Wednesday, November 09, 2011 Leadership: "Heck, getting out of bed in the morning is dangerous- it just beats the alternative"

I have posted about the organization on numerous occasions. I expressed concerns that this organization's representation as an alternative aggregator of health IT difficulty cases, compared to established organizations and resources such as FDA's Medwatch and MAUDE database, was probably not a good idea:

November 15, 2010: Web Site to Collect EHR Safety Reports

November 16, 2010: EHRevent: survey amateurism, bias, or something else?

November 17, 2010: Some answers about new site "" for health IT and drug adverse event reporting

November 22, 2010: CEO Edward Fotsch MD: The Real Challenge with EHRs is -- User Error?

July 24, 2011: and "The National Database of EHR Errors Being Called For" - Where's the Beef?

The Nov. 22, 2010 post " CEO Edward Fotsch MD: The Real Challenge with EHRs is -- User Error? " is particularly relevant to this one.

I saw the following remarkable comment by CEO Edward Fotsch MD on the HISTalk blog. It was in a comment section regarding the new Institute of Medicine report "Health IT and Patient Safety: Building Safer Systems for Better Care" on health IT risks (my initial post on that topic is here):

ed fotsch Says:

Re: the IOM/ONC report it seems to me that the IOM started with the wrong question. Question #1 posed should have been- ‘Are Health IT/EHR systems, when implemented appropriately, safer and better than the current paper system in most hospitals and MD offices; as opposed to the question that apparently was posed: ‘are EHRs safe.’

Heck, getting out of bed in the morning is dangerous- it just beats the alternative. Once question #1 HAD been answered, question #2 could have been tee’d up- ‘How can we make EHRs better?” But that ship has sailed and now they and we in Tidy-Bowl mode. The wrong question was asked so we’re dealing with what may be the right answer to the wrong question. And it will be hard to get the toothpaste back in the tube, worms back in the can, etc. on this one from an ONC/IOM standpoint- and yes the press will have a field day, those running for office will have more fodder and Republicans (no issue per se with Republicans BTW) who are pushing for less (not more) government regulation will have a field day with this set of recommendations.

November 8th, 2011 at 10:53 pm

While I do not know Dr. Fotsch, my questions about this comment are as follows:

  • Are its viewpoints entirely objective with regard to health IT?

  • Is it consistent with a physician-executive who thinks critically about risk, and knows the literature (such as here), or with someone who leans toward technologically deterministic views about healthcare IT?

  • Is it a reasonable view from the CEO of an organization seeking a position of enormous public responsibility as the "central place for reporting adverse EHR events or near misses or potential problems or issues with electronic health records", as described of in the aforementioned Nov, 22, 2010 post?

  • It is an appropriate comment for someone holding such a position?

These questions repeat some of the concerns as expressed in my previous posts.

I responded as follows at HIStalk in the same comment thread. Emphases in the original:

To Dr. Fotcsh:

My opinion differs. I believe the IOM asked the correct questions.

The answer to your proposed question “‘Are Health IT/EHR systems, when implemented appropriately, safer and better than the current paper system in most hospitals and MD offices” is – nobody really knows. The IOM explicitly acknowledges this:

… “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.”

The technology is experimental.

In my opinion, that invokes the medical adage “First, do no harm.” There exist protocols for human subjects experimentation. The health IT industry has exempted itself from those protocols.

My overall thoughts on the IOM report are at

-- SS


Anonymous said...

There are innumerable unanswered questions about what EHRevent is doing with the adverse event reports and how it is handling the privacy of those who report.

Why are the reports being covered up such that I can not view them?

Is he selling them?

Based on EHRevent's CEO's biased comment (his lack of objectivity was previously suspected) and his refusal to speak to those queries, I advise doctors and other HIT users to avoid reporting to this para PSO since you will never know how this biased leader may use the report.

Despite the minimization of the FDA's role by the IOM, Secretary Sebelius, and ONCHIT, its MAUDE MedWatch Database is unequaled as a source of information; and that is where the adverse HIT events and hazards should be reported.

Anonymous said...

The incidence of near misses, errors, errors causing injury, errors causing death, errors of doctors and nurses whose cognition is disrupted, and delays in care that have appeared since the advent of EMRs is unknown and is likely higher than with paper records.

Many of the errors that occur with EMRs are hard to find because there are so many layers of pop up screens and cryptic description that defy efficient sleuthing. Thus, many errors go unnoticed cause it wastes too much time to find them or to figure out the adversity to the patients.