Is ONC’s definition of "Significant EHR Risk" when body bags start to accumulate on the steps of the Capitol?

In a June 25, 2013 Bloomberg News article “Digital Health Records’ Risks Emerge as Deaths Blamed on Systems” by technology reporter Jordan Robertson (http://go.bloomberg.com/tech-blog/author/jrobertson40/),  Mr. Robertson wrote:

… “So far,
the evidence we have doesn’t suggest that health information technology
is a significant factor in safety events,” said Jodi Daniel (
http://www.healthit.gov/newsroom/jodi-daniel-jd-mph), director
of ONC’s office of policy and planning.
“That said, we’re very
interested in understanding where there may be a correlation and how to
mitigate risks that do occur.”

In my opinion this statement represents gross negligence by a government official.  Ms. Daniel is unarguably working for a government agency pushing this technology.   She makes the claim that “so far the evidence we have doesn’t suggest significant risk” while surely being aware (or having the fiduciary responsibility to be aware) of the impediments to having such evidence.

From my March 2012 post “Doctors and EHRs: Reframing the ‘Modernists v. Luddites’ Canard to The Accurate ‘Ardent Technophiles vs. Pragmatists’ Reality” at http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html  (yes, this was more than a year ago):

… The Institute of Medicine of the National Academies noted this in their late 2011 study on EHR safety:

… While some studies suggest improvements in patient safety can be
made, others have found no effect. Instances of health IT–associated
harm have been reported. However, little published evidence could be found quantifying the magnitude of the risk.

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.
[IOM (Institute of Medicine). 2012. Health IT and Patient Safety: Building Safer Systems for Better Care (PDF). Washington, DC: The National Academies Press, pg. S-2.]

Also in the IOM report:


“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.

More worrisome, some case reports suggest that poorly designed health IT can create new hazards in the already complex delivery of care. Although the magnitude of the risk associated with health IT is not known,
some examples illustrate the concerns. Dosing errors, failure to detect
life-threatening illnesses, and delaying treatment due to poor
human–computer interactions or loss of data have led to serious injury
and death.”

I also noted that the ‘impediments to generating evidence’ effectively rise to the level of legalized censorship, as observed by Koppel and Kreda regarding gag and hold-harmless clauses in their JAMA article “Health Care Information Technology Vendors’ Hold Harmless Clause: Implications for Patients and Clinicians“, JAMA 2009;301(12):1276-1278. doi: 10.1001/jama.2009.398.

FDA had similar findings about impediments to knowledge of health IT risks, see my Aug. 2010 post “Internal FDA memorandum of Feb. 23, 2010 to Jeffrey Shuren on HIT risks. Smoking gun?” at http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html.

I also note this from amednews.com’s coverage of the ECRI Deep Dive Study (http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html):

… In spring 2012, a surgeon tried to
electronically access a patient’s
radiology study in the operating room but the computer would show only a
blue screen. The patient’s time under anesthesia was extended while OR
staff struggled to get the display to function properly. That is just
one example of 171 health information technology-related problems
reported [voluntarily] during a nine-week
period [from 36 hospitals] to the ECRI Institute PSO, a patient safety organization in
Plymouth Meeting, Pa., that works with health systems and hospital
associations in Kentucky, Michigan, Ohio, Tennessee and elsewhere to
analyze and prevent adverse events. Eight of the incidents reported involved patient harm, and three may
have contributed to patient deaths, said the institute’s 48-page report,
first made privately available to the PSO’s members and partners in
December 2012. The report, shared with American Medical News in
February, highlights how the health IT systems meant to make care safer
and more efficient can sometimes expose patients to harm.

One wonders if Ms. Daniels’ definition of “significant” is when body bags start to accumulate on the steps of the Capitol.

I also note she is not a clinician but a JD/MPH.

I am increasingly of the opinion that non-clinicians need to be removed from positions of health IT leadership at regional and national levels.

In large part many just don’t seem to have the experience, insights and perhaps ethics necessary to understand the implications of their decisions.

At the very least, such people who never made it to medical school or nursing school need to be kept on a very short leash by those who did.

— SS