Health policy and regulation from official public bodies across the EU, UK, Switzerland, Norway and the US.
Decree 2026-153 establishes compliance-control procedures for digital health services subject to interoperability, security and ethics standards.
ANS - French Digital Health Agency · FranceMHRA guidance on the registration process and requirements for medical devices in Great Britain and Northern Ireland.
UK MHRA · UKGuidance 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-widegematik opens public consultation on standardised rules for interoperable health data exchange across healthcare software systems.
gematik (German Digital Health) · GermanyBriefing 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 · 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-wideThe 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) · GermanyCitizens must be able to obtain prescribed medicines during prolonged crises or heightened alert; e-prescription and dispensing systems must function during disruptions.
E-hälsomyndigheten (Swedish eHealth Agency) · SwedenResources 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) · SwedenGuidance on how to notify the MHRA of intention to carry out a clinical investigation for medical devices.
UK MHRA · UKProposed amendments to CLIA regulations to permit virtual access for laboratory testing data, digital images for cytology proficiency testing, and updated personnel and reporting requirements.
US Federal Register - CMS Rules · United StatesEstablishes 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-wideRevised guidance on IVDR classification rules for in vitro diagnostic devices published.
EC Public Health · EU-widePublication of MDCG guidance on the allocation of unique device identification (UDI) responsibilities between manufacturers and distributors.
Czechia SUKL · Czech RepublicGuidance on device qualification and classification of ambient voice technology-enabled products as medical devices in Great Britain.
UK MHRA · UKFDA guidance on regulatory application of drug labeling authorities to software outputs disseminated by or on behalf of drug sponsors for use with prescription drugs.
US Federal Register - FDA Guidance Notices · United StatesNewNew 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 · UK