The U.S. Food and Drug Administration (FDA) just issued draft guidance on the Use of Electronic Health Record Data in Clinical Investigations for comment within the next 60 days.

The guidance is intended to assist all parties associated with clinical research with the appropriate use of electronic health records in FDA-regulated clinical investigations, which in general, includes information from medical devices.

The draft guidance, which is non-binding, would apply to the use of electronic health information in prospective clinical investigations involving human drugs and biologic products, medical devices and a combination thereof.

Comments to the draft guidance should be submitted by July 16, 2016.

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