<?xml version="1.0" encoding="UTF-8"?><rss xmlns:dc="http://purl.org/dc/elements/1.1/" xmlns:content="http://purl.org/rss/1.0/modules/content/" xmlns:atom="http://www.w3.org/2005/Atom" version="2.0"><channel><title><![CDATA[AI: Global Regulatory Round-Up]]></title><description><![CDATA[<p dir="auto"><strong><a href="https://healthai.agency/" rel="nofollow ugc">HealthAI</a></strong> recently launched a monthly round-up of regulatory news, powered by <strong><a href="https://www.medboard.com/" rel="nofollow ugc">MedBoard</a></strong>, 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.</p>
<p dir="auto">From regulatory steps to pilots and consultations, the round-up brings together key developments shaping how AI is governed across different countries and regions.</p>
<p dir="auto"><strong>May’s updates</strong> 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.</p>
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<p dir="auto"><strong>Australia, Canada, New Zealand, United Kingdom &amp; United States</strong> – Joint guidance outlines governance and risk management considerations for the adoption of agentic AI systems. <strong><a href="https://" rel="nofollow ugc">Link</a></strong></p>
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<p dir="auto"><strong>Australia, Canada, New Zealand, UK &amp; US</strong> – Joint guidance outlines governance and risk management considerations for the adoption of agentic AI systems. <strong><a href="https://www.cyber.gc.ca/en/news-events/joint-guidance-careful-adoption-agentic-artificial-intelligence-services" rel="nofollow ugc">Link</a></strong></p>
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<p dir="auto"><strong>Australia</strong> - Cybersecurity Centre produces updated comment on Frontier AI models and their impact on cyber security. <strong><a href="https://www.cyber.gov.au/about-us/view-all-content/news/frontier-models-and-their-impact-on-cyber-security-update" rel="nofollow ugc">Link</a></strong></p>
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<p dir="auto"><strong>Australia</strong> - 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. <strong><a href="https://www.oaic.gov.au/__data/assets/pdf_file/0027/263925/ADM-Issues-Paper.pdf" rel="nofollow ugc">Link</a></strong></p>
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<p dir="auto"><strong>China</strong> - Ministry of Industry and Information Technology produces notice on Implementation of the Artificial Intelligence Technology Ethics Review and Service Pilot Plan. <strong><a href="https://www.miit.gov.cn/jgsj/kjs/wjfb/art/2026/art_1a0b2b0b0deb47099202871e0b70551b.html" rel="nofollow ugc">Link</a></strong></p>
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<p dir="auto"><strong>Croatia</strong> – Data protection authority issues guidance for organizations developing AI models and systems, including privacy and compliance considerations. <strong><a href="https://azop.hr/wp-content/uploads/2026/05/AZOP-Smjernice-za-razvoj-AI-sustava.pdf" rel="nofollow ugc">Link</a></strong></p>
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<p dir="auto"><strong>European Union</strong> – Draft Commission guidelines clarify the classification of AI systems as high-risk under the AI Act. <strong><a href="https://digital-strategy.ec.europa.eu/en/library/draft-commission-guidelines-classification-high-risk-ai-systems" rel="nofollow ugc">Link</a></strong></p>
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<p dir="auto"><strong>European Union</strong> – Consultation launched on draft guidance covering transparency obligations under the AI Act. <strong><a href="https://digital-strategy.ec.europa.eu/en/consultations/consultation-draft-guidelines-transparency-obligations-under-ai-act" rel="nofollow ugc">Link</a></strong></p>
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<p dir="auto"><strong>European Union</strong> – EU institutions reach agreement on measures intended to simplify implementation of AI rules while maintaining key safeguards. <strong><a href="https://ec.europa.eu/commission/presscorner/detail/en/ip_26_1024" rel="nofollow ugc">Link</a></strong></p>
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<p dir="auto"><strong>European Union &amp; Japan</strong> – Partners expand cooperation on AI, data governance, quantum technologies, and semiconductor innovation. <strong><a href="https://digital-strategy.ec.europa.eu/en/news/eu-and-japan-accelerate-cooperation-ai-data-quantum-and-chips" rel="nofollow ugc">Link</a></strong></p>
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<p dir="auto"><strong>European Union &amp; Africa</strong> – New cooperation initiative strengthens collaboration on artificial intelligence governance and capacity-building. <strong><a href="https://digital-strategy.ec.europa.eu/en/node/16775/printable/pdf" rel="nofollow ugc">Link</a></strong></p>
