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AMA And Almost 100 Physician Societies Sound Off To CMS On Health IT, Use "F" Word

In a remarkable development, the American Medical Association and nearly one hundred other physician specialty societies submitted a letter to CMS on Mar. 15 (in PDF at <a href="http://www.ama-assn.org/ama1/pub/upload/mm/399/meaningful-use-comments-15mar2010.pdf" target="_blank">http://www.ama-assn.org/ama1/pub/upload/mm/399/meaningful-use-comments-15mar2010.pdf</a>). These organizations wish to prevent physicians from purchasing ill conceived and poorly designed HIT that does not support better practice. The organizations also express deep concern about ominous reporting requirements and overly aggressive timelines, the latter an issue I've written about repeatedly such as in my formal reply to ONC's "Proposed Establishment of Certification Programs for Health Information Technology" <a href="http://hcrenewal.blogspot.com/2010/03/on-oncs-proposed-establishment-of.html">at this link</a>. The entire letter is available at the PDF link above and is quite lengthy, but the section of the letter that immediately caught my eye is this: <blockquote>... Aggressive timelines and criteria during the initial stage of the incentive program will only serve to undermine this effort. Some government officials have relayed that complex measures and high reporting thresholds are needed to discourage EPs ["eligible professionals" eligible for ARRA money -ed.] from switching back to the use of paper during this transition to EHRs. We are very troubled by this assertion. Physicians are deeply supportive of and committed to incorporating well-developed EHRs into their practices to improve quality of care delivery, enhance patient safety, as well as support practice efficiencies. [Some are - many are not - perhaps the medical specialty societies need to stop acting as if they speak for all physicians - ed.] It is also very unlikely that after physicians make a significant up front investment in health IT and changes to their workflow that they will revert back to manual processes. </blockquote> That assertion, in fact, is not quite true, as in "Failure, De-installation Of EHRs Abound" <a href="http://www.modernhealthcare.com/apps/pbcs.dll/article?AID=/20071030/FREE/310300002/0/FRONTPAGE#">here</a>. However, coercion through ominous reporting requirements is not going to improve adoption rates and will undermine HIT efforts as well, for example via physician fear of the uses to which the data will be put by a coercive, authoritarian-leaning government. Now comes what I believe is the most critical passage where the "F" word ("failure") is used: <blockquote> We believe that the larger concern should be deterring the purchasing of costly EHR products that fail to improve physician workflow, patient care, and practice needs. Industry experts have cited that such failures have adversely affected EHR adoption rates ranging from 50 to 80 percent. [<a href="http://www.tinyurl.com/hostileuserexper" style="font-weight: bold; font-style: italic;">Mission hostile health IT</a> falls into that category - ed.] </blockquote> Note the acknowledgment of healthcare IT failure. The letter was a bit weak in the area of <a href="http://hcrenewal.blogspot.com/2010/02/fda-on-health-it-adverse-consequences.html">patient safety related to HIT</a>. Further, it presented physicians as monolithic eager adopters of HIT (a characterization that is most assuredly false), and minimized the issue of the messiness and Murphy's Law nature of IT installation and maintenance that often make IT a nightmare. The fact, however, that a letter from the major medical societies challenged the irrational exuberance and beliefs in technological determinism that surround health IT (i.e., that computerization 'automagically' fosters improvement), and used the "failure" word is itself somewhat astonishing. I was not inventing anything when I began <a href="http://www.tinyurl.com/healthITfailure">writing about HIT difficulties over ten years ago</a> using the "failure" word, merely reporting the obvious (to those sober about IT) from observation and reports of many colleagues. It's good to see the rest of the medical world start to catch up with common sense. -- SS Addendum: the letter was also signed by the following groups: American Academy of Dermatology Association American Academy of Family Physicians American Academy of Home Care Physicians American Academy of Neurology Professional Association American Academy of Ophthalmology American Academy of Otolaryngology – Head and Neck Surgery American Academy of Pain Medicine American Academy of Physical Medicine and Rehabilitation American Academy of Sleep Medicine American Association of Clinical Endocrinologists American College of Cardiology American College of Chest Physicians American College of Gastroenterology American College of Obstetricians and Gynecologists American College of Osteopathic Family Physicians American College of Osteopathic Internists American College of Osteopathic Surgeons American Academy of Pediatrics American College of Physicians American College of Radiation Oncology American College of Rheumatology American College of Surgeons American Gastroenterological Association American Geriatrics Society American Medical Association American Osteopathic Academy of Orthopedics American Osteopathic Association American Psychiatric Association American Society for Clinical Pathology American Society for Gastrointestinal Endoscopy American Society for Radiation Oncology American Society of Anesthesiologists American Society of Clinical Oncology American Society of Hematology American Society of Nephrology American Society of Plastic Surgeons American Thoracic Society American Urological Association Heart Rhythm Society Infectious Diseases Society of America Joint Council of Allergy, Asthma and Immunology Medical Group Management Association North American Spine Society Renal Physicians Association Society for Cardiovascular Angiography and Interventions Society for Vascular Surgery Society of Hospital Medicine The Endocrine Society Medical Association of the State of Alabama Alaska State Medical Association Arizona Medical Association Arkansas Medical Society California Medical Association Colorado Medical Society Connecticut State Medical Society Medical Society of Delaware Medical Society of the District of Columbia Florida Medical Association, Inc. Medical Association of Georgia Hawaii Medical Association Idaho Medical Association Illinois State Medical Society Indiana State Medical Association Iowa Medical Society Kansas Medical Society Kentucky Medical Association Louisiana State Medical Society Maine Medical Association MedChi, The Maryland State Medical Society Massachusetts Medical Society Michigan State Medical Society Minnesota Medical Association Mississippi State Medical Association Missouri State Medical Association Montana Medical Association Nevada State Medical Association New Hampshire Medical Society Medical Society of New Jersey New Mexico Medical Society Medical Society of the State of New York North Carolina Medical Society North Dakota Medical Association Ohio State Medical Association Oklahoma State Medical Association Oregon Medical Association Pennsylvania Medical Society Rhode Island Medical Society South Carolina Medical Association South Dakota State Medical Association Utah Medical Association Wisconsin Medical Society Vermont Medical Society Medical Society of Virginia Washington State Medical Association West Virginia State Medical Association Wyoming Medical Society

AMA And Almost 100 Physician Societies Sound Off To CMS On Health IT, Use "F" Word

In a remarkable development, the American Medical Association and nearly one hundred other physician specialty societies submitted a letter ...

