Do you want the Food and Drug Administration (FDA) to regulate your smartphone? Many in the booming digital health industry are indifferent to the risks of the FDA regulating apps as medical devices. As I noted in a recent Health Alert, the FDA’s current doctrine is to allow most new apps onto the market without regulation. However, this openness is defined only in rules written by the FDA itself, not legislation. Rep. Marsha Blackburn and others in Congress have proposed to amend the law to prevent the FDA from overreaching.
Entrepreneurs and patients who think that the FDA’s current posture is eternal should be aware of a campaign to regulate apps for health. Here’s a recent article from Mother Jones:
Read the entire article at NCPA's Health Policy Blog.