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,

Louise

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

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

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."

Panel discussion moderated by Australian political commentator Tony Jones, who hosts the show "Q&A" on the Australian Broadcasting Corporation.  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 produces winners...and losers (per the empirical research of Social Informatics). 

Me presenting my keynote, driving home the point that IT on its own won't "revolutionize" healthcare; it is a tool to facilitate the true enablers of healthcare - clinicians - a point that should never be forgotten.  Click to enlarge. From the excellent multimedia piece on the conference at this link.

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, work by Australian Professor Jon Patrick of U. Sydney on health IT defects, and other sources as aggregated at this link.

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 terms "electronic medical record" (EMR) and "electronic health record" (EHR) - a source of endless, wasted contention on definitions of which is which - being anachronisms from an earlier age of IT.  I pointed out that in 2012 what these innocuous terms somewhat deceptively and disarmingly represent are in reality complex enterprise clinical resource management and clinician workflow control systems – where many, many things can go wrong.

"EHR":  an innocuous "file cabinet" for records, or something else entirely?  Click to enlarge.

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., in specialized settings; weak observational studies vs. randomized clinical trials) while reports of UC’s are risk management-relevant incident 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.  Dr. Patrick graciously hosted me at his Sydney home for several days after the conference and he and his wife gave me a wonderful tour of the city.  Click to enlarge.

Finally, I had a question from the audience, from fellow blogger Matthew Holt of the Health Care Blog.  (I've had some online debate with him before, such as in the comment thread at my April 2012 post here.)

Matthew asked me a somewhat hostile question (perhaps in retaliation for the thrashing he received at the end of my May 2009 post on the WaPo's HIT Lobby article here), 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.  It is exploitation.

(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

Aug. 11, 2012 Addendum:

An excellent multimedia video of HIC 2012 produced as the conference proceeded has been posted on YouTube at http://www.youtube.com/watch?v=DZg_46wY0E0.  It was finished and shown immediately after the conference's conclusion.

-- SS

10:51 PM

The Machinery Behind Healthcare Reform: How the HIT Lobby is Pushing Experimental and Unsafe Technology on Unconsented Patients and Clinicians

(To those who linked here from "The Health Care Blog", see my footnote at the end of this post. Also, I suggest readers at least peek at each and every hyperlink I've placed in this essay. It takes time, but it's illuminating - ed.)

In many past posts on Healthcare Renewal I have commented on a bewildering healthcare and IT industry blindness to a growing body of literature and experiences of those "in the trenches" that throw doubts upon Utopian views of health IT as a panacea for healthcare's problems. Those responsible for this literature advise caution and the highest levels of scientific rigor in the large scale adoption of clinical information technology if that technology is to actually improve healthcare, myself included. We know the difficulties and risks. Bad healthcare informatics wastes money and distracts clinicians. Bad healthcare informatics can kill. "Primum non nocerum" is a critical ideology in health IT.

I first wrote about these observations a decade ago and was merely standing on the shoulders of those who preceded me with their own critical thoughts and observations regarding cybernetic miracles in medicine.

I've also been puzzled about the sudden lurch by the current administration to commit tens of billions of dollars to national HIT, along with eventual penalties for resistance, within the ridiculously short time frame of 2014 and with little public discussion. The provisions seemed to simply "appear" in H.R. 1 EH, a.k.a. the Economic Recovery Act of 2009. I wrote about this here.

Finally, I was curious about the timing of a remarkable set of reports from highly respected U.S. organizations on HIT issues, such as a Dec. 2008 Sentinel Events Alert from the Joint Commission and a Jan. 2009 report from the U.S. National Research Council. What motivated their release?

The answers to these questions have become bit clearer via a remarkable article from the Washington Post. It reveals an administration heavily influenced by - no surprise - powerful industry lobbyists. (I thought this administration had pledged a different mode of government conduct, but as has been said, campaigning is done with poetry, and governing is done with prose.)

Here is an interesting explanation of how medicine has been cross-occupationally invaded by the IT industry, probably ten or more years before that industry really has the depth of understanding, depth of talent and capabilities to make useful, usable, safe, and cost effective national health IT a reality:

The Machinery Behind Health-Care Reform
How an Industry Lobby Scored a Swift, Unexpected Victory by Channeling Billions to Electronic Records

By Robert O'Harrow Jr.
Washington Post Staff Writer
Saturday, May 16, 2009
When President Obama won approval for his $787 billion stimulus package in February, large sections of the 407-page bill focused on a push for new technology that would not stimulate the economy for years.

