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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: <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> <blockquote class="tr_bq"><blockquote class="tr_bq">(ii) Plaintiffs Software Design Defect Claims are Preempted by the Federal HITECH Act ... To the extent Plaintiff attempts to bring a common law product liability claim against [name redacted] Hospital for required use of EMR software [see addendum below - ed.], such a claim is barred due to Federal Preemption of this area with the passage of the Health Information Technology for Economic and Clinical Health (HITECH) Act. 42 U.S.C. 201, 300, et seq. Specifically, the design, manufacture, specification, certification and sale of EMR in the United States is a highly regulated industry under the jurisdiction of the Department of Health and Human Services (HHS). The HHS draws its statutory authority to design and certify EMR as safe and effective under the HITECH act as amended. Id. The Supremacy Clause of the United States Constitution, article VI, clause 2, preempts any state law that conflicts with the exercise of federal power. Fid. Fed. Say. & Loan Ass’n v. de la Cuesta, 458 U.S. 141, 102 S. Ct. 3014 (1982). “Pre-emption may be either express or implied, and ‘is compelled whether Congress’ command is explicitly stated in the statute’s language or implicitly contained in its structure and purpose.” Matter of Calun Elec. Power Co-op., Inc., 109 F.3d 248, 254 (5th Cir. 1997) citing Jones v. Rath Packing Co., 430 U.s. 519, 525 (1977). In this case, to impose common law liability upon [name redacted] Hospital for using certified EHR technology, which was in compliance with federal law and regulations for Health Information Technology, would directly conflict with Congress’ statutory scheme for fostering and promoting the implementation and use of EHR  </blockquote> I really don't think Congress intended HIT to maim and kill patients with impunity.  In any case, this assertion was thrown out in its entirety several months ago, but here it is again in a new set of objections.  I find its reappearance remarkable.  I also wonder if the industry is behind it.</blockquote> 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: <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. 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. Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology, 75 Fed. Reg. 44589 (July 28, 2010). 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. </blockquote> 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... The facts about health IT "certification" are trivial to verify.  As the hospital admission where my mother was injured, and the injury itself, were in May 2010, "using certified EHR technology in compliance with federal law and regulations for Health Information Technology" was not possible at that time.  (Not to mention the facilities' EHR's were not actually "certified" until December 2010 via the ONC database of certified systems.) Thus, the defense attorney by re-issuing this claim in August 2012 (to the new judge overseeing the case re-filing) is now knowingly lying to the Court in sworn filings, 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. 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. 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). It will be interesting to see how the judge responds to an attorney knowingly trying to blow smoke up his behind. -- SS Addendum:  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. -- SS

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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Needed: A Webcast on Disruptive and Criminal Hospital Executives

