Thursday, August 9, 2012

My Presentation to the Health Informatics Society Of Australia: "Critical Thinking on Building Trusted, Transformative Medical Information: Improving Health IT as the First Step"

In early 2011 I was invited to present at the annual convention of the Health Informatics Society of Australia (HISA) by its CEO, Louise Schaper, PhD.  HISA was aware of my writings and thought a presentation at their conference would be of interest to the Australian informatics and healthcare governance community.

Dr. Schaper wrote:

From: Louise Schaper
Sent: Thursday, March 24, 2011 10:50 AM
To: Scot Silverstein
Subject: HIC invitation to deliver a keynote presentation

Hi Scot,

I trust this email finds you well and I hope spring is bringing you some warmer weather and cheer.

I wanted to let you know that the Health Informatics Conference committee met recently and expressed a high level of interest in having you deliver a keynote address at HIC and also to form part of a panel presentation. 

I know you may not be able to make a commitment to come to Australia in August, but I wanted to let you know what we would love to have you, if circumstances permit you being here.  I’m confident we could have your trip sponsored (providing you don’t mind spending some face-time with the sponsoring organisation) and generate some media coverage around your visit.

The preliminary program will be advertised in the next few weeks and at the moment I’m leaving a ‘spot’ for you in the hope that you may be able to join us.  I know you are in difficult and upsetting circumstances so please know that I’m not intending to add to any pressure – I just wanted to let you know that we would be honoured if you are able to deliver an address at HIC this year and I will keep a speaking spot reserved for you if you think you may be able to accept our invitation.

Thanks for your time Scot.  I look forward to hearing from you.

Kindest regards,


Sadly, the "difficult and upsetting circumstances" she mentioned were my involvement in caring for my mother, seriously injured in May 2010 in a healthcare information technology-related medical misadventure and, by this time, dying.

I was thus unable to attend.

My mother passed away June 6, 2011 of her injuries.

In January 2012, Dr. Schaper was gracious enough to re-invite me to the annual 2012 conference in Sydney.  I accepted.

I enjoyed taking pictures like this with my trusty (and portable) Canon SX110 IS.  Click to enlarge.

I attended HIC 2012, held in the Darling Harbour Convention Centre in Sydney 30 July - 2 August 2012.

My powerpoint slides for the presentation entitled "Critical Thinking on Building Trusted, Transformative Medical Information:  Improving Health IT as the First Step" are at this link.

Darling Harbour Convention Centre, Sydney, Australia. Click to enlarge.

Australia has embarked on a national Personally Controlled Electronic Health Record (PCEHR) project under the auspices of Nehta, the National E-Health Transition Authority.  I find this an interesting approach to national health IT; unlike the U.S., whose project is top-down (centrally controlled records), Australia seems to have learned from our mistakes and is initiating health IT as a bottom-up (patient-controlled) initiative.

At the conference last week, I delivered a keynote address on the theme of improving health IT as an essential step in leveraging the capabilities of the technology.

Being that I am anti-"bad IT" and pro-"good IT", implicit in my address was the issue of the technology's untrustworthiness in 2012, largely due to the unregulated free-for-all its market represents and the poor engineering that is the result.

I also participated in a Panel Discussion led by Australian investigative journalist and popular political TV program host Tony Jones.  Mr. Jones hosts the Australian Broadcasting Corporation's "Q&A - Adventures in Democracy."

I don't have a picture of my panel moderated by Tony Jones at present, but here is another panel at HIC 2012. Click to enlarge.

I will highlight several key points I made in my keynote and on the panel:

  • Critical thinking is essential at all times in healthcare ... or your patient's dead.
  • Critical thinking is not mindless criticism; on the contrary, it is reflective, inquisitive, logical thinking that is focused on deciding what to believe or do.
  • Health IT must be trusted by users and patients [And be free of major downsides] - as a primary step before HIT can optimally benefit healthcare 
  • I pointed out I am not suggesting anything new and that, in fact, I am suggesting something old:  "First, do no harm."
  • I pointed out the "revolutions" usually have downsides, and IT always produced winners...and losers.

I then posed a series of questions of great relevance to understanding health IT realities.  Click to enlarge:


I left it to the audience to answer these questions.

I then posed the question "Is health IT being done well?"

