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FDA Safety and Innovation Act: To contain an "Appropriate, risk-based regulatory framework pertaining to health information technology"

Congress has just released an an Act "to amend the <a href="http://www.fda.gov/regulatoryinformation/legislation/federalfooddrugandcosmeticactfdcact/default.htm" target="_blank">Federal Food, Drug, and Cosmetic (FD&C) Act</a> to revise and extend the user-fee programs for prescription drugs and medical devices, to establish userfee programs for generic drugs and biosimilars, and for other purposes."  Health IT provisions are included. This Act, S. 3187, is entitled the ‘‘Food and Drug Administration Safety and Innovation Act.’’  PDF fulltext is located at this link:  <a href="http://www.gpo.gov/fdsys/pkg/BILLS-112s3187enr/pdf/BILLS-112s3187enr.pdf">http://www.gpo.gov/fdsys/pkg/BILLS-112s3187enr/pdf/BILLS-112s3187enr.pdf</a> With regard to health IT, the Act states the following.  A risk-based regulatory framework pertaining to health IT is to be developed (emphases mine): <blockquote class="tr_bq"> <div align="left" style="font-family: Arial,Helvetica,sans-serif;">SEC. 618. HEALTH INFORMATION TECHNOLOGY.</div><div style="font-family: Arial,Helvetica,sans-serif;"></div><div align="left" style="font-family: Arial,Helvetica,sans-serif;"> </div> <div align="left" style="font-family: Arial,Helvetica,sans-serif;">(a) REPORT.—Not later than 18 months after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this section as the ‘‘Secretary’’), acting through the Commissioner of Food and Drugs, and in consultation with the National Coordinator for Health Information Technology and the Chairman of the Federal Communications Commission, shall post on the Internet Web sites of the Food and Drug Administration, the Federal Communications Commission, and the Office of the National Coordinator for Health Information Technology, a report that contains a proposed strategy and recommendations on an appropriate, risk-based regulatory framework pertaining to health information technology, including mobile medical applications, that promotes innovation, protects patient safety, and avoids regulatory duplication.</div><div style="font-family: Arial,Helvetica,sans-serif;"></div><div style="font-family: Arial,Helvetica,sans-serif;"> </div> <div align="left" style="font-family: Arial,Helvetica,sans-serif;"> </div><div align="left" style="font-family: Arial,Helvetica,sans-serif;">(b) WORKING GROUP.—</div><div align="left" style="font-family: Arial,Helvetica,sans-serif;"> </div><div style="font-family: Arial,Helvetica,sans-serif;"></div><blockquote dir="ltr" style="margin-right: 0px;"><div style="font-family: Arial,Helvetica,sans-serif;"></div><div align="left" style="font-family: Arial,Helvetica,sans-serif;">(1) IN GENERAL.—In carrying out subsection (a), the Secretary may convene a working group of external stakeholders and experts to provide appropriate input on the strategy and recommendations required for the report under subsection (a).</div><div style="font-family: Arial,Helvetica,sans-serif;"></div><div style="font-family: Arial,Helvetica,sans-serif;"> </div> <div align="left" style="font-family: Arial,Helvetica,sans-serif;">(2) REPRESENTATIVES.—If the Secretary convenes the working group under paragraph (1), the Secretary, in consultation with the Commissioner of Food and Drugs, the National Coordinator for Health Information Technology, and the Chairman of the Federal Communications Commission, shall determine the number of representatives participating in the working group, and shall, to the extent practicable, ensure that the working group is geographically diverse and includes representatives of patients, consumers, health care providers, startup companies, health plans or other third-party payers, venture capital investors, information technology vendors, health information technology vendors, small businesses, purchasers, employers, and other stakeholders with relevant expertise, as determined by the Secretary.</div> </blockquote></blockquote> While a welcome development, it is to be determined if the Working Group representatives will include critical thinkers without conflict of interest, whose contributions to the health IT debate in this country are needed a lot more than the traditional <a href="http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html" target="_blank">hyper-enthusiasts</a>, industry courtiers and opportunists. I am actually not hopeful. The "promotes innovation" and "avoids regulatory duplication" phrases are of especially great concern.  As I've written before, "innovation" that involves non-consented experimentation is not innovation at all, it is exploitation, and "regulatory duplication" can become an excuse for milquetoast regulation by the conflicted (e.g., regulatory capture) or poorly qualified. I also note that this Act, while welcome, is long overdue - another example of putting the cart before the horse (<a href="http://hcrenewal.blogspot.com/2012/06/cart-before-horse-part-3-ahrqs-health.html" target="_blank">link</a>), with a national project (including CMS penalties for non-adopters) now several years underway. Final thought:  if health IT were safe as has been claimed now for decades, or had been made safe through proper development and clinical trials-based testing, we would not need health IT provisions in a  "Food and Drug Administration Safety and Innovation Act" in 2012. -- SS

FDA Safety and Innovation Act: To contain an "Appropriate, risk-based regulatory framework pertaining to health information technology"

Congress has just released an an Act "to amend the Federal Food, Drug, and Cosmetic (FD&C) Act to revise and extend the user-fee p...

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The Revolving Door's Bearings Overheat - Two Examples of the Health Care Insiders Who Keep it Spinning

