A Right Royal Mess: EHRs and Royal Berkshire NHS Foundation Trust

Almost every theme I've written about for the past 15 years, at this blog and at my teaching site (<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/" target="_blank">link</a>) regarding health IT mismanagement is present here:<br /><br /><blockquote class="tr_bq"><b><span style="font-size: large;"><a href="http://www.ehi.co.uk/insight/analysis/1033/a-right-royal-mess" target="_blank">A Right Royal Mess</a></span><br />     <br />ehealth INSIDER<br />12 February 2013 </b><br /><br />Newly released reports on Royal Berkshire NHS Foundation Trust’s implementation of Cerner Millennium show that many crucial issues were not addressed prior to go-live; and that the trust is continuing to face considerable operational and financial issues because of the system. Rebecca Todd reports.</blockquote><br />Read it at the link above.<br /><br />I feel this scenario is being repeated in many countries, including the U.S., with many different vendor products.  The industry's pathologies and self-serving memes are difficult to overcome.<br /><br />As Orwell said:  "To see what is in front of one's nose needs a constant struggle."<br /><br />But don't worry...you're perfectly safe.  Computers, after all, improve healthcare and are entirely beneficent, according to the pundits.  Every untoward event is a mere "anecdote."<br /><br />-- SS<br /><br /><b>Addendum 2/15/13:</b>  just to illustrate my point, there's also this:<br /><br /><blockquote class="tr_bq"><span style="font-size: large;"><b><a href="http://www.ehi.co.uk/news/EHI/8392/monitor-blasts-rotherham%27s-epr-programme" target="_blank">Monitor blasts Rotherham's EPR programme</a></b></span><br />ehealth INSIDER<br />15 February 2013<br />Lis Evenstad  <br /><br />The Rotherham NHS Foundation Trust has been found in significant breach of its terms of authorisation by Monitor, with its electronic patient record implementation identified as a key issue.<br /><br />The trust this month admitted it was facing "persistant serious issues" with the deployment of its <b>Meditech EPR</b> including "clinician and staff acceptance and usability" ... “The trust <b>has not managed EPR implementation in an effective way</b> and significant operational and financial risks will remain until the trust has a robust and operationally effective EPR system." ... “It is unclear whether the trust has sufficient visibility over <b>operational performance and quality issues, including incidents of patient harm</b>,” it adds.</blockquote><br />-- SS

A Right Royal Mess: EHRs and Royal Berkshire NHS Foundation Trust

Almost every theme I've written about for the past 15 years, at this blog and at my teaching site ( link ) regarding health IT mismanage...

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Defense Attorney Lies Under Oath In Sworn Filing to Protect Hospital's Health IT

At my Aug. 7. 2012 post "<a href="http://hcrenewal.blogspot.com/2012/08/pa-attorney-puts-onc-approved-hit.html">Malpractice Attorney Puts ONC-Authorized Testing and Certification Bodies (ATCBs) at Risk of Litigation?"</a> I wrote:<br /><br /><blockquote class="tr_bq"> ... I returned to the U.S. to find that the defense attorney for the hospital where my mother was severely injured, and then died as a result, is once again raising an absurd issue in objections to the medical malpractice Complaint that was refiled within the Statute of Limitations for technical reasons.   The President Judge of the county where the case is filed had dismissed this complaint (among many others) some time ago: </blockquote><br /><blockquote class="tr_bq"><blockquote class="tr_bq"><b>(ii) Plaintiffs Software Design Defect Claims are Preempted by the Federal HITECH Act</b><br /><br />... To the extent Plaintiff attempts to bring a common law product liability claim against [name redacted] Hospital <b>for required use of EMR software</b> <b><i style="color: red;">[see addendum below - ed.]</i></b>, such a claim is barred due to Federal Preemption of this area with the passage of the Health Information Technology for Economic and Clinical Health (HITECH) Act. 42 U.S.C. 201, 300, et seq.<br /><br />Specifically, the design, manufacture, specification, certification and sale of EMR in the United States is a <b>highly regulated industry </b>under the jurisdiction of the Department of Health and Human Services (HHS). <b>The HHS draws its statutory authority to design and certify EMR as safe and effective </b>under the HITECH act as amended. Id.<br /><br />The Supremacy Clause of the United States Constitution, article VI, clause 2, <b>preempts any state law that conflicts with the exercise of federal power. </b>Fid. Fed. Say. & Loan Ass’n v. de la Cuesta, 458 U.S. 141, 102 S. Ct. 3014 (1982). “Pre-emption may be either express or implied, and ‘is compelled whether Congress’ command is explicitly stated in the statute’s language or implicitly contained in its structure and purpose.” Matter of Calun Elec. Power Co-op., Inc., 109 F.3d 248, 254 (5th Cir. 1997) citing Jones v. Rath Packing Co., 430 U.s. 519, 525 (1977).<br /><br />In this case, to impose common law liability upon [name redacted] Hospital for <b>using certified EHR technology, which was in compliance with federal law and regulations for Health Information Technology</b>, would directly conflict with Congress’ statutory scheme for fostering and promoting the implementation and use of EHR<span style="background-color: white;"></span>  <i style="color: red;"><b><br /></b></i></blockquote><br />I really don't think Congress intended HIT to maim and kill patients with impunity.  In any case, this assertion was thrown out in its entirety several months ago, but<i> here it is again in a new set of objections.  </i>I find its reappearance remarkable.  I also wonder if the industry is behind it.</blockquote><br />What I didn't post is the reply to this nonsense that was presented to the court by Plaintiff (me), via Plaintiff's counsel after my analysis of this passage, in a Memorandum of Law to the court Dec. 5, 2011:<br /><br /><blockquote class="tr_bq">... HHS does not regulate the design, manufacture, specification, certification, and sale of EMRs or any other clinical information technology. The HITECH Act itself does not establish standards and certification criteria for health information technology, but instead establishes the HIT Standards Committee to implement such specifications and standards for certification. HITECH Act § 3003, 42 U.S.C. § 300jj-13. <br /><br /><b>The initial set of standards specifications and certification criteria were not published until July 28, 2010, approximately 2 months after Mrs. Silverstein entered [name redacted] Hospital. </b>Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology, 75 Fed. Reg. 44589 (July 28, 2010). <b>Therefore, it would have been impossible for [name redacted] Hospital’s EMR system “to be in compliance with federal law and regulations for Health Information Technology” during the time of Mrs. Silverstein’s admission. </b></blockquote><br />These facts were filed with the Court and delivered to the defense on Dec. 5, 2011 regarding health IT certification.  An Affidavit/Certificate of Service to the defendants was also filed with the Response and Memorandum of Law as is customary, and are noted on the Prothontary website.  No "I didn't receive it" excuse is possible...<br /><br />The facts about health IT "certification" are trivial to verify.  <br /><br />As the hospital admission where my mother was injured, and the injury itself, were in May 2010, "<b>using certified EHR technology</b> <b>in compliance with federal law and regulations for Health Information Technology</b>" was <i>not possible at that time</i>.  (Not to mention the facilities' EHR's were not actually "certified" until December 2010 via the ONC database of certified systems.)<br /><br />Thus, the defense attorney by re-issuing this claim in August 2012 (to the new judge overseeing the case re-filing) is now <i>knowingly lying to the Court in sworn filings</i>, in order to harass, cause unnecessary delays in litigation, and needlessly increase the cost of litigation while collecting hourly fees for production of frivolous and untrue assertions.<br /><br />The attorney is also making a mockery of the court system in the locality where the case is being heard, and also insulting the judges' intelligence. <br /><br />These are the lengths to which hospitals and defense attorneys seem to be willing to go in defense of health IT.  I find this remarkable (but not surprising).<br /><br />It will be interesting to see how the judge responds to an attorney knowingly trying to blow smoke up his behind.<br /><br />-- SS<br /><br /><b>Addendum:  </b>Also pointed out in earlier filings was the fact that use of EMR's is not "required."   It seems the defense attorney, besides being a liar, has a thick skull.<br /><br />-- SS<br /><br />

Defense Attorney Lies Under Oath In Sworn Filing to Protect Hospital's Health IT

At my Aug. 7. 2012 post " Malpractice Attorney Puts ONC-Authorized Testing and Certification Bodies (ATCBs) at Risk of Litigation?"...

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FDA Safety and Innovation Act: To contain an "Appropriate, risk-based regulatory framework pertaining to health information technology"

Congress has just released an an Act "to amend the <a href="http://www.fda.gov/regulatoryinformation/legislation/federalfooddrugandcosmeticactfdcact/default.htm" target="_blank">Federal Food, Drug, and Cosmetic (FD&C) Act</a> to revise and extend the user-fee programs for prescription drugs and medical devices, to establish userfee programs for generic drugs and biosimilars, and for other purposes."  Health IT provisions are included.<br /><br />This Act, S. 3187, is entitled the ‘‘<b>Food and Drug Administration Safety and Innovation Act</b>.’’  PDF fulltext is located at this link:  <a href="http://www.gpo.gov/fdsys/pkg/BILLS-112s3187enr/pdf/BILLS-112s3187enr.pdf">http://www.gpo.gov/fdsys/pkg/BILLS-112s3187enr/pdf/BILLS-112s3187enr.pdf</a><br /><br />With regard to health IT, the Act states the following.  A risk-based regulatory framework pertaining to health IT is to be developed (emphases mine):<br /><br /><b><span style="font-family: NewCenturySchlbk-Bold; font-size: xx-small;"><span style="font-family: NewCenturySchlbk-Bold; font-size: xx-small;"></span></span></b><br /><blockquote class="tr_bq"><span style="font-size: small;"><b><span style="font-family: NewCenturySchlbk-Bold;"><span style="font-family: NewCenturySchlbk-Bold;"></span></span></b></span><br /><div align="left" style="font-family: Arial,Helvetica,sans-serif;"><span style="font-size: small;"><b>SEC. 618. HEALTH INFORMATION TECHNOLOGY.</b></span></div><div style="font-family: Arial,Helvetica,sans-serif;"><span style="font-size: small;"><b></b></span></div><div align="left" style="font-family: Arial,Helvetica,sans-serif;"><span style="font-size: small;"><b><br /></b></span></div><span style="font-family: Arial,Helvetica,sans-serif; font-size: small;"><b> </b></span><span style="font-family: NewCenturySchlbk-Roman; font-size: small;"></span><br /><div align="left" style="font-family: Arial,Helvetica,sans-serif;"><span style="font-size: small;">(a) R</span><span style="font-size: small;">EPORT</span><span style="font-size: small;">.—Not later than 18 months after the date of enactment of this Act, the Secretary of Health and Human Services</span><span style="font-size: small;"> (referred to in this section as the ‘‘Secretary’’), acting through the</span><span style="font-size: small;"> Commissioner of Food and Drugs, and in consultation with the</span><span style="font-size: small;"> National Coordinator for Health Information Technology and the</span><span style="font-size: small;"> Chairman of the Federal Communications Commission, shall post</span><span style="font-size: small;"> on the Internet Web sites of the Food and Drug Administration,</span><span style="font-size: small;"> the Federal Communications Commission, and the Office of the</span><span style="font-size: small;"> National Coordinator for Health Information Technology, <b>a report that contains a proposed strategy and recommendations on an appropriate, risk-based regulatory framework pertaining to health information technology, </b>including mobile medical applications, that</span><span style="font-size: small;"> promotes innovation, protects patient safety, and avoids regulatory</span><span style="font-size: small;"> duplication.</span></div><div style="font-family: Arial,Helvetica,sans-serif;"><span style="font-size: small;"></span></div><div style="font-family: Arial,Helvetica,sans-serif;"><span style="font-size: small;"> </span></div><span style="font-family: NewCenturySchlbk-Roman; font-size: small;"></span><br /><div align="left" style="font-family: Arial,Helvetica,sans-serif;"><span style="font-size: small;"><br /></span></div><div align="left" style="font-family: Arial,Helvetica,sans-serif;"><span style="font-size: small;">(b) W</span><span style="font-size: small;">ORKING </span><span style="font-size: small;">G</span><span style="font-size: small;">ROUP</span><span style="font-size: small;">.—</span></div><div align="left" style="font-family: Arial,Helvetica,sans-serif;"><span style="font-size: small;"> </span></div><div style="font-family: Arial,Helvetica,sans-serif;"><span style="font-size: small;"></span></div><blockquote dir="ltr" style="margin-right: 0px;"><div style="font-family: Arial,Helvetica,sans-serif;"><span style="font-size: small;"></span></div><div align="left" style="font-family: Arial,Helvetica,sans-serif;"><span style="font-size: small;">(1) I</span><span style="font-size: small;">N GENERAL</span><span style="font-size: small;">.—In carrying out subsection (a), the Secretary may convene a working group of external stakeholders</span><span style="font-size: small;"> and experts to provide appropriate input on the strategy and</span><span style="font-size: small;"> recommendations required for the report under subsection (a).</span></div><div style="font-family: Arial,Helvetica,sans-serif;"><span style="font-size: small;"></span></div><div style="font-family: Arial,Helvetica,sans-serif;"><span style="font-size: small;"> </span></div><span style="font-family: NewCenturySchlbk-Roman; font-size: small;"></span><br /><div align="left" style="font-family: Arial,Helvetica,sans-serif;"><span style="font-size: small;">(2) R</span><span style="font-size: small;">EPRESENTATIVES</span><span style="font-size: small;">.—If the Secretary convenes the working group under paragraph (1), the Secretary, in consultation</span><span style="font-size: small;"> with the Commissioner of Food and Drugs, the National</span><span style="font-size: small;"> Coordinator for Health Information Technology, and the Chairman</span><span style="font-size: small;"> of the Federal Communications Commission,<b> shall determine the number of representatives participating in the working group, and shall, to the extent practicable, ensure that the working group is geographically diverse</b> and includes</span><span style="font-size: small;"> representatives of patients, consumers, health care providers,</span><span style="font-size: small;"> startup companies, health plans or other third-party payers,</span><span style="font-size: small;"> venture capital investors, information technology vendors,</span><span style="font-size: small;"> health information technology vendors, small businesses, purchasers,</span><span style="font-size: small;"> employers, <b>and other stakeholders with relevant expertise</b>, </span><span style="font-size: small;">as determined by the Secretary.</span></div><span style="font-family: NewCenturySchlbk-Roman; font-size: small;"><span style="font-family: NewCenturySchlbk-Roman;"></span></span><br /><span style="font-family: NewCenturySchlbk-Roman; font-size: small;"><span style="font-family: NewCenturySchlbk-Roman;"></span></span></blockquote></blockquote><br />While a welcome development, it is to be determined if the Working Group representatives will include critical thinkers without conflict of interest, whose contributions to the health IT debate in this country are needed a lot more than the traditional <a href="http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html" target="_blank">hyper-enthusiasts</a>, industry courtiers and opportunists.<br /><br />I am actually not hopeful.<br /><br />The "promotes innovation" and "avoids regulatory duplication" phrases are of especially great concern.  As I've written before, "innovation" that involves non-consented experimentation is not innovation at all, it is exploitation, and "regulatory duplication" can become an excuse for milquetoast regulation by the conflicted (e.g., regulatory capture) or poorly qualified.<br /><br />I also note that this Act, while welcome, is long overdue - another example of putting the <b>cart before the horse</b> (<a href="http://hcrenewal.blogspot.com/2012/06/cart-before-horse-part-3-ahrqs-health.html" target="_blank">link</a>), with a national project (including CMS penalties for non-adopters) now several years underway.<br /><br />Final thought:  if health IT were safe as has been claimed now for decades, or <b>had been made safe </b>through proper development and clinical trials-based testing, we would not need health IT provisions in a  "Food and Drug Administration Safety and Innovation Act" in 2012.<br /><br />-- SS

FDA Safety and Innovation Act: To contain an "Appropriate, risk-based regulatory framework pertaining to health information technology"

Congress has just released an an Act "to amend the Federal Food, Drug, and Cosmetic (FD&C) Act to revise and extend the user-fee p...

