Oct 22, 2013 press release from the office of Conressman Marsha Blackburn:”Congressman Marsha Blackburn (R-TN07) joined Representatives Gene Green (D-TX29), Dr. Phil Gingrey (R-GA11), Diana DeGette (D-CO01), Greg Walden (R-OR02), and G. K. Butterfield (D-NC01) today in introducing the Sensible Oversight for Technology which Advances Regulatory Efficiency (SOFTWARE) Act to provide regulatory clarity regarding mobile medical applications, clinical decision support, electronic health records, and other health care related software. By building on the guidance recently released by the FDA and codifying their risk based regulatory approach this important legislation provides the regulatory certainty that technology companies need in order to continue to drive innovation and ensure patient safety. “- The draft bill is at the link provided and indicates that “Clinical software and health software shall not be subject to regulation under this Act.” meaning by FDA.
The Bill can be viewed here: https://www.congress.gov/bill/114th-congress/house-bill/2396