I received this, unsolicited, via email: <blockquote class="tr_bq">Webcast:  Managing Disruptive Docs in a New Era of Hospital-Physician Relations If you haven't already purchased this live Webcast, don't miss out! Left unchecked, disruptive physicians do more than just create a negative work environment; they endanger patient care and can lead to million-dollar lawsuits and bad publicity.  Our top experts will show you early intervention techniques and a range of effective resources that can help you reduce behavioral problems, retain star physicians, create a healthier workplace and save millions in potential lawsuits. The agenda includes:     Defining and identifying causes of disruptive behavior     Economic consequences of disruptive behavior     Overcoming disruptive physician problems This program will be guided by your questions, so register now and ask away! </blockquote><blockquote class="tr_bq">Your instructors: Alan Rosenstein, MD, MBA Medical Director of Physician Wellness Services David Danielson, JD, CPA Senior Vice President, Clinical Risk Management, Sanford Health Scott Hurst Former Director of Physician Alignment and Recruitment, CHRISTUS Spohn Health System Managing Disruptive Docs in a New Era of Hospital-Physician Relations is designed to help CEOs, COOs, CMOs, group practice administrators, HR leaders, and physicians learn strategies and tactics to prevent, reduce, and limit the severity of disruptive physician incidents.</blockquote> "Disruptive physician" is a vague term subject to enormous abuse, leading to <a href="http://www.aapsonline.org/index.php/article/sham_peer_review_resources_physicians/" target="_blank">sham peer review</a> among other totalitarian tactics.   It reminds me of the old Soviet Union's politics. <table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiaZGkgvYub9OiuiXN2A_9Y57CTEJFCv8iKNfY4K7pA4HQW3dkVL-lHxHWLXPsFN4cplq0kC4fe42SsNySpr5W3e1WBLtbuuSyFgzbNL_OS9kiRFL5kidQezG61bXRNwk2iNoA23fTkqvcV/s1600/poster-06.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="219" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiaZGkgvYub9OiuiXN2A_9Y57CTEJFCv8iKNfY4K7pA4HQW3dkVL-lHxHWLXPsFN4cplq0kC4fe42SsNySpr5W3e1WBLtbuuSyFgzbNL_OS9kiRFL5kidQezG61bXRNwk2iNoA23fTkqvcV/s320/poster-06.jpg" width="320" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">You have been deemed a Disruptive Physician, Comrade.  You will be given a fair trial, then shot</td></tr></tbody></table> <a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiaZGkgvYub9OiuiXN2A_9Y57CTEJFCv8iKNfY4K7pA4HQW3dkVL-lHxHWLXPsFN4cplq0kC4fe42SsNySpr5W3e1WBLtbuuSyFgzbNL_OS9kiRFL5kidQezG61bXRNwk2iNoA23fTkqvcV/s1600/poster-06.jpg" style="margin-left: 1em; margin-right: 1em;"></a> In particular, this label can be used to suppress clinician concerns about care quality in an era of cost cutting and care manipulation through electronic workflow control systems (e.g., EHR's CPOE, CDS etc.) The potential of being labelled as "disruptive" may be one reason why physician outcry against the very low quality of healthcare IT systems and dangers posed by them is relatively uncommon. Patients - you - ultimately suffer when your physicians fear being your outspoken advocates. As the many stories of healthcare executive malfeasance and profiteering at the expense of patients on this blog indicate, what is really needed for true healthcare reform are webcasts on: MANAGING DISRUPTIVE AND CRIMINAL HOSPITAL EXECUTIVES IN AN ERA OF RAMPANT CORPORATIZATION OF MEDICINE. -- SS Addendum:  here are additional resources on the “Disruptive Physician”: Abuse of the “Disruptive Physician” Clause,<a href="http://www.jpands.org/vol9no3/huntoon.pdf" target="_blank"> http://www.jpands.org/vol9no3/huntoon.pdf</a> The Insulting Physician “Code of Conduct”,<a href="http://www.jpands.org/vol13no1/huntoon.pdf" target="_blank"> http://www.jpands.org/vol13no1/huntoon.pdf</a> In the latter article, Lawrence Huntoon MD PhD, and expert on abuses of this label, notes: <blockquote class="tr_bq">... The typical physician code of conduct is initiated by a hospital administration. Its wording is curiously similar from one hospital to the next, suggesting that a template is being circulated. ... The physician code of conduct is intentionally insulting, demeaning, and degrading to physicians, and reduces physicians to being treated like juvenile delinquents at a reform school. It assumes that all physicians, like juvenile delinquents, need to be subjected to a long list of prohibited behaviors because, in the hospital administration’s view, physicians are predisposed to such things as theft, destruction of property, and physical and sexual assault. Conspicuous by its absence is any mention of “disruptive” or “abusive” hospital administrators, or any similar code of conduct applicable to a hospital administration.</blockquote> Dr. Huntoon then goes on to make a recommendation, a "hospital administration’s code of conduct": <blockquote class="tr_bq">... The term “disruptive hospital administrator” and/or “abusive hospital administrator” should be incorporated into the hospital administration’s code of conduct and should be defined as anyone in the hospital administration who, in the view of the medical staff (as determined by majority vote), interferes with the ability of physicians to provide safe and high-quality care to patients in the hospital.</blockquote> His detailed criteria for “disruptive hospital administrator” in the latter article are worth reading in their entirety. -- SS

Needed: A Webcast on Disruptive and Criminal Hospital Executives

I received this, unsolicited, via email: Webcast: Managing Disruptive Docs in a New Era of Hospital-Physician Relations If you haven't ...

