New Draft Guidance on Use of Electronic Health Record Data in Clinical Investigations Announced By FDA
By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law On May 17, 2016, the United States Food and Drug Administration (FDA) published a draft guidance titled “Use of Electronic Health Record Data in Clinical Investigations” (Draft Guidance) which emphasizes interoperability and outlines other best practices for effectively […]