Developing Computable Phenotypes for Medical Product Safety Surveillance: Innovative Methods and Data Sources

With expanding real-world data, developing accurate computable phenotypes is vital for medical product safety surveillance. This symposium presentation highlights methods used in the FDA’s Sentinel System to build and validate phenotypes. Additionally, it addresses challenges in generalizability, validation, and regulatory use, offering practical guidance for safety signal detection and evaluation. It was presented at the 2025 ISPE Annual Meeting.