Thursday, February 03, 2011

Brief Comments on the President’s Council of Advisors on Science and Technology (PCAST) Report on Health IT

A short post. In Dec. 2010 the President’s Council of Advisors on Science and Technology issued a 108-page report entitled:


The PCAST health IT report is available from in PDF format here. Rather than reproduce the executive summary of the report, a terse "PCAST Report Summary" can be seen about midway down the page of the HISTalk blog here. My comments are simple and twofold:

1. The term "risk" is absent from the PCAST report in the context of risk to patients from clinical IT. Instead, the context is largely about the risk to patients of NOT having health IT.

2. The term "safety" is similarly absent in the context of adverse effects of HIT, and only present in the context of how HIT will improve safety, except for one instance where the match to my search for the term "safety" was not in the text, but in the cited URL itself:

... The Food and Drug Administration (FDA), while not currently regulating EHRs, currently does receive voluntary reports of death and injury associated with EHR malfunctions. FDA officials have suggested possible future regulatory strategies that could include mandatory adverse event reporting, or even classifying EHRs as medical devices, which would make them subject to pre-market regulation. [13] [13] Healthcare IT News (February 26, 2010) at

I find this paucity of a certain context for these terms in a report to the President of the United States striking. Finally, ONC solicited responses to the PCAST report. The American Medical Informatics Association (AMIA) issued a response that is very good. It outlines practical matters, the need for more Medical Informatics specialists and incorporation of their work into national efforts at a common "language" for medicine, interoperability, and other issues. For instance:

AMIA applauds the PCAST report for addressing important issues regarding interoperability and quality improvement. However, we note that the report highlights potential shortcomings and inadequacies in the current approaches and proposes a number of activities in addition to or instead of those currently underway. AMIA believes that the report would benefit from additional details and specificity to support the recommendations that are proposed. The report does not mention the significant prior work that has been conducted in these areas. Additional consideration of data and lessons learned from the scientific and peer-reviewed literature would help to further support and substantiate the ideas presented.

The AMIA response is available at this link (also PDF). Also see summaries of other responses to the PCAST report at the Jan. 23, 2011 e-CareManagement blog post aptly entitled "Comments to ONC: PCAST HIT Report Becomes a Political Piñata." -- SS


Anonymous said...

Excellent points about the "risk" and "safety" words.

How is it that these devices are deemed automatically safe for the patients?

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