Global AI in Health Regulation Tracker: FDA PCCP Guidance and EU AI Act Deadlines
The latest update to a global AI health regulation tracker highlights key regulatory instruments impacting clinical AI, including the FDA’s final guidance on predetermined change control plans for AI‑enabled device software and the forthcoming high‑risk regime under the EU AI Act. It underscores that many clinical decision support and diagnostic tools will fall under strict conformity assessment and documentation requirements.
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LOG Standards provides an independent accreditation signal for AI models used in healthcare, helping hospitals, care networks, and AI companies bring clinical AI readiness and governance into clearer conversations.
Our AI Intelligence Briefing tracks the latest developments in AI safety, AI in medicine, mental health AI, clinical AI governance, and regulatory policy — keeping healthcare stakeholders informed about the rapidly evolving AI landscape.