News

MEMBER STATE10 May 2026

Austria goes live on MyHealth@EU with first corridor to Czech Republic

Austria activated its MyHealth@EU services on 25 February 2026, launching both the EU-Rezept cross-border ePrescription and the EU-Patientenkurzakte Patient Summary. Patients opt in via the ELGA portal using ID-Austria authentication; the first cross-border corridor runs to the Czech Republic, with additional Member States to follow during 2026. The EU-Rezept becomes mandatory across all EU Member States from 2029, but Austria reaches operational capability four years early — moving from MyHealth@EU preparation to a live cross-border ePrescription corridor. For practitioners tracking the gap between MyHealth@EU readiness on paper and actual cross-border data flow, Austria has just crossed it.

Source: Austrian Ministry of Social AffairsRead more →
INFRASTRUCTURE10 May 2026

Cyprus and Greece activate bilateral Patient Summary and ePrescription exchange

Cyprus and Greece officially activated bilateral cross-border digital health data exchange on 24 November 2025 under Project HUMAN, an EU-funded Interreg initiative. The system enables exchange of Patient Summary records — allergies, current medication, past illnesses, surgical history — and supports cross-border issuance and dispensing of electronic prescriptions in both directions, with citizens authenticating via Cy Login and consent managed by Cyprus's National eHealth Authority. Greece is now Cyprus's fifth confirmed live bilateral exchange partner, alongside Spain, Croatia, Poland, and Luxembourg. For Greece, this is the first dated public confirmation of operational MyHealth@EU exchange capability — moving the country from "preparing" to "live" on the D2 dimension well ahead of the 2029 mandate.

Source: Interreg EuropeRead more →
COMMISSION10 May 2026

EDPB adopts research data guidelines citing EHDS as legal derogation

The European Data Protection Board adopted Guidelines 1/2026 on the processing of personal data for scientific research purposes on 15 April 2026, with public consultation open until 25 June 2026. The guidelines explicitly cite EHDS Article 53(1)(e) as a valid Article 9(2) derogation under GDPR for secondary use of health data — the first authoritative EDPB-level position connecting GDPR to the EHDS secondary use framework. National Health Data Access Bodies (HDABs) and Secure Processing Environments designing their access permit procedures have until now been working without a formal EDPB-endorsed legal basis. The 25 June consultation deadline matters: comments shape the version that will guide every Member State's secondary use processing once EHDS applies in March 2029.

Source: EDPBRead more →
MEMBER STATE10 May 2026

Finland's amended Secondary Use Act enters force, restructures permit routes

Finland's amendments to the Act on the Secondary Use of Health and Social Data entered into force on 1 May 2026. Applicants seeking data from multiple public data controllers can now choose whether to submit a single permit application centrally to Findata or separate applications to each controller, and clinical research is expressly excluded from the Act's scope. Finland operates the only fully mature Health Data Access Body (HDAB) function in the EU, and these amendments refine its model four years before EHDS secondary use provisions apply in March 2029. The Act will be amended again to implement EHDS Regulation 2025/327 — the changes now show how the most advanced national framework adapts rather than rebuilds.

Source: FindataRead more →
MEMBER STATE10 May 2026

Germany begins financial sanctions for ePA non-compliance

From 1 January 2026, German physicians who do not use software certified for the elektronische Patientenakte (ePA) or who fail to populate it with mandatory data face up to a 2.5% reduction in service billing and a halved TI-Pauschale (telematics infrastructure allowance). The sanctions follow the October 2025 mandatory-use requirement and the January 2025 opt-out launch that created records for nearly all 74 million statutory health insurance members. Hospital sanctions begin on a staggered schedule from April 2026. Germany is now the largest Member State to enforce electronic health record use through financial penalty rather than mandate alone — the strongest signal yet that the patient data infrastructure required for EHDS cross-border exchange in 2029 is being built whether providers want it or not.

Source: ICLGRead more →
FUNDING10 May 2026

HaDEA opens €14.4 million Digital Europe call for EEHRxF deployment

The European Health and Digital Executive Agency (HaDEA) published the DIGITAL-2026-BESTUSE-10-EHDS call on 10 April 2026, with a €14.4 million budget for deploying the European Electronic Health Record Exchange Format (EEHRxF) and digital health services supporting EHDS primary and secondary use. The call opened on 21 April 2026; applications are due by 17:00 Brussels time on 1 October 2026. The award uses a cascading funding model — the winning consortium passes through grants of up to €120,000 to hospitals, clinics, and SMEs. EEHRxF deployment is one of the slowest-moving parts of the EHDS technical stack; consortia that wait until late summer to assemble will not make the October cut-off.

