Decree 2026-153 establishes compliance-control procedures for digital health services subject to interoperability, security and ethics standards.
ANS - French Digital Health Agency · FranceEstablishes interoperable cross-border identification and authentication mechanism for natural persons, health professionals and healthcare providers for cross-border personal electronic health data exchange.
EUR-Lex Official Journal · EU-wideGuidance on implementing National Commission recommendations to improve safety, clarity and fairness in healthcare AI across the UK.
UK MHRA · UKGovernment response clarifying how it intends to implement the independent National Commission's recommendations on AI regulation in healthcare.
UK MHRA · UKStudy examines AI technologies in healthcare, EU legal frameworks for data reuse in medical AI development, and presents policy recommendations to address implementation challenges.
European Parliament - SANT Subcommittee (Public Health) · EU-wideBriefing on AI use in protein, peptide and nucleic acid design across biopharmaceutical research, industrial biotechnology and vaccine development, with regulatory implications for the EU.
European Parliament - SANT Subcommittee (Public Health) · EU-wideEuropean Commission launches Forum and Stakeholder Community to support implementation of the European Health Data Space (EHDS), inviting patients, healthcare professionals, companies and researchers to participate.
ANS - French Digital Health Agency · FranceThe connection portal for Sweden's national digital health infrastructure now provides improved support for organisations preparing to connect.
E-hälsomyndigheten (Swedish eHealth Agency) · SwedenCommission recommends a future regulatory framework for AI in healthcare, advising government on governance and oversight mechanisms.
UK MHRA · UKgematik explains ePA data protection and security architecture, confirming that only patients and authorised medical personnel can access records through Germany's secure health network.
gematik (German Digital Health) · GermanyResources to help developers use patient-reported outcomes in digital mental health technologies for evidence generation, monitoring and user safety.
UK MHRA · UKTen guiding principles for developing machine learning-based medical devices.
UK MHRA · UKE-hälsomyndigheten publishes a terminology catalogue with standardised terms and quality-assured definitions for health, care and social services.
E-hälsomyndigheten (Swedish eHealth Agency) · SwedenE-hälsomyndigheten updated assessment criteria for e-health specifications eligible for national common specification status.
E-hälsomyndigheten (Swedish eHealth Agency) · SwedenEstablishes minimum metadata elements and characteristics that health data holders must provide for dataset descriptions enabling secondary use of electronic health data under EHDS.
EUR-Lex Official Journal · EU-wideGuidance on device qualification and classification of ambient voice technology-enabled products as medical devices in Great Britain.
UK MHRA · UKNew TI-Messenger specification enables integration into primary healthcare software systems, allowing secure messaging directly within existing practice and pharmacy applications.
gematik (German Digital Health) · GermanyFDA announces draft guidance on premarket submission requirements for robotically-assisted surgical devices.
US Federal Register - FDA Guidance Notices · United StatesGuidance on integration of hospital patient portals with the electronic health record (ePA) and primary systems in downstream care settings, with process and care pathway recommendations.
gematik (German Digital Health) · GermanyMHRA guidance clarifies how medical device law applies to ambient voice technology products in UK health and care settings.
UK MHRA · UKHigh-risk AI systems in medical devices must meet AI Act requirements on risk management, data governance, documentation, logging, transparency and oversight, with penalties up to €15M or 3% of global turnover.
EC AI Act & Regulation · EU-wideGuidance to help manufacturers of digital mental health technologies determine regulatory qualification and appropriate device classification.
UK MHRA · UKFrench Digital Health Agency announces updates to the HDS (Health Data Hosting) reference framework version 2.1 and advises on preparation.
ANS - French Digital Health Agency · FranceThe European Commission's AI Office, national competent authorities, and the European Data Protection Supervisor share enforcement of the AI Act across different AI system categories.
EU AI Act Implementation · EU-wideFrom 2 August 2026, AI Act enforcement begins and transparency rules require AI systems to disclose interaction with users and label AI-generated or altered content.
EU AI Act Implementation · EU-wideGuidance on how to qualify and classify safety wristbands used in telecare services as medical devices and their regulatory classification.
Poland URPL · PolandSwissmedic updated its Q&A and guidance document on mobile technologies.
Swissmedic · SwitzerlandINFARMED publishes guidance clarifying the regulatory framework for digital health solutions including software, mobile applications and AI-based solutions as medical devices.
Portugal INFARMED · PortugalProposed amendments to enable information sharing, regulatory reform, and development of a future medical device licensing regime.
UK MHRA · UKGuidance on how the AI Act's transparency requirements apply to artificial intelligence used in medical devices.
Finland Fimea · FinlandCommission policy to increase AI experts and literacy among workers and the public; Article 4 AI Act obligations on providers and deployers entered into force February 2025, amended July 2026.
EU AI Act Implementation · EU-wideGuidelines for commissioners and procurement teams on adult social care telecare services and alarm receiving centre operations.
UK DHSC · UKGuidelines for commissioners and procurement teams on adult social care telecare services and personal alarm device procurement.
UK DHSC · UKGuidelines for commissioners and procurement teams on telecare services for adult social care, focused on grouped living alarm devices.
UK DHSC · UKGuidance on digital maturity standards for care providers and integration with CQC inspection and rating frameworks.
UK DHSC · UKGuidance for adult social care providers on selection and implementation of digital social care records software systems.
UK DHSC · UKApplications for phase 3 of the AI Airlock regulatory sandbox are now open.
UK MHRA · UKNews announcement 26 March 2026 Frequently Asked Questions on the European Health Data Space 1 min read
European Health Data Space · EU-wideDEA and HHS extend telemedicine flexibilities for controlled-medication prescribing through December 31, 2026.
US Federal Register - DEA Telehealth Rules · United StatesFindings from the National Commission's call for evidence and research activities on AI regulation in healthcare.
UK MHRA · UKUK MHRA National Commission is seeking evidence to shape regulation of AI in healthcare and support an AI-enabled NHS.
UK MHRA · UKMHRA seeks evidence on AI regulation in healthcare to inform the National Commission's recommendations.
UK MHRA · UKSpanish DPA publishes technical guidance on how GDPR principles of accuracy and data minimisation apply to personal data processing incorporating artificial intelligence systems.
AEPD (Spanish Data Protection Agency) · SpainMHRA guidance on how it determines whether a borderline product meets the definition of a medical device and whether device regulations apply.
UK MHRA · UKThe Iberoamerican Network of Data Protection Authorities has approved a reference document establishing enhanced safeguards for processing neurodata outside healthcare contexts.
AEPD (Spanish Data Protection Agency) · SpainVersion 5 of the EC manual on borderline and classification decisions under MDR and IVDR published.
EC Public Health · EU-wideImplementing regulation establishing the governance structure and operational procedures for the European Health Data Space Board.
EUR-Lex Official Journal · EU-wideThe EHDS is the EU's first sector-specific common data space, establishing a framework for health data access and use across member states.
European Health Data Space · EU-wideEHDS Regulation becomes law 20 days after publication in the EU Official Journal.
European Commission · EU-wide