Digital Health Regulatory & Safety Intelligence Center

Healthcare AI is entering a new regulatory era. FDA’s Predetermined Change Control Plan (PCCP) pilot is creating adaptive pathways for AI that evolves after deployment. The EU AI Act is imposing compliance deadlines that most healthcare AI companies aren’t ready to meet. And post-market surveillance data from 500K+ patient deployments is revealing safety signals that pre-market trials never caught.

This 5-article intelligence cluster covers the regulatory and safety landscape that every healthcare AI stakeholder needs to understand — from clinical trial data and post-market safety signals to FDA regulatory pilots and EU AI Act compliance readiness.

The common thread: external validation. 81% of healthcare AI systems degrade when deployed outside their training data. The companies that survive the next regulatory wave will be those that invested in real-world validation before it became mandatory.