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Allscripts shares plunge on weak outlook, board changes, unhappy customers - but mostly unhappy customers, I surmise

Glen Tullman is CEO of the health IT seller Allscripts-Misys Healthcare.  He was an <a href="http://blogs.wsj.com/health/2009/01/26/allscripts-ceo-urges-one-two-punch-on-electronic-medical-records/" target="_blank">advisor to the Obama campaign</a> on health information technology issues.<br /><br />My organization had to sue his company for non-working products a few years ago (<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/DUCOM_EMR_Complaint.pdf" target="_blank">link to PDF of civil complaint</a>) .<br /><br />Apparently other customers were unhappy as well.  This from Reuters:<br /><br /><blockquote class="tr_bq"><span style="font-weight: bold;"></span><a href="http://www.reuters.com/article/2012/04/27/us-allscripts-shares-idUSBRE83Q0PL20120427" target="_blank"><span style="font-weight: bold;">Allscripts shares plunge on weak outlook, board changes</span></a> <br /><br />Fri Apr 27, 2012 9:24am EDT<br /><br />(Reuters) - <a href="http://www.allscripts.com/" target="_blank">Allscripts</a> Healthcare Solutions Inc's shares plunged 42 percent in premarket trade on Friday, after the company forecast weak full-year earnings, hurt by software development costs and weaker bookings.<br /><br />On Thursday, the healthcare information technology provider reported a lower-than-expected quarterly profit and also announced the resignation of its CFO, three directors and board Chairman Phil Pead.<br /><br />Citigroup analyst George Hill said the results were strongly disappointing and downgraded the company's stock to "neutral" from "buy."<br /><br />Hill said he was most troubled by the loss of long tenured CFO Bill Davis, who had been the public face of Allscripts to investors for many years.<br /><br />"We suspect CEO Glen Tullman won a power struggle at the 11th hour leading to the board departures," Hill said.<br /><br /><b>"Too few customers are buying its products, due to lack of confidence or satisfaction," Barclays Capital analyst Lawrence Marsh wrote in a note.</b><br /><br />Allscripts shares were trading at $9.27 in premarket trade. They had closed at $16.02 Thursday on the Nasdaq.<br /><br />(Reporting by Shailesh Kuber in Bangalore; Editing by Joyjeet Das)</blockquote><br />The statement 'too few customers are buying its products, due to lack of confidence or satisfaction', speaks volumes about the state of health IT in general in 2012.<br /><br />That state includes eventual regulation after an <a href="http://hcrenewal.blogspot.com/2011/11/iom-report-on-health-it-safety-nix-fda.html" target="_blank">IOM report on dubious safety</a>, mission hostile user interfaces as <a href="http://hcrenewal.blogspot.com/2011/10/nist-on-ehr-mission-hostile-user.html" target="_blank">identified by NIST</a> and others that will require expensive remediation (due to the industry arrogantly ignoring this crucial issue for decades), <a href="http://hcrenewal.blogspot.com/2011/11/lifespan-rhode-island-yet-another.html" target="_blank">'glitches'</a> due to poor or non-existent validation and quality control that will increasingly result in expensive litigation when <a href="http://hcrenewal.blogspot.com/2011/06/babys-death-spotlights-safety-risks.html" target="_blank">patients are harmed</a>, likely government investigations and clawbacks due to <a href="http://hcrenewal.blogspot.com/2011/02/does-emr-facilitated-upcoding-formely_15.html" target="_blank">EHR-promoted upcoding</a>, and an increasing awareness that many of the so-called miracle 'revolutionary' gains (as opposed to facilitation of medical practice) are largely <a href="http://hcrenewal.blogspot.com/2011/02/updated-reading-list-on-health-it.html" target="_blank">illusory</a> industry-promoted memes not based on robust, scientifically-generated evidence.<br /><br />I'd pull out of this market - if I had any money invested in it.  I have none, and never have, because I have great lack of confidence in the industry that began when I was first exposed to it and its leaders - that being in 1992.<br /><br />I note that the <a href="http://www.hipaasurvivalguide.com/hitech-act-summary.php" target="_blank">HITECH</a> component of ARRA, containing incentives and penalties related to health care information technology designed to accelerate the adoption of EHR systems, was advanced largely via advice to the President on the wonders of health IT.  (I thought HITECH was a <a href="http://hcrenewal.blogspot.com/2009/01/i-ask-again-should-us-call-moratorium.html" target="_blank">reckless, premature move</a> destined to waste billions of dollars as did the erstwhile <a href="http://hcrenewal.blogspot.com/2011/09/npfit-programme-going-pffft.html" target="_blank">NPfIT in the NHS</a>, and I still stand by that prediction.)<br /><br />-- SS<br /><br /><b>4/27/12 Addendum:</b><br /><br />EHR glitches like <a href="http://hcrenewal.blogspot.com/2011/05/twelve-hour-health-it-glitch-at.html" target="_blank">this</a> and <a href="http://hcrenewal.blogspot.com/2011/11/lifespan-rhode-island-yet-another.html" target="_blank">this</a> never seem to affect patients... <br /><br />-- SS<br /><blockquote class="tr_bq"></blockquote>

Allscripts shares plunge on weak outlook, board changes, unhappy customers - but mostly unhappy customers, I surmise

Glen Tullman is CEO of the health IT seller Allscripts-Misys Healthcare.  He was an advisor to the Obama campaign on health information t...

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True or Not? Death By Deletion, Adventist Health System IT Whistleblower Patricia Moleski Speaks Out

Not sure what to make of this yet:<br /><br /><br /><div style="text-align: center;"><a href="http://workmancompensationlawyers.net/12/23/death-by-deletion-adventist-health-system-it-whistleblower-patricia-moleski-speaks-out/"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5714029864071150194" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjlHdzwxZwvVcxZUB0fkLhI1MY8nXfdxFdIjjuBc56E72oN5YBlT5GoMyAubm_fK9QYC-tWvL1LaEu6HTSGjLZEw-grfGGaprfwkdHRgGgJOtFluHvWylSud8uEHR8EQiig-vsqw1HY3Bz5/s320/moleski.jpg" style="display: block; margin: 0px auto 10px; text-align: center; cursor: pointer; width: 311px; height: 258px;" /></a><span style="font-size:85%;">Whistleblower Patricia Moleski speaks out about health IT abuses - play at <a href="http://workmancompensationlawyers.net/12/23/death-by-deletion-adventist-health-system-it-whistleblower-patricia-moleski-speaks-out/">http://workmancompensationlawyers.net/12/23/death-by-deletion-adventist-health-system-it-whistleblower-patricia-moleski-speaks-out/</a></span><br /></div><br /><br />A former hospital IT worker claims very deliberate mass spoliation (e.g., deletion) of electronic medical record evidence to limit her (ex)-employer's liability for EHR-related medical malpractice on patients and injured workers who were entitled to workers compensation, as well as EHR defects.<br /><br />She alleges that IT personnel are used as naïve accomplices to perform the spoliation acts. She grew suspicious when she was asked to delete nursing information about a patient who committed suicide by jumping out a hospital window after an EHR-related drug overdose.<br /><br />The video is over an hour long and is worth listening to.<br /><br />She made these claims to the FBI and alleged to have suffered retaliation including firing, and possible terroristic activities directed against her.<br /><br /><a href="http://www.barbclark.org/e_mail_to_governor_christ.pdf">A Feb. 2010 letter to Gov. Crist, Sen. Grassley</a> and many other government officials, a <a href="http://www.barbclark.org/counter_claim_petition_against_adventist_health_system_sunbelt_healthcare_corporation.pdf">9th Judicial Circuit court document</a> for Orange County, FL (PDF), and other details - some scary - can be found via a google search on this person's name: <a href="https://www.google.com/search?q=Patricia%20Moleski">https://www.google.com/search?q=Patricia%20Moleski</a> .<br /><br /><br /><div style="text-align: center;"><a href="http://www.barbclark.org/e_mail_to_governor_christ.pdf"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5714192301488956402" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh3r5LNUCzUdeRm_RB7sSNhCtI1DOljSSvPRHqzXTI4QQD4SHy3BHvRLtzutycP2ewk0HYO5UoQ0cggetV0XsV4u5ckhXdWgOmJYTJR-G0wmIg4UjxAb2x6e3_eXqQi0mHHiUHN8n4WIgko/s320/moleski_letter.jpg" style="display: block; margin: 0px auto 10px; text-align: center; cursor: pointer; width: 324px; height: 392px;" /></a><span style="font-size:85%;">A Feb. 2010 letter to Sen. Grassley, former Fla. Governor Crist, various other senators, news media, etc. alleging serious, systematic, purposeful HIT evidence tampering and erasure. Click to bring up full letter.</span><br /></div><br /><br />This could be the "Libby Zion" (or Bernard Madoff?) case of the health IT world if these allegations are true.<br /><br />-- SS

True or Not? Death By Deletion, Adventist Health System IT Whistleblower Patricia Moleski Speaks Out

Not sure what to make of this yet: Whistleblower Patricia Moleski speaks out about health IT abuses - play at http://workmancompensationlawy...

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Health IT: Ddulites and Irrational Exuberance