The inclusion of as much as $36.5 billion in spending to create a nationwide network of electronic health records fulfilled one of Obama's key campaign promises -- to launch the reform of America's costly health-care system.

But it was more than a political victory for the new administration. It also represented a triumph for an influential trade group whose members now stand to gain billions in taxpayer dollars.

A Washington Post review found that the trade group, the Healthcare Information and Management Systems Society (HIMSS), had worked closely with technology vendors, researchers and other allies in a sophisticated, decade-long [lobbying] campaign to shape public opinion and win over Washington's political machinery ... At the center of those efforts is the Healthcare Information and Management Systems Society. Started a half-century ago, it represents 350 companies and about 20,000 members. Corporate members include government contractors such as Lockheed Martin and Northrop Grumman, health-care technology giants such as McKesson, Ingenix and GE Healthcare, and drug industry leaders, including the Pharmaceutical Research and Manufacturers of America.

With financial backing from the industry, they started advocacy groups, generated research to show the potential for massive savings and met routinely with lawmakers and other government officials.

A lot of voices were left out of that trade group's lobbying, including the open source EHR proponents following the traditions of the VistA effort, as one can learn about in the book "Medical Informatics 20/20" by VA pioneers Goldstein, Groen et al. These traditions are largely alien to the commercial IT sector as evidenced by the mission hostile clinical IT products they put out (see my series on that issue starting here) and even known grossly defective software for use on live patients.

The HIMSS trade group's massive conflicts of interest also seem to have blinded it to the longstanding concerns of many experts in medical informatics, social science and related fields that current approaches to health IT are insufficient and may impair healthcare quality initiatives (let's be frank about what that really means - it means patient harm).

The creation of advocacy groups backed by industry financing also seems eerily similar to many stories on HC Renewal and other blogs about the pharmaceutical industry, as does "generated research." That "research" may also have been industry funded, and it is my belief the impartiality and soundness of such research needs to be critically and impartially re-examined.

Their proposals made little headway in Congress, in part because of the complexity of the issues and questions about whether the technology and federal subsidies would work as billed.

In other words, Congress was doing its job regarding lobbying by proponents of an experimental technology in which they had a major financial stake. Until...

As the downturn worsened last year, advocates helped persuade Obama's advisers to dust off [i.e., uncritically accept lock, stock and barrel - ed.] electronic records legislation that had stalled in Congress -- legislation that the advocates had a hand in writing, the Post review found.
Their sudden success shows how the economic crisis created a remarkable opening for a political and financial windfall: the enactment of a sweeping new policy with no bureaucratic delays and virtually no public debate about an initiative aimed at transforming a sector that accounts for more than a sixth of the American economy.

Let me add that while the advocates "had a hand" in writing the legislation [i.e., they wrote the legislation - ed.], researchers and critical thinkers regarding the downsides of health IT industry in its present state seem to have had little voice in this legislation.

"It was perhaps a once-in-a-generation opportunity to make something happen," said H. Stephen Lieber, the trade group's president. Obama "identified the vehicle that he could use to move his policy agenda forward without the crippling policy debate."

I find this simply outrageous. The reason for policy debates in healthcare and especially healthcare IT is to avoid crippling or killing patients.
Lieber is not a clinician. Who is he to cheer (and perhaps to have spearheaded) the short circuiting of "policy debate" on health IT? According to his bio, he holds an MA from the School of Social Service Administration at the University of Chicago, a BA in Psychology from the University of Arkansas, and has completed additional course work at the graduate schools of business at both universities and at the Keller Graduate School of Management.

... Many technology advocates, including health policy specialists, say that networked electronic patient records that can be transmitted instantly would make health care more efficient and provide valuable insights about costs and care.... Some advocates also say the savings could amount to tens of billions of dollars each year from reduced paperwork, faster communication and the prevention of harmful drug interactions. An equally important benefit, they say, could be to enable researchers to determine the most effective procedures for an ailment. Such an approach would rely on unprecedented data-mining into medical records and the practices of doctors, a kind of surveillance that also would enable insurers to cut costs by controlling more precisely the care that patients receive [Leading to rationing to increase profits? - ed.]

