healthy4u: ONC ATCB

WSJ, Koppel and Soumerai: A Major Glitch for Digitized Health-Care Records - Cost Savings Illusory

Two EHR experts from Ivy-league institutions (which are typically hyperenthusiast-oriented) doubt cost savings from EHR technology. <blockquote class="tr_bq">Wall Street Journal Opinion September 17, 2012 <a href="http://online.wsj.com/article/SB10000872396390443847404577627041964831020.html?mod=googlenews_wsj" target="_blank">A Major Glitch for Digitized Health-Care Records</a> Savings promised by the government and vendors of information technology are little more than hype. By <a href="http://www.populationmedicine.org/content/personnelDetail.asp?PID=164&CID=1&Sub=Y" target="_blank">STEPHEN SOUMERAI</a> And <a href="http://sociology.sas.upenn.edu/r_koppel" target="_blank">ROSS KOPPEL</a> In two years, hundreds of thousands of American physicians and thousands of hospitals that fail to buy and install costly health-care information technologies—such as digital records for prescriptions and patient histories—will face penalties through reduced Medicare and Medicaid payments. At the same time, the government expects to pay out tens of billions of dollars in subsidies and incentives to providers who install these technology programs. </blockquote> Which, of course, means printing more money for luxuries we cannot afford in the midst of the worst economic downturn since 1929... <blockquote class="tr_bq">The mandate, part of the 2009 stimulus legislation [I think it would be more accurate to say "sneaked into the 2009 stimulus legislation for IT industry benefit" - ed.], was a major goal of health-care information technology lobbyists and their allies in Congress and the White House. The lobbyists promised that these technologies would make medical administration more efficient and lower medical costs by up to $100 billion annually. </blockquote> By up to $100 billion annually?   (Perhaps these lobbyists need lie detector tests - and/or drug tests to see what they may have been smoking?)  I note the lobbying was covered in the Washington Post in "<a href="http://www.washingtonpost.com/wp-dyn/content/article/2009/05/15/AR2009051503667.html?hpid=topnews">The Machinery Behind Health-Care Reform: How an Industry Lobby Scored a Swift, Unexpected Victory by Channeling Billions to Electronic Records</a>" by Robert O'Harrow Jr., May 16, 2009. <blockquote class="tr_bq">Many doctors and health-care administrators are wary of such claims—a wariness based on their own experience. An extensive new study indicates that the caution is justified: The savings turn out to be chimerical.</blockquote> Some still have empirical observational skills and common sense, fortunately.  In my early days of health IT involvement two decades ago as an NIH-sponsored Medical Informatics post doctoral fellow, I believed there was some cost savings possible, but certainly not in the tens or hundreds of billions per year.  The technology was not solving problems that could lead to such savings (see for instance my Dec. 2010 post "<a href="http://hcrenewal.blogspot.com/2010/12/is-healthcare-it-solution-to-wrong.html" target="_blank">Is Healthcare IT a Solution to the Wrong Problem?</a>").  My experiences since my fellowship have only confirmed my own early opinions. <blockquote class="tr_bq">Since 2009, almost a third of health providers, a group that ranges from small private practices to huge hospitals—have installed at least some "health IT" technology. It wasn't cheap. For a major hospital, a full suite of technology products can cost $150 million to $200 million. Implementation—linking and integrating systems, training, data entry and the like—can raise the total bill to $1 billion.</blockquote> That's countless billions that could have been spent on actual healthcare delivery itself, especially for underserved populations and the poor.  Instead, that money was funnelled to the IT industry for an experimental, unregulated, unvetted technology to be applied on live patients (and without patient consent, I add). <blockquote class="tr_bq">But the software—sold by hundreds of health IT firms—is generally clunky, frustrating, user-unfriendly and inefficient. For instance, a doctor looking for a patient's current medications might have to click and scroll through many different screens to find that essential information. Depending on where and when information on a patient's prescriptions were entered, the complete list of medications may only be found across five different screens.</blockquote> Examples of that from actual systems (sketched to avoid IP problems) is at my ten part series on mission-hostile health IT at this blog, shortened link <a href="http://www.tinyurl.com/hostileuserexper">http://www.tinyurl.com/hostileuserexper</a>. <blockquote class="tr_bq">Now, a comprehensive evaluation of the scientific literature has confirmed what many researchers suspected: The savings claimed by government agencies and vendors of health IT are little more than hype. To conduct the study, faculty at McMaster University in Hamilton, Ontario, and its programs for assessment of technology in health—and other research centers, including in the U.S.—sifted through almost 36,000 studies of health IT. The studies included information about highly valued computerized alerts—when drugs are prescribed, for instance—to prevent drug interactions and dosage errors. From among those studies the researchers identified 31 that specifically examined the outcomes in light of the technology's cost-savings claims. With a few isolated exceptions, the preponderance of evidence shows that the systems had not improved health or saved money. </blockquote> One must understand this in the context of what these systems really are, what they do, and the problems they can actually address as in my post on 'solution to the wrong problem' mentioned supra. <blockquote class="tr_bq">The authors of "The Economics of Health Information Technology in Medication Management: A Systematic Review of Economic Evaluations" found no evidence from four to five decades of studies that health IT reduces overall health costs. Three studies examined in that McMaster review incorporated the gold standard of evidence: large randomized, controlled trials. They provide the best measure of the effects of health IT systems on total medical costs.