The title is not a typo.<br /><br />I've often tried to explain the phenomenon of irrational exuberance where computers are concerned, especially in the domain of health IT.<br /><br />In face of the literature references provided throughout this blog, including at posts such as <a href="http://hcrenewal.blogspot.com/2011/02/updated-reading-list-on-health-it.html">this reading list</a> and at sites such as <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/">here</a>, one would think rational people would temper their exuberance somewhat, at the very least towards rapid national rollouts - as opposed to constrained, controlled experiments until the industry learns how to get the technology "right."<br /><br />However, more than a decade of writing has had little effect.<br /><br />I've also attempted to explain the phenomenon of irrational exuberance on a belief in technological determinism, on industry propaganda, on unquestioning IT faith being a quasi-"religion", and on profiteering or other quid pro quo. (The latter, I'm certain, is operative to an extent.)<br /><br />I have now come across a term, though, that I believe accurately encapsulates the phenomenon of unquestioning beliefs that health IT + clinician automagically --> a "revolution" in medicine.<br /><br />It may be a <span style="font-style: italic;">character trait. </span>The trait<span style="font-style: italic;"> </span>has been described by the term "<span style="font-weight: bold;">Ddulite</span>." (Pronounced, I would say, 'da-dew-light'.) It is obviously a play on "Luddite" with the fist four characters backwards.<br /><br />Apart from its historical meaning, a <span style="font-weight: bold;">Luddite</span> is "<span class="ssens"><a href="http://www.merriam-webster.com/dictionary/luddite">one who is opposed to change, especially technological change</a>" (Merriam-Webster).</span><br /><br />A <span style="font-weight: bold;">Ddulite</span>, on the other hand, is the opposite of a Luddite. A Ddulite is:<br /><br /><a href="http://www.thefacultylounge.org/2011/12/ddulites.html" style="font-style: italic;"></a><br /><blockquote><a href="http://www.thefacultylounge.org/2011/12/ddulites.html" style="font-style: italic;">A person who prefers new tech to old tech even when the old tech is better--more functional</a></blockquote><br />or alternately:<br /><br /><a href="http://alltopics.com/argument-favor-ddulites.html" style="font-style: italic;"></a><br /><blockquote><a href="http://alltopics.com/argument-favor-ddulites.html" style="font-style: italic;">A person with a preference for higher tech solutions even in cases where lower tech alternatives have greater and more appropriate functionality</a>. </blockquote><br />My own definition, especially in healthcare:<br /><br /><span style="font-weight: bold;"><span style="color: red; font-style: italic;"></span></span><br /><blockquote><span style="font-weight: bold;"><span style="color: red; font-style: italic;">Hyper-enthusiastic technophiles who </span></span><span style="color: red; font-style: italic; font-weight: bold;">either deliberately ignore or are blinded to technology's downsides</span><span style="font-weight: bold;"><span style="color: red; font-style: italic;">, ethical issues, and repeated local and mass failures. </span></span>[1]</blockquote><br />Such people ignore the downsides, even if the downsides are deadly - in which case I believe it justified to describe Ddulites as "<span style="font-style: italic;">radical technophiles</span>."<br /><br />The Ddulite simply assumes if it's new technology, it has to be better, no matter the evidence because, well, it's new technology.<br /><br />In other words, irrational exuberance in IT in general, and HIT specifically, is not merely a belief, it's a <span style="font-style: italic;">character trait</span>, perhaps an ideology.<br /><br />That could help explain why some otherwise very bright people, even people who promote evidence-based medical practice, seem to become blind and deaf in regard to HIT, as in the recent comment thread on my post "<a href="http://hcrenewal.blogspot.com/2012/02/kevinmd-how-algorithm-driven-medicine.html">KevinMD: How algorithm driven medicine can affect (make more dangerous, actually) patient care</a>."<br /><br />When it comes to evidence-based IT practice, a Ddulite is eager to provide extraordinary special accommodation towards IT flaws, ethics, known dangers, etc. Someone of this ideology finds it exceptionally easy to dismiss or ignore any and all evidence that could contradict the technology's powers to "transform" medicine, and perhaps even worse (for patients), that could contradict its infallible beneficence.<br /><br />Unfortunately, IT is not a magic bullet ... <span style="font-weight: bold;">it can be just a bullet, period</span>, unless "done well", an undertaking of almost <a href="http://en.wikipedia.org/wiki/Wicked_problem">wicked complexity</a>.<br /><br />Being a Ddulite can, in fact, lead to recklessness and negligence. A transition to IT must always respect the findings of <a href="http://rkcsi.indiana.edu/About/AboutDocs/SI_report.pdf">Social Informatics</a> (PDF): see especially Sec. 3.1 '<span style="font-style: italic;">Key Social Informatics Ideas</span>' starting on pg. 117. The transition must be done - especially in a scientific domain - in a scientific manner.<br /><br />In medicine, that means applying the rigors of medical research, medical science and medical ethics to the conception, design, implementation and lifecycle of health IT, <span style="font-weight: bold;">with all that implies</span>. This is certainly not the state of the HIT enterprise in 2012, which is largely based on a management information systems, i.e. merchant-computing, paradigm.<br /><br />People who offer unquestioning loyalty to cybernetics, and who reflexively accuse those who are circumspect about commercial health IT of being "Luddites" who proffer "<a href="http://hcrenewal.blogspot.com/2011/08/from-senior-clinician-down-under.html">anecdotes</a>", perhaps need to look in the mirror. They then need to think critically as to whether their reflection demonstrates Ddulite characteristics.<br /><br /><div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEifWfyKYjpgBz5Kk5fyAUpjjrSNaNoMjFL-QsYFvzzeS_npkxE4ZRSpq_vmQmJOeunGfDQnhUA-cuXpKKjgi5rxtJVGuRa3DwGHC7nPLeD9XyWFwnAn7yoP8aa3ZsA6kpYnW6ytagBI483a/s1600/In_a_Mirror%252C_Darkly_%2528ENT_episode%2529_Part_II.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5706894737912216594" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEifWfyKYjpgBz5Kk5fyAUpjjrSNaNoMjFL-QsYFvzzeS_npkxE4ZRSpq_vmQmJOeunGfDQnhUA-cuXpKKjgi5rxtJVGuRa3DwGHC7nPLeD9XyWFwnAn7yoP8aa3ZsA6kpYnW6ytagBI483a/s320/In_a_Mirror%252C_Darkly_%2528ENT_episode%2529_Part_II.jpg" style="cursor: pointer; display: block; height: 124px; margin: 0px auto 10px; text-align: center; width: 164px;" /></a><span style="font-size: 85%;">Unquestioning loyalty to the Empire: </span><span style="font-size: 85%;"><a href="http://en.wikipedia.org/wiki/In_a_Mirror,_Darkly">In A Mirror, Darkly</a></span></div><br />-- SS<br /><br style="font-weight: bold;" /><span style="font-weight: bold;">Feb. 19, 2012 addendum:</span><br /><br />Also see my post "<a href="http://hcrenewal.blogspot.com/2012/02/health-it-ddulites-and-disregard-for.html">Health IT Ddulites and Disregard for the Rights of Others</a>" that adds another observation about the Ddulite mindset.<br /><br /><span style="font-size: 85%;">Notes:<br /><br />[1] On mass IT failures repeatedly ignored, se<b style="mso-bidi-font-weight: normal;"><span style="font-family: Arial; font-size: 10.0pt;"></span></b>e "<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/Goldfinch_pessimism_PAR.pdf">Pessimism, Computer Failure, and Information Systems Development in the Public Sector</a>", Shaun Goldfinch, University of Otago, New Zealand, Public Administration Review 67;5:917-929, Sept/Oct. 2007.</span>

Health IT: Ddulites and Irrational Exuberance

The title is not a typo. I've often tried to explain the phenomenon of irrational exuberance where computers are concerned, especially i...

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Perhaps Hospitals Don't Care Much That EHRs Can Be Dangerous, Because EHRs Lets them Attract 'Good Paying Customers' And Exclude the Old and Poor

This comes as no surprise to me. I believe it may help explain hospital's cavalier attitudes towards the risks of today's commercial health IT.<br /><br />It's all about money. <br /><br />We already knew that (for example, see my Feb. 2011 post "<a href="http://hcrenewal.blogspot.com/2011/02/does-emr-facilitated-upcoding-formely_15.html">Does EHR-Incited Upcoding (Also Known as 'Fraud') Need Investigation by CMS, And Could it Explain HIT Irrational Exuberance?</a>"), but the following news adds to the pecuniary motivations:<br /><br /><blockquote>Kaiser Health News<br /><br /><span style="font-size:130%;"><a href="http://www.kaiserhealthnews.org/Stories/2012/February/06/Hospitals-Mine-Patient-Records.aspx"><span style="font-weight: bold;">Critics say hospitals cherry pick best-paying patients </span></a></span><br />By Phil Galewitz<br />KHN Staff Writer<br /><br />Feb 05, 2012<br /><br />When the oversized postcard arrived last August from Provena St. Joseph Medical Center promoting a lung cancer screening for current or former smokers over 55, Steven Boyd wondered how the hospital had found him.<br /><br />Boyd, 59, of Joliet, Ill., had smoked for decades, as had his wife, Karol.<br /><br />Provena didn't send the mailing to everyone who lived near the hospital, just those who had a stronger likelihood of having smoked based on their age, income, insurance status and other demographic criteria.<br /><br />The nonprofit center is <span style="font-weight: bold;">one of a growing number of hospitals using their patients' health and financial records to help pitch their most lucrative services, such as cancer, heart and orthopedic care.</span> As part of these direct mail campaigns, they are also buying detailed information about local residents compiled by consumer marketing firms — everything from age, income and marital status to shopping habits and whether they have children or pets at home.<br /><br />Hospitals say they are promoting needed services, such as cancer screenings and cholesterol tests, but <span style="font-weight: bold;">they often use the data to target patients with private health insurance, which typically pay higher rates than government coverage.</span> At an industry conference last year, Provena Health marketing executive Lisa Lagger said such efforts had <span style="font-weight: bold;">helped attract higher-paying patients, including those covered by "profitable Blue Cross and less Medicare." <span style="font-style: italic; color: rgb(255, 0, 0);"></span><br /></span></blockquote><br />Not to mention helping exclude those covered by Medicaid, or the uninsured.<br /><br /><p><b></b></p><blockquote><p><b>Strategy Draws Fire</b></p><p>While the strategies are increasing revenues, they are drawing fire from patient advocates and privacy groups, who criticize the hospitals <span style="font-weight: bold;">for using private medical records to pursue profits.</span></p><p><br /></p></blockquote><p></p>I don't recall anywhere on the releases at area hospitals saying they would be using their own clinical data for marketing purposes (which likely involve third party contractors). It might be in the fine print, however. I also don't recall any place to sign and give informed consent to the use of experimental medical devices such as the EHR's used to collect the marketing data, either, but that's addressed elsewhere on this blog such as <a href="http://hcrenewal.blogspot.com/2009/03/draft-patient-rights-statement-and.html">here</a>.<br /><br /><blockquote><br />Doug Heller, executive director of <a href="http://www.consumerwatchdog.org/" target="_blank">Consumer Watchdog</a>, a California-based consumer advocacy group, says he is bothered by efforts to "cherry pick" the best-paying patients.<br /><br />"When marketing is picking and choosing based on people's financial status, it is inherently discriminating against patients who have every right and need for medical information," Heller says. "This is another example of how our health system has gone off the rails."</blockquote><p></p><br />I would go beyond "off the rails." How about, straight to perverse? EHR data is used to attract paying customers and then expose them to risk of being maimed due to the disruptive nature of the HIT itself.<br /><br /><blockquote>Deven McGraw, director of the health privacy project at the Center for Democracy and Technology in Washington, says<span style="font-weight: bold;"> federal law allows hospitals to use confidential medical records to inform patients about things that may help them. </span></blockquote><br />"If it's technically legal, we can do it, and who gives a damn about the ethics?" is what is being expressed here.<br /><br /><p></p><blockquote><p>"You want health providers to communicate to patients about health options that may be beneficial to their health," McGraw says. <span style="font-weight: bold;">"But sometimes this is about generating business for a new piece of equipment that the hospital just bought."</span><br /></p><p>Using such information for marketing "creeps closer to the line," between what is legal and what is not, she says.</p></blockquote><p></p><br />And helping recoup the costs of that hundred-million dollar EHR setup, too.<br /><br /><blockquote><br />... Tess Niehaus, vice president of marketing at St. Anthony’s Medical Center in St. Louis, says the approach has been quite successful and makes no apologies for going after the most lucrative business.<br /><br />"We are here to serve everybody but we <span style="font-weight: bold;">market for good paying patients</span> because it preserves our ability to serve everyone," she says. <span style="font-weight: bold; font-style: italic; color: rgb(255, 0, 0);">[And the ability to proffer generous executive salaries and raises - ed.]</span><br /></blockquote><p></p><br />"Good paying patients?" Does that imply there are bad paying patients? (Might those "bad paying patients" be predominantly the elderly and/or minorities?)<br /><blockquote><br />While the practice is legal, most people would be shocked to <span style="font-weight: bold;">know their </span><a style="font-weight: bold;" href="http://www.worldprivacyforum.org/pdf/TestimonyofPamDixonfs.pdf" target="_blank">records may be shared</a><span style="font-weight: bold;"> with nonmedical personnel and outside firms to help hospitals attract business,</span> says Pam Dixon, executive director of the World Privacy Forum, an advocacy group based in California. "I am really bothered by the <span style="font-weight: bold;">overabundance of information that is flowing that is unnecessary and risky,</span>" she says. </blockquote><br />As I've written before, <a href="http://hcrenewal.blogspot.com/2012/01/2011-closes-on-note-of-electronic.html">don't worry, your most sensitive data's safe in the hands of the extremely skilled health IT professionals</a> at most hospitals.<br /><br /><p></p><blockquote><p>While hospitals may profit from offering cholesterol tests and mammograms, the big payoff is in what those screenings may lead to – additional tests and procedures, including surgery.<span style="font-weight: bold;"><br /></span></p><p><span style="font-weight: bold;">"It's all about downstream revenue,"</span> says Patrick Kane, senior vice president of marketing at Cape Cod Healthcare in Massachusetts who used such approaches at Wellmont Health System in Kingsport, Tenn. <span style="font-weight: bold;">"The old adage in business is that it’s easier to sell an existing customer new services, rather than find a new customer."</span></p></blockquote><p></p><br />So much for medical professionalism and conservatism. At least Mr. Kane admits it's all about money.<br /><br /><blockquote>... Provena's Lagger says the approach boosted the system's bottom line so it could serve people regardless of insurance status.<span style="font-weight: bold;"> "This is a means to an end," she says. </span></blockquote><br />The ends don't always justify the means, but that may be a hard concept for some in today's amoral culture to understand.<br /><br /><blockquote>... Much of the expertise for such campaigns is provided by three consulting firms -- <a href="https://www.cpm.com/index.cfm/customers/testimonials/" target="_blank">CPM Marketing</a> of Madison, Wis., <a href="http://www.blogger.com/www.medseek.com" target="_blank">Medseek</a> of Birmingham Ala. and New York-based <a href="http://thomsonreuters.com/" target="_blank">Thomson Reuters</a>. They typically charge hospitals $100,000 a year or more.<br /><br />CPM, which merged in November with Denver, Colo.-based HealthGrades, a health ratings firm, added 100 new hospitals last year to give it a total of 400. Medseek works with more than 250 hospitals and Thomson Reuters, with 150.</blockquote><p></p><br />Remember Darrin Stevens on <a href="http://en.wikipedia.org/wiki/Bewitched"><span style="font-style: italic;">Bewitched</span></a>? "Larry, I've got a great idea for a new campaign! Let's troll for patients using their private data! Never mind that I have donkey ears today... that darn mother in law of mine, Endora!"<br /><br /><p></p><blockquote><p>The targeting worked in the case of Boyd, who called the number on the back and scheduled the CT scan a few days later. The $169 test showed his lungs were clear, but found potential blockages in coronary arteries that his Provena-affiliated doctor is monitoring.</p><p>"In hindsight, I’m glad I had the test," he says.</p></blockquote><p></p><br />No mention of patients who had unnecessary testing and interventions that led to bad outcomes ... or patients injured by the very EHR systems that make such marketing possible.<br /><br />-- SS

Perhaps Hospitals Don't Care Much That EHRs Can Be Dangerous, Because EHRs Lets them Attract 'Good Paying Customers' And Exclude the Old and Poor

This comes as no surprise to me. I believe it may help explain hospital's cavalier attitudes towards the risks of today's commercia...

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A comment posted to the website "Doctors Helping Doctors Transform Healthcare", Peter Basch, William Bria et al.

