FDA Recommends HHS-Certified EHRs For Clinical Trials

Clinical trial sponsors are free to use any electronic health record system that meets FDA standards to collect clinical trial data, but the agency recommends use of Office of the National Coordinator for Health Information Technology-certified systems to better ensure that the EHR meets requirements for interoperability, reliability and confidentiality.

While there are a plethora of electronic health record (EHR) systems on the market, FDA encourages clinical trial sponsors to use platforms that meet the HHS Office of the National Coordinator for Health Information Technology's (ONC) certification program.

In a short, but wide-reaching draft guidance published May 17, FDA outlines its recommendations for what elements sponsors should consider when using an EHR system to collect and...

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