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 POLITICO Morning eHealth, in “Questions Ahead for VA-Cerner Marriage,” by David Pittman.
Following is an excerpt:
Where’s the FDA in all of this? Bradley Merrill Thompson, general counsel of the Clinical Decision Support Coalition: “According to the 2015 mobile medical app guidance document from FDA, the agency had already declared as enforcement discretion mobile apps that track and trend health data, but the SOFTWARE Act [signed into law last year as part of 21st Century Cures] clarified that FDA actually has no regulatory authority over such software. In the eyes of many developers, that’s much better than simply FDA promising to use enforcement discretion.”