A new website has appeared that purports to be:<br /><br /><blockquote>A collaborative effort led primarily by doctors for doctors to provide a "trusted resource" for physicians as they work to transform health care - initially through the use of health IT.</blockquote><br />The site is entitled "<span style="font-weight: bold;">Doctors Helping Doctors Transform Health Care</span>" and is at <a href="http://doctorshelpingdoctorstransformhealthcare.org/">this link</a>. (I note that when one encounters such platitudinous and potentially highly ideological titles, one should ask "<span style="font-style: italic;">transform how, and into what</span>, <span style="font-style: italic;">exactly?</span><span style="font-style: italic;">"</span> I presume "transform" means, in part, to <span style="font-style: italic;">reduce</span><span style="font-style: italic;"> </span><span>risk</span> and <span style="font-style: italic;">improve</span><span style="font-style: italic;"> safety</span><span style="font-style: italic;"> </span><span style="font-style: italic;">and outcomes</span> - while <span>protecting</span> patient<span style="font-weight: bold;"> and</span> physician rights.)<br /><br />The site has a significant number of people on their advisory board (<a href="http://doctorshelpingdoctorstransformhealthcare.org/leadership/">link</a>), but no information on compensation. I note there are industry people involved, representing a potential conflict of interest.<br /><br />According to one of the principals, <a href="http://doctorshelpingdoctorstransformhealthcare.org/author/pbasch/"><strong style="font-weight: normal;">Peter Basch, MD</strong></a>, Medical Director, Ambulatory EHR and Health Information Technology Policy, MedStar Health, Washington, DC, <a href="http://doctorshelpingdoctorstransformhealthcare.org/2011/why-doctors-helping-doctors/">on funding:</a><br /><br /><p><strong></strong></p><blockquote><p><strong>A Few Words About Our Supporters</strong></p> <p>It takes resources to create and maintain this site, to make the work of <em>Doctors Helping Doctors</em> possible. We have solicited unrestricted contributions from individuals and organizations who believe in our mission and are able to support its work. In particular, we wish to thank Patrick Soon-Shiong of the Chan Soon-Shiong Family Foundation, John Glaser of Siemens Health Services; and Andy Slavitt of Optum’s Institute for Sustainable Health.</p></blockquote><p></p><br />To my knowledge, I've never met Dr. Basch, but at meetings I have met one of the other principals of the new website, <a href="http://doctorshelpingdoctorstransformhealthcare.org/author/wbria/"><strong style="font-weight: normal;">William Bria, III, MD</strong></a>, Chief Medical Information Officer, Shriners Hospitals for Children; President and Co-Founder, Association of Medical Directors of Information Systems (AMDIS), St. Petersburg, FL.<br /><br />Dr. Basch's writing has appeared at Healthcare Renewal before, such as at<span style="font-weight: bold;"> </span>the Jan. 2009 post "<a href="http://hcrenewal.blogspot.com/2009/01/throwing-national-research-council.html">Throwing The National Research Council Report On Health IT Under The Bus, Part 1: MedStar Health</a>."<br /><br />In the new site, Dr. Basch states that:<br /><br /><blockquote>As early adopters, EHR implementers, and practicing physicians, we have seen the “bad and the ugly” as well as the promise of health IT. We understand how health IT can and should be used to make care better, safer, and more value-laden. As such, we believe that unnecessarily harsh criticism of Meaningful Use—which we have heard from some quarters—<span style="text-decoration: underline;">and</span> uncritical cheerleading—which we have also heard—are equally unhelpful.<br /><br /><span style="font-weight: bold;">We see physician “extremism” essentially marginalizing</span> what is needed now more than ever—a clear and constructive physician voice, articulating not for compliance with Meaningful Use, but rather leveraging the opportunity that Meaningful Use presents, and consistently inserting the highest ideals that led us all to choose a career in medicine.</blockquote><br />While on the surface this is not an unreasonable position, I fear the word "extremism" is used as a metaphor for those who express genuinely critical appraisals of the state of health IT as it now exists, on issues regarding safety, efficacy, usability, need for regulation, vendor, buyer and user liability, and other "unpleasant" topics.<br /><br />I do note precious little on the site about educating physicians on the considerable downsides of health IT as it currently exists, nor on the scientific literature expressing doubts about its safety, efficacy, usability, ROI and other issues (such as <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=readinglist">here</a>).<br /><br />There is, it would seem obvious, no ethical excuse for introducing medical devices and other technology of unknown benefit and of unknown risk magnitude (as recently reported by the IOM, see <a href="http://hcrenewal.blogspot.com/2011/11/iom-report-on-health-it-safety-nix-fda.html">this post</a>), that is <a href="http://hcrenewal.blogspot.com/2011/04/fda-decides-regulating-implantable.html">unregulated</a>, into life-critical domains such as medicine without explicit acknowledgement of <span style="font-style: italic;">experimentation</span>. Human subjects experimentation requires, of course, explicit informed consent under the <a href="http://grants.nih.gov/grants/policy/hs/ethical_guidelines.htm">many guidelines</a> formulated as a result of past systemic abuses. Also, users need to be fully aware of the risks.<br /><br />Such informed consent cannot be accomplished, and awareness attained by physicians regarding the dangers of use of health IT in its present form, through simple "best practices" protagonism.<br /><br />For instance, health IT can be inherently defective and/or <a href="http://www.tinyurl.com/hostileuserexper">mission hostile</a> (worse, the industry is unregulated), and can injure or kill. Several illustrative examples just off the top of my head are at:<br /><br /><ul><li><span style="font-size:85%;">"<a href="http://hcrenewal.blogspot.com/2011/12/fda-recalls-health-it-software-because.html">FDA Recalls Draeger Health IT Device Because This Product May Cause Serious Adverse Health Consequences, Including Death</a>";</span></li></ul><ul><li><span style="font-size:85%;">"<a href="http://hcrenewal.blogspot.com/2011/11/lifespan-rhode-island-yet-another.html">Lifespan (Rhode Island): Yet another health IT 'glitch' affecting thousands</a>";</span></li></ul><ul><li><span style="font-size:85%;">"<a href="http://hcrenewal.blogspot.com/2010/07/maude-database-patient-outcome-death.html">FDA MAUDE Database: Patient Outcome - Death</a>" and "<a href="http://hcrenewal.blogspot.com/2011/01/maude-and-hit-risk-mother-mary-what-in.html">FDA Manufacturer and User Facility Device Experience (MAUDE) database - case reports of EHR defects</a>";</span></li></ul><ul><li><span style="font-size:85%;">"<a href="http://hcrenewal.blogspot.com/2010/12/ecri-healthcare-it-in-top-ten-health.html">ECRI: Healthcare IT In Top Ten Health Technology Threats to Patient Safety</a>";</span></li></ul><ul><li><span style="font-size:85%;">"<a href="http://iig.umit.at/efmi/badinformatics.htm">Bad Health Informatics Can Kill</a>" [European Federation for Medical Informatics];<br /></span></li></ul><ul><li><span style="font-size:85%;"> "<a href="http://sydney.edu.au/engineering/it/%7Ehitru/index.php?option=com_content&task=view&id=91&Itemid=146">A Study of an Enterprise Health information System</a>" [Australia - severe deficiencies in software engineering noted in major U.S. vendor ED EHR system that cause user confusion as well as data corruption/loss];</span></li></ul><ul><li><span style="font-size:85%;">"<a href="http://www.isb.nhs.uk/documents/isb-0160/dscn-18-2009/0160182009specification.pdf">Health informatics — Guidance on the management of clinical risk relating to the deployment and use of health software</a>" [ISO/UK NHS - with an accounting of EHR-related medical errors in Annex A];<br /></span></li></ul><ul><li><span style="font-size:85%;"> and a personal account "<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=diary">A Diary of EHR-Initiated Tragedy</a>."</span></li></ul><br />Not even including privacy and confidentiality issues (see <a href="http://hcrenewal.blogspot.com/search/label/medical%20record%20privacy">this query link</a> on those issues), should physicians, nurses, patients and other stakeholders not be explicitly educated on the issues of risk, that can be greatly replicated/amplified across hundreds or thousands of patients by EHRs as opposed to paper, and on actual injuries and deaths that have occured? If not, why not?<br /><br />Are not these issues and the issue of the <a href="http://hcrenewal.blogspot.com/2010/08/health-it-via-observation-and-research.html">lack of a culture of safety in the health IT field</a> at least as important, <span style="font-weight: bold;">if not more important</span> for clinicians, patients, healthcare executives and other stakeholders to be strongly aware of than "best practices" and "meaningful use?"<br /><br />(I note that the "<span style="font-style: italic;">negative reports are mere anecdotes</span>" argument commonly used by health IT pundits only shows, as in the Aug. 2011 essay by a senior clinician in Australia "<a href="http://hcrenewal.blogspot.com/2011/08/from-senior-clinician-down-under.html">From a Senior Clinician Down Under: Anecdotes and Medicine, We are Actually Talking About Two Different Things</a>", that those making that argument need to attend revision courses in research methodology and risk management.)<br /><br />In consideration of the "Doctors Helping Doctors" site's seemingly uncritical pro-HIT advocacy, I have posted the following note at the end of Dr. Basch's introductory essay. The comment appears <a href="http://doctorshelpingdoctorstransformhealthcare.org/2011/why-doctors-helping-doctors/#comment-20">at this link</a> and is awaiting moderation.<br /><br />The comment's remaining online would be a sign that the site is not another attempt to "<a href="http://hcrenewal.blogspot.com/2011/03/how-lousy-health-it-gets-pushed-on.html">control the channel</a>", and is truly serious about being "trusted." It would be a sign of a site truly concerned with "physicians helping physicians transform health care" <span style="font-weight: bold;">while not sacrificing patients as unconsenting test subjects</span> of unregulated, experimental <a href="http://hcrenewal.blogspot.com/2011/04/fda-decides-regulating-implantable.html">software-based medical devices</a> in the process.<br /><br /><cite class="fn"><a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/" rel="external nofollow" class="url"></a></cite><blockquote><cite class="fn"><a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/" rel="external nofollow" class="url">S Silverstein MD</a></cite> <span class="says">says:</span> <div class="comment-meta commentmetadata"> <a href="http://doctorshelpingdoctorstransformhealthcare.org/2011/why-doctors-helping-doctors/#comment-20">December 17, 2011 at 10:29 pm</a> </div><br />Doctors,<br /><br />One way to help doctors transform healthcare would be to educate them on the downsides of information technology in healthcare, how to avoid them, and the conflicting literature on benefits (e.g., as at <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=readinglis">http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=readinglist</a>).<br /><br />I do not see such information here yet.<br /><br />I do expect some such information will follow.<br /><br />Sincerely,<br /><br />Scot Silverstein<br /><br />---------------------------------------------------<br />Scot M. Silverstein, MD<br />Consultant/Independent Expert Witness in Healthcare Informatics (May 2010-present)<br />Adjunct faculty in Healthcare Informatics and IT (Sept. 2007-present)<br />Assistant Professor of Healthcare Informatics and IT, and Director, Institute for Healthcare Informatics (2005-7)<br /><br />Drexel University<br />College of Information Science and Technology<br />3141 Chestnut St., Philadelphia, PA 19104-2875<br /><br />Email: sms88 AT drexel DOT e-d-u<br />Bio: <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/biography.htm">http://www.ischool.drexel.edu/faculty/ssilverstein/biography.htm</a><br />Common Examples of Healthcare IT Difficulties: <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/">http://www.ischool.drexel.edu/faculty/ssilverstein/cases/ </a><br /><br />Note: I am cross-posting this comment on Healthcare Renewal blog under the title "A comment posted to the website 'Doctors Helping Doctors Transform Healthcare, Peter Basch, William Bria et al.'"</blockquote><br />It is my hope the comment stays, and receives a reasoned reply.<br /><br />-- SS<br /><br /><span style="font-weight: bold;">Dec. 23, 2011 addendum:</span><br /><br />My comment appears to have disappeared. I leave it to the reader to determine what that means about the site "Doctors Helping Doctors Transform Healthcare."<br /><br />-- SS

A comment posted to the website "Doctors Helping Doctors Transform Healthcare", Peter Basch, William Bria et al.

A new website has appeared that purports to be: A collaborative effort led primarily by doctors for doctors to provide a "trusted resou...

