr Thacker seemed to cause offense because he has been involved in investigating conflicts of interest affecting medical academics. Thus, it seems that discussing such conflicts of interest has become politically incorrect. This seems to be a fairly blatant instantiation of the <a href="http://hcrenewal.blogspot.com/2007/08/bling-bling-poltical-correctness-and.html">anechoic effect</a>. See also <a href="http://carlatpsychiatry.blogspot.com/2009/03/tufts-blows-it.html">comments</a> by Dr Daniel Carlat on the Carlat Psychiatry Blog. ADDENDUM (31 March, 2009) - also see <a href="http://scienceblogs.com/effectmeasure/2009/03/more_on_conflicts_of_interest.php#more">comments</a> on the Effect Measure Blog.

The Political Incorrectness of Discussing Conflicts of Interest in Medical Academia

From today's Boston Globe , Tufts University has withdrawn an invitation for a top aide to US Senator Charles E. Grassley to give the ke...

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Changes to our sales and marketing organizations

Google has grown very quickly in a very short period of time. When companies grow that quickly it's almost impossible to get everything right—and we certainly didn't. In some areas we've created overlapping organizations which not only duplicate effort but also complicate the decision-making process. That makes our teams less effective and efficient than they should be. In addition, we over-invested in some areas in preparation for the growth trends we were experiencing at the time. So today we have informed Googlers that we plan to reduce the number of roles within our sales and marketing organizations by just under 200 globally. Making changes of this kind is never easy—and we recognize that the recession makes the timing even more difficult for the Googlers concerned. We did look at a number of different options but ultimately concluded that we had to restructure our organizations in order to improve our effectiveness and efficiency as a business. We will give each person time to try and find another position at Google, as well as outplacement support, and provide severance packages for those who leave the company. Finally, I would like to take this opportunity to thank everyone affected for all they have contributed to Google. Posted by Omid Kordestani, Senior VP, Global Sales and Business Development

Changes to our sales and marketing organizations

Google has grown very quickly in a very short period of time. When companies grow that quickly it's almost impossible to get everything...

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This Former Chief Medical Informatics Officer is Feeling a Bit Betrayed

In thinking further about the "hold harmless" and "defects gag clause" originated by Health IT vendors and agreed to by hospital executives as I described at <a href="http://hcrenewal.blogspot.com/2009/03/health-it-hold-harmless-and-defects-gag.html">Have Hospital Executives Violated Their Fiduciary Responsibilities by Signing Such Contracts?</a>, I can state I feel a sense of (past) betrayal. Only now thanks to a Penn sociologist and a software consultant (plus the fortitude of JAMA, under some criticisms recently on other matters, in publishing this article) do we formally find out that hospitals have been literally "dumping" on physicians by signing contracts with the HIT vendors leaving the docs "holding the bag" for software errors and malfunctions, and gagging their organizations from openly talking about defects and problems. In other words, physicians hold the risk, everyone else holds the money. Actually, since EMR mostly benefits the payers, I'd more correctly say hospital administrations have largely sold physicians down the river, an act that echoes of contempt and betrayal let alone breach of fiduciary responsibility and the Joint Commission standards I believe apply as in the post linked above. It's not as if hospital administrations cannot negotiate these issues, nor are they forced to sign such provisions if vendors refuse to negotiate. They could send such vendors out the door. If this had been done as a routine by hospital executives, the health IT vendors would have been forced to give in years ago. Health IT was and is not mandatory for operations; the latest survey in NEJM indicates <a href="http://www.nytimes.com/2009/03/26/business/26health.html?_r=1">only ~9% of hospitals are using EMRs</a>. I also believe possible claims of ignorance and/or "we didn't read the fine print" don't fly. Hospital execs have the responsibility and duty to research such issues and read the fine print, or at the very least counsel did. In effect, at best the spinelessness of hospital administrations over the years may have spoiled the vendors to expect such concessions. (One also wonders about special "incentives" that might make hospital administrations weaker than they might otherwise be on such issues.) Now I better understand perhaps why as CMIO/Director of Informatics at Christiana Care Health System in the late 1990's I never got to see the HIT contracts. I likely would have been a lot less eager to try to "sell" the EMR idea to the medical staff if I had been aware of the "vendor held harmless" provisions they faced if a software design problem or glitch in these immensely complex devices contributed to patient harm. I also feel betrayed in my CMIO role by not being informed of these contract provisions. I wonder how many former and present CMIO's out there are now thinking along the same lines. Ironically, as a Group Director at Merck Research Labs two years later I did review my department's informatics contracts, in fact I was required to, all several million dollars' worth, and in fact was involved in vendor negotiations (I had a personal grant of authority of $100,000 for smaller contracts). Pharma truly reveals hospitals for the IT backwater they are. Finally, there appears to be a mainstream media boycott of the Koppel/Kreda article. As of 1:30 PM EST March 26, Google news <a href="http://news.google.com/news?um=1&ned=us&hl=en&q=koppel+kreda">shows almost no coverage</a> except JAMA, ZDNet and Fox Business News. With Google <a href="http://www.google.com/search?hl=en&q=Health+Care+Information+Technology+Vendors%27+%22Hold+Harmless%22+Clause%3A&btnG=Search">web search</a>, I find mostly copies of the U. Penn press release, and links to a few blogs, including this one. I've previously noted this fascinating, Google-revealed phenomena about <a href="http://www.powerlineblog.com/archives/2006/09/015074.php">media noncoverage of politically inconvenient stories</a>. I've contacted the WSJ who printed my <a href="http://hcrenewal.blogspot.com/2009/02/medinformaticsmd-in-wall-street-journal.html">editorial letter</a> on Health IT last month. Perhaps they'll get the scoop on the issues raised by Koppel and Kreda. -- SS