Two recent stories illustrate a kind of conflict of interest affecting government health care policy. Note that neither story appeared in any one media outlet, but had to be pieced together from several sources, not all contemporaneous. The Peripetatic Architect of Health Care Reform Implementation Here is the story of Steve Larsen's latest career move, <a href="http://online.wsj.com/article/SB10001424052702303822204577468680618029466.html">per the Wall Street Journal</a>, <blockquote>A top official in charge of implementing the federal health-care overhaul said Friday he would step down in mid-July, shortly after the Supreme Court is expected to rule on the fate of the law. The official, Steve Larsen, heads the office at the Centers for Medicare and Medicaid Services that oversees most of the insurance provisions in the 2010 law. Those include setting up exchanges for consumers to shop for plans and obtain subsidies for premiums, establishing rules on how much money insurers must spend on medical benefits, and administering a federal program to provide insurance for consumers with pre-existing conditions. Mr. Larsen said in an interview that his departure was '100% for personal and family reasons,' and that he hadn't considered the timing of the court decision. He cited his need to pay tuition for his college-bound children,... </blockquote> The Wall Street Journal coverage made it sound like Mr Larsen was fleeing his post to avoid dealing with how the Supreme Court's decision on the Obama administration's health care reform law might complicate future functions of his office, <blockquote>Mr. Larsen's departure highlights the challenges the administration will face once the Supreme Court rules. If the court upholds the law, the administration has a 2014 deadline to put it in place, including persuading states to set up the exchanges or establishing them on states' behalf. If the court strikes down the law's key requirement, that most individuals purchase insurance or pay a fine, federal officials will have to establish whether they can make the remaining insurance elements of the law work, which would face stiff opposition from insurance companies and from Republican lawmakers who have pledged to overturn the law. If the court voids the law entirely, officials will have to start undoing hundreds of its requirements that are set up to take effect or are, in many cases, already in place. </blockquote> It only briefly mentioned where Mr Larsen was going, ostensibly in hopes that a better salary would aid in his tuition payments, <blockquote>[he] said he would be working at a health-services business unit of UnitedHealth Group, an insurer</blockquote> On the other hand, a <a href="http://www.bna.com/cciio-director-steve-n12884910135/">report from Bloomberg </a>suggested that UnitedHealth thought he would be well worth his salary, <blockquote>Larsen will be executive vice president at Optum, a health services and information technology company that is part of UnitedHealth Group Inc., of Minnetonka, Minn., the company confirmed. UnitedHealth Group is the parent company of UnitedHealthcare, the largest health insurer in the United States in terms of policyholders and revenues. 'We are excited to welcome Steve Larsen to Optum,' company spokesman Matthew Stearns told BNA in an email. 'Steve's extensive, broad-based experience in health care will further enhance the support Optum provides to the health system and consumers in a rapidly evolving environment.'</blockquote>It is funny how that experience seemed to be about crafting the regulations under which Optum, or at least its parent corporation would have to operate. But wait, there is more. Bloomberg also mentioned that Mr Larsen had previously gone from a state government health policy position to the insurance industry before he wound up at the CCIIO. <blockquote>Prior to joining the Obama administration to implement PPACA, Larsen served in a number of capacities at Amerigroup Corp., a public managed care company serving Medicaid and Medicare beneficiaries, according to his biography on the CCIIO website. Larsen also was Maryland insurance commissioner for six years, chairman of the Maryland Public Service Commission for Gov. Martin O'Malley (D),... </blockquote>To clarify, Amerigroup is a publicly-held, Fortune 500 for-profit corporation (look <a href="http://phx.corporate-ir.net/phoenix.zhtml?c=122199&p=irol-IRHome">here</a>). So in summary, and in chronological order, as best as I can establish it, Mr Larsen went from a Maryland state government policy position that affected health (and other insurance) companies, to a health insurance company (Amerigroup), to a US government policy position that affected health insurance, and now to another health insurance company (UnitedHealth). The Peripatetic Legislative Policy Director Brett Roper moved in the opposite direction, to government from industry, and to the Republican legislative majority, not the executive branch now controlled by the Democrats. Early in June, <a href="http://www.republicreport.org/2012/brett-loper-boehner/">on the Republic Report</a>, <blockquote>In late 2010, as Congressman John Boehner (R-OH) prepared to take the gavel as Speaker, he hired a lobbyist named Brett Loper as his new policy chief. Loper left his job at the Advanced Medical Technology Association, a lobby group for medical device-makers, to join Boehner.</blockquote> The Association did not seem to sad to see him go, <blockquote>Republic Report reviewed ethics forms disclosed filed with the House clerk’s office, and noticed that Loper actually received a $100,147 bonus in 2011 for leaving his medical device lobbying group and becoming a public servant.</blockquote> But wait, there is more. Loper also previously made more than one transition between government and industry. As <a href="http://www.politico.com/news/stories/1210/46211.html">Politico reported </a>in 2010, before Loper worked for the Advanced Medical Technology Association, <blockquote>Loper worked in senior positions for then House Majority Leader Tom DeLay and as the House Ways and Means Committee Republican staff director under then-ranking member Rep. Jim McCrery of Louisiana</blockquote> But wait, there is still more. In 2011, the <a href="http://www.theatlantic.com/politics/archive/2011/04/corruption-watch-john-boehners-abramoff-connection/73396">Atlantic reported</a>, <blockquote>In December, Boehner hired Brett Loper to be his policy director. At the time, articles focused on Loper's previous job as a lobbyist for the Advanced Medical Technology, where Loper vigorously resisted attempts to reduce the deficit by fighting cuts in fees to his clients proposed by the Obama administration. That is part of the story. But missing from the pieces about Loper have been his connection to the Abramoff scandal and knowledge of how to use government money to 'nfluence'legislators. Sometimes a picture is worth a thousand words. Here is a photo of Loper (far right), basking in the tropical sun of the Marianas Islands, with Michael Scanlon (center), Jack Abramoff's partner in crime. What is Loper doing in the Marianas? As a staff member for Tom Delay, Loper was part of a mission to deliver money from the "favor factory," otherwise known as the Appropriations Committee of Congress, to two legislators in the Marianas, Norm Palacios and Alejo Mendiola (between Scanlon and Loper, above). In exchange for money for their two pet projects, Palacios and Mendiola agreed to switch their votes and support Abramoff's key ally in the Marianas, Benigno Fitial, in his bid to become Speaker of the House there. The gambit worked. Fitial won. Abramoff -- whose lobbying contract to the Marianas had been canceled -- was re-hired by the Marianas. In that capacity, Abramoff resumed lobbying for the continuation of abusive labor practices in the islands. (For more on this, see my film, 'Casino Jack and the United States of Money.') Abramoff also continued to make sure that the grateful garment factory owners flowed campaign cash to key mainland Republican legislators, including Tom Delay. </blockquote> Note that according to the <a href="http://www.washingtonpost.com/wp-dyn/content/linkset/2005/06/22/LI2005062200936.html">Washington Post web-page on the Abramoff scandal</a>, <blockquote>Former Republican lobbyist Jack Abramoff was sentenced to five years and 10 months in prison on March 29, after pleading guilty to fraud, tax evasion and conspiracy to bribe public officials in a deal that requires him to cooperate in an investigation into his relationshps with members of Congress. Sources familiar with the federal probe have told The Post that half a dozen lawmakers are under scrutiny, along with Hill aides, former business associates and government officials. The scandal prompted Rep. Tom DeLay (R-Tex.) and Rep. Robert Ney (R-Ohio) to give up their leadership posts,...</blockquote> So Mr Larsen went from Republican senior legislative staff positions, during which time he associated with the now admittedly guilty Abramoff, to an industry trade association, and then back to a Republican senior legislative staff position. Summary So here are two recent good examples of a particular type of conflict of interest involving government and health care corporations. Both cases are of people who have made multiple transitions through the "revolving door" between the health care corporate world, and government agencies and organizations that are involved in policies that affect that world. These transitions' multiplicity appears to represent a conflict of interest because these peoples' frequent revolutions through the door might diminish any sense that they ever have a primary interest on behalf of any immediate employer when another employer on the other side of the supposed arms' length government-industry relationship is always beckoning. Thus the people involved appear to have become members of a peculiar class always in transition, and hence more attuned to self-interest than to promoting the health of patients and the population (which ought to have been the primary concern for government leaders.) As Matt Kelley <a href="http://www.complianceweek.com/as-the-revolving-regulatory-door-turns/article/246085">on the Compliance Week blog </a>wrote in response to the Larsen story, <blockquote>if you ever wonder why so many Americans feel like their country is slipping away from them, the revolving door—the sense that a private club of success exists in this country, and most Americans don't get to go through it, but merely live with the dictates of those who do—is a big reason why.</blockquote>As we wrote before health policy in the US, in particular, has become an insiders' game. Unless it is redirected to reflect patients' and the public's health, facilitated by the knowledge of unbiased clinical and policy experts rather than corporate public relations, expect our efforts at health care reform to just increase health care dysfunction. Physicians, public health advocates, whatever unbiased health policy experts remain must educate the public about how health policy has been turned into a corporate sandbox. We must try to somehow activate the public to call for health care policy of the people, by the people, and for the people.

