Over the last year, something shifted. The EMA–FDA joint Good AI Practice Principles (Jan 2026), the CIOMS Working Group XIV final report (Dec 2025), and the EU AI Act high-risk rules taking effect this August have moved AI in PV from “interesting pilot” to “regulated activity.”
Here’s a brief deck mapping where the top 10 health authorities stand — FDA, EMA, MHRA, Health Canada, PMDA, NMPA, TGA, ANVISA, MFDS, and Swissmedic — plus the CIOMS/WHO/ICH harmonization layer.