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<p dir="auto"><strong>Germany</strong> – New roadmap provides practical guidance on complying with AI Act requirements for high-risk AI medical devices. <strong><a href="https://www.bfdi.bund.de/SharedDocs/Kurzmeldungen/DE/2026/07_Orientierungshilfe.html" rel="nofollow ugc">Link</a></strong></p>
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<p dir="auto"><strong>Peru</strong> - Government presents the National Artificial Intelligence Strategy (ENIA) to strengthen the safe, inclusive and ethical management of AI. <strong><a href="https://www.gob.pe/institucion/pcm/noticias/1387571-gobierno-presenta-la-estrategia-nacional-de-inteligencia-artificial-enia-para-fortalecer-la-gestion-segura-inclusiva-y-etica-de-la-ia" rel="nofollow ugc">Link</a></strong></p>
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<p dir="auto"><strong>Sweden</strong> – National data protection authority comments on the provisional agreement to amend the EU AI Act. <strong><a href="https://www.imy.se/nyheter/preliminar-overenskommelse-om-andringar-i-ai-forordningen/" rel="nofollow ugc">Link</a></strong></p>
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<p dir="auto"><strong>United Kingdom</strong> – Government guidance examines risks associated with AI, open-source code, and vulnerability management in the public sector. <strong><a href="https://www.gov.uk/guidance/ai-open-code-and-vulnerability-risk-in-the-public-sector" rel="nofollow ugc">Link</a></strong></p>
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</ul>
<p dir="auto"><strong>March &amp; April’s round-up</strong> 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.</p>
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<p dir="auto"><strong>Bangladesh DGDA</strong> – New guideline sets out regulatory expectations for artificial intelligence and medical robotics in healthcare. <strong><a href="https://objectstorage.ap-dcc-gazipur-1.oraclecloud15.com/n/axvjbnqprylg/b/V2Ministry/o/office-dgda/2026/3/33cd4d6a-3a66-42a6-8908-cde63c55097e.pdf" rel="nofollow ugc">Link</a></strong></p>
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<p dir="auto"><strong>Belgium Data Protection Authority</strong> – Guidance explains how artificial intelligence affects privacy and data protection obligations. <strong><a href="https://www.gegevensbeschermingsautoriteit.be/publications/the-impact-of-artificial-intelligence-on-privacy.pdf" rel="nofollow ugc">Link</a></strong></p>
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<p dir="auto"><strong>Canada</strong> – Health Canada New pre-market guidance outlines expectations for machine learning-enabled medical devices. <strong><a href="https://www.canada.ca/content/dam/hc-sc/documents/services/drugs-health-products/medical-devices/application-information/guidance-documents/pre-market-guidance-machine-learning-enabled-medical-devices/pre-market-guidance-machine-learning-enabled-medical-devices.pdf" rel="nofollow ugc">Link</a></strong></p>
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<p dir="auto"><strong>Ecuador</strong> – Launch of a regulatory sandbox to support responsible AI development and innovation. <strong><a href="https://www.telecomunicaciones.gob.ec/" rel="nofollow ugc">Link</a></strong></p>
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<p dir="auto"><strong>European Commission</strong> – New study mapping the use and impact of AI in healthcare across Europe. <strong><a href="https://digital-strategy.ec.europa.eu/en/library/" rel="nofollow ugc">Link</a></strong></p>
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<p dir="auto"><strong>European Commission</strong> – AI Continent Action Plan reports major milestones for Europe’s AI infrastructure, innovation, and adoption agenda. <strong><a href="https://digital-strategy.ec.europa.eu/en/node/16601/printable/pdf" rel="nofollow ugc">Link</a></strong></p>
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<p dir="auto"><strong>European Commission</strong> – Third GPAI Signatory Taskforce meeting discusses the Safety and Security chapter of the Code of Practice for general-purpose AI. <strong><a href="https://digital-strategy.ec.europa.eu/en/news/third-gpai-signatory-taskforce-meeting-safety-and-security-chapter" rel="nofollow ugc">Link</a></strong></p>
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<p dir="auto"><strong>European Commission</strong> – Targeted consultation opens on how to measure the energy consumption and emissions of AI models and systems. <strong><a href="https://digital-strategy.ec.europa.eu/en/consultations/targeted-consultation-measuring-energy-consumption-and-emissions-ai-models-and-systems" rel="nofollow ugc">Link</a></strong></p>
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<p dir="auto"><strong>European Commission</strong> – Draft open for feedback until today, focused on implementing regulation outlining requirements under the EU AI Act, specifically for general-purpose AI models. <strong><a href="https://digital-strategy.ec.europa.eu/en/policies/regulatory-framework-ai" rel="nofollow ugc">Link</a></strong></p>
