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

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

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

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

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iGoogle's got game... themes!

I'm happy to announce the launch of iGoogle game themes. These themes offer our users new iGoogle backdrops inspired by their favorite video games, including classics like "Mario" and "Mega Man" and new sensations like "Wii Sports" and "Spore." Like our <a href="http://googleblog.blogspot.com/2008/04/where-art-thou.html" id="m_na" title="iGoogle artist themes">iGoogle artist themes</a>, <a href="http://googleblog.blogspot.com/2008/09/more-eye-candy-for-igoogle.html" id="jc5v" title="fashion and music themes">fashion and music themes</a> and <a href="http://googleblog.blogspot.com/2008/12/creating-change-with-your-homepage.html" id="dqgk" title="themes for causes">themes for causes</a>, we hope that the game themes delight our users and reflect their personal interests. As you can imagine, these themes in particular have captivated our iGoogle software engineers who are gamers themselves. I'll now turn the post over to one of our engineers who worked closely on the project, Matthew Chan, for more details. A gamer's POV I confess, I'm a game geek. My first experience with video games was spending hours and hours (not to mention my weekly allowance) playing "Donkey Kong" and "Galaga" at a nearby arcade until my fingers ached. These days I no longer have to ride my bike to the neighborhood arcade to play video games — I can do it in the comfort of my own home anytime I want! And even better... starting today, I can have images of my favorite childhood games right on my iGoogle page. iGoogle now has graphics from all sorts of games that I know will excite my fellow gamers. Picture your homepage with "Burnout" cars zooming in the background, Ryu from "Street Fighter" blasting hadoukens across your page, or rock stars jamming out to tunes from "Guitar Hero." It doesn't end there. For those of you who used to dream about completing the Triforce or getting out of tombs alive, choose from "Zelda" or "Tomb Raider." Want more? Try "Dungeons & Dragons," "The Sims 3," or "World of Warcraft" on for size. So come check out the new game themes (<a href="http://www.google.com/help/ig/gaming/">www.google.com/gamingthemes</a>) and choose your favorite one. If you can't decide, no worries. Just add the <a href="http://www.google.com/ig/directory?type=themes&url=skins/games_sampler.xml" id="wbrp" title="game theme of the day">game theme of the day</a> and enjoy seeing a different one on your iGoogle page every day. Here's a look at the themes in action: <object height="350" width="425"> <param name="movie" value="http://www.youtube.com/v/TzFPOHmrt2Q"> <embed src="http://www.youtube.com/v/TzFPOHmrt2Q" type="application/x-shockwave-flash" height="350" width="425"></embed> </object> Posted by Marissa Mayer, VP of Search Products and User Experience, and Matthew Chan, iGoogle engineer

iGoogle's got game... themes!

I'm happy to announce the launch of iGoogle game themes. These themes offer our users new iGoogle backdrops inspired by their favorite v...