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ONC and Misdirection Regarding Mass Healthcare IT Failure

In my keynote address to the Health Informatics Society of Australia in Sydney recently, I cautioned attendees including those in government to be wary of <a href="http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html" target="_blank">healthcare IT hyper-enthusiast</a> misdirection and logical fallacy (a.k.a. public relations). In the LA Times story "<a href="http://www.latimes.com/business/la-fi-hospital-data-outage-20120803,0,5302779.story?track=rss&cid=dlvr.it&dlvrit=52116" target="_blank">Patient data outage exposes risks of electronic medical records</a>" on the Cerner EHR outage I wrote of in my post "<a href="http://hcrenewal.blogspot.com/2012/08/massive-health-it-outage-but-of-course.html" target="_blank">Massive Health IT Outage: But, Of Course, Patient Safety Was Not Compromised</a>" (the title, of course, being satirical), Jacob Reider, acting chief medical officer at the federal Office of the National Coordinator for Health Information Technology is quoted.  He said: <blockquote class="tr_bq">"These types of outages are quite rare and there's no way to completely eliminate human error." </blockquote> This is precisely the type of political spin and hyper-enthusiast misdirection I cautioned the Australian health authorities to evaluate critically. As comedian Scott Adams <a href="http://www.leany.com/logic/Adams.html" target="_blank">humorously noted</a> regarding irrelevancy, a hundred dollars is a good price for a toaster, compared to buying a Ferrari. Further, when you're the patient harmed or killed, or the victim is a family member, you really don't care how "rare" the outages are. Airline crashes are "rare", too.   So, shall they just be tolerated as a "cost of doing business" and spun away? (As I once wrote, the asteroid colliding with Earth that caused the extinction of the dinosaurs was a truly "rare" event.) It seems absurd for me to have to point out that paper, unless there is a mass outbreak of use of disappearing ink, or locally hosted clinical IT, do not go blank en masse across multiple states and countries for any length of time, raising risk across multiple hospitals greatly, acutely and simultaneously.   Yet, I have to point out this obvious fact in the face of misdirection. Locally hosted health IT, of course, can only cause "local" chart disappearances.  "Local" is a relative term, however, depending on HC organization size, as in the example of a Dec. 2011 regional University of Pittsburgh Medical Center (UPMC) 14-hour outage affecting thousands <a href="http://hcrenewal.blogspot.com/2011/12/yet-another-glitch-affecting-thousands.html" target="_blank">here</a>. Further, EHR's and other clinical IT, whether hosted locally or afar, had better offer truly major advantages, without major risks and disadvantages, over older medical records technologies before exposing large numbers of patients to an invasive IT industry and the largest unconsented human subjects experiment in history. Unfortunately, those basic criteria are not yet apparent with today's systems (see for instance this <a href="http://hcrenewal.blogspot.com/2011/02/updated-reading-list-on-health-it.html" target="_blank">reading list</a>). EHR's and other clinical IT, forming in reality an enterprise clinical resource management and clinician workflow control apparatus, have introduced new risk modes including mass <a href="http://hcrenewal.blogspot.com/2012/06/more-electronic-medical-record-breaches.html" target="_blank">chart theft</a> (sometimes tens of thousands in the blink of an eye); also, mass chart disappearances as in this case - all not possible with paper. At the very least, if hospitals want enterprise clinical resource management and clinician workflow control systems, these should not be relegated to a distant third party.  Patients are not guinea pigs upon whom to test the <a href="http://en.wikipedia.org/wiki/Application_service_provider" target="_blank">ASP software model</a> ("software as a service") that, upon failure for any reason, threatens their lives. Finally, these complications are a further example why this industry cannot go on without meaningful oversight.  The unprecedented special medical device regulatory accommodations must end. -- SS

ONC and Misdirection Regarding Mass Healthcare IT Failure

In my keynote address to the Health Informatics Society of Australia in Sydney recently, I cautioned attendees including those in government...

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Joint Commission Should Be Named As Defendant If Patients Harmed by EHR "Outages"

