FDA pledges new guidance for generative AI medical devices as Epic shares updates from its user conference

The Food and Drug Administration released a discussion paper outlining its plans to regulate generative‑AI‑powered medical devices. The agency said it will issue formal guidance to clarify how existing rules apply to these emerging technologies.

In the paper, the FDA invited comments from industry, clinicians and the public, emphasizing the need for a balanced approach that protects patients while encouraging innovation. The agency indicated that the forthcoming guidance will address issues such as algorithm transparency, validation and post‑market monitoring.

Separately, Epic announced several developments at its recent User Group Meeting, highlighting new features and integrations aimed at improving health‑system workflows. The updates were presented to a broad audience of Epic customers and partners, underscoring the company's continued focus on digital health solutions.