Showing posts sorted by relevance for query irrational exuberance. Sort by date Show all posts
Showing posts sorted by relevance for query irrational exuberance. Sort by date Show all posts

Home Posts filed under >Search results for irrational exuberance

Health IT: Ddulites and Irrational Exuberance

The title is not a typo.

I've often tried to explain the phenomenon of irrational exuberance where computers are concerned, especially in the domain of health IT.

In face of the literature references provided throughout this blog, including at posts such as this reading list and at sites such as here, one would think rational people would temper their exuberance somewhat, at the very least towards rapid national rollouts - as opposed to constrained, controlled experiments until the industry learns how to get the technology "right."

However, more than a decade of writing has had little effect.

I've also attempted to explain the phenomenon of irrational exuberance on a belief in technological determinism, on industry propaganda, on unquestioning IT faith being a quasi-"religion", and on profiteering or other quid pro quo. (The latter, I'm certain, is operative to an extent.)

I have now come across a term, though, that I believe accurately encapsulates the phenomenon of unquestioning beliefs that health IT + clinician automagically --> a "revolution" in medicine.

It may be a character trait. The trait has been described by the term "Ddulite." (Pronounced, I would say, 'da-dew-light'.) It is obviously a play on "Luddite" with the fist four characters backwards.

Apart from its historical meaning, a Luddite is "one who is opposed to change, especially technological change" (Merriam-Webster).

A Ddulite, on the other hand, is the opposite of a Luddite. A Ddulite is:

A person who prefers new tech to old tech even when the old tech is better--more functional

or alternately:

A person with a preference for higher tech solutions even in cases where lower tech alternatives have greater and more appropriate functionality.

My own definition, especially in healthcare:

Hyper-enthusiastic technophiles who either deliberately ignore or are blinded to technology's downsides, ethical issues, and repeated local and mass failures. [1]

Such people ignore the downsides, even if the downsides are deadly - in which case I believe it justified to describe Ddulites as "radical technophiles."

The Ddulite simply assumes if it's new technology, it has to be better, no matter the evidence because, well, it's new technology.

In other words, irrational exuberance in IT in general, and HIT specifically, is not merely a belief, it's a character trait, perhaps an ideology.

That could help explain why some otherwise very bright people, even people who promote evidence-based medical practice, seem to become blind and deaf in regard to HIT, as in the recent comment thread on my post "KevinMD: How algorithm driven medicine can affect (make more dangerous, actually) patient care."

When it comes to evidence-based IT practice, a Ddulite is eager to provide extraordinary special accommodation towards IT flaws, ethics, known dangers, etc. Someone of this ideology finds it exceptionally easy to dismiss or ignore any and all evidence that could contradict the technology's powers to "transform" medicine, and perhaps even worse (for patients), that could contradict its infallible beneficence.

Unfortunately, IT is not a magic bullet ... it can be just a bullet, period, unless "done well", an undertaking of almost wicked complexity.

Being a Ddulite can, in fact, lead to recklessness and negligence. A transition to IT must always respect the findings of Social Informatics (PDF): see especially Sec. 3.1 'Key Social Informatics Ideas' starting on pg. 117. The transition must be done - especially in a scientific domain - in a scientific manner.

In medicine, that means applying the rigors of medical research, medical science and medical ethics to the conception, design, implementation and lifecycle of health IT, with all that implies. This is certainly not the state of the HIT enterprise in 2012, which is largely based on a management information systems, i.e. merchant-computing, paradigm.

People who offer unquestioning loyalty to cybernetics, and who reflexively accuse those who are circumspect about commercial health IT of being "Luddites" who proffer "anecdotes", perhaps need to look in the mirror. They then need to think critically as to whether their reflection demonstrates Ddulite characteristics.

Unquestioning loyalty to the Empire: In A Mirror, Darkly

-- SS

Feb. 19, 2012 addendum:

Also see my post "Health IT Ddulites and Disregard for the Rights of Others" that adds another observation about the Ddulite mindset.

Notes:

[1] On mass IT failures repeatedly ignored, see "Pessimism, Computer Failure, and Information Systems Development in the Public Sector", Shaun Goldfinch, University of Otago, New Zealand, Public Administration Review 67;5:917-929, Sept/Oct. 2007.

Does EHR-Incited Upcoding (Also Known as "Fraud") Need Investigation by CMS, And Could it Explain HIT Irrational Exuberance?

It has long puzzled me why an experimental technology that costs tens or hundreds of billions of dollars to roll out organizationally and nationally, that individual medical centers are spending upwards of $100 million or more upon, and that has a track record as poor as suggested in posts such as "An Updated Reading List on Health IT" and "MAUDE and HIT Risks: Mother Mary, What in God's Name is Going on Here?" is so popular.

At a Feb. 2010 post "A Lawsuit Over Healthcare IT Whistleblowing and Wrongful Discharge" I summed up other critical HIT issues succinctly, with abundant hyperlinks to other materials as below:

... I have written about health IT problems extensively on this blog and at my academic website on HIT failure. These include but are not limited to: medical informatics specialists ignored by nonclinician IT personnel [the link is to another case involving critical care]; inverted and paradoxical organizational structures where IT facilitators become HIT project leaders and clinical leaders become HIT project facilitators; ill-conceived and poorly implemented mission hostile health IT; perverse and in fact clinically cavalier IT "politics"; failure to obtain patient informed consent as if health IT is an elite world not subject to the same ethical obligations as medicine; probable violations of Joint Commission safety standards and hospital executive fiduciary obligations, and numerous others.

At a Jan. 2011 post "Healthcare IT Delirium" wrote that:

... On top of an irrational exuberance (see this blog query) largely unsupported by the literature (e.g. here), the technology is experimental, its rollout is a grand national experiment in social re-engineering of medicine, there is no patient informed consent, nobody is in control, and nobody is taking responsibility for regulating the domain despite known risks. The results will very likely reflect the Wild West free-for-all that is now extant.

Finally, at a Feb. 2011 post "An Updated Reading List on Health IT" I aggregated recent literature that sheds significant doubts on health IT beneficence.

Is the popularity of health IT as it exists in 2011 a paradox, or not?

When I was dealing with public employees in a transit authority several decades ago, I learned that mysterious circumstances and paradoxes were not paradoxes at all. The assumptions were simply wrong. Often, mysterious circumstances proved to be related to money (as in worker's comp fraud) and/or money related to [illegal] drugs.

Below are some charts and data from a HC Renewal reader, an ED physician, that may answer the mystery of the "irrational exuberance" exhibited by healthcare organizations towards clearly disruptive, medically risky and liability-provoking experimental technology. This is especially so in high risk areas such as an ED.

It should be noted that my recommendations as a CMIO a number of years ago in a very large regional medical center were that an ED would benefit best clinically from paper charts supplemented by document imaging, so that images of past charts could be instantly retrieved. ED's are busy places where clinicians have little time for distractions (such as computer data entry), but where access to past charts can be important. ED charts are also not generally very long or complex documents. Further, document imaging is a mature technology (e.g., Documentum).

