Integrating Human and Artificial Intelligence for Robust Postmarketing Safety Surveillance Systems: Reflections From the FDA Sentinel Innovation Center

To describe considerations for integration of human and artificial intelligence for creating a postmarketing surveillance system capable of timely and reliably identifying causal effects of medications on safety endpoints.

The FDA has prioritized more extensive Electronic Health Records (EHR) integration along with generative artificial intelligence and machine learning (Gen AI/ML) into the national active surveillance program for medical products—the Sentinel Initiative. Based on our experience of leading these efforts, we provide perspectives on the opportunities and challenges of Gen AI/ML integration into Sentinel.