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Google, at your service

It used to be that creating a webpage was a pursuit reserved for the truly tech-savvy, requiring a geek's expertise in HTML, Java, or C++ coding. These days, it's a different story. Working with a <a href="http://en.wikipedia.org/wiki/Web_hosting_service">hosting service</a> has made things a great deal easier, as they can help you reserve a name for your site (www.[insertyournamehere].com), and they often provide tools to help get you set up, with minimal to zero programming experience required. Today, we're releasing <a href="http://www.google.com/webmasters/provider/">Google Services for Websites</a>, a few more tools that your hosting company can now enable to help you improve your website. This expanded program includes Webmaster Tools, AdSense, Custom Search, and Site Search, making it easier to drive traffic to your site, monetize your site through the Google ad network, and add various search capabilities to help your visitors find information on your site faster. <a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgwRgngGtX7sRpHltymHS1zjSD6aIfc0vO8GnTCnNMEUY7MV0zOL5mPsfY5cJ-QZUix0SnACoAzLjKKv0pZM8aRp3lc4ONM-mMJJbPxrdKZ5AE_szhf_HSz8DFqJhbifJVZmHXQXk5NOdTy/s1600-h/Fatcow.png" onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5317258453625747218" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgwRgngGtX7sRpHltymHS1zjSD6aIfc0vO8GnTCnNMEUY7MV0zOL5mPsfY5cJ-QZUix0SnACoAzLjKKv0pZM8aRp3lc4ONM-mMJJbPxrdKZ5AE_szhf_HSz8DFqJhbifJVZmHXQXk5NOdTy/s400/Fatcow.png" style="display:block; margin:0px auto 10px; text-align:center;cursor:pointer; cursor:hand;width: 400px; height: 329px;" /></a> For more information, check out our <a href="http://googleenterprise.blogspot.com/2009/03/google-services-for-websites-expands-to.html">Enterprise Blog</a>, <a href="http://googlewebmastercentral.blogspot.com/2009/03/making-more-tools-available-with-just.html">Webmasters Blog</a> and <a href="http://googlecustomsearch.blogspot.com/2009/03/google-services-for-websites-includes.html">Custom Search Blog</a>. And if your hosting service doesn't have Google Services for Websites yet, send them to <a href="http://www.google.com/webmasters/provider/">this page</a>. We hope you find these new tools helpful. Posted by Rajat Mukherjee, Group Product Manager

Google, at your service

It used to be that creating a webpage was a pursuit reserved for the truly tech-savvy, requiring a geek's expertise in HTML, Java, or C+...

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Google's 2009 EMEA Faculty Summit

Our <a href="http://maps.google.com/maps?q=Brandschenkestrasse+110+8002+Z%C3%BCrich+Switzerland&oe=utf-8&rls=org.mozilla:en-US:official&client=firefox-a&um=1&ie=UTF-8&split=0&gl=us&ei=ZszHSdWIDYKOsQPen6HgBg&sa=X&oi=geocode_result&resnum=1&ct=title">Zurich office</a> was proud to host Google's second annual EMEA (Europe, Middle East, and Africa regions) Faculty Summit last month. Eighty leading academics joined us from 66 universities in 24 countries for this three-day event. The Faculty Summit's purpose is to increase collaboration between key universities and our engineering teams. This year, we organised more than 40 talks and presentations, plus panels, networking and social events to help our guests learn more about Google's work in their regions. In return, Googlers gained valuable insight into challenges faced by the region's universities and new developments in the academic world. Event highlights included a keynote by leading cryptographer and Turing Award winner Adi Shamir on the topic of privacy and security as related to cloud computing. Further discussion centered on topics ranging from the power and limitations of cryptographic technology to usability issues introduced by security requirements, with some debate over the balance between preventing abuse and identifying and reporting abusers. <a href="http://www.google.com/corporate/execs.html#spector">Alfred Spector</a> (VP of Research), Jeff Walz (University Relations) and I spoke about Google's engineering efforts and the impact of our university relations initiatives, with much discussion focusing on our involvement in the Arab and African regions. Rapidly expanding markets in the Middle East and Africa represent a major engineering challenge for us, and we are eager to continue collaboration with leading academic attendees from the region well beyond the Summit. We were pleased to welcome representatives from the Al Arabiya news channel, who highlighted this topic in a recent broadcast. We also heard from Google 'Research Award' and 'CS4HS' (Computer Science for High School) grant recipients and EMEA-based academics spending long-term sabbaticals at Google, who described their experiences over the past year. <a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgloocDo1m14fgSPaeNRYTo-Szsh-F6yokTKe1FmDIrmBc-sAorh0S417luit-NlQNDiEamCOfL5JYj1XyFX1LsHfr1g4mVN6UtmGg8yNoSsbNvINoRVN0BnYWZOeYvxPh4vQGy6MDcYLi8/s1600-h/_mg_6766.jpg" onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5317164078926582530" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgloocDo1m14fgSPaeNRYTo-Szsh-F6yokTKe1FmDIrmBc-sAorh0S417luit-NlQNDiEamCOfL5JYj1XyFX1LsHfr1g4mVN6UtmGg8yNoSsbNvINoRVN0BnYWZOeYvxPh4vQGy6MDcYLi8/s400/_mg_6766.jpg" style="display:block; margin:0px auto 10px; text-align:center;cursor:pointer; cursor:hand;width: 400px; height: 267px;" /></a> This year also saw new additions to the Faculty Summit agenda, including a networking session allowing academics to discuss collaboration options one-on-one with specific Google engineers. This session spurred a great deal of activity — for instance, multiple Googlers are booked to deliver guest lectures at external events and universities and several attendees have been invited to present their findings on research ranging from 'Software Visualisation' to 'Mobile Agile Testing' at Google engineering offices across EMEA. We plan to make these networking sessions a focal point at future Faculty Summits! I'd like to thank the organising team for their help in planning and executing this important event for the second year running. The 2009 EMEA Faculty Summit proved to be an incisive and informative event resulting in new academic and industrial collaborations. We look forward to reporting back on these synergies as they develop over the next year! Posted by Nelson Mattos, VP of Engineering