At my recent post "<a href="http://hcrenewal.blogspot.com/2012/08/massive-health-it-outage-but-of-course.html">Massive Health IT Outage: But, Of Course, Patient Safety Was Not Compromised</a>" over a massive, outrageous Cerner outage to hospitals contracting their clinical IT via an <a href="http://en.wikipedia.org/wiki/Application_service_provider" target="_blank">ASP model</a> (that is, 'software as a service'), I observed: <blockquote class="tr_bq">... The Joint Commission, for example, likely issued its stamp of approval for the affected hospitals, hospitals who had outsourced their crucial medical records functions to an outside party that sometimes went mute.  If someone was injured or died due to this outage, they would not care very much about the supposed advantages.</blockquote> From the JC's page "<a href="http://www.jointcommission.org/about_us/about_the_joint_commission_main.aspx" target="_blank">About the Joint Commission</a>": <blockquote class="tr_bq">An independent, not-for-profit organization, The Joint Commission accredits and certifies more than 19,000 health care organizations and programs in the United States. Joint Commission accreditation and certification is recognized nationwide as a symbol of quality that reflects an organization’s commitment to meeting certain performance standards.</blockquote> It's time to up the ante regarding this accreditation body, fully aware of health IT risks (e.g., the Dec 2008 <a href="http://hcrenewal.blogspot.com/2008/12/joint-commission-sentinel-events-alert.html" target="_blank">Sentinel Events Alert on Health IT</a>) but to date having done little about them.  Through my legal work and my speaking to Plaintiff's attorneys, I am becoming increasingly aware of medical malpractice cases that  involve an EHR or related clinical IT systems at JC-accredited organizations. In effect, the JC has accredited hospitals whose entire clinical command-and-control structure (the term EHR is an anachronism; these systems are in reality enterprise clinical resource management and clinician workflow control devices) can disappear in the blink of an eye, without warning, raising risk to patients greatly. If I discover that a patient was harmed or killed as a result of, or related to, this massive recent outage of outsourced medical records/workflow control  infrastructure, I will be recommending that the Joint Commission, including its leadership, which likely certified the hospital(s) involved for safe operations in areas such as Information Management, be named as defendants. I have informed the JC leadership by email.   -- SS

Joint Commission Should Be Named As Defendant If Patients Harmed by EHR "Outages"

At my recent post " Massive Health IT Outage: But, Of Course, Patient Safety Was Not Compromised " over a massive, outrageous Cer...

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Massive Health IT Outage: But, Of Course, Patient Safety Was Not Compromised

Having been 'Down Under' in Sydney addressing the Health Informatics Society of Australia on the need to slow down their national health IT program - and on the need to think critically about HIT seller public relations exaggerations and hubris - and being very busy, I missed this quite stunning story of a major health IT outage. Just a typical "<a href="http://hcrenewal.blogspot.com/search/label/glitch" target="_blank">glitch</a>": <blockquote class="tr_bq"><a href="http://ukcampaign4change.com/2012/07/31/lessons-from-a-major-outage/" target="_blank">Some lessons from a major outage</a> Posted on July 31, 2012 By Tony Collins Last week Cerner had a major outage across the US. Its international customers might also have been affected. <a href="http://www.informationweek.com/news/healthcare/EMR/240004446">InformationWeek Healthcare reported</a> that Cerner’s remote hosting service went down for about six hours on Monday, 23 July. It hit “hospital and physician practice clients all over the country”. Information Week said the unusual outage “reportedly took down the vendor’s entire network” and raised “new questions about the reliability of cloud-based hosting services”. A Cerner spokesperson Kelli Christman told Information Week,</blockquote> <blockquote class="tr_bq"><blockquote>“Cerner’s remote-hosted clients experienced unscheduled downtime this week. Our clients all have downtime procedures in place to ensure patient safety.  [Meaning, for the most part, blank paper - ed.] The issue has been resolved and clients are back up and running. A human error caused the outage.  [I don't think they mean human error as in poor disaster recovery and business continuity engineering - ed.]  As a result, we are reviewing our training protocol and documented work instructions for any improvements that can be made.”</blockquote></blockquote> <blockquote class="tr_bq">Christman did not respond to a question about how many Cerner clients were affected. <a href="http://histalk2.com/2012/07/">HIStalk</a>, a popular health IT blog, reported that hospital staff resorted to paper [if that was true, that paper was OK in an unplanned workflow disruption of major proportions, then why do we need to spend billions on health IT, one might ask? - ed.] but it is unclear whether they would have had access to the most recent information on patients. One Tweet by @UhVeeNesh said “Thank you Cerner for being down all day. Just how I like to start my week…with the computer system crashing for all of NorCal [Northern California].”</blockquote> Tony Collins is a commentator for ComputerWorldUK.com.  He's quoted me, as I wrote in my May 2011 post <a href="http://blogs.computerworlduk.com/the-tony-collins-blog/2011/05/the-national-programme-of-failed-it-in-the-nhs/">Key lesson from the NPfIT - The Tony Collins Blog. </a> This incident brings to life longstanding concerns about hospitals outsourcing their crucial functions to IT companies.   Quite simply, I think it's insane, at least in the foreseeable future, as this example shows. It also brings to mind the concerns that health IT, as an unregulated technology, causes dangers in hospitals with inadequate internal disaster and business continuity functions aside from fresh sheets of paper.  Such capabilities would likely be mandatory if health IT were meaningfully regulated. The Joint Commission, for example, likely issued its stamp of approval for the affected hospitals, hospitals who had outsourced their crucial medical records functions to an outside party that sometimes went mute.  If someone was injured or died due to this outage, they would not care very much about the supposed advantages. There's this in the article: <blockquote class="tr_bq"> ... “Issue appears to have something to do with DNS entries being deleted across RHO network and possible Active Directory corruption. Outage was across all North America clients as well as some international clients.”</blockquote> Of course, <a href="http://hcrenewal.blogspot.com/2011/12/yet-another-glitch-affecting-thousands.html" target="_blank">patient safety was not compromised</a>. Finally: Imagine being a patient, perhaps with a complex history, in extremis at the time of this outage.   I, for one, do not want my own medical care nor that of my relatives and friends subject to cybernetic recordkeeping unreliability and incompetence like this, and the risk it creates. -- SS Aug. 8, 2012 addendum: The Los Angeles Times covered this outage in a story aptly entitled "<a href="http://www.latimes.com/business/la-fi-hospital-data-outage-20120803,0,5302779.story?track=rss&cid=dlvr.it&dlvrit=52116" target="_blank">Patient data outage exposes risks of electronic medical records</a>." They write: <blockquote class="tr_bq">Dozens of hospitals across the country lost access to crucial electronic medical records for about five hours during a major computer outage last week, raising fresh concerns about whether poorly designed technology can compromise patient care. </blockquote> My only comment is that the answer to this question is rather axiomatic. They also quote Jacob Reider, acting chief medical officer at the federal Office of the National Coordinator for Health Information Technology, who said: <blockquote class="tr_bq">"These types of outages are quite rare and there's no way to completely eliminate human error" </blockquote> This is precisely the type of political spin and misdirection I cautioned the Australian health authorities to evaluate critically. Paper, unless there is a mass outbreak of use of disappearing ink, or locally hosted clinical IT, do not go blank en masse across multiple states and countries for any length of time, raising risk across multiple hospitals greatly, acutely and simultaneously.  (Locally hosted IT outages only cause "local" mayhem; see my further thoughts on this issue <a href="http://hcrenewal.blogspot.com/2012/08/onc-and-irrelevant-comparisons.html" target="_blank">here</a>). -- SS

