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E-Health Hazards: Provider Liability and Electronic Health Record Systems

Sharona Hoffman, Professor of Law and Bioethics and Co-Director of the Law-Medicine Center, Case Western Reserve University School of Law, and Andy Podgurski, Professor of Electrical Engineering and Computer Science at Case Western, had written an important article on HIT that I highlighted in my March 2009 post "<a href="http://hcrenewal.blogspot.com/2009/03/lets-deregulate-pharma-information.html">Let's Deregulate Pharmaceutical Information Technology</a>." In that article, entitled "<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/regulation_and_oversight_hoffman.pdf">Finding a Cure: The Case for Regulation And Oversight of Electronic Health Records Systems"</a>, Harvard Journal of Law & Technology 2008 vol. 22, No. 1, they called for premarketing and postmarketing surveillance of healthcare IT, adverse events reporting, and tight regulation as in the medical device and pharmaceutical industries. They summarized and amplified their views in the short piece "<a href="http://www.thehastingscenter.org/Bioethicsforum/Post.aspx?id=3284#">Why Electronic Health Record Systems Require Safety Regulation</a>", Bioethics Forum, March 20, 2009. In a remarkable new followup article entitled "E-Health Hazards: Provider Liability and Electronic Health Record Systems" <a href="http://works.bepress.com/sharona_hoffman/7/" style="font-weight: bold;">available here</a>, they expand their case in a highly organized and extremely well documented piece. The abstract is as follows: <blockquote style="font-family:arial;">In the foreseeable future, electronic health record (EHR) systems are likely to become a fixture in medical settings. The potential benefits of computerization could be substantial, but EHR systems also give rise to new liability risks for health care providers that have received little attention in the legal literature. This Article features a first of its kind, comprehensive analysis of the liability risks associated with use of this complex and important technology. In addition, it develops recommendations to address these liability concerns. Appropriate measures include federal regulations designed to ensure the quality and safety of EHR systems along with agency guidance and well crafted clinical practice guidelines for EHR system users. In formulating its recommendations, the Article proposes a novel, uniform process for developing authoritative clinical practice guidelines and explores how EHR technology itself can enable experts to gather evidence of best practices. The authors argue that without thoughtful interventions and sound guidance from government and medical organizations, this promising technology may encumber rather than support clinicians and may hinder rather than promote health outcome improvements. </blockquote> They point out that: <blockquote style="font-family:arial;">EHR systems can facilitate access to patients’ medical records, improve the quality of care and the accuracy of treatment decisions, achieve cost savings, and promote clinical research. Without discounting any of these potential benefits, this article focuses on the risks of EHR systems and on liability concerns associated with their use ... The liability risks of EHR systems have received little attention in the legal literature. This new technology may bring with it novel responsibilities, burdens, and complexities for medical practices at the same time that it can potentially enhance health outcomes. </blockquote> The liability risks are not just to hospitals, but to EHR users of all stripes. They find current efforts at HIT "certification" severely lacking in usefulness, and strongly support federal regulation of health IT due to the risks and dangers involved. The authors are opposed to vendor "hold harmless" and "defects nondisclosure" clauses, and have included in their article many well thought out solutions to the double-edged sword that HIT represents. In summary, though, they believe that: <blockquote style="font-family:arial;">EHR systems cannot remain unregulated and largely unscrutinized. It is only with appropriate interventions that they will become a much-hoped for blessing rather than a curse for health care professionals and patients.<o:p></o:p> </blockquote> Download the article <a href="http://works.bepress.com/context/sharona_hoffman/article/1006/type/native/viewcontent">at this link</a>. Read the whole thing. I am in strong agreement with their positions. The unregulated free-for-all that has been the health IT marketplace, with dangerous and even <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/failurecases/?loc=cases&sloc=clinical%20computing%20problems%20in%20ICU">outrageous practices</a> I noted starting a decade ago, must come to an end as the market matures and as diffusion of this technology massively increases per the government mandates now in effect. The rationalizations for problems, the excuses for defects and the starry eyed utopian exuberance about this technology (not to mention the conflict-of-interest and/or <a href="http://www.washingtonpost.com/wp-dyn/content/article/2009/05/15/AR2009051503667.html?hpid=topnews">HIT lobby</a>-driven irrational exuberance) must come to an end. -- SS

E-Health Hazards: Provider Liability and Electronic Health Record Systems

Sharona Hoffman, Professor of Law and Bioethics and Co-Director of the Law-Medicine Center, Case Western Reserve University School of Law, a...

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Cannot Get Away From Medical Information Errors, Continued

In "<a href="http://hcrenewal.blogspot.com/2007/10/this-informaticist-cant-escape-clinical.html">This informaticist can't escape clinical IT issues even on personal business</a>", I observed that I encountered HIT informational issues even in my own family matters, when least expecting them. I've had a few incidents since then, generally each time I've taken relatives to the hospital as a medical advocate. It seems every time I step into a hospital as a medical advocate such issues arise, whether they be complaints from staff about IT, my mother being prescribed an IV antibiotic in the ED that an hour before I'd told the intake nurse she was severely allergic to, that fact being dutifully entered into the EHR - or as in the case below, outright errors regarding surgical procedures. Either medical information errors follow me around, or they are more common than I realize, because I just spent a few days as a medical advocate for a very long and dear friend. She had a suspicious thyroid nodule found at the time of exam for excision of a small breast carcinoma. She was set to have a thyroidectomy at a major NYC hospital with relatively advanced HIT capabilities and large endowments from very wealthy contributors, whose paintings hang in the lobbies (and where some high level informatics professionals are involved in clinical IT projects). When I arrived the evening prior to surgery, my friend showed me her pre-op instructions. They were printed out in a neat and organized fashion, and she'd shown me the calcium supplements she'd purchased as the instructions advised. "Calcium supplements?", I asked... The computer form, properly labeled with her name and ID and the name of the nurse practitioner she'd seen for preop evaluation, was quite improperly entitled "Preoperative instructions to patients undergoing parathyroidectomy." First thing I did in the morning was insist on seeing the surgeon in person. I wanted zero chance for error. Fortunately, the surgeon was familiar with her case and knew this was an error. Suppose, however, the surgeon was not so knowledgeable about the patient, or unavailable, or called away for some emergency and someone else filling in? I do not know if the error was simple human error by the NP or someone prior who'd performed data entry, a wrong selection due to a mission hostile user interface in the setting of overwork, a computer error due to some cross-link between (to non biomedical personnel) two similar-sounding terms - parathyroid vs. thyroid - or some other cause. Needless to say, if this error had resulted in an unnecessary and injurious parathyroidectomy and necessity for followup thyroidectomy on a postoperative area, and had been as a result of IT problems either totally or partially , it is likely the vendor would have been "held harmless" and the defect nondisclosed to other organizations. (Anecdotally, on going to the bathroom, I also noted a group of residents on rounds energetically discussing what "template" was the correct one in which to enter patient data of some type. When I rounded years ago, I remember discussing medical issues...) While I agree the likelihood of major IT contribution to this error was low, this was a reminder of just how problematic healthcare quality can be, even with advanced IT. I think the solution is not to see IT as a panacea, and maintain adequate human involvement (with humans not overburdened feeding the bureaucratic machine) in safety issues. -- SS

Cannot Get Away From Medical Information Errors, Continued

In " This informaticist can't escape clinical IT issues even on personal business ", I observed that I encountered HIT informa...