The Revolving Door's Bearings Overheat - Two Examples of the Health Care Insiders Who Keep it Spinning

Two recent stories illustrate a kind of conflict of interest affecting government health care policy. Note that neither story appeared in an...

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Banking as the Standard Healthcare Should Look Up To On Medical Information Security?

At past posts "<a href="http://hcrenewal.blogspot.com/2012/03/at-my-oct.html" target="_blank">Don't Worry, Your Electronic Medical Records Are Getting Safer With Every Passing Day</a>", "<a href="http://hcrenewal.blogspot.com/2011/09/another-episode-of-dont-worry-your.html" target="_blank">Another Episode of "But Don't Worry, Your Records are Safe...</a>" and "<a href="http://hcrenewal.blogspot.com/2011/10/still-more-ehr-chaos-pandemonium-bedlam.html">Still More Electronic Medical Data Chaos, Pandemonium, Bedlam, Tumult and Maelstrom: But Don't Worry, Your Data is Secure</a>", "<a href="http://hcrenewal.blogspot.com/2012/04/dont-worry-your-records-are-safe-part.html" target="_blank">Don't Worry, Your Records are Safe - Part IV</a>" and others, I wrote on the issue of medical record security. Banking has been held as the standard as to which medicine has been compared, with medicine being called archaic and behind the times for its reliance on paper.  Banking security is cited as a reason why electronic medical records can also be secured. There's this: <blockquote class="tr_bq"><a href="http://news.sky.com/story/952931/fraud-ring-in-hacking-attack-on-60-banks" target="_blank">Fraud Ring In Hacking Attack On 60 Banks</a>  June 27, 2012 Some 60m euro is stolen from bank accounts in a massive cyber raid, after fraudsters raid dozens of banks around the world. By Pete Norman, Sky News Online Sixty million euro has been stolen from bank accounts in a massive cyber bank raid after fraudsters raided dozens of financial institutions around the world. According to a joint report by software security firm McAfee and Guardian Analytics, more than 60 firms have suffered from what it has called an "insider level of understanding". "The fraudsters' objective in these attacks is to siphon large amounts from high balance accounts, hence the name chosen for this research - Operation High Roller," the report said. "If all of the attempted fraud campaigns were as successful as the Netherlands example we describe in this report, the total attempted fraud could be as high as 2bn euro (£1.6bn)." The automated malicious software programme was discovered to use servers to process thousands of attempted thefts from both commercial firms and private individuals. The stolen money was then sent to so-called mule accounts in caches of a few hundreds and 100,000 euro (£80,000) at a time. Credit unions, large multinational banks and regional banks have all been attacked. Sky News defence and security editor Sam Kiley said: "It does include British financial institutions and has jumped over to North America and South America. "What they have done differently from routine attacks is that they have got into the bank servers and constructed software that is automated. "It can get around some of the mechanisms that alert the banking system to abnormal activity." The details of the global fraud come just a day after the MI5 boss warned of the new cyber security threat to UK business. McAfee researchers have been able to track the global fraud, which still continues, across countries and continents. "They have identified 60 different servers, many of them in Russia, and they have identified one alone that has been used to steal 60m euro," Kiley said. "There are dozens of servers still grinding away at this fraud – in effect stealing money."</blockquote> That's all very reassuring.   Let's put all of our personal medical secrets online ASAP.  Don't worry, your information's safe and secure. -- SS

Banking as the Standard Healthcare Should Look Up To On Medical Information Security?

At past posts " Don't Worry, Your Electronic Medical Records Are Getting Safer With Every Passing Day ", " Another Episod...

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"More Marketing Than Science" - An Anonymous Confession About Deceptive Marketing Published in the British Medical Journal

