Health data is among the most sensitive categories of personal data and is subject to layered regulation. In Europe the General Data Protection Regulation treats health data as a special category with strict conditions for processing, while the European Health Data Space establishes rules for both the primary use of health data in care and its secondary use in research and policy-making. This page collects the updates HealthSignal tracks on the EHDS, GDPR guidance for healthcare, interoperability, and national data protection developments, from official public bodies.
Version 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 · FranceLeer más
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 StatesOfficial 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 · FranceThe 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-wideUpdated guidance on electronic exchange of individual case safety reports in E2B(R3) format via B2B gateway.
Swissmedic · SwitzerlandMHRA 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-wideCross-border exchange of patient summaries and ePrescriptions becomes mandatory for all EU Member States.
European Commission · EU-widegematik 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 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-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 StatesEDPB 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-wideCMS 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 StatesMHRA invites suppliers to join Risk Ledger and complete security profiles to strengthen supply chain cyber security.
UK MHRA · UKEU action plan announced to strengthen cybersecurity of hospitals and healthcare providers.
EC Digital Health · EU-wideCMS 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 StatesThe privacy code of conduct on mobile health apps aims to promote trust among users and provide a
EC Digital Health · EU-wideANS invites input on a new authentication-delegation module for the Pro Santé Connect digital health infrastructure standard.
ANS - French Digital Health Agency · FranceThe EDPB has approved guidelines on the processing of personal data through blockchain technology.
AEPD (Spanish Data Protection Agency) · SpainCommission seeks stakeholder input on simplifying EU rules governing data, cybersecurity and AI in a forthcoming Digital Omnibus legislative package.
EU AI Act Implementation · 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 StatesJoint informative circular on the mandatory use of legally valid medical prescriptions for dispensing prescription medicines.
Portugal INFARMED · PortugalFrench Digital Health Agency invites input on CI-SIS guidance for data transfer and computerised patient records using updated FHIR standards.
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AEPD (Spanish Data Protection Agency) · SpainGuidance on clinical trial record retention and archiving requirements covering ownership, data integrity, and transitional provisions.
UK MHRA · UKNICE invites input on adopting a new EQ-5D-5L value set to improve health-related quality-of-life assessments in treatment evaluation.
UK NICE · UKHMA and EMA convene a multi-stakeholder forum on AI and data to build trustworthy AI on solid data foundations.
Slovenia JAZMP · SloveniaThe eHealth Digital Service Infrastructure (eHDSI) is an infrastructure ensuring the continuity of care for European citizens while they are travelling abroad in the EU. This gives EU countries the possibility to exch...
MyHealth@EU Cross-Border Services · EU-wideePA apps are receiving updates enabling push notifications for patient activity, allowing users to control alerts about record access and document uploads.
gematik (German Digital Health) · GermanyShareholders mandate gematik to create a roadmap for consolidating and unifying the operation of core Telematic Infrastructure components.
gematik (German Digital Health) · GermanyOver 300 representatives from manufacturers, providers and partner organisations met at the TI-Forum 2026 to discuss operation, security and future development of Germany's Telematic Infrastructure.
gematik (German Digital Health) · GermanyMHRA's Improving Patient Information project aims to modernise how medicines product information is delivered, making it more accessible, trusted, and future-ready.
UK MHRA · UKStakeholder dialogue on EHDS implementation challenges and measures to facilitate compliance and foster innovation.
European Health Data Space · EU-wideActualité
ANS - French Digital Health Agency · FranceFrench Digital Health Agency publishes the framework for the Vital Card App, advancing digital health identity infrastructure.
ANS - French Digital Health Agency · FranceActualités
ANS - French Digital Health Agency · FranceThe pilot phase of DUI-ViaTrajectoire interoperability integration concludes, enabling broader deployment across the French health system.
ANS - French Digital Health Agency · FranceFrequently Asked Questions on the European Health Data Space Study on the deployment of AI in healthcare - Publications Office of the EUrep Factsheet - European Health Data Space Factsheet - Cybersecurity of hospitals...
European Health Data Space · EU-wide