Regulation of artificial intelligence moved from concept to compliance in 2025. The European Union’s AI Act entered its first operational phase, the United States advanced federal guidance and state legislation, the United Kingdom expanded regulator-led oversight, and China codified labeling and ethics obligations. Together, these global developments signal the emergence of auditable AI governance frameworks across major jurisdictions. This commentary distills the most consequential legal and regulatory actions of 2025 and offers a practical playbook for clinicians and AI-governance leaders within health systems preparing for 2026 implementation milestones.
European Commission. Artificial Intelligence Act: Regulation (EU) 2024/1689. Official J Eur Union, 2024.
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US Office of Management and Budget. M-25-21: Managing Risks from Artificial Intelligence in Government and M-25-22: Acquiring AI Capabilities. OMB: Washington, DC; 2025.
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US Food and Drug Administration. Predetermined Change Control Plans for Machine Learning–Enabled Medical Devices: Final Guidance. FDA: Silver Spring, MD; 2025.
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Office of the National Coordinator for Health Information Technology. Health Data, Technology, and Interoperability: HTI-2 Final Rule. Federal Register; 2025.
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California Legislature. SB 53 (Artificial Intelligence Safety and Disclosure Act). LegiScan: Sacramento, CA; 2025.
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Competition and Markets Authority & Information Commissioner’s Office. Joint Statement on Foundation Models and Data Protection. CMA: London; 2025.
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United Kingdom Parliament. Digital Markets, Competition and Consumers Act 2024. The Stationery Office: London; 2025.
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Cyberspace Administration of China. Provisions on the Administration of Deep Synthesis and Generative Artificial Intelligence Services. CLT: Beijing; 2025.
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Ministry of Science and Technology (China). Global Artificial Intelligence Governance Initiative Action Plan. Beijing; 2025.