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<p dir="auto"><strong>European Commission</strong> – Draft Code of Practice on labelling and transparency of AI-generated content. <strong><a href="https://digital-strategy.ec.europa.eu/en/policies/" rel="nofollow ugc">Link</a></strong></p>
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<p dir="auto"><strong>European Commission</strong> Joint Research Centre – New article explores how AI is moving from promise to practice in cardiovascular care. <strong><a href="https://joint-research-centre.ec.europa.eu/jrc-news-and-updates/artificial-intelligence-cardiovascular-care-promise-practice-2026-04-07_en" rel="nofollow ugc">Link</a></strong></p>
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<p dir="auto"><strong>European Medicines Agency</strong> – Updated workplan on the use of data and AI in medicines regulation (2026-2028). <strong><a href="https://www.ema.europa.eu/" rel="nofollow ugc">Link</a></strong></p>
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<p dir="auto"><strong>France</strong> – Public consultation on draft guidance for AI use in healthcare led by CNIL (open until 16 of April 2026). <strong><a href="https://www.cnil.fr/" rel="nofollow ugc">Link</a></strong></p>
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<p dir="auto"><strong>Germany</strong> – Update on pilot initiative testing AI in real-world regulatory environments (“real-world laboratory”). <strong><a href="https://www.bfdi.bund.de/" rel="nofollow ugc">Link</a></strong></p>
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<p dir="auto"><strong>Ireland</strong> – New national “AI for Care” strategy outlining priorities for AI in healthcare (2026–2030). <strong><a href="https://www.gov.ie/en/department-of-health/publications/ai-for-care-the-artificial-intelligence-ai-strategy-for-healthcare-in-ireland-2026-2030/" rel="nofollow ugc">Link</a></strong></p>
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<p dir="auto"><strong>IMDRF</strong> – Draft technical framework proposes lifecycle management principles for AI-enabled medical devices. <strong><a href="https://www.imdrf.org/sites/default/files/2026-04/IMDRF%20AIML%20WG%20N93%20DRAFT%202026%20-%20Technical%20Framework%20for%20Artificial%20Intelligence%20Life%20Cycle%20Management.pdf" rel="nofollow ugc">Link</a></strong></p>
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<p dir="auto"><strong>Japan PMDA</strong> – PMDA announces the use of generative AI to support its own regulatory operations. <strong><a href="https://www.pmda.go.jp/files/000280170.pdf" rel="nofollow ugc">Link</a></strong></p>
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<p dir="auto"><strong>Kenya</strong> Pharmacy and Poisons Board – New guideline defines the regulatory approach for medical device software in Kenya. <strong><a href="https://web.pharmacyboardkenya.org/download/guideline-on-regulation-of-medical-device-software-in-kenya-mdsw/?wpdmdl=13521&amp;refresh=69e0dffc78f941776345084" rel="nofollow ugc">Link</a></strong></p>
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<p dir="auto"><strong>Netherlands</strong> – New national report examining the use of algorithms and AI. <strong><a href="https://www.rijksoverheid.nl/" rel="nofollow ugc">Link</a></strong></p>
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<p dir="auto"><strong>Poland UODO</strong> – Data protection authority comments on Poland’s draft Act on Artificial Intelligence Systems. <strong><a href="https://uodo.gov.pl/pl/file/7338" rel="nofollow ugc">Link</a></strong></p>
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<p dir="auto"><strong>Singapore</strong> – Updated AI in Healthcare Guidelines (AIHGle 2.0), with practical implementation guidance. <strong><a href="https://www.smartnation.gov.sg/" rel="nofollow ugc">Link</a></strong></p>
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<p dir="auto"><strong>United Kingdom</strong> DSIT – UK Tech Secretary launches Sovereign AI, setting out the government’s direction on domestic AI capability. <strong><a href="https://www.gov.uk/government/speeches/tech-secretary-launches-sovereign-ai" rel="nofollow ugc">Link</a></strong></p>
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<p dir="auto"><strong>United Kingdom</strong> ICO – New regulations adopt a Code of Practice on AI and automated decision-making under the Data Protection Act 2018. <strong><a href="https://www.legislation.gov.uk/uksi/2026/425/pdfs/uksi_20260425_en.pdf" rel="nofollow ugc">Link</a></strong></p>
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<p dir="auto"><strong>United Kingdom</strong> MHRA – MHRA expands its AI Airlock regulatory sandbox with £3.6 million in funding over three years. <strong><a href="https://www.gov.uk/government/news/mhra-expands-ai-airlock-programme-with-a-36-million-funding-boost-over-three-years" rel="nofollow ugc">Link</a></strong></p>
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</ul>
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