4/13/2011

The FDA is updating its software policies, raising questions about whether the agency will regulate EHRs. "As of right now we're not regulating EHRs, and it may turn out that we won't," said Dr. Jeffrey Shuren, who heads the FDA's Center for Devices and Radiological Health. He added that, regardless of the decision on that issue, interoperability and standards for device integration need attention.

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