International Frameworks
Laws, regulations, and guidance on healthcare AI from international bodies and national governments outside the U.S.
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| Country/Region | Issuing Body | Policy Name/Title | Policy Type | Date Issued/Significantly Updated | Status | Link to text |
|---|---|---|---|---|---|---|
| Singapore | MOH Artificial Intelligence in Healthcare Guidelines (AIHGle) | Guidelines | 2025-09-04 | Active | LINK | |
| Australia | Artificial intelligence explained – Medical devices | Guidance | 2025-8-29 | Active | LINK | |
| Australia | Regulation of software, including AI – SaMD rules and guidance | Guidance | 2025-08-13 | Active | LINK | |
| European Union | MDCG 2025-4 – Guidance on the safe making available of medical device software apps on online platforms | Guidance | 2025-06-16 | Active | LINK | |
| European Union | MDCG 2019-11 – Guidance on Qualification and Classification of Software under MDR/IVDR | Guidance | 2025-06 | Active | LINK | |
| European Union | Regulation 2025/327 – European Health Data Space | Regulation | 2025-03-05 | Active | LINK | |
| Canada | Guidance on Machine Learning‑enabled Medical Devices | Guidance | 2025-02-05 | Active | LINK | |
| International | Good Machine Learning Practice for Medical Device Development – Guiding Principles (IMDRF/AIML WG/N88 FINAL:2025) | Guidance | 2025-01-30 | Active | LINK | |
| Singapore; South Korea | Guiding Principles for Conducting Clinical Trial for Machine Learning‑enabled Medical Devices | Guidance | 2024-12-11 | Active | LINK | |
| European Union | Reflection paper – Use of Artificial Intelligence in the Medicinal Product Lifecycle | Guidance | 2024-09-30 | Active | LINK | |
| International/Europe | Framework Convention on Artificial Intelligence and Human Rights, Democracy and the Rule of Law (CETS No. 225) | Treaty | 2024-09-05 | Open for signature; not yet in force | LINK | |
| European Union | Regulation (EU) 2024/1689 – Artificial Intelligence Act (AI Act) | Law | 2024-07-12 | Active | LINK | |
| United Kingdom | Software and AI as a Medical Device Change Programme – Roadmap | Roadmap | 2024-04-30 | Active | LINK | |
| United Kingdom | Impact of AI on the Regulation of Medical Products – Policy Paper | Policy Paper | 2024-04-30 | Active | LINK | |
| International | Ethics and Governance of AI for Health – Guidance on Large Multi‑Modal Models | Guidance | 2024-01-18 | Active | LINK | |
| Singapore | Model AI Governance Framework for Generative AI (v1.0) | Guidance | 2024-01-16 | Active | LINK | |
| International | Regulatory Considerations on Artificial Intelligence for Health | Considerations | 2023-10-19 | Active | LINK | |
| China | Interim Measures for the Management of Generative AI Services | Interim | 2023-07-10 | Active | LINK | |
| International | Regulatory Considerations on Artificial Intelligence for Health (FG‑AI4H DEL02) | Guidance | 2022-09-22 | Active | LINK | |
| International | Machine Learning‑enabled Medical Devices – Key Terms and Definitions (AIMD WG) | Guidance | 2022-05-09 | Active | LINK | |
| International | Recommendation on the Ethics of Artificial Intelligence | Recommendation | 2021-11 | Active | LINK | |
| International | Ethics and Governance of Artificial Intelligence for Health – WHO Guidance | Guidance | 2021-06-28 | Active | LINK | |
| New Zealand | Algorithm Charter for Aotearoa New Zealand | Charter | 2020-07 | Active | LINK | |
| International | OECD Recommendation on Artificial Intelligence (OECD/LEGAL/0449) | Recommendation | 2019-05-22 | Active | LINK |