Those ED recommendations still stand.

(Incidentally, a relative, injured in 2010 via an EHR issue, would certainly be in far better shape had this been the case. The error would not have occurred. I've worked in settings where document imaging systems were used.)

Note that the data and charts below are estimates only, pointing to a potentially huge problem -- with computer-assisted Medicare fraud implications -- if the projections are reasonable.

First, from the ED physician reader, a graph showing an increase in overall ED billing levels of 2002 versus 2008:

(E/M level increases, 2002 compared to 2008. Via CMS data; see below. Click to enlarge)


This appears to indicate a great increase in upper level (level 4 and 5) billings from 2002 to 2008 in ED's with increasing advent of EHR (part of this is likely due to "paper template" charting).

A very terse summary of these billing codes, for laypeople. Claims submitted to managed care organizations and States include the emergency levels of screening and treatment. They range from CPT 99281 ("straightforward medical decision making") to CPT 99285 ("medical decision making of high complexity"). These codes reflect not only the complexity of the treatment but also the time and difficulty of making a diagnosis:

  • 99281 - level 1 - very short visit - low level service, minimal charge
  • 99282 - level 2 - e.g. ankle sprain
  • 99283 - level 3 - limited focus history & physical exam performed, e.g. physisian evaluation with additional tests such as an x-ray.
  • 99284 - level 4 - significant history & physical exam performed, significant or major injury, often admission
  • 99825 - level 5 - significant time, e.g., 45 minutes to an hour spent by physician. (Note that considering that a high % of ED visits are using that code, it might be physically impossible for ED physicians to be spending this much time seeing each patient.)


Second, a spreadsheet with some estimated numbers:


(Click to enlarge)


There appears to be an absolute increase in Medicare/Medicaid payments to ER doctors due to this billing-upcoding phenomenon from 2002 to 2008 (roughly $2 billion in payments, which at 80% allowed Medicare rate represents appx. a $2.6 Billion increase in billing)

The 2006-2008 billing levels for each specialty are public info on the CMS website. The hard part was obtaining earlier numbers. These were found in 2 papers from 2004 and 2006:

Variation in Coding of Evaluation and Management (E&M) Services by Hospital Emergency Departments
Paul Shoemaker, FACHE, President and CEO
American Hospital Directory, Inc.
Jan. 2004
http://www.ahd.com/EMstudy040108.pdf


Variations and Trends in the Coding of Evaluation and Management (E&M) Services by Hospital Emergency Departments
Paul Shoemaker, FACHE
Leatrice Ford RN, BSN, CCS, Founder, ConsultCare Partners, LLC
May 2006
http://www.ahd.com/EMstudy060530.pdf

Apparently Shoemaker and Ford were able to get CMS data for 2002 and 2004 and draw the conclusions that while some hospitals and ER groups were undercoding, there was a significant level of upcoding occurring.

Note that the above projections assume the same Medicare physician allowables for 2002 and 2008; lesser values in 2002 (compared to 2008) would push the 2008 payment increases upward.

Finally, some actual ED screens from a major HIT vendor, McKesson, that "encourage" physicians to upcode.

The "coding engine" of this ED EHR system produces "recommendations" for "additional documentation" to support a higher level of coding. Such incentives themselves might be legitimate, but can create moral hazard - and the means, motive and opportunity for "playing with the coding a little bit" - if physicians' coding levels are monitored by their organizations.


(Click to enlarge. An abscess. ED EHR advising physician to "provide more documentation" in order to upcode from level 2 based on the data entered, to level 5 or maximum, via unknown algorithms. A "Correct Deficiencies" button brings up screens with selections a physician can click on to "support" the cybernetic upcoding.)



(Click to enlarge. In this example an ED physician is begin cybernetically cajoled - uh, "reminded" - to enter data to support upcoding a sprained ankle evaluation from a level 3 to a level 5.)


It should be remembered that increased ED coding levels by ED groups, often contractors to hospitals, may permit hospitals to increase their own billing charges for services rendered to the ED patients.

In summary:

  • With little solid evidence of major clinical benefit, ED physicians seem to be paradoxically "asked" to utilize distracting, often mission hostile, even hateful ED EHR systems that many despise, even in face of the critical nature of an ED environment and increased risks and liabilities that can occur with distractions such as data entry. This is a seeming paradox.
  • The ED physicians, after automated coding algorithms analyze the clinical data entered, may be "reminded" that if they fill in a few more details, the visit might be significantly upcoded.
  • Payers such as CMS have little or no way to ascertain the veracity of the additional entered information that may result.
  • The ED physicians' coding levels may be monitored by their employer(s) i.e., group or hospital compared to the "possible" coding levels suggested by the vendor software algorithms. ED EHR software makes this easy. This would create the means, motive and opportunity for upcoding, so as to prevent negative repercussions on a "low coding" doctor. (The ED physician who submitted this data claims that this is so in his organization, and in others.)
While the above is not a rigorous analysis, if it overall reflects the current situation with ED and other EHR's in the field in 2011, we may be seeing:

  • A significant explanation for "irrational exuberance" around health IT - which would actually not be so irrational after all (just unethical) - with potentially deadly results;
  • A highly systematic, major fraud participated in by major stakeholders, from software vendor to purchaser to clinical user to biller. This would represent a cybernetically-facilitated swindle of major (and growing) proportions; and
  • Claims of purported savings from health IT that we hear about from pundits and government officials being a rather pathetic joke.

Perhaps CMS (and other payers as well) could perform the needed rigorous investigation using their data and resources, to either confirm or disprove these findings. That's what we, the taxpayer, pay the government for.

-- SS

Medicare/Medicaid Cuts? Spend Money on Patients - Not Computer Experiments

There has recently been much debate about how to save this country from European-style financial ruin. From "GOP 2012 budget proposal cuts taxes on rich, cuts Medicare in the future", Examiner.com, April 3, 2011:

On Tuesday House Budget Committee Chairman Paul Ryan (R-WI) is expected to release the Republicans’ 2012 budget proposal. Currently Democratic and Republican leaders are trying to negotiate a compromise on the 2011 budget would make some cuts to discretionary spending. Republicans have said they would not be able to propose really significant cuts to lower the deficit until 2012. According to reports, the GOP proposal would dramatically cut taxes on corporations and the rich, while also making significant cuts to Medicare and Medicaid.

I propose the cuts to Medicare and Medicaid, which will directly affect medical care delivery to the elderly and poor, be traded for cutting extravagant expenditures for experimental medical computer technology. This could be accomplished through repeal of HITECH and diversion of those funds to patient care, where it's more urgently needed.

Let scarce taxpayer dollars be spent on the health of human beings, not on machines of uncertain value and risk at their current state of evolution in 2011.

