FDAs mHealth regulation scheme wasn't well articulated https://t.co/v3SGQCyaAT Agree (2012) https://t.co/ggl9typFcK pic.twitter.com/fFvfXQ28uf
— mHealth Insight (@mHealthInsight) December 26, 2015
This takes it a bit too far (like most cartoons do), but it sometimes feels like this is reality. As I read yesterday, the FDA isn’t designed to regulate the digital health technologies that are hitting the market today. I think that’s the biggest challenge they face. They have to remake who they are if they’re going to start regulating all that’s happening.
We’re in a funny spot right now where the doctors don’t trust many apps because the FDA hasn’t approved them and so they’re not sure if they can be trusted and the app makers largely don’t want to go to the effort and cost of FDA approval. In many cases, it would be like trying to fit a square peg in a round hole. Somethings gotta give.