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Yet more health IT articles based on functionalist and determinist assumptions of the general format “what is the impact of technology X on outcome Y"

The article "<span style="font-weight: bold;">Tensions and Paradoxes in Electronic Patient Record Research: A Systematic Literature Review Using the Meta-narrative Method</span>" by Greenhalgh, Potts, Wong, Bark and Swinglehurst at University College London appeared in the Dec. 2009 <a href="http://www.milbank.org/quarterly.html">Milbank Quarterly</a>. I wrote about it extensively and quoted it at <a href="http://hcrenewal.blogspot.com/2009/12/healthcare-it-as-cybernetic-miracle.html">this post</a>. A key statement:<br /><br /><blockquote>... This review has also identified some areas where more research does <span style="font-weight: bold; font-style: italic;">not</span> appear to be needed ... [including] simplified experimental studies <span style="font-weight: bold;"> based on functionalist and determinist assumptions of the general format “what is the impact of technology X on outcome Y?” or variations thereof </span>... the circumstances in which they add value are more limited than is often assumed.<br /><br />We [also] believe that surveys of attitudes of patients or staff towards ‘the EPR’ or ‘computerization’ which are not adequately contextualized have almost no enduring value.</blockquote><br />So guess what was just published in the NEJM?<br /><br />An article <span style="font-weight: bold;">based on functionalist and determinist assumptions of the general format “what is the impact of technology X on outcome Y."</span><br /><br />In a special article entitled "<span style="font-weight: bold;">Electronic Health Records and Quality of Diabetes Care</span>", NEJM August 31, 2011 (<a href="http://healthpolicyandreform.nejm.org/?p=15235&query=TOC">link</a>), a study was performed in which the researchers:<br /><br /><blockquote>... compared EHRs with paper-based records in a long-term regional collaborative that seeks to improve care and outcomes for patients with chronic conditions. </blockquote><br />They found that:<br /><blockquote><br />... EHR sites were associated with higher levels of achievement of and improvement in regionally vetted standards for diabetes care and outcomes. Our findings focus on composite standards, although the results were similar for virtually all component standards. </blockquote><br />This is not really news. I had the same results in a more limited EHR data-based study of diabetics ... in 1997.<br /><br />As I've often written, health IT can be of great benefit...but only if done well. (I have to frequently repeat that there is massive, perhaps <a href="http://en.wikipedia.org/wiki/Wicked_problem">wicked</a> complexity behind those simple two words "done well.") When not done well, disaster can strike.<br /><br />There are no statistics in in the NEJM article regarding complications, "close calls", patient injuries, or patient deaths due to the implementation of health IT. I sincerely doubt the incidence was zero. Their dismissal or lack of mention is common in the medical and health IT literature and seems to reflect an amoral, pervasive paternalism in medicine. The amoral paternalism in turn seems to be a repeat of the attitudes towards experimentation that led to the many human subjects protections that apply everywhere else in biomedicine (<a href="http://ohsr.od.nih.gov/guidelines/index.html">link</a>) - except computing - e.g.:<br /><p><a href="http://ohsr.od.nih.gov/guidelines/45cfr46.html"></a></p><blockquote><p><a href="http://ohsr.od.nih.gov/guidelines/45cfr46.html">45 CFR 46</a> Protection Of Human Subjects</p> <p><a href="http://ohsr.od.nih.gov/guidelines/GrayBooklet82404.pdf">Guidelines for Conduct of Research Involving Human Subjects at NIH (Gray Booklet) (pdf file)</a></p> <p><a href="http://ohsr.od.nih.gov/guidelines/belmont.html">The Belmont Report</a> Ethical Principles and Guidelines for the Protection of Human Subjects of Research</p> <p><a href="http://ohsr.od.nih.gov/guidelines/nuremberg.html">Nuremberg Code</a> Directives for Human Experimentation</p> <p><a href="http://ohsr.od.nih.gov/guidelines/helsinki.html">World Medical Association Declaration Of Helsinki</a></p> </blockquote><br />To their credit, the NEJM authors did issue several caveats:<br /><br /><blockquote>... we compared sites that had sophisticated EHR systems<span style="font-weight: bold;"> with paper-based organizations that, as safety-net practices, care for a vulnerable patient population and may have fewer quality-related resources than other paper-based practices</span> ... Our results, showing accelerated improvement in care and outcomes, should encourage those concerned that the quality of ambulatory care may fail to improve with increased adoption of EHRs <span style="font-weight: bold; font-style: italic; color: rgb(255, 0, 0);">[per numerous past studies - ed.]</span> ... our study <span style="font-weight: bold;">did not determine changes in achievement after the conversion from paper to electronic record</span>s, which would provide more compelling evidence of the benefits of EHRs.</blockquote><br />One might wonder how the tens or hundreds of millions of dollars spent on EMR's might compare, with regard to disease management, with the results achieved by hundreds of dedicated people who could be hired for that purpose for far less money. In other words, the ROI issues of the health IT investment vs. alternatives are not addressed (they rarely are), and truly robust RCT's were not performed comparing the two alternatives.<br /><br />Greenhalgh et al. also wrote in the aforementioned Milbank article:<br /><br /><blockquote>... as a cross-cutting theme in all the above areas, the realpolitik of EPR projects within and between organizations and interest groups should be more explicitly explored ... Orlikowski and Yates have called for more research on the “<span style="font-weight: bold;">messy, dynamic, contested, contingent, negotiated, improvised, heterogeneous, and multi-level character of ICTs [<span style="font-style: italic; color: rgb(255, 0, 0);">information & communications technologies - ed.]</span> in organizations</span>” (page 132) (Orlikowski and Yates 2006).<br /><br />We suggest that sponsors and publishers<span style="font-weight: bold;"> eschew sanitized accounts of successful projects</span> and instead <span style="font-weight: bold;">invite studies of the EPR in organizations that “tell it like it is” – perhaps using the critical fiction technique to ensure anonymity</span> (Winter 1986).</blockquote><br />There's no trace of that in the new NEJM article. Where health IT is concerned, that's where the money is (no pun intended) in learning how to "do health IT well."<br /><br />-- SS

Yet more health IT articles based on functionalist and determinist assumptions of the general format “what is the impact of technology X on outcome Y"

The article " Tensions and Paradoxes in Electronic Patient Record Research: A Systematic Literature Review Using the Meta-narrative Met...

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On Penalties for Alteration of Electronic Health Records

I am increasingly hearing stories of alleged alterations occurring in electronic medical records.<br /><br />Since there is no permanent paper record in an increasing number of facilities, some might believe digital alterations might be easier to get away with.<br /><br />Not so, according to S. Sandy Sanbar, MD, PhD, JD, FCLM in a <a href="http://www.ablminc.org/Model_Curriculum_LMME_2010/BOOK_Legal%20Medicine-7th_2007/Ch34-Medical%20Records,%20Paper%20and%20Electronic.pdf">book chapter partly on advantages and disadvantage of electronic records</a> (PDF) from the American Board of Legal Medicine, <a href="http://www.ablminc.org/">http://www.ablminc.org/</a>:<br /><br /><blockquote><span style="font-weight: bold;">Alteration, Destruction, or Loss of Medical Records</span><br /><br />... no entry in the medical record should ever be altered or backdated.<br /><br />In the law of evidence, the loss, destruction, or significant alteration of evidence is termed “spoliation of evidence.” Thus, when medical records that have been altered, or had portions removed, or cases in which the record cannot be found come before the court, the evidentiary concept of spoliation of evidence is invoked. The common law evidentiary inference concept or remedy for spoliation is explained by Wigmore as an indication that the spoiler’s case is weak, and “operates, indefinitely though strongly, against the whole mass of alleged facts constituting his cause” (2 Wigmore<br />(3d ed. 1940) §278 p. 120 (emphasis added). [25]<br /><br />Therefore, alterations to records can prove to be disastrous. Records with alterations are absolutely deadly in court. Document examination is now a sophisticated science. With skill and uncanny accuracy, experts may be able to determine the time that entries were made in medical records and who made them. [26] <span style="font-weight: bold; font-style: italic; color: rgb(255, 0, 0);">[Electronic records can greatly facilitate this process, and there are specialty companies with the forensic expertise to analyze EMR data for tampering - ed.]</span><br /><br />Courts reason that destroying or altering records in anticipation of or in response to a discovery request falls under the umbrella of misuse of discovery. Discovery rules provide a broad range of sanctions for the misuse of discovery. Sanctions can include monetary fines, contempt charges, establishing or precluding the facts at issue, striking pleadings, dismissing all or parts of the action, and even granting a default judgment against the offending party. In addition to these evidence and discovery sanctions, many penal codes include criminal penalties for perjury and spoliation. [27] In several jurisdictions, spoliation of evidence itself is a cause of action in tort. [28]<br /><br />Therefore, tampering with medical records may make malpractice cases impossible to defend. Further, providers who falsify a patient’s record may be found civilly and criminally liable. Proof of such charges will result in loss of hospital privileges and even loss of license to practice [29].</blockquote><br />As I look for new avenues to explore regarding the legal EHR, which is an interest of mine (having supervised a Johns Hopkins postdoc's thesis on that topic), gaining expertise in EHR alteration detection is a prime area for me.<br /><br />Another good source of information on this topic is a new book "<span style="font-weight: bold;">Basics of e-Discovery</span>", PA Bar Institute, PBI number 2010-6139. Unfortunately, the book is not free, but is available in law libraries such as the library at my university, Drexel:<br /><blockquote><br />EARLE MACK SCHOOL OF LAW AT DREXEL UNIVERSITY LEGAL RESEARCH CENTER<br />SUBJECT Civil and appellate procedure.<br />TITLE Basics of e-Discovery.<br />IMPRINT [Mechanicsburg, Pa.] (5080 Ritter Rd., Mechanicsburg 17055-6903) : Pennsylvania Bar Institute, c2010.<br />DESCRIPT xii, 160 p. : ill. ; 28 cm.<br />SERIES PBI ; no. 2010-6139.<br />CALL NO. KFP537.5 .E4 B38 2010<br />LOCATION Legal Research Center Pennsylvania Collection</blockquote><br />It is my belief that EHR alteration, facilitated (or seemingly so) through the elimination of a permanent paper record, needs to uniformly carry very serious consequences, including permanent loss of involvement in clinical affairs, and incarceration.<br /><br />-- SS

On Penalties for Alteration of Electronic Health Records

I am increasingly hearing stories of alleged alterations occurring in electronic medical records. Since there is no permanent paper record i...

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Another Blow to the Health IT Idealists: Sony CEO Howard Stringer, and HHS OIG, on Information Security

In a series of Healthcare Renewal posts such as those linked below, I pointed out that healthcare IT information security was largely a pipe dream, and that plans to create a national network of health information, while a seductive idea dating to the beginnings of computer networking, is not a good idea now.<br /><br /><ul><li>"<a href="http://hcrenewal.blogspot.com/2010/02/networked-emrs-and-healthcare.html">Networked EMR's and Healthcare Information Security: Practical When Massive IT Security Breaches Continue</a>?",</li></ul><ul><li>"<a href="http://hcrenewal.blogspot.com/2010/02/networked-interoperable-secure-national.html">Networked, Interoperable, Secure National Medical Records a Castle in the Sky?</a>",</li></ul><ul><li>"<a href="http://hcrenewal.blogspot.com/2010/01/it-flaws-and-coverups-of-same-why-i.html">Operation Aurora And a Widespread Reluctance to Discuss IT Flaws: Is Universal Healthcare IT Really a Good Idea in 2010?</a>",</li></ul><ul><li>"<a href="http://hcrenewal.blogspot.com/2010/10/medical-data-breach-of-week-but-your.html">Medical data breach of the week - but your EMR data is secure, trust us, we're IT experts</a>", </li></ul><ul><li>"<a href="http://hcrenewal.blogspot.com/2010/11/insurers-test-data-profiles-to-identify.html">Insurers Test Data Profiles to Identify Risky Clients</a>",</li></ul><ul><li>and <a href="http://hcrenewal.blogspot.com/search/label/medical%20record%20privacy">others</a></li></ul><br />Now you can hear it from another source: The CEO of one of the world's largest electronic companies, Sony.<br /><br />Emphases mine:<br /><span style="font-weight: bold;"><br /></span><a href="http://online.wsj.com/article/SB10001424052748703421204576328982377107892.html"></a><blockquote><a style="font-weight: bold;" href="http://online.wsj.com/article/SB10001424052748703421204576328982377107892.html">Sony CEO Warns of 'Bad New World' </a><br /><span style="font-weight: bold;">Wall Street Journal</span><br /><span style="font-weight: bold;">May 8, 2011</span><br /><br /><p>TOKYO—After spending weeks to resolve a massive Internet security breach, <a href="http://online.wsj.com/public/quotes/main.html?type=djn&symbol=SNE" class="companyRollover link11unvisited">Sony</a> Corp. Chief Executive <a href="http://topics.wsj.com/person/s/howard-stringer/243" class="topicLink">Howard Stringer</a> said he c<span style="font-weight: bold;">an't guarantee the security of the company's videogame network or any other Web system in the "bad new world" of cybercrime.</span><br /></p><p>Mr. Stringer's comments in a phone interview Tuesday, ahead of a New York roundtable discussion with reporters, come on the heels of a trying month for Sony. The company partially restored two of its online game systems and a streaming movie and music service over the weekend after shutting the services for several weeks when a <span style="font-weight: bold;">breach compromised the personal information of more than 100 million account holders.</span><br /></p><p>While Sony has restored part of the PlayStation Network—an online game system for its PlayStation 3 videogame console—in the U.S. and Europe and bolstered security measures, Mr. Stringer, 69 years old, said <span style="font-weight: bold;">maintaining the service's security is a "never-ending process" and he doesn't know if anyone is "100% secure."</span><br /></p><p>He said the security breach at PSN, Sony Online Entertainment, an online game service for personal-computer users, and its Qriocity streaming video and music network his company could lead the way to bigger problems well beyond Sony, or the gaming industry. He warned <span style="font-weight: bold;">hackers may one day target the global financial system, the power grid or air-traffic control systems</span>.<span style="font-weight: bold; font-style: italic; color: rgb(204, 0, 0);"> [And healthcare, where identity theft, data alteration, and data destruction might occur - ed.]</span><br /></p><div style="overflow: hidden; text-decoration: none; border: medium none;"> <div style="overflow: hidden; text-decoration: none; border: medium none;"></div></div></blockquote><div style="overflow: hidden; text-decoration: none; border: medium none;"><div style="overflow: hidden; text-decoration: none; border: medium none;"><br />I really don't think this is the time to be setting up a national health information network.<br /><br />Beyond that, I offer no additional comments, other than that regarding the impossibility of keeping healthcare information secure on a national or even regional network, you may have heard it first here at Healthcare Renewal.<br /><br />It would be prudent and consistent with the Hippocratic Oath to tone down our grandiose expectations and grandiose plans for these technologies in healthcare.<br /><br />If you feel insecure yet, just wait a moment.<span style="font-weight: bold;"><br /><br />Going from very, very bad to very much worse:</span><br /><br />An independent audit of ONC's and CMS's security programs by the HHS OIG (Office of the Inspector General) produced concerning if not alarming results to say the least:<br /><br /><a href="http://www.healthleadersmedia.com/content/FIN-266313/HIT-Security-Problems-Found-at-CMS-ONC"></a><blockquote><a style="font-weight: bold;" href="http://www.healthleadersmedia.com/content/FIN-266313/HIT-Security-Problems-Found-at-CMS-ONC">Federal Audits Find HIT Security Problems at CMS, ONC </a><br /><span style="font-weight: bold;">John Commins, for HealthLeaders Media</span><br /><span style="font-weight: bold;">May 18, 2011</span><span><br /><br />Audits of the federal agencies charged with implementing and monitoring security measures for healthcare information technology <span style="font-weight: bold;"> identified this week lax oversight and insufficient standards for healthcare providers.</span></span><span><br /><br />The audits were conducted by the Department of Health and Human Services' Office of Inspector General, and t<span style="font-weight: bold;">argeted HIT security standards, privacy protection under HIPAA, and other security measures at the Centers for Medicare & Medicaid Services, and the Office of the National Coordinator</span>. "</span>These two reports are being issued simultaneously because OIG found weaknesses in the two HHS agencies entrusted with keeping sensitive patient records private and secure," OIG said in a media release.<span><br /><br />The CMS audit, </span><i>Nationwide Rollup Review of the Centers for Medicare & Medicaid Services Health Insurance Portability and Accountability Act of 1996 Oversight</i>, <span>examined seven hospitals across the country and<span style="font-weight: bold;"> found 151 "vulnerabilities" in systems and controls that are designed to safeguard electronic protected health information</span>.</span><span><br /><br />Those lapses included <span style="font-weight: bold;">124 "high impact vulnerabilities"</span> such as </span>unencrypted laptops and portable drives containing sensitive personal health information, outdated antivirus software and patches, unsecured networks, and the failure to detect rogue devices intruding on wireless networks, the OIG audit said.<span><br /><br />"<span style="font-weight: bold;">These vulnerabilities placed the confidentiality, integrity, and availability of ePHI at risk. </span>Outsiders or employees at some hospitals could have accessed, and at one hospital did access, systems and beneficiaries' personal data and performed unauthorized acts without the hospitals' knowledge," the OIG audit said. "As a result, CMS had limited assurance that controls were in place and operating as intended to protect electronic protected health information,<span style="font-weight: bold;"> thereby leaving ePHI vulnerable to attack and compromise.</span></span><br /><br />OIG's Audit of Information Technology Security Included in Health Information Technology Standards examined ONC's mandate under the HITECH Act to develop HIT security as part of a national HIT interoperability infrastructure. The audit found <span style="font-weight: bold;">"no HIT standards that included general information IT security controls … which provide the structure, policies, and procedures that apply to a healthcare provider's overall computer operations, ensure the proper operation of information systems <span style="font-style: italic; color: rgb(255, 0, 0);">[which obviously also impacts patient safety - ed.]</span>, and create a secure environment for application systems and controls.</span></blockquote><p><br /></p><p>That's not very reassuring. In fact, it is downright frightening. ONC has to learn such lessons from HHS OIG? Read the whole thing.</p><p>I somewhat mordantly note that organizations such as ONC and CMS would probably never hire a person like me, who might actually kick-start true critical thinking on these issues. This is due to my non-<span style="font-style: italic;">bien pensant</span> "bad attitudes", and lack of faith in cybernetic idols.</p><p><br /></p><p><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgmnwU_sH88Ham6kL2ikFt88_2qx899yg4zsSynC9_sggBBClRDUYMxnZnxfE06yrPqWhz7crbwSYQdkbQc8scVnH0kyg5Y9-g4MUsvHlEcswajJ_WzalDVaLBTGwwOB4RJ7rim6pJZRmDD/s1600/golden_calf.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5608090912264648962" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgmnwU_sH88Ham6kL2ikFt88_2qx899yg4zsSynC9_sggBBClRDUYMxnZnxfE06yrPqWhz7crbwSYQdkbQc8scVnH0kyg5Y9-g4MUsvHlEcswajJ_WzalDVaLBTGwwOB4RJ7rim6pJZRmDD/s320/golden_calf.jpg" style="display: block; margin: 0px auto 10px; text-align: center; cursor: pointer; width: 305px; height: 217px;" /></a></p><p style="text-align: center;"><span style="font-size:85%;">Click to enlarge. A well-known idol of gold. Computer circuits use gold, no?</span><br /></p><p>-- SS<span style="font-weight: bold;"><br /></span></p><br /></div></div>