At my Jan. 2011 post "US House of Representatives Proposes to Defund Largest Non-Consented Medical Experiment in U.S. History: HITECH" I had written about H.R.408, the Spending Reduction Act of 2011 Introduced in the House of Representatives:

In a new bill in the House of Representatives, the ‘‘Spending Reduction Act of 2011’’ (link - PDF), it is proposed to cut unobligated funds of, among others, division A of the "American Recovery and Reinvestment Act of 2009":

... Spending Reduction Act of 2011

DIVISION A—APPROPRIATIONS PROVISIONS

... TITLE XIII—HEALTH INFORMATION TECHNOLOGY

Title XIII of the ARRA along with title IV of division B is better known as HITECH:

SEC. 13001. SHORT TITLE; TABLE OF CONTENTS OF TITLE.

(a) SHORT TITLE.—This title (and title IV of division B) may be cited as the ‘‘Health Information Technology for Economic and Clinical Health Act’’ or the ‘‘HITECH Act’’.

I commented that it looked like HITECH was one of a number of spending extravaganzas on the proposed chopping block.

Health IT under the country's current financial condition is indeed an extravagance, especially considering the experimental nature of the technology and the doubts expressed by experts as to its true value in its current state of development (see "An Updated Reading List on Health IT" at my Drexel Univ. Healthcare IT failures site).

This recent revelation should also be considered:

The quality of the technology is likely far, far worse than anyone, including the pessimists, imagined. The HIT problem reports in FDA's MAUDE database (link) are child's play compared to the following.

The unprecedented, recent, detailed analysis of a major American electronic health record system for use in Emergency Departments (of all places) by an Australian health IT expert at the following links is simply astonishing, if not downright frightening. See:


If even a fraction of this analysis is correct, we should simply take those billions of dollars and turn them into cigar wrappers.

Or perhaps coffins.

I will also repeat some of my rationale in my Jan. 2011 post for repeal of HITECH:

  • This country cannot afford HITECH at this time. Put simply, we are broke, and the national deficit is ballooning far out of control. The money would be far better spent at this time on care of those who cannot afford that care.
  • HITECH appeared as if out of nowhere, with little to no input time from stakeholders. This suggests lobbying by those with conflicts of interest to push this bill onto the public, affecting their medical care without informed consent (see my March 2009 post "Draft Patient Rights Statement and Informed Consent on Use of HIT"). The bill includes persuasion along with economic coercion for non-adopting organizations and physicians. ("Adoption" = adherence to government-set standards of "meaningful use" of poorly usable technology.) I disapprove of the stealth process by which HITECH appeared. This is the U.S., not the old USSR.
  • Mass social experiments involving major systemic changes to our healthcare delivery system, with exceptional claims being made about IT, need to be backed by exceptional evidence. That evidence is lacking. In fact, the evidence might actually point in the negative direction. See my aforementioned post "An Updated Reading List on Health IT."
  • The technology is not ready. It is dangerous in unqualified hands, which most every medical center and physician office is in 2011 (i.e., an IT backwater). The field of health IT was somehow transformed from an experimental field into the 'savior of medicine' without the proof of value and safety that would ordinarily be required to move an experimental technology from lab to national rollout. Per the Washington Post, this process appears to have been a highly politicized one, favoring the corporate elites. The Washington Post’s 2009 article on the influential HIT vendor lobby “The Machinery Behind Healthcare Reform” is at this link.

To these I will add a few more reasons to convert HITECH extravagance in time of financial distress and high unemployment to direct care provision:

  • A similar experiment in the much smaller and strongly government-managed healthcare system of the UK didn't exactly have stellar results (link, link). We also have been warned not to make the same multi-billion dollar errors (link).
  • The cavalier attitudes by the administration-appointed ONC director Blumenthal towards evidence of health IT-caused adverse effects, including deaths, reported to him by the FDA (see this Feb. 23, 2010 Internal FDA Memorandum on Health IT Safety Issues, PDF).

Despite the fact that the Director of FDA's Center for Device and Radiological Health Jeffrey Shuren (a physician and lawyer) testified these reports were likely just the "tip of the iceberg", ONC director Blumenthal glibly stated, per the Aug. 2010 Huffington Post Investigative Fund article FDA, Obama Digital Medical Records Team at Odds over Safety Oversight, that FDA's reports of health IT related injuries and deaths were “anecdotal":

ONC director Blumenthal, the point man for the administration, has called the FDA’s injury findings “anecdotal and fragmentary.” He told the Investigative Fund that he believed nothing in the report indicated a need for regulation.

These exact cavalier attitudes about "anecdotes" just failed in the Supreme Court. (See my Mar. 27, 2011 post about the Zicam decision in "Those Who Dismiss Healthcare (and Healthcare IT) Adverse Events Reports as Mere "Anecdotes" Have Lost - Supreme Court-Style").

More reasons for diverting HITECH funds to patient care include government waste driven by irrational exuberance and idealism:

  • More on purported cost savings - Peter Orszag, former head of the Congressional Budget Office, said the use of electronic health records, without a major change in health care delivery, "would not significantly reduce overall health care costs" in the agency's 2007 report on long-term health care spending. He also said that according to data from the report, the return on investment for EHR's "is not going to be as substantial as people think." The CBO concluded that predictions of cost savings from EHR's relied on "overly optimistic" assumptions and said much is unknown about the potential impact of health information technology. [That is, it is an experimental technology - ed.] Mass savings from health IT is an assertion that is both unproven and highly unlikely in my view.

Finally, here's another reason to withdraw HITECH for now:

  • As I'd written in a series of essays at this blog query link, we simply don't know how to make computerized medical information reasonably private and secure. (One might wonder whether the current administration, sponsors of the out-of-the-blue HITECH act, actually wants healthcare information to be private and secure.)

I reiterate from my January 2011 post:

I would not weep for the HITECH act's passing. It would allow the restoration of health IT back to an unrushed and careful experiment.

It would also give time to work out the significant issues causing health IT difficulty (such as raised in 2009 by our National Research Council) before we embark on national health IT diffusion.

In other words, its passing would reduce risk and help restore an essential level of sanity and due diligence to the healthcare IT sector, now afflicted by irrational exuberance bordering on delirium.

We would avoid the largest unconsented medical experiment in US history, which as I have repeatedly written I feel would be disastrous with current levels of understanding of this technology and how to design, deploy and manage it. (My relative's 2010 HIT-related injuries only strengthened my convictions in this regard.)

Disclosure: I have no financial conflicts of interest regarding HITECH or health IT to weep about. Others do, and it's not hard to predict their financial interests will push them to oppose HITECH repeal "by any means necessary."

A replacement HITECH act that's "HIGH" on research and caution, but not so high on stealth, coercion and idealistic euphoria would be welcomed.

-- SS

Health Care Policy of the Insiders, by the Insiders, for the Insiders - the Newt Gingrich Case Files

Newt Gingrich's rise to the top of the pack of Republican contenders for the US presidency has earned him increased scrutiny.  The resulting investigative reporting has provided a revealing set of case studies showing how insiders have come to dominate US health care policy.

Below I have reorganized the information presented in a series of news articles from mid-November to mid-December, 2011.

