HIMSSCast: Is the FDA taking digital health regulation in the right direction?


With its recent launch of the Digital Health Center for Excellence, the FDA has shown a new spotlight on its ongoing work of changing how the regulation of digital health and digital therapeutics works, to better match the realities of modern technology. But is the organization taking the right steps for the right reasons? Or is it heading into dangerous territory for developers and their end users – the patients?

Host Jonah Comstock and MobiHealthNews Associate Editor Dave Muoio discuss this pivotal question with Bradley Merrill Thompson, a Member of the Firm at Epstein Becker Green, founder of the AI Startups in Health Coalition (AISHC) and occasional MobiHealthNews contributor.

Click these links to listen and subscribe on Apple Podcasts, Spotify, Google Podcasts, or Amazon Music.

Talking points:

  • The FDA’s new Center for Excellence.
  • Why launch the Center now?
  • What’s going on with Pre-Cert?
  • The risk of FDA surveillance overreach.
  • Data subjectivity in post-market surveillance.
  • How should FDA regulate AI?
  • FDA time is money – the importance of prioritization.


More about this episode:

FDA establishes Digital Health Center of Excellence

Q&A: A firsthand account of FDA’s Pre-Cert Program

The AISHC’s position paper

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