The British Medical Journal just published an anonymous article by a pharmaceutical company insider that explained once again how pharmaceutical companies turn research studies, apparently scholarly articles, and medical education into stealth marketing efforts.  (See Anonymous.  Post-marketing observational studies: my experience in the drug industry.  Brit Med J 2012; 344: 28.  Link <a href="http://www.bmj.com/content/344/bmj.e3990">here</a>.) We have previously discussed examples of health care corporate insiders confessing their individual efforts to turn medical research and education into marketing.  For example, peruse <a href="http://hcrenewal.blogspot.com/search/label/key%20opinion%20leaders">this</a>.  We have also discussed how documents made public through litigation have revealed marketing plans for specific drugs that used apparently academic, educational, or scholarly publications and venues to market without revealing this transformation.  For example, see the Neurontin marketing plan (see post <a href="http://hcrenewal.blogspot.com/2006/08/stealth-marketing-of-neurontin.html">here</a>), and the Lexapro marketing plan (see post <a href="http://hcrenewal.blogspot.com/2009/09/lexapro-marketing-plan-was-meant-to.html">here</a>).  We have also discussed numerous examples of <a href="http://hcrenewal.blogspot.com/search/label/manipulating%20clinical%20research">manipulation of particular research studies</a> by those with vested interests, and outright <a href="http://hcrenewal.blogspot.com/search/label/suppression%20of%20medical%20research">suppression of studies</a> whose results did not favor such vested interests. Yet I suspect majorities of health care academics and professionals, health care policy makers, and the public at large do not realize, or would not admit that the evidence base for making health care decisions, and the general academic and professional discourse has been so corrupted.  So it is worthwhile to review once again how an insider summarized this corruption. Research Studies Designed Primarily as Marketing Vehicles In general, the anonymous author suggested that at least some studies were done for marketing, not scientific purposes: <blockquote>some of the studies I worked on were not designed to determine the overall risk:benefit balance of the drug in the general population. They were designed to support and disseminate a marketing message. Whether it was to highlight a questionable advantage over a 'me-too' competitor drug or to increase disease awareness among the medical community (particularly in so called invented diseases) and in turn increase product penetration in the market, the truth is that these studies had more marketing than science behind them.</blockquote> Furthermore, the studies were supervised not by physicians or scientists, but by marketers in the marketing department, <blockquote>Although the medical department developed the publication plans, designed the study, performed the statistical analysis, and wrote the final paper (which when published was passed on to marketing and sales to be used as marketing material), the marketing team responsible for that product were directly involved in all stages. They also closely supervised the content of other educational 'scientific' materials produced in the medical department and intended for potential prescribers. Instructions from marketing to the medical staff involved were clear: to ensure that the benefits of the drug were emphasised and the disadvantages were minimised where possible.</blockquote> Manipulation of Research Design, Implementation, or Analysis The author described how the marketers manipulated research studies so they would produce the results desired from a marketing perspective, regardless of their underlying truth, <blockquote>Since marketing claims needed to be backed-up scientifically, we occasionally resorted to 'playing' with the data that had originally failed to show the expected result. This was done by altering the statistical method until any statistical significance was found. Such a result might not have supported the marketing claim, but it was always worth giving it a go to see what results you could produce. And it was possible because the protocols of post-marketing studies were lax, and it was not a requirement to specify any statistical methodology in detail. On the other hand, the studies were hypothesis testing (such as cohort studies, case-control studies) rather than hypothesis generating (such as case reports or adverse events reports), so playing with the data felt uncomfortable. Other practices to ensure the marketing message was clear in the final publication included omission of negative results, usually in secondary outcome measures that had not been specified in the protocol, or inflating the importance of secondary outcome measures if they were positive when the primary measure was not.</blockquote> So to summarize, the marketers would control the statistical analyses, promoting multiple analyses to attempt to come up with the "right" result that would support the marketing message (although the more kinds of analyses one tries, the more likely one is likely to come up with false results by chance alone). Presumably the marketers did not care whether or not the results were really true, which is perhaps why even they felt "uncomfortable" in some circumstances. They would also foster the suppression of negative results, and the dredging of data for extra outcome measures when analysis showed no advantage in terms of the real primary outcomes. Suppression of negative results could be viewed as plain lying. Deliberate analysis of multiple end-points again risks identifying random error as true results. The Role of Key Opinion Leaders The author described how key opinion leaders, that is, health care professionals thought to be especially influential on practice or policy, were hired to become marketers presumably without revealing this intention. <blockquote>Every big international observational study had a large advisory board. This was critical since the success of a newly launched drug in the market would depend on how many key opinion leaders were part of the study. Not only would they add credibility to the results, but they would also be key in influencing decision makers and other prescribers. In regional studies with thousands of patients, the study’s advisory board was formed by at least one key opinion leader from each country in that region, ensuring that areas important in terms of possible sales were covered. The contributions of the key opinion leaders to the study were always positive, but in my experience more directed towards designing new studies to answer their specific clinical questions rather than critically appraising our results and conclusions. In general, the relationship was amicable. We took them to the best hotels and restaurants during our advisory board meetings, and they appeared as authors in our research. Later, they would act as the company’s 'ambassadors,' giving conferences, teaching doctors, or talking to the media about the benefits of the drug.</blockquote> Note that even the anonymous author could not bring him or herself to call the key opinion leaders salespeople, or marketers, but used the ambiguous wterm "ambassadors." Nonetheless, the role of key opinion leaders described would clearly be that of marketers or salespeople. However, it is extremely doubtful that any of these KOLs felt they had to declare that they were paid salespeople when presenting at conferences, teaching doctors, or talking about the media. I would suggest that their actions would therefore fit <a href="http://www.transparency.org/whoweare/organisation/faqs_on_corruption">Transparency International's definition</a> of ethical corruption, "abuse of entrusted power for private gain." The KOLs are entrusted to be professional, and in many cases, scholarly. Using a professional or scholarly guise to act as a salesperson appears to be abuse of that entrusted power, in my humble opinion. In nearly every case, KOLs are paid, often handsomely, by the companies whose products they are selling. Thus, key opinion leaders acting as described by the anonymous author appear to be ethically corrupt. Summary The evidence of unethical marketing practices by commercial health care firms is mounting. Although I am most familiar with evidence from the US, there is mounting evidence that these practices are global, often done by companies that are not US based, and meant to influence practice and policy world-wide. As the evidence mounts, it becomes increasingly clear that many such marketing practices are corrupt, at least in an ethical sense. Whether they may break laws in particular countries is a question for someone else. The latest BMJ article is a reminder how skeptical the shrinking group of health care professionals who do not have conflicts of interest, are not biased in favor of particular products, and who put patients' interests first must be about ALL published research, scholarly publications, and apparently educational activities. Advocates of true evidence-based medicine must be extremely careful to try to use the least biased and manipulated parts of the evidence-base. The mounting evidence suggests that at a minimum, all research reports, scholarly articles, media reports, conferences, and educational programs should provide full, detailed disclosure of all conflicts of interest. Perhaps having to make a declaration like "I am paid 50,000 Euros a year by the marketing department of company X to help market drug Y" before a supposedly educational talk would make some health care professionals think twice about such relationships. However, even such detailed disclosure may not be sufficient to hamper marketing practices that now appear overtly corrupt. In my humble opinion, it is time to consider a global ban on the funding or influencing of human research by companies and other organizations which stand to gain financially according to the results of the research, or whose products and services are subject of such research. It is also time to consider a global ban on the funding or influencing of health care education by such organizations. However, so many people are making so much money from the current practices that I doubt such proposals would get much support, or even public notice beyond this humble blog.

"More Marketing Than Science" - An Anonymous Confession About Deceptive Marketing Published in the British Medical Journal

The British Medical Journal just published an anonymous article by a pharmaceutical company insider that explained once again how pharmaceut...

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FDA: Software Failures Responsible for 24% Of All Medical Device Recalls

At "<a href="https://threatpost.com/en_us/blogs/fda-software-failures-responsible-24-all-medical-device-recalls-062012" target="_blank">FDA: Software Failures Responsible for 24% Of All Medical Device Recalls</a>" via Kapersky Labs, a software security company, it is observed (emphases mine): <blockquote class="tr_bq">Software failures were behind 24 percent of all the medical device recalls in 2011, according to data from the U.S. Food and Drug Administration, which said it is gearing up its labs to spend more time analyzing the quality and security of software-based medical instruments and equipment. The FDA's Office of Science and Engineering Laboratories (OSEL) released the data in its 2011 Annual Report on June 15, amid reports of a compromise of a Web site used to distribute software updates for hospital respirators. The absence of solid architecture and "principled engineering practices" in software development affects a wide range of medical devices, with potentially life-threatening consequences, the Agency said. In response, FDA told Threatpost that it is developing tools to disassemble and test medical device software and locate security problems and weak design. ... "Manufacturers are responsible for identifying risks and hazards associated with medical device software (or) firmware, including risks related to security, and are responsible for putting appropriate mitigations in place to address patient safety," the agency said in an e-mail statement. </blockquote> <a href="http://hcrenewal.blogspot.com/2011/04/fda-decides-regulating-implantable.html" target="_blank">Health IT medical devices</a> are the exception, of course.  A health IT virtual medical device is always of <a href="http://sydney.edu.au/engineering/it/%7Ehitru/essays/Pt%207%20-%20The%20Integrated%20Assessment%20-%20The%20Washup.pdf" target="_blank">rock-solid architecture</a>, always uses "<a href="http://hcrenewal.blogspot.com/2011/10/nist-on-ehr-mission-hostile-user.html" target="_blank">principled engineering practices</a>" in software development, and never has <a href="http://hcrenewal.blogspot.com/2011/06/babys-death-spotlights-safety-risks.html" target="_blank">life-threatening consequences</a>, of course. Hence its special regulatory accommodations over non-virtual (tangible) medical devices. -- SS

FDA: Software Failures Responsible for 24% Of All Medical Device Recalls

At " FDA: Software Failures Responsible for 24% Of All Medical Device Recalls " via Kapersky Labs, a software security company, it...

