Two senators are pushing for less government oversight when it comes to electronic health records. A draft bill by Senate Finance Committee Chair Orrin Hatch (R-Utah) and Sen. Michael Bennet (D-Colo) would exempt certain EHRs and clinical decision support software from FDA supervision.
According to a report in Healthcare DIVE, the proposal would change the definition of medical devices in the Food, Drug and Cosmetic Act to exempt EHRs—but not diagnostic imaging data—from agency review as long as the software was approved prior to marketing.
It is not clear when the senators plan to introduce the bill. For more information, see HealthcareDIVE and this report in iHealthBeat.
