Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was the featured guest on MobiHealthNews HIMSSCast, in “Is the FDA Taking Digital Health Regulation in the Right Direction?” with Jonah Comstock and Dave Muoio.
Following is an excerpt:
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.
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.
