European Health Data Space HealthData@EU requirements

Siemens Healthineers welcomes the opportunity to comment on the technical requirements under the European Health Data Space Regulation and supports the objective of a harmonized, interoperable framework for the primary and secondary use of electronic health data across the Union. Our detailed comments are set out in the attached position paper.

We welcome the draft in principle, in particular the clear functional separation between the central platforms technical routing functions and substantive access decisions by the competent bodies, as well as the proportionate, graduated system of corrective measures, temporary disconnection and, where applicable, definitive exclusion. However, we recommend clarification and revision in several areas: 1.

PHDS.pl (Polish Health Data Space) is an independent EHDS knowledge platform in Poland. We support the federated architecture, which allows Member States to build on existing national infrastructures, and the broad understanding of interoperability in Article 5(3).

Dr.Max feedback on the draft Commission Implementing Regulation on HealthData@EU Ares(2026)8339104 Dr.Max operates retail pharmacies in multiple EU Member States and supports the objectives of the European Health Data Space and HealthData@EU.

GSK supports a risk-based and proportionate implementation of HealthData@EU that enables trusted secondary use of health data for research, innovation and public health purposes while maintaining high standards of privacy, security and accountability.

MyData-TRUST, a Belgian consultancy providing data protection services to the life sciences sector, welcomes the draft Implementing Regulation on HealthData@EU as a sound basis for secure, interoperable cross-border secondary use of health data. The separation between the platform's purely technical role and the substantive decisions of health data access bodies (Art. 4(2)) should be preserved.

The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) welcomes the draft Commission Implementing Regulation setting out the technical requirements, interoperability, and operational framework for HealthData@EU under Regulation (EU) 2025/327.

Feedback from the European Federation for Medical Informatics (EFMI) on the draft Commission Implementing Regulation on HealthData@EU (Ares(2026)8339104) 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.

The ENFIELD EU Project welcomes the development of technical requirements for HealthData@EU and recommends that they explicitly support the trustworthy secondary use of health data for AI development, validation and monitoring.

Sanofi welcomes the EHDS and its potential to drive health innovation in Europe while urging implementation clarity, protections, and lead times needed for genuine research value. The following is our feedback on the draft HealthData@EU implementing regulation: Connected Entities (Articles 2(b) & 5) Publish implementation timelines well in advance given varying digital maturity of entities.

On behalf of Health-RI, we welcome the opportunity to contribute to the public consultation on the draft implementing act concerning HealthData@EU under Article 75 of the European Health Data Space (EHDS) Regulation.

Opening of the attached position paper · the full paper is on the Commission’s record (source link above)

The European Society for Medical Oncology (ESMO), representing over 50,000 members globally, welcomes the publication of the draft Implementing Act setting out the technical and functional framework for the HealthData@EU infrastructure under the European Health Data Space (EHDS) as well as the specifications of the IT tool for enforcement transparency.

The Malta Sociological Association (MSA) notes the development of technical requirements for HealthData@EU and recognises the potential value of secure health data for research, evidence-informed policymaking and improved health systems. Given the sensitivity of health data, implementation should place public trust, privacy, transparency and accountability at its centre.

Timeline to Release Technical Documentation Article 5.4 states that specifications will be released "sufficiently in advance of the start of those checks to enable the entities concerned to prepare their system and connection." Given the overall deadline to start exchanging data in early 2029, providing specifications much later than the finalised implementing acts will already put some vendors and Member States at…

MedTech Europe welcomes the opportunity to respond to the public consultation on the draft Commission Implementing Act on HealthData@EU, adopted pursuant to the European Health Data Space (EHDS) Regulation. We support the Commissions objective of establishing a secure, interoperable and trustworthy cross-border infrastructure for the secondary use of electronic health data.

The attachment contains Nictizs consolidated comments on the draft implementing act concerning HealthData@EU under Article 75 of the European Health Data Space Regulation. The comments focus on clear governance, reliable operation of the central platform, proportionate compliance checks, incident and disconnection procedures, and the allocation of responsibilities.

Ballot on the Draft HealthData@EU Implementing Regulation by ChipSoft (Netherlands) Balloters: Olav Trauschke, Roel Barelds Overall Assessment The draft generally falls within the mandate provided by Articles 63(7) and 75(12) of the EHDS Regulation and is broadly consistent with related EU legislation, including the GDPR, Regulation (EU) 2018/1725, NIS2, and the Interoperable Europe Act.

Opening of the attached position paper · the full paper is on the Commission’s record (source link above)

The professional association of German pathologists (BDP) represents the professional policy interests of pathologists, including neurologists, in surgeries, institutes, hospitals and university hospitals. In addition to purely textual findings, pathologists generate other comprehensive data. This includes, in particular, large-scale images (whole-slide images) and molecular pathological data.

Filed in German · English published by the European Commission

Findata supports the establishment of HealthData@EU as a centrally coordinated infrastructure combining the Commission-operated central platform with systems and components operated by connected entities. The Compliance Check Framework will be essential for translating the Regulation and the applicable technical documentation into transparent assessment criteria, evidence requirements and testing methods.

