healthy4u: ECRI Deep Dive Study

Forbes contributor Nicole Fisher, claimed proponent of healthcare human rights, writes long article on EHRs that neglects to mention patient harm

The field of health IT lives a charmed life. Even self-stated human rights advocates in healthcare won't seem to broach the topic of EHR-related harms and lack of informed consent processes regarding their use in a patient's care, even when authors openly state their concerns for patient and human rights. This is despite known harms at potentially alarming levels as indicated by organizations including the IOM, FDA, ECRI Institute, AHRQ, Harvard Med Mal insurer CRICO, The Joint Commission, NHS in the UK, and others. Forbes contributor Nicole Fisher (<a href="http://www.forbes.com/sites/nicolefisher/">http://www.forbes.com/sites/nicolefisher/</a>) published an article in Forbes dated 3/18/2014 and entitled "Electronic Health Records - Expensive, Disruptive And Here To Stay" (<a href="http://www.forbes.com/sites/nicolefisher/2014/03/18/electronic-health-records-expensive-disruptive-and-here-to-stay/">http://www.forbes.com/sites/nicolefisher/2014/03/18/electronic-health-records-expensive-disruptive-and-here-to-stay/</a>). You can read the article at the above link.  It focuses on physician distraction and dissatisfaction, poor usability and usefulness, expense, and related issues.  Of course, quotes from HHS figure prominently. Nowhere, however, is mention of EHR-related harms to patients, such as reported by the aforementioned organizations mentioned - as in this very small sample list of posts, which contain links to source: <blockquote class="tr_bq">Patient Safety & Quality Healthcare: "CRICO Malpractice Claims Analysis Confirms Risks in EHRs" <a href="http://hcrenewal.blogspot.com/2014/02/patient-safety-quality-healthcare.html">hcrenewal.blogspot.com/2014/02/patient-safety-quality-healthcare.html</a> Peering Underneath the Iceberg's Water Level: ECRI "Deep Dive" Study of Health IT "Events" <a href="http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html">http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html</a> Internal FDA memorandum on HIT risks <a href="http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html">http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html</a> IOM Report - "Health IT and Patient Safety: Building Safer Systems for Better Care" <a href="http://hcrenewal.blogspot.com/2011/11/iom-report-on-health-it-safety-nix-fda.html">http://hcrenewal.blogspot.com/2011/11/iom-report-on-health-it-safety-nix-fda.html</a> EHRs and Deadly glitches <a href="http://hcrenewal.blogspot.com/search/label/glitch">http://hcrenewal.blogspot.com/search/label/glitch</a> (multiple posts) Not to forget issues of breach of privacy:  <a href="http://hcrenewal.blogspot.com/search/label/medical%20record%20privacy">http://hcrenewal.blogspot.com/search/label/medical%20record%20privacy</a> (multiple posts)</blockquote> Nor are mentioned the issues of the experimental, unregulated nature of this technology, and the lack of any informed consent process regarding patient's rights to decide whether or not to have these systems used in their care. The only mention of "unintended consequences" links to "<a href="http://www.emrandhipaa.com/guest/2014/03/11/unintended-icd-10-consequences-inadequate-clinical-documentation-can-negatively-impact-physician-profiles-icd-10-tuesdays/">Unintended ICD-10 Consequences: Inadequate Clinical Documentation Can Negatively Impact Physician Profiles</a>." This is in my view disappointing, and seems to be yet another extraordinary