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Huge Insurance Company WellPoint Settles Once Again, Providing a Window On the Ethical Questions Its Birth Presented

Another month, another question about the ethical conduct of for-profit insurance giant WellPoint.  WellPoint Settles Allegations its Predecessor Anthem Cheated its Former Policy-Holders This time the issue was how the company treated people insured by its now Anthem subsidiary a long time ago.  Here is the Reuters <a href="http://www.reuters.com/article/2012/06/15/us-wellpoint-settlement-idUSBRE85E1F020120615">version</a>: <blockquote>Health insurer WellPoint Inc has agreed to pay $90 million to settle a class-action lawsuit against its Anthem unit over accusations the company did not fairly compensate former members when Anthem was converted from a mutual company into a stock company.</blockquote> The Indianapolis Star <a href="http://www.indystar.com/article/20120616/BUSINESS03/306160003/WellPoint-settles-former-Anthem-policyholders-90M">noted</a>: <blockquote>WellPoint had fought the lawsuit for seven years in court. The lawsuit alleged that WellPoint's Anthem subsidiary underpaid policyholders who opted to receive cash instead of stock when the Blue Cross-Blue Shield franchisee converted in 2001 into a stock company.</blockquote> Of course, a WellPoint spokesman denied the company had done anything wrong, per Reuters, <blockquote>Anthem spokeswoman Kristin Binns said in an e-mailed statement. 'We continue to believe that in all ways the company acted appropriately and in the best interests of its former members,...' </blockquote>The Historic Context: the Conversion of Non-Profit Health Insurers into For-Profit Corporations This may seem very dry and only of historical interest, but consider the historical context. Per <a href="http://wendellpotter.com/deadlyspin/">Wendell Potter's Deadly Spin</a>, after the Clinton administration's failed attempt at health reform, leaders of previously non-profit Blue Cross and Blue Shield insurance plans saw a new opportunity. In the mid-1990s, <blockquote>the Blue Cross and Blue Shield Association took a little-noticed but monumental step. The trade group, a bastion of non-profit health insurers that included the founders of the modern health insurance system, modified its bylaws to permit members to convert into public-stock companies.</blockquote> Potter opined about the executives' main motivation for conversion to for-profit status, and then consolidation of the resulting companies, <blockquote>They would earn bigger pay packages for managing larger businesses, and if they could convert them to for-profit companies, they would earn even more.</blockquote> So, <blockquote>Fourteen Blue Cross plans, most of which dominated their state-wide markets, converted from nonprofits to for-profits, and by 2004 all fourteen wound up as wholly owned subsidiaries of WellPoint.... </blockquote>The Anthem Demutualization as a Step to WellPoint Executives' Enrichment Anthem began as a non-profit insurance company, Blue Cross/Blue Shield of Indiana. Its hired managers first converted it into a mutual insurance company, a company that was owned by its policy-holders, and hence somewhat a non-profit in spirit. Then the executives started to acquire other formerly non-profit Blue Cross and Blue Shield plans. Then they converted the mutual insurance company into a pure for-profit. The for-profit Anthem eventually acquired WellPoint, taking that company's name. The resulting company then had become the biggest for-profit US health care insurer. In 2003, as the acquisition of WellPoint was pending, the Indianapolis Star <a href="http://www2.indystar.com/articles/2/135877-3402-031.html">reported</a>: <blockquote>The top executive at Anthem Inc. will receive a $42.5 million stock-and-cash award for guiding the company as it became the state's largest firm and now stands to become the nation's largest health benefits company. Larry C. Glasscock will receive the merit-based performance award over the next three years on top of his salary, bonus and other compensation of $3.73 million last year. It's the most compensation Glasscock has received since he became the company's chief executive in 1999 and helped convert it to a publicly traded concern in 2001</blockquote> Furthermore, <blockquote>Award amounts of $16 million each went to Glasscock's two highest-ranking associates: executive vice presidents David R. Frick, an attorney and former Indianapolis deputy mayor, and Michael L. Smith, a former chief executive of moving company Mayflower Group. In addition, the president of Anthem Midwest, Keith R. Faller, will get a stock-and-cash award of $11.9 million, while Anthem Southeast President Thomas G. Snead Jr. got $4.36 million.</blockquote> The allegation that the company's hired managers failed to adequately reimburse policy-holders for the policy-owners' ownership interests in the mutual version of Anthem was the basis of the law-suit that was just settled. The Anthem demutualization was a key step in the formation of the WellPoint behemoth. Its creation was the rationale to make the executives listed above rich. The allegations made in the lawsuit just settled suggest that they earned these huge windfalls on the backs of the policy-holders who at one point thought it was their company, and formerly thought that their insurer was a benign non-profit organization. A Continuing Record of Ethical Misadventures Thus, the lawsuit just settled suggests that WellPoint was born in ethically questionable circumstances, and that its creation served more to enrich its hired executives, who may have started as hired leaders of mission-oriented non-profit organizations. So in retrospect maybe it is not so surprising that WellPoint's leadership has continued to generate a series of ethical questions. Since we began <a href="http://hcrenewal.blogspot.com/">Health Care Renewal</a>, we have noted that the company: <ul><li>settled a RICO (racketeer influenced corrupt organization) law-suit in California over its alleged systematic attempts to withhold payments from physicians (see 2005 post <a href="http://hcrenewal.blogspot.com/2005/07/wellpoint-settles-rico-law-suit.html">here</a>).