Google's 2009 EMEA Faculty Summit

Our Zurich office was proud to host Google's second annual EMEA (Europe, Middle East, and Africa regions) Faculty Summit last month. Ei...

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BLOGSCAN - The Mysterious Disappearance of a Report Critical of Industry Funding of CME

On the Carlat Psychiatry Blog, Dr Daniel Carlat <a href="http://carlatpsychiatry.blogspot.com/2009/03/ama-ethics-and-404-not-found.html">discussed</a> the mysterious disappearance of a report by the AMA's Council on Ethical and Judicial Affairs (CEJA) which recommended the end of commercial funding of continuing medical education (CME). The report was tabled, and is now no longer available on the AMA web-site. (Although, it has not completely vanished off the webs. See the comments on Dr Carlat's post.) Meanwhile, the AMA has posted a series of "fact sheets" from their <a href="http://www.ama-assn.org/ama/pub/education-careers/continuing-medical-education/events/national-task-force-cme-provider-industry.shtml">National Task Force on CME Provider/Industry Collaboration</a> which seem notably friendly to "collaboration" among educators and industry.

BLOGSCAN - The Mysterious Disappearance of a Report Critical of Industry Funding of CME

On the Carlat Psychiatry Blog, Dr Daniel Carlat discussed the mysterious disappearance of a report by the AMA's Council on Ethical and ...

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Citizen participation that scales: a call to action

At Google we hold weekly <a href="http://en.wikipedia.org/wiki/Town_hall_meeting">town hall</a>-style meetings with our founders, CEO, and guest speakers, which always feature a Q&A session. Managing Q&A is a unique challenge with an audience of thousands, in offices around the world, who inevitably want to ask more questions than we have time to answer. To help address this challenge, we developed <a href="http://moderator.appspot.com/">Google Moderator</a>, built on <a href="http://code.google.com/appengine/">App Engine</a>. Moderator gives participants a way to submit questions and vote for the ones they want answered. And thanks to the scale that App Engine provides, this application can now support tens of thousands of people at once. This gives everyone the chance to be heard in a way that gives priority to the issues that matter most to the broader group. <a href="http://www.youtube.com/watch?v=hjJm_Hzc6Yg">As you may have heard</a>, the White House is hosting an online town hall meeting on Thursday and has asked people to submit questions for the president and vote on which ones they think he should answer. We think technology can be a force for greater accountability and access between citizens and their elected officials. We're excited that the White House has chosen to use the power of cloud-based applications like Google Moderator and App Engine to scale the president's direct dialogue with the American people. To take part in this experiment in citizen participation, please visit: <a href="http://whitehouse.gov/OpenForQuestions">http://WhiteHouse.gov/OpenForQuestions</a> Posted by Vic Gundotra, Vice President, Engineering

Citizen participation that scales: a call to action

At Google we hold weekly town hall -style meetings with our founders, CEO, and guest speakers, which always feature a Q&A session. Manag...