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On Optimal Expertise for Leadership in Biomedicine

There has recently been debate on these pages regarding optimal expertise for biomedical leadership, precipitated by Roy Poses' posts "<a href="http://hcrenewal.blogspot.com/2009/08/health-care-leaders-dont-know-much.html">Health Care Leaders: Don't Know Much About Health Care</a>" and "<a href="http://hcrenewal.blogspot.com/2009/08/ny-times-proclaims-anyone-can-run.html">NY Times Proclaims Anyone Can Run a Health Care Organization with a Little Studying Up</a>". I am resurfacing a post I wrote in Jan. 2009 entitled "<a href="http://hcrenewal.blogspot.com/2009/01/pfizerwyeth-merger-and-sacrificing.html" rel="nofollow">Pfizer/Wyeth Merger And Sacrificing The Future: Laying Off Scientific Staff All Over The Place</a>" that I believe succinctly states the problems with 'management by amateur.' Read the entire post, but here are the highlights: <blockquote>... Those in charge [and who lack domain credentials -ed.] cannot see that which the domain specialist sees. They cannot see because they lack the training, experience, and what is described as 'meta-competence' (in <a href="http://gagne.homedns.org/%7Etgagne/contrib/unskilled.html">this brilliant article</a> on competence [the Dunning-Kruger effect - ed.]) essential to seeing that which is obvious. Obvious, that is, to those who do not lack these characteristics. In addition, I've also observed that some lack the fundamental analytical abilities essential to understanding and managing the complexities of biomedical R&D. Why those without domain expertise are in charge of organizations whose long term viability depends entirely on the most advanced and creative pursuit of biomedical 'miracles' is another matter. I won't address this here, other than saying it reflects the adverse consequences of a bias that has evolved in management "science." That bias is the belief that all the world consists of faceless labor resources performing easily definable processes upon interchangeable widgets, and that management can therefore be done by generic managers, exclusively. Some of the world is like that [i.e., fast food chains - ed.], but some isn't, such as biomedical R&D. [And clinical medicine as well - ed.] <div style="text-align: left;">Management in the absence of domain expertise in this industry is, in fact, mismanagement. </div> There is nothing here to spin, there is nothing to debate. There is nothing to discuss. This is a first principle. Failure to accept this reality results in corporate failure. </blockquote>Those who believe otherwise are engaging in magical thinking. Further, those without biomedical domain knowledge who disagree should be prepared to discuss how their lack of domain knowledge might affect their insights and opinions on such complex matters, compared to those with both domain knowledge and leadership experience. A question is this: based on the same Western traditions of inquiry and <a href="http://freeinquiry.com/critical-thinking.html">critical thinking</a> that led to modern biomedical science and its accomplishments, whose opinion is likely to be more valid? -- SS

On Optimal Expertise for Leadership in Biomedicine

There has recently been debate on these pages regarding optimal expertise for biomedical leadership, precipitated by Roy Poses' posts ...

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Translate documents: sharing across languages and generations

My cousin is in first grade and sometimes she writes short stories for class. I try to share the stories with her grandparents, but because Japanese is their first language and they don't speak English very well, it's been tough. Today we're releasing a feature for <a href="http://docs.google.com/">Google Docs</a> to make this kind of multi-lingual sharing easier — you can now automatically translate documents into <a href="http://www.google.com/intl/en/help/faq_translation.html#langpairs">42 different languages</a>. So for my cousin's latest story, I helped her type it up in Google Docs and then clicked "Translate document" from the "Tools" menu. In a matter of seconds, Google Docs has translated the whole story into Japanese using <a href="http://www.google.com/intl/en/help/faq_translation.html#whatis">Google Translate's technology</a>. <a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhg4rtLsTAkQtZHNjN83EKUeFsJQXH6YZbW0r2jFYaTPaZlf5gDxv4e7_hrDAnrgmX2oN2ECT4niIme0MvTJptV51JOihofOs91vcM8Bljy5NwlTluyjcsHTYUqxam6pPLR5vUDJRynd0Af/s1600-h/docs1.png" onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5374671815542712786" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhg4rtLsTAkQtZHNjN83EKUeFsJQXH6YZbW0r2jFYaTPaZlf5gDxv4e7_hrDAnrgmX2oN2ECT4niIme0MvTJptV51JOihofOs91vcM8Bljy5NwlTluyjcsHTYUqxam6pPLR5vUDJRynd0Af/s400/docs1.png" style="margin: 0px auto 10px; display: block; text-align: center; cursor: pointer; width: 400px; height: 267px;" /></a> <a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhPoFdWhrACGTQwW6rE-Y6VTH-ScNvG6Gd8sWFRb-wdsoSOt-XcLN0QD0e53HBYJ0wSfktfwrFYsXlvPfvUeU0_88v5vi01-VSNHyyCEi8WrV2z5wGF77LmMSrPW4n9vkApKyMGciDoF_Ai/s1600-h/docs2.png" onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5374672032057769922" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhPoFdWhrACGTQwW6rE-Y6VTH-ScNvG6Gd8sWFRb-wdsoSOt-XcLN0QD0e53HBYJ0wSfktfwrFYsXlvPfvUeU0_88v5vi01-VSNHyyCEi8WrV2z5wGF77LmMSrPW4n9vkApKyMGciDoF_Ai/s400/docs2.png" style="margin: 0px auto 10px; display: block; text-align: center; cursor: pointer; width: 400px; height: 270px;" /></a> You can replace the original document with the translation or make a new translated version. I like keeping an English version for friends here and creating a separate Japanese version for her grandparents. All the formatting and layout is preserved no matter what language it's in — translations aren't perfect, but we are continuously working on improving translation quality over time. We hope this new feature helps you more easily share information without worrying about language barriers. Posted by Rita Chen, Associate Product Manager Intern, Google Docs