healthcare IT industry accommodation, remarkable for an author with the following bio (emphases mine): <blockquote class="tr_bq"><a href="http://www.forbes.com/sites/nicolefisher/">http://www.forbes.com/sites/nicolefisher/</a> Nicole Fisher is the Founder and Principal at HHR Strategies, a health care and human rights focused advising firm. Additionally, she is a Senior Policy Advisor and health policy expert on health economic analyses mainly focusing on Medicare, Medicaid and health reform, specifically as they impact women and children. Nicole runs a Health Innovation and Policy page at Forbes.com highlighting and advising companies, ideas and people that are changing the health care landscape. She is also currently pursuing her PhD at the University of North Carolina in the Health Policy and Management Department. Her writing has appeared in other publications such as Health Affairs, Wall Street Journal, Washington Post, Centers for Medicare & Medicaid Services Journal, Wright on Health, The Health Care Blog and Health Services Research. Before pursuing her PhD in health policy, Nicole earned her Master’s degree in Public Policy from the University of Chicago and her undergraduate degree from the University of Missouri. Her health care and policy work at those institutions had an emphasis on underserved populations, women's and children’s issues. She presides on several Boards for domestic and international health organizations and frequently speaks on health reform and human rights.</blockquote> One might conclude the computer has more rights than the patient and the clinician via this Forbes piece. Finally, although I am a domain specialist (<a href="http://www.kaiserhealthnews.org/stories/2013/february/18/scot-silverstein-health-information-technology.aspx">http://www.kaiserhealthnews.org/stories/2013/february/18/scot-silverstein-health-information-technology.aspx</a>), I am getting rather tired of having to point out the obvious to major media outlets and writers, in essence doing their homework for them.  I'm sure other bloggers feel the same way.  The title of the Forbes piece should have been "Electronic Health Records - Expensive, Disruptive, Deadly." To the author of the Forbes piece and other HIT writers, here is the face (and gravestone) of someone injured by this "disruptive" technology.   <a href="http://hcrenewal.blogspot.com/2011/06/my-mother-passed-away.html">http://hcrenewal.blogspot.com/2011/06/my-mother-passed-away.html</a> A few babies too:  <a href="http://hcrenewal.blogspot.com/2011/06/babys-death-spotlights-safety-risks.html">http://hcrenewal.blogspot.com/2011/06/babys-death-spotlights-safety-risks.html</a> A family man:  <a href="http://hcrenewal.blogspot.com/2011/09/sweet-death-that-wasnt-very-sweet-how_24.html">http://hcrenewal.blogspot.com/2011/09/sweet-death-that-wasnt-very-sweet-how_24.html</a> I know of others from my legal work supporting the EHR-related injured and deceased that I cannot mention.  And I am but one person. If health IT were causing rapes** and child abuse, rather then merely causing mundane severe injuries and equally mundane deaths, would the media would pay more attention? -- SS ** I sadly note that EHR's without proper security measures in force actually did enable rape-like behavior in 2011, as at "EHR as Molestation Candidate Selector: What was this Resident looking for in the EHR before 'examining' female patients?" at <a href="http://hcrenewal.blogspot.com/2011/02/what-was-this-medical-resident-looking.html">http://hcrenewal.blogspot.com/2011/02/what-was-this-medical-resident-looking.html</a>.

