Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in MobiHealthNews, in “As Cures Bill Heads Towards Vote, Here’s What It Could Mean for Digital Health,” by Heather Mack.
Following is an excerpt:
For digital health companies building software for clinical decision support, the bill brings clarity over how the FDA would seek to regulate them. As health software companies are working on technology to help doctors do a more thorough job in both diagnosis and treatment decision-making (through apps, telemedicine and digital references), there is a real need for clinical guidelines, said Bradley Merrill Thompson, a partner at Epstein Becker Green who specializes in the FDA and digital health.
“Health software companies are working on exciting technologies that help doctors do a more thorough job in both the diagnosis and treatment decision making process. Software can analyze patient data quickly, and through reference to the literally millions of peer reviewed articles, clinical guidelines and other such clinical intelligence, make recommendations to the physicians,” Thompson wrote in an email to MobiHealthNews. “But there has been a cloud over this industry in the form of an uncertain regulatory environment.”