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 | Policy Name/Title | Issuing Body | Policy Type | Date Issued/Significantly Updated | Status | Link to text |
|---|---|---|---|---|---|---|
| Ireland | Health Information and Quality Authority | National Guidance | 2026-07-29 | Published | LINK | |
| Malaysia | Ministry of Digital; AI Malaysia Berhad (National AI Office) | National Action Plan | 2026-07-28 | Active | LINK | |
| European Union | European Parliament and Council of the European Union | Regulation | 2026-07-24 | In Force | LINK | |
| European Union | Member State Coordination Group on Health Technology Assessment | Regulatory Guidance / General Principles | 2026-07-16 | Adopted | LINK | |
| Canada | Government of Canada | National Strategy | 2026-06-04 | Active | LINK | |
| International | World Health Assembly | Resolution | 2026-05-23 | Adopted | LINK | |
| United Kingdom | NHS England | Information Governance Guidance | 2026-05-20 | Published | LINK | |
| United Arab Emirates | UAE Cabinet | National Policy | 2026-05-18 | Approved | LINK | |
| International | World Health Organization | Discussion Paper | 2026-04-25 | Published | LINK | |
| United Kingdom | NHS England | Guidance | 2026-04-24 | Active | LINK | |
| United Kingdom | General Pharmaceutical Council | Regulatory Position Statement | 2026-04-20 | Active | LINK | |
| China | Cyberspace Administration of China; National Development and Reform Commission; Ministry of Industry and Information Technology; Ministry of Public Security; State Administration for Market Regulation | Regulation | 2026-04-10 | Published | LINK | |
| Canada | Health Canada | Guidance | 2026-04-01 | Active | LINK | |
| International | Organisation for Economic Co-operation and Development (OECD) | Framework | 2026-03-27 | Active | LINK | |
| Zimbabwe | Government of Zimbabwe | National AI Strategy | 2026-03-13 | Active | LINK | |
| Ireland | Department of Health | Strategy | 2026-03-11 | Active | LINK | |
| China | National Medical Products Administration | Implementation Opinions | 2026-03-11 | Issued | LINK | |
| New Zealand | Medical Council of New Zealand | Guidance | 2026-03-10 | Active | LINK | |
| Singapore | Ministry of Health Singapore; Health Sciences Authority | Guidance | 2026-03-10 | Active | LINK | |
| Brazil | Federal Council of Medicine (Conselho Federal de Medicina) | Regulation | 2026-02-27 | Published | LINK | |
| India | Ministry of Health and Family Welfare | Strategy | 2026-02-17 | Active | LINK | |
| Singapore | Health Sciences Authority; Government of Singapore | Regulation / Exemption Order | 2026-02-13 | Active | LINK | |
| Australia | Therapeutic Goods Administration | Regulatory Guidance | 2026-02-05 | Published | LINK | |
| Israel | Ministry of Health | Guidance | 2026-02-01 | Active | LINK | |
| South Korea | South Korean Ministry of Government Legislation | Law | 2026-01-22 | In Effect | LINK | |
| Global | World Health Organization | Global Strategy | 2025-12-01 | Published | LINK | |
| Spain | Ministry of Health/Interterritorial Council of the National Health System | National AI in health strategy | 2025-11-12 | Active | LINK | |
| Global | United Nations Educational, Scientific and Cultural Organization | Recommendation | 2025-11-11 | Adopted | LINK | |
| Australia | Australian Health Practitioner Regulation Agency & National Boards | Guidance | 2025-10-07 | Active | LINK | |
| Japan | Pharmaceuticals and Medical Devices Agency | Action Plan | 2025-09-26 | Published | LINK | |
| Italy | Parliament of Italy & Presidency of the Republic | Law | 2025-09-25 | Active | LINK | |
| Malaysia | Malaysian Medical Council | Guidance | 2025-09-01 | Active | LINK | |
| Australia | Australian Government Department of Health, Disability and Ageing | Report | 2025-07-23 | Published | LINK | |
| International | World Health Organization; International Telecommunication Union; World Intellectual Property Organization | Technical brief | 2025-07-11 | Active | LINK | |
| European Union | European Commission; European AI Office | Implementation Framework | 2025-07-10 | Active | LINK | |
| France | French Ministry of Labour, Health, Solidarity and Families – Digital Health Delegation and partners | Strategy | 2025-07-01 | Active | LINK | |
| European Union | Medical Device Coordination Group | Guidance | 2025-06-19 | Published | LINK | |
| European Union | Medical Device Coordination Group | Guidance | 2025-06-17 | Published | LINK | |
| European Union | European Commission | Guidance | 2025-06-16 | Active | LINK | |
| Jamaica | Ministry of Health & Wellness | Strategy | 2025-06-10 | Active | LINK | |
| European Union | EMA & HMA | Guidance | 2025-05-07 | Active | LINK | |
| New Zealand | New Zealand Ministry of Health (Manatū Hauora) | Framework | 2025-04-14 | Active | LINK | |
| European Union | European Parliament & Council | Regulation | 2025-03-05 | Active | LINK | |
| United Kingdom | MHRA | Guidance | 2025-02-03 | Active | LINK | |
| International | International Medical Device Regulators Forum | Guidance | 2025-01-30 | Active | LINK | |
| Canada | Health Canada | Guidance | 2025-01-30 | Active | LINK | |
| Holy See | Dicastery for the Doctrine of the Faith and Dicastery for Culture and Education | Guidance | 2025-01-28 | Active | LINK | |
| South Korea | Ministry of Health and Welfare | National AI in health R&D roadmap | 2025-01-13 | Active | LINK | |
| Singapore; South Korea | HSA (Singapore); MFDS (Korea) | Guidance | 2024-12-11 | Active | LINK | |
| United Arab Emirates | Dubai Health Authority | Law | 2024-12-06 | Active | LINK | |
| European Union | European Medicines Agency | Guidance | 2024-09-30 | Active | LINK | |
| International/Europe | Council of Europe | Treaty | 2024-09-05 | Open for signature; not in force | LINK | |
| Dominican Republic | Ministerio de Salud Pública | Strategy | 2024-08-07 | Active | LINK | |
| International | Pan American Health Organization; World Health Organization; Inter-American Development Bank | Guidance | 2024-08-01 | Active | LINK | |
| United Kingdom | Medicines and Healthcare products Regulatory Agency | Roadmap | 2024-04-30 | Active | LINK | |
| United Kingdom | MHRA | Policy Paper | 2024-04-30 | Active | LINK | |
| International | World Health Organization | Guidance | 2024-01-18 | Published | LINK | |
| Singapore | AI Verify Foundation; IMDA/PDPC | Guidance | 2024-01-16 | Active | LINK | |
| International | World Health Organization | Considerations | 2023-10-19 | Active | LINK | |
| China | Cyberspace Administration of China | Interim | 2023-07-10 | Active | LINK | |
| India | Indian Council of Medical Research | Guidance | 2023-03-22 | Active | LINK | |
| International | International Medical Device Regulators Forum | Guidance | 2022-05-09 | Active | LINK | |
| International | UNESCO General Conference | Recommendation | 2021-11-01 | Active | LINK | |
| New Zealand | New Zealand Government | Charter | 2020-07-01 | Active | LINK | |
| International | OECD Council | Recommendation | 2019-05-22 | Active | LINK |