These assertions have never been proven in a scientifically robust manner. Further, there is a growing body of literature expressing significant doubts about these predictions of cybernetic miracles from health IT (see short partial lists of examples here and here) that has largely been ignored - in the worst traditions of pseudoscience and scientific fraud - by the industry and its lobbyists. In fact, the latter assertion - comparative effectiveness research based on EHR data - may have moved from scientific possibility (e.g., better detection of major adverse drug and therapy events) to anti-scientific pipe dream, as in my essay "Have we suffered a complete breakdown in the scientific method with regard to EHR and clinical IT?" I am not even considering massive potential for abuses created by online national health records.

"Finally, we're going to have access to millions and millions of patient records online," said Blackford Middleton, a physician, Harvard professor and chairman of the Center for Information Technology Leadership, whose studies have concluded the health-care system could save $77.8 billion each year through the universal use of information technology networks. "This is the biggest step for health-care information technology in this country's history."
But others said the case was far from being so clear. Some observers said the projected savings are overly optimistic and that launching such vast computer networks under tight deadlines is risky, a lesson learned by the Bush administration when it botched a variety of homeland security systems rushed into place after the Sept. 11 terrorist attacks.

While I respect Blackford Middleton as a former leader of the EHR company from which I selected the EHR for Christiana Care Health System in the late 1990's, I also respect those "others" who say the case is far from clear. It is through science and an open political process that such debates need to be resolved, not through lobbying and utopianism. The potential for adverse, unexpected consequences in such a major social re-engineering effort are simply too great for cavalier attitudes or utopianism. We are already seeing adverse consequences - just the most recent examples are here and here.

Industry "roll out HIT no matter what, patient and clinician informed consent be damned" attitudes also teeter on the precipice of human rights violation. In fact, the corporatization of health IT and the treatment of health IT as if it were any other IT not involving third parties with special rights (i.e., patients) may have already resulted in serious breaches of hospital executive fiduciary responsibilities towards safety and (in the U.S.) of their Joint Commission safety standards obligations as well; see my essay here.

Some proponents said they worry that an over-reliance on technology as a solution could distract the health-care system from difficult questions about quality of care. They said efforts to find a quick technological fix will likely run up against complex cultural challenges.

The latter quote sounds like me, stating the obvious. Allow me to translate the applied, real world meaning of "cultural challenges." It means increased political infighting between stakeholders, power grabs, distractions and chaos on the medical floor and in the medical office, and other social and political upheavals within medicine that will likely distract from the ability of already harried clinicians to provide care.

"I would like to believe that the effective use of technology to augment health care will lead to substantial savings and improvements in the quality of care," said Mark Frisse, a physician and professor of biomedical informatics at Vanderbilt University, who leads an electronic health record program in Nashville. "But the evidence does not consistently bear this out."

Dr. Frisse is quite correct, although I would add that the evidence that does not bear out these beliefs is many, many times stronger than that which, say, caused VIOXX to be pulled off the market.

"HIMSS has a very effective grass roots advocacy program that reaches all levels of government," Dave Roberts, a senior executive, said in the group's literature... HIMSS has a "strategic alliance" with the Center for Information Technology Leadership, a nonprofit that produces research reports -- which HIMSS prints and distributes to Congress and elsewhere.

I agree with that description. Missing from the description, and one I would not add, is a "scientific organization."

After volunteering on John Kerry's presidential campaign in 2004, [now-chairman of the board of HIMSS and their ally, the Center for Information Technology Leadership] Middleton said he was recruited as an Obama volunteer last year and provided information about electronic records to the candidate's health-care policy group. Middleton said he worked with several campaign officials, including David Blumenthal, a colleague at Partners HealthCare and a Harvard professor, who was Obama's health-care adviser and is now the administration's national coordinator for health technology.

"We didn't have to go very far to get our information," said one senior Obama adviser, who was not authorized to speak publicly and discussed the campaign on the condition of anonymity. Blumenthal "taught all the rest of us everything we know."