Mr Gingrich's Consulting Empire

A general description of Mr Gingrich's health care "think tank" appeared in the Washington Post.(1)
A think tank founded by GOP presidential candidate Newt Gingrich collected at least $37 million over the past eight years from major health-care companies and industry groups, offering special access to the former House speaker and other perks, according to records and interviews.

The Center for Health Transformation, which opened in 2003, brought in dues of as much as $200,000 per year from insurers and other health-care firms, offering some of them 'access to Newt Gingrich' and 'direct Newt interaction,' according to promotional materials.

Despite its name, the CHT was for-profit. Much of its actual workings are confidential, per the Post,(1)
Susan Meyers, a center spokeswoman, declined to comment on the think tank’s income or staffing levels because it is a private-sector organization.

Despite its pretentious name, the CHT was apparently a vehicle for its wealthy corporate clients to influence health policy to favor their business interests.  A NY Times article(2) reported that:
His consultancy practice was centered around his ability to help big corporate interests speak the language of Republicans and navigate the corridors of Capitol Hill on issues vital to their businesses.

According to a Bloomberg article(3), the work was quite lucrative:
Two companies founded by Newt Gingrich announced yesterday that they had grossed $55 million between 2001 and 2010, part of an effort to quiet questions about how the former U.S. House speaker earned millions since he resigned from Congress in 1999.

That revenue supports the Center for Health Transformation and The Gingrich Group LLC, which have a staff of as many as 30 people, stage health-care policy events, and provide advice to clients, Nancy Desmond, the chairman and chief executive officer of the firms, said in a written statement.

The CHT was linked to a small corporate empire, as described by the Washington Post,(4)
Former House speaker Newt Gingrich transfigured himself from a political flameout into a thriving business conglomerate. The power of the Gingrich brand fueled a for-profit collection of enterprises that generated close to $100 million in revenue over the past decade, said his longtime attorney Randy Evans.

Among Gingrich’s moneymaking ventures: a health-care think tank financed by six-figure dues from corporations; a consulting business; a communications firm that handled his speeches of up to $60,000 a pop, media appearances and books; a historical documentary production company; a separate operation to administer the royalties for the historical fiction that Gingrich writes with two co-authors; even an in-house literary agency that has counted among its clients a presidential campaign rival, former senator Rick Santorum (R-Pa.).

Separate from all of that was his nonprofit political operation, American Solutions for Winning the Future.

Relationships with Big Health Care Corporations

The Center for Health Transformation was largely funded by big health care corporations. The Post first noted,(1)
The biggest funders, ... [included] firms such as AstraZeneca, Blue Cross Blue Shield and Novo Nordisk,...

Also,(1)
The center has listed scores of firms and industry groups as members over the years, amounting to a Who’s Who of the medical field, from GE Healthcare to the American Hospital Association to Wellpoint, the nation’s largest health insurer.

Other clients were listed in a Bloomberg article,(5)
Among the member companies were drugmaker Johnson & Johnson (JNJ) and health insurer Blue Cross and Blue Shield Association....

Also,(5)
Pfizer Inc. (PFE), the world’s largest drugmaker, had consulting contracts with Gingrich, according to two people familiar with the arrangements. Pfizer spokesman Ray Kerins didn’t respond to requests for comment.

The Pharmaceutical Research and Manufacturers of America, the industry’s trade group, was also a client. His firm 'was retained by the PhRMA general counsel’s office at one time to provide advice on a positioning project,' the group said.
In addition, as noted below, clients included important firms in the health care information technology (IT) sector, including GE, IBM, Microsoft, Allscripts, and Siemens.

Below, we present several cases in which Mr Gingrich apparently intervened on behalf of his clients to promote their business interests in the guise of promoting his views on health policy solutions.  In some cases, the views he promoted did not fit with what is generally regarded as his political philosophy, suggesting that the interests of his paying clients overrode his political views.

Case: End of Life Care

The New York Times reported,(2)
Writing on the Web site of the Washington Post, Mr Gingrich praised Gundersen Lutheran Health System of LaCrosse, Wis., for its successful efforts to persuade most patients to have 'advance directives,' saying if Medicare had followed Gundersen's lead on end-of-life care and other practices, it would 'save more than $33 billion a year.'

Note that
Gundersen was one of the paying clients of Mr. Gingrich's Center for Health Transformation....

However,
within weeks, Mr. Gingrich would find himself on the wrong end of what some Republicans labeled the 'death panel' issue.

At that point, Mr Gingrich abruptly changed his tune,
As it happens, shortly after Mr. Gingrich wrote his article praising Gundersen, he joined the conservative critics of the provision. 'You are asking us to trust turning power over to the government,' Mr Gingrich told George Stephanopoulos of ABC News that August 'when there are clearly people in America who believe in establishing euthanasia, including selective standards.'

This suggested that Mr Gingrich took up the cause of end-of-life decision making not be cause he deeply believed in it, but because it was expeditious given the wishes of his clients, despite the assertion made by his spokesperson,(2)
Mr. Hammond said that Mr. Gingrich did not take policy positions for pay; rather, he said, clients sought him out because of the views he already held and his expertise in communicating ideas.

Case: Medicare Prescription Coverage Sans Negotiations about Drug Prices

As reported by Bloomberg,(5)
When U.S. House Republican leaders in 2003 were short of votes to pass a $395 billion Medicare prescription drug benefit, they recruited former House Speaker Newt Gingrich for help.

In a hushed room on Capitol Hill, Gingrich told his former Republican colleagues that if he could endorse the measure, they should be comfortable with it, too, said two former senior House aides who attended the closed-door session.

Two days later, after a vote was held open for three hours as leaders corralled the final ayes, the measure passed and was eventually signed into law by President George W. Bush.

What Gingrich didn’t mention during the Republican caucus meeting was that he was also building a for-profit, health-care research company and seeking financing from drugmakers, which were investing $128.6 million in lobbying for passage of the new benefit for seniors.

Note that the legislation that provided Medicare drug coverage forbade the government from negotiating prices with drugmakers.  This was unprecedented, because drug coverage from the US Veterans Administration and Medicaid did not come with the obligation to pay whatever the drug-makers charged.  The inability of Medicare to negotiate the prices it paid for drugs certainly helped the companies' revenues while driving up the costs of Medicare, the federal deficit and the costs of health care in general.

Case: Promoting Expensive Diabetes Care

The Washington Post reported,(4)
Novo Nordisk, a Denmark-based drug firm that specializes in diabetes treatments.... paid a total of $1.2 million to Gingrich’s foundation over six years as a 'founding charter member.'

'It was strictly a business, nonpolitical relationship,' Novo Nordisk spokesman Ken Inchausti said. 'We admired his leadership on issues related to health-care delivery systems. We thought the CHT brought something to the table to us in terms of finding ways to help people prevent diabetes.'

Gingrich loaned his celebrity to causes that, whatever their other merits, could also be good for Novo Nordisk’s bottom line. For instance, he was the keynote speaker at Novo Nordisk’s 'diabetes summit' in 2005 and joined the company in issuing a 'call to action' to fight diabetes in Texas and Georgia.
One wonders how many of the widely promoted "summits" and other star-studded conferences on health care featuring corporate  and political leaders as speakers are just stealth health policy advocacy or stealth marketing.