</blockquote> I point out that randomized controlled trials (RCT's) are notably rare in health IT studies.  Most "confirmatory" studies on health IT benefits are less powerful retrospective/observational studies in specialized settings, with many biases, poor science, etc.  In that sense, such studies can be considered non-generalizable and anecdotal at best (more on the "anecdotes" issue is below). Of course, the pundits and Ddulites ("Luddite" with first four letters reversed; meaning ardent hyperenthusiasts) will likely say "it will all be fixed in version 2.0" despite decades of opportunity to get health IT "right" and demonstrate generalized improved outcomes and cost savings: <blockquote class="tr_bq"> ... At "<a href="http://hcrenewal.blogspot.com/2012/02/health-it-ddulites-and-irrational.html">Health IT: Ddulites and Irrational Exuberance</a>" and related posts (<a href="http://hcrenewal.blogspot.com/search/label/Ddulite">query link</a>) I've described the phenomenon of the: 'Hyper-enthusiastic technophile who either deliberately ignores or is blinded to technology's downsides, ethical issues, and repeated local and mass failures.'</blockquote> From Regenstrief Institute, one of the premier and pioneering centers for Medical Informatics research and teaching: <blockquote class="tr_bq">A study from Regenstrief, a leading health IT research center associated with the Indiana University School of Medicine, found that there were no savings, and another from the same center found a significant increase in costs of $2,200 per doctor per year. The third study measured a small and statistically questionable savings of $22 per patient each year.</blockquote> That's probably not taking into account increased medical malpractice costs as exemplified <a href="http://hcrenewal.blogspot.com/2011/06/babys-death-spotlights-safety-risks.html" target="_blank">here</a> and <a href="http://hcrenewal.blogspot.com/2011/09/sweet-death-that-wasnt-very-sweet-how_24.html" target="_blank">here</a> and by other settlements I know of but cannot mention due to my consulting role in those cases. A primer on health IT risks, containing a number of key articles and links, is downloadable at <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/HIT_issues_Primer.zip">http://www.ischool.drexel.edu/faculty/ssilverstein/HIT_issues_Primer.zip</a>.  <blockquote class="tr_bq">In short, the most rigorous studies to date contradict the widely broadcast claims that the national investment in health IT—some $1 trillion will be spent, by our estimate—will pay off in reducing medical costs. Those studies that do claim savings rarely include the full cost of installation, training and maintenance—a large chunk of that trillion dollars—for the nation's nearly 6,000 hospitals and more than 600,000 physicians.</blockquote> $1 trillion would pay for a tremendous amount of actual healthcare delivery, I note. These system lifecycle costs, known as "total cost of ownership", are due to upgrades and necessary changes as medicine itself, including the science, business and legal components change over time.   The costs are generally underestimated ahead of time.  A good source on these issues is the article "<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/Goldfinch_pessimism_PAR.pdf" target="_blank">Pessimism, Computer Failure, and Information Systems Development in the Public Sector</a>"  (Public Administration Review 67;5:917-929, Sept/Oct. 2007).  This is a cautionary article on IT that recommends much more critical attitudes towards major IT initiatives in all sectors.  <blockquote class="tr_bq">But by the time these health-care providers find out that the promised cost savings are an illusion, it will be too late. Having spent hundreds of millions on the technology, they won't be able to afford to throw it out like a defective toaster.</blockquote> There, I disagree.  We may have to "throw it out" as the disruptions to good medical care by bad health IT (BHIT) increase, unless the industry reforms itself very rapidly.  As I state in the introduction to my teaching website "<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/" target="_blank">Contemporary Issues in Medical Informatics: Good IT, Bad IT, and Common Examples of Healthcare Information Technology Difficulties</a>" (started in late 1998 due, in fact, to my observations of inappropriate leadership and poor quality of health IT): <blockquote class="tr_bq">The site takes a view consistent with medicine’s core values and with patients’ rights that health IT, as a medical apparatus that increasingly forms an enterprise clinical resource management and clinician workflow control mechanism, remains experimental and should be subject to the same ethical considerations, validation processes and regulatory oversight to which almost all other medical technologies and pharmaceuticals are subjected. The site is pro-health IT, but only when the health IT is “good IT” - as opposed to “bad IT." Good Health IT ("GHIT") is defined as IT that provides a good user experience, enhances cognitive function, puts essential information as effortlessly as possible into the physician’s hands, keeps eHealth information secure, protects patient privacy and facilitates better practice of medicine and better outcomes. Bad Health IT ("BHIT") is defined as IT that is ill-suited to purpose, hard to use, unreliable, loses data or provides incorrect data, causes cognitive overload, slows rather than facilitates users, lacks appropriate alerts, creates the need for hypervigilance (i.e., towards avoiding IT-related mishaps) that increases stress, is lacking in security, compromises patient privacy or otherwise demonstrates suboptimal design and/or implementation. This site challenges medically and ethically controversial views that health IT merits special accommodations in terms of freedom from scientific rigor and evidence-based practices, freedom from regulation, and freedom from accountability.  </blockquote> I  hold little hope of these issues being seriously addressed - let alone solved - any time in the near future due to: 1)  the irrational exuberance about this technology, cf: Twitter feeds on hashtags #EHR, #EMR, #HCIT and similar; 2)  the industry-promoted myths and fabrications over decades; 3)  the FDA-admitted impediments to information diffusion about defects and harms (<a href="http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html" target="_blank">link</a>); 4)  IOM-admitted impediments to same (<a href="http://hcrenewal.blogspot.com/2011/11/iom-report-on-health-it-safety-nix-fda.html" target="_blank">link</a>);and 5)  the latter's industry-favoring, Milquetoast 2012 recommendations on monitoring, remediation and regulation. These are indicative of an industry that has neatly avoided any meaningful regulation and is, in plain terms, out of control. <blockquote class="tr_bq">Why are we pushing ahead to digitize even more of the health-care system, when the technology record so far is so disappointing? So strong is the belief in health IT that skeptics and their science are not always welcome. Studies published several years ago in the Journal of the American Medical Association and the Annals of Internal Medicine reported that health IT systems evaluated by their own developers were far more likely to be judged "successful" than those assessed by independent evaluators. </blockquote>"Not welcome" is an understatement.  ONC itself is guilty of bad science, as in its grossly deficient March 2011 Health Affairs paper on health IT benefits. (See my Oct. 2011 post "<a href="http://hcrenewal.blogspot.com/2011/03/benefits-of-health-information.html" target="_blank">ONC: The Benefits Of Health Information Technology: A Review Of The Recent Literature Shows Predominantly Positive Results</a>".  Also see my Aug. 2012 post "<a href="http://hcrenewal.blogspot.com/2012/08/onc-and-irrelevant-comparisons.html" target="_blank">ONC and Misdirection Regarding Mass Healthcare IT Failure</a>".) So bad is the "Health IT critique not welcome" phenomemon that, for example, Medical Informatics leaders such as Bill Hersh of Oregon Health Sciences University (OHSU) openly attack those who are candid on health IT risks (and make fools of themselves via the open attacks), such as the attack I wrote of at my Sept. 2010 post "<a href="http://hcrenewal.blogspot.com/2010/09/dangers-of-critical-thinking-in.html" target="_blank">The Dangers of Critical Thinking in A Politicized, Irrational Culture</a>". Also common in the "Health IT Critique Not Welcome Here" club, and probably deliberately so, is mistaking risk management activities for research observations and calling the former, even when reported by credible witnesses, "anecdotal" while calling at-best weak HIT-positive studies "definitive science."  See "<a href="http://hcrenewal.blogspot.com/2011/08/from-senior-clinician-down-under.html" target="_blank">From a Senior Clinician Down Under: Anecdotes and Medicine, We are Actually Talking About Two Different Things</a>" for the definitive rebuttal of that type of patient-endangering intellectual blindness or dishonesty. <blockquote class="tr_bq">Government agencies like the Office of the National Coordinator of Healthcare Information Technology (an agency of the Department of Health and Human Services) serve as health IT industry boosters. ONC routinely touts stories of the technology's alleged benefits.</blockquote> But almost never the opposite, which is equally if not more important.  Further, they tout "certification" as a means of HIT safety evaluation and assurance, or do not deny that misconception, despite statements by the very certification bodies or ATCB's they appoint to the contrary.  Yet they need to come clean on this. (I've seen the claim of 'certification equals safety' in actual legal briefs in defense of health IT.)  See my Feb. 2012 post "<a href="http://hcrenewal.blogspot.com/2012/02/hospitals-and-doctors-use-health-it-at.html" target="_blank">Hospitals and Doctors Use Health IT at Their Own Risk - Even if Certified</a>." ONC also seems to turn a blind eye to industry-ghostwriting abuses in the public comments period of Notices of Proposed Rulemaking for "meaningful use" (itself an Orwellian term) rules.  See for instance my Sept. 2012 posts "<a href="http://hcrenewal.blogspot.com/2012/08/health-it-vendor-epic-uses-clients-as.html">Health IT Vendor EPIC Caught Red-Handed: Ghostwriting And Using Customers as Stealth Lobbyists - Did ONC Ignore This?</a>" and "<a href="http://hcrenewal.blogspot.com/2012/09/from-what-i-can-tell-epic-was.html" target="_blank">Was EPIC successful in watering down the Meaningful Use Stage 2 Final Rule?</a>" <blockquote class="tr_bq">We fully share the hope that health IT will achieve the promised cost and quality benefits. As applied researchers and evaluators, we actively work to realize both goals. But this will require an accurate appraisal of the technology's successes and failures, not a mixture of cheerleading and financial pressure by government agencies based on unsubstantiated promises.</blockquote> I share the same sentiments.  