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A Simple Lesson for the Health IT Industry

From an Op Ed "<a href="http://online.wsj.com/article/SB10001424052748703734504575125533112150508.html">Living with the Electronic Car</a>" in today's Wall Street Journal: <blockquote>"A Toyota executive recently explained to a Congressional committee investigating claims of uncontrolled acceleration: "We need to reduce the number of things we ask our customers to do correctly." In fact, the exec was describing the essence of responsible engineering - though perhaps the balance in auto design has gotten out of whack."</blockquote> Considering the feedback from physicians on the needless complexity of electronic medical records and other computerized medical devices for example at "<a href="http://hcrenewal.blogspot.com/2010/01/honest-physician-survey-on-ehrs.html">An Honest Physician Survey on EHR's</a>", it seems the healthcare IT industry has yet to learn this simple lesson. I'm frankly not convinced there's "anyone home" in this complexity-loving industry who could fathom such advice as a good business practice. It also seems that industry may not give a damn about such lessons, even in the most safety critical of environments, the intensive care unit, as long as profits are maintained. See for example "<a href="http://hcrenewal.blogspot.com/2010/02/lawsuit-over-health-it-whistleblowing.html">A Lawsuit Over Healthcare IT Whistleblowing and Wrongful Discharge: Malin v. Siemens Healthcare</a>." Also see "<a href="http://hcrenewal.blogspot.com/2010/03/third-party-reviews-of-devices-come.html">Third-Party Reviews of Medical Devices Come Under Scrutiny at the FDA - Except Healthcare IT Medical Devices, Which Get Special Accommodation</a>" on political maneuvering by this industry to avoid the federal regulation other healthcare drug and device sectors have been subject to for decades (largely as a result of public health disasters such as <a href="http://en.wikipedia.org/wiki/Harrison_Narcotics_Tax_Act">this</a> and <a href="http://en.wikipedia.org/wiki/Thalidomide">this</a>, I might add). The interesting aspect of these issues is that the executives and officials behind these decisions and machinations are setting themselves up as near-indefensible defendants in future litigation by patients (and their estates) harmed or killed by healthcare IT-related problems. For instance, I had communications with the Joint Commission leadership over issues I raised in my July 22, 2009 JAMA letter to the editor "<a href="http://jama.ama-assn.org/cgi/content/extract/302/4/382">Health Care Information Technology, Hospital Responsibilities, and Joint Commission Standards</a>." Namely, on how hospital executives were violating their fiduciary and Joint Commission safety standards obligations, and jeapardizing patient safety, in signing the traditional health IT contract calling for confidentiality about health IT malfunctions and defects. The JC Leadership is quite well aware of this letter and my more thorough essay <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/failurecases/?loc=cases&sloc=koppel_kreda">here</a>. Nothing has been heard from the Joint Commission on these issues since. Perhaps never before have the malpractice lawyers been provided a better scenario for taking the houses and personal property from irresponsible and/or conflicted healthcare and health IT regulators and other officials via lawsuits as health IT diffusion increases, with its "<a href="http://hcrenewal.blogspot.com/2010/02/fda-on-health-it-adverse-consequences.html">tip of the iceberg</a>" injury and death occurrences now firmly established. -- SS

A Simple Lesson for the Health IT Industry

From an Op Ed " Living with the Electronic Car " in today's Wall Street Journal: "A Toyota executive recently explained t...

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Abbott's TriCor Fails To Beat A Sugar Pill in Diabetics - And In Pharma's Current Death Spiral, Forget About a Drug That Will

In numerous national publications today, we are once again reminded that lowering the risk of diabetics for vascular events (MI/heart attack, CVA/stroke etc.) and death is far more complex than lowering measures such as cholesterol and blood pressure. Note these articles: <a href="http://blogs.forbes.com/sciencebiz/2010/03/abbotts-tricor-fails-to-beat-a-sugar-pill/"></a><blockquote><a href="http://blogs.forbes.com/sciencebiz/2010/03/abbotts-tricor-fails-to-beat-a-sugar-pill/">Abbott's TriCor Fails To Beat A Sugar Pill</a> March 14, 2010 - 9:58 am Matthew Herper Forbes.com ATLANTA -- A popular triglyceride-lowering drug that has been taken by millions of Americans failed to prevent heart disease in a big federal study being presented today. The drug, TriCor from Abbott Laboratories, has been used for over a quarter of a century to lower levels of fatty particles in the blood called triglycerides. The presumption has been that doing so would prevent heart attacks or heart-related deaths. TriCor has annual sales of more than $1 billion. But the new study being presented at the American College of Cardiology meeting casts doubt on this. In the study, funded by the National Heart, Lung and Blood Institute, 5,500 patients with diabetes got either TriCor or a placebo. After five years, there was no difference in the rate of heart attacks, strokes and deaths in the patients who got Tricor versus those who took a sugar pill. </blockquote>and <a href="http://online.wsj.com/article/SB10001424052748703457104575121951874047506.html"></a><blockquote><a href="http://online.wsj.com/article/SB10001424052748703457104575121951874047506.html">Search for Better Diabetes Therapy Falls Short</a> Mar. 14, 2010, 9:39 P.M. ET Ron Winslow Wall Street Journal Current Treatments, While Effective, Failed to Also Help Prevent Heart Attacks and Stroke ATLANTA—New strategies to prevent and treat diabetes and heart disease failed to improve care in two major studies, frustrating researchers' efforts to find more-effective approaches to the world's burgeoning diabetes epidemic. The studies are among the first large trials to test whether treatments recommended for diabetes patients also reduce the risk of heart attacks and strokes. Diabetics are between two and four times as likely to die of cardiovascular causes as nondiabetics. The lack of data on whether strategies to treat diabetes actually lower heart risk is of growing concern to physicians, researchers and regulators. One new study, called Accord, found that treating blood pressure to lower levels than recommended in current practice doesn't further reduce risk of death, heart attack and stroke among people with diabetes. The same study also found that the drug Tricor, marketed by <a class="companyRollover link11unvisited" href="http://online.wsj.com/public/quotes/main.html?type=djn&symbol=ABT">Abbott Laboratories</a>, failed to prevent such events even though it lowered levels of blood fats called triglycerides that are associated with high diabetes risk. In the other report, dubbed Navigator, a diabetes drug called Starlix failed to prevent people at high risk of diabetes from progressing to the disease. The blood-pressure medicine Diovan did modestly reduce risk of developing diabetes in the same study, but neither drug significantly cut the risk of heart-related deaths, heart attacks and strokes. Both pills in this study are sold by <a class="companyRollover link11unvisited" href="http://online.wsj.com/public/quotes/main.html?type=djn&symbol=NVS">Novartis</a> SA of Switzerland.</blockquote> There is a meta-issue I wish to bring up: It's clear there are many phenomena going on in diabetes and other metabolic disorders that we simply do not understand. It's also very likely that there are new drugs, yet undiscovered, that could be developed and that would improve mortality and morbidity. It's too bad the pharmaceutical industry is now largely run by <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/failurecases/?loc=cases&sloc=pharma">dyscompetents, incompetents</a>, and other <a href="http://hcrenewal.blogspot.com/2009/01/pfizerwyeth-merger-and-sacrificing.html">management charlatans</a>, not to mention those responsible for questionable or outright criminal behaviors (such as <a href="http://hcrenewal.blogspot.com/search/label/fraud">here</a>, <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">here</a>). This privileged class has apparently so demoralized pharma rank and file including the very soul of drug discovery (chemists) - based for example on "layoff thread" comments on a very popular blog for medicinal, synthetic and other chemists such as <a href="http://pipeline.corante.com/archives/2010/02/17/merck_announces_cuts.php">here</a> - that these new drugs are increasingly unlikely to be developed at all. The industry in its current anti-intellectual, "lay them off and watch the stock price rise", short-term narrow-minded idiocy-driven death spiral is basically good for nothing except money games. Pity. -- SS

Abbott's TriCor Fails To Beat A Sugar Pill in Diabetics - And In Pharma's Current Death Spiral, Forget About a Drug That Will

In numerous national publications today, we are once again reminded that lowering the risk of diabetics for vascular events (MI/heart attack...

