Health AI Will Fail Unless We Cross the Chasm
These reflections began at the HealthAI Global Governance Forum, held in Nairobi on 2 December 2025 specifically during a session on the “Innovative Pre-Market Approaches to Validate and Regulate AI in Health.”It was a session about the future of Software as a Medical Device (SaMD), regulatory adaptation, living labs, cognitive trust, continuous monitoring, and the…