As I've often written, the Achilles heel of the health IT sector is its ignoring the very science and evidence-based approaches of the field - medicine - that health IT is supposed to somehow "revolutionize" and "transform." It is, quite frankly, the utmost in hypocrisy for an industry that demands evidence-based medicine - and touts its expensive products as leading to that change - to itself not practice what I've called "evidence-based computing." <blockquote class="tr_bq"> Mr (sic) Soumerai is professor of population medicine at Harvard Medical School and Harvard Pilgrim Health Care Institute. Mr. Koppel is a professor of sociology and medicine at the University of Pennsylvania and principal investigator of its Study of Hospital Workplace Culture. </blockquote> <a href="http://www.populationmedicine.org/content/personnelDetail.asp?PID=164&CID=1&Sub=Y" target="_blank">Dr. Soumerai</a> also co-authored "<a href="http://www.huffingtonpost.com/stephen-soumerai/dont-repeat-the-uks-elect_b_790470.html" id="title_permalink" title="Permalink">Don't Repeat the UK's Electronic Health Records Failure"</a> with Anthony Avery, Professor of Primary Care at the University of Nottingham Medical School, UK, Huffington Post, Dec. 5, 2010. I also expect to hear an "Ivy tower academics - what do they know?" refrain from the industry.  However, this will not hold water, as the Ivory tower inhabitants, as I previously stated, are almost uniformly of the Ddulite-hyperenthusist persuasion and touted when they speak or write in uncritical favor of health IT. -- SS Addendum: Penn Wharton professors had a similar opinion on cost-savings in 2009: <blockquote class="tr_bq"><a href="http://knowledge.wharton.upenn.edu/article.cfm?articleid=2260">Information Technology: Not a Cure for the High Cost of Health Care</a>: Knowledge@Wharton, Wharton School of Business, University of Pennsylvania, June 10, 2009. (PDF version available <a href="http://knowledge.wharton.upenn.edu/createpdf.cfm?articleid=2260">at this link</a>) </blockquote> As I observed in my June 20, 2009 post "<a href="http://hcrenewal.blogspot.com/2009/06/improving-patient-safety-in-eu-hit.html" target="_blank">Improving Patient Safety In The EU: HIT Should Be Classified As Medical Devices. And, Can We Drop the "Massive Cost Savings" Fable?</a>", in a WSJ article that same day entitled "<a href="http://online.wsj.com/article/SB10001424052970204005504574235751720822322.html">The Myth of Prevention</a>", Abraham Verghese, Professor and Senior Associate Chair for the Theory and Practice of Medicine at Stanford echoed the Wharton professors' doubts about the cost savings and ultimate value of electronic medical records: <blockquote>... I have similar problems with the way President Obama hopes to pay for the huge and costly health reform package he has in mind that will cover all Americans; he is counting on the “savings” that will come as a result of investing in preventive care and investing in the electronic medical record among other things. It’s a dangerous and probably an incorrect projection. </blockquote> I also had related observations published in a Letter to the Editor in the WSJ in February of that year: <blockquote class="tr_bq"><a href="http://online.wsj.com/article/SB123492035330205101.html" target="_blank">Digitizing Medical Records May Help, but It's Complex</a>, Feb. 18, 2009 You observe that the true political goal is socialized medicine facilitated by health care information technology. You note that the public is being deceived, as the rules behind this takeover were stealthily inserted in the stimulus bill. I have a different view on who is deceiving whom. In fact, it is the government that has been deceived by the HIT industry and its pundits. Stated directly, the administration is deluded about the true difficulty of making large-scale health IT work. The beneficiaries will largely be the IT industry and IT management consultants. For £12.7 billion the U.K., which already has socialized medicine, still does not have a working national HIT system, but instead has a major IT quagmire, some of it caused by U.S. HIT vendors. HIT (with a few exceptions) is largely a disaster. I'm far more concerned about a mega-expensive IT misadventure than an IT-empowered takeover of medicine. The stimulus bill, to its credit, recognizes the need for research on improving HIT. However this is a tool to facilitate clinical care, not a cybernetic miracle to revolutionize medicine. The government has bought the IT magic bullet exuberance hook, line and sinker. I can only hope patients get something worthwhile for the $20 billion. Scot Silverstein, M.D. Faculty Biomedical Informatics Drexel University Institute for Healthcare Informatics Philadelphia</blockquote> Next time you hear from some pundit about enormous "cost savings" from clinical IT, remember this post. Let's implement health IT - and do it well, i.e., good health IT (GHIT) instead of bad health IT (BHIT)- to facilitate clinicians, not to work financial miracles or "revolutionize" anything. <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/AVvXsEhGg0COl5XruSc2M6Tqlbl-KZ69phovYcYzjTceLKGrUR8eAXyQ16-yjmxXJ0OPEbJVRC91slcIJsa4BGJwtZ87D_vM7iBpmTA0awNgSxrNfGGSY42ITYjS6g6SuGfW3SdFDyfur7oq1Ato/s1600/slide1.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="240" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhGg0COl5XruSc2M6Tqlbl-KZ69phovYcYzjTceLKGrUR8eAXyQ16-yjmxXJ0OPEbJVRC91slcIJsa4BGJwtZ87D_vM7iBpmTA0awNgSxrNfGGSY42ITYjS6g6SuGfW3SdFDyfur7oq1Ato/s320/slide1.jpg" width="320" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">A slide from my Aug. 1, 2012 <a href="http://hcrenewal.blogspot.com/2012/08/my-presentation-to-health-informatics.html" target="_blank">presentation</a> to the Health Informatics Society of Australia at HIC2012.  Click to enlarge.</td></tr></tbody></table> -- SS