Massive Health IT Outage: But, Of Course, Patient Safety Was Not Compromised

Having been 'Down Under' in Sydney addressing the Health Informatics Society of Australia on the need to slow down their national he...

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

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

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

I am jet-lagged after returning from Sydney, Australia, where I delivered one of the keynote addresses at the Health Informatics Society of ...

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Private Equity, Obfuscatory Advertising, and Making Health Care a Commodity: Lessons from Cerberus Capital Management

The use of advertising by Steward Health Care, currently a regional hospital system here in New England, continues to provide lessons about how public relations and marketing may be used to shape the health care policy debate.  Stand by because the story is convoluted. Steward Promotes "New Health Care," Whatever That May Be This week, Commonwealth <a href="http://www.commonwealthmagazine.org/News-and-Features/Online-exclusives/2012/Summer/010-Steward-ads-promote-its-new-health-care.aspx">reported</a> on Steward's latest high profile advertising campaign in the Boston area, <blockquote>Steward Health Care is using the Olympics to hone its image. The Boston-based chain of 10 community hospitals, many of which were on the verge of going under when Steward acquired them, is running a series of ads on WHDH-TV (Channel 7) during Olympics coverage that cast the company as a delivery system for a new type of world-class health care.</blockquote> While visible, the advertisements are notably vague. One features <blockquote>a Steward employee who says she believes 'world class health care is here.' Another of the initial ads features individual doctors and technicians pledging to be stewards of 'the new health care,' which is the tagline for all of the Steward ads. What the 'new health care' means is never fully explained in the ads</blockquote> One local health care expert <blockquote>Paul Levy, the former CEO of Beth Israel Deaconness Medical Center, said he thinks the ads are part of a campaign by [Steward Health Care owner] Cerberus [Capital Management] to make Steward more attractive to would-be buyers. 'This has very little to do with anything other than establishing the image and the brand of the Steward hospitals so when the day comes when Cerberus sells the company it will be better received in the public markets,' Levy said.</blockquote> The article had noted that <blockquote>Cerberus Capital Management, a New York private equity firm, owns Steward,...</blockquote> So it is possible that no one at Steward really has any idea what sort of "new health care" the organization is promoting Steward's CEO Promotes Health Care as a Commodity However, there is reason to think that the top leadership of Steward, and probably of Cerberus Capital Management, the private equity group that owns it, actually does have a clear idea what new health care they are promoting. Almost simultaneous with the Commonwealth article and the Olympic advertising campaign an <a href="http://management.fortune.cnn.com/2012/08/02/steward-health-de-la-torre">interview</a> appeared with Steward's CEO in Fortune. CEO Dr Ralph de la Torre first pitched medicine as science, <blockquote>A lot of us physicians went into medicine because we loved the art aspect of it. There wasn't a lot of real hard-core science when many of today's doctors went into medicine. It was your intuition, your abilities, the gestalt of what was going on. But something happened in medicine along the way. It started becoming a real science, and a lot of studies have come out that guide what we do and how we do it. We as a society need to understand that science has to guide our practice of medicine. Not everyone with a headache needs a CAT scan; not everybody with a sprained ankle needs an MRI.</blockquote> This sounds like it could be an affirmation of evidence-based medicine, the approach that attempts to base medicine on systematic search for and critical review of the best clinical research, among other things. However, De la Torre takes it a big step further, citing: <blockquote>In deference to those who love the individual hospital, you have to look back at America and the trends in industries that have gone from being art to science, to being commodities. Health care is becoming a commodity. The car industry started off as an art, people hand-shaping the bodies, hand-building the engines. As it became a commodity and was all about making cars accessible to everybody, it became more about standardization. It's not different from the banking industry and other industries as they've matured. Health care is finally maturing as an industry, and part of that maturation process is consolidation. It's getting economies of scale and in many ways making it a commodity.</blockquote> Apparently Dr De la Torre does not see a distinction any longer between health care, or to use an old-fashioned word, medicine, traditionally considered an art or practice of caring for individual patients, and making automobiles on an assembly line. Dr De la Torre may be deeply misinterpreting evidence-based medicine, which is about evidence from clinical research, but also much more. Consider how the Cochrane Collaboration <a href="http://www.cochrane.org/about-us/evidence-based-health-care/">discusses it</a>: <blockquote>Evidence-based health care Evidence-based health care is the conscientious use of current best evidence in making decisions about the care of individual patients or the delivery of health services. Current best evidence is up-to-date information from relevant, valid research about the effects of different forms of health care, the potential for harm from exposure to particular agents, the