Forbes contributor Nicole Fisher, claimed proponent of healthcare human rights, writes long article on EHRs that neglects to mention patient harm

The field of health IT lives a charmed life. Even self-stated human rights advocates in healthcare won't seem to broach the topic of EHR...

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Five Years Into Compelled National Adoption of Electronic Medical Records, Which Were Advertised As Capable Of Only Good, ONC Issues Safety "Suggestions"

Ten years after creation of the ONC office, and almost five years into compelled national adoption of health IT under HITECH (financial penalties soon start to accrue for non-users or non-adopters of "certified" systems and in at least one state, denial of medical licensure), the HHS's Office of the National Coordinator for health IT released the cutely-named "SAFER" guides ("Safety Assurance Factors for EHR Resilience"). That's progress.  (A previous ONC leader, for instance, had opined that the FDA’s injury findings related to health IT that appeared in the <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/Internal-FDA-Report-on-Adverse-Events-Involving-Health-Information-IT.pdf">Internal FDA memorandum on HIT risks</a> were merely “anecdotal and fragmentary”;  see my April 2, 2011 post "Making a Stat Less Significant: Common Sense on 'Side Effects' Lacking in Healthcare IT Sector" at <a href="http://hcrenewal.blogspot.com/2011/04/common-sense-on-side-effects-lacking-in.html">http://hcrenewal.blogspot.com/2011/04/common-sense-on-side-effects-lacking-in.html</a>.) While these Guides are a welcome first step, I observe: These Guides are really an admission HHS and the pundits have been pushing a technology, at best, of an unknown safety profile onto medicine and onto the public.  (The harm profile is becoming better understood, e.g., see the ECRI Institute Deep Dive Study on health IT risk at <a href="http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html">http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html</a>, a study not just remarkable for its results but also for its strange regulator and press invisibility).  I guess that's par for the course in today's world. I also opine these guides would not have appeared at all, if not for grass-roots efforts in exposing health IT dangers over the years. That said, more on the guides, and a link to them: <blockquote class="tr_bq"><a href="http://www.healthit.gov/policy-researchers-implementers/safer">http://www.healthit.gov/policy-researchers-implementers/safer</a> SAFER Guides The SAFER guides consist of nine guides organized into three broad groups. These guides enable healthcare organizations to address EHR safety in a variety of areas. Most organizations will want to start with the Foundational Guides, and proceed from there to address their areas of greatest interest or concern. The guides identify recommended practices to optimize the safety and safe use of EHRs. The content of the guides can be explored here, at the links below, or interactive PDF versions of the guides can be downloaded and completed locally for self-assessment of an organization’s degree of conformance to the Recommended Practices. The downloaded guides can be filled out, saved, and transmitted between team members.</blockquote> The overall purpose: <blockquote class="tr_bq">This guide is designed to help safely manage the individual and organizational responsibilities in a complex "sociotechnical" healthcare organization. </blockquote> (I note that "sociotechnical" is not really a decriptor of an organization; rather, it is a descriptor of inter-related issues in a healthcare organization.  More properly, a healthcare organization is an entity where implementation of health IT requires "consideration of many sociotechnical issues", or, "is an organization that is sociotechnically complex".  I also note a somewhat loose use of the scientific term "Informatics" in the guides, e.g., "Informatics-type department."  But, whatever.  