Health policy and regulation from official public bodies across the EU, UK, Switzerland, Norway and the US.
Final rule removes and revises health IT certification criteria and regulatory provisions to reduce burden and support innovation.
US Federal Register - HHS Rules · United StatesSwedish eHealth Agency submits consultation response on government proposal for national health data infrastructure regulation.
E-hälsomyndigheten (Swedish eHealth Agency) · Swedengematik opens public consultation on standardised rules for interoperable health data exchange across healthcare software systems.
gematik (German Digital Health) · GermanyFrench Digital Health Agency invites stakeholders to contribute to European Health Data Space implementation work.
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) · Swedengematik 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) · GermanyThe Swedish Government proposes new legislation requiring healthcare providers and regions to submit data to E-hälsomyndigheten; stakeholder consultation now open.
E-hälsomyndigheten (Swedish eHealth Agency) · SwedenStudy 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-wideE-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-wideFrench 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 · FranceCitizens 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) · SwedenGuidance for adult social care providers on optimising use of digital social care records systems.
UK DHSC · UKNews announcement 26 March 2026 Frequently Asked Questions on the European Health Data Space 1 min read
European Health Data Space · EU-wideProposed 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 StatesNew TI-Messenger specification enables integration into primary healthcare software systems, allowing secure messaging directly within existing practice and pharmacy applications.
gematik (German Digital Health) · GermanyGuidance 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) · GermanySpanish 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) · SpainThe 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) · SpainFDA announces final ICH guidance on harmonized digital clinical trial protocol standards, templates, and technical specifications for international regulatory exchange.
US Federal Register - FDA Guidance Notices · United StatesImplementing 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-wideEHDS infrastructure operational for patient care data exchange and research access; providers and EHR manufacturers must comply with interoperability requirements; fines up to €20M or 4% of turnover.
European Health Data Space · EU-wideExplains what session replay tools are, how they work, and what rights individuals have when their online activity is recorded.
CNIL - Health Data · FranceJoint guidance on secure data processing environments from a data protection perspective, developed by Spanish and Greek data protection authorities with international expert collaboration.
AEPD (Spanish Data Protection Agency) · SpainSpanish data protection authority publishes guidance on safely using AI assistants and agents, recommending users control what information is shared and limit agent autonomy.
AEPD (Spanish Data Protection Agency) · Spain