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Third-Party Reviews of Medical Devices Come Under Scrutiny at the FDA - Except Healthcare IT Medical Devices, Which Get Special Accommodation

This WSJ article caught my eye: <a href="http://online.wsj.com/article/SB10001424052748703447104575117892340074732.html"></a><blockquote><a href="http://online.wsj.com/article/SB10001424052748703447104575117892340074732.html">Third-Party Reviews of Devices Come Under Scrutiny at the FDA </a> March 15, 2010 By ALICIA MUNDY and JARED A. FAVOLE WASHINGTON—When medical-equipment makers like Philips Electronics NV, Siemens AG and General Electric Co. need approval for some new devices, they don't always have to start at the Food and Drug Administration. They can pay companies to do the reviews, which are then routinely approved by FDA officials most of the time. Now this third-party outsourcing program has come under fire at the FDA, and the agency is weighing whether to end it. Agency officials question the quality of the reviews and whether they have served the program's original purpose: saving U.S. taxpayers money. The "real value to industry may be that this is perceived as a way to 'sneak things,'" said an FDA official at a December meeting on device approvals, according to minutes reviewed by The Wall Street Journal. Some third-party reviewers advertise speed and a friendlier process. </blockquote> At a time when the FDA is moving against third party device reviews, HHS and its Office of the National Coordinator for health IT (ONC) are soliciting to create third party EHR "certification" bodies for <a href="http://hcrenewal.blogspot.com/2009/11/2009-pivotal-year-in-healthcare-it.html">healthcare information technology (HIT) medical devices</a> such as electronic medical records systems, decision support tools, clinician order entry and alerting, etc. (see RIN 0991-AB59, "Proposed Establishment of Certification Programs for Health Information Technology", PDF available <a href="http://www.federalregister.gov/OFRUpload/OFRData/2010-04991_PI.pdf">at this link</a>.) This comes at the same time as FDA admitting this technology harms and kills patients, but the extent is unknown (existing FDA data is likely the "tip of the iceberg" reports Jeffrey Shuren MD JD at the HIT Policy Committee, Adoption/Certification Workgroup, special meeting on health IT safety on February 25, 2010). See: "FDA on Health IT Adverse Consequences: 44 Reported Injuries And 6 Deaths, Probably Just 'Tip of Iceberg'" at <a href="http://hcrenewal.blogspot.com/2010/02/fda-on-health-it-adverse-consequences.html" rel="nofollow" target="_blank">http://hcrenewal.blogspot.com/2010/02/fda-on-health-it-adverse-consequences.html</a> and "On ONC's "Proposed Establishment of Certification Programs for Health Information Technology" at <a href="http://hcrenewal.blogspot.com/2010/03/on-oncs-proposed-establishment-of.html" rel="nofollow" target="_blank">http://hcrenewal.blogspot.com/2010/03/on-oncs-proposed-establishment-of.html</a> More from the WSJ article: <blockquote>... The agency's concerns about the third-party reviews come as the FDA is re-evaluating its entire device-approval process. In addition, the agency has recently announced tighter regulation of some machines that deliver radiation in the wake of reports of more than 300 cases of overdoses from CT scanners at four hospitals. Changes under consideration at the FDA include terminating the third-party program, limiting the kinds of devices that it covers, or giving the outside reviewers more data on devices to improve the quality of their work, according to the minutes and interviews with agency officials. Jeffrey Shuren, the device division director, said the FDA will release proposed changes later this year and cautioned that no decisions have been made. To qualify for an outsourced review, a new device must be similar to a device already on the market, and it must carry low or moderate risk to the patient. The December 2009 minutes say "third parties often don't have appropriate expertise." The minutes cite "poor quality of review documents— they often just repeat what is in the submission, and don't provide any analysis of the data."</blockquote> (The point on lack of expertise is a point I raise in my aforementioned commentary on ONC's "Proposed Establishment of Certification Programs for HIT." I wrote: HHS should not be creating new, potentially (likely?) amateur organizations and bureaucracies overseeing these new virtual medical devices that will have variable (or no) experience in software validation, certification, regulation, postmarketing safety surveillance, etc. Rather, HHS should be leveraging existing governmental expertise in certifying, validating and regulating mission critical IT.) The industry as always is looking out for - itself, patients coming in second: <blockquote>Terry Sweeney, vice president of clinical affairs at Philips Healthcare, said the third-partyprogram benefits industry and helps relieve the FDA of a burden. "Every week's delay [i.e., in rigorously assuring medical device safety - ed.] can cost the company a large sum of money," he said.</blockquote> It's not like the time differential is enormous: <blockquote> It takes an average of about 72 days for a company to get final clearance for a device when it goes the third-party route, according to the FDA. That includes the time for the agency to sign off on the outside reviewer's conclusion and compares with an average 109 days for similar applications that go directly to the FDA.</blockquote> So, the vendors seem to be saying, let's compromise the device safety evaluation process via third party reviewers so we can get to market a month sooner. The FDA is having serious second thoughts about this state of affairs. Worse, on health IT devices, the HHS itself via ONC is soliciting for the creation of third party reviewers for HIT, while the FDA itself seems marginalized or even unwilling to shoulder the burden of patient protection from faulty HIT. Odd. Why do computerized HIT medical devices such as EMR's get special government accommodation? -- SS <div style="text-align: justify;">For more on HIT challenges see "Contemporary Issues in Medical Informatics: Common Examples of Healthcare Information Technology Difficulties" - <a href="http://tinyurl.com/healthITfailure" style="font-style: italic;">http://www.tinyurl.com/healthITfailure</a></div>

Third-Party Reviews of Medical Devices Come Under Scrutiny at the FDA - Except Healthcare IT Medical Devices, Which Get Special Accommodation

This WSJ article caught my eye: Third-Party Reviews of Devices Come Under Scrutiny at the FDA March 15, 2010 By ALICIA MUNDY and JARED A. FA...