Case: Irrational Exuberance for Electronic Health Records

My fellow Health Care Renewal blogger has often discussed the "irrational exuberance" for electronic health records (EHRs) despite scant information about their benefits, and increasing data suggesting their harms.  It now appears that Mr Gingrich, sponsored by copious funds from the health care IT sector, has been a major source of such exuberance. 

Mr Gingrich had a complex relationship with the health care information technology (IT) industry. It began to come out first in a NY Times story,(6)
When the center [for Health Transformation] sponsored a 'health transformation summit' at the Florida State Capitol in March 2006, lawmakers who attended Mr. Gingrich's keynote speech inside the House chamber received a booklet promoting not just ideas but also the specific services of two dozen of his clients. Executives from some of those companies sat on panels for discussions that lawmakers were encouraged to attend after Mr. Gingrich's address.

Gerard White, president of Clearwave, which paid about $50,000 to become a center member, used the occasion to pitch his company's system for managing patient data.

This had all began earlier,
Two years before the Florida 'summit,' Mr. Gingrich made a presentation to Republican lawmakers in Georgia, promoting the work of his member companies by citing specific benefits if they were hired. For example, 'VitalSpring could save the State Employee Program over $20 million a year.'

Minutes of the members-only conference call from March 2004 said the center had 'arranged joint meetings' for members to present their work on electronic health records to top federal officials, noting that Mr. Gingrich 'reported very positive feedback overall from these meetings.'

He also pressed for passage of a federal bill to increase the use of electronic health records, collaborating with one of its co-sponsors, Representative Patrick J. Kennedy of Rhode Island, and Senator Hillary Rodham Clinton of New York, both Democrats.

Furthermore,
Many of the ideas he has pushed involve the increased use of information technology, and companies specializing in that are well represented in the center's roster. They also figured prominently in an early center initiative, teaming up in 2003 with the conservative Georgia Public Policy Foundation to promote changes in health care in Mr. Gingrich's home state.

At his discussion with Georgia House Republicans in 2004, Mr. Gingrich gave examples of companies whose services could 'both improve health and start saving money,' according to the center's summary of his presentation.

And there is more,
In Washington, Mr. Gingrich's push for electronic health records illustrated how his own policy advocacy and ties to former Congressional colleagues made him a sought-out consultant for companies like Astra Zeneca and Siemens. Mr. Gingrich hailed HealthTrio, one of the center's 'founding charter members,' during a hearing held in 2003 by Senator Larry Craig, Republican of Ohio. Telling the senator that HealthTrio's chief executive had helped design the electronic records program in the United Kingdon, Mr. Gingrich said the company 'estimates we could have an electronic health record for American for about 10 cents per month, per person.'

The center later arranged for HealthTrio and I.B.M to meet with senior federal health officials and congressional leaders 'to review the U.K. approach and how it might be applied in the U.S.,' according to center records.

Some of the ideas promoted by the center found their way into the electronic health records legislation proposed by Mr. Kennedy, which was prepared with input from Mr. Gingrich.
This is especially ironic, given that the UK NHS electronic health record initiative has become a crashing failure (for example, see this post).

Even more involvement with the push for electronic health records (EHRs) appeared in a Boston Globe article,(7)
Newt Gingrich seized the TV airwaves in 2009 to bash President Obama’s stimulus package, calling it 'entirely a pork-barrel bill' that would do little to solve the recession.

Later, in a separate web video, the former House speaker stepped back from his blanket criticism. He explained that he strongly supported spending $27 billion of stimulus funds to encourage doctors and hospitals to create electronic medical records for their patients. Left unsaid was that the Gingrich Group, his consulting business in Washington, received large payments from medical technology companies that stand to profit from the federal money.

In particular,
The stimulus infusion Gingrich supported is expected to benefit health care technology companies, including those who have been clients such as GE Healthcare and Allscripts.

GE Healthcare said it pays Gingrich’s center to act as a 'collaborator and facilitator' among a diverse group of health care interests.

'We work with the Center for Health Transformation in an effort to improve the effectiveness of the health system through the use of information technology,' said GE Healthcare spokesman Corey Miller.

Allscripts spokeswoman Ariana Nikitas said the company ended its relationship with Gingrich’s center two years ago but considered the venture 'a think-tank to advance health care efforts.'

It does not stop there. Per the NY Times,(8)
Mr. Gingrich was cheering a $19 billion part of the [Obama stimulus] package that promoted the use of electronic health records, something that benefited clients of his consulting business. 'I am delighted that President Obama has picked this as a key part of the stimulus package,' he told health care executives in a January 2009 conference call.

After the bill was passed a month later, Mr. Gingrich's consultancy, the Center for Health Transformation, joined two of his clients, Allscripts and Microsoft, in an 'Electronic Health Records Stimulus Tour' that traveled the country, encouraging doctors and hospitals to buy their products with billions in federal subsidies.
We, particularly InformaticsMD, have frequently commented on how health care information technology has been promoted not just by enthusiasts in the field, and by companies that manufacture such devices, but by the government.  The bandwagon has gone down the road despite little clinical evidence that such technology is beneficial, and increasing evidence of its harms.  Now it appears that an important reason for this ruch to promote expensive, but unproven devices comes from the sort of stealth health care policy advocacy on behalf of corporate vested interests described above.
Summary

So Newt Gingrich parlayed his political track record into a lucrative "consultancy" which enthusiastically promoted the health policy objectives of its clients, who included some of the biggest US health care corporations.  Some of the policy positions the consultancy promoted seemed to run counter to Mr Gingrich's political record.  Worse, some of the initiative he successfully promoted seem to have contributed to US health care dysfunction.

These stories, some of which are many years old, only came out after Mr Gingrich became the front runner for the Republican nomination for US President.  Had he not chosen to re-enter politics, it is not clear when reporters would have had time to due the required investigations.  One wonders how many similar stories have not been made public because they do not involve prominent presidential candidates.

The bottom line seems to be that there are myriad ways corporate and political insiders push health policy agendas because of self-interest, regardless of their effects on patients' and the public's health.  Health policy in the US has become an insiders' game.  Unless it is redirected to reflect patients' and the public's health, facilitated by the knowledge of unbiased clinical and policy experts rather than corporate public relations, expect our efforts at health care reform to just increase health care dysfunction. 

Physicians, public health advocates, whatever unbiased health policy experts remain must educate the public about how health policy has been turned into a corporate sandbox.  We must try to somehow activate the public to call for health care policy of the people, by the people, and for the people.