</li><li>subsidiary New York Empire Blue Cross and Blue Shield misplaced a computer disc containing confidential information on 75,000 policy-holders (see 2007 story <a href="http://www.nytimes.com/2007/03/14/business/14insure.html">here</a>).</li><li>California Anthem Blue Cross subsidiary cancelled individual insurance policies after their owners made large claims (a practices sometimes called rescission).  The company was ordered to pay a million dollar fine in early 2007 for this (see post <a href="http://hcrenewal.blogspot.com/2007/03/wellpoint-fined-1-million-for-canceling.html">here</a>).  A state agency charged that some of these cancellations by another WellPoint subsidiary were improper (see post <a href="http://hcrenewal.blogspot.com/2007/07/more-than-half-of-wellpoints-policy.html">here</a>).  WellPoint was alleged to have pushed physicians to look for patients' medical problems that would allow rescission (see post <a href="http://hcrenewal.blogspot.com/2008/02/wellpoint-halts-attempts-to-have.html">here</a>).  It turned out that California never collected the 2007 fine noted above, allegedly because the state agency feared that WellPoint had become too powerful to take on (see post <a href="http://hcrenewal.blogspot.com/2008/07/wellpoint-settles-but-has-it-become-too.html">here</a>). But in 2008, WellPoint agreed to pay more fines for its rescission practices (see post <a href="http://hcrenewal.blogspot.com/2008/07/fines-re-statements-and-more-fines-just.html">here</a>).  In 2009, WellPoint executives were defiant about their continued intention to make rescission in hearings before the US congress (see post <a href="http://hcrenewal.blogspot.com/2009/06/managed-care-executives-will-not-limit.html">here</a>).</li><li>California Blue Cross subsidiary allegedly attempted to get physicians to sign contracts whose confidentiality provisions would have prevented them from consulting lawyers about the contracts (see 2007 post <a href="http://hcrenewal.blogspot.com/2007/11/physicians-and-contracts-cautionary.html">here</a>).</li><li>formerly acclaimed CFO was fired for unclear reasons, and then allegations from numerous women of what now might be called Tiger Woods-like activities surfaced (see post <a href="http://hcrenewal.blogspot.com/2008/01/more-managed-care-management-mumbo.html">here</a>).</li><li>announced that its investment portfolio was hardly immune from the losses prevalent in late 2008 (see post <a href="http://hcrenewal.blogspot.com/2008/10/if-this-is-how-wellpoint-has-managed.html">here</a>).</li><li>was sanctioned by the US government in early 2009 for erroneously denying coverage to senior patients who subscribed to its Medicare drug plans (see 2009 post <a href="http://hcrenewal.blogspot.com/2009/01/wellpoint-sanctioned.html">here</a>).</li><li>settled charges that it had used a questionable data-base (built by Ingenix, a subsidiary of ostensible WellPoint competitor UnitedHealth) to determine fees paid to physicians for out-of-network care (see 2009 post <a href="http://hcrenewal.blogspot.com/2009/02/wellpoint-settles.html">here</a>).  </li><li>violated state law more than 700 times over a three-year period by failing to pay medical claims on time and misrepresenting policy provisions to customers, according to the California health insurance commissioner (see 2010 post <a href="http://hcrenewal.blogspot.com/2010/02/argument-over-insurance-rate-hikes.html">here</a>). </li><li>exposed confidential data from about 470,000 patients (see 2010 post <a href="http://hcrenewal.blogspot.com/2010/06/wellpoint-dont-know-much-about-computer.html">here</a>) and settled the resulting lawsuit in 2011 (see post <a href="http://hcrenewal.blogspot.com/2011/10/still-more-ehr-chaos-pandemonium-bedlam.html">here</a>).</li><li>fired a top executive who publicly apologized for the company's excessively high charges (see 2010 post here).</li><li>California Anthem subsidiary was fined for systematically failing to make fair and timely payments to doctors and hospitals (see 2010 post <a href="http://hcrenewal.blogspot.com/2010/12/health-insurers-sanctioned-fined.html">here</a>).</li><li>management was accused of hiding the company's political contributions from the company's own stock-holders (see 2012 posts <a href="http://hcrenewal.blogspot.com/2012/04/some-of-wellpoints-owners-stockholders.html">here</a> and <a href="http://hcrenewal.blogspot.com/2012/05/wall-street-journal-defends-hired.html">here</a>).</li></ul>Meanwhile, top hired managers have continued to draw bloated compensation from the company.  For example, as we noted <a href="http://hcrenewal.blogspot.com/2012/04/some-of-wellpoints-owners-stockholders.html">here</a>, current WellPoint CEO Angela Braly got $13.2 million compensation, and received an additional $6.9 million from newly vested restricted stock units in 2011, despite falling company earnings. Summary: A Company Too Big to Manage Except to Enrich Its Executives Thus, we have seen an amazing string of incidents suggesting that company leadership has consistently put short-term revenues, and the resulting exaggerated management compensation, before stock-holders' interests, and before patients' interests.  Yet this pattern, so plain above, has largely not been assembled from its component pieces in public other than on Health Care Renewal.  Lack of perception of this pattern may explain why this incredible compilation of ethical missteps has failed to generate any calls for massive revisions in how this company is lead and governed, or perhaps calls to dismantle such a large for-profit company as unmanageable except as a source of nearly unlimited dollars for the enrichment of its top insiders. True health care reform would require the leaders of health care organizations to uphold the health care mission ahead of their own self-interest, and to be accountable to the organizations' owners, when they exist, and to patients and the public at large.