SNOMED International welcomes the draft European Commission Implementing Regulation on HealthData@EU and the explicit recognition of semantic interoperability as a design principle for the cross-border secondary-use infrastructure.

Bundesverband Gesundheits-IT – bvitg e. V. Bvitg Position on European Health Data Space – technical requirements for HealthData@EU Kontakt [name removed] [email removed] Bundesverband Gesundheits-IT – bvitg e. V. Aspect 1: Further clarification Art.

Opening of the attached position paper · the full paper is on the Commission’s record (source link above)

The European Association of E-Pharmacies (EAEP), which represents the e-pharmacy sector on the European continent, welcomes the opportunity to provide its feedback on the technical requirements for the HealthData@EU infrastructure. The EAEP feedback is attached.

Fresenius welcomes the proposed Implementing Regulation for HealthData@EU. It provides the technical framework for secure cross-border access to health data for secondary use and sets up a tool for cooperation between health data access bodies. If designed well, the system can support better public health decisions, stronger patient safety and more reliable regulatory evidence.

The European Genome-phenome Archive (EGA) team at the Centre for Genomic Regulation (CRG) acknowledges the publication of the draft Commission Implementing Regulation on HealthData@EU and welcomes several areas of strong alignment between the proposed framework and the ongoing development of Federated EGA (FEGA) in Europe, as well as EGAs broader contribution to the future implementation of the European Health Data…

Doing research in public health, and looking at different diseases (i.e. diabetes type 1 or 2, or different diabetes sub-categories such as LADA) or different capabilities of citizens to improve and apply their digital health literacy skills are just some of the intriguing topics, where secondary use of health data across the EU would be important to analyse.

THL welcomes the objective of enabling health data applicants to submit a single application through HealthData@EU. This is particularly important where datasets are discoverable through the catalogue of an authorised participant but are held, maintained or governed by health data holders established in one or more Member States.

Founded in 2016, The Guild comprises twenty-three of Europes most distinguished research-intensive universities in seventeen countries, and is dedicated to enhancing the voice of academic institutions, their researchers and their students.

It will be very brave for the individual member states to agree with this implementation act. While the draft text establishes a structured framework for digital health integration, a critical review against broader legal, administrative, and stakeholder evidence reveals severe systemic vulnerabilities.

In Japan, the Next Generation Medical Infrastructure Act enables medical information to be used for research and development and other purposes in the medical field through databases held by certified operators under the Act. Under this existing legal framework, foreign entities are, in principle, also permitted to use medical information.

PHOENIX group supports the objective of enabling secure, interoperable access to electronic health data for legitimate secondary-use purposes. However, the Delegated Regulation should provide greater legal and operational clarity on who may become an authorized participant and which uses of accessed data are permitted, particularly where commercial actors or intermediaries may derive value from data contributed by…

page 2: HD@EU supports routing and submission of applications, so no complete DAAMS system including dossier, history, messaging with other stakeholders, etc. -> if this is not part of the CP, how does an applicant access his history? by accessing every individual national DAAMS? how are case numbers synchronised?

AINDO welcomes the proposed framework for HealthData@EU and supports the development of a secure, coherent and interoperable European infrastructure for the secondary use of health data. AINDO considers it particularly important that the technical specifications and information exchanges developed under HealthData@EU remain coherent with the wider EHDS framework, including secure processing environments, output…

AESGP welcomes the proposed technical framework for HealthData@EU and would like to highlight three aspects that are critical for the long-term value, interoperability and scientific utility of the European Health Data Space. 1. Future-proof metadata standards and capture of OTC medicines Metadata requirements should be designed to support future use cases and evolving research needs.

This feed back is porvided in the name of the COMFORTage 38 partners in 12 EU countries with representatives from cminical sites, research and academic centers, industry and public competence centers. We reproduce here the main headlines but the attached document provides many additional comments and recommendations for the drafting of the technical documentation.

The European Society of Anaesthesiology and Intensive Care (ESAIC) welcomes the draft Implementing Regulation on HealthData@EU and the rollout of a unified infrastructure for secondary health data use across the European Health Data Space.

Submitter: Vivli Europe Reply to HealthData@EU Public Consultation 28.09.2026 Vivli Europe welcomes the European Commissions draft Implementing Regulation on HealthData@EU and commends the substantial progress being made towards establishing a common European infrastructure for the secondary use of health data.

(2/2) Third, Articles 17-23 should translate data minimisation, purpose limitation, confidentiality and security into concrete technical safeguards. Personal data and metadata processed by the central platform should be limited to what is strictly necessary; access should be traceable and subject to clear authorisation, and technical design must not enable re-profiling, excessive access requests or the treatment of…

(1/2) PGEU welcomes the objective of establishing a secure, interoperable and trustworthy HealthData@EU infrastructure for the secondary use of electronic health data. The technical framework should, however, operationalise the highest standards of data protection, confidentiality and professional ethics, while avoiding unnecessary burdens on healthcare professionals and community pharmacies.

