European Health Data Space (EHDS) for developers
Regulation (EU) 2025/327 for software teams: the 2029 and 2031 dates, EHR system components, wellness app labelling, the FHIR exchange format and what to build now.
The European Health Data Space is an EU regulation — Regulation (EU) 2025/327, in force since 26 March 2025 — that gives people in the EU the right to access and share their electronic health data, sets common formats for exchanging it across borders, and puts requirements on software that stores and exchanges health records. Most obligations apply from March 2029 and March 2031, which is about one product generation away. For developers it means: a common European exchange format built on HL7 FHIR, mandatory interoperability and access logging in EHR systems, labelling for wellness apps that claim to work with them, and new rules for reusing health data for research. This page summarises what is decided, what is still being specified, and what to build now.
Timeline
According to the European Commission:
| Date | What applies |
|---|---|
| 26 March 2025 | The regulation enters into force; transition begins |
| March 2027 | Deadline for key implementing acts from the Commission (technical specifications) |
| March 2029 | Exchange of the first priority categories — patient summaries and ePrescriptions / eDispensations — in all Member States; secondary-use rules start for most data categories |
| March 2031 | Exchange of the second group — medical images, laboratory results and hospital discharge reports; secondary-use rules for the remaining categories (such as genomic data) |
| March 2035 | Third countries and international organisations can apply to join HealthData@EU for secondary use |
The two halves
Primary use — care. People get electronic access to their own priority data, can share it with health professionals in another Member State through national contact points (MyHealth@EU), can add information, restrict access, and see information about who accessed their data. Health professionals get access to the data they need for care.
Secondary use — research, innovation, policy. Researchers and companies can apply to health data access bodies for access to health data for permitted purposes, processed in secure environments, under rules on what may and may not be done with it.
What changes for software
EHR systems. The regulation sets a legal and technical framework for software that stores and shares electronic health records. Manufacturers must show conformity with essential requirements, including two harmonised software components — a European interoperability component for exchanging data in the European format and a European logging component that records access to data. Common specifications for these come through implementing acts.
Wellness applications. Apps that claim to be interoperable with EHR systems — fitness trackers and health apps that send data into them — fall under labelling and information requirements (Articles 47 and 48 of the regulation).
Medical devices and AI systems that claim interoperability with EHR systems must meet the relevant essential requirements on interoperability as well.
The details — exact data sets, profiles and conformity procedures — are being specified in implementing acts and supporting standards. Read the regulation on EUR-Lex and follow the implementing acts rather than relying on summaries, including this one.
The exchange format: FHIR
The European electronic health record exchange format is being specified around HL7 FHIR, with HL7 Europe implementation guides for the priority categories:
- Patient Summary, based on the International Patient Summary (IPS).
- Laboratory Report, Hospital Discharge Report and Imaging Report.
- An EU Health Data API guide (in ballot at the time of writing) for how systems expose those documents through FHIR APIs.
If your data is already structured as FHIR R4 with standard code systems (LOINC for results, SNOMED CT and ICD-10 for problems, ATC for medicines, UCUM for units), mapping to the European profiles is a matter of constraints rather than a rewrite. If it lives in custom tables, the gap is larger.
What to build now
- Store clinical data as FHIR R4 (or keep a reliable mapping to it), with standard codes and units.
- Be able to produce an International Patient Summary for a person on request.
- Keep laboratory results structured: LOINC code, UCUM unit, reference range, status, times and the issuing laboratory — what the European laboratory profile asks for.
- Log every access to a person's data, with who, when and what, and make it visible to the person.
- Model consent and restrictions per person, so access can be limited by the person rather than only by your roles.
- Host in the EU and document your GDPR basis; EHDS builds on GDPR, it does not replace it.
Where Anpheros fits
Anpheros is EU-hosted health data infrastructure built on FHIR R4, and several of the capabilities above are already part of it: Patient/{id}/$summary returns an International Patient Summary following the HL7 IPS implementation guide; laboratory Observations can be checked against a European laboratory profile ($validate?profile=eu-lab, also in the free FHIR R4 validator); every read and write is logged and visible to the patient; and access by other applications requires the patient's consent, which they can revoke.
That does not make Anpheros, or an application built on it, an EHDS-certified EHR system. Anpheros does not connect to national contact points or MyHealth@EU, does not implement the harmonised components as they will be specified, and is not a health data access body. Treat it as a head start on data structure, summaries, logging and consent, not as compliance.
Frequently asked questions
When does the EHDS apply?
It entered into force on 26 March 2025. Most obligations start in March 2029 (patient summaries, ePrescriptions and most secondary-use rules) and March 2031 (images, lab results, discharge reports and the remaining secondary-use categories).
Does the EHDS require FHIR?
The regulation requires a European electronic health record exchange format, specified in implementing acts; the work on that format and its implementation guides is built on HL7 FHIR, starting from the International Patient Summary.
Does the EHDS apply to health and fitness apps?
Wellness apps that claim interoperability with EHR systems are subject to labelling and information requirements. Apps that are medical devices remain under the medical device rules and must also meet the interoperability requirements when they claim to work with EHR systems.
What is the European logging component?
One of the two harmonised software components EHR systems must include: it records access to personal electronic health data, supporting people's right to see who accessed their data.
Is Anpheros EHDS compliant?
Anpheros is not a certified EHR system. It already provides FHIR R4 storage, International Patient Summaries, European laboratory profile checks, per-patient access logs and consent, which are building blocks for the requirements.