SOFTWARE Act Introduced To Curb FDA Health IT Oversight-thegraysheet: Rep. Marsha Blackburn, R-Tenn., and a bipartisan group of colleagues in the House introduced the SOFTWARE Act Oct. 22 to redefine the regulation of health information technology, with the probable effect of deregulating much of the sector. Besides Blackburn, the bill is cosponsored by Reps. Gene Green, D-Texas, Phil Gingrey, R-Ga., Diana DeGette, D-Colo., Greg Walden, R-Ore., and G.K. Butterfield, D-N.C. “Under current law, the FDA could use its definition of a medical device to assert broad regulatory authority over a wide array of software,” the lawmakers noted in a statement unveiling the legislation. “The SOFTWARE Act tailors their authority to the realities of the 21st century by focusing their authority onto the products that pose a potential risk to human health.
