Bad Science (and Perhaps Conflict of Interest) At ONC / HHS

This article recently appeared, quoting Jacob Reider, M.D., chief medical officer at ONC on an upcoming Health IT Safety Plan:

Health Data Management

http://www.healthdatamanagement.com/news/HIMSS13-ONC-HIT-safety-plan-45809-1.html 

ONC Sets Early Summer for Release of HIT Safety Plan

The Office of the National Coordinator for Health Information Technology anticipates releasing a final health information technology safety plan by early summer, officials announced on March 5 at HIMSS13 in New Orleans.

ONC released a draft plan in December and accepted public comment until February 4. The draft followed an Institute of Medicine report that ONC commissioned that highlighted the need for better understanding of the HIT impacts on safety, as well as shared responsibilities among all stakeholders to improve safety, Jodi Daniel, director of the ONC office of policy and planning, said during an educational session.

There is little doubt that use of I.T. results in fewer medical errors, particularly medication-related because of electronic prescriptions and clinical decision support, noted Jacob Reider, M.D., chief medical officer at ONC. “It’s obvious that in many areas there will be fewer errors, but at the same time, in other areas there will be more errors.” Consequently, a priority of the plan will be implementing a framework to help the industry better understand what the trouble areas will be as I.T. use increases.

Less than 1 percent of patient safety events are related to HIT, Reider contended, but the industry needs more data to better understand the level of harm from such events and how to improve the technology. HIT-related errors, he reminded the audience, are not always the fault of vendors; providers can introduce risk when customizing their systems.

The upcoming safety plan release is fine and good, but I, for one, wonder if it can be trusted.

The level of bias and lack of knowledge of the domain, evidence of incomplete research, and/or poor scientific judgement inherent in the statements I bolded above are disturbing.  They are also  reminiscent of the problems in the ONC-authored paper discussed at this link.

First:

• There is little doubt that use of I.T. results in fewer medical errors

On the contrary, there is significant well-researched doubt in that the evidence is quite contradictory.  Let's cite the IOM's 2012 report on health IT risk:

… “For example, the number of patients who receive the correct medication in hospitals increases when these hospitals implement well-planned, robust computerized prescribing mechanisms and use barcoding systems. But even in these instances, the ability to generalize the results across the health care system may be limited. For other products— including electronic health records, which are being employed with more and more frequency— some studies find improvements in patient safety, while other studies find no effect.   

IOM (Institute of Medicine) 2012. Health IT and Patient Safety: Building Safer Systems for Better Care (PDF). Washington, DC: The National Academies Press.

Let's quote one of the IOM study panel members, an international authority on safety, Dr. Richard Cook:

... HIT's cornucopia has been promised repeatedly since the 1960's. Nothing like the promises has materialized.  Indeed, the IOM committee that was commissioned to evaluate the best evidence on this subject found no persuasive evidence that HIT improved patient safety. I know because I was there. 

The body of literature here also contains relevant studies contradicting Dr. Reider's quoted, dispositive statement.

Next:

• It’s obvious that in many areas there will be fewer errors

This statement requires no response, but I'll respond anyway.  

In science, stating something is "obvious" (i.e., what is referred to at the site "36 Humorous Methods of Proof" as "Proof by obviousness") is, on its face, bad science.

Next:

• Less than 1 percent of patient safety events are related to HIT

The aforementioned IOM report was quite clear on the following:

... Several reasons health IT–related safety data are lacking include the absence of measures and a central repository (or linkages among decentralized repositories) to collect, analyze, and act on information related to safety of this technology. Another impediment to gathering safety data is contractual barriers (e.g., nondisclosure, confidentiality clauses) that can prevent users from sharing information about health IT–related adverse events. These barriers limit users’ abilities to share knowledge of risk-prone user interfaces, for instance through screenshots and descriptions of potentially unsafe processes. In addition, some vendors include language in their sales contracts and escape responsibility for errors or defects in their software (i.e., “hold harmless clauses”). The committee believes these types of contractual restrictions limit transparency, which significantly contributes to the gaps in knowledge of health IT–related patient safety risks. These barriers to generating evidence pose unacceptable risks to safety.

