Work

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

Year: 2026

Type: article

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.

Source: npj Digital Medicine

DOI: 10.1038/s41746-026-02785-1

Authors: Stephen Gilbert, Tinglong Dai

Institutions: Else Kröner Fresenius Center for Digital Health, Technische Universität Dresden, Johns Hopkins University

Language: English

Topic: Artificial Intelligence in Healthcare and Education

Subfield: Health Informatics

Field: Medicine

Domain: Health Sciences

Open Access status: gold

Estimated APC paid: $4,090

Funders: Johns Hopkins University, Technische Universität Dresden, Carey Business School, Johns Hopkins University