Translate documents: sharing across languages and generations

My cousin is in first grade and sometimes she writes short stories for class. I try to share the stories with her grandparents, but because ...

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Cross-occupational invasion of medicine by IT, exemplified

I have written on these pages about a cross-occupational invasion of medicine by IT personnel, wherein the IT personnel seem to forget that they are facilitators of healthcare, not enablers, with a primary purpose of serving the needs of clinicians.<div> </div><div>The <a href="http://www.histalk.com/">HISTalk</a> site recently posted an attorney's views on the "hold harmless" and "defects nondisclosure" controversy <a href="http://jama.ama-assn.org/cgi/content/extract/301/12/1276">first reported on by Koppel and Kreda</a> in JAMA, and amplified in my <a href="http://hcrenewal.blogspot.com/2009/07/health-care-information-technology.html">letter to the editor</a> in the same publication. The attorney's views at HISTalk (link below) are quite reasonable regarding such practices.</div><div> </div><div>However, the user comments thread reveals some attitudes exemplifying the "invasion" of which I've written. Both the attorney's post and the responses by a poster under the nom-de-blog "Programmer" to others' concerns can be read <a href="http://histalk2.com/2009/08/24/hitlaw-82409/">at this link</a>.</div><div> </div><div>Read it all. The attitudes of "Programmer" (assuming they are genuine, which is likely) are remarkable.</div><div> </div><div>-- SS </div>

Cross-occupational invasion of medicine by IT, exemplified

I have written on these pages about a cross-occupational invasion of medicine by IT personnel, wherein the IT personnel seem to forget that ...

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Five years of introducing students to open source

