IOM kicks off study of EMR safety as FDA regulation looms

The Institute of Medicine is back on the EMR beat.

This week, the IOM Committee on Patient Safety and Health Information Technology held its first meeting as it embarks on a yearlong study of medical errors related to EMRs and other electronic patient data that will culminate in a report with recommendations for improving EMR safety. One possibility, according to the New York Times, is that EMRs eventually could be regulated by the FDA.

"All options for assuring safety are on the table," national health IT coordinator Dr. David Blumenthal tells the Times. Blumenthal's Office of the National Coordinator for Health Information Technology provided the IOM with $989,000 to convene the panel and produce the report.

While FDA regulation of EMRs may be a long way off, some hospitals already voluntarily report EMR malfunctions to the agency. Through February, the FDA had received 260 reports of potentially harmful health IT malfunctions, resulting in 44 injuries and six deaths in 2008 and 2009. "Because these reports are purely voluntary, they may represent only the tip of the iceberg," Dr. Jeffrey Shuren, director of the FDA Center for Devices and Radiological Health, says.

Blumenthal says although there is consensus in the health IT community that EMRs can improve patient safety, he acknowledges that much is unknown. "At the same time, any time you change the world, you create risks," Blumenthal tells the Times. "We want to make sure that implementation is as safe as it can be and all safety benefits are realized.

"If the IOM concludes that some sort of regulation is necessary, we will want to balance regulation and innovation as we do in every marketplace," Blumenthal adds.

That is not enough to placate some on the vendor side, however. "The policing of design by a third party or agency, however well intended, will likely stifle innovation and inhibit the growth and development of electronic health records in the future," Epic Systems Executive VP Carl Dvorak says.

In a statement provided to the Times, the Healthcare Information and Management Systems Society--which is not, as the venerable newspaper says, based in Washington, but rather in Chicago--says it "supports the administration's decision to ask the Institute of Medicine to study this complex issue and report back over the next 12 months." HIMSS does not take a position on potential FDA regulation.

For additional details:
- read this New York Times story

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