AI: Global Regulatory Round-Up

[Chris Johnston]

HealthAI recently launched a monthly round-up of regulatory news, powered by MedBoard, to help keep with the fast-evolving landscape of AI governance in health. If this is useful let me know and I can set up a repository of links where it's easier to access.

From regulatory steps to pilots and consultations, the round-up brings together key developments shaping how AI is governed across different countries and regions.

May’s updates focused on the continued implementation of the EU AI Act, new guidance for AI-enabled medical devices, and emerging approaches to governing high-risk AI systems across multiple jurisdictions.

• Australia, Canada, New Zealand, United Kingdom & United States – Joint guidance outlines governance and risk management considerations for the adoption of agentic AI systems. Link

• Australia, Canada, New Zealand, UK & US – Joint guidance outlines governance and risk management considerations for the adoption of agentic AI systems. Link

• Australia - Cybersecurity Centre produces updated comment on Frontier AI models and their impact on cyber security. Link

• Australia - The country also published guidance on the automated decision-making (ADM) transparency obligation and is seeking feedback from relevant stakeholders until the 15th of June. Link

• China - Ministry of Industry and Information Technology produces notice on Implementation of the Artificial Intelligence Technology Ethics Review and Service Pilot Plan. Link

• Croatia – Data protection authority issues guidance for organizations developing AI models and systems, including privacy and compliance considerations. Link

• European Union – Draft Commission guidelines clarify the classification of AI systems as high-risk under the AI Act. Link

• European Union – Consultation launched on draft guidance covering transparency obligations under the AI Act. Link

• European Union – EU institutions reach agreement on measures intended to simplify implementation of AI rules while maintaining key safeguards. Link

• European Union & Japan – Partners expand cooperation on AI, data governance, quantum technologies, and semiconductor innovation. Link

• European Union & Africa – New cooperation initiative strengthens collaboration on artificial intelligence governance and capacity-building. Link

• Germany – New roadmap provides practical guidance on complying with AI Act requirements for high-risk AI medical devices. Link

• Peru - Government presents the National Artificial Intelligence Strategy (ENIA) to strengthen the safe, inclusive and ethical management of AI. Link

• Sweden – National data protection authority comments on the provisional agreement to amend the EU AI Act. Link

• United Kingdom – Government guidance examines risks associated with AI, open-source code, and vulnerability management in the public sector. Link

March & April’s round-up of governance developments reflected the growing shift from high-level AI strategies toward implementation in practice, including new regulatory guidance, consultations, sandbox expansion, lifecycle management frameworks, and the integration of AI into regulatory operations themselves.

• Bangladesh DGDA – New guideline sets out regulatory expectations for artificial intelligence and medical robotics in healthcare. Link

• Belgium Data Protection Authority – Guidance explains how artificial intelligence affects privacy and data protection obligations. Link

• Canada – Health Canada New pre-market guidance outlines expectations for machine learning-enabled medical devices. Link

• Ecuador – Launch of a regulatory sandbox to support responsible AI development and innovation. Link

• European Commission – New study mapping the use and impact of AI in healthcare across Europe. Link

• European Commission – AI Continent Action Plan reports major milestones for Europe’s AI infrastructure, innovation, and adoption agenda. Link

• European Commission – Third GPAI Signatory Taskforce meeting discusses the Safety and Security chapter of the Code of Practice for general-purpose AI. Link

• European Commission – Targeted consultation opens on how to measure the energy consumption and emissions of AI models and systems. Link

• European Commission – Draft open for feedback until today, focused on implementing regulation outlining requirements under the EU AI Act, specifically for general-purpose AI models. Link

• European Commission – Draft Code of Practice on labelling and transparency of AI-generated content. Link

• European Commission Joint Research Centre – New article explores how AI is moving from promise to practice in cardiovascular care. Link

• European Medicines Agency – Updated workplan on the use of data and AI in medicines regulation (2026-2028). Link

• France – Public consultation on draft guidance for AI use in healthcare led by CNIL (open until 16 of April 2026). Link

• Germany – Update on pilot initiative testing AI in real-world regulatory environments (“real-world laboratory”). Link

• Ireland – New national “AI for Care” strategy outlining priorities for AI in healthcare (2026–2030). Link

• IMDRF – Draft technical framework proposes lifecycle management principles for AI-enabled medical devices. Link

• Japan PMDA – PMDA announces the use of generative AI to support its own regulatory operations. Link

• Kenya Pharmacy and Poisons Board – New guideline defines the regulatory approach for medical device software in Kenya. Link

• Netherlands – New national report examining the use of algorithms and AI. Link

• Poland UODO – Data protection authority comments on Poland’s draft Act on Artificial Intelligence Systems. Link

• Singapore – Updated AI in Healthcare Guidelines (AIHGle 2.0), with practical implementation guidance. Link

• United Kingdom DSIT – UK Tech Secretary launches Sovereign AI, setting out the government’s direction on domestic AI capability. Link

• United Kingdom ICO – New regulations adopt a Code of Practice on AI and automated decision-making under the Data Protection Act 2018. Link

• United Kingdom MHRA – MHRA expands its AI Airlock regulatory sandbox with £3.6 million in funding over three years. Link