Source: HaDEARead more →
MEMBER STATE10 May 2026

OECD publishes first health system review of Bulgaria, confirms NHIS operational

The Organisation for Economic Co-operation and Development (OECD) published its first comprehensive health system review of Bulgaria on 30 March 2026, with the Bulgarian delegation led by Health Minister Silvi Kirilov presenting to the OECD Health Committee in Paris. The review documents the National Health Information System (NHIS) — a unified electronic health record portal with electronic prescriptions and electronic referrals, built on a 2020 health information portal foundation, covering all healthcare professionals across settings. For Bulgaria's D3 patient access score, this is the first authoritative external confirmation that the infrastructure is operational rather than aspirational. The review also accelerates Bulgaria's OECD accession path, which historically pulls along further investment in EHDS-aligned reforms.

Source: OECDRead more →
MEMBER STATE10 May 2026

Romania commits €100 million from PNRR to PIAS health platform

Romania's Health Minister Alexandru Rogobete announced a €100 million Health Insurance Information Platform (PIAS), funded through the National Recovery and Resilience Plan (PNRR), with first modules due by end of 2025 and full deployment targeted for August 2026. PIAS will integrate patient records, prescriptions, referrals, and medical leave certificates into a single national digital system — Romania's first integrated patient data infrastructure at scale. The €100 million sits within a €400 million PNRR digitalisation envelope and follows the Draft National Health Digitalization Strategy 2026–2030 published in January. For a country that the most recent EU figures placed at the bottom on patient access to electronic health records, PIAS is the first funded build rather than another strategy document — execution against PNRR milestones is now the variable that determines whether Romania reaches the 2029 EHDS primary use window with operational infrastructure.

Source: Romania InsiderRead more →
INFRASTRUCTURE31 Mar 2026

HL7 Europe and IHE-Europe open ballot on two EHDS FHIR Implementation Guides

HL7 Europe and IHE-Europe opened coordinated ballots for two Fast Healthcare Interoperability Resources (FHIR) Implementation Guides built under their EURIDICE collaboration: the Imaging Study Report IG and the EU Health Data API IG. Both define electronic health record (EHR) functionalities meeting the interoperability requirements of the EHDS Regulation (EU) 2025/327, with comments and votes due by 30 April 2026. Both organisations are offering the specifications to the European Commission for reference in EHDS Implementing Acts, positioning them as the technical baseline for interoperability compliance when the regulation applies from March 2027. EHR vendors and national implementation teams should track these ballots closely: the outcome will shape how imaging data exchange and health data API standards are defined across the 27 Member States.

Source: HL7 EuropeRead more →
COMMISSION26 Mar 2026

Commission updates EHDS FAQ to 67 questions on regulation's first anniversary

DG SANTE published version 1.1 of the EHDS Frequently Asked Questions, a 61-page guidance document now covering 67 questions across primary use, secondary use, EHR requirements, HDABs, governance, and international aspects. The update adds six new questions — on EHR product scope, future data access extractions, HDAB appeal procedures, and the EHDS relationship with the Cyber Resilience Act and social security coordination — and expands three existing entries on EHR definitions and territorial scope. This is the first update since the original FAQ was published in March 2025, landing exactly one year after the regulation entered into force. For EHR vendors, the new Q24 clarifies which products fall within the regulation's scope — a definition that determines certification obligations under Chapter III. Member States preparing national implementing measures now have Commission guidance on HDAB appeal procedures and cross-regulation interplay ahead of the March 2027 deadline for implementing acts.

Source: European CommissionRead more →
COMMISSION25 Mar 2026

Commission comitology committee begins work on approximately 20 EHDS implementing acts

The comitology committee responsible for the EHDS implementing acts has started its work. Composed of Member State representatives and chaired by the Commission, the committee must adopt approximately 20 implementing acts covering technical specifications for EHR exchange formats, EHR system requirements, and secure processing environment standards by 26 March 2027. Until these acts are finalised, EHR vendors and health data holders face regulatory uncertainty on the exact technical requirements they must meet. One year to adopt 20 acts is an ambitious timeline — any slippage here delays everything downstream, from the 2029 primary use deadline to the 2031 full operational date.

Source: European CommissionRead more →
MEMBER STATE25 Mar 2026

Netherlands confirms opt-out for primary use and advances HDAB designation

Minister Bruijn sent a parliamentary letter detailing the Netherlands' EHDS implementation plans, confirming the country will introduce an opt-out right for primary use of health data — an optional provision under the regulation that reflects Dutch concerns about balancing medical confidentiality with data availability. Preparations for designating both the Digital Health Authority (Autoriteit Digitale Gezondheid) and the Health Data Access Body are underway, with the HDAB-NL programme now established across four partner organisations: RIVM, CBS, ICTU, and Health-RI. A legislative proposal for national EHDS implementation will go to public consultation in the first half of 2026, with parliamentary submission expected in Q1 2027. This is one of the most detailed national implementation roadmaps published by any Member State, and the four-organisation HDAB consortium signals institutional commitment to secondary use infrastructure that most countries have not yet matched.

