Given the rapid proliferation of AI-equipped medical devices across U.S. healthcare, unintended effects should surprise no one. 

The FDA’s fledgling Digital Health Advisory Committee (DHAC) only held its first meeting last week, but it has already committed its thinking to writing. 

It’s been years since AI proponents started promising big returns on healthcare providers’ investments in the technology. The results have yet to catch up with the pitches. What’s the holdup? 

The pace of AI adoption is quickening in the sector, which includes biopharmaceuticals, digital health, clinical diagnostics and medical devices.

If you work with healthcare AI, you owe it to patients, families and communities to keep certain principles top of mind in everything you do. 

What makes an organization an AI leader? Demonstrating success in one of two pursuits. 

As debate simmers over how best to regulate AI, experts continue to offer guidance on where to start, how to proceed and what to emphasize. A new resource models its recommendations on what its authors call the “SETO Loop.”

With generative AI coming into its own, AI regulators must avoid relying too much on principles of risk management—and not enough on those of uncertainty management.