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Health Care Information Technology Vendors' "Hold Harmless" Clause - The Largest IT Industry Abuse Ever?

Dear fellow physicians, nurses and other clinicians: You thought frivolous medical malpractice suits were a problem? Guess what: It's worse. Along with your patients you are nonconsented beta testers and experimental subjects of the health IT industry, and potential victims of the computer industry's arrogance and dysfunction. In the remarkable article <a href="http://jama.ama-assn.org/cgi/content/extract/301/12/1276">Health Care Information Technology Vendors' "Hold Harmless" Clause - Implications for Patients and Clinicians</a>, Ross Koppel and David Kreda, Journal of the American Medical Association, 2009;301(12):1276-1278, we learn that: <blockquote style="font-family:arial;">Healthcare information technology (HIT) vendors enjoy a contractual and legal structure that renders them virtually liability-free—“held harmless” is the term-of-art—even when their proprietary products may be implicated in adverse events involving patients. This contractual and legal device shifts liability and remedial burdens to physicians, nurses, hospitals, and clinics, even when these HIT users are strictly following vendor instructions...HIT vendors are not responsible for errors their systems introduce in patient treatment because physicians, nurses, pharmacists, and healthcare technicians should be able to identify—and correct—any errors generated by software faults. [Yes - we're all knowing magicians with the power to read minds, infer incorrect lab values via therapeutic touch, and possess encyclopedic knowledge in our heads at all times. This raises the question: if we are that omniscient to be able to identify and correct software faults with 100 percent accuracy to avoid patient harm, then why do we need electronic medical records at all? - ed.] </blockquote> Also see the Univ. of Pennsylvania press release "Why Are Healthcare Information Manufacturers Free of All Liability When Their Products Can Result in Medical Errors?" <a href="http://sev.prnewswire.com/null/20090324/DC8755624032009-1.html">here</a>. In the new Koppel and Kreda JAMA article we also learn that: <blockquote style="font-family:arial;">HIT implementations are massively complex, and are fraught with delays, errors, resistance, work process redesign, frustration, and outright failure. Healthcare facilities cannot predict the myriad scenarios in which software failures could result in patient harm and liability, and they are not likely to be knowledgeable a priori about frequent vendor updates.</blockquote> We additionally learn that: <blockquote style="font-family:arial;">The significant disparity between buyers and sellers in knowledge and resources [about healthcare IT problems] is profound and consequential. Vendors retain company confidential knowledge about designs, faults, software-operations, and glitches. Their counsel have crafted contractual terms that absolve them of liability and other punitive strictures while compelling users’ non-disclosure of their systems’ problematic, or even disastrous, software faults. [This is simply astonishing. In other words, health IT customers and users have a gag order imposed on them regarding software faults and defects, while clinicians -- through their ingenuity, their labor in finding defect workarounds, and their liability -- serve (as I've written) as captive beta testers and an insurance company for HIT vendors - ed.] </blockquote> These observations are nothing short of astonishing. They do help explain, however, the near silence of hospitals and their executives regarding healthcare IT faults, an observation I made in this 2006 AMIA presentation about the scarcity of such information: <blockquote style="font-family:arial;">Access Patterns to a Website on Healthcare IT Failure (<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/failurecases/content/documents/AMIA2006_poster.pdf">Abstract</a> [pdf], <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/failurecases/content/documents/FINAL_Healthcare%20IT%20Failure_Oct_19_2006.ppt">Poster</a> [ppt].)