Huge Insurance Company WellPoint Settles Once Again, Providing a Window On the Ethical Questions Its Birth Presented

Another month, another question about the ethical conduct of for-profit insurance giant WellPoint. WellPoint Settles Allegations its Predec...

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AMIA Board: specification of core competencies in Biomedical Informatics

In 1998 I launched a website called "Medical Informatics and Leadership of Clinical Computing" (now entitled "Contemporary Issues in Medical Informatics- Common Examples of Healthcare Information Technology Difficulties" at <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/" target="_blank">this link</a>). Its theme was that leadership of IT in healthcare was severely lacking in the formal competencies needed to reach any measure of success, and in fact the lack of informatics competencies in the usual IT actors was causing wasted resources and patient harm. I had also commented that the term "Medical Informatics" itself was being misappropriated by anyone claiming to do anything with computers in medicine, even the creation of trivial and/or low-value programs. Sadly, little has changed in that regard since 1998; in fact things are much worse.  The meaning of the term "Medical Informatics" itself has become severely blurred, and job listings that use the term are largely misguided.  They often seek a nurse (most common) or doctor (less common) without formal education in the domain, who's dabbled with hospital IT systems, to lead clinical IT projects.  This is a totally inappropriate and even dangerous approach (example <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=leadership" target="_blank">here</a>). The American Medical Informatics Association has released a paper "AMIA Board white paper: definition of biomedical informatics and specification of core competencies for graduate education in the discipline" that is long, long overdue.  As of this writing, full text is available a this link:  <a href="http://jamia.bmj.com/content/early/2012/06/07/amiajnl-2012-001053.full">http://jamia.bmj.com/content/early/2012/06/07/amiajnl-2012-001053.full</a>. This paper certainly provides a robust affirmation of ONC's recommendations on healthcare IT leadership roles that I wrote of in my Oct. 2009 post "<a href="http://hcrenewal.blogspot.com/2009/12/onc-defines-taxonomy-of-health-it.html" target="_blank">ONC Defines a Taxonomy of Robust Healthcare IT Leadership</a>." Some highlights of the new AMIA paper: <blockquote class="tr_bq">Abstract <div id="p-2">The AMIA biomedical informatics (BMI) core competencies have been designed to support and guide graduate education in BMI, the core scientific discipline underlying the breadth of the field's research, practice, and education. The core definition of BMI adopted by AMIA specifies that BMI is ‘the interdisciplinary field that studies and pursues the effective uses of biomedical data, information, and knowledge for scientific inquiry, problem solving and decision making, motivated by efforts to improve human health.’ Application areas range from bioinformatics to clinical and public health informatics and span the spectrum from the molecular to population levels of health and biomedicine. The shared core informatics competencies of BMI draw on the practical experience of many specific informatics sub-disciplines. The AMIA BMI analysis highlights the central shared set of competencies that should guide curriculum design and that graduate students should be expected to master. </div></blockquote> Note that Biomedical Informatics, which the Board feels is a broader term encompassing all of the information-science disciplines in healthcare and biomedical research, is defined as "a core scientific discipline underlying the breadth of the field's research, practice, and education."  One does not acquire expertise in a scientific discipline without first rigorously studying that discipline, e.g., as is done in medical school to gain optimal understanding of clinical medicine. <blockquote class="tr_bq">... The present articulation of BMI core competencies is intended to support AMIA and its members in promoting the discipline as a career choice, and to provide guidance to students and curriculum developers when choosing, designing (and implementing), or re-designing graduate-level academic BMI programs.</blockquote> (Who needs graduate education in Biomedical Informatics when all that seems to be needed is a little on-the-job dabbling?) <blockquote class="tr_bq">... Defining BMI as the scientific core of a discipline that has broad applications across health and biomedicine highlights its foundational role and refutes the kind of reductionism that superficially explains BMI simply as the application of information technology (IT) to biomedical and health problems.</blockquote> I termed that phenomenon "Medical Instamatics" on that late 1990's site.  Unfortunately, the "reductionism" is all too prevalent today.  People whose BMI education and skill levels (which I define as the ability to apply deep knowledge and experience to successfully manage the unexpected, not just manage traditional activities via a book of "process"), are often at the amateur level -- in the same sense that I am a <a href="http://www.arrl.org/" target="_blank">radio amateur</a>, not a telecommunications/engineering professional -- or worse.  This wreaks havoc (as <a href="http://hcrenewal.blogspot.com/2011/02/updated-reading-list-on-health-it.html" target="_blank">here</a>) in health IT, especially when led by senior management also incognizant of the issues. <blockquote class="tr_bq"><div id="p-11">Definition: Biomedical informatics (BMI) is the interdisciplinary field that studies and pursues the effective uses of biomedical data, information, and knowledge for scientific inquiry, problem solving, and decision making, driven by efforts to improve human health. </div></blockquote><blockquote><blockquote class="tr_bq"><div id="p-12">Scope and breadth of discipline: BMI investigates and supports reasoning, modeling, simulation, experimentation, and translation across the spectrum from molecules to individuals and to populations, from biological to social systems, bridging basic and clinical research and practice and the healthcare enterprise. </div></blockquote></blockquote><blockquote><blockquote><div id="p-13">Theory and methodology: BMI develops, studies, and applies theories, methods, and processes for the generation, storage, retrieval, use, management, and sharing of biomedical data, information, and knowledge. </div></blockquote></blockquote><blockquote><blockquote><div id="p-14">Technological approach: BMI builds on and contributes to computer, telecommunication, and information sciences and technologies, emphasizing their application in biomedicine. </div></blockquote></blockquote><blockquote><blockquote><div id="p-15">Human and social context: BMI, recognizing that people are the ultimate users of biomedical information, draws upon the social and behavioral sciences to inform the design and evaluation of technical solutions, policies, and the evolution of economic, ethical, social, educational, and organizational systems. </div></blockquote></blockquote> There is also a call for experts to: <ul class="list-unord" id="list-3"><li id="list-item-6"> <div id="p-24">Acquire professional perspective: Understand and analyze the history and values of the discipline and its relationship to other fields while demonstrating an ability to read, interpret, and critique the core literature.</div></li></ul> In effect, health IT amateurs, including those in traditional business computing, have little to no formal education or experience in reasoning, modeling, simulation, experimentation, and translation; developing, studying, and applying theories; building on and contributing to computer, telecommunication, and information sciences and technologies; and drawing upon the social and behavioral sciences to inform design of these complex systems. <blockquote class="tr_bq">BMI is the core scientific discipline that supports applied research and practice in several biomedical disciplines, including health informatics, which is composed of clinical informatics (including subfields such as medical, nursing, and dental informatics) and public health informatics (sometimes referred to more broadly as population informatics to capture its inclusion of global health informatics). There are related notions, such as consumer health informatics, which involves elements of both clinical and public health informatics. BMI in turn draws on the practical experience of the applied subspecialties, and works in the context of clinical and public health systems and organizations to develop experiments, interventions, and approaches that will have scalable impact in solving health informatics problems. However, it is the depth of informatics methods, shared across the spectrum from the molecular to the population levels<a class="xref-bibr" href="http://jamia.bmj.com/content/early/2012/06/07/amiajnl-2012-001053.full#ref-3" id="xref-ref-3-2"></a> that defines the core discipline of BMI and provides its coherence and its professional foundation for defining a common set of core competencies.