WSJ, Koppel and Soumerai: A Major Glitch for Digitized Health-Care Records - Cost Savings Illusory

Two EHR experts from Ivy-league institutions (which are typically hyperenthusiast-oriented) doubt cost savings from EHR technology.Wall Street JournalOpinionSeptember 17, 2012A Major Glitch for Digiti…

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18 Sep 2012

Malpractice Attorney Puts ONC-Authorized Testing and Certification Bodies (ATCBs) at Risk of Litigation?

I am jet-lagged after returning from Sydney, Australia, where I delivered one of the keynote addresses at the Health Informatics Society of Australia annual conference, HIC 2012 (<a href="http://www.hisa.org.au/page/hic2012/">http://www.hisa.org.au/page/hic2012/</a>). My theme in a talk entitled "Critical Thinking on Building Trusted, Transformative Medical Information:  Improving Health IT as the First Step" was health IT trust and safety.  I was actually invited in 2011 but could not attend; I was helping care for my mother, who was severely injured due to a HIT-related mishap in 2010.  Her death in 2011 allowed me to attend now on re-invitation. More on my presentation later. <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/AVvXsEj6lP4Fd1BwQ4z78pmsNlemesGCSJIe0BQFak7ql6oxzhL6857puno0QD9JORCr47hnUV926YrdPBT8Z4V5zh9mbuE9XPum50jj09EuGgKG7rsAWkyydCgkh9U74CRujIVwVvNZKLE3F0Og/s1600/bridge.JPG" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="240" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEj6lP4Fd1BwQ4z78pmsNlemesGCSJIe0BQFak7ql6oxzhL6857puno0QD9JORCr47hnUV926YrdPBT8Z4V5zh9mbuE9XPum50jj09EuGgKG7rsAWkyydCgkh9U74CRujIVwVvNZKLE3F0Og/s320/bridge.JPG" width="320" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">A beautiful view of the Sydney Harbour Bridge and Opera House, taken with a mere Canon SX110IS.  Click to enlarge.</td></tr></tbody></table> In the meantime, I returned to the U.S. to find that the defense attorney for the hospital where my mother was severely injured, and then died as a result, is once again raising an absurd issue in objections to the medical malpractice Complaint that was refiled within the Statute of Limitations for technical reasons.   The President Judge of the county where the case is filed had dismissed this complaint (among many others) some time ago: <blockquote class="tr_bq">(ii) Plaintiffs Software Design Defect Claims are Preempted by the Federal HITECH Act ... To the extent Plaintiff attempts to bring a common law product liability claim against [name redacted] Hospital for required use of EMR software, such a claim is barred due to Federal Preemption of this area with the passage of the Health Information Technology for Economic and Clinical Health (HITECH) Act. 42 U.S.C. 201, 300, et seq. Specifically, the design, manufacture, specification, certification and sale of EMR in the United States is a highly regulated industry under the jurisdiction of the Department of Health and Human Services (HHS). The HHS draws its statutory authority to design and certify EMR as safe and effective under the HITECH act as amended. Id. The Supremacy Clause of the United States Constitution, article VI, clause 2, preempts any state law that conflicts with the exercise of federal power. Fid. Fed. Say. & Loan Ass’n v. de la Cuesta, 458 U.S. 141, 102 S. Ct. 3014 (1982). “Pre-emption may be either express or implied, and ‘is compelled whether Congress’ command is explicitly stated in the statute’s language or implicitly contained in its structure and purpose.” Matter of Calun Elec. Power Co-op., Inc., 109 F.3d 248, 254 (5th Cir. 1997) citing Jones v. Rath Packing Co., 430 U.s. 519, 525 (1977). In this case, to impose common law liability upon [name redacted] Hospital for using certified EHR technology, which was in compliance with federal law and regulations for Health Information Technology, would directly conflict with Congress’ statutory scheme for fostering and promoting the implementation and use of EHR  </blockquote> I really don't think Congress intended HIT to maim and kill patients with impunity.  In any case, this assertion was thrown out in its entirety several months ago, but here it is again in a new set of objections.  I find its reappearance remarkable.  I also wonder if the industry is behind it. As per numerous posts in this blog, such assertions are false - and likely knowingly so in this situation.  (In that case, this would be an even more serious matter.) For example as I pointed out at my Feb. 2012 post <a href="http://hcrenewal.blogspot.com/2012/02/hospitals-and-doctors-use-health-it-at.html" target="_blank">Hospitals and Doctors Use Health IT at Their Own Risk - Even if "Certified"</a>, ONC-Authorized Testing and Certification Bodies (ATCB's) answered my questions about safety, legal indemnification etc.  Their work has nothing to do with certifying HIT as safe by their own admission. Also, as in my April 2011 post <a href="http://hcrenewal.blogspot.com/2011/04/fda-decides-regulating-implantable.html" target="_blank">FDA Decides Regulating Implantable Defibrillator Medical Devices a "Political Hot Potato"; Demurs</a> and my Nov. 2011 post <a href="http://hcrenewal.blogspot.com/2011/11/iom-report-on-health-it-safety-nix-fda.html" target="_blank">IOM Report - "Health IT and Patient Safety: Building Safer Systems for Better Care</a>, the HIT industry is unregulated. On the HIT regulation issue, IOM has itself stated in no uncertain terms that HIT is non-regulated (not "a highly regulated industry") in their report to HHS.  For instance, in the aforementioned 2012 report they state (as one example): <blockquote class="tr_bq">... If the Secretary [of HHS] deems it necessary for the FDA to regulate EHRs and other currently nonregulated health IT products, clear determinations will need to be made about whether all health IT products classify as medical devices for the purposes of regulation. If FDA regulation is deemed necessary, the FDA will need to commit sufficient resources and add capacity and expertise to be effective. </blockquote> I won't even address the claim that the HITECH Act represents or intended to represent Federal pre-emption of state common law rights.   It's without merit, and actually absurd. Worst of all, statements in legal dockets that "HHS draws its statutory authority to design and certify EMR as safe and effective under the HITECH Act" (in reality, private non-governmental ONC-Authorized Testing and Certification Bodies or ATCB's are appointed by ONC to "certify" HIT features and functionality to be compliant with "Meaningful Use" guidelines and do not test for safety or efficacy) potentially puts those private ATCB's at risk for being named defendants in lawsuits where HIT was found unsafe and/or ineffective if upheld. I am sure the ATCB's and ONC would not be happy about that. -- SS