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City Hospital System Board Member Fined for Conflict of Interest Involving Proprietary, Off-Shore Medical School

Sometimes I think I have now seen every type of conflict of interest that could afflict health care, but then some amazing new variation on the theme comes along... Last year, the New York Times <a href="http://www.nytimes.com/2008/08/05/nyregion/05grenada.html">reported </a>on an unusual deal between the New York City Health and Hospitals Corporation and a proprietary (for-profit) Caribbean medical school that attracts US citizens who were not admitted to US medical schools: <blockquote>New York City’s Health and Hospitals Corporation has signed a 10-year, $100 million contract with a profit-making medical school in the Caribbean to provide clinical training for hundreds of students at the city’s 11 public hospitals. The unusual deal, proposed by a member of the corporation’s board who has long worked for the Caribbean school, has been met by an outcry from New York medical schools fearing that clerkship slots will grow scarcer and that they might have to increase tuitions to compete. Critics worry that the hospital corporation, whose mission is to serve the city’s poor, is conferring prestige on a foreign school whose curriculum, they say, is more vocational than research-based and often caters to affluent students who could not get into schools in the United States. They say that the contract, with St. George’s University School of Medicine on the island of Grenada, has turned a meritocracy into a bounty system in which struggling city hospitals collect more for every St. George’s student they take, and could squeeze out local students. 'This changes the whole dynamic from an academic relationship to a dollar-based relationship,' said Dr. Michael J. Reichgott, associate dean for clinical affairs and graduate medical education at Albert Einstein College of Medicine in the Bronx. Traditionally, medical schools have sent third- and fourth-year students into city hospitals to work — and learn — alongside doctors without being charged. Under the contract, which was signed last year but never publicly announced, St. George’s pays the hospitals $400 to $425 per student per week — St. George’s charges students about $1,000 a week in tuition — on top of an annual fee of $50,000 for hospitals that take 24 or more St. George’s students. The contract also bans the hospitals from providing clerkships to other Caribbean medical schools — a critical provision to St. George’s, which has faced heightened competition in recent years, particularly from Ross University on the island of Dominica, part of DeVry Inc., a publicly traded educational company, since 2003. </blockquote> Note that the contract was unusual in several ways.  Not only did it permit a for-profit, proprietary medical school which is not accredited in the US pay hospitals to provide clerkships which they traditionally had provided without a fee to not-for-profit, US medical schools, but also it included a clause that apparently prevented other for-profit, proprietary medical schools from competing for these training physicians by also paying fees, and was signed in secret, only becoming public because of the Times' reporting.  Furthermore, not only was the contract unusual, but the processes that lead to its approval were also unusual: <blockquote>The board member who first proposed the exclusive contract, Dr. Daniel D. Ricciardi — a 1981 graduate of St. George’s and a rheumatologist affiliated with Long Island College Hospital in Brooklyn — said he had recused himself from deliberations involving St. George’s. Dr. Ricciardi, who has been on the 16-member corporation board since 2000 and on the St. George’s faculty for about 15 years, said he did not benefit financially from the deal. He was promoted to St. George’s dean of clinical studies and put in charge of United States clerkships shortly before the contract was signed. 'I don’t have to go to confession on this one, I really don’t,' he said. 'Everybody’s saying there’s a conflict here, and it comes back to me. They’re disgruntled, jealous. A report was written on the school, and the judgment was made based on merit, not on political push.'</blockquote>Dr Ricciardi may or may not have felt obligated to discuss this issue during confession, but three days later, the NY Times again <a href="http://www.nytimes.com/2008/08/08/nyregion/08grenada.html">reported</a>: <blockquote>A board member of New York City’s Health and Hospitals Corporation resigned on Thursday, after the agency began an inquiry into his role in securing a 10-year, $100 million contract for a Caribbean medical school where he has long had a paid position. The board member, Dr. Daniel D. Ricciardi, submitted a brief letter of resignation to the president of the corporation, Alan D. Aviles. Dr. Ricciardi did not give any reasons for his resignation in his letter, saying only that he had been proud, 'as a first-generation New Yorker,' to support efforts to provide affordable quality health care to city residents. He had been a board member since 2000. But in a brief telephone interview on Thursday, he expressed bitterness, saying: 'You know what? The elite of the 0.1 percent that you represent have won once again. God bless.'</blockquote>And just to provide the icing on the cake, despite Dr Ricciardi's denial that his job at St George's constituted a conflict of interest, two weeks ago, the NY Times <a href="http://www.nytimes.com/2010/03/03/nyregion/03conflict.html">further reported</a>: <blockquote>A former board member of New York City’s public hospital system has been fined $13,500 for his role in soliciting coveted training spots in city hospitals for students from a Caribbean medical school, the city’s Conflicts of Interest Board said Tuesday. The former board member, Dr. Daniel D. Ricciardi, agreed to the fine in a settlement in which he admitted that he had held high-ranking paid positions at St. George’s University School of Medicine in Grenada while soliciting clinical clerkships — a critical part of medical education — from personnel in the city hospital system, which he also helped to lead. Dr. Ricciardi, a rheumatologist and 1981 graduate of St. George’s, acknowledged that from January 2000, when he was appointed to the board of the Health and Hospitals Corporation, to August 2008, when he resigned after The New York Times disclosed the potential conflict, he had served in positions at St. George’s including dean of clinical studies, chairman of medicine and director of medical education. During the same period, he said, he had contacted personnel at Kings County Hospital Center, Metropolitan Hospital Center, Woodhull Medical and Mental Health Center, Lincoln Medical and Mental Health Center, and Elmhurst Hospital Center to try to get them to increase the number of placements available to St. George’s students, a violation of prohibitions against representing a private interest before his public agency. 'I now acknowledge that my dual capacities created at least the appearance that the actions I took as an H.H.C. board member were done in part to benefit the school,' Dr. Ricciardi said in the settlement, dated Feb. 24. Ana Marengo, a spokeswoman for the Health and Hospitals Corporation, said Tuesday that the contract was granted through competitive bidding, and that Dr. Ricciardi had recused himself from the board’s deliberations. But Dr. Ricciardi admitted that he had violated city law prohibiting a public servant from having a position in a company that he knows is doing business with his city agency. Dr. Ricciardi said in the settlement that he had disclosed his affiliation with St. George’s to the hospitals corporation, and that he had not intended to violate any laws. </blockquote> We constantly hear from its advocates that commercialized health care will lead to wonderful innovation.  At least, it certainly seems to lead to innovation in the creation of new variants of conflicts of interest.  Here, we see a board member of a municipal, not-for-profit hospital system also working for a for-profit off-shore medical school, and apparently using his board position to provide competitive benefits to that medical school, by means of a contract that was meant to be secret.  Each time we think we have begun to understand the extent that <a href="http://hcrenewal.blogspot.com/search/label/conflicts%20of%20interest">conflicts of interest</a> pervade health care, we find new examples suggesting we have underestimated. As we have now said ad infinitum, an important reason for rising costs, declining access, stagnant quality, and disgruntled professionals are health care leaders who undermine the missions of their own institutions in pursuit of self-interest, often driven by their own conflicts of interest.  We have now seen an amazing set of variations on this theme.  If we truly want to reform health care, we need to ensure that its leaders put their organizations' missions, and the fundamental values of health care, ahead of their own self interest.

