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-wideStudy 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-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) · 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) · 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) · SwedenE-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) · SwedenProposed 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-wideNew 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) · GermanyFrench 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 · FranceMHRA guidance on the use of real-world data and real-world evidence in regulatory decision-making for medicines and medical devices.
UK MHRA · UKFederal Council endorses harmonised national contact-tracing system and supporting legal, organisational and technical changes for future pandemics.
Swiss Federal Office of Public Health · SwitzerlandGuidance for adult social care providers on selection and implementation of digital social care records software 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-wideSpanish 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-wideFinal rules amend price transparency requirements for non-grandfathered group and individual health plans, standardizing machine-readable pricing files with new data elements and reporting thresholds.
US Federal Register - HHS Rules · United StatesIndividuals may seek compensation from courts for damages caused by data breaches resulting from GDPR violations; CNIL does not award compensation.
CNIL - Health Data · FranceEDPB adopts guidelines on administrative fines under GDPR and on interplay between Digital Service Act and GDPR.
EDPB (European Data Protection Board) · EU-wideProposed requirements for electronic prior authorization for drugs and extended interoperability standards across Medicare Advantage, Medicaid, CHIP, and QHP issuers.
US Federal Register - CMS Rules · United StatesUpdated guidance on electronic exchange of individual case safety reports in E2B(R3) format via B2B gateway.
Swissmedic · SwitzerlandCross-border exchange of patient summaries and ePrescriptions becomes mandatory for all EU Member States.
European Commission · EU-wideFimea invites stakeholder input on amendments to regulations governing pharmacy online services.
Finland Fimea · FinlandThe European Data Protection Board adopted a statement on smart glasses and published a report on their uses and data protection challenges.
CNIL - Health Data · FranceMHRA sets out data requirements and governance expectations for the UK Health Data Research Service to enable regulatory decision-making.
UK MHRA · UKMHRA invites suppliers to join Risk Ledger and complete security profiles to strengthen supply chain cyber security.
UK MHRA · UKgematik publishes guidance on implementing and using KIM (secure healthcare email) in care facilities, based on pilot experience in Hamburg region.
gematik (German Digital Health) · GermanyGuidance on implementing MSSanté secure messaging across healthcare facilities in France.
ANS - French Digital Health Agency · FranceArticle 5 prohibitions on biometric categorization, social scoring, and emotion recognition in workplace and education settings enter into force.
European Commission · EU-wideUpdated guidance and eligibility tool published to support early information provision for joint clinical assessments under the EU HTA Regulation.
EC Public Health · EU-wideEDPB adopts guidance on privacy and surveillance risks posed by smart glasses, including video recording and evidence administration.
EDPB (European Data Protection Board) · EU-wideDEA finalizes rules preventing illegal distribution of controlled substances via internet, including telehealth prescribing restrictions and identity verification requirements.
US Federal Register - DEA Telehealth Rules · United StatesDEA issues interim rule amending regulations to implement the Ryan Haight Act's provisions preventing illegal distribution of controlled substances via the Internet.
US Federal Register - DEA Telehealth Rules · United StatesEuropean Commission invites input on the second joint action implementing the European Health Data Space framework.
EC Public Health · EU-wideEU action plan announced to strengthen cybersecurity of hospitals and healthcare providers.
EC Digital Health · EU-wideThe privacy code of conduct on mobile health apps aims to promote trust among users and provide a
EC Digital Health · EU-wideEDPB adopts final guidelines on anonymisation, web scraping for generative AI, and personal data processing through blockchain technologies.
EDPB (European Data Protection Board) · EU-wideEU Action Plan addresses risks and opportunities of advanced AI models for cybersecurity, bringing together Member States, industry and EU organisations.
EU AI Act Implementation · EU-wideAmendment to Socialstyrelsen's regulations on mandatory reporting obligations to the Swedish National Patient Register.
Socialstyrelsen - Föreskrifter (SE) · SwedenCMS revises IPPS and LTCH payment rates for FY 2027, updates quality program requirements, and ONC adopts updated health IT standards.
US Federal Register - CMS Rules · United States