European Health Data Space MyHealth@EU requirements

Feedback on the Draft Implementing Regulation for MyHealth@EU Security for Transitional NCPs and EEHRxF Alignment This feedback addresses specific technical and procedural concerns identified in the draft implementing regulation for MyHealth@EU (Draft PLAN/2702/2025) and the overarching European Health Data Space (EHDS) framework. 1.

Cancer Patients Europe (CPE) welcomes the draft Commission Implementing Regulation on MyHealth@EU adopted under Article 23(4) and (8) of Regulation (EU) 2025/327, and supports its objective of enabling secure, interoperable cross-border exchange of personal electronic health data under the European Health Data Space.

The FJL welcomes the development of [email removed] the continuity of care, this infrastructure represents a major strategic opportunity for European biomedical research. It should not be limited to a tool that distorts clinical data, but should be seen as a structuring lever for health research and innovation, within a framework that guarantees clear limits and the patient’s complete control over the use of his or…

Filed in French · English published by the European Commission

The Portuguese Pharmaceutical Society supports MyHealth@EU as the common infrastructure for the cross-border primary use of electronic health data. For pharmacists, it will deliver value only if it makes cross-border electronic prescriptions safer, faster, and legally clear, while preserving confidentiality and continuity of supply.

SNOMED International welcomes the initiative and offers to act as a strategic partner to the European Commission. This includes supporting the Commission in the development and operation of the Central Terminology Service, as well as enabling the use of the SNOMED CT International Edition (monthly releases), the SNOMED CT Global Patient Set (GPS), SNOMED CT translations and extensions and leveraging a governance…

Dear Sir/Madam, The Federation of Austrian Social Insurances welcomes proposals that contribute to enhancing clarity in the implementation of the EHDS Regulation. We likewise consider it of particular importance to submit our observations within the framework of the public consultation.

The Finnish Medicines Agency Fimea is grateful for the possibility to provide comments. We find that there are still some unclarities related to MyHealth@EU infrastructure and particularly in the interpretation of the chapter 6 in the Article 23 (MyHealth@EU): Member States shall ensure that pharmacies operating on their territories, including online pharmacies, are able to dispense electronic prescriptions issued…

The Health Information and Quality Authority has a legal remit to set national standards for health information in Ireland and assess compliance with those standards. We welcome this draft Implementing Regulation under Article 23 of the EHDS as a key step towards making cross-border digital health services operational in practice.

MyHealth@EU is the infrastructure set up under the European Health Data Space that supports the cross-border exchange of personal electronic health data, such as patient summaries and prescriptions. This initiative sets out detailed requirements for this infrastructure, including the Commission’s role as processor of personal data.

Filed in Italian · English published by the European Commission

Below (attached) are the comments from the Finnish Social Insurance Institution Kela which 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.

To enable effective cross-border communication, the regulation central terminology services will be provided by the Commission, enabling Member States to provide mappings and translations to and from coding systems and values used in the exchange of personal electronic health data (Article 3). However, this technical requirement highlights the risk of a loss of essential clinical detail.

The xShare project recommends the following amendments in the draft requirements for cross-border exchange of personal health data (MyHealth@EU) 1. Section Cross-border data exchange and central interoperability platform for digital health (Art.3-13) o In Article 4, include a standalone point on the Commission and Steering Groups responsibility to set up end-to-end testing assets.

Part 2. Most community pharmacies are SMEs and costs will likely be passed on by vendors. The principle of proportionality should explicitly include an assessment of negative net impact in highly digitalised countries.

Part 1 PGEU supports MyHealth@EU as the common infrastructure for cross-border primary use of electronic health data. For community pharmacists, it will deliver value only if it makes cross-border ePrescriptions safer, faster and legally clear at the pharmacy counter, while preserving confidentiality and continuity of supply.

Comments to the Commission Implementing Regulation (EU) on MyHealth@EU, Ref. Ares(2026)3673221: 1. Article 4(2). In connection with the adoption of the EHDS and the start of the timelines for its implementation, it is necessary to adopt as soon as possible all technical and operational requirements needed for this process.

The ongoing implementation of the European Health Data Space (EHDS), particularly regarