Draft Senate Bill Removes Electronic Patient Records, CDS From FDA Jurisdiction

A bipartisan Senate health committee duo is floating legislation that would take FDA out of the business of regulating certain health-related software, including electronic patient records and clinical decision software (CDS), according to a draft bill that was making the rounds among Washington lobbyists Friday (Nov. 21). The bill, which carries the names of Sens. Orrin Hatch (R-UT) and Michael Bennet (D-CO), if officially introduced would add to other Senate and House proposals to limit FDA's authority in this area...