Another Blow to the Health IT Idealists: Sony CEO Howard Stringer, and HHS OIG, on Information Security

In a series of Healthcare Renewal posts such as those linked below, I pointed out that healthcare IT information security was largely a pip...

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CPOE Cesspool

<span>An accomplished physician who <a href="http://hcrenewal.blogspot.com/2011/04/when-will-first-class-action-lawsuit-on.html">read my post on CPOE</a> at Memorial Sloan Kettering causing medical errors and near misses, and lack of FD&C Act regulation of health IT medical devices, relates the following:<br /><br /><blockquote>So I want to stop medications on a patient. The device only allows me to stop one at a time, and for each one, it requires me to type in a reason.<br /><br />Then, I get another pop up screen to enter my password.<br /><br /><span style="font-weight: bold;">Six clicks and two manual entries to stop an aspirin</span>, not counting the click to get to the med list. <span style="font-weight: bold; font-style: italic; color: rgb(255, 0, 0);"> [What a valuable use of physician time! - ed.]</span><br /><br />Also, I have found that when I want an order for something that is labor intensive to enter, and I ask house staff <span style="font-weight: bold; font-style: italic; color: rgb(255, 0, 0);">[trainees - ed.]</span> to do it, I get balking as to why I want that treatment or infusion.<br /><br />The arguments, I have found, are not really about the treatment. They are about their avoiding the pain in the ass of having to deal with the user unfriendly screens for that order.<br /><br />The doctors all put up with this.</blockquote><br />Yet for some reason this waste of valuable clinician time due </span>to antediluvian<span> HIT design, and even wild goose chases for critical medications such as in my Apr. 5, 2011 post "</span><a href="http://hcrenewal.blogspot.com/2011/04/special-k-red-berries-mission-hostile.html">Mission Hostile Health IT Obstructs Physicians From Ordering Life Saving Drugs In Critical Emergency</a>"<span>, are considered "progress" in medicine.<br /><br />World class medical centers such as Sloan Kettering consider CPOE a "<a href="http://hcrenewal.blogspot.com/2011/04/when-will-first-class-action-lawsuit-on.html">critical vulnerability</a>" towards near misses and outright medical errors.<br /><br />Still, this IT toxicity is considered "progress" right up to our Department of HHS and POTUS.<br /><br />Why?<br /><br />-- SS<br /></span>

CPOE Cesspool

An accomplished physician who read my post on CPOE at Memorial Sloan Kettering causing medical errors and near misses, and lack of FD&C...

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What's Killing Pharma, With Some Lessons For Hospital IT

<div>An excellent essay on the pathologies killing the pharmaceutical industry is at this link:<a href="http://www.eyesopen.com/en/blog/what-is-really-killing-pharma"> http://www.eyesopen.com/en/blog/what-is-really-killing-pharma</a> .<br /><br />The essay talks about mismanagement, marketing over R&D, management fads, ill-informed managers and many other issues we've discussed in one context or another here at Healthcare Renewal.<br /><br />This paragraph in particular struck my eye for several reasons:<br /><br /><blockquote>... Another good one <span style="font-weight: bold; font-style: italic; color: rgb(255, 0, 0);">[reason pharma is dying - ed.]</span>: <span style="font-weight: bold;">empowering IT departments to make scientists use the same infrastructure as the guy at the front desk.</span> Rather than see that scientists often have different computing needs than other parts of the business, IT demands obeisance to the corporate norm. In doing so, they hinder the kind of innovation (e.g., Linux, GPU solutions) that used to regularly occur because scientists are quite computer literate, thank you. <span style="font-weight: bold;">Instead, IT departments make it impossible for competent people to manage their own resources. They create obstacles instead of removing them.</span> Machine was made for Man, not Man for the Machine.</blockquote><br />The paragraph struck me because:<br /><br /><ul><li>It fits with my experience and that of my colleagues in other pharmas. See my essay "<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=pharma">Sure path to R&D and industrial failure: Conflation of IT with information science in the pharmaceutical industry</a>."</li></ul><ul><li>Replace "scientists" with "doctors" and you have defined a major problem with health IT In the healthcare delivery sector.</li></ul><ul><li>Finally, this bon mot is extremely apropos to both environments: "<span style="font-weight: bold;">Machine was made for Man, not Man for the Machine</span>."</li></ul>Sixty years into the "computer revolution", pharma, healthcare, and the IT industry itself <span style="font-style: italic;">have</span> <span style="font-style: italic;">not learned this simple lesson</span>.<br /><br />I have to believe in 2011 this phenomenon is at least in part due to an abundance of powerful computers relative to the supply of humans in these industries with densely-interconnected gray matter.<br /><br />I think the author of the aforementioned piece agrees. He concludes:<br /><br /><blockquote>... The film industry long ago recognized that what is important is<span style="font-weight: bold;"> talent</span>. No one can predict what will be a blockbuster (drug or movie), but <span style="font-weight: bold;">Hollywood has at least recognized that movie-making is a talent-based industry</span>. Perhaps today’s pharma chiefs need to see themselves as latter-day studio heads—I’m sure they’d love that!—and come to the same conclusions. Define the vision, <span style="font-weight: bold;">get and keep the right people, stop making it harder for talented people to do their jobs, give them the time and resources to be creative. </span>Then maybe, just maybe, they would start curing pharma.</blockquote><br /><br />-- SS<br /></div>

What's Killing Pharma, With Some Lessons For Hospital IT

An excellent essay on the pathologies killing the pharmaceutical industry is at this link: http://www.eyesopen.com/en/blog/what-is-really-...

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How Terrible Health IT (And Other Healthcare Toxic Waste) Gets Pushed on Naïve and Malleable Physicians, Hospital Executives and Governments

Over at "<a href="http://brodyhooked.blogspot.com/">Hooked: Ethics, Medicine, and Pharma</a>", <span id="ctl00_ucBreadcrumbs_lblCustomBreadcrumbs">University of Texas Medical Branch at Galveston (</span>UTMB) Institute for the Medical Humanities professor <a href="http://www.utmb.edu/imh/faculty.asp?FacID=53">Howard Brody MD, PhD</a> offers a fascinating piece "<a style="font-weight: bold;" href="http://brodyhooked.blogspot.com/2010/06/how-does-drug-industry-exert-power.html">How Does the Drug Industry Exert Power? An Anthropological Perspective</a><span style="font-weight: bold;">."</span><br /><br />The piece is based on writings of of <a href="http://www4.uwm.edu/letsci/anthropology/faculty/applbaum.cfm">Kalman Applbaum</a>, of the Department of Anthropology, University of Wisconsin-Milwaukee, and summarizes how the drug industry achieves its aims in today's society.<br /><br />In Prof. Brody's post:<br /><br /><blockquote>... Applbaum begins by teaching us marketing neophytes about "channels." Marketing drugs is highly complicated because there's no direct pipeline from the manufacturer to the end-user. Lots of folks control and manipulate the pathway that delivers the drug eventually to the mouth or body of the patient--most notably the physician who has to write the prescription, but also insurance companies, government regulators, managers of hospital formularies, and numerous other players.<br /><br />The key to selling drugs successfully today is first, to be able to <span style="font-weight: bold;">control the channel</span>:<br /><br />"Pharmaceutical manufacturers, like other marketing-driven enterprises, have realized that it is less in the product, the brand or even the patent where their fortunes lie, but in the stream, the marketing channel.<br /><br />Once you control the channel, <span style="font-weight: bold;">you can insert any product you like into it, no matter how useless or dangerous."</span> <span style="font-weight: bold; font-style: italic; color: rgb(255, 0, 0);">[Such as </span><span style="font-weight: bold; font-style: italic; color: rgb(255, 0, 0);">grossly </span><a href="http://sydney.edu.au/engineering/it/%7Ehitru/index.php?option=com_content&task=view&id=91&Itemid=146"><span style="font-weight: bold; font-style: italic;">unfit for purpose</span></a><span style="font-weight: bold; font-style: italic; color: rgb(255, 0, 0);">, clinically disruptive, </span><a href="http://www.tinyurl.com/hostileuserexper"><span style="font-weight: bold; font-style: italic;">mission hostile</span></a> <span style="font-weight: bold; font-style: italic; color: rgb(255, 0, 0);">healthcare IT - ed.]</span><br /><br />But, if Rule One is control the channel, Rule Two is <span style="font-weight: bold;">not to appear obviously to do so</span>.<span style="font-style: italic;"><br /></span></blockquote><strong style="font-weight: normal;"><em></em></strong><br />Read the entire post at the above link.<br /><br />The observation that "once you control the channel, you can insert any product you like into it, <span style="font-style: italic;">no matter how useless or dangerous</span>" explains many observations about the <span style="font-weight: bold;">healthcare IT industry as well</span>, such as how reports from the U.S. <a href="http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=12572">National Research Council</a> and many others (e.g., <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=2009">here</a>, <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=readinglist">here</a>, and <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=firstnet">here</a>) can simply be ignored.<br /><br />In the health IT industry, that "channel" is controlled, right up to the highest levels of numerous governments.<br /><br />Observations such at my April 2010 post "<a href="http://hcrenewal.blogspot.com/2010/04/healthcare-it-corporate-ethics-101.html">Healthcare IT Corporate Ethics 101: A Strategy for Cerner Corporation to Address the HIT Stimulus Plan</a>";<br /><br />at my post just a few days later on the "disappearance" of materials cited in my above exposé, "<a href="http://hcrenewal.blogspot.com/2010/04/corporate-ethics-101-paper-and-website.html">Cerner - Fuqua School of Business 'Corporate Ethics 101' Paper and Website Disappear</a>";<br /><br />and at my Jan. 2010 post "<a href="http://hcrenewal.blogspot.com/2010/01/more-on-perversity-in-hit-world.html">More on Perversity in the Healthcare IT World: Is Meditech Employing Sockpuppets?</a>" (where I exposed a likely industry shill through IP forensics), among others, can be placed better into context as components of "controlling the channel" for health IT, and not appearing obvious in doing it.<br /><br />Physicians especially need to re-learn the mantra "<span style="font-weight: bold;">Critical thinking always, or your patient's dead</span>" of my late mentor, cardiothoracic surgery pioneer Victor Satinsky MD.<br /><br />Medical schools also should be developing and teaching courses in how the healthcare industries attempt to "control the channel."<br /><br />These issues go far beyond the mere "tension management" issues of forbidding students, residents and attending physicians from accepting coffee cups, lunches, stethoscopes or other gifts of nominal value from the industry.<br /><br />-- SS

How Terrible Health IT (And Other Healthcare Toxic Waste) Gets Pushed on Naïve and Malleable Physicians, Hospital Executives and Governments

Over at " Hooked: Ethics, Medicine, and Pharma ", University of Texas Medical Branch at Galveston ( UTMB) Institute for the Medica...

