FDA Draft Guide Pushes Sponsors To Use Interoperable EHR Systems

FDA's new draft guide on using data from electronic health records (EHRs) in clinical investigations encourages sponsors to work with health care organizations with interoperable systems, but concedes that practical challenges such as complex and diverse clinical data standards may hinder information exchange. The guide comes after FDA Commissioner Robert Califf recently advocated creation of a modern national evidence generation system to support medical product evaluation and clinical care decisions. He said such a system depends on interoperability and connectivity,...