What FDA's Step Back Means in Building Credibility
What you'll discover
FDA has said, we just cannot regulate it. Go ahead and do it. Now the problem is that if you are going to go ahead and do it, you need to create proper frameworks, organization frameworks.
Junaid Kalia, MD
At CES 2026, the FDA officially announced it won't regulate wellness devices or Clinical Decision Support tools—removing approval bottlenecks and accelerating innovation. But this regulatory shift transfers responsibility to healthcare organizations themselves. Who builds the frameworks for data management when there's no FDA requirement? How do health systems justify physician time reviewing continuous patient streams without reimbursement pathways? And where does liability fall in this new landscape?
In this episode, Dr. Junaid and Ed tackle the AI governance vacuum, exploring how healthcare AI agents can scale care, from filtering patient data to managing population health. They share J.P. Morgan Healthcare Conference updates on why organizational trust, rather than just regulatory stamps, is the key to successful AI in healthcare.
Referenced in the episode
Medical disclaimer. This podcast is for general informational purposes and is not medical advice. Listening does not create a doctor and patient relationship. Views expressed by the guests and co-hosts are their own and do not represent their employers. No specific vendor or product is endorsed. No PHI is shared.