Senators Deb Fischer (R-Neb.) and Angus King (I-Maine) announced legislation that would limit FDA’s regulatory oversight to focus on products that pose the greatest health risks.
The bill, “The Preventing Regulatory Overreach To Enhance Care Technology (PROTECT) Act of 2014,” would relieve categories of low-risk clinical and health software from the medical device tax, according to an announcement.
As such, this legislation would “protect low-risk health IT from unnecessary regulatory burdens that stifle opportunities for job creation, innovation and improved care,” according to the policymakers.
The PROTECT Act is supported by IBM, athenahealth, Software & Information Industry Association, Newborn Coalition and McKesson.
Similar legislation addressing health software, the SOFTWARE Act (H.R. 3303), was introduced in the House of Representatives by Rep. Marsha Blackburn (R-Tenn.) last fall.
Read the entire bill here.