I provided links to various evidence that it was not, such as the National Research Council 2009 report on health IT; AMIA's report on its workshop on healthcare IT failure, the 2012 U.S. IOM report on safety, the 2012 U.S. NIST report on usability, and the work by Australian Professor Jon Patrick of U. Sydney on health IT defects.

Again, I did not impose views on the audience.  I didn't need to, as that corpus speaks for itself.

I also clarified terminology that reduces essential caution, such as the term "EHR" and "EMR" (a source of endless wasted contention on definitions) being anachronisms from an earlier age of IT.  I pointed out that in 2012 what these innocuous terms somewhat deceptively represent are complex enterprise clinical resource management and clinician workflow control systems – where many, many things can go wrong.

I asked if case reports of health IT unintended consequences (UC’s) were “anecdotal” and to be played down, while studies of health IT benefits to date solid science.  I then asked if the reality might be that studies of health IT benefits to date were mostly anecdotal (e.g., specialized settings, non-RCT’s) while reports of UC’s are risk management-relevant case report “red flags” pointing to possible systemic problems.

I pointed out the common seller marketing memes of beneficence and deterministic efficacy, and asked if these were realistic.  I also pointed out the need for transparency about HIT risks, and the impediments to this transparency.

Finally, I indicated what was the likely problem affecting all countries involved in EHR projects: that the rigor, ethics and skepticism of medical science itself not applied in the domain of health IT.

I suggested a simple solution:  a paradigm shift in thinking about health IT as another medical device, that needed to be subject to the same methodologies and ethical considerations applicable for decades (or more) in the healthcare delivery sector such as medical devices, pharmaceuticals, and research (and other risk-prone industries e.g., aviation and automotive).

My goal was to provoke thinking about these issues, to circumvent blank, uncritical acceptance of industry and industry-supporter memes.

I believe I succeeded.  Feedback I received was that the audience, including government officials, found many new things to consider as they embark on their national health IT projects.

I also heard that some HIT seller representatives were squirming a bit.  That was not unexpected.  I was taking "control of their message" away from them.

University of Sydney Professor Jon Patrick presenting on computational linguistics.   Jon is the author of a treatise on health IT defects (at this link), mentioned numerous times on this blog.  Click to enlarge.

Finally, I had a question from the audience, from fellow blogger Matthew Holt of the Health Care Blog.  Matthew asked me a somewhat hostile question that I was well prepared for, expecting a question along these lines from the seller community, actually.  The question was preceded by a bit of a soliloquy of the "You're trying to stop innovation through regulation" type, with a tad of Merck/VIOXX ad hominem thrown in (I ran Merck Research Labs' Biomedical libraries and IT group in 2000-2003).

His question was along the lines of - you were at Merck; VIOXX was bad; health IT allowed discovery of the VIOXX problem by Kaiser several years before anyone else; you're trying to halt IT innovation via demanding regulation of the technology thus harming such capabilities and other innovations.

The audience was visibly unsettled.  Someone even hollered out their disapproval of the question.

My response was along the lines that:

  • VIOXX was certainly not Merck at its best, but regulation didn't stop Merck from "revolutionizing" asthma and osteoporosis via Singulair and Fosamax;
  • That I'm certainly not against innovation; I'm highly pro-innovation;
  • That our definitions of "innovation" in medicine might differ, in that innovation without adherence to medical ethics is not really innovation. 

(I forgot to mention that I gave an invited presentation to Merck's Drug Surveillance department in 2006, PPT here, long after I was their employee, on the potential use of EHR data to detect drug adverse events sooner than traditional phase IV studies or ad-hoc reporting allowed.)

When I spoke of medical innovation requiring ethics, nearly the full audience at my keynote address - hundreds of people - broke out in applause.

I knew at that point that my talk was a success.

This author with HISA CEO Louise Schaper , PhD. Click to enlarge.

More photos of my trip are here.

-- SS

Addendum:  Another added pleasure in my visit Down Under. As Australia and the U.S. respect each other's amateur radio licenses, I was able to operate my handheld radio as "KU3E portable Victor-Kilo." VK is the international radio prefix for Oz.  Contacting Australia from the U.S. is considered a "holy grail" of ham radio.  It was interesting to hear amateur radio "from the other end."

Yaesu VX-3 Multiband Transceiver

-- 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?" I wrote:

 ... 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:

(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 

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.

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:

... 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.

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