Source: ICTrechtRead more →
MEMBER STATE25 Mar 2026

Romania publishes draft national health digitalization strategy for 2026–2030

Romania's Ministry of Health has published its Draft National Health Digitalization Strategy 2026–2030 for public consultation. The strategy targets fragmented health data, limited interoperability between systems, and insufficient digital skills among healthcare professionals, with priorities including electronic health record infrastructure, telemedicine platforms, and workforce digital competencies. For a country that currently lacks the basic infrastructure required for EHDS primary use obligations, this is the first comprehensive attempt to lay the groundwork — but moving from consultation to funded implementation within EHDS timelines will be the real test.

Source: US International Trade AdministrationRead more →
MEMBER STATE24 Mar 2026

Bulgaria mandates centralized electronic health records and launches citizen eHealth app

Bulgaria promulgated amendments to the Public Health Act on 8 October 2024 requiring that all medical activities, regardless of funding source, be recorded in each citizen's centralized electronic health record. The law also introduced an eHealth mobile application allowing citizens to access their records via QR code, with new identification options including electronic health cards and SMS passwords. Bulgaria had one of the weakest patient access frameworks in the EU, with fragmented records across public and private providers. The legislative mandate and mobile access tool represent the country's first concrete steps toward meeting EHDS primary use requirements for patient access under Dimension 3.

Source: SchoenherrRead more →
INFRASTRUCTURE24 Mar 2026

Nine EU4Health projects detail how eight Member States will expand MyHealth@EU services

HaDEA published operational details for nine EU4Health-funded projects extending MyHealth@EU beyond the current Patient Summary and ePrescription baseline. Belgium is establishing its National Contact Point for eHealth for the first time. Denmark and Romania will begin NCPeH implementation in 2026, with Romania targeting medical imaging and laboratory results. Cyprus is strengthening ePrescription services and preparing for lab results and imaging exchange. Finland, Lithuania, and Spain are each adding cross-border laboratory result services — the first moves toward the broader data categories required by the 2031 deadline. Germany is enabling dispensing of foreign ePrescriptions, closing a gap that has limited practical use of the cross-border system for patients visiting German pharmacies.

Source: HaDEARead more →
COMMISSION24 Mar 2026

TEHDAS2 second consultation draws 750 responses across 11 draft secondary use guidelines

The TEHDAS2 joint action closed its second public consultation in November 2025 with over 750 responses across 11 draft documents covering fees, penalties, data access procedures, data protection, secure processing environments, and citizens' rights under EHDS secondary use. Individual documents received between 40 and 99 responses, with representation from 12 to 16 European countries per document. Eastern and Southern European countries were underrepresented in submissions, raising the risk that the final guidance — due in the first half of 2026 — will not reflect the implementation realities of the Member States furthest from readiness. These documents will serve as the de facto operational playbook for Health Data Access Bodies and secure processing environments before the Commission's formal implementing acts arrive.

Source: TEHDASRead more →
MEMBER STATE23 Mar 2026

Greece launches GR-HDAB project to build Health Data Access Body and HealthData@EU connection

Greece's Ministry of Health launched the GR-HDAB project in December 2023 — a 48-month programme to build the full stack of EHDS secondary use infrastructure. Led by GRNET and IDIKA (the e-Government Centre for Social Security), the project will deliver a national Health Data Access Body, a Secure Processing Environment, a National Dataset Catalogue for health data, and a connection to the HealthData@EU cross-border infrastructure.

Source: GRNETRead more →
MEMBER STATE23 Mar 2026

Ireland approves procurement for National Electronic Health Record, commits €263 million to digital health in 2026

Minister for Health Jennifer Carroll MacNeill received Government approval on 5 February 2026 for the HSE to begin vendor shortlisting for a National Electronic Health Record — the largest digital transformation in Irish health service history. The €263 million digital health budget for 2026, up from €190 million in 2025, covers the National EHR, the Children's Health Ireland EHR, a Maternity and Newborn Health Record, and the Community Connect programme.

Source: Irish GovernmentRead more →
INFRASTRUCTURE22 Mar 2026

HaDEA awards €8.2 million to connect Denmark, Belgium, Romania and Slovakia to MyHealth@EU

The European Health and Digital Executive Agency (HaDEA) announced nine new EU4Health-funded projects totalling €8.22 million to expand the MyHealth@EU cross-border health data infrastructure. Denmark will build its National Contact Point for eHealth from scratch under the EHDSIDenmark project, implementing Patient Summary and ePrescription services. Belgium, Romania, and Slovakia each received funding to establish or extend their own National Contact Points for cross-border health data exchange.

Source: HaDEARead more →
MEMBER STATE22 Mar 2026

Hungary opens national eHealth infrastructure to AI developers under new data access rules

Hungary's amended health data law (Act XXIX of 2024) took effect on 1 January 2026, allowing the operator of the national eHealth infrastructure (EESZT) to grant researchers and medical technology companies access to stored health data for AI algorithm training, testing, and development, as well as for medical device evaluation. Applicants must obtain ethics committee authorisation from the Medical Research Council and process only anonymised data, with pseudonymised data permitted only where anonymisation is demonstrably insufficient.

Source: Baker McKenzieRead more →