This is the inaugural edition of the AiGovOps Foundation's semi-annual Healthcare AI Governance report. Every six months, we publish a practitioner-facing deep dive into where the field actually stands — not where vendors claim it is.
Healthcare AI has crossed an inflection point: clinical AI is moving from pilot to production at scale, and the governance expectations around FDA SaMD pathways, HIPAA, and clinical validation are hardening accordingly.
The report examines what's changed this spring, where the real risks concentrate, and what governance practices distinguish the organizations shipping trustworthy clinical AI from those accumulating liability.