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Will The True Incidence of Healthcare IT-Caused Patient Adverse Outcomes Please Stand Up?

The 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>, Ross Koppel and David Kreda, Journal of the American Medical Association, 2009; 301(12):1276-1278 (JAMA) has caused much discussion in healthcare IT circles. I have become aware of discussions centered on issues such as: <ul style="font-family:arial;"><li>The factors besides vendor design flaws and defects that contribute to the unsafe and ineffective use of health information technology,</li></ul><ul style="font-family:arial;"><li>The degree of effect caused by end user organization customizations,</li></ul><ul style="font-family:arial;"><li>whether a focus on legal or regulatory action is misplaced </li></ul><ul style="font-family:arial;"><li>Whether such regulation could "stifle innovation", and</li></ul><ul style="font-family:arial;"><li>Other interesting and stimulating related issues. </li></ul>These discussions miss the forest for the trees, unfortunately. They are all speculation. I could just as easily - as a thought experiment - argue and rationally support a point of view that vendor defects, shortcomings, ill conceived user interfaces etc. are the greatest cause of HIT problems, that a sole focus on regulatory action is the best path, and that regulation would not stifle innovation but promote it by forcing complacent, lazy companies protected by the current status quo to become competitive, to hire the very best and brightest and most experienced who they now forgo as "too disruptive, too expensive, lack the latest programming skills", etc. None of this speculation really matters in the big scheme of things. What does matter is the fact that we now have before us a "grand confounder" - the anechoic effect caused by vendor contracting - that throws into doubt existing assumptions about HIT-caused errors. Who among us can now say what the number of physician observed defects really is, what the rate of HIT error really is? I've had several of my colleagues already tell me since the Koppel article that they know of HIT caused errors and even patient adverse consequences, but they are afraid to speak out. What is the morbidity and mortality change associated with use of HIT vs. paper? Who really knows? There is a significant, perhaps high likelihood that the current state of HIT contracting, and the muting effect it creates, combined with fear of retaliation by potential objective HIT reporters (a.k.a. whistleblowers) makes any such estimation highly questionable at best. Speculation is irrelevant. What we need is a return to the rigor of medicine - to science - in HIT itself. That can only happen in an environment where users are free(er) to share their observations and findings about HIT problems. Such one-sided, safety adverse HIT contractual clauses must end. -- SS

Will The True Incidence of Healthcare IT-Caused Patient Adverse Outcomes Please Stand Up?

The article Health Care Information Technology Vendors' "Hold Harmless" Clause - Implications for Patients and Clinicians , Ro...

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The Retirement of a Generic Manager

A frequent theme on Health Care Renewal has been the adverse effects of health care leadership by <a href="http://hcrenewal.blogspot.com/2009/01/pfizerwyeth-merger-and-sacrificing.html">generic managers </a>with no background or experience in health care, and no intuitive understanding of its values. This type of leadership arose after some health care economists called for abolishing the <a href="http://hcrenewal.blogspot.com/2006/03/consequences-of-breaking-physicians.html">supposed physicians' "guild,"</a> and transferring power over health care to managers as a way to control health care costs. This has not lead to control of health care costs. The recent <a href="http://www.nytimes.com/2009/03/31/business/31wagoner.html">coverage by the New York Times </a>of the sudden retirement of the CEO of General Motors suggests that the notion that organizations should be run by generic managers is one whose time ought to be past. Wagoner presided over a dramatic decline in the fortunes of GM. <blockquote> Mr. Wagoner presided over some of the biggest losses in G.M. history. In 2002, the company had predicted that it would earn $10 a share by the middle of the decade. Instead, G.M. lost $30.9 billion in 2008, when its per-share loss translated to more than $50 a share. G.M. stock, an economic bellwether that sold above $35 only three years ago, closed Friday at $3.62; it has fallen as low as $1.27 in the last year. In 1994, when he took charge of G.M.’s North American operations, the company made up 33.2 percent of auto sales in the United States. Last month, G.M. represented only 18.8 percent of American car and truck sales.... </blockquote> The problem may have been, in part, that Mr Wagoner was never a "car guy." <blockquote> 'It’s a pretty unceremonious ending,' said John Casesa, an industry analyst and managing partner of the Casesa Shapiro Group. 'G.M. lost its way in the ’70s, but the company didn’t know it until 20 years late. The hole was much deeper than he realized when he became C.E.O.' And, Mr. Casesa said, Mr. Wagoner’s finance background might have been a poor fit: 'The most successful auto companies are run by people who came out of the revenue-generating functions — manufacturing, design, marketing — making cars and selling cars.' Mr. Wagoner, the analyst said, 'skipped the whole apprenticeship that most auto C.E.O.’s experience.' </blockquote> The notion that a finance guy should run a car company makes not much more sense than the notion that a finance guy (or marketer, accountant, or lawyer) should run a hospital or a drug company. Yet now most health care organizations are run by such generic managers. Is it any wonder that while such generic managers have made a lot of money, they have been unsuccessful in controlling health care costs, much less solving any other aspect of the the health are crisis?