City Hospital System Board Member Fined for Conflict of Interest Involving Proprietary, Off-Shore Medical School

Sometimes I think I have now seen every type of conflict of interest that could afflict health care, but then some amazing new variation on ...

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FDA Asks Hospitals to Report Safety Glitches in Digital Health Systems

A theme of my writings on this blog and on my <a href="http://www.tinyurl.com/healthITfailure">teaching site</a> for the past decade has been mismanagement of healthcare information technology by an industry and people who have been operating for many years far beyond their qualifications and competencies. Technology requiring the highest levels of biomedical-IT cross disciplinary expertise has most commonly been designed, managed, implemented, led and defended by amateurs [see note 1]. As a result of this mismanagement, the technology is not without its perils. The problem is that this industry suffers from constricted information flows for a number of reasons, and we do not know the magnitude of the perils. Even speculation is difficult since data is scarce. The technology remains experimental. After a commitment of tens of billions of economic recovery act funds to roll out this technology nationally, the Federal government has finally taken notice: <a href="http://huffpostfund.org/stories/2010/03/fda-asks-hospitals-report-safety-glitches-digital-health-systems"></a> <blockquote><a href="http://huffpostfund.org/stories/2010/03/fda-asks-hospitals-report-safety-glitches-digital-health-systems">FDA Asks Hospitals to Report Safety Glitches in Digital Health Systems</a> In Letter to 350 Health Centers, Agency Signals Growing Concern By Fred Schulte and Emma Schwartz Huffington Post Investigative Fund 3:24 pm | 11 Mar 2010 Concern over safety risks posed by health information technology has led the Food and Drug Administration to step up scrutiny of the products, including digital medical records systems on which the government plans to spend billions of dollars in coming years. The FDA last month asked a network of 350 hospitals it set up across the country to report data on potential hazards from a range of computer-assisted medical devices, according to an agency document obtained by the Huffington Post Investigative Fund.</blockquote> This should have occurred a decade ago, but better late than never (of course, this action will not help people already harmed by this technology such as <a href="http://hcrenewal.blogspot.com/2010/02/fda-on-health-it-adverse-consequences.html">these</a> and <a href="http://www.jointcommission.org/SentinelEvents/SentinelEventAlert/sea_42.htm">these</a>). <blockquote>The FDA action comes as federal officials forge ahead with plans to use as much as $27 billion in economic stimulus money to replace paper patient records with digital ones. The Obama administration wants to create a digital health file for every American by 2014, saying the conversion will save money and improve the quality of health care.</blockquote> From an <a href="http://www.heartland.org/article/24761/Research_Commentary_Health_Information_Technology.html">analysis</a> that I concur with from the Heartland Institute: ... Proponents of this spending rely heavily on a short RAND Corporation analysis from 2005 that predicted $77 billion in annual savings and improved outcomes. RAND estimated “implementation would cost around $8 billion per year, assuming adoption by 90 percent of hospitals and doctors offices over 15 years.” It said, “The benefits can include dramatic efficiency savings, greatly increased safety, and health benefits.” Unfortunately, RAND assumed an error-free system that is quickly and enthusiastically adopted by virtually the entire health care system. That might happen, but it is an absolute best-case scenario. [See my aforementioned HIT teaching site on why a "best case scenario" is a near impossibility - ed.] Even then, instead of “dramatic savings,” the $77 billion hoped-for savings amounted to a mere 4.5 percent of total costs, placed at $1.7 trillion by RAND. Far more likely is that every penny of the $20 billion will be wasted on systems that don’t work and can never be implemented. [As per my <a href="http://online.wsj.com/article/SB123492035330205101.html">Feb. 18, 2009 Letter to the Editor</a> in the Wall Street Journal - ed.] That was the outcome of federal attempts to upgrade technology at the IRS, the FBI, and the air traffic control system. And these are all relatively simple enterprises involving single federal agencies. Health IT is vastly more complex and must include hundreds of thousands of private organizations that have invested in legacy systems that work reasonably well and are as varied as there are providers. Back to the Huffington Post Investigative Fund article: <blockquote>... Reports that hospitals send to the FDA are to be posted on an agency Web site. The FDA maintains it has the authority to regulate the technology, but has not taken steps to do so, leaving the industry largely to police itself. Reporting of problems is voluntary and most manufacturers have not done so.</blockquote> I think it accurate to say reporting is nearly nonexistent, yet I regularly hear stories from colleagues, former students, and others that make my hair stand on end. These people are afraid to speak out publicly, lest their careers be threatened by hospital sham peer review, vendor lawsuits, or other forms of retaliation against 'whistleblowers' (see an example <a href="http://hcrenewal.blogspot.com/2010/02/lawsuit-over-health-it-whistleblowing.html">here</a>). <blockquote>... In the letter sent to hospitals last month, Marilyn Flack, of the FDA’s Center for Devices and Radiological Health, said use of digital medical equipment “continues to grow and affect patient care and safety.” The FDA “is exploring problems….that may affect patient safety,” she wrote. The agency plans to collect reports using its Medical Product Surveillance Network, called MedSun. It is asking hospitals to note a wide range of problems involving electronic health records and other computerized systems for hospital laboratories, pharmacies and anesthesia and radiology devices, including hand-held ones.