This Former Chief Medical Informatics Officer is Feeling a Bit Betrayed

In thinking further about the "hold harmless" and "defects gag clause" originated by Health IT vendors and agreed to by ...

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Health IT "Hold Harmless" and Defects Gag Clauses: Have Hospital Executives Violated Their Fiduciary Responsibilities By Signing Such Contracts?

<div style="text-align: justify;">July 2009 - Note: also see my letter to the editor in JAMA on this same topic, "Health Care Information Technology, Hospital Responsibilities, and Joint Commission Standards", published July 22, 2009, available online at <a href="http://jama.ama-assn.org/cgi/content/extract/302/4/382">this link</a>. </div> Regarding healthcare IT "Hold Harmless" and Defects Gag Clauses as revealed by the JAMA article <a href="http://jama.ama-assn.org/cgi/content/extract/301/12/1276">Health Care Information Technology Vendors' "Hold Harmless" Clause - Implications for Patients and Clinicians</a> by Koppel and Kreda: Have hospital executives violated their fiduciary responsibilities by signing such contracts, and violated Joint Commission standards of hospital leadership conduct as well? <blockquote style="font-style: italic;font-family:arial;"> <a href="http://www.infoplease.com/ce6/society/A0818616.html">Fiduciary</a> (fidOO'shēe"rē), in law, a person who is obliged to discharge faithfully a responsibility of trust toward another. Among the common fiduciary relationships are guardian to ward, parent to child, lawyer to client, corporate director to corporation, trustee to trust, and business partner to business partner. In discharging a trust, the fiduciary must be absolutely open and fair. Certain business methods that would be acceptable between independent parties dealing with one another “at arm's length” may expose a fiduciary to liability for having abused a position of trust.</blockquote> Hospital management conduct is not bound by traditional business law only, just as physicians and other clinicians hold additional obligations. In both cases, obligations go beyond that of, say, a manager or worker at a McDonald's or a Wal-Mart. In healthcare there are "special" third parties involved with critical rights and responsibilities, namely, patients and clinicians. At <a href="http://hcrenewal.blogspot.com/2009/03/health-care-information-technology.html" style="font-family: arial;">Health Care Information Technology Vendors' "Hold Harmless" Clause</a> I expressed great concern about the remarkable revelations in Koppel and Kreda's expose of arguably unethical and clearly inexcusable contracting practices by healthcare IT producers and vendors. The vendors have declared themselves off limits from liability even if patients die as a result of software defects and malfunctions, pushing that liability onto clinicians. Vendors have simultaneously declared themselves the Ministry of Information, Soviet style, on such defects. I also expressed my concern that the contractual suppression of information dissemination on health IT problems and defects may be one reason websites on health IT difficulties, such as the <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/medinfo.htm" style="font-family: arial;">site I started in 1998</a> (in fact cited by Koppel and Kreda) remain uncommon on the Web. This is despite my documentation of continued, ongoing, world wide interest in this topic (see my 2006 AMIA abstract on this issue <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/failurecases/content/documents/AMIA2006_poster.pdf" style="font-family: arial;">here</a>, PDF, and poster <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/failurecases/content/documents/FINAL_Healthcare%20IT%20Failure_Oct_19_2006.ppt" style="font-family: arial;">here</a>, PPT). It is not just the vendors who may be acting against the best interests of medical science and patient safety, however. It also seems to me that hospital executives, boards and counsel have fiduciary responsibilities, as well as obligations under principles of due diligence, Joint Commission and other regulatory guidelines, etc. to protect not just patients from defective technologies but also to protect their staffs from unfair risks and legal liabilities. I note that these health IT contracts have apparently been signed willingly by hospital executives, against the best interests of patients and medical staffs. Nobody is holding a gun to their heads, and nobody is forbidding negotiation of terms. As a former CMIO/Director of Informatics I would