Recent Food and Drug Administration draft guidance on use of electronic health records data when conducting clinical trials is useful, even if the nature of such guidance has limitations.
That’s the view of Jeff Smith, vice president of public policy at the American Medical Informatics Association. While the guidance is not binding, “you can see where FDA wants to go, but that’s where they start and stop,” Smith notes, adding that, most times, draft guidance does not result in some form of formal final guidance, even though a public comment period often accompanies a draft.
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