</blockquote> The Joint Commission also made this observation in their Dec. 2008 <a href="http://www.jointcommission.org/SentinelEvents/SentinelEventAlert/sea_42.htm">Sentinel Events Alert on Health IT</a>: <blockquote>There is a dearth of data on the incidence of adverse events directly caused by HIT overall. </blockquote> The new JAMA article may also explain why HIT is so often done so poorly as to present a mission hostile user experience, as I started to write about a decade ago at my healthcare IT difficulties website <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/failurecases/">here</a>, as I outlined in an eight part series starting <a href="http://hcrenewal.blogspot.com/2009/02/are-health-it-designers-idiots-part-1.html">here</a>, as the American College of Physician Executives noted <a href="http://hcrenewal.blogspot.com/2009/03/health-it-industry-out-of-control.html">here</a>, as the National Research Council noted <a href="http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=12572">here</a> ("Current Approaches to US Healthcare IT are Insufficient"), and as many others noted as well: <blockquote style="font-family:arial;">Healthcare IT News (3/10, Merrill) reported, a survey conducted by the American College of Physician Executives found "that although more physician leaders are using healthcare information technology, they still find it clunky and unresponsive to their needs." The survey of 1,000 ACPE members "revealed that the biggest source of frustration is a lack of input from physicians when designing and implementing healthcare information technology systems. Many said involving clinicians at the planning stages would pre-empt many of the problems that crop up later." One respondent noted that "systems are chosen according to administrative criteria rather than what physicians need."</blockquote> Without accountability, a manufacturer is unmotivated to produce quality products at the expense of profits. They become complacent and lazy. This is an excellent reason why major HIT applications are as abhorrent as they are and violate so many fundamental principles of human computer interaction and resilience engineering. It can also explain why talent management within the vendors is biased against hiring medical informatics experts, who would resist intellectual laziness of their non-informatics profit oriented (and unaccountable) counterparts. Koppel and Kreda note that such stipulations defeat patient safety efforts and are contrary to the principles of evidence based medicine. I can add that such stipulations are contrary to the principles of good engineering. These stipulations further instantiate my observation that health IT lacks the rigor of medical science itself, its major Achilles heel. This is one reason why I believe a national HIT initiative at this point in time is going to be, <a href="http://www.publications.parliament.uk/pa/cm200809/cmselect/cmpubacc/153/15304.htm">as in the UK</a>, nothing short of an expensive debacle. The existence of "hold harmless" clauses and gag orders raises many questions: <ul><li>Clinical supervisors of other physicians are indeed practicing medicine. Are Health IT vendors in fact practicing medicine by cybernetic proxy via these IT systems? </li><li>Aren't the vendors' own claims of revolutionary healthcare quality improvements mediated via EMR's, alerts and reminders, clinical decision support, etc., malfunctions of which physicians may be held liable, prima facie evidence that the vendors are in fact practicing medicine by proxy? </li><li>Should not these purveyors of cybernetic (i.e., virtual) medical devices be held accountable for their products, as in the pharmaceutical and the non-cybernetic (i.e., physical) medical device industries? </li><li>How did such a situation regarding critical healthcare devices arise?</li><li>In what other healthcare or other technology intensive industries, if any, do similar conditions exist, and what are the repercussions? </li><li>How long has this situation existed?</li><li>Why is it tolerated by clinicians?</li><li>Why is it tolerated by clinical leaders?</li><li>Why is it tolerated by medical professional societies, such as the AMA, the ACPE, etc., supposedly representing their members' interests?</li><li>Why is it tolerated by hospitals and their executive leadership and boards of directors?</li><li>Why is it tolerated by IS departments in hospitals?</li><li>Why is it tolerated by hospital general counsel?</li><li>Are there possible civil tort/RICO (racketeering)/criminal implications regarding patients injured by defective health IT where defects were known but not disclosed?</li><li>Is not such a protective arrangement prima facie evidence that this technology is indeed experimental, with patients and clinicians as unconsented experimental subjects? </li><li>Why is it tolerated by our government?