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AMA, Deluded on Health IT, Begs For Doctor Penalty Extension - Not Penalty Termination

The American Medical Association (AMA) has become worse than useless:<br /><br /><blockquote><span style="font-weight: bold;">AMA urges issuance of EMR penalties be delayed</span><br /><br /><a href="http://library.cqpress.com/cqweekly/login.php?requested=%2Fcqweekly%2Findex.php&PHPSESSID=199il1erbvjc117chl5h4pauo7">Congressional Quarterly</a>'s CQ Weekly (3/14, Zeller) reports that "Congress strongly believes that electronic medical records will bring down the cost of healthcare, so much so that it has passed two laws providing incentives for doctors who upgrade their systems and levying penalties on those who don't."<br /><br />But, <span style="font-weight: bold;">the American Medical Association is urging that the penalties be delayed</span>. Notably, the association "says a Government Accountability Office study released in February bolsters its point that the two laws create <span style="font-weight: bold;">competing incentives that contradict each other.</span>" <span style="font-weight: bold; font-style: italic; color: rgb(255, 0, 0);">[Just our </span><a href="http://www.gallup.com/poll/145238/congress-job-approval-rating-worst-gallup-history.aspx"><span style="font-weight: bold; font-style: italic;">sub-15%</span></a><span style="font-weight: bold; font-style: italic; color: rgb(255, 0, 0);"> approval rating Congress at work - ed.] </span><br /><br />The article adds that the Department of Health and Human Services "announced that doctors will face penalties of 1 percent of their Medicare fees if they don't start issuing electronic prescriptions this year," which the AMA says would be a waste because <span style="font-weight: bold;">physicians would buy e-prescribing software that they would discard when they install records systems in 2012</span>. <span style="font-weight: bold; font-style: italic; color: rgb(255, 0, 0);"><br /><br />[Lest they face other Medicare penalties for non-"meaningful use" of EMR's - ed.] </span></blockquote><span style="font-weight: bold;"><br /></span>Aside from the Congressional mayhem created by conflicts between e-Prescribing and EMR coercion laws, if the AMA were not completely useless, and truly represented physicians (and patients), they'd be <span style="font-weight: bold;">pushing not for a delay in penalties, but for their <span style="font-style: italic;">abolition</span></span>.<br /><br />This would help return HIT to a sensible voluntary path from the path of irrational exuberance it's now on.<br /><br />-- SS<a name="S2"><span style="font-weight: bold;"><br /><br /></span></a>

AMA, Deluded on Health IT, Begs For Doctor Penalty Extension - Not Penalty Termination

The American Medical Association (AMA) has become worse than useless: AMA urges issuance of EMR penalties be delayed Congressional Quarterly...

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Is Microsoft slowly edging towards an "exit stage left" in health IT?

Interesting item seen <a href="http://histalk2.com/2011/03/10/news-31111/">here</a>:<br /><blockquote><br />From <strong>Dabney</strong>:<span style="color: rgb(51, 0, 51);"> </span><span style="color: rgb(51, 0, 51);">“Re: former Sentillion exec departures from Microsoft. Microsoft transferred their 800 Health Solutions Group people into the small-to-medium commercial sector group (Microsoft Business Solutions) last Monday. Peter Neupert and his whole organization have been pushed out of the incubation group in Microsoft Research with the guys who sell Microsoft Axapta ERP and CRM for small commercial customers. That will mark the end of acquisitions and spending of Microsoft on health because they haven’t had any significant sales of Amalga UIS in the past year after already withdrawing Amalga HIS and Amalga RIS/PACS from the market. <span style="font-weight: bold;">Microsoft is slowly edging towards an exit stage left in health IT.</span></span></blockquote><br />Why would this not surprise me if true?<br /><br />Because I <span style="font-style: italic;">predicted it. </span><br /><br />In July 2006, nearly 5 years ago, in my July 2006 post "<a href="http://hcrenewal.blogspot.com/2006/07/bill-have-you-lost-your-mind.html">Bill, Have You Lost Your Mind?</a>"<br /><br />Nobody was listening, just as nobody seems to be listening to my current dire predictions for the <span style="font-style: italic;">National Program for IT in the HHS</span>™ .<br /><br />Wait until 2016...<br /><br />-- SS

Is Microsoft slowly edging towards an "exit stage left" in health IT?

Interesting item seen here : From Dabney : “Re: former Sentillion exec departures from Microsoft. Microsoft transferred their 800 Healt...

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ONC: "The Benefits Of Health Information Technology: A Review Of The Recent Literature Shows Predominantly Positive Results"

