Device, software, AI, health-data and reimbursement rules from 75 official public sources across the EU, UK, Switzerland and the US — all of it stored and classified, so you can filter to what binds you. Translated to English. Updated daily.
Official 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 · FranceVersion 2.1 of the health data hosting (HDS) certification framework, published October 2026, strengthens transparency requirements on third-country data transfers and foreign legislation submission; compliance required three months after publication.
ANS - French Digital Health Agency · FranceHMA and EMA invite stakeholders to a forum on artificial intelligence and data governance in medicines regulation.
Slovenia JAZMP · SloveniaSpanish data protection authority examines how data quality, accuracy and minimisation principles apply to personal data processing by AI systems.
AEPD (Spanish Data Protection Agency) · Spaingematik publishes practical guidance for care facilities on implementing and using KIM, the secure health-sector email service within Germany's Telematikinfrastruktur.
gematik (German Digital Health) · GermanyEHDS Regulation becomes binding law 20 days after publication in the EU Official Journal.
European Commission · EU-wideCMS proposes electronic prior authorization requirements and interoperability standards for drug authorizations across Medicare Advantage, Medicaid, CHIP, and exchange QHP issuers.
US Federal Register - CMS Rules · United StatesCross-border exchange of patient summaries and ePrescriptions becomes mandatory for all EU Member States.
European Commission · EU-wideUpdated HDS certification standards now mandatory for all health data hosting providers serving French market; ANS enforcement penalties operational.
ANS - French Digital Health Agency · FranceEU Regulation 2025/327 establishes the European Health Data Space framework; supporting guidelines cover patient summaries, laboratory results, medical imaging, e-prescription and cross-border health data exchange.
European Health Data Space · EU-wideHealthcare providers and EHR manufacturers must implement EHDS infrastructure for patient data exchange and research access, with 3-month response deadlines and fines up to €20M or 4% of turnover.
European Health Data Space · EU-wideCross-border exchange of Patient Summaries and ePrescriptions/eDispensations becomes mandatory; healthcare providers must enable electronic health data access; full EHR compliance required by March 2029.
European Health Data Space · 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-wideANS publishes guidance to help health facilities implement and scale secure messaging (MSSanté) across their operations.
ANS - French Digital Health Agency · FranceANS invites public input on a new module of the Pro Santé Connect standard addressing authentication delegation mechanisms.
ANS - French Digital Health Agency · FranceCMS revises Medicare IPPS and LTCH payment rates for FY 2027, updates quality program requirements, and ONC adopts updated health IT standards and specifications.
US Federal Register - CMS Rules · United StatesSwissmedic updates guidance on electronic exchange of individual case safety reports in E2B(R3) format via B2B gateway, effective 01.08.2026.
Swissmedic · SwitzerlandCMS and CDC seek public input on updating CLIA regulations covering breath testing, laboratory processes, emergency preparedness, biosafety, biosecurity, and cybersecurity.
US Federal Register - CMS Rules · United StatesGuidance clarifying implementation and compliance questions on the European Health Data Space regulation.
European Health Data Space · EU-wideANS invites participation in consultation on data transfer specifications for computerised user files and a new version of the FHIR implementation guide.
ANS - French Digital Health Agency · FranceEC invites public input on TEHDAS2, the second joint action implementing the European Health Data Space framework.
EC Public Health · EU-wideThe European Health Data Space is a cornerstone of the European Health Union and the first common EU data space dedicated to a specific sector.
European Health Data Space · EU-wideCode of conduct establishing privacy standards for mobile health apps to build user trust and confidence.
EC Digital Health · EU-wideThe 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) · SpainEU Commission seeks stakeholder input on simplifying AI Act, data and cybersecurity rules through a Digital Omnibus legislative package.
EU AI Act Implementation · EU-wideThe European Data Protection Board has approved guidelines on the processing of personal data through blockchain technology.
AEPD (Spanish Data Protection Agency) · SpainMHRA sets out data requirements and expectations for the UK Health Data Research Service to support regulatory decisions.
UK MHRA · UKAmendment to Swedish regulations on mandatory reporting obligations to Socialstyrelsen's patient register.
Socialstyrelsen - Föreskrifter (SE) · SwedenMember State Coordination Group on HTA adopts guiding principles on data transparency for health technology assessment.
EC Public Health · EU-wideEDPB and European Commission invite stakeholder input on joint guidelines addressing the intersection of data protection and competition law.
EDPB (European Data Protection Board) · EU-wide