Malpractice Attorney Puts ONC-Authorized Testing and Certification Bodies (ATCBs) at Risk of Litigation?

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07 Aug 2012

WSJ "There's a Medical App for That—Or Not" - Misinformation on Health IT Safety Regulation?

There's a health IT meme that just won't die (patients may, but not the meme). It's the meme that health IT "certification" is a certification of safety. I expressed concern about the term "certification" being misunderstood even before the meme formally appeared, when the term was adopted by HHS with regard to evaluation of health IT for adherence to the "meaningful use" pre-flight features checklist.  See my mid-2009 post "<a href="http://hcrenewal.blogspot.com/2009/08/cchit-has-company.html" target="_blank">CCHIT Has Company</a>" where I observed: <blockquote class="tr_bq">HIT "certification." ... is a term I put in quotes since it really is "features qualification" at this point, not certification such as a physician receives after passing Specialty Boards.</blockquote> The "features qualification" is an assurance that the EHR functions in way that could enable an eligible provider or eligible hospital to meet the Center for Medicare & Medicaid Services' (CMS) requirements of "Meaningful Use."  No rigorous safety testing in any meaningful sense is done, and no testing under real-world conditions is done at all. I've seen the meme in various publications and venues.  I've even seen it in legal documents in medical malpractice cases where EHR's were involved, as an attempted defense. Now the WSJ has fallen for the health IT Certification meme. An article "<a href="http://online.wsj.com/article/SB10001424052702303674004577432742562311810.html" target="_blank">There's a Medical App for That—Or Not</a>" was published on May 29, 2012.  Its theme is special regulatory accommodation for health IT in the form of opposition to FDA regulation of devices such as "portable health records and programs that let doctors and patients keep track of data on iPads." In the article, this assertion about health IT "certification" is made: <blockquote class="tr_bq">... The FDA's approach to health-information technology risks snuffing out activity at a critical frontier of health care. Poor, slow regulation would encourage programmers to move on, leaving health care to roil away for yet another generation, fragmented, disconnected and choking on paperwork. The process already exists for safeguarding the public for computers in health care. It's not FDA premarket review but the health information technology certification program, established under President George W. Bush and still working fine under the Obama Health and Human Services Department. The government sets the standards and an independent nonprofit [ATCB, i.e., ONC Authorized Testing and Certification Bodies - ed.] ensures that apps meet those standards. It's a regulatory process as nimble as the breakout industry it's meant to monitor. That is where and how these apps should be regulated.</blockquote> It's a wonderful meme.  Unfortunately, it's wrong.  Dead wrong. Certification by an ATCB does not "safeguard the public."   Two ONC Authorized Testing and Certification Bodies (ATCB's) admitted this in email, as in my Feb. 2012 post "<a href="http://hcrenewal.blogspot.com/2012/02/hospitals-and-doctors-use-health-it-at.html" target="_blank">Hospitals and Doctors Use Health IT at Their Own Risk - Even if Certified</a>".  I had asked them, point-blank: <blockquote>"Is EHR certification by an ATCB a certification of EHR safety, effectiveness, and a legal indemnification, i.e., certifying freedom from liability for EHR use of clinical users or organizations? Or does it signify less than that?"</blockquote> I received two replies from major ONC ATCB's indicating that "certification" is merely assurance that HIT meets a minimal set of "meaningful use" guidelines, not that it's been vetted for safety.  For instance: <blockquote class="tr_bq">From: Joani Hughes (Drummond Group) Sent: Monday, March 05, 2012 1:06 PM To: Scot Silverstein Subject: RE: EHR certification question Per our testing team: It is less than that. It does not address indemnification although a certification could be used as a conditional part of some other form of indemnification function, such as a waiver or TOA, but that is ultimately out of the scope of the certification itself. Certification in this sense is an assurance that the EHR functions in way that could enable an eligible provider or eligible hospital to meet the CMS requirements of Meaningful Use Stage 1. Or to restate it more directly, CMS is expecting eligible providers or eligible hospitals to use their EHR in “meaningful way” quantified by various quantitative measure metrics and eligible providers or eligible hospitals can only be assured they can do this if they obtain a certified EHR technology. Please let me know if you have any questions. Thank you, Joani. Joani Hughes Client Services Coordinator Drummond Group Inc.