Device, software, AI, health-data and reimbursement rules from 77 official sources across the EU, UK, Switzerland and the US. Updated daily.
gematik 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) · GermanyE-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) · SwedenVersion 2.1 of the health data hosting certification framework, published October 2026, strengthens transparency requirements on third-country data transfers and foreign legislation submission.
ANS - French Digital Health Agency · FranceSpanish 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) · SpainThe 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-wideMHRA sets out data requirements and governance expectations for the UK Health Data Research Service to enable regulatory decision-making.
UK MHRA · UKNews announcement 26 March 2026 Frequently Asked Questions on the European Health Data Space 1 min read
European Health Data Space · EU-wideOfficial publication of the decree establishing the Ségur du numérique en santé programme for paramedical professionals and midwives, setting the regulatory framework for software interoperability and secure health data exchange.
ANS - French Digital Health Agency · Francegematik publishes guidance on implementing and using KIM (secure healthcare email) in care facilities, based on pilot experience in Hamburg region.
gematik (German Digital Health) · GermanyFDA 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-wideEHDS Regulation becomes law 20 days after publication in the EU Official Journal.
European Commission · EU-wideUpdated HDS certification standards for health data hosting providers are now mandatory; ANS enforcement penalties are operational.
ANS - French Digital Health Agency · FranceMyHealth@EU infrastructure for primary use becomes mandatory; cross-border Patient Summaries and ePrescriptions/eDispensations exchange required; full EHR vendor compliance deadline March 2029.
European Health Data Space · 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-wideUpdated guidance and eligibility tool published to support early information provision for joint clinical assessments under the EU HTA Regulation.
EC Public Health · 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 · SwitzerlandEDPB 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) · SwedenEuropean Commission invites input on the second joint action implementing the European Health Data Space framework.
EC Public Health · EU-wideCross-border exchange of patient summaries and ePrescriptions becomes mandatory for all EU Member States.
European Commission · EU-wideMHRA invites suppliers to join Risk Ledger and complete security profiles to strengthen supply chain cyber security.
UK MHRA · UKGuidance on implementing MSSanté secure messaging across healthcare facilities in France.
ANS - French Digital Health Agency · FranceThe privacy code of conduct on mobile health apps aims to promote trust among users and provide a
EC Digital Health · EU-wideArticle 5 prohibitions on biometric categorization, social scoring, and emotion recognition in workplace and education settings enter into force.
European Commission · EU-wideEDPB adopts guidelines on GDPR compliance for personal data processing via blockchain, addressing privacy protection in distributed ledger environments.
AEPD (Spanish Data Protection Agency) · Spain