The Retirement of a Generic Manager

A frequent theme on Health Care Renewal has been the adverse effects of health care leadership by generic managers with no background or exp...

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Getting your Medicare records in Google Health

Google Health is working with the <a href="http://www.cms.hhs.gov/">Centers for Medicare and Medicaid Services (CMS)</a> on a pilot program in Arizona and Utah that lets Medicare beneficiaries import their Medicare claims data into Google Health. The pilot is one of several CMS programs to test out how the government can give beneficiaries secure access to their medical data online. Before I came to Google, I worked at the <a href="http://www.hhs.gov/" onclick="javascript: pageTracker._trackPageview('/outgoing/hhs.gov');">U.S. Department of Health and Human Services</a>, which houses CMS. At the time, the idea of giving beneficiaries access to their own Medicare claims data in electronic format was just that — an idea. Today, it's becoming a reality. And given the more than $19 billion investment the government is making in Health IT as part of the <a href="http://www.whitehouse.gov/the_press_office/arra_public_review/" onclick="javascript: pageTracker._trackPageview('/outgoing/whitehouse.gov/the_press_office/arra_public_review/');">stimulus package</a>, now is the perfect time. As a part-time caregiver to my mother who has a serious chronic illness and someone who just lost both elderly grandparents in the past four months to illness, I can see the benefit of having all of my family’s medical information organized in one place. When Google Health <a href="http://googleblog.blogspot.com/2008/05/peek-into-our-search-factory.html" onclick="javascript: pageTracker._trackPageview('/outgoing/googleblog.blogspot.com/2008/05/peek-into-our-search-factory.html');">launched</a> last year, I promptly set up accounts for my mother and both grandparents. But at the time, I found it frustrating that I was not able to access electronic copies of my grandparents' Medicare claims — where most of their medical data resided. The Medicare Arizona and Utah pilot is designed to give beneficiaries choice in the tools they use to manage their medical records online. Google Health is one of four personal health records (PHR) that beneficiaries can choose from. While only traditional fee-for-service (FFS) Medicare beneficiaries with a primary residence in Arizona and Utah are eligible to participate, this includes nearly 1.1 million beneficiaries living in those regions. For beneficiaries who choose to participate, it's important to know that Medicare does not have access to information in your Google Health Account — Medicare will only be sending data to your Account. Beneficiaries who participate in the pilot will still have access to data imported into their Google Health Accounts after the pilot concludes at the end of 2009. And with the recently launched Google Health <a href="http://googleblog.blogspot.com/2009/03/google-health-helping-you-better.html" onclick="javascript: pageTracker._trackPageview('/outgoing/googleblog.blogspot.com/2009/03/google-health-helping-you-better.html');">sharing feature</a>, any beneficiary enrolled in this pilot can now share this data with family members and doctors in their care network. If I had this type of electronic access to my grandparents' medical records during my family's medical crisis, it would have been a huge help to me. I applaud CMS for taking this big step towards empowering consumers with access to their own health records. If you're a Medicare beneficiary living in Arizona or Utah and are interested in participating in the pilot, you can <a href="http://www.google.com/intl/en-US/health/medicarephrchoice.html" onclick="javascript: pageTracker._trackPageview('/outgoing/google.com/intl/en-US/health/medicarephrchoice.html');">get started here</a>. Posted by Missy Krasner, Product Marketing Manager, Google Health

Getting your Medicare records in Google Health

Google Health is working with the Centers for Medicare and Medicaid Services (CMS) on a pilot program in Arizona and Utah that lets Medicar...

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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 onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}" href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEj4wE2fi5qPrMD8PI9anV0ENOELhNuxbrXWTU2NAZbyVkkxsXoladO3r105UNyy9OdD6ImxWRnLSHVkG7rfeRvWgkHG2F3OhH1_NeAOOGKMSyL3PVxomm4Vqpyrlmpc1LdAH563sX7WPhXL/s1600-h/donotwant.JPG"><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 onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}" href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEir98md7bwzUMThGcPnwXv04DMCpx0qNbgaI6HUFhMzGAwjL4m2RPuAqdTGJKYzK_MH5lZA81DE66rAMTeK-qoo9_zakPlKdWcproC9PGEI52JNmCSI50buYCDEi7SCyqcpTQTNgZXFNuEJ/s1600-h/light+switch.jpg"><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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