Public consultation on the draft Commission Implementing Regulation EFMI_Feedback_HealthDataEU_IR_2026-09-29 on HealthData@EU
On 29 September 2026, EFMI submitted feedback to the European Commission’s public consultation on the draft Implementing Regulation on HealthData@EU, which will underpin the secondary use of health data under the European Health Data Space (EHDS).
EFMI, founded in 1976, is the federation of national health and medical informatics societies of more than 30 European countries and of institutional members (hospitals, research institutes and universities), and the European regional council of IMIA. Our members will design, operate and evaluate the national contact points, health data access bodies, secure processing environments and research infrastructures that will form HealthData@EU. We welcome the draft and offer six constructive suggestions.
- Federated by design, as a development principle. We recognise that in its first years HealthData@EU will mainly interconnect dataset catalogues and route data access applications between health data access bodies (Art. 4). We ask that the technical documentation (Art. 5) and the annual work plan (Art. 8) state, as a longer-term development goal, the capability to support federated and distributed analysis across secure processing environments, so that data can remain local while cross-border studies stay feasible: common interfaces for remote execution of analysis, harmonised output control and provenance of results.
- Open standards and public specifications. We ask for a clear commitment to open international standards and public, versioned specifications that support interoperable health data throughout its lifecycle, in primary and secondary use. Metadata and catalogue specifications should make the whole clinical record visible, including nursing and allied-health data, so that the WHO Family of International Classifications (such as ICD) and nursing terminologies (such as ICNP) are represented alongside other established terminologies.
- Open, consultative governance. The steering group (Art. 6-8) should publish the technical documentation and the annual work plan well in advance and commit to consultation and dialogue, before major releases, with scientific and professional societies, with data holders such as hospitals and research institutes, and with other stakeholders.
- Proportionate conditions for research infrastructures and data holders. Criteria and compliance checks for authorised participants, in particular Union research infrastructures (Art. 9-16), should be clear, proportionate and timely, recognise existing certifications and audits, and avoid becoming a barrier to academic research. The same proportionality should reach the hospitals and research institutes that, as data holders, will ultimately supply the data.
- Secure processing environments fit for science. The environments foreseen in Art. 21-23 need harmonised output-checking rules with predictable turnaround, support for reproducibility (code, software versions, provenance) and interoperable analytical tooling for researchers.
- Skills and evaluation. The minimum criteria (Art. 9) should foresee competence requirements and training for the staff of connected entities, and the monitoring of HealthData@EU (Art. 6) should be public and rest on simple indicators, for instance time to permit, number of cross-border studies completed and output-checking turnaround.
EFMI offers the steering group its expertise in education, professional accreditation and the evaluation of health information systems, and evidence from its members on national EHDS implementation. We will continue this dialogue at Medical Informatics Europe 2027 (Tallinn), and we stand ready to take part in the consultations foreseen under this Regulation.
On behalf of the EFMI Board,
Lars Lindsköld
President, European Federation for Medical Informatics
Contact: board@efmi.org