He may have taught them "everything they know", but he apparently did not teach them everything that is important to know. Obama's team has seemingly thrown a significant body of literature on HIT drawbacks and risks under the bus. This is the essence of scientific naïveté and quackery.

Middleton said he provided many of those details.
"I sent them a LOT of stuff, many papers and most of the reports. I probably spoke or communicated with David Blumenthal, David Cutler (the health economist on the team), or Dora Hughes about every other week during the heat of the campaign," Middleton said in an e-mail.

While Blumenthal goes on in the article to minimize Middleton's influence, I can only wonder if any of the HIT industry lobbyists sent "this stuff" to the campaign.

The stimulus bill suggests that the government will recoup about a third of the spending allocated for electronic health records over the next decade, an assumption that some health-care observers question, in part because of a critical analysis by the Congressional Budget Office last year.

The CBO, then led by Orszag, examined the industry-funded study behind the $77.8 billion assertion, among other things, and concluded that it relied on "overly optimistic" assumptions and said much is unknown about the potential impact of health information technology.

I can add that not only is there much unknown about the potential, but there is much unknown about the true difficulties of making it all actually work as promised. See this seminal short article on why this is so.

This is a spectacularly poor way to run major national initiatives costing tens of billions of dollars and upon which patient wellbeing rides. Blindly.

Joseph Antos, a health-care policy specialist who has examined the legislation, said the risks of the technology plan are high because of the haste with which it is being implemented and the special interests seeking to profit from it.

"This is the real way things get done [and the "real" way true disasters such as our recent world wide financial chaos get initiated - ed.]," said Antos, of the American Enterprise Institute, a Washington think tank. "The stimulus bill looked like a bonanza to an awful lot of people." [I tend to take "awful lot of people" quite literally in this case.]

Haste is an understatement. A more reasonable timeframe might have been 2024, not 2014.

I can add that if this initiative blows up as it has in the UK, then the only triumph will be the financial triumph of the trade group and its apparatchiks. The losers will be the administration, patients, clinicians, and everyone else in the healthcare system. [6/29/09 addendum: it's worse than I thought. The UK's NPfIT in the NHS was suspected to have been doomed from the start, but proceeded anyway; see "16 key points in Gateway Reviews on NHS IT scheme" and the Gateway Reviews themselves, released under a UK FOI request - ed.]

In all seriousness, and with recognition of the harshness of this observation, I add that the patients who might die as a result of hastily and poorly designed and implemented health IT under this rushed "real way" initiative, will have in effect been murdered by this lobby.

-- SS

Footnote:

It is interesting to watch the "circling of the wagons" that is starting over the WaPO story. It is in fact predictable that ad hominem, distortion of views, etc. will follow. For example, Matthew Holt of The Health Care Blog, who writes (emphases mine):

I draw your attention to a troika of articles, all of which show how things can be slightly misinterpreted.

First, who knew that Blackford Middleton was either the most influential health policy wonk out there, or single-handedly responsible for the Haliburtonization of health IT? If you read the WaPo article about it, it looks as though there was some kind of terrible conspiracy to impose an evil fraud in terms of unnecessary health IT spending on the taxpayer. And for example MedinfomaticsMD over at Health Care Renewal (who appears to have jumped from the position that some health IT installations have real problems to the less tenable one that all EMRs kill) is just one going loopy about it.

"Loopy?"

Merriam-Webster:

Loopy:

1 : having or characterized by loops
2 : crazy, bizarre

— loop·i·ly \-pə-lē\ adverb

— loop·i·ness \-pē-nəs\ noun

Ad hominem (link) is no substitute for a logical argument, in fact it is a logical fallacy. Further, an over the top statement that I've "jumped to a less tenable position that all EMR's kill" is quite disappointing from someone who clearly has the intellect to know how amateurishly political an attack that is on a physician-informaticist in this field for almost two decades. One who is trying to take a strong pro-patient, ethical stance while balancing the need to develop safe and effective health IT along more reasonable timelines, and without the behind-the-scenes corporate influence we write about at Healthcare Renewal.

-- SS

2012 Addendum:  see the end of my post regarding my keynote presentation to the Health Informatics Society of Australia at this link for more on Matthew Holt's apparent disdain for my positions regarding HIT ethcs.

4:06 PM