References


1.  Eggen D. Gingrich think tank collected millions from health-care industry.  Washington Post.  November 17, 2011.  Link here.
2. Rutenberg J. Gingrich faces more scrutiny over corporate clients. NY Times, November, 17, 2011. Link here.
3. Benson C, Lerer L. Gingrich health center and group paid $55M. Bloomberg, November 22, 2011. Link here.
4. Tumulty K, Eggen D. Newt Gingrich Inc.: how the GOP hopeful went from political flameout to fortune. Washington Post, November 26, 2011. Link here.
5. Davis JH, Jensen K. Gingrich campaigning as change agent profited as an insider. Bloomberg, November 18, 2011. Link here.
6. McIntire M, Rutenberg J. Gingrich gave push to clients, not just ideas. NY Times, November 29, 2011. Link here.
7. Rowland C. Newt Gingrich supported $27 billion of President Obama's stimulus for electronic medical records, helping his consulting clients. Boston Globe, December 16, 2011. Link here.
8. Rutenberg J, McIntire M. Gingrich push on health care appears at odds with G.O.P. NY Times, December 16, 2011. Link here.

New York Times: Panel Set to Study Safety of Electronic Patient Data

New York Times author Milt Freudenheim has published an interesting article on health IT:

"Panel Set to Study Safety of Electronic Patient Data" (Dec. 13, 2010, link)

In the article Mr. Freudenheim presents various viewpoints on health IT safety and usability, and reports on an upcoming Institute of Medicine (IOM) Committee on Healthcare IT safety.

In general, the expressed viewpoints reported upon are consistent with the position in the Healthcare IT Ecosystem of those quoted. I wish to add some commentary to a number of those stated positions.

Mr. Freudenheim observes:

Taking a fresh look at such concerns, the Institute of Medicine created the Committee on Patient Safety and Health Information Technology to run a yearlong study and issue recommendations. The 16-member panel is meeting for the first time on Tuesday in Washington.


(This new IOM Committee is in addition to a 2009 study by the National Academies/National Research Council that concluded that "Current Approaches to U.S. Health Care Information Technology are Insufficient", which has largely been invisible. The IOM is the health arm of the National Academies.)

I would add that this Committee is at least a decade late. That it is occurring at all seems to be at the behest of a multitude of complaints and "blows of the whistle" from clinicians who increasingly depend (either voluntarily or by coercion) on this technology to provide safe care.

I would also add that it is my hope the IOM committee with not be overly politicized, considering the stated unconditional exuberance of the past two administrations towards health IT, and that a wide variety of stakeholders will be heard. (For instance, as a medical informatics specialist whose relative was injured as a result of HIT interference with care continuity, will I be allowed to testify?)

Mr. Freudenheim then relates the points of view of stakeholders.

In February, the F.D.A. said it had received 260 reports of malfunctions related to health information technology “with the potential for patient harm,” including 44 reported injuries and six reported deaths in 2008 and 2009. The malfunctions were reported voluntarily to the agency, mainly by hospitals.

“Because these reports are purely voluntary, they may represent only the tip of the iceberg,” said Dr. Jeffrey Shuren, a senior F.D.A. policy and enforcement official.


I'd written about this at "FDA on Health IT Adverse Consequences: 44 Reported Injuries and 6 Deaths, Probably Just Tip of Iceberg" where I noted:

This is a technology almost universally touted as inherently beneficial, right up to our most senior elected leaders, who are now pushing this unproven technology under threat of penalty for non-adopters.

Healthcare IT irrational exuberance can perhaps be illustrated in statements such as this:

“We have the capacity to transform health with one thunderous click of a mouse after another,” said (former) HHS Secretary Michael Leavitt - 2005 HIMSS Summit

I also opined at "If The Benefits Of Healthcare IT Can Be Guesstimated, So Can And Should The Dangers" that one could, as a type of thought experiment, extrapolate from these numbers to guesstimate the effects of universal health IT in the US. The results were startling, even if just an experiment:

[We might have] 880,000 injuries per year, 120,000 deaths when universal HIT use is achieved ... While this is a mere thought experiment, the result certainly suggests we need to know the actual rates of HIT-related patient harm, and act to understand and minimize these events.

In setting national healthcare policy, we should not rely on thought experiments - but even more importantly, we should not be relying on guesswork and wishful thinking as we are currently.

Unfortunately, national policy has been set up to now on wishful thinking. As I stated, the IOM meeting is coming none too soon.

The NYT article then reports on a statement made by ONC Chair David Blumenthal:

“All options for assuring safety are on the table,” said Dr. David Blumenthal, the Obama administration’s national coordinator for health information technology.


Yet Dr. Blumenthal is clearly an adherent to unbridled exuberance about health IT. At "Science or Politics? The New England Journal and the 'Meaningful Use' Regulation for Electronic Health Records" I wrote:

... In the NEJM article "The 'Meaningful Use' Regulation for Electronic Health Records", David Blumenthal, M.D., M.P.P. (ONC Chair) and Marilyn Tavenner, R.N., M.H.A. (10.1056/NEJMp1006114, July 13, 2010) available at this link, the opening statement is (emphases mine):

The widespread use of electronic health records (EHRs) in the United States is inevitable. EHRs will improve caregivers’ decisions and patients’ outcomes. Once patients experience the benefits of this technology, they will demand nothing less from their providers. Hundreds of thousands of physicians have already seen these benefits in their clinical practice.

I think it fair to say those are grandiose statements and predictions presented with a tone of utmost certainty in one of the world's most respected scientific medical journals.

Even though it is a "perspectives" article, I once long ago learned that in writing in esteemed scientific journals of worldwide impact, statements of certainty were at best avoided, or if made should be exceptionally well referenced.

I note the lack of footnotes showing the source(s) of these statements.

I also note the lack of mention of literature refuting or potentially refuting these statements of certainty. [Followed by a list of such literature just off the top of my head - ed.]

Dr. Blumenthal then appeals to authority:

Dr. Blumenthal said health information experts like Dr. Donald M. Berwick, the Medicare and Medicaid administrator, and Dr. Brent James, of Intermountain Healthcare, based in Salt Lake City, “agree that electronic health records will improve the safety of care.”

I am unaware of the expertise of Dr. Berwick and Dr. James in this domain, and the peer reviewed literature they've written that supports such a statement while soundly refuting literature written by other experts that indicates otherwise.

(Perhaps at Intermountain, custom systems that took decades to develop utilizing their Medical Informatics expertise do show safety gains, but such systems and the lessons learned building them are not easily portable to a country's worth of organizations and practitioners, especially under HITECH timeframes.)

Freudenheim then quotes Blumenthal as stating:

“At the same time, any time you change the world you create risks,” Dr. Blumenthal said in a telephone interview last weekend.


This sounds typical of utopian ideology. Yes, any time you change the world you create risks, but you should not attempt to change the world cavalierly and blindly to those risks. (That's the path the National Program for Health IT in the United States has been on, until the IOM meeting was called.) Idealists tend to believe the collateral damage that is caused by utopian experiments (e.g., communism) are a necessary sacrifice to achieve the utopia. Such values are both abhorrent and alien to medicine.

“We want to make sure that implementation is as safe as it can be and all safety benefits are realized.”


