The AI Regulations Hub is a curated directory of official regulatory frameworks, regulatory authorities, and policy resources governing artificial intelligence across major jurisdictions.
This page provides direct links to laws, regulatory guidance, and government policy resources related to AI governance, including healthcare AI, data governance, safety standards, and algorithmic accountability.
The goal is to provide a single reference point for navigating the global medical device AI regulatory landscape.
How to use this page
Each section below lists the primary authorities and regulatory resources relevant to AI governance in that jurisdiction. Links point directly to official government or institutional pages where possible.
Table of Contents
Global Governance Organizations
Several international organizations have developed frameworks, standards, and guidance influencing national AI governance and regulatory approaches.
OECD
The OECD has developed widely adopted principles and policy tools promoting trustworthy AI and international coordination on AI governance.
- OECD AI Principles – https://oecd.ai/en/ai-principles
- OECD AI Policy Observatory – https://oecd.ai
- OECD AI policy initiatives – https://oecd.ai/en/dashboards/policy-initiatives
UNESCO
UNESCO developed the Recommendation on the Ethics of Artificial Intelligence, one of the first global normative frameworks for ethical AI governance.
- UNESCO AI ethics recommendation – https://www.unesco.org/en/artificial-intelligence/recommendation-ethics
- UNESCO AI governance resources – https://www.unesco.org/en/artificial-intelligence
WHO
WHO provides guidance on the responsible use of AI in healthcare systems and medical technologies.
- WHO AI in health guidance – https://www.who.int/publications/i/item/9789240029200
- WHO digital health and AI – https://www.who.int/health-topics/digital-health
EUROPE
Europe has one of the most comprehensive AI regulatory environments, combining AI-specific legislation with strong privacy and healthcare governance frameworks.
EU AI Act
The EU AI Act is the first comprehensive legal framework regulating artificial intelligence across the European Union.
- European Commission AI Act page – https://digital-strategy.ec.europa.eu/en/policies/european-approach-artificial-intelligence
- EU AI Act legislation – https://eur-lex.europa.eu
- AI Act policy overview – https://digital-strategy.ec.europa.eu/en/policies/regulatory-framework-ai
GDPR & AI
- European Data Protection Board – https://edpb.europa.eu
- GDPR legislation – https://gdpr.eu
- European Commission data protection portal – https://ec.europa.eu/info/law/law-topic/data-protection
Medical AI Governance
- European Medicines Agency – https://www.ema.europa.eu
- EU medical device regulation – https://health.ec.europa.eu/medical-devices_en
United States
AI governance in the United States is shaped primarily by federal agencies, sector-specific regulation, and emerging state laws.
Food and Drug Administration (FDA)
- FDA AI/ML medical device framework – https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-software-medical-device
- FDA digital health policy – https://www.fda.gov/medical-devices/digital-health-center-excellence
HHS / ONC
- HHS AI initiatives – https://www.hhs.gov
- ONC health IT governance – https://www.healthit.gov
NIST
- NIST AI Risk Management Framework – https://www.nist.gov/itl/ai-risk-management-framework
- NIST AI governance resources – https://www.nist.gov/artificial-intelligence
United Kingdom
MHRA
- MHRA AI and software medical devices – https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency
UK AI Governance
- UK AI regulation policy – https://www.gov.uk/government/publications/ai-regulation-a-pro-innovation-approach
- UK AI strategy – https://www.gov.uk/government/publications/national-ai-strategy
China
- Cyberspace Administration of China – https://www.cac.gov.cn
- Generative AI regulations – https://www.cac.gov.cn/2023-07/13/c_1690898327029107.htm
Disclaimer
This page provides links to publicly available regulatory resources and official policy materials. Readers should consult the original sources for the most current regulatory information.