Cures Exempts Some Medical Software; More Clarity Needed, Attorneys Say

Congress took a step in clarifying how FDA should regulate standalone medical software through language in the 21st Century Cures Act, but clarity over what is considered high- or low-risk Clinical Decision Support software is still needed, industry attorneys told Inside Health Policy . The newly signed law removes several categories of software from being defined as a medical device; a move the attorney said was positive for the overall healthcare system, especially software vendors, due to reduced reporting requirements...