On October 22, Representative Marsha Blackburn (R-TN) along with five bipartisan cosponsors, Representatives Gene Green (D-TX), Dr. Phil Gingrey (R-GA), Diana DeGette (D-CO), Greg Walden (R-OR), and G. K. Butterfield (D-NC), introduced the Sensible Oversight for Technology which Advances Regulatory Efficiency – the SOFTWARE Act (HR 3303). The legislation seeks to provide regulatory clarity for mobile medical applications, clinical decision support, electronic health records (EHRs), and other healthcare software. The legislation has been referred to the House Committee on Energy and Commerce, of which Rep. Blackburn serves as the Vice Chairman, and the five cosponsors are members.
According to a press release from Rep. Blackburn’s office, this legislation seeks to build on the guidance recently released by the Food and Drug Administration (FDA) and evaluating the risk based regulatory approach set forth by the agency. This bill would provide the regulatory certainty to allow technology developers to continue innovate while ensuring patient safety.
The release states, “... [T]oday the Food and Drug Administration (FDA) lacks the necessary tools to appropriately oversee these innovative products without overstepping their authority and stifling innovation. 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 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. “
Earlier this month, Rep. Blackburn announced she planned to introduce this bill at a Telecommunications Industry Association (TIA) event.