accuracy of diagnostic tests, and the predictive power of prognostic factors [1]. Evidence-based clinical practice is an approach to decision-making in which the clinician uses the best evidence available, in consultation with the patient, to decide upon the option which suits that patient best [2]. Evidence-based medicine is the conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients. The practice of evidence-based medicine means integrating individual clinical expertise with the best available external clinical evidence from systematic research [3]. [1] Cochrane AL. Effectiveness and Efficiency : Random Reflections on Health Services. London: Nuffield Provincial Hospitals Trust, 1972. Reprinted in 1989 in association with the BMJ. Reprinted in 1999 for Nuffield Trust by the Royal Society of Medicine Press, London, <a href="http://www.rsmpress.co.uk/bkcochra.htm">ISBN 1-85315-394-X.</a>[2] Gray JAM. 1997. Evidence-based healthcare: how to make health policy and management decisions. London: Churchill Livingstone. [3] Sackett DL, Rosenberg WMC, Gray JAM, Haynes RB, Richardson WS. 1996. Evidence based medicine: what it is and what it isn't. BMJ 312: 71–2 [3] [<a href="http://www.bmj.com/cgi/content/full/312/7023/71">Full text</a>]</blockquote> Note the emphasis on making decisions for individuals based on what is best for each, and the integration of evidence from clinical research with clinical expertise. This is far from commoditization. Nonetheless, Dr De la Torre seems to envision "new health care" like a 1930s automobile assembly line, with the physicians and other health professionals cast as assembly line workers, and the patients cast as automobiles. Our next example may provide some explanations for this point of view. Steward's Advertising Raises Questions of Whose Hands Should be on Health Care As we <a href="http://hcrenewal.blogspot.com/2012/07/steward-health-care-vs-rhode-island.html">discussed earlier</a>, Steward Health Care has been working on acquiring a struggling local Rhode Island hospital system, and in doing so is in a dispute with the statewide non-profit Blue Cross health insurance company. Steward had been putting daily full-page advertisements in the local paper. A recent version (27 July, 2012), had this text: <blockquote>RHODE ISLAND TO BLUE CROSS: GET YOUR HANDS OFF OUR HOSPITALS With 80% of the market under its control, Blue Cross & Blue Shield of Rhode Island thinks it can decide which hospitals survive or fail. The people of Rhode Island beg to differ. For the past decade, they've watched Blue Cross starve Landmark Medical Center of its funding. And this year, when Blue Cross issued an ultimatum to terminate the hospital, Rhode Islanders heard enough. <div class="separator" style="clear: both; text-align: center;"></div>In a poll conducted this week by John Marttila, a nationally recognized leader on public attitudes concerning health care, 76% of respondents said that Blue Cross shouldn't be allowed to use their monopoly to dictate the fate of Rhode Island hospitals. They also felt, by a 2-1 margin, that if Landmark did indeed close, Blue Cross would be to blame.</blockquote> <div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEik-dnE6y2ihGLxzXIj8PiyX2dNd6bOnzodaTIVxmP8RXQHBDCe4P3W9mJpZQpDYYimKwXpzK2z3ldDZIVz8FHREcjMsOrOr9Sg0FFhoCt7WAQGIzWw37tJoK4aHvZwcXoT8EhbU_2_4A5h/s1600/StewardBCBSAdvertisement2%2528072712%2529.gif" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" eda="true" height="233" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEik-dnE6y2ihGLxzXIj8PiyX2dNd6bOnzodaTIVxmP8RXQHBDCe4P3W9mJpZQpDYYimKwXpzK2z3ldDZIVz8FHREcjMsOrOr9Sg0FFhoCt7WAQGIzWw37tJoK4aHvZwcXoT8EhbU_2_4A5h/s320/StewardBCBSAdvertisement2%2528072712%2529.gif" width="320" /></a></div>However, soon after, investigative <a href="http://digital.olivesoftware.com/Olive/ODE/ProJo/LandingPage/LandingPage.aspx?href=VFBKLzIwMTIvMDcvMjc.&pageno=MTE.&entity=QXIwMTEwMQ..&view=ZW50aXR5">reporting</a> by the Providence Journal's Ms Felice Freyer revealed that maybe the poll should have been interpreted differently. Not unexpectedly, Ms Freyer revealed the poll to have been "commissioned by Steward." Its basic results were really: <blockquote>Just over half the respondents knew that Landmark was being sold to Steward, and of those, 58 percent did not have an opinion, 29 percent supported the sale, and 13 percent opposed it. However, among those who knew about the sale and also live in northern Rhode Island, the approval rating was higher –– 37 percent support the sale, with 15 percent disapproving and 48 percent having no opinion. </blockquote> The pollster than provided prompting, perhaps in an attempt to get results more favorable to its client: <blockquote>One of the questions starts with this statement: 'Blue Cross Blue Shield provides health insurance to 80 percent of Rhode Island. By refusing to negotiate on reimbursement rates, Blue Cross can essentially determine if hospitals in the state stay open or if hospitals close.' Based on that statement, 76 percent of respondents agreed that 'Blue Cross should not be allowed to use its monopoly to dictate which hospitals stay open and which close their doors.' </blockquote> Unfortunately, it appears that the prompting statement was perhaps not fully accurate: <blockquote>In 2011, Blue Cross covered 66 percent of Rhode Islanders with private health insurance, not 80 percent, according to a report by the Office of the Health Insurance Commissioner. Blue Cross denies that it has refused to negotiate. 'We have negotiated in good faith and have offered a fair contract to Landmark Hospital that is consistent with our reimbursement arrangements for other independent hospitals,' Blue Cross said in a statement. 