never have signed such a contract. Period. (Of course, CMIO's and Directors of Informatics don't generally sign or even see health IT contracts, as they are Chiefs and Directors of Nothing.) Have hospital executives, boards of directors and counsel been violating their responsibilities and obligations every time they've signed a healthcare IT "hold vendors harmless, it's all on your docs" and "shhhh! keep the defects secret" contract? Have they abused their positions of trust? NIH research leaders and grant reviewers, as an example, consider seriously any problems with research that might place not just research subjects but also investigators at risk, medically, legally and otherwise. I perform this function on NIH study section panels. Let's look at the Joint Commission Hospital Accreditation Program <a href="http://www.jointcommission.org/Standards/SII/sii_hap_ld.htm" style="font-family: arial;">Leadership Chapter</a>, and its standards for hospital leadership (<a href="http://www.jointcommission.org/NR/rdonlyres/D53206E8-D42B-416B-B887-491B6D5AA163/0/HAP_LD.pdf" style="font-family: arial;">link</a>, PDF): <blockquote style="font-family:arial;">Leadership LD.01.03.01 Standard LD.01.03.01 The governing body is ultimately accountable for the safety and quality of care, treatment, and services. Rationale for LD.01.03.01 The governing body’s ultimate responsibility for safety and quality derives from their legal responsibility and operational authority for [organization] performance. In this context, the governing body provides for internal structures and resources, including staff, that support safety and quality. </blockquote> The governing body has a legal responsibility for safety and quality, not just a moral obligation. One of the "internal structures" is healthcare IT that is safe and effective and that does not expose patients or staff to undue risks. How does signing "hold harmless" and "defects gag order" clauses with an HIT vendor serve such a purpose, exactly? Hospital executives know, should know, or should have known that such provisions would remove incentives for health IT vendors to produce the best products and to correct deficiencies rapidly, thus increasing risk to patients and clinicians. <blockquote style="font-family:arial;">Elements of Performance for LD.01.03.01 5. The governing body provides for the resources needed to maintain safe, quality care, treatment, and services. </blockquote> One of those resources is health IT. <blockquote style="font-family:arial;">Standard LD.02.01.01 The mission, vision, and goals of the [organization] support the safety and quality of care, treatment, and services. Rationale for LD.02.01.01 The primary responsibility of leaders is to provide for the safety and quality of care, treatment, and services. The purpose of the [organization]’s mission, vision, and goals, is to define how the [organization] will achieve safety and quality. The leaders are more likely to be aligned with the mission, vision, and goals when they create them together. The common purpose of the [organization] is most likely achieved when it is understood by all who work in or are served by the [organization]. </blockquote> How is a contract with an HIT vendor that calls for hiding defects in health IT and exposing staff to liability for defects in same serving the above purposes? <blockquote style="font-family:arial;"> Standard LD.02.03.01 The governing body, senior managers and leaders of the organized medical staff regularly communicate with each other on issues of safety and quality. </blockquote> Does that include communication on health IT defects? Can a medical staff member ask to see a database of such defects when the hospital has signed a nondisclosure of defects agreement with an HIT vendor? <blockquote style="font-family:arial;">Rationale for LD.02.03.01 Leaders, who provide for safety and quality, must communicate with each other on matters affecting the [organization] and those it serves. </blockquote> I ask the same question as above. <blockquote style="font-family:arial;"> Standard LD.03.01.01 Leaders create and maintain a culture of safety and quality throughout the [organization]. </blockquote> Safety for whom, exactly? Patients, or patients and staff? How is exposing professional staff to undeserved liability from defective health IT serving the creation of a culture of safety and quality for them? How is suppressing information on health IT defects and problems helping patient safety and care quality? How is lack of seeking informed consent on health IT use