<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjiNBefv5FOOWCcB3oCsVMdrya1YtaF2TyRmOEIwgWaC6dvDYoz-ltMKqiLiyZaJKCs88EO8EBqGTPSUFYbycNNLnNDlsuYdkNpEKLTr5UHXq6nm2rAVELvXQwXgYSvfkEPcNBMhNdRMtpm/s1600-h/GSOCLogo2009.png" onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5374350768142386402" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjiNBefv5FOOWCcB3oCsVMdrya1YtaF2TyRmOEIwgWaC6dvDYoz-ltMKqiLiyZaJKCs88EO8EBqGTPSUFYbycNNLnNDlsuYdkNpEKLTr5UHXq6nm2rAVELvXQwXgYSvfkEPcNBMhNdRMtpm/s320/GSOCLogo2009.png" style="margin: 0pt 0pt 10px 10px; float: right; cursor: pointer; width: 320px; height: 214px;" /></a>We've just concluded our fifth <a href="http://code.google.com/soc/">Google Summer of Code</a>, our <a href="http://googleblog.blogspot.com/2009/03/supporting-students-in-open-source.html">flagship global program</a> to introduce college and university students to open source development. Once again, the results this year have been impressive. Nearly 2,000 mentors from 64 countries participated in the program. They worked to bring 1,000 students from 69 countries into the communities of <a href="http://socghop.appspot.com/program/accepted_orgs/google/gsoc2009">150 free and open source projects</a>. We're particularly excited this year to have introduced several students to open source development that has a direct impact on social causes, from <a href="http://socghop.appspot.com/org/home/google/gsoc2009/mifos">microfinance software</a> to <a href="http://socghop.appspot.com/org/home/google/gsoc2009/sugarlabs">global educational initiatives</a> to <a href="http://socghop.appspot.com/org/home/google/gsoc2009/sunlight">making government data more transparent and accessible</a>. Three months and hundreds of thousands of lines of code later, 85 percent of our student participants have successfully completed their projects. We'll be publishing more extensive program statistics and wrap up reports in the coming weeks on the <a href="http://google-opensource.blogspot.com/">Google Open Source Blog</a>, so stay tuned there for more news about Google Summer of Code. We'd like to congratulate all of our student participants for their hard work and tremendous achievements this summer. We're excited to hear that many of our students have planned out the next few months of their coding work with their chosen open source project. Finally, our sincerest thanks to all of our mentors for volunteering their time and expertise to help these students more actively engage with open source development. <a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjL033tQbAwIUwnaaqHP1SPoq07cHjn9TPUJqrk4O_fUsfFqK-yd1K_Xjijvq1KMIgwsfcX3czt5WXnuii4VzWjaF6TlxC5Lm7G0HVE5vPutWlj5qXNGILu-Wgn9RWKEUkZyb8TQXp1TRtz/s1600-h/soc.jpg" onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5374350985593503762" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjL033tQbAwIUwnaaqHP1SPoq07cHjn9TPUJqrk4O_fUsfFqK-yd1K_Xjijvq1KMIgwsfcX3czt5WXnuii4VzWjaF6TlxC5Lm7G0HVE5vPutWlj5qXNGILu-Wgn9RWKEUkZyb8TQXp1TRtz/s400/soc.jpg" style="margin: 0px auto 10px; display: block; text-align: center; cursor: pointer; width: 400px; height: 300px;" /></a> Posted by Leslie Hawthorn, Program Manager, Open Source Team

Five years of introducing students to open source

We've just concluded our fifth Google Summer of Code , our flagship global program to introduce college and university students to open...

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More books in more places: public domain EPUB downloads on Google Books

Try doing a search for [<a href="http://books.google.com/books?q=hamlet&btnG=Search+Books">Hamlet</a>] on Google Books. The first few results you'll get are "Full View" books — which means you can read the full text. And, because the book is in the public domain, you can also download a copy of <a href="http://books.google.com/books?id=VBoVAAAAYAAJ&printsec=frontcover&dq=hamlet&ei=bFOVSpTIAojMlQSP95WcBw#v=onepage&q=&f=false">Hamlet</a> in PDF form. Starting today, you'll be able to download these and over one million public domain books from <a href="http://books.google.com/">Google Books</a> in an additional format. We're excited to now offer downloads in EPUB format, a free and open industry standard for electronic books. It's supported by a wide variety of applications, so once you download a book, you'll be able to read it on any device or through any reading application that supports the format. That means that people will be able to access public domain works that we've digitized from libraries around the world in more ways, including some that haven't even been built or imagined yet. We founded Google Books on the premise that anyone, anywhere, anytime should have the tools to explore the great works of history and culture. We began digitizing these books because we thought it was important for people to be able to find and read them, and we want them to be able to do so anywhere — not just when they happen to be at a computer. This feature takes us one step closer towards realizing that goal by helping support open standards that enable people to access these books in more places, on more devices and through more applications. To find out more, check out our post on the <a href="http://booksearch.blogspot.com/2009/08/download-over-million-public-domain.html">Google Books blog</a>. Posted by Brandon Badger, Product Manager

More books in more places: public domain EPUB downloads on Google Books

Try doing a search for [ Hamlet ] on Google Books. The first few results you'll get are "Full View" books — which means you ca...

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