</blockquote> The other ATCB, ICSA Labs, stated that: <blockquote class="tr_bq">... Certification by an ATCB signifies that the product or system tested has the capabilities to meet specific criteria published by NIST and approved by the Office of the National Coordinator. In this case the criteria are designed to support providers and hospitals achieve "Meaningful Use." A subset of the criteria deal with the security and patient privacy capabilities of the system. Here is a list of the specific criteria involved in our testing: <a href="http://healthcare.nist.gov/use_testing/effective_requirements.html" target="_blank">http://healthcare.nist.gov/use_testing/effective_requirements.html</a> In a nutshell, ONC-ATCB Certification deals with testing the capabilities of a system, some of them relate to patient safety, privacy and security functions (audit logging, encryption, emergency access, etc.). What was suggested in the email below (freedom from liability for users of the system, etc.) would be out of scope for ONC-ATCB testing based on the given criteria. [I.e., certification criteria - ed.] I hope that helps to answer your question.</blockquote> I had noted that: <blockquote class="tr_bq">... My question was certainly answered [by the ATCB responses]. ONC certification is not a safety validation, such as in a document from NASA on aerospace software safety certification, "<a href="http://ntrs.nasa.gov/archive/nasa/casi.ntrs.nasa.gov/20040014965_2004000657.pdf">Certification Processes for Safety-Critical and Mission-Critical Aerospace Software</a>" (PDF) which specifies at pg. 6-7:</blockquote><blockquote><blockquote>In order to meet most regulatory guidelines, developers must build a safety case as a means of documenting the safety justification of a system. The safety case is a record of all safety activities associated with a system throughout its life. Items contained in a safety case include the following: • Description of the system/software • Evidence of competence of personnel involved in development of safety-critical software and any safety activity • Specification of safety requirements • Results of hazard and risk analysis • Details of risk reduction techniques employed • Results of design analysis showing that the system design meets all required safety targets • Verification and validation strategy • Results of all verification and validation activities • Records of safety reviews • Records of any incidents which occur throughout the life of the system • Records of all changes to the system and justification of its continued safety</blockquote></blockquote> A CCHIT ATCB juror, a physician informatics specialist, has also done a guest post in Jan. 2012 on HC Renewal about the certification process, reproducing his testimony to HHS on the issue.  That post is "<a href="http://hcrenewal.blogspot.com/2011/01/dr-monteith-hit-testimony-to-hhs.html" target="_blank">Interesting HIT Testimony to HHS Standards Committee, Jan. 11, 2011, by Dr. Monteith</a>."  Dr. Monteith testified (emphases mine): <blockquote class="tr_bq"><div class="MsoNormal">... I’m “pro-HIT.” For all intents and purposes, I haven’t handwritten a prescription since 1999.</div><div class="MsoNormal"> </div><div class="MsoNormal">That said and with all due respect to the capable people who have worked hard to try to improve health care through HIT, here’s my frank message:</div><div class="MsoNormal"> </div><div class="MsoNormal">ONC’s strategy has put the cart before the horse. HIT is not ready for widespread implementation. </div><div class="MsoNormal"> </div><div class="MsoNormal">... ONC has promoted HIT as if there are clear evidence-based products and processes supporting widespread HIT implementation.</div><div class="MsoNormal"> </div><div class="MsoNormal">But what’s clear is that we are experimenting…with lives, privacy and careers.</div> ... I have documented scores of error types with our certified EHR, and literally hundreds of EHR-generated errors, including consistently incorrect diagnoses, ambiguous eRxs, etc. <div class="MsoNormal">As a CCHIT Juror, I’ve seen an inadequate process. Don’t get me wrong, the problem is not CCHIT. The problem stems from MU.</div><div class="MsoNormal"> </div><div class="MsoNormal">EHRs are being certified even though they take 20 minutes to do a simple task that should take about 20 seconds to do in the field.  [Which can contribute to mistakes and "use error" - ed.] Certification is an “open book” test. How can so many do so poorly?</div><div class="MsoNormal"> </div><div class="MsoNormal">For example, our EHR is certified, even though it cannot generate eRxs from within the EHR, as required by MU.</div><div class="MsoNormal"> </div><div class="MsoNormal">To CCHIT’s credit, our EHR vendor did not pass certification. Sadly, our vendor went to another certification body, and now they’re certified.</div><div class="MsoNormal"> </div><div class="MsoNormal">MU does not address many important issues. Usability has received little more than lip-service. What about safety problems and reporting safety problems? What about computer generated alerts, almost all of which are known to be ignored or overridden (usually for good reason)?</div><div class="MsoNormal">  </div><div class="MsoNormal">The concept of “unintended consequences” comes to mind.</div><div class="MsoNormal"> </div><div class="MsoNormal">All that said, the problem really isn’t MU and its gross shortcomings, it is ONC trying to do the impossible:</div><div class="MsoNormal"> </div><div class="MsoNormal">ONC is trying to artificially force a cure for cancer, basically trying to promote one into being, when in fact we need to let one evolve through an evidence-based, disciplined process of scientific discovery and the marketplace.