When a word is used in healthcare today, it means, paraphrasing what a character in a Lewis Carroll book said to a woman named Alice, just what the healthcare leadership chooses it to mean - neither more nor less. (The irony is that Medical Informatics is a field that has as one of its major core competencies the defining of precise language and definitions.) Read the Guides at the above link, but these "guides" are really a set of "Health IT 101", Masters-of-the-Obvious rules of thumb, presented in a "sparse display" format. For instance: <ul><li>The highest-level decision makers (e.g., boards of directors or owners of physician practices) are committed to promoting a culture of safety that incorporates the safety and safe use of EHRs.</li></ul><ul><li>An effective decision-making structure exists for managing and optimizing the safety and safe use of the EHR.</li></ul><ul><li>Staff members are assigned responsibility for the management of clinical decision support (CDS) content.</li></ul><ul><li>Practicing clinicians are involved in all levels of EHR safety-related decision making that impact clinical use.</li></ul> I won't display them further. While this is not an unwelcome development, here are the caveats: 1.  Disclaimer on page 1 of "Organizational Responsibilities" document: <blockquote class="tr_bq">In some instances, Meaningful Use and/or HIPAA Security Rule requirements are identified in connection with recommended practices. The SAFER Guides are not intended to be used for legal compliance purposes, and implementation of a recommended practice does not guarantee compliance with Meaningful Use, HIPAA, or other laws. The SAFER Guides are for informational purposes only and are not intended to be an exhaustive or definitive source. They do not constitute legal advice or offer recommendations based on a healthcare provider’s specific circumstances. Users of the SAFER Guides are encouraged to consult with their own legal counsel with regard to compliance with Meaningful Use, HIPAA, and other laws.</blockquote> "For informational purposes only?" Wow.  I feel SAFER already ... (too late for my mother, though). <table cellpadding="0" class="Bs nH iY" role="presentation"><tbody><tr><td class="Bu">Who is going to evaluate whether hospitals are carrying out these recommendations properly?    Joint Commission?  FDA?  As it appears now, the answer is ... nobody.  </td></tr></tbody></table> In effect, these "guidelines" are issued for "self-assessment" in a regulatory vacuum, with no validation of compliance, no reporting requirements, no formal surveillance, etc.  Hiring the right people, doing all these things, and doing them effectively, is not cheap. Translation: these guidelines are safely ignored, to be put on a shelf somewhere. 2.  The focus of these documents seems to put the responsibility for health IT safety on the customer/user.  Problem is, the ability to compensate for the deficits of fundamentally poorly designed and bad health IT is limited, just as a "safe flying practices" manuals for pilots cannot compensate completely for faulty aircraft design.  Especially if the manuals are for "self assessment" and there is no FAA-mandated oversight, testing and operational surveillance ... 3.  Thus, these guides appear to be a "baby step" in the true sense of the word, and "tension management" in the political sense, a term used by my claimed-Communist sociology professor several decades ago to refer to government actions that made it appear, falsely, that the government was truly "doing something" for the people.  While I am certainly not a Communist, he had a point... <div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjWSGFFdv9UG9AMt1HpcQpSULolTX-pATxEc9hW4tQJiNySMgmh3P8MjLvCnvrqc2bXIClwbKrJs4_UHUN_mFdTJps6bwhtffM3I2Ftgl4xzfTyfFlIUNWR5o3uwlnTApItIDurTvsb3mJT/s1600/caspar.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="200" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjWSGFFdv9UG9AMt1HpcQpSULolTX-pATxEc9hW4tQJiNySMgmh3P8MjLvCnvrqc2bXIClwbKrJs4_UHUN_mFdTJps6bwhtffM3I2Ftgl4xzfTyfFlIUNWR5o3uwlnTApItIDurTvsb3mJT/s1600/caspar.jpg" width="145" /></a></div> In summary, while welcome, at best a "milk and toast" award needs to be given to HHS and its health IT arm, ONC for these guidelines. -- SS

Five Years Into Compelled National Adoption of Electronic Medical Records, Which Were Advertised As Capable Of Only Good, ONC Issues Safety "Suggestions"

Ten years after creation of the ONC office, and almost five years into compelled national adoption of health IT under HITECH (financial pena...