'Unfortunately, Steward has been unwilling to enter into a contract under those conditions.' </blockquote> While they touted probably methodologically biased survey results, Steward's local advertising campaign's headline might prompt some people to think about whose hands should really be on their health care. The advertising tries to limit this question to Blue Cross' influence. However, one might also ask whose hands control Steward Health Care? Whose Hands are on Steward Health Care? As the Commonwealth article above pointed out, Steward Health Care is a wholly owned subsidiary of Cerberus Capital Management, a New York based private equity firm. Cerberus' <a href="http://www.cerberuscapital.com/team/senior_executive_leadership">top leadership </a>includes - CEO Steven A Feinberg, who, as we <a href="http://hcrenewal.blogspot.com/2012/07/steward-health-care-vs-rhode-island.html">noted</a> previously, was listed as number 21 on a list of the 25 most powerful businessmen in 2007 <a href="http://money.cnn.com/galleries/2007/fortune/0711/gallery.power_25.fortune/21.html">by Fortune</a>, at that time running through Cerberus 50 companies with total revenues of $120 billion.  <a href="http://en.wikipedia.org/wiki/Steve_Feinberg">On Wikipedia</a>, his net worth was estimated as $2 billion in 2008. - Chairman John W Snow, who, as we <a href="http://hcrenewal.blogspot.com/2012/07/steward-health-care-vs-rhode-island.html">noted</a> previously, resigned as Treasury Secretary in the administration of President George W Bush "in 2006 only because it was revealed that he had not paid any taxes on $24 million in income from CSX, which had forgiven Snow's repayment of a gigantic loan that the company had made to him," according to Chareles Ferguson in <a href="http://www.randomhouse.com/book/213722/predator-nation-by-charles-h-ferguson">Predator Nation</a>. - Chairman, Cereberus Global Investments J Danforth Quayle, the controversial former US Vice President during the George H W Bush administration. Furthermore, Cerberus Capital Management, which wholly owns Steward Health Care, owns several other businesses.  As we noted <a href="http://hcrenewal.blogspot.com/2011/05/continuing-parade-of-legal-settlements.html">here</a>, these include, DynCorp (see <a href="http://www.dyn-intl.com/history.aspx">their web-site</a>), which has been called one of the "leading mercenary firms," by <a href="http://www.thenation.com/blog/mercenary-owners-they-are-changin-sort">an article</a> in the Nation.  As reported <a href="http://www.bloomberg.com/news/2011-04-22/dyncorp-to-pay-7-7-million-for-inflated-claims-on-iraq-work-u-s-says.html">by Bloomberg</a>, DynCorp, and hence indirectly about Cerberus, and Steward Health Care, in 2011 settled accusations that it overbilled the US government for construction work in Iraq.   Furthermore, as we noted <a href="http://hcrenewal.blogspot.com/2011/02/send-mercenaries-guns-and-money.html">here</a>, Cerberus also owns the biggest manufacturer of firearms and ammunition in the US. As <a href="http://www.businessweek.com/magazine/content/10_33/b4191041673261.htm">reported</a> by BusinessWeek in 2010, Cerberus owns 13 brands of fire-arms and munitions under the umbrella Freedom Group. So while Cerberus Capital Management would like us to believe that Rhode Island residents question the hands of Blue Cross Blue Shield of Rhode Island on a struggling local hospital system, it seems to be trying to avoid questions about whose hands would be on the hospital system were Cerberus Capital Management's subsidiary Steward Health Care to acquire it.  Summary So, to recapitulate this winding story....   A regional hospital system has been pushing its "new health care" idea.  However, its former surgeon CEO promotes new health care as commoditized health care, assembly line health care, in which doctors become assembly line workers and patients become widgets.  This seems bizarre until one realizes that the CEO actually works for a huge private equity firm whose goal is to make a lot of money in the short-term.  Standardized, commoditized health care is likely to be cheaper to provide than individualized health care.  Private equity firms thrive by cutting their subsidiaries' costs, and then selling them quickly, sometimes before the long-term consequences of these cuts become apparent.  (Look <a href="http://hcrenewal.blogspot.com/2012/01/barbarians-at-gate-making-private.html">here</a>.) So there are two lessons. To repeat the lesson from our <a href="http://hcrenewal.blogspot.com/2012/07/steward-health-care-vs-rhode-island.html">earlier post</a>, everybody, doctors, other health care professionals, health policy makers, patients, and the public ought to be extremely skeptical of the marketing and public relations efforts of big health care organizations.  Based on the examples above, they ought to be particularly skeptical of organizations that are overtly for profit, and/or have a clear focus on short-term revenue generation.  As a society we need to think about how to best counter these biased, incomplete, sometimes grossly deceptive efforts to manipulate public psychology and opinions through our rights to free speech and a free press. To add a lesson, everybody, doctors, other health professionals, health policy makers, patients and the public ought to be extremely wary of the ongoing corporatization of medicine and health care.  Corporate leaders who often get large incentives for maximizing short term revenue are likely to be enthused about turning our health care into a commodity.  Doctors and health care professionals should not want to be assembly line workers, and patients surely should not want to be widgets.

Private Equity, Obfuscatory Advertising, and Making Health Care a Commodity: Lessons from Cerberus Capital Management

The use of advertising by Steward Health Care, currently a regional hospital system here in New England, continues to provide lessons about ...

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