</div></blockquote><div class="MsoNormal"> </div><div class="MsoNormal">Needless to say, as was learned at great cost in past decades, a "disciplined process" in medicine includes meaningful safety regulation by objective outside experts. </div><div class="MsoNormal"> </div>Further, the certifiers have no authority to do important things such as forcibly remove dangerous software from the market.  An example is the forced Class 1 recall of a defective system as I wrote about in my Dec. 2011 post "<a href="http://hcrenewal.blogspot.com/2011/12/fda-recalls-health-it-software-because.html" target="_blank">FDA Recalls Draeger Health IT Device Because This Product May Cause Serious Adverse Health Consequences, Including Death</a>".   Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death. In that situation, the producer had been simply advising users (in critical care environments, no less) to "work around the defects" that could indicate incorrect recommended dosage values of critical meds, including a drug dosage up to ten times the indicated dosage, as well as corrupt critical cardiovascular monitoring data.  As I observed: <blockquote class="tr_bq">... I find a software company advising clinicians to make sure to "work around" blatant IT defects in "acute care environments" the height of arrogance and contempt for patient safety. </blockquote> Without formal regulatory authority to take actions such as this FDA recall, "safeguarding the public" is a meaningless platitude. It's also likely the ATCB's, which are private businesses, would not want the responsibility of "safeguarding the public."  That responsibility would open them up to litigation when patient injuries or death were caused, or were contributed to, by "certified" health IT. I have in the past also noted that the use of the term "certification" might have been deliberate, to mislead potential buyers exactly into thinking that "certification" is akin to a UL certification of an electrical appliance for safety, or an FAA approval of a new aircraft's flight-worthiness. The WSJ needs to clarify and/or retract its statement, as the statement is misinformation. At my Feb. 2012 post "<a href="http://hcrenewal.blogspot.com/2012/02/health-it-ddulites-and-disregard-for.html" target="_blank">Health IT Ddulites and Disregard for the Rights of Others</a>" I observed: <blockquote class="tr_bq">Ddulites [HIT hyper-enthusiasts - ed.] ... ignore the downsides (patient harms) of health IT. This is despite being already aware of, or informed of patient harms, even by reputable sources such as <a href="http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html">FDA</a> (Internal FDA memo on H-IT risks), <a href="http://hcrenewal.blogspot.com/2008/12/joint-commission-sentinel-events-alert.html">The Joint Commission</a> (Sentinel Events Alert on health IT), the <a href="http://www.isb.nhs.uk/documents/isb-0160/dscn-18-2009/0160182009specification.pdf">NHS</a> (Examples of potential harm presented by health software - Annex A starting at p. 38), and the <a href="http://hcrenewal.blogspot.com/2010/12/ecri-healthcare-it-in-top-ten-health.html">ECRI Institute</a> (Top ten healthcare technology risks), to name just a <a href="http://hcrenewal.blogspot.com/2011/02/updated-reading-list-on-health-it.html">few</a>. In fact, the hyper-enthusiastic health IT technophiles will go out of their way to incorrectly dismiss risk management-valuable case reports as "anecdotes" not worthy of consideration (see "Anecdotes and medicine" essay <a href="http://hcrenewal.blogspot.com/2011/08/from-senior-clinician-down-under.html">at this link</a>). They will also make unsubstantiated, often hysterical-sounding claims that health IT systems are necessary to, or simply will "transform" (into what, exactly, is usually left a mystery) or even "revolutionize" medicine (whatever that means). </blockquote> Health IT is a potentially dangerous technology.   It requires meaningful regulation to "safeguard the public."  How many incidents like <a href="http://hcrenewal.blogspot.com/2011/11/lifespan-rhode-island-yet-another.html" target="_blank">this</a> and <a href="http://hcrenewal.blogspot.com/2011/12/yet-another-glitch-affecting-thousands.html" target="_blank">this</a> will it take before that is understood by the hyper-enthusiasts? I've emailed the ATCB's that had responded to my aforementioned query for clarification on the WSJ assertion about their role, being that the statement is in contradiction to their earlier replies to me.  I also advised them of the potential liability issues. However, if it turns out to be true that the ONC-ATCB's do intend themselves as the ultimate watchdog and assurer of public safety related to EHR's, that needs to be known by the public and their representatives. -- SS

WSJ "There's a Medical App for That—Or Not" - Misinformation on Health IT Safety Regulation?

There's a health IT meme that just won't die (patients may, but not the meme).It's the meme that health IT "certification" is a certification of safety.I expressed concern about the term "certificatio…

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03 Jun 2012

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