Blumenthal's been painted into a corner by tons of complaints on HIT safety; ONC must act, even if just putting on a show about safety considerations. If there were true concern for safety he'd recommend slowing down HITECH timelines until the industry gets its act together and our understanding of HIT usability, safety, and other issues is resolved; cf.: statements of HIMSS leaders on 'needing to be patient' for the industry to get healthcare IT right:

As I'd written about HIMSS admissions of health IT unsuitability to task at "NIST Provides Healthcare IT Industry with Remedial Undergraduate Computer Science Education":

... What have been their product design and development practices, such that leaders of their own trade group HIMSS (as I pointed out in other posts) opine we should be "patient" for them to figure it all out about how to do health IT better and they need more time, and that the technology does not support its users properly due to lack of efficiency and usability of EMRs currently available? (As at my July 2010 post "The National Program for Healthcare IT in the U.S., and the Elephant in the Living Room".)

Further, from the NYT article:

He [Blumenthal] said that if the Institute of Medicine “concludes that regulation is an important part of this fabric of assuring safety, we will want to balance regulation and innovation as we do in every marketplace.”


That he even needs to make such a statement is likely revealing of biases on regulation, which seem aligned to the industry. To wit:

“The policing of design by a third party or agency, however well intended, will likely stifle innovation and inhibit the growth and development of electronic health records in the future,” said Carl Dvorak, executive vice president of Epic Systems, which has built electronic records systems for Kaiser Permanente and other large health care and hospital groups.


There is a lack of evidence supporting such a statement (e.g., pharma has been regulated for decades, as is its clinical IT). The fact that NIST has just delivered Computer Science 101-level usability guidelines to the HIT industry in its recent report “NIST Guide to the Processes Approach for Improving the Usability of Electronic Health Records” to help solve the HIT unusability crisis also suggests that 30+ years of un-regulation did not facilitate ‘innovation.’

In fact 'unregulation' appears to have led to prima facie innovation failure and paralysis as far as usability is concerned.

Unusable health IT might as well not exist as far as clinicians are concerned. It is a menace to the safe practice of medicine. This is a first principle.

Per the NYT, the industry trade group HIMSS has gone mum:

The industry has recently avoided speaking out on a role for the F.D.A. In a statement for this article, the Healthcare Information and Management Systems Society, a Washington-based industry group, said only that it “supports the administration’s decision to ask the Institute of Medicine to study this complex issue and report back over the next 12 months.”


They are certainly not taking a leadership role on this issue. In my humble opinion they will allow regulation, only kicking and screaming and being dragged into it by force. Patients come second to profits - the only factor that will be "stifled" as vendors are coerced to make better products.

The NYT article goes on:

Last month, in protest of one common industry practice, the American Medical Informatics Association said “hold harmless” clauses in many purchasing contracts were unethical. The clauses typically absolve manufacturers of responsibility for any errors or misuse.

“We said we value innovation, but we don’t value it more than safety,” said Kenneth W. Goodman, a University of Miami bioethicist who headed an association advisory group on patient safety.


It took a lot of writing and politicking to get AMIA to this point as well, at least to express it openly (cf.: my efforts here).

Finally, with regard to the IOM meetings on HIT safety, there will be industry stakeholders in attendance such as CCHIT and EPIC.

I believe they should be held to scientific standards of delivery. If they deliver marketing-based spin, they should be called to present scientific evidence for their stance – and not just “positive” evidence. They should be made to refute “negative” evidence as well, not ignore it.

In summary, I welcome the New York Times bringing these issues to the public.

I also welcome IOM's entry into studying HIT safety. While a "Committee on Patient Safety and Health Information Technology" should have been convened years ago, it's better late than never. (Except for patients already injured or killed, of course.)

The results may remain as invisible as the aforementioned National Research Council study. I also doubt the Committee's findings will change hearts and minds. Idealism, profit motive, and irrational exuberance are hard to rectify.

But their effects on people's behaviors can - and should - be regulated.

-- SS

EHR: "The Dangerous Decade"

A new perspective piece has appeared in the Journal of the American Medical Informatics Association. Although it is not freely available, I thought posting the abstract and the opening would be of interest:


The dangerous decade
JAMIA
Published Online First 24 November 2011
Enrico Coiera, Jos Aarts, Casimir Kulikowski

Abstract

Over the next 10 years, more information and communication technology (ICT) will be deployed in the health system than in its entire previous history. Systems will be larger in scope, more complex, and move from regional to national and supranational scale. Yet we are at roughly the same place the aviation industry was in the 1950s with respect to system safety. Even if ICT harm rates do not increase, increased ICT use will increase the absolute number of ICT related harms. Factors that could diminish ICT harm include adoption of common standards, technology maturity, better system development, testing, implementation and end user training. Factors that will increase harm rates include complexity and heterogeneity of systems and their interfaces, rapid implementation and poor training of users. Mitigating these harms will not be easy, as organizational inertia is likely to generate a hysteresis-like lag, where the paths to increase and decrease harm are not identical.


The perspective piece then opens with this:

There is a paradox in the relationship between information and communication technology (ICT) and patient safety. ICT can improve the quality, safety and effectiveness of clinical services and patient outcomes,1 although the evidence base for this is sometimes weak.2 As a consequence, the rapid deployment of ICT on a national scale is a priority for many nations faced with a diminishing clinical workforce, increasing workloads, and resource constraints. 3 4
However, ICT use can also lead to patient harm.5 Many commentators have raised concerns that ICT has yet to deliver on its promises,6 or that the rapid adoption of ICT is a risk.7 7a Errors persist in clinical practice even after ICT is introduced,8 because manual processes co-exist with the automated, and the interfaces between the two are seldom perfect. Others counter that such overemphasis on ICT-related harm only delays the implementation of a crucial technology that will save lives.9
It appears that we are caught in a bind. The demands for health system reform are now so compelling that there appears no choice but to implement complex ICT on a large, often national, scale. Yet these ICT systems appear less mature than we would like and our understanding about how to implement and use them safely remains in its infancy. As such, we are faced with a pressing policy challenge on both the national and international stages.10

They raise these rhetorical questions:

... Where is the ‘kill switch’ in our health ICT systems when large-scale privacy breaches are occurring, or large volumes of critical patient data are being corrupted? Who is authorized to activate such a switch?

The answers to these questions are, quite frankly: nowhere, and nobody. What we have instead is an environment of 'irrational exuberance' -- as well as 'rational exuberance', i.e., opportunism, often of a pecuniary nature.

To the authors' other observations I would add that:

1) "Organizational inertia" is probably too narrow a concern. I would broaden it to "cultural inertia", especially since the health IT "ecosystem" is grossly lacking of a culture of safety and accountability;

2) The authors note that "Predicting the actual harm rate and total patient harms that we will see through the use of ICT in healthcare over the next decade is currently not possible."

While I agree, and agree this inability needs to be remediated, extrapolations can be performed to achieve estimates. Regarding increased ICT use increasing the absolute number of related harms, that number could already be quite substantial as I wrote in an April 16, 2010 thought experiment at "If The Benefits Of Healthcare IT Can Be Guesstimated, So Can And Should The Dangers."