</blockquote> Here is the FDA letter. Click to enlarge: <div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhBrPpLZ8pDyADfYTXcfGCqUs7Hc9zKAdgJw1rKxAekOW8d9gLfx3TVF5iYQjuzGeIqYQlFyLV3ShPV8lLcu1U1CnlNI001Ued5mPCn5pQ7yqK44orMFPb9S7UvSLeU0mbmLuphMQ4pE0yU/s1600-h/fda1.jpg" onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5447572877662219554" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhBrPpLZ8pDyADfYTXcfGCqUs7Hc9zKAdgJw1rKxAekOW8d9gLfx3TVF5iYQjuzGeIqYQlFyLV3ShPV8lLcu1U1CnlNI001Ued5mPCn5pQ7yqK44orMFPb9S7UvSLeU0mbmLuphMQ4pE0yU/s320/fda1.jpg" style="cursor: pointer; display: block; height: 225px; margin: 0px auto 10px; text-align: center; width: 194px;" /></a>FDA letter on health IT safety reporting, page 1 (click to enlarge) </div> <div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh-xMO35Uk_kFsukCFUKScfk8neovITPgSsUrwoRXerdnx1pyxzgVT6Io5l8G-vQIM78BdDdgXaRebWyC559LUMUyKUOwyO8nT2W4p1uSlRKfb41aPfWZpBkiUl3uJKJ09HkS4MIV7UR1R-/s1600-h/fda2.jpg" onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5447573067472695730" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh-xMO35Uk_kFsukCFUKScfk8neovITPgSsUrwoRXerdnx1pyxzgVT6Io5l8G-vQIM78BdDdgXaRebWyC559LUMUyKUOwyO8nT2W4p1uSlRKfb41aPfWZpBkiUl3uJKJ09HkS4MIV7UR1R-/s320/fda2.jpg" style="cursor: pointer; display: block; height: 219px; margin: 0px auto 10px; text-align: center; width: 189px;" /></a>FDA letter on health IT safety reporting, page 2 (click to enlarge)</div> I note that this letter is remarkable, a real breakthrough. It is also remarkable that this 'breakthrough' had to wait until 2010, not 1990 or 2000, and only after the government has pushed hard to spread this technology nationally without knowing the flip side. The expression "ready, fire, aim" comes to mind. Some of the 'glitches' were mentioned: <blockquote> ... She also cited an example of a software package used in a hospital emergency room in which lab tests “ordered for one patient returned the results for another.” In another case, a hospital in the MedSun network reported an operating room software product that often “locked up” during surgery, without alerting anyone that “data entry had ceased.” According to the FDA letter: “At the end of the surgical procedure, surgical procedure notes were incomplete—compromising the accuracy of the data as nurses had to manually re-enter from memory many of the surgical notes.” In a third case cited by Flack, a radiology workstation became “extremely slow, delaying procedures and causing X-ray techs to subject patients to repeat X-rays.” The cause was determined to be a software glitch that happened when too many characters were entered in.</blockquote> These 'glitches' largely come from poor design, engineering, implementation and support and don't even include <a href="http://www.tinyurl.com/hostileuserexper">mission hostile user experiences</a> from software that is 'working correctly.' <blockquote>... Arthur Bartosch, director of Biomedical Engineering Services at Westchester Medical Center in New York, agreed [that in the past, cinical engineering staff would not have been involved in health IT safety reporting]. He said he planned to circulate the FDA’s alert to the hospital’s chief medical information officer and they would “probably” create a task force to figure out how to document any problems.</blockquote> It is pathognomonic of IT irrational exuberance and special accommodation given to this technology (greased by ignorance, money, politics and other pathologies among healthcare and hospital leadership juntas) that such 'task forces' are not as common as health IT itself. <blockquote>... “The fundamental problem we have here is we’re dealing with an industry that really isn’t used to a transparent reporting of problems,” [Paul Egerman, co-chair of a government panel looking at the safety of health information technology] said. [Isn't used to transparent reporting? I would have said "hostile to the extreme" regarding that kind of transparency - ed.] Egerman, whose advisory panel expects to make its findings public in April, said government officials have a long way to go in fully understanding the potential hazards of adopting the new technology.</blockquote> I noted a "hit" from EOP.gov (Executive Office of the President) on my <a href="http://www.tinyurl.com/healthITfailure">ten year old HIT teaching site</a> just yesterday. I believe it is the first. Welcome to Medical Informatics 101, Mr. President. <blockquote>“Are there much more serious problems that we would know about if we had the data?,” he said. “These are all reasonable questions to ask.”</blockquote> I injured my career in the past for asking just those questions, having been badgered to stop asking them essentially to the point of constructive discharge in my former CMIO role. Let's see if the change of culture is real, or just talk. It's not that safety reporting and transparency are anything new or special. From the Joint Commission in their August 2009 <a href="http://www.jointcommission.org/SentinelEvents/SentinelEventAlert/sea_43.htm">Sentinel Events Alert #43</a>: <blockquote>Existing Joint Commission requirements: The Leadership chapter in the standards manual addresses leadership and safety, specifically relating to the organization's governing body, the chief executive and senior managers, and medical and clinical staff leaders. The standards specifically require that these three leadership groups create a culture of safety (11) by creating an atmosphere of trust and fairness that encourages reporting of risks and adverse events, by allocating the resources necessary to support safety, by discussing and reporting safety issues and indicators, and by developing plans to assure and improve safety performance, especially in relation to high-risk or problem-prone processes. Other issues covered in the standards are: the implementation of important systems within the organization that support safety; the organization's safety program for reporting adverse events and near misses; and the design or modification of processes to support safety. </blockquote>And: <blockquote> Suggested Actions (item #2): Institute an organization-wide policy of transparency that sheds light on all adverse events and patient safety issues within the organization, thereby creating an environment where it is safe for everyone to talk about real and potential organizational vulnerabilities and to support each other in an effort to report vulnerabilities and failures without fear of reprisal. (8,9)</blockquote> Finally, considering that the average salary offered to a hospital "Director of Informatics" is a penurious $90-120K per annum with respect to the true expertise required for top roles (don't just take my word for it, take <a href="http://hcrenewal.blogspot.com/2009/12/onc-defines-taxonomy-of-health-it.html">ONC's</a>), and that <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/failurecases/?loc=cases&sloc=leadership">'lowball hiring'</a> in terms of expertise is pervasive, I predict that if robust error reporting takes place, the next few years in HIT will be a wild ride indeed. -- SS [1] I use the term "amateur" in the same sense that I am a <a href="http://www.arrl.org/" style="font-style: italic;">telecommunications amateur</a>, not a professional. Even though I hold the highest license class possible, the Extra, I would not even dream of leading a large telecom project.