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"We’ve resolved 6,036 issues and have 3,517 open issues": Extolling EPIC EHR Virtues at University of Arizona Health System

The public may believe that, in healthcare, only the Obamacare insurance exchange website has lots of bugs.  On those, see my Oct. 10. 2013 post "Drudge Report, Oct. 10, 2013, 9 AM EST: All that needs to be said about government, computing and healthcare" at <a href="http://hcrenewal.blogspot.com/2013/10/drudge-report-oct-10-2013-9-am-est-all.html">http://hcrenewal.blogspot.com/2013/10/drudge-report-oct-10-2013-9-am-est-all.html</a>. Another pillar of the Affordable Care Act, electronic medical records (promoted with incentives for adopters and with penalties for non-adopters via the HITECH section of the 2009 economic recovery act or ARRA) are pretty damn bad themselves.  Only, those systems don't make it hard to find insurance.  Through bugs and other features of bad health IT, they directly interfere with safety and provision of quality care: <blockquote class="tr_bq">Bad Health IT ("BHIT") is ill-suited to purpose, hard to use, unreliable, loses data or provides incorrect data, is difficult and/or prohibitively expensive to customize to the needs of different medical specialists and subspecialists, 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.  </blockquote> At my Oct. 20, 2010 post "Medical center has more than 6000 'issues' with Cerner CPOE system in four months - has patient harm resulted?" (<a href="http://hcrenewal.blogspot.com/2010/10/medical-center-has-more-than-6000.html">http://hcrenewal.blogspot.com/2010/10/medical-center-has-more-than-6000.html</a>) I observed: <blockquote class="tr_bq">From the October 2010 "News for Physicians affiliated with Munson Medical Center" newsletter, a large medical center in Northern Michigan, about more than six thousand "issues" with their Cerner CPOE. ... One wonders how many of those 6,000, and how many of the 600 remaining "issues" <a href="http://hcrenewal.blogspot.com/2009/03/draft-patient-rights-statement-and.html">fall into categories of</a> "likely to cause patient harm in short term if uncorrected" or "may cause in patient harm in medium or long term." I note that Cerner CPOE is not a new product, nor are similar products from other vendors also afflicted with long lists of "issues." That there could be more than 6,000 "issues" at a new site suggests deep rooted, severe problems with CPOE specifically and health IT design and implementation processes in general. </blockquote> Here's another such multi-"issue"-laden EHR, this at University of Arizona Health Network.  Image of frequent periodic "EHR Update" below. <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/AVvXsEhgZkzPXU8Sfpv_3NWc4TPK2B79BvEEnxLU1_Y6OAXuVdcPoJYfHmde-XQXkeW7gO1iLUDVxRtzTpO7be0qDVU4nCD88O45plTy_9168SBdVJ2EiVBb9yChYToK_5OQJfDRSOyh6NF-HqUv/s1600/U_Az2.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhgZkzPXU8Sfpv_3NWc4TPK2B79BvEEnxLU1_Y6OAXuVdcPoJYfHmde-XQXkeW7gO1iLUDVxRtzTpO7be0qDVU4nCD88O45plTy_9168SBdVJ2EiVBb9yChYToK_5OQJfDRSOyh6NF-HqUv/s1600/U_Az2.jpg" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">"We’ve resolved 6,036 issues and have 3,517 open issues."</td></tr></tbody></table><div class="separator" style="clear: both; text-align: center;"></div> [Ignore the 'kewl dark sunglasses' worn by the hipsters at the top of this announcement.  Not sure if this has something to do with EPIC, but I consider the wearing of dark sunglasses by clinicians or any other staff in a hospital setting - where people are sick and/or dying - to be in exceptionally bad taste.] The text starts: <blockquote class="tr_bq">ISSUES UPDATE as of 4:00 p.m., Nov. 8 We’ve resolved 6,036 issues and have 3,517 open issues.</blockquote> That's a total of nearly ten thousand "issues."  As of now, that is.  "Issue" is a euphemism for "glitch" a.k.a. "software defect" and/or "implementation error", see <a href="http://hcrenewal.blogspot.com/search/label/glitch">http://hcrenewal.blogspot.com/search/label/glitch</a>. These "issues" are  in a supposedly "mature" product for which this organization has spent enormous sums of money, that has undergone "innovation" for several decades now - in an environment free from regulation, I might add. Many of the "issues" reduce patient safety, and could or already may have resulted in patient harm.  Such items on this listing, seen below, which is updated frequently, include: <ul></ul><blockquote class="tr_bq"><ul><li>Pharmacy Medication Mapping Errors – Making good progress: watch for further notices.  [Perhaps these should have been tested and fixed before go-live? - ed.]</li></ul><ul><li>Microbiology Results Mapping Incorrectly [does that mean "mapping" to the wrong patient? - ed.]  – all known errors fixed, monitoring and working on enhancements. [As above, perhaps these should have been tested and fixed before go-live? - ed.]</li></ul><ul><li>Prescription printing - output for prescription printing has been fixed</li></ul><ul><li>Refill requests for providers will be routed to the CLIN SUPPORT In Basket pool for the provider’s department.  This was a decision made by UAHN leadership. [Not sure why this is being done; perhaps for approval by managers? - ed.]  </li></ul><ul><li>Errors transmitting prescriptions will also be sent to the CLIN SUPPORT In Basket.  [Errors transmitting prescriptions? That's not reassuring regarding data integrity.  See ECRI report below  - ed.]