Yesterday the Clinical Decision Support (CDS) Coalition released a comment broadly criticizing the FDA’s recent CDS draft guidance, noting that the draft would expand the scope of FDA regulations, and that it fails to take a risk-based approach, lumping in many low-risk programs already on the market.
“The resulting overregulation would be to the detriment of patient care,” CDS Coalition Leader...
Back in March, when President Donald Trump chose Dr. Scott Gottlieb to head up the FDA under his administration, MobiHealthNews noted that he had a history of advocating for a hands-off approach to mobile health regulation. Now, just three months later (and a little over a month after his confirmation to the post), Gottlieb has articulated his new -- and somewhat radical -- approach to mobile...