</li></ul> Regarding the last point, the Obama administration has promised an atmosphere of national accountability and responsibility. Why, then, has it simultaneously employed the coercive force of government (payment penalties for HIT non adopters after the absurdly short period of five years from now, 2014) to push an exploratory medical device from an unaccountable industry of unproven ROI at a cost of tens of billions of dollars on to the medical profession? This reality raises another question as I suggested in my <a href="http://hcrenewal.blogspot.com/2009/02/medinformaticsmd-in-wall-street-journal.html">WSJ Letter to the Editor</a> of February 18, 2009. I wrote: <blockquote style="font-family:arial;">Dear Wall Street Journal: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.</blockquote> In other words, was the administration misled by the health IT industry? I believe it might have been. As an example, Mr. Obama's healthcare IT policy campaign adviser <a href="http://blogs.wsj.com/health/2009/01/26/allscripts-ceo-urges-one-two-punch-on-electronic-medical-records/">per the WSJ</a> Glen Tullman, CEO of HIT vendor AllScripts and Board member of the industry-created government contractor CCHIT ("Certification Commission for Healthcare IT"), probably didn't tell Mr. Obama his company was selling goods that did not function properly. (Here is a link to my organization's <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/DUCOM_EMR_Complaint.pdf">Civil Complaint against AllScripts</a>, PDF). We apparently cannot know how many other organizations had their own complaints that might not have made it into litigation, due to the aforementioned gag orders. (Ironically, I found out about the lawsuit at my own organization only through an anonymous comment at the HIT gossip site <a href="http://histalk.blog-city.com/news_051607.htm">HISTalk</a>.) Incidentally, by matter of pure speculation, I was not permitted involvement in that implementation despite having been a pioneering CMIO at a larger healthcare system years prior and the only formally educated medical informaticist at my organization. My writings on health IT dysfunction were well known to the IT staff and likely the vendor after a short web search; it would have been in the vendors' interests to keep me away from sales and implementation of known deficient health IT. Again, this is simply speculation. On the other hand, I am aware of major healthcare organizations with "portfolios" of hundreds or thousands of issues and defects awaiting remediation, and CMIO's struggling against cavalier bureaucracies who want the doctors even in critical care areas to live with the problems, and vendors who are not in a hurry to fix their products. Some of the problems rise to the level of critical with regard to patient safety. Under contract, the problems cannot be disclosed to the public, to patients whose care might fall under the aegis of these systems, or to other healthcare organizations seeking the same systems. I hope to be a plaintiff's witness when the inevitable lawsuits for patient injury place such capricious vendor, hospital and IT leadership on the witness stand. Finally, in fairness the JAMA article discusses issues beyond the vendors' control such as misuse or poor training done by the host organization using the IT. Possible remedies to the situation of unaccountability for the outcomes of HIT misdesign, malfunction and other defects are outlined in the article. See it or the press release at the above links if you lack JAMA access. As I've written numerous times on this site, due to the implications and especially now due to the revelation that the scarcity of adverse events information related to HIT is probably by design, I favor stringent health IT regulation <a href="http://hcrenewal.blogspot.com/2009/03/lets-deregulate-pharma-information.html">as in pharmaceutical IT</a>. Whatever happens, however, I know this. For the sake of patient safety: <div style="text-align: left;">This sorry, abusive and inexcusable travesty must end ... now. </div> Finally, to health IT vendors, as my early medical mentor, pioneering cardiovascular surgeon and educator Victor P. Satinsky, MD might have said: If you can't take the heat of the responsibilities of clinical medicine, then get out of our kitchen. -- SS

Health Care Information Technology Vendors' "Hold Harmless" Clause - The Largest IT Industry Abuse Ever?

Dear fellow physicians, nurses and other clinicians: You thought frivolous medical malpractice suits were a problem? Guess what: It's wo...

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