A new bill introduced this week by a bipartisan trio of U.S. senators would remove low-risk health information technology from the FDA’s purview – and from the 2.3% medical device tax imposed under the Affordable Care Act.
Sens. Deb Fischer (R-Neb.), Angus King (D-Maine) and Marco Rubio (R-Fla.) co-sponsored the Preventing Regulatory Overreach to Enhance Care Technology (PROTECT) Act, introducing the measure on the Senate floor Feb. 10.
The FDA can regulate HIT software, including smartphone apps, under a mandate established in 1976 by the Medical Device Regulation Act. The PROTECT bill would exempt categories of low-risk clinical and health software from that oversight, establishing instead a new regulatory regime under the National Institute of Standards & Technology and other federal agencies, the legislators said this week.
"The regulatory time line for risky devices should not be the same for low-risk software that gets released every 60 days, has major updates every month, and sees regular changes every week. Having an approval process that takes longer than the shelf life of the average device operating system stifles opportunity and it stifles innovation," Fischer said Monday. "Innovators, regulators, and consumers need clarity and certainty into how these regulations are going to be enforced. Since mobile wellness apps and most clinical decision support technologies pose little risk to patients, they should not be subject to the same costly painstaking processes as medical devices."
King noted that the heart of the bill is "our attempt to differentiate between medical software, which has a direct impact upon patient health, and software that is more peripheral."
"[That] and can range from the app I have on my iPhone, which is a pedometer that tells me how much I have walked each day and how much I should walk each day, to the kind of software that is being developed across the country to assist medical practices in their billing and in the operational part of the medical business," King said.
Fischer, King and Rubio were the bill’s only co-sponsors as of this writing, according to a government website.