from patients whose care is mediated by health IT devices with known but undisclosable defects creating a culture of quality? How is hiding such defects creating a culture of quality in the community's other hospitals, that may be considering purchase of the very same health IT? <blockquote style="font-family:arial;">Standard LD.03.04.01 The [organization] communicates information related to safety and quality to those who need it, including staff, licensed independent practitioners, [patient]s, families, and external interested parties. Rationale for LD.03.04.01 Effective communication is essential among individuals and groups within the [organization], and between the [organization] and external parties. Poor communication often contributes to adverse events and can compromise safety and quality of care, treatment, and services. Effective communication is timely, accurate, and usable by the audience. </blockquote> Are physicians and nurses explicitly informed by administration that clinicians are liable for bad outcomes due to software problems? Are they informed of the gag clause? Are patients informed of unremediated health IT defects existing at time of service? This standard seems a veritable smoking gun regarding breach of fiduciary responsibility and Joint Commission obligations when hospital leadership signs agreements specifically excluding the sharing information about health IT defects and complaints. It is already known that hospitals maintain lists of health IT defects, some in the thousands of items. A number of the defects rise to the level of creating considerable risk to patients, and nobody is in a hurry to remediate them. (See my proposed although somewhat tongue in cheek "HIT Informed Consent" that describes some of these known defect categories <a href="http://hcrenewal.blogspot.com/2009/03/draft-patient-rights-statement-and.html" style="font-family: arial;">here</a>). <blockquote style="font-family:arial;">Standard LD.04.04.03 New or modified services or processes are well-designed. ... 3. The hospital's design of new or modified services or processes incorporates: Information about potential risks to patients. 4. The hospital's design of new or modified services or processes incorporates: Evidence-based information in the decision-making process. Note: For example, evidence-based information could include practice guidelines, successful practices, information from current literature, and clinical standards. </blockquote> How does the contractual inability to communicate about health IT defects, which its executives willingly sign, serve this purpose? <blockquote style="font-family:arial;">Standard LD.04.04.05 The [organization] has an organization-wide, integrated [patient] safety program. ... 12. The hospital disseminates lessons learned from root cause analyses, system or process failures, and the results of proactive risk assessments to all staff who provide services for the specific situation. </blockquote> Disseminates lessons learned, except when the HIT contract they've signed with a vendor forbids it, that is. The practices of the health IT industry, and the dealings of the hospital leadership with that industry, may in fact be a scandal of national (or international) proportions. I urge physicians and concerned others reading this to read the Univ. of PA press release "Why Are Healthcare Information Manufacturers Free of All Liability When Their Products Can Result in Medical Errors?" <a href="http://sev.prnewswire.com/null/20090324/DC8755624032009-1.html" style="font-family: arial;">here</a>, obtain the JAMA article by Koppel and Kreda, and call their congressional and other representatives to have these self-serving industry practices that ignore protection of patients and practitioners from undue jeopardy stopped. I also believe any clinician under lawsuit related to hospital HIT malfunction, and/or patients harmed, should consider suit against the management that signed the contracts allowing the defective IT's entry into the hospital and mandated clinicians to use the HIT. I, for one, already have begun discussing these issues with my representatives in Washington, and they've expressed great surprise at these revelations. -- SS

Health IT "Hold Harmless" and Defects Gag Clauses: Have Hospital Executives Violated Their Fiduciary Responsibilities By Signing Such Contracts?

July 2009 - Note : also see my letter to the editor in JAMA on this same topic, "Health Care Information Technology, Hospital Responsib...

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