</li></ul></blockquote><ul></ul> This is not to mention that all of the "reminders" that follow are a distraction to clinical personnel, who cannot be expected to remember all of them. Bad as this is, at my April 1, 2012 post "University of Arizona Medical Center, $10 million in the red in operations, to spend $100M on new EHR system" (<a href="http://hcrenewal.blogspot.com/2012/04/university-of-arizona-medical-center-10.html">http://hcrenewal.blogspot.com/2012/04/university-of-arizona-medical-center-10.html</a>) I observed that: <blockquote class="tr_bq">... $100 million+ is probably enough to pay for AN ENTIRE NEW HOSPITAL or hospital wing ... or a lot of human medical records professionals. </blockquote> To add more bitter icing to this cake, I wrote about a campaign for clinicians to speak only in wonderful terms about the new U. Arizona Health System EHR at my Oct. 3, 2013 post "Words that Work: Singing Only Positive - And Often Unsubstantiated - EHR Praise As 'Advised' At The University Of Arizona Health Network."  I observed the following about the "words that work" is the shameless 'suggested' script: <blockquote class="tr_bq">• Efficient - see aforementioned links as well as "Common Examples of Healthcare IT Difficulties" at <a href="http://cci.drexel.edu/faculty/ssilverstein/cases/">http://cci.drexel.edu/faculty/ssilverstein/cases/</a> • Convenient - as above.  According to whom?  Compared to what?  Pen and paper? • Improves patient safety and quality - see IOM report post at <a href="http://hcrenewal.blogspot.com/2011/11/iom-report-on-health-it-safety-nix-fda.html">http://hcrenewal.blogspot.com/2011/11/iom-report-on-health-it-safety-nix-fda.html</a> .  We as a nation are only now studying safety of this technology, and the results are not looking entirely convincing, e.g. ECRI Deep Dive Study of health IT safety at <a href="http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html">http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html</a>.  171 health IT mishaps in 36 hospitals, voluntarily reported over 9 weeks, with 8 reported injuries and 3 reported possible deaths is not what I would call something that "improves patient safety and quality" without qualifications. • The Cadillac of its kind - according to whom? • Patients at hospitals using this system love it -  Do most patients even know what it, or any EHR, looks like?  Have they provided informed consent to its use? • Exciting - clinician surveys such as by physicians at <a href="http://hcrenewal.blogspot.com/2010/01/honest-physician-survey-on-ehrs.html">http://hcrenewal.blogspot.com/2010/01/honest-physician-survey-on-ehrs.html</a> and by nurses at <a href="http://hcrenewal.blogspot.com/2013/07/candid-nurse-opinions-on-ehrs-at.html">http://hcrenewal.blogspot.com/2013/07/candid-nurse-opinions-on-ehrs-at.html</a> shed doubt on that assertion. • The best thing for our patients - again, according to whom? • Sophisticated new system - "New"?  Not so much, just new for U. Arizona Health.  "Sophisticated", as if that's a virtue?  Too much "sophistication" is in part what causes clinician stress and burnout, raising risk</blockquote> Considering the near 10,000 issues, the new ECRI Institute report "Top Ten Technology Hazards in Healthcare", 2014 edition comes to mind (<a href="https://www.ecri.org/Press/Pages/2014_Top_Ten_Hazards.aspx">https://www.ecri.org/Press/Pages/2014_Top_Ten_Hazards.aspx</a>).  Named in that report, as has been the case for the past several years, is healthcare IT.  This year's problem description is: <blockquote class="tr_bq">#4. Data Integrity Failures in EHRs and other Health IT Systems</blockquote> "Data integrity failures" include "issues" (per the bad health IT description) such as: data loss, data corruption, data attributed to the wrong patient, etc. <blockquote class="tr_bq"> ECRI Institute, a nonprofit organization, dedicates itself to bringing the discipline of applied scientific research to healthcare to discover which medical procedures, devices, drugs, and processes are best to enable improved patient care. As pioneers in this science for 45 years, ECRI Institute marries experience and independence with the objectivity of evidence-based research. Strict conflict-of-interest guidelines ensure objectivity. ECRI Institute is designated an Evidence-based Practice Center by the U.S. Agency for Healthcare Research and Quality. ECRI Institute PSO is listed as a federally certified Patient Safety Organization by the U.S. Department of Health and Human Services. For more information, visit <a href="http://www.ecri.org/">www.ecri.org</a>.</blockquote> ECRI also produced the 2012 Deep Dive Study of Health IT Risk (<a href="http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html">http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html</a>), where in a volunteer study at 36 member PSO hospitals, 171 health IT "mishaps" were reported in just 9 weeks, 8 of which caused patient injury and 3 of which may have contribute to patient death. In summary, The University of Arizona Health System, with components in the red, is spending hundreds of millions of dollars on an EHR system, that has had decades to mature. Yet, they are finding 10,000 "issues" already, a number of which reduce patient safety and are unresolved, with many more likely to be found. They are also 'advising' their staff to speak in glowing, unsubstantiated terms to patients about an EHR system that has 10,000 issues, and not seeking patient consent to its use in mediating and regulating their care - or giving elective patients the information that might allow them to choose another less "buggy" hospital. If (when) patient harm results from such cavalier hospital (mis)management, the juries are going to just love the dark sunglasses, I bet. -- SS