Ironically and tragically, that post was written just five days before I wrote a confidential warning letter to a hospital about EHR deficiencies I'd noted in my mother's care there, and just one month before she was severely injured at that hospital by an EHR-related error of a nature as identified in the letter. Thus, the numbers in the thought experiment should be incremented accordingly;

3) I would say regarding safety that the health IT sector is roughly in the same place as aviation was in the 1920's (e.g., unregulated, experimental technology abounding), not the 1950's, and as the maritime passenger service was in ca. 1912 (April to be precise); and

4) The authors observe that "There is however caution in the [2011 IOM] report [on health IT safety here, PDF] that safety regulations would impede industry innovation, an argument which would literally not fly in the aviation industry ... the caution toward recommending regulation may however be misplaced. Simply put, if healthcare wants the benefits of ICT then it must actively manage its risks."

I strongly agree that the IOM's cautions on regulation are misplaced, as I wrote here. Robust regulation could diminish ICT harm as in pharmaceuticals and medical devices (and aviation).

Innovation will not be harmed, and the IT industry needs to -- and can afford to -- accept the responsibilities and obligations of being involved in healthcare. See for example "No More Soft Landings For Software: Liability for Defects in an Industry That Has Come of Age" (PDF), Zollers, McMullin et al., Santa Clara Computer & High Technology Law Journal, Vol. 21 No. 4, 2005.

-- SS

ONC's "Health Data Palooza" - A Title of Exceptionally Bad Taste, For a "See No Evil" Meeting

The Office of the National Coordinator of Health IT has sent out this announcement:


Subject: HEALTH DATA PALOOZA III: Unleashing the Power of Data to Improve Health
From:    ONC Health IT
Date:    Thu, May 10, 2012 10:36 am

HEALTH DATA PALOOZA III: Unleashing the Power of Data to Improve Health

June 5-6th, Washington DC
Health Data and Innovation Week
www.hdiforum.org | #healthdata

CONFIRMED SPEAKERS
Kathleen Sebelius, Secretary of Health and Human Services
Marc Bertolini, CEO Aetna
Thomas Goetz, Execuitve Editor of WIRED
Atul Gawande, surgeon and author
Bill Frist, former Republican Majority Leader
Dominique Dawes, two time gold medal winner
Todd Park, US Chief Technology Officer


Hear from Farzad Mostashari, National Coordinator for Health IT on data liberation
ONC will host breakout sessions on Consumer e-Health, HealthData.gov,
and Uses of Data by ACOs
ONC will release nine challenges during this year’s event! 


This title for a government-sponsored meeting is bizarre and tasteless in my opinion.  What is deemed by ONC to be the major source of this data?  Health IT.

"Palooza?"

From Urban Dictionary:

An all-out crazy party; partying at one place with a ton of people like there's no tomorrow; The art of throwing a very drunken extravagant party with a plethora of friends

"Data Liberation?"    

What about "patient liberation" -- from risk?

Considering it unlikely that issues in the bulleted points below, commented on in detail in past posts on this blog, will be discussed at this meeting, the title of the meeting is especially tasteless:
  • There is a markedly unscientific "irrational exuberance" pushing clinical IT into wide use at a dangerously rapid pace. This exuberance is contradicted by a growing body of literature that shows the benefits are likely far less than stated, e.g., by way of example, the ad-hoc set at http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=readinglist 
  • The technology remains experimental, its rollout is a human subjects experiment on a massive scale lacking nearly all the protections of other human subjects experimentation and for IT in mission critical settings (e.g., informed consent, formal quality control/validation/regulation, formal postmarket surveillance and reporting) due to extraordinary legal and regulatory special accommodations afforded the technology and its purveyors;
  • Defects of in-use systems are rampant, inappropriately turning patients and clinicians into software alpha and beta testers (e.g., as in the voluntary FDA MAUDE database, http://hcrenewal.blogspot.com/2011/01/maude-and-hit-risk-mother-mary-what-in.html which contains information for just one HIT vendor, Cerner, who voluntarily reports such issues);
  • The technology is unsupportive of clinician cognitive needs (2009 National Research Council study, which also stated that accelerating interdisciplinary research in biomedical informatics, computer science, social science, and health care engineering will be essential to perfect this technology);
  • The roles of scientific discovery and anecdote have been turned on their heads. RCT's of clinical IT are nearly non-existent and lower-level evidence (e.g., weak observational, pre-post, qualitative, and other study types) are cited as "scientific proof" of efficacy and safety justifying hundreds of billions of dollars of taxpayer (or is it Chinese loan?) expenditures.  Yet, risk management-relevant case reports of harmful events and near misses, crucial to help organizations and regulatory agencies understand risks are dismissed as "anecdotal" (e.g., Blumenthal: "The [ONC] committee [investigating FDA reports of HIT endangement] said that nothing it had found would give them any pause that a policy of introducing EMR's could impede patient safety," he said, while ONC issued an article based on questionable research methods entitled "The Benefits Of Health Information Technology: A Review Of The Recent Literature Shows Predominantly Positive Results" extolling the virtues of HIT, written about at http://hcrenewal.blogspot.com/2011/03/benefits-of-health-information.html).
  • Risks are definite, with known patient injury and death, but the magnitude is admittedly unknown by JC (2008 Sentinel Event Alert), FDA (2010 Internal memo on HIT risks and statements of Jeffrey Shuren MD JD about known harms likely being "the tip of the iceberg"), IOM (2011 report on HIT risk), ECRI Institute (Top ten healthcare technology hazards for 2011 and 2012), NORCAL Mutual Insurance Company 2009 report on EHR risks, others;
  • Existence of severe impediments to information diffusion about risks explicitly admitted by FDA (2010 memo), IOM (2011 report), others;
  • Usability of commercial products in real world settings is often poor (e.g., NIST 2011 study on usability), promoting "use error" (user interface designs that engender users to make errors of commission or omission, where many errors are due not to user error per se but due to designs that are flawed, e.g., poorly written messaging, misuse of color-coding conventions, omission of information, etc.)
  • These systems promote capture and display of clinically irrelevant information in the interest of charge capture, and result in reams of "legible gibberish" with many negative characteristics that make it difficult for other clinicians and reviewers to establish a cohesive, definitive narrative of clinical events and timelines.

Health IT and health data issues are not 'partying' affairs. An un-seriousness about anything related to health IT seems in vogue of late.

Finally, I ask:  does this "Health Data Palooza" bring my Ddulite term to life?

Ddulite: Hyper-enthusiastic technophiles who either deliberately ignore or are blinded to technology's downsides, ethical issues, and repeated local and mass failures.

A Ddulite Palooza.  How charming.

Like the recent extravagances of other government agencies such as GSA in Las Vegas and the Secret Service in Colombia, let's hope this Data Palooza is a Palooza in name only.

In light of those recent scandals, calling a government sponsored meeting a "Palooza" seems inappropriate on that basis as well.

-- SS

5/13/12  Addendum:

A commenter pointed this flyer out:


(click to enlarge)

I post it here with no additional comments.

-- SS