Why Governance Matters More in FDA’s Major Reforms for 2026

Описание: Get advisory insights about Healthcare AI — at zero cost:
https://junaidkaliamd.substack.com/

The FDA stepped back. Now, organizational governance is the only thing standing between innovation and liability.

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.

What You Will Discover:
[00:00] Intro
[00:57] What changed in the regulatory landscape?
[03:47] How the shift affects clinician workflows
[05:10] Who should pay for clinical data platforms?
[09:19] JPM Conference Insights
[11:53] The importance of governance and trust
[15:01] Biologics, biosimilars, and China competition
[17:11] Practical strategies for continuous learning

Referenced in the show:
🖇️ "Supercharging a New FDA: Marty Makary on Science, Power & Patients" –    • Supercharging a New FDA: Marty Makary on S...  
🖇️A Field Guide to Deploying AI Agents in Clinical Practice – https://mitsloan.mit.edu/shared/ods/d...

Connect with us:

Dr. Junaid Kalia, Neurocritical Care Specialist and Founder of Savelife.AI™
💼LinkedIn -   / junaidkaliamd  
🔗Website - https://www.junaidkalia.com/
📹YouTube -    / @junaidkaliamd  
📑Substack - https://substack.com/@junaidkaliamd2025?

Dr. Harvey Castro, ER Physician, #DrGPT™
💼LinkedIn -   / harveycastromd  
🔗Website - https://www.harveycastromd.com/
📷Instagram - https://www.instagram.com/harveycastr...
📑Substack - https://harveycastromd.substack.com/

Edward Marx, CEO, Advisor
💼LinkedIn -   / edwardmarx  
🔗Website - https://www.marxadvisory.com/
📹YouTube -    / @edwardmarx  


Visit our website:
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