Stichting ZorgTTP welcomes the draft Implementing Regulation on HealthData@EU and supports the objective of creating a secure, interoperable and trustworthy infrastructure for the secondary use of health data across Europe. The draft provides valuable clarity regarding governance, compliance, security and operational responsibilities within HealthData@EU.

In Germany, statutory health insurance funds and the National Association of Statutory Health Insurance Funds (GKV-Spitzenverband) have a central role in providing administrative healthcare and claims data. As custodians of claims and administrative healthcare data for around 75 million insured people, the health insurance funds fall within the EHDS definition of health data holders.

The EAU welcomes the opportunity to respond to the public consultation on the implementing Decision on the technical and functional framework for the HealthData@EU infrastructure, which will enable secure and interoperable cross-border access to electronic health data for secondary use.

The Finnish Social Insurance Institution (Kela) is responsible for the practical development and maintenance of the so-called Kanta Services in Finland. The Kanta Services are a set of digital services that store citizens' social welfare and health care data and they are a nationwide solution that cover all of Finland.

The European Health Data Space (EHDS) is a key initiative for enabling a secure ecosystem for secondary use of health data across the European Union. DICA and IKNL are actively preparing for the implementation of the EHDS by assessing its organisational, legal, technical, and data governance readiness.

Contribution from the European Brain Data Hub (EBDH) Roland Pochet, Chair The European Brain Data Hub (EBDH) welcomes the launch of HealthData@EU and the aim of creating a secure and interoperable European infrastructure enabling the secondary use of electronic health data for research, innovation and the public good.

Filed in French · English published by the European Commission

DATAspaceHealth (dataspacehealth.eu) is an SME operating a health data space that already implements HealthDCAT-AP (Implementing Regulation (EU) 2026/2098), catalogue synchronisation, data access requests and permits, activity logging and incident registration. We welcome the draft and offer seven practical suggestions from the implementation side. 1. Technical documentation as open, versioned assets (Arts. 3-5).

Dedalus outlines the following core industrial priorities for the European implementation framework for Secondary Use of data: Valuing the Role of Qualified "Service Providers" (Article 9): The draft law allows national hubs (NCPs/HDABs) to hire external technology partners. Private tech companies are ready to cooperate in building and running such network.

The establishment of HealthDCAT-AP as a common metadata framework is an important step towards semantic interoperability within the European Health Data Space. A further aspect that may deserve consideration is the operational connection between Health Data Holders and national Health Data Access Bodies (HDABs).

Filed in Italian · English published by the European Commission

Merck welcomes the opportunity to comment on the draft Commission Implementing Regulation laying down the technical requirements of HealthData@EU. Merck would like to highlight areas where further clarifications or revisions would significantly enhance the implementation. Our comments are listed in the attached document.

We welcome the Draft Commission Implementing Regulation on HealthData@EU. This infrastructure is a vital step toward realizing the European Health Data Space (EHDS). However, to ensure the infrastructure truly enables cross-border research and is valuable for all European citizens, we submit three key recommendations regarding Chapter II (Architecture, technical documentation and interoperability).

We welcome the development of a common European framework for the use of health data and the rollout of HealthData@EU. We identified twelve areas where further clarification, harmonisation and practical guidance could support effective implementation..Our main message is that technical interoperability should be a means, not an end.

Fondazione GIMEMA Franco Mandelli ETS is an Italian non-profit organisation promoting multicentre research in haematological diseases through non-commercial clinical trials and observational studies. Its ECRIN-certified Data Center provides data management, biostatistics and quality management for studies mainly sponsored by GIMEMA.

We welcome the European Commissions draft Implementing Regulation on HealthData@EU and support its overall direction. The draft establishes HealthData@EU as a centrally coordinated but distributed architecture, combining a Commission-operated central platform with systems and components operated by connected entities.

Submission to the European Commission consultation on technical requirements for HealthData@EU Consultation: European Health Data Space technical requirements for HealthData@EU (Have Your Say initiative 16155) Submitted by: Prof Ray O'Sullivan, clinician-entrepreneur, patient-facing medical AI and health-data governance Date: September 2026 Summary position The technical infrastructure for HealthData@EU should be…

IRCCS Neuromed welcomes and strongly supports the proposed technical and functional framework for HealthData@EU. Drawing on our practical experience as a clinical research institution and health data holder contributing to the EUCAIM federation, we consider this framework an important and timely step towards secure and interoperable cross-border access to electronic health data for secondary use.

Muchas gracias por compartir esta consulta de la Comisión Europea. Desde Fenin consideramos que el desarrollo de HealthData@EU constituye una pieza estratégica para hacer efectivo el potencial del Espacio Europeo de Datos de Salud (EEDS/EHDS) y, especialmente, para facilitar la investigación, la innovación, la generación de evidencia y el desarrollo y evaluación de nuevas tecnologías sanitarias.