What question did this study set out to answer?

The aim is to understand the landscape of medical AI oversight and the collaborative efforts required among various entities.

May 24, 2026Open Access

Expert perspectives on the ecosystem of medical AI oversight in the GenAI era

SGStephen GilbertHochschule für Technik und Wirtschaft Dresden – University of Applied Sciences TDTinglong DaiJohns Hopkins University

Key Points

The aim is to understand the landscape of medical AI oversight and the collaborative efforts required among various entities.
Interviews with Dr. Shantanu Nundy, an expert in AI governance and digital health policy.
Analysis of the responsibilities of regulators, health systems, and clinicians in the AI oversight ecosystem.
Discussion of strategies for innovators to interact effectively with the FDA.
Oversight of GenAI medical devices requires coordinated efforts across multiple regulatory agencies.
Clinicians play a critical role in integrating and overseeing AI technologies within health systems.
The article offers practical advice for innovators on navigating FDA engagement.

Abstract

In this third article of a three-article series on interviews with Dr Shantanu Nundy, an advisor in the office of the Commissioner of the US FDA on AI governance and digital health policy, we explore how the oversight of generative AI (GenAI) and large language model (LLM)-enabled medical devices extends beyond the remit of any single regulator, requiring coordination among government agencies, health systems, and practicing clinicians. We also discuss practical advice for innovators seeking to engage productively with the FDA.

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