Scaling Clinical AI to One Million Patients Taught Us Things No Pilot Study Could

A multi-center analysis reveals clinical AI tools validated at single sites face significant reproducibility and data harmonization challenges when scaled across diverse health systems, patient demographics, and EHR standards. Regulatory bodies like the FDA and WHO are tightening scrutiny on AI endpoints in clinical trials, emphasising data standardization, ongoing performance monitoring, and documented cross-site harmonization protocols.

This Wire brief sits within Fusion42's coverage of Healthtech Infrastructure and Digital Health.