Wednesday, January 04, 2012

Just Say "No" to the Term "Anecdotes"; and HIT as a Medical Metadevice

A New Year's thought: there needs to be a push in healthcare for dropping of the word "anecdote" to describe case reports of health IT-related errors.

This word even appears in the late 2011 IOM report on HIT safety (PDF), e.g., the preface:

... We found that specific types of health IT can improve patient safety under the right conditions, but those conditions cannot be replicated easily and require continual effort to achieve. We tried to balance the findings in the literature with anecdotes from the field but came to the realization that the information needed for an objective analysis and assessment of the safety of health IT and its use was not available.

The "A" word needs to be dropped from the healthcare IT lexicon, since such reports from reliable sources are in fact incident reports purposed for risk management activities.

Incident reports do not need peer review for consideration for that purpose.

Of note, I do not believe the incident reports filed in hospitals when something awry occurs are labelled "anecdotes", either.

See the Aug. 2011 post "From a Senior Clinician Down Under: Anecdotes and Medicine, We are Actually Talking About Two Different Things" for more on this topic.

And on another vein, the issue of HIT being a medical device:

As the good State Rep. Marino of my home state of Pennsylvania and others oddly proffer - that 'certification' of health IT, having nothing to do with safety or usability, relieves HIT from being a device [1] - and as the IOM itself debates exactly what to call HIT and under what guidelines to regulate it, another term/category for HIT devices is needed.

In the spirit of the naming of the UMLS Metathesaurus, and in consideration of HIT's informational governance/orchestration of other medical devices and personnel (including the 'carbon units' known as clinicians and patients) -- I suggest the term "metadevice" for HIT.

Healthcare metadevices need their own specific regulation, apart from traditional medical devices.

-- SS


[1] As in line 21- 24 on page 6 of the "Safeguarding Access For Every Medicare Patient Act" Bill (PDF) that I wrote about here. The Bill states: "CLARIFICATION OF AUTHORITY. Certified EHR’s shall not be considered a device for purposes of the Federal Food, Drug, and Cosmetic Act."

(This proposal, of course, raises the question of whether Rep. Marino believes non-certified HIT shall be considered a medical device, a topic for another time.)

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