"We’ve resolved 6,036 issues and have 3,517 open issues": Extolling EPIC EHR Virtues at University of Arizona Health System

The public may believe that, in healthcare, only the Obamacare insurance exchange website has lots of bugs. On those, see my Oct. 10. 2013...

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An Open Letter to David Bates, MD, Chair, ONC FDASIA Health IT Policy Committee on Recommendations Against Premarket Testing and Validation of Health IT

From <a href="http://www.healthit.gov/policy-researchers-implementers/federal-advisory-committees-facas/fdasia">http://www.healthit.gov/policy-researchers-implementers/federal-advisory-committees-facas/fdasia</a>: <blockquote class="tr_bq">The Food and Drug Administration Safety Innovation Act (FDASIA) Health IT Policy Committee Workgroup is charged with providing expert input on issues and concepts identified by the Food and Drug Administration (FDA), Office of the National Coordinator for Health IT (ONC), and the Federal Communications Commission (FCC) to inform the development of a report on an appropriate, risk-based regulatory framework pertaining to health information technology including mobile medical applications that promotes innovation, protects patient safety, and avoids regulatory duplication.</blockquote> My Open Letter to the Committee's chair speaks for itself: <blockquote class="tr_bq">From: Scot Silverstein Date: Mon, Sep 16, 2013 at 9:39 AM Subject: ONC FDASIA Health IT Policy Committee's recommendations on Premarket Surveillance To: David Bates Sept. 16, 2013 David Bates, Chair, ONC FDASIA Health IT Policy Committee via email     Dear David, I am disappointed (and in fact appalled) at the ONC FDASIA Health IT Policy Committee's recommendations that health IT including typical commercial EHR/CPOE systems not be subjected to a premarket testing and validation process.  I believe this recommendation is, quite frankly, negligent. [1] As you know, my own mother was injured and then died as a result of EHR deficiencies, and nearly injured or killed again in the recuperation period from her initial injuries by more health IT problems in a second EHR used in her care.  In my legal consulting and from my colleagues, as well as from the literature, I hear about other injuries/deaths and many "near misses" as well.  That your recommendations came in the face of the recent ECRI Deep Dive study is even more appalling, with the latter's finding of 171 health IT-related incidents in 9 weeks from 36 member PSO hospitals, resulting in 8 injuries and 3 possible deaths, all reported voluntarily. [2] It is my expert opinion the issues that cause these outcomes would never have made it into production systems, had a reasonable, competent, unbiased premarket testing and validation process been in place. Consequently, I have shared the FDASIA HIT Policy Committee's recommendations with the Plaintiff's Bar, and will use its recommendations in my presentations to various chapters of the American Association for Justice (the trial lawyer's association) - as well as to interested Defense attorneys so they may advise their clients accordingly. I am also making recommendations that in any torts, individual or class, regarding EHR problems that would likely have been averted with competent premarket testing and validation, that the FDASIA HIT Policy Committee members who agreed with the recommendation be considered possible defendants. I am sorry it has come to this. Please note I am also posting this message for public viewing at the Healthcare Renewal weblog of the Foundation for Integrity and Responsibility in Medicine (FIRM). Sincerely, Scot Silverstein, MD Consultant/Independent Expert Witness in Healthcare Informatics Adjunct Faculty, Drexel University, College of Computing and Informatics Notes: [1] FDA Law Blog, Recommendations of FDASIA Health IT Workgroup Accepted, September 11, 2013, available at <a href="http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2013/09/recommendations-of-fdasia-health-it-workgroup-accepted.html">http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2013/09/recommendations-of-fdasia-health-it-workgroup-accepted.html</a>: "Of particular interest is the recommendation that health IT should generally not be subject to FDA premarket requirements, with a few exceptions:  medical device accessories, high-risk clinical decision support, and higher risk software use cases." [2] "Peering Underneath the Iceberg's Water Level: AMNews on the New ECRI 'Deep Dive' Study of Health IT Events" , Feb. 28. 2013, available at <a href="http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html">http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html</a>.</blockquote> ----------------------------------------------- Note: the following are listed on the linked site above as members of the committee: <div>Member List</div><ul><li>David Bates, Chair, Brigham and Women’s Hospital</li><li>Patricia Brennan, University of Wisconsin-Madison</li><li>Geoff Clapp, Better</li><li>Todd Cooper, Breakthrough Solutions Foundry, Inc.</li><li>Meghan Dierks, Harvard Medical Faculty, Division of Clinical Informatics</li><li>Esther Dyson, EDventure Holdings</li><li>Richard Eaton, Medical Imaging & Technology Alliance</li><li>Anura Fernando, Underwriters Laboratories</li><li>Lauren Fifield, Practice Fusion, Inc.</li><li>Michael Flis, Roche Diagnostics</li><li>Elisabeth George, Philips Healthcare</li><li>Julian Goldman, Massachusetts General Hospital/ Partners Healthcare</li><li>T. Drew Hickerson, Happtique, Inc.</li><li>Jeffrey Jacques, Aetna</li><li>Robert Jarrin, Qualcomm Incorporated</li><li>Mo Kaushal, Aberdare Ventures/National Venture Capital Association</li><li>Keith Larsen, Intermountain Health</li><li>Mary Anne Leach, Children’s Hospital Colorado</li><li>Meg Marshall, Cerner Corporation</li><li>Mary Mastenbrook, Consumer</li><li>Jackie McCarthy, CTIA - The Wireless Association</li><li>Anna McCollister-Slipp, Galileo Analytics</li><li>Jonathan Potter, Application Developers Alliance</li><li>Jared Quoyeser, Intel Corporation</li><li>Martin Sepulveda, IBM</li><li>Joseph Smith, West Health</li><li>Paul Tang, Palo Alto Medical Foundation</li><li>Bradley Thompson, Epstein Becker Green, P.C</li><li>Michael Swiernik, MobileHealthRx, Inc.</li></ul>Federal Ex Officios <ul><li>Jodi Daniel, ONC</li><li>Bakul Patel, FDA</li><li>Matthew Quinn, FCC</li></ul>  -- SS