... The magnitude of the risk associated with health IT is not known.

Likewise, FDA has concluded that what they know on HIT-related patient safety events is likely "the tip of the iceberg"  due to systematic impediments to knowing, as has the ECRI Institute who has only now begun to study the issue with any degree of rigor.  (The results are of great concern to anyone who should know, or should have made it their business to know, as at this link.)

Perhaps Dr. Reider needs a lesson on basic epistemology:  "We simply don't know what we don't know."

Finally:

• HIT-related errors, he reminded the audience, are not always the fault of vendors; providers can introduce risk when customizing their systems.

I find it remarkable that a government official uses a public/industry platform HIMSS to defend an industry, while at the same time stating more study is needed to understand the causative factors of harm from the industry's products.

This raises the question of conflict of interest, and the possibility this official is not impartial or trying to be "fair" but aiming towards protecting an industry he once worked for - and to where he's likely to return at some point.  (See Roy Poses' posts on "revolving doors" for examples of that.)

From his government biography here:

Dr. Jacob Reider
Director, Office of the Chief Medical Officer

Jacob Reider, MD is a family physician with 20 years of experience in health information technology and special interest in clinical innovation, user experience, and clinical decision support. His background includes leadership roles in nearly all facets of the health IT domain – from small start-up companies to academic facilities, primary care medical groups, and large health IT development organizations. Dr. Reider has served as a member of the Board of Trustees of the American Medical Students Association, the Society of Teachers of Family Medicine, and has served in directorial positions on boards of several innovative health IT companies.

  
I note I do not find evidence of formal medical informatics education, which selfsame ONC recommends for leadership roles in health IT (see my Dec. 2009 post "ONC Defines a Taxonomy of Robust Healthcare IT Leadership"), but I do find roles such as:

Chief Medical Informatics Officer
Allscripts
June 2009 – January 2011 (1 year 8 months)

Medical Director
Allscripts
March 2007 – June 2009 (2 years 4 months)

Chief Medical Officer
MedRemote (Now Nuance)
November 1999 – December 2002 (3 years 2 months)

One might reasonably wonder what personal gains might accrue to Dr. Reider from the promotion of health IT - which includes downplaying its current risks - from an influential government perch.  (I for example held many Merck stock options after my late 2003 departure.  They remained underwater until expiration, but even a a $10 or $20 increase in stock price could have bought me, say, a new sports car or even house.)

I also note that the former CEO of Allscripts, Glen Tullman was, in fact, a close confidant of our current President and advisor on health IT during his first campaign:

A tireless advocate of technology in medicine, Tullman has been featured in virtually every major news outlet. An early supporter of fellow Chicagoan Barack Obama, Tullman introduced him to the Electronic Health Record (EHR) and served on his finance and healthcare committees during the 2008 presidential campaign.

Is it any wonder, then, that my expectation is that the forthcoming ONC HIT safety plan will be biased towards industry, reflect poor science and incomplete/selective research, and overall be a whitewash?

I'll be presenting on issues such as this to the Plaintiff's Bar.  They seem to be the last protectors of people's/patient's rights where clinical IT is concerned - a role they seem most familiar with in other sectors.

I emailed Dr. Reider a link to this post with a request that if he has robust evidence to support his assertions that is not publicly available, to please release it.

-- SS

Mar. 16, 2012 Addendum: 

A correspondent asked me the following that I thought deserved mention beyond the comments section:

"How would he know, exactly, when we know, that they never tallied the thousands of e-Rx errors from a national Siemens defect that was disclosed only at the Brown Medical Center Hospitals (Lifespan) but was a systemwide defect; nor from the Cerner convert to e-Rx defect that was evident at the Trinity Health System; and millions of other errors from when the e-Rx system was unavailable. Or, do they simply do not count those?"

My response?  No, they probably consider those "anecdotal." 

-- SS