The U.S. Food and Drug Administration’s regulation of mobile health products is a definite gray area, and that was reflected during Wednesday night’s #mHealth tweet chat.
Most of the participants — who ranged from medical students to physicians to health IT professionals — agreed that some kind of approval process is needed in order to protect patients, but that the FDA doesn’t have the resources required to regulate all of them.
The challenge, then, comes in defining what should be reviewed and who should do the reviewing. One tweeter suggested that medical societies regulate their own specialty’s apps. Would that free the hands of the FDA any?
With the Rise of AI, What IP Disputes in Healthcare Are Likely to Emerge?
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
Below are some highlights from the chat.