An Open Letter to David Bates, MD, Chair, ONC FDASIA Health IT Policy Committee on Recommendations Against Premarket Testing and Validation of Health IT

From http://www.healthit.gov/policy-researchers-implementers/federal-advisory-committees-facas/fdasia : The Food and Drug Administration Saf...

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More Perversity on Health IT Risks, and ... EHR Sense from Nurses on "Nurse Talk", a Syndicated Radio Show

As I mentioned on July 2 <a href="http://hcrenewal.blogspot.com/2013/07/is-oncs-definition-of-significant-ehr.html">at this post</a>, in a June 25, 2013 Bloomberg News article "<a href="http://www.bloomberg.com/news/2013-06-25/digital-health-records-risks-emerge-as-deaths-blamed-on-systems.html">Digital Health Records’ Risks Emerge as Deaths Blamed on Systems</a>" by technology reporter Jordan Robertson an EHR-harms case in which I am (unfortunately) intimately involved as substitute plaintiff is mentioned: that of the death of my mother. I'd previously written about EHR-related electronic encounters with truly perverse individuals at my Jan. 2010 post "More on Perversity in the Healthcare IT World: Is Meditech Employing Sockpuppets?" at <a href="http://hcrenewal.blogspot.com/2010/01/more-on-perversity-in-hit-world.html">http://hcrenewal.blogspot.com/2010/01/more-on-perversity-in-hit-world.html</a>. There were quite a few thoughtful comments in the reader comments of the June 25, 2013 Bloomberg article, but also the typical callous, incompetent and/or bizarre comments that an anonymous forum invites (really, semi-anonymous, as the website tracks IP's of commenters).  The anonymous comment below stood out from the rest as a worst-case example of perverse defense of health IT (it may have been removed by now): <blockquote class="tr_bq">Pharm Aid 1 week ago I'm surprised at the poor quality of reporting in this article.  First, Scot Silverstein has been on jihad against electronic medical records LONG before his dear mother passed away in 2011.  According to Silverstein's own website, he opposed EMRs back as far as 2009. Second, the article fails to mention Silverstein's conflict of interest here - he works in this space.  Essentially, Silverstein contacts a vendor of EMRs, offers his "consulting" services.  This totally smacks of a shakedown to me.  If they don't hire him, he criticizes them and claims they are killing people.  Don't take my word for it, check out his website and blog. Third, the number of medical errors from paper-based records is staggering.  According to a study from 7 years ago, a staggering number - 23% - of patients at one health system had medication errors attributed to illegible paper-based charts.  This is roughly consistent with other studies, including the epic IOM report on errors in medicine.</blockquote> Let me point out the perversities.  I am assuming the comment was not simply deliberately false character assassination and that the writer believed what he/she was writing - which if not, would show the industry's cheerleaders in an even worse light than if the assumption is the poster believes what he/she wrote: <ul><li>No expression of sympathy or remorse at my mother's death, whatever the cause.</li></ul><ul><li>Gross and almost humorously silly caricature of my "consulting" (which is as expert witness) and defamatory comments.</li></ul><ul><li>Gross mischaracterization of this blog and my Drexel Univ. healthcare informatics teaching site at <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases">http://www.ischool.drexel.edu/faculty/ssilverstein/cases</a>.</li></ul><ul><li>A mysterious invocation of some unnamed article on paper records at one health system.   I note that N=1 for both the mysterious unnamed study and its subject institution, representing the absolute worst regarding drawing conclusions, especially conclusions that we need to spend hundreds of billions of healthcare dollars on what today is largely bad health IT (see definitions of good and bad health IT at the aforementioned Drexel site).</li></ul><ul><li>An apparent mischaracterization of the "epic" 1999 IOM report "To Err is Human"on errors in medicine (<a href="http://www.iom.edu/~/media/Files/Report%20Files/1999/To-Err-is-Human/To%20Err%20is%20Human%201999%20%20report%20brief.pdf">http://www.iom.edu/~/media/Files/Report%20Files/1999/To-Err-is-Human/To%20Err%20is%20Human%201999%20%20report%20brief.pdf</a>).  It's clear that many if not most medical errors have nothing whatsoever to do with documentation, either paper or electronic (I made that point at my Dec. 2010 post "Is health IT the solution to the wrong problem?" at <a href="http://hcrenewal.blogspot.com/2010/12/is-healthcare-it-solution-to-wrong.html">http://hcrenewal.blogspot.com/2010/12/is-healthcare-it-solution-to-wrong.html</a>).  From that 1999 IOM report's summary:</li></ul><blockquote class="tr_bq">... Among the problems that commonly occur during the course of providing health care are adverse drug events and improper transfusions, surgical injuries and wrong-site surgery, suicides, restraint-related injuries or death, falls, burns, pressure ulcers, and mistaken patient identities. </blockquote><ul><li> As to "[my] claims that EHRs are [injuring and] killing people", I merely report what others find - that still others deliberately dismiss (e.g., as "anecdotal") - or ignore. Just the latest example is the ECRI Deep Dive study (<a href="http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html">http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html</a>).  171 health information technology-related problems voluntarily reported during a nine-week period to the ECRI Institute PSO from just 36 hospitals.  Eight of the incidents reported involved patient harm, and three may have contributed to patient deaths, said the institute.  Other examples appear at HC Renewal.</li></ul> In summary, there is someone out there who reads Bloomberg and who either 1) supports health IT, but lacks empathy, lacks judgment, and lacks scientific and critical thinking skills or 2) is simply a confabulator and liar. Perversity regarding health IT needs sunlight - lots of it. ----------------------- Here's some of that sunlight in a talk program on "Nurse Talk", a nationally syndicated radio show by and for nurses. <blockquote class="tr_bq"><a href="http://nursetalksite.com/">Nurse Talk</a> is heard on the air in major metropolitan areas on both the West and East Coasts, and worldwide on the Internet, and has partnerships with the largest groups of nurses in the country. </blockquote> Listen to the July 3, 2013 program "RNs DeAnn McEwen and Michelle Mahon on Electronic Medical Records" at <a href="http://nursetalksite.com/2013/07/03/rns-deann-mcewen-and-michelle-mahon/">http://nursetalksite.com/2013/07/03/rns-deann-mcewen-and-michelle-mahon/</a>. -- SS

More Perversity on Health IT Risks, and ... EHR Sense from Nurses on "Nurse Talk", a Syndicated Radio Show

As I mentioned on July 2 at this post , in a June 25, 2013 Bloomberg News article " Digital Health Records’ Risks Emerge as Deaths Blam...

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