</blockquote> Here is the diagrammatic represention of the above in the full article: <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/AVvXsEiX0WhgzQnpXO8Sql66EOfWJVSqULu2qvMhhkceeEnMfmVzwyYi4C_q3RTsX3ET_IucsBpfwlghcZdLrPFR8fAGmIzTHdsIut9g_tdM8_0ngC16xdZAyUqsYWzdqPb-qx2WJ0FRSGXGOIC8/s1600/F1.large.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="220" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiX0WhgzQnpXO8Sql66EOfWJVSqULu2qvMhhkceeEnMfmVzwyYi4C_q3RTsX3ET_IucsBpfwlghcZdLrPFR8fAGmIzTHdsIut9g_tdM8_0ngC16xdZAyUqsYWzdqPb-qx2WJ0FRSGXGOIC8/s320/F1.large.jpg" width="320" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">Biomedical informatics and its areas of application and practice, spanning the range from molecules to populations and society</td><td class="tr-caption" style="text-align: center;"></td><td class="tr-caption" style="text-align: center;"></td></tr></tbody></table> Finally, excerpts from the meat of the article on Prerequisite knowledge and skills.  This depth and breadth of knowledge does not come from studying business computing, dabbling with systems by nurses or physicians lacking formal domain education at the graduate level or beyond, or by guessing by the seat of one's pants: <ul class="list-unord" id="list-2"><li id="list-item-14"><ul class="list-unord" id="list-4"><li id="list-item-16"> <div id="p-34">Fundamental knowledge: Understand the fundamentals of the field in the context of the effective use of biomedical data, information, and knowledge. For example:</div><ul class="list-unord" id="list-5"><li id="list-item-19"> <div id="p-37">... Healthcare: screening, diagnosis (diagnoses, test results), prognosis, treatment (medications, procedures), prevention, billing, healthcare teams, quality assurance, safety, error reduction, comparative effectiveness, medical records, personalized medicine, health economics, information security and privacy.</div></li></ul></li><li id="list-item-22"> <div id="p-40">Procedural knowledge and skills: For substantive problems related to scientific inquiry, problem solving, and decision making, apply, analyze, evaluate, and create solutions based on biomedical informatics approaches.</div><ul class="list-unord" id="list-6"><li id="list-item-23"> <div id="p-41">Understand and analyze complex biomedical informatics problems in terms of data, information, and knowledge.</div></li><li id="list-item-24"> <div id="p-42">Apply, analyze, evaluate, and create biomedical informatics methods that solve substantive problems within and across biomedical domains.</div></li><li id="list-item-25"> <div id="p-43">Relate such knowledge and methods to other problems within and across levels of the biomedical spectrum.</div></li></ul></li></ul></li><li id="list-item-26"> <div id="p-44">Theory and methodology: BMI develops, studies, and applies theories, methods, and processes for the generation, storage, retrieval, use, management, and sharing of biomedical data, information, and knowledge. All involve the ability to reason and relate to biomedical information, concepts, and models spanning molecules to individuals to populations: </div><ul class="list-unord" id="list-7"><li id="list-item-27"> <div id="p-45">Theories: Understand and apply syntactic, semantic, cognitive, social, and pragmatic theories as they are used in biomedical informatics. </div></li><li id="list-item-28"> <div id="p-46">Typology: Understand, and analyze the types and nature of biomedical data, information, and knowledge.</div></li><li id="list-item-29"> <div id="p-47">Frameworks: Understand, and apply the common conceptual frameworks that are used in biomedical informatics.</div><ul class="list-unord" id="list-8"><li id="list-item-30"> <div id="p-48">A framework is a modeling approach (eg, belief networks), programming approach (eg, object-oriented programming), representational scheme (eg, problem space models), or an architectural design (eg, web services).</div></li></ul></li><li id="list-item-31"> <div id="p-49">Knowledge representation: Understand and apply representations and models that are applicable to biomedical data, information, and knowledge.</div><ul class="list-unord" id="list-9"><li id="list-item-32"> <div id="p-50">A knowledge representation is a method of encoding concepts and relationships in a domain using definitions that are computable (eg, first order logics).</div></li></ul></li><li id="list-item-33"> <div id="p-51">Methods and processes: Understand and apply existing methods (eg, simulated annealing) and processes (eg, goal-oriented reasoning) used in different contexts of biomedical informatics.</div></li></ul></li><li id="list-item-34"> <div id="p-52">Technological approach: BMI builds on and contributes to computer, telecommunication, and information sciences and technologies, emphasizing their application in biomedicine. </div><ul class="list-unord" id="list-10"><li id="list-item-35"> <div id="p-53">Prerequisite knowledge and skills: Assumes familiarity with data structures, algorithms, programming, mathematics, statistics.</div></li><li id="list-item-36"> <div id="p-54">Fundamental knowledge: Understand and apply technological approaches in the context of biomedical problems. For example:</div><ul class="list-unord" id="list-11"><li id="list-item-37"> <div id="p-55">Imaging and signal analysis.</div></li><li id="list-item-38"> <div id="p-56">Information documentation, storage, and retrieval.</div></li><li id="list-item-39"> <div id="p-57">Machine learning, including data mining.</div></li><li id="list-item-40"> <div id="p-58">Networking, security, databases.</div></li><li id="list-item-41"> <div id="p-59">Natural language processing, semantic technologies.</div></li><li id="list-item-42"> <div id="p-60">Representation of logical and probabilistic knowledge and reasoning.</div></li><li id="list-item-43"> <div id="p-61">Simulation and modeling.</div></li><li id="list-item-44"> <div id="p-62">Software engineering.</div></li></ul></li><li id="list-item-45"> <div id="p-63">Procedural knowledge and skills: For substantive problems, understand and apply methods of inquiry and criteria for selecting and utilizing algorithms, techniques, and methods.</div></li></ul></li><li id="list-item-49"> <div id="p-67">Human and social context: BMI, recognizing that people are the ultimate users of biomedical information, draws upon the social and behavioral sciences to inform the design and evaluation of technical solutions, policies, and the evolution of economic, ethical, social, educational, and organizational systems. </div><ul class="list-unord" id="list-13"><li id="list-item-50"> <div id="p-68">Prerequisite knowledge and skills: Familiarity with fundamentals of social, organizational, cognitive, and decision sciences.</div></li><li id="list-item-51"> <div id="p-69">Fundamental knowledge: Understand and apply knowledge in the following areas:</div><ul class="list-unord" id="list-14"><li id="list-item-52"> <div id="p-70">Design: for example, human-centered design, usability, human factors, cognitive and ergonomic sciences and engineering.</div></li><li id="list-item-53"> <div id="p-71">Evaluation: for example, study design, controlled trials, observational studies, hypothesis testing, ethnographic methods, field observational methods, qualitative methods, mixed methods.</div></li><li id="list-item-54"> <div id="p-72">Social, behavioral, communication, and organizational sciences: for example, computer supported cooperative work, social networks, change management, human factors engineering, cognitive task analysis, project management.</div></li><li id="list-item-55"> <div id="p-73">Ethical, legal, social issues: for example, human subjects, HIPAA, informed consent, secondary use of data, confidentiality, privacy.</div></li><li id="list-item-56"> <div id="p-74">Economic, social and organizational context of biomedical research, pharmaceutical and biotechnology industries, medical instrumentation, healthcare, and public health.</div><div id="p-74"> </div><div id="p-74"> </div></li></ul></li></ul></li></ul>While nobody is an expert in all of these areas, skills in many of them are essential for successful and safety-promoting leadership in the health IT domain. I repeat, this depth and breadth of knowledge does not come from studying business computing, dabbling with health IT, or by guessing by the seat of one's pants.  It comes about from rigorous education and experience in the appropriate domains at the graduate and (especially) post-doctoral levels. Amateurs mistakenly put in leadership positions, and their organizations, are going to increasingly find themselves in legal hot water over mistakes in design and implementation that result in patient harm, security breaches, overbilling and other issues. That is probably what it will take to have hospitals manage health IT talent more appropriately. Finally, I plead guilty to tooting my own profession's horn. Somebody needs to when the stakes are so high for patients. -- SS

AMIA Board: specification of core competencies in Biomedical Informatics

In 1998 I launched a website called " Medical Informatics and Leadership of Clinical Computing " (now entitled " Contemporary...

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