International Frameworks

Laws, regulations, and guidance on healthcare AI from international bodies and national governments outside the U.S.

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Country/RegionPolicy Name/TitleIssuing BodyPolicy TypeDate Issued/Significantly UpdatedStatusLink to text
InternationalWorld Health AssemblyResolution2026-05-23AdoptedLINK
ChinaCyberspace Administration of China; National Development and Reform Commission; Ministry of Industry and Information Technology; Ministry of Public Security; State Administration for Market RegulationRegulation2026-04-10Effective 2026-07-15LINK
CanadaHealth CanadaGuidance2026-04-01ActiveLINK
InternationalOrganisation for Economic Co-operation and Development (OECD)Framework2026-03-27ActiveLINK
ZimbabweGovernment of ZimbabweNational AI Strategy2026-03-13ActiveLINK
IrelandDepartment of HealthStrategy2026-03-11ActiveLINK
New ZealandMedical Council of New ZealandGuidance2026-03-10ActiveLINK
SingaporeMinistry of Health Singapore; Health Sciences AuthorityGuidance2026-03-10ActiveLINK
BrazilFederal Council of Medicine (Conselho Federal de Medicina)Regulation2026-02-27PublishedLINK
IndiaMinistry of Health and Family WelfareStrategy2026-02-17ActiveLINK
SingaporeHealth Sciences Authority; Government of SingaporeRegulation / Exemption Order2026-02-13ActiveLINK
IsraelMinistry of HealthGuidance2026-02-01ActiveLINK
South KoreaSouth Korean Ministry of Government LegislationLaw2026-01-22In EffectLINK
SpainMinistry of Health/Interterritorial Council of the National Health SystemNational AI in health strategy2025-11-12ActiveLINK
GlobalUNESCOReccomendation2025-11-01ActiveLINK
InternationalWorld Health OrganizationGuidance2025-11-01ActiveLINK
AustraliaAustralian Health Practitioner Regulation Agency & National BoardsGuidance2025-10-07ActiveLINK
JapanPharmaceuticals and Medical Devices AgencyStrategy2025-09-26ActiveLINK
ItalyParliament of Italy & Presidency of the RepublicLaw2025-09-25ActiveLINK
MalaysiaMalaysian Medical CouncilGuidance2025-09-01ActiveLINK
AustraliaTherapeutic Goods AdministrationGuidance2025-08-29ActiveLINK
AustraliaTherapeutic Goods AdministrationGuidance2025-08-13ActiveLINK
InternationalWorld Health Organization; International Telecommunication Union; World Intellectual Property OrganizationTechnical brief2025-07-11ActiveLINK
European UnionEuropean Commission; European AI OfficeImplementation Framework2025-07-10ActiveLINK
FranceFrench Ministry of Labour, Health, Solidarity and Families – Digital Health Delegation and partnersStrategy2025-07-01ActiveLINK
European UnionEuropean CommissionGuidance2025-06-26ActiveLINK
European UnionEuropean CommissionGuidance2025-06-16ActiveLINK
JamaicaMinistry of Health & WellnessStrategy2025-06-10ActiveLINK
European UnionMedical Device Coordination GroupGuidance2025-06-01ActiveLINK
European UnionEMA & HMAGuidance2025-05-07ActiveLINK
GlobalWorld Health OrganizationStrategy2025-05-01ActiveLINK
United KingdomNHS EnglandGuidance2025-04-27ActiveLINK
New ZealandNew Zealand Ministry of Health (Manatū Hauora)Framework2025-04-14ActiveLINK
InternationalWorld Health OrganizationGuidance2025-03-25ActiveLINK
European UnionEuropean Parliament & CouncilRegulation2025-03-05ActiveLINK
AustraliaAustralian Government Department of Health, Disability and AgeingReport2025-03-01ActiveLINK
United KingdomMHRAGuidance2025-02-03ActiveLINK
InternationalInternational Medical Device Regulators ForumGuidance2025-01-30ActiveLINK
CanadaHealth CanadaGuidance2025-01-30ActiveLINK
Holy SeeDicastery for the Doctrine of the Faith and Dicastery for Culture and EducationGuidance2025-01-28ActiveLINK
South KoreaMinistry of Health and WelfareNational AI in health R&D roadmap2025-01-13ActiveLINK
Singapore; South KoreaHSA (Singapore); MFDS (Korea)Guidance2024-12-11ActiveLINK
United Arab EmiratesDubai Health AuthorityLaw2024-12-06ActiveLINK
European UnionEuropean Medicines AgencyGuidance2024-09-30ActiveLINK
International/EuropeCouncil of EuropeTreaty2024-09-05ActiveLINK
Dominican RepublicMinisterio de Salud PúblicaStrategy2024-08-07ActiveLINK
InternationalPan American Health Organization; World Health Organization; Inter-American Development BankGuidance2024-08-01ActiveLINK
European UnionEuropean Parliament & CouncilLaw2024-07-12ActiveLINK
United KingdomMedicines and Healthcare products Regulatory AgencyRoadmap2024-04-30ActiveLINK
United KingdomMHRAPolicy Paper2024-04-30ActiveLINK
SingaporeAI Verify Foundation; IMDA/PDPCGuidance2024-01-16ActiveLINK
InternationalWorld Health OrganizationConsiderations2023-10-19ActiveLINK
ChinaCyberspace Administration of ChinaInterim2023-07-10ActiveLINK
IndiaIndian Council of Medical ResearchGuidance2023-03-22ActiveLINK
InternationalInternational Telecommunication Union FG‑AI4HGuidance2022-09-22ActiveLINK
InternationalInternational Medical Device Regulators ForumGuidance2022-05-09ActiveLINK
InternationalUNESCO General ConferenceRecommendation2021-11-01ActiveLINK
InternationalWorld Health OrganizationGuidance2021-06-28ActiveLINK
New ZealandNew Zealand GovernmentCharter2020-07-01ActiveLINK
InternationalOECD CouncilRecommendation2019-05-22ActiveLINK