RICHMOND, Va. — The Food and Drug Administration is working on a proposed rule to regulate only electronic health records that are transferred directly from the medical device to a database.
Tim Stitely, the FDA’s chief information officer, said June 4 the agency is close to releasing a draft proposed rule in the Federal Register that would outline how the oversight would work.
“As the ability for direct capture evolves, the current direction FDA is heading is the medical record becomes part of the device,” he said after a panel discussion on health information technology at the 27th annual Management of Change conference, sponsored by the Industry Advisory Council and the American Council for Technology. “I don’t think now [EHRs] as defined will be regulated by the FDA. It is not a medical device, food, drug or other thing we regulate.”

Source:  Government Health IT News - FDA to propose rule on e-health records

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