The Office of the National Coordinator for Health IT in the US (ONC) has just published an article in "Health Affairs" entitled <span style="font-weight: bold;">"</span><a style="font-weight: bold;" href="http://content.healthaffairs.org/content/30/3/464.full.html">The Benefits Of Health Information Technology: A Review Of The Recent Literature Shows Predominantly Positive Results</a><span style="font-weight: bold;">",</span> Buntin, Burke, Hoaglin and Blumenthal, Health Affairs, 30, no.3 (2011):464-471, doi: 10.1377/hlthaff.2011.0178.<br /><br />It is available at the hyperlink above, but may not be publicly accessible.<br /><br />The authors all are, or were, ONC officials:<br /><blockquote><br />Melinda Beeuwkes Buntin (Melinda.buntin@hhs.gov) is director of the Office of Economic Analysis, Evaluation, and Modeling, Office of the National Coordinator for Health Information Technology (ONC), Department of Health and Human Services, in Washington, D.C. Matthew F. Burke is a policy analyst at the ONC. Michael C. Hoaglin is a former policy analyst at the ONC. David Blumenthal is the national coordinator for health information technology.</blockquote><br />The abstract is as follows:<br /><br /><blockquote><span style="font-weight: bold;">ABSTRACT </span><br />An unprecedented <span style="font-weight: bold; font-style: italic; color: rgb(255, 0, 0);">[indeed- ed.]</span> federal effort is under way to boost<span style="font-weight: bold; font-style: italic; color: rgb(255, 0, 0);"> [coerce? - ed.] </span>the adoption of electronic health records and spur innovation in health care delivery.We reviewed the recent literature on health information technology to determine its effect on outcomes, including quality, efficiency, and provider satisfaction.We found that 92 percent of the recent articles on health information technology reached conclusions that were positive overall. We also found that the benefits of the technology are beginning to emerge in smaller practices and organizations, as well as in large organizations that were early adopters. However, dissatisfaction with electronic health records among some providers remains a problem and a barrier to achieving the potential of health information technology. <span style="font-weight: bold; font-style: italic; color: rgb(255, 0, 0);">[Some? That sounds like an understatement - ed.]</span> These realities highlight the need for studies that document the challenging aspects of implementing health information technology more specifically <span style="font-weight: bold;">and how these challenges might be addressed.</span></blockquote><br />I have long stated, at least since 1999, <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/">that</a>:<br /><br /><span style="font-family:Arial;"></span><blockquote><span style="font-family:Arial;">Healthcare information technology (HIT) holds great promise towards improving healthcare quality, safety and costs. </span><br /></blockquote><br />The new ONC review article is certainly pointing in this direction. Perhaps Health Affairs will release it to general circulation.<br /><br />However, I also wrote:<br /><br /><span style="font-family:Arial;"></span><blockquote><span style="font-family:Arial;">As we enter the second decade of the 21st century, however, this potential has been largely unrealized. Significant factors impeding HIT achievement have been false assumptions concerning the challenges presented by this still-experimental technology, and underestimations of the expertise essential to achieve the potential benefits of HIT. This often results in clinician-unfriendly HIT design, and HIT leaders and stakeholders operating outside (often far outside) the boundaries of their professional competencies. Until these issues are acknowledged and corrected, HIT efforts will unnecessarily over-utilize precious healthcare resources, will be unlikely to achieve claimed benefits for many years to come, and may actually cause harm</span>.</blockquote><br />Whether the new ONC article demonstrates that these issues are starting to approach resolution, or is just another opinion paper not fully supported by facts, is not certain.<br /><br />Two charts are presented that summarize the findings (click to enlarge):<br /><br /><br /><div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhpT4pnuIMRS5O0EfqAKR1EYdoGMP-sWmxDx58YmBBgvGXdiAibl3sHbk4l5TMv6fEP2CgrImXYKDZ_hj_3p-NujJNbQh08r-BLxlRP8BoGlNS19YuBonqW7uWYwATUKrIFfhnjNHo1ObS1/s1600/exhibit1.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5582297616857961330" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhpT4pnuIMRS5O0EfqAKR1EYdoGMP-sWmxDx58YmBBgvGXdiAibl3sHbk4l5TMv6fEP2CgrImXYKDZ_hj_3p-NujJNbQh08r-BLxlRP8BoGlNS19YuBonqW7uWYwATUKrIFfhnjNHo1ObS1/s320/exhibit1.jpg" style="display: block; margin: 0px auto 10px; text-align: center; cursor: pointer; width: 358px; height: 234px;" /></a><span style="font-size:85%;">(Click to enlarge.) Evaluations Of Outcome Measures Of Health Information Technology, By Type And Rating</span><br /><br /></div><br /><br /><div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgpyARa0N5ySQFkIkB-WAOLjomnivQ6d5rbjZoXQbEv9cE4o8vLNBOV2e9hZrb8z019f6pMIHYiJPv_gx128rPq0TNk88VrECAiTVm8YwOiFTHBisj58VbphMhab9sH1NrbDTb60PEqm_am/s1600/exhibit2.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5582297684257203138" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgpyARa0N5ySQFkIkB-WAOLjomnivQ6d5rbjZoXQbEv9cE4o8vLNBOV2e9hZrb8z019f6pMIHYiJPv_gx128rPq0TNk88VrECAiTVm8YwOiFTHBisj58VbphMhab9sH1NrbDTb60PEqm_am/s320/exhibit2.jpg" style="display: block; margin: 0px auto 10px; text-align: center; cursor: pointer; width: 354px; height: 196px;" /></a><span style="font-size:85%;">(Click to enlarge.) </span><span style="font-size:85%;">Health Information Technology: Study Design And Scope Factors Associated With Positive Overall Conclusions</span><br /></div><br />There are several caveats. The first has to do with possible selection bias that can be present in any review article.<br /><br />On article selection for the review:<br /><blockquote><br />... we decided that to be included in this review, an article had to address a relevant aspect of health IT, as listed in the Appendix [7]; examine the use of health information technology in clinical practice; and measure qualitative or quantitative outcomes. Analyses that forecast the effects of a health IT component were included only if they were based on effects experienced during actual use. ... <span style="font-weight: bold;">Using this framework, the review team removed 2,692 articles based on their titles.</span> An additional 1,270 articles were determined to be outside the study’s scope after the team examined the article abstracts. <span style="font-weight: bold;">For example, 269 abstracts focused solely on health IT adoption</span>.<br /><br /><span style="font-weight: bold; font-style: italic; color: rgb(255, 0, 0);">[What, exactly, does that mean? Were the problems with HIT adoption potentially significant towards causation of lack of benefit, and/or presence of harm, for instance? - ed]</span><br /><br />By the third review stage, the review team had 231 articles. An additional forty-three were excluded after further review because they did not meet the criteria, and <span style="font-weight: bold;">thirty-four review articles were dropped from the analyses because they did not present new work</span>.<br /><br /><span style="font-weight: bold; font-style: italic; color: rgb(255, 0, 0);">[What does that mean? Did they drop highly comprehensive articles showing uncertainty in the literature about HIT, such as Greenhalgh's "Tensions and Paradoxes in Electronic Patient Record Research: A Systematic Literature Review Using the Meta-narrative Method" from University College London? That article appeared in the Dec. 2009</span> <a style="font-style: italic; font-weight: bold;" href="http://www.milbank.org/quarterly.html">Milbank Quarterly</a><span style="font-style: italic;">. <span style="font-weight: bold;"><span style="color: rgb(255, 0, 0);">I wrote about it</span> <a href="http://hcrenewal.blogspot.com/2009/12/healthcare-it-as-cybernetic-miracle.html">at this link</a>.</span></span><span style="color: rgb(255, 0, 0); font-style: italic; font-weight: bold;">]</span><br /><br />This left 154 studies that met our inclusion criteria, 100 of which were conducted in the United States. This is comparable to the 182 studies found over a slightly longer time period that were evaluated by Goldzweig and colleagues.<br /></blockquote><br />I should also note that no mention is made of independent reviewers of the article corpus and elimination process. It appears the entire effort was conducted within ONC itself, where a bias towards finding positive results is likely present (and understandable).<br /><br />Another caveat is the the Health Affairs/ONC article appears to bypass a body of literature, both peer-reviewed and non-peer reviewed, that sheds doubt on health IT in its present form from a number of angles such as I recently aggregated at "<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=readinglist">An updated reading list on HIT</a>" and at "<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=2009">2009 a pivotal year in healthcare IT</a>." Bypassing literature such as this is a possible major weakness.<br /><br />Further, in the current political environment, it is not hard to imagine that articles highly critical of health IT, or revealing major mishaps and possibly exposing organizations to litigation, are scarce.<br /><br />I addressed that in a paper "<a href="http://www.scribd.com/doc/28747771/Remediating-an-Unintended-Consequence-of-Healthcare-IT-A-Dearth-of-Data-on-Unintended-Consequences-of-Healthcare-IT"><span style="font-weight: bold;">Remediating an Unintended Consequence of Healthcare IT: A Dearth of Data on Unintended Consequences of Healthcare IT</span></a>." The paper itself was initially found needing revisions, largely in format, by a small group of blinded reviewers in the Medical Informatics community (with the exception of one faux-newshound who commented that "material like this could be read in any major newspaper", a rather perplexing comment considering the topic). Rather than revise, and not being on the tenure treadmill, I chose instead to publish at the Scribd link above.<br /><br />The ONC paper does acknowledge this:<br /><br /><blockquote>A recent study found that for clinical trials, studies with positive results are roughly four times more likely to be published than those without positive findings. Because the articles were limited to health IT adopters, we anticipated that authors more often approached studies looking for benefits rather than adverse effects.<br /></blockquote><br />They do, however, then issue a value judgment:<br /><br /><blockquote>It is important to note that although publication bias may lead to an underestimation of the trade-offs associated with health IT, the benefits found in the published articles are real.</blockquote><br />I"m not sure a dear relative of mine would find that value judgment heartening. They suffered a crippling injury that would likely not have occurred if paper had been used in the ED rather than an EHR.<br /><br />I note that if a pharmaceutical company were to issue such a value judgment about a drug as justification for national marketing, they'd likely be nailed to the cross...<br /><br />The ONC paper also ignores accounts of "near misses" and actual patient injury from impeccable sources, such as in "<a href="http://www.isb.nhs.uk/documents/isb-0160/dscn-18-2009">Health informatics — Guidance on the management of clinical risk relating to the deployment and use of health software</a>. UK National Health Service, DSCN18 (2009), formerly ISO/TR 29322:2008(E)":<br /><br /><blockquote><span style="font-size:85%;">Annex A<br /><br />Examples of potential harm presented by health software<br /><br /><span style="font-weight: bold;">GP prescribing decision support</span><br />In 2004 the four most commonly used primary care systems were subjected to eighteen, potentially serious, realistic scenarios including an aspirin prescription for an eight year old, penicillin for a patient with penicillin allergy and a combined oral contraceptive for a patient with a history of deep vein thrombosis. Using dummy records, all eighteen scenarios failed to produce appropriate alerts by all of the systems, most of the time. The best score was a system that flagged up seven appropriate alerts. The health organization clearly has, in such a system deployment, a key responsibility to ensure that knowledge bases used within a design are correctly populated and aligned with clinical practice within their organization.<br /><br /><span style="font-weight: bold;">Inadvertent accidental prescribing of dangerous drugs (such as methotrexate</span>)<br />This incident occurred when a user of a primary care system attempted to issue two repeat items. The items were highlighted and instead of the issue selected repeats button, the prescribe acute issues from the formulary button was pressed. This brought up the formulary dialogue which contained the high risk items. Either the issue button was then pressed or the particular items were double clicked. When the warning messages came up, they were all ignored and proceed and issue selected. The user chose the first item presented on the formulary list, which just so happened to be a methotrexate injection. In this particular case, it was determined that patient risk was minimal as the treatment was rarely used in primary care and would, in practice, be rejected by the pharmacist. To preclude any recurrence of the problem, access to the high risk formulary was removed from the formulary part of the acute drug issue dialogue. This example again demonstrates the need to align clinical practice and authority levels with the knowledge and rule bases within the system. Wherever possible, design and implementation of health software systems should be undertaken to improve control and accuracy, note introduce new exposures. Furthermore the hazard and risk assessment of this situation may well not apply in other settings, e.g. prescription issue by nursing staff on a ward versus a pharmacist in a retail store.<br /><br /><span style="font-weight: bold;">Incorrect patient details retrieved from radiology information system</span><br />This incident arose from the fact that medical reference numbers (MRNs) are usually prefixed by an alpha code. Some hospitals however do not use these prefixes and identical MRNs can be generated. This gave rise to the creation of shared MRNs and subsequent confusion of records in the central datastore when retrieval key is the Medical Record Number. Four specific instances were found where a patient number had been entered in the radiology information system and incorrect patient details had been retrieved. The manufacturer could have built in an appropriate format check during development. Alternatively, the problem could have been spotted by the health organization if a structured risk assessment had been undertaken.<br /><br /><span style="font-weight: bold;">Drug mapping error</span><br />Sodium valproate 200 mg slow release was incorrectly mapped to sodium valproate 200 mg in a formulary encoded into a health software system. These are anti-epilepsy drugs and thus the implications for patient safety could be significant. This particular incident is just one of many that have been reported in relation to drug mapping.<br /><br />An initial investigation indicated that 35 prescriptions had been generated using the incorrect map. Corrective action included contacting the relevant primary care practices to check upon patient health and the supplier to correct the mapping process to ensure no further incorrect prescriptions were generated. As before, this was a design/coding error by the manufacturer but was compounded by the health organization not checking the mappings and failing either to build in appropriate prescribing controls, or map the controls to health organization individuals with the appropriate experience and authority.<br /><br /><span style="font-weight: bold;">Pre-natal screening</span><br />The ages of women who had undergone pre-natal screening were wrongly computed by a health software system. As a result 150 women were wrongly notified that they were at no risk. Of these, four gave birth to Down's syndrome babies and two others made belated decisions to have abortions.<br /><br /><span style="font-weight: bold;">Patient identification</span><br />A student died of meningitis because of a misspelling of her name and inadequacy in computer use. The student was admitted and a blood test proved negative for meningitis. The following day another blood test was taken and filed on a new computer entry but the letter ―p was missed in the spelling of the name. When a doctor looked up results they were presented with only the first negative tests result because of the misspelling. If the second result had been seen it would have triggered further investigations and probable diagnosis of meningitis. The investigating panel concluded that problems with the health software system had been greater than first thought and in this case there was a combination of a misspelled name and the doctor not being able to use the computer system property. The health software system could have been designed to use unique numbers either instead of the name or in addition to it.</span></blockquote><br />They also missed consideration of serious IT defects reports as in the FDA's Maude database that I wrote about at my Jan. 2011 post "<a href="http://hcrenewal.blogspot.com/2011/01/maude-and-hit-risk-mother-mary-what-in.html">MAUDE and HIT Risks</a>."<br /><br />Another confounding factor is the issue of possible unreliability of the medical literature itself as expressed in a recent post on the <a href="http://hcrenewal.blogspot.com/2011/01/ibms-watson-jeopardy-and-revolutioning.html">IBM Watson supercomputer exuberance</a>:<br /><br /><blockquote>Consider the issue of the medical literature suffering from numerous conflict of interest and dishonesty-related phenomema making it increasingly untrustworthy, as <strong style="font-weight: normal;">pointed out by Roy Poses in a Dec. 2010 post "</strong><a href="http://hcrenewal.blogspot.com/2010/12/lancet-emphasizes-threats-to-academic.html">The Lancet Emphasizes the Threats to the Academic Medical Mission</a>", at my Aug. 2009 post "<a href="http://hcrenewal.blogspot.com/2009/08/has-ghostwriting-infected-experts-with.html">Has Ghostwriting Infected The "Experts" With Tainted Knowledge, Creating Vectors for Further Spread and Mutation of the Scientific Knowledge Base?</a>" and <a href="http://hcrenewal.blogspot.com/search/label/pseudo-evidence%20based%20medicine">elsewhere</a> on this blog.</blockquote><br />They do state what I have been writing about for over a decade now:<br /><br /><blockquote>... In fact, the stronger finding may be that the “human element” is critical to health IT implementation. The association between the assessment of provider satisfaction and negative findings is a strong one. This highlights the importance of strong leadership and staff “buy-in” <span style="font-weight: bold; font-style: italic; color: rgb(255, 0, 0);">[which will only occur if the systems are not miserable examples of poor engineering, not due to P.R. or the irrational exuberance of others - ed.]</span> if systems are to successfully manage and see benefit from health information technology. <span style="font-weight: bold;">The negative findings also highlight the need for studies that document the challenging aspects of implementing health IT more specifically and how these challenges might be addressed.</span></blockquote><br />Dear ONC: see <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/">this site</a>, and the many posts since 2004 on this blog.<br /><br />I was surprised to see this:<br /><blockquote><br />... Taking a cue from the literature on continuous quality improvement,<span style="font-weight: bold;"> every negative</span><span style="font-weight: bold;"> finding can be a treasure</span> if it yields information on how to improve implementation strategies and design better health information technologies.</blockquote><br />As in my post <a href="http://hcrenewal.blogspot.com/2011/03/australian-ed-ehr-study-putting-lie-to.html">at this link</a>, does this mean that 'anecdotal' accounts of HIT problems will no longer be summarily dismissed? I wonder.<br /><br />I have also written in the past that in order to truly understand a domain, one must look at both evidence of the upside, and evidence of the downside. My concern is that the latter was not well addressed in this paper. A beneficial technology with a significant downside, especially in medicine, is not ready for national rollout (cf. Vioxx).<br /><br />In summary, the new ONC paper may present a glimmer of hope that health IT is starting to produce real results. On the other hand, its possible deficiencies and biases might also make it more a political statement than anything else. It will certainly be used as such from the high government perch of HHS regardless. This has already started:<br /><blockquote><br />... President Obama and Congress envisioned that the HITECH Act would provide benefits in the form of lower costs, better quality of care, and improved patient outcomes. This review of the recent literature on the effects of health information technology is reassuring: It indicates that the expansion of health IT in the health care system<span style="font-weight: bold;"> is worthwhile.<br /><span style="font-style: italic; color: rgb(255, 0, 0);"><br />[Note the use of "is worthwhile" as opposed to "may be worthwhile", a continuation of the "it's proven, nothing else to say" style I noted </span></span><span style="font-weight: bold; font-style: italic;"><span style="color: rgb(255, 0, 0);">at my July 2010 post</span> "<a href="http://hcrenewal.blogspot.com/2010/07/new-england-journal-on-meaningful-use.html">Science or Politics? The New England Journal and "The 'Meaningful Use' Regulation for Electronic Health Records</a>."</span><span style="font-weight: bold;"><span style="font-style: italic; color: rgb(255, 0, 0);"> Such statements of absolute certainty are of concern; they remind me of the global warming debate - ed.</span><span style="color: rgb(255, 0, 0); font-style: italic;">]</span></span><br /><br />...Thus, with HITECH, providers have an unparalleled opportunity to accelerate their adoption of health information technology and <span style="font-weight: bold;">realize benefits for their practices, institutions, patients, and the broader system</span>. <span style="font-weight: bold; font-style: italic; color: rgb(255, 0, 0);">[Ditto - ed.]</span><br /></blockquote><br />Does the article truly show a breakthrough, or is it a flawed review by a governmental agency that will be used for political purposes? I simply do not know which.<br /><br />I am certain, however, that there will be active debate and dissection of this paper and its source articles in the months to come by those with more time, resources, and expertise than I have at my disposal.<br /><br />-- SS<br /><br /><span style="font-weight: bold;">March 10, 2011 </span><span style="font-weight: bold;">addendum:</span><br /><br /><a href="http://www.icms.qmul.ac.uk/chs/staff/trishagreenhalgh.html">Trisha Greenhalgh</a> at Barts and The London School of Medicine and Dentistry and the author of the aforementioned comprehensive review article "<span style="font-weight: bold;">Tensions and Paradoxes in Electronic Patient Record Research: A Systematic Literature Review Using the Meta-narrative Metho</span>d" (<a href="http://hcrenewal.blogspot.com/2009/12/healthcare-it-as-cybernetic-miracle.html">link to my essay</a>), had this observation about the following passage in the ONC paper:<br /><br /><blockquote>“Our findings must be qualified by two important limitations: the question of publication bias, and the fact that we implicitly gave equal weight to all studies regardless of study design or sample size.”</blockquote><br />Prof. Greenhalgh relates: "Given these very fundamental acknowledged biases, I’m very surprised anyone published this paper in its present form.”<br /><br />-- SS<br /><br /><span style="font-weight: bold;">March 14, 2011 addendum:</span><br /><br />Dr. Roy Poses had this to say:<br /><blockquote><br />Dr Silverstein commented on a new review of research of health care information technology whose results were mainly optimistic. The authors were from the US government agency that promotes health care IT, so its optimism is not surprising. However, its credibility was unclear, since it did not appear to be systematic.<span style="font-weight: bold; font-style: italic;"> <span style="color: rgb(255, 0, 0);">[In general, one at least assesses and takes into account the methodologic quality of studies used in a</span> <a href="http://en.wikipedia.org/wiki/Systematic_review">systematic review</a>, a<span style="color: rgb(255, 0, 0);">nd does not "</span></span><span style="font-weight: bold; font-style: italic; color: rgb(255, 0, 0);">give equal weight to all studies regardless of study design or sample size"</span><span style="color: rgb(255, 0, 0);"> </span><span style="font-weight: bold; font-style: italic;"><span style="color: rgb(255, 0, 0);">- ed.]</span></span><br /><br />Furthermore, the authors had no methodologic standards whatsoever for article inclusion. [<span style="font-weight: bold; font-style: italic; color: rgb(255, 0, 0);">They did, sort of, as in my paragraphs "</span><span style="font-weight: bold; font-style: italic; color: rgb(255, 0, 0);">On article selection for the review:"</span><span style="font-weight: bold; font-style: italic; color: rgb(255, 0, 0);">, but one might term the standards "loose" - ed.]</span> The review included qualitative studies that were probably not meant to be evaluative, and observational studies subject to severe methodologic bias.<br /><br />The publication of this review demonstrated how the conventional wisdom is continually reinforced based on the strength of the influence of its proponents, rather than the strength of the supporting evidence. Adaptation of new drugs and devices should be based on evidence that their benefits outweigh their harms, rather than the enthusiasm and financial interests of their proponents.</blockquote><br /><br />-- SS

ONC: "The Benefits Of Health Information Technology: A Review Of The Recent Literature Shows Predominantly Positive Results"

The Office of the National Coordinator for Health IT in the US (ONC) has just published an article in "Health Affairs" entitled &q...

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