How AI & Wearables Are Shaping The Future of Healthcare with Dr. Ami Bhatt

What It Covers

Dr. Ami Bhatt, FDA Digital Health Chair and American College of Cardiology Chief Innovation Officer, explains how the FDA is building infrastructure for AI healthcare tools, why wearables are essential for population health goals, and how the gap between consumer wellness technology and clinical medicine is closing through regulatory modernization and clinician education.

Key Questions Answered

• •FDA's New Approach: The FDA Digital Health Advisory Committee shifts from pure regulation to building infrastructure with guardrails. The focus is approve-and-monitor rather than approve-and-release, requiring post-implementation metric measurement as algorithms evolve. This allows faster access to digital health technologies while maintaining safety through continuous monitoring of real-world outcomes and performance data.
• •Wearables for Population Health: Achieving population health goals requires widespread wearable adoption because cardiometabolic risk factors drive longevity outcomes. The gap between medical remote monitoring and consumer wearables is closing through AI algorithms that integrate wearable data with electronic health records. FDA-cleared features like ECG monitoring enable care pathways that identify rising-risk patients in their communities before conditions worsen.
• •Patient Communication Strategy: When bringing wearable data to appointments, message clinicians beforehand with two focused concerns rather than overwhelming them with printouts. State what you have already tried and request time to discuss specific findings with the doctor or their team. This partnership approach recognizes time constraints in fee-for-service healthcare while demonstrating patient agency and preparation.
• •Human-AI Interaction Research: Studies show gastroenterologists who used AI to detect polyps during colonoscopies began missing polyps after AI removal within weeks, revealing deskilling risks. Research now focuses on determining when AI helps clinicians improve versus when it creates dependency or is unnecessary. The goal is matching AI assistance to clinician expertise levels and clinical contexts appropriately.
• •Startup Scaling Advice: Companies building AI health tools should go deep on one technology rather than attempting comprehensive platforms. Most successful digital health technologies get adopted into existing platforms rather than creating standalone user experiences. Early FDA engagement provides guidance on regulation, payment codes, clinical workflows, and market gaps beyond just approval decisions, improving chances of clinical adoption.