ACT Brief: AI Architecture and Model Ownership Due Diligence, FDA Framework for Generative AI Medical Devices, and Heidi Overton Nominated for FDA Commissioner

This is the Applied Clinical Trials Brief—your fast track to the latest insights shaping clinical operations and drug development.

• In part three of her interview, Amber Hill, PhD, founder and CEO of Research Grid, makes the case that AI architecture is the most important due diligence sponsors can do before adopting any AI tool in clinical development. Who built the model, who owns the data, and how outputs are traced matter far more than flashy capabilities when operating in regulated environments.
• The FDA issued a discussion paper proposing a regulatory framework for generative AI-enabled medical devices, including a two-axis risk assessment model and competency-based premarket evaluation. The framework distinguishes between non-directive informational functions and autonomous action-taking functions, flagging patient-facing implementations as potentially higher risk than clinician-facing tools and proposing postmarket monitoring through periodic re-benchmarking and performance degradation tracking.
• President Trump selected Heidi Overton, deputy director of the White House Domestic Policy Council, as his nominee for FDA commissioner, filling the role vacant since Marty Makary resigned in May. Overton, a physician with surgery training at Johns Hopkins and prior service in the first Trump administration, arrives as the agency faces staff losses exceeding 3,000 over the past year and pressure to rebuild confidence amid concerns over political influence.

That's all for today's ACT Brief. Join us tomorrow for more updates shaping clinical operations and drug development. Thanks for listening.