FDA contemplates regulating EHRs

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The PharmEHR Summit, held in Philadelphia April 7 and 8, gathered senior executives from pharmaceutical and device manufacturers, EHR vendors and the FDA to discuss the impact of rapid EHR adoption on drug regulatory and marketing issues.

At issue is whether or not the FDA will decide to regulate EHRs as medical devices.

The FDA will issue new rules about software either later this year or in 2012. FDA regulation could mean that EHR vendors would face review of manufacturing processes and design controls, as well as FDA testing to demonstrate whether a system does what it claims to do.

The Office of the National Coordinator for Health IT is leading an assessment of the role the federal government should play in addressing EHR safety; the Institute of Medicine is also conducting a study on the topic.