FDA Asks Hospitals to Report Safety Glitches in Digital Health Systems

A theme of my writings on this blog and on my teaching site for the past decade has been mismanagement of healthcare information technology...

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On ONC's "Proposed Establishment of Certification Programs for Health Information Technology"

The Office of the National Coordinator for Health Information Technology of HHS (the Department of Health and Human Services) has issued a proposed rule "RIN 0991-AB59 Proposed Establishment of Certification Programs for Health Information Technology." The proposed rule is available in PDF at <a href="https://exchangeweb.drexel.edu/owa/redir.aspx?C=d44356eef22c45a1a68b35783d08c904&URL=http%3a%2f%2fwww.federalregister.gov%2fOFRUpload%2fOFRData%2f2010-04991_PI.pdf">this link</a> and more information is available from ONC itself <a href="http://healthit.hhs.gov/portal/server.pt?open=512&objID=1745&parentname=CommunityPage&parentid=11&mode=2&in_hi_userid=10741&cached=true">at this link</a>. I have written a response to the proposed rule that will be sent as a public comment to the Federal eRulemaking Portal (<a href="http://www.regulations.gov/search/Regs/home.html">http://www.regulations.gov/search/Regs/home.html</a>). I reproduce my response below: <blockquote>Mar. 9, 2010 Re: RIN 0991-AB59, "Proposed Establishment of Certification Programs for Health Information Technology" (<a href="http://www.federalregister.gov/OFRUpload/OFRData/2010-04991_PI.pdf">http://www.federalregister.gov/OFRUpload/OFRData/2010-04991_PI.pdf</a>): Dear HHS/ONC: I believe the deadlines driving establishment of a certification program for health IT as proposed in RIN 0991-AB59, as well as for achieving “meaningful use of healthcare IT” and for onset of medicare penalties for “non adopters”, will result in diffusion of healthcare IT that, in the words of the Jan. 2009 National Research Council report on health IT “will not be sufficient to achieve medical leaders' vision of health care in the 21st century and may even set back the cause” (<a href="http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=12572">http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=12572</a>). I believe the national health IT system that will result will be injurious to patients at an unacceptably high level as well. I am a physician and Yale-trained medical informatician and have been writing about the challenges of healthcare IT since the late 1990’s. My bio is at <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/biography.htm">http://www.ischool.drexel.edu/faculty/ssilverstein/biography.htm</a> and my teaching site on HIT difficulties is at <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/failurecases/">http://www.ischool.drexel.edu/faculty/ssilverstein/failurecases/</a> . I also write on Medical Informatics and HIT for the Healthcare Renewal blog of the Foundation for Integrity and Responsibility in Medicine (FIRM), a 501(c)(3) policy think tank, at <a href="http://hcrenewal.blogspot.com/"> </a><a href="http://hcrenewal.blogspot.com/">http://hcrenewal.blogspot.com</a>. I have labored over the past decade to steer health IT efforts away from known and predictable paths of difficulty, failure and adverse consequences based on medical science, the science of Medical Informatics, ethical considerations, and the experience of other nations with HIT. I am writing to you to express serious concerns about ONC’s HIT Certification Program NPRM (<a href="http://www.federalregister.gov/OFRUpload/OFRData/2010-04991_PI.pdf">http://www.federalregister.gov/OFRUpload/OFRData/2010-04991_PI.pdf</a>). In effect, the NPRM calls for healthcare IT to receive a special governmental accommodation, apparently in part due to politically-decided, and certainly non-scientifically derived timelines. The special accommodations are in the areas of certification, post-market surveillance and inadequate use of existing regulatory expertise over safety-critical IT by agencies with specific domain expertise in that undertaking, thus “reinventing the wheel.” (On the non-scientific nature of the timelines, see, for example, “Predicting the Adoption of Electronic Health Records by Physicians: When Will Health Care be Paperless?”, Ford et. al, JAMIA 2006 13: 106-112, <a href="http://jamia.bmj.com/content/13/1/106.full.pdf">http://jamia.bmj.com/content/13/1/106.full.pdf</a>.) [note: also see addendum below - ed.] First and foremost, the term “safety” itself appears in the RIN 0991-AB59 proposal text only four times, and not in the context of strong provisions to safeguard patients from adverse consequences of healthcare IT. This in and of itself is, quite frankly, of great concern, especially in the context of known HIT safety issues. For instance, FDA’s testimony at ONC’s HIT Policy Committee Adoption/Certification Workgroup meeting on HIT safety (Feb. 25, 2010) itself revealed known patient injuries and deaths related to healthcare IT difficulties. Even more importantly than the fact of these HIT-related adverse events, however, was the revelation that the true extent of these adverse events is unknown. As FDA’s Jeffrey Shuren, MD, JD expressed it, the data he provided is likely “just the tip of the iceberg.” This supports the contention that the technology is still in an experimental phase, rather than being tried and true. A growing body of literature supports that view (e.g., see “2009 a pivotal year in HIT” at <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/failurecases/?loc=cases&sloc=2009">http://www.ischool.drexel.edu/faculty/ssilverstein/failurecases/?loc=cases&sloc=2009</a>). It also seems that unscientifically arrived at timelines (i.e., the politically-decided timelines for HIT adoption and achievement of “meaningful use”) that ignore the experimental nature of healthcare IT – that it is not yet “ready for prime time” in a national rollout - are promoting a rush to a superficial certification and surveillance process. This is alien to the science, culture and ethical obligations of medicine and its practitioners. The latter process, surveillance, is apparently intended to merely surveil continued conformance of HIT to agreed-upon standards, not patient safety as in the pharmaceutical and tangible-medical device postmarketing surveillance process. I consider HIT a medical device that is virtual in nature, but a medical device nonetheless, a position the EU is steering towards. See "The Medical Products Agency’s Working Group on Medical Information Systems: Project summary" (available in English translation in PDF at <a href="http://www.lakemedelsverket.se/upload/foretag/medicinteknik/en/Medical-Information-Systems-Report_2009-06-18.pdf">http://www.lakemedelsverket.se/upload/foretag/medicinteknik/en/Medical-Information-Systems-Report_2009-06-18.pdf</a>). While I believe the NPRM proposal is a step up from the former certification roles envisioned by CCHIT and HIMSS, the proposal still lacks the rigor I have called for in many of my writings about HIT over the past decade. On the formation of new “ONC-Approved Accreditors” (ONC-AA’s) for certification, this is a special accommodation for the HIT industry that appears to inexplicably place that sector in a favored position compared to the pharmaceutical, medical device and other industries that utilize safety-critical IT. The FDA, for example, has significant expertise in validating and regulating IT in the pharmaceutical and medical device industries, including that used in clinical trials which bear similarities to HIT used in the delivery sector. For instance, see "General Principles of Software Validation; Final Guidance for Industry and FDA Staff" at <a href="http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm126955.pdf">http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm126955.pdf</a>. This document opens with the statement: <ul style="font-style: italic;"><li>This guidance outlines general validation principles that the Food and Drug Administration (FDA) considers to be applicable to the validation of medical device software or the validation of software used to design, develop, or manufacture medical devices.</li></ul>As yet another example, NASA has published a document “Certification Processes for Safety-Critical and Mission Critical Aerospace Software” (<a href="http://ntrs.nasa.gov/archive/nasa/casi.ntrs.nasa.gov/20040014965_2004000657.pdf">http://ntrs.nasa.gov/archive/nasa/casi.ntrs.nasa.gov/20040014965_2004000657.pdf</a>). This document begins: <ul><li>Since safety-critical aerospace software is prevalent and important to human life, what is the rationale behind certification of such software? In other words, how do engineers know when a new software product works properly and is safe to fly? In the United States, software must undergo a certification process described in various standards by various regulatory bodies including NASA and the Requirements and Technical Concepts for Aviation (RTCA) which is enforced by the Federal Aviation Administration (FAA). </li></ul><ul><li>How do researchers know which standards apply to their software? Each NASA center and the FAA have unique certification processes for different types of software. For example, there are special processes for the Space Shuttle and different processes for the Space Station. Any software that flies onboard an aircraft in FAA airspace must adhere to special FAA certification processes. There are also different processes depending upon whether the software is safety- or mission-critical or falls into another category. The UK and Europe have similar certification processes.</li></ul>HHS should not be creating new, potentially (likely?) amateur organizations and bureaucracies overseeing these new virtual medical devices that will have variable (or no) experience in software validation, certification, regulation, postmarketing safety surveillance, etc. Rather, HHS should be leveraging existing governmental expertise in certifying, validating and regulating mission critical IT. Further, what is to protect these new bureaucracies from being staffed by those with conflicts of interest with the industry whose products they are purported to certify and surveil? At the very least, existing federal agencies have policies on such conflicts. Of note, we have a prime example of what can occur due to politically-mediated rushing of healthcare IT – that of the UK’s National Programme for Healthcare IT (NPfIT). British PM Tony Blair repeatedly sought to shorten the timetable for the NHS national IT programme in a move that would have brought results for patients in time for a general election in 2005 (see <a href="http://www.computerweekly.com/Articles/2008/02/18/229447/secret-downing-street-papers-reveal-tony-blair-rushed-nhs.htm">http://www.computerweekly.com/Articles/2008/02/18/229447/secret-downing-street-papers-reveal-tony-blair-rushed-nhs.htm</a>.) The result was predictable. A summary of the UK’s House of Commons, Public Accounts Committee’s 2009 report on near-disastrous problems in their £12.7 billion national EMR program is at <a href="http://www.publications.parliament.uk/pa/cm200809/cmselect/cmpubacc/153/15304.htm">http://www.publications.parliament.uk/pa/cm200809/cmselect/cmpubacc/153/15304.htm</a>. From that summary: <ul><li>“Recent progress in deploying the new care records systems has been very disappointing …The Programme is not providing value for money at present because there have been few successful deployments of the Millennium system and none of Lorenzo in any Acute Trust … Despite our previous recommendation, the estimate of £3.6 billion for the Programme's local costs remains unreliable … Little clinical functionality has been deployed to date, with the result that the expectations of clinical staff have not been met … Patients and doctors have understandable concerns about data security."</li></ul>And so forth. Further, from the UK National Audit Office Executive Summary of 16 May 2008 (<a href="http://www.nao.org.uk/publications/0708/the_national_programme_for_it.aspx">http://www.nao.org.uk/publications/0708/the_national_programme_for_it.aspx</a>): <ul><li>At the outset of the Programme, the aim was for implementation of the systems to be complete and for every patient to have an electronic care record by 2010, although the timetable from 2006 was described as tentative. While some parts of the Programme are complete or well advanced, the original timescales for the Care Records Service – one of the key components of the Programme – have not been met.</li></ul>We ignore the UK experience at our peril, an experience in a medical environment smaller and far more government-controlled than our own. Finally, I call attention below to the actual ONC NPRM passages from which my concerns arise on “time constraints” leading to a rushed and superficial certification program (which I believe is frankly cavalier and irresponsible considering the stakes involved). I believe that a rushed National Program for HIT in the United States will suffer the same fate as the aforementioned National Programme for IT in the UK, and perhaps even a worse fate as the UK’s socialized medicine system is certainly a smaller, more homogeneous and more controllable testbed environment for experimenting with HIT. In summary, I believe the current approach to Healthcare IT certification is inadequate, in large part due to time constraints set upon the effort that are themselves artificially rushed and inadequate. I believe much more significant leveraging of existing biomedical and mission critical IT certification/validation expertise is essential, and that patient safety, not continuing adherence to existing standards should be a primary concern of post-implementation surveillance. Thank you for considering these views. </blockquote>I believe rushing health IT, and burying our heads in the sand about the predictable and demonstrated repercussions of doing so as outlined above and on this and other websites, is a very bad idea. <div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhksuvG_OwxvNyiohApoOAQ4ofgs_OsB1YICTOqtN6iChXHujW-hwBgYz1wxX24H0zt_lg5M-OPodzx0MhhoZDIGngKKu7HBq2XjWp-0NXzKgSbI9FJDVNYpOg1f5gDXV23lYl7VYEz7WGC/s1600-h/ostrich.jpg" onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5446726800377792402" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhksuvG_OwxvNyiohApoOAQ4ofgs_OsB1YICTOqtN6iChXHujW-hwBgYz1wxX24H0zt_lg5M-OPodzx0MhhoZDIGngKKu7HBq2XjWp-0NXzKgSbI9FJDVNYpOg1f5gDXV23lYl7VYEz7WGC/s320/ostrich.jpg" style="display: block; margin: 0px auto 10px; text-align: center; cursor: pointer; width: 181px; height: 178px;" /></a>Making like an ostrich on national-scale healthcare IT is a very bad idea. </div> I have written about FDA myself and not always in complementary terms (e.g., <a href="http://hcrenewal.blogspot.com/2008/11/staring-idiocy-in-face-fda-as-gold.html">here</a>, <a href="http://hcrenewal.blogspot.com/2007/03/computer-debacle-broken-down-process-at.html">here</a>), but my concern is that the creation of multiple new potentially amateur organizations does not bode well for HIT, either. The key to successful HIT certification, validation and patient safety is 1) leveraging the needed expertise but 2) without industry conflict of interest and 3) without the pathologies of the HIT 'ecosystem' and culture spoiling the environment (see my <a href="http://www.tinyurl.com/healthITfailure">aforementioned website on HIT difficulties</a> for more on that topic, as well as the <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/failurecases/?loc=cases&sloc=ecosystem">HIT ecosystem essay</a> at that site). Perhaps a new federal HHS subunit is a potential solution - a Clinical Computing Administration (CCA) with regulatory teeth. The oversight of hundreds of billions of dollars of technology and the patients the technology itself affects calls for a quite serious approach to these issues, in my view. -- SS March 9, 2010 Addendum: On rushing national health IT programs - unknown to me when I wrote the post above, this article just appeared in the British Press: <blockquote> <a href="http://www.telegraph.co.uk/health/healthnews/7408379/Patients-medical-records-go-online-without-consent.html" style="font-weight: bold;">Patients' medical records go online without consent</a> Telegraph.co.UK By <a href="http://www.telegraph.co.uk/journalists/kate-devlin/" title="Kate Devlin">Kate Devlin</a>, Medical Correspondent Published: 10:20PM GMT 09 Mar 2010 Those who do not wish to have their details on the £11 billion computer system are supposed to be able to opt out by informing health authorities. But doctors have accused the Government of rushing the project through, meaning that patients have had their details uploaded to the database before they have had a chance to object. ... Hamish Meldrum, [the British Medical Association] chairman, writes: "The breakneck speed with which this programme is being implemented is of huge concern ... "If the process continues to be rushed, not only will the rights of patients be damaged, but the limited confidence of the public and the medical profession in NHS IT will be further eroded." ... Norman Lamb, the Liberal Democrat health spokesman, said: "The Government needs to end its obsession with massive central databases. "The NHS IT scheme has been a disastrous waste of money and the national programme should be abandoned." </blockquote> Read the whole thing. -- SS

On ONC's "Proposed Establishment of Certification Programs for Health Information Technology"

The Office of the National Coordinator for Health Information Technology of HHS (the Department of Health and Human Services) has issued a p...

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