by Conor Hale
The agency makes it clear that acceptance depends on the ability to verify the quality and integrity of EHR data. (FDA)
The FDA recently finalized an eagerly-awaited guidance on the incorporation of electronic health records and real-world data into clinical trials and product submissions, including the use of patient medical histories, pharmacy records, radiology scans and lab test results from routine care, including from foreign clinical sites.
While EHR systems themselves are not under the control of the FDA or its regulated entities—and the agency said it does not intend to assess the compliance of EHRs with federal regulations—it still makes clear that its overall acceptance of a submission depends on its ability to verify the quality and integrity of the data.