InformationWeek, February 14, 2014
Two US senators want to give health IT software developers an easier path to consumers by turning the Food and Drug Administration's guidelines into a statute and moving oversight of these apps over to the National Institute of Standards and Technology (NIST). The move would protect jobs, cut regulatory burdens, and allow the FDA to focus its limited resources on technologies and devices that need the department's scrutiny, the lawmakers say. Under the Preventing Regulatory Overreach To Enhance Care Technology (PROTECT) Act of 2014, the FDA would no longer oversee "low risk health-IT" solutions such as electronic health records, scheduling software, and fitness apps, according to sponsors Sen. Angus King (I-Maine) and Sen. Deb Fischer (R-Neb.).