Health IT Groups Protest FDA's Call For ONC-Certified Data In Clinical Trials

Key health IT groups take issue with FDA's press for use of ONC-certified electronic health record date in clinical trials, telling the agency that ONC requirements don't meet the rigor required for clinical investigations and impede data interoperability. Industry stakeholders raised concerns about the reliability of existing data sources and questioned the interoperability of current electronic health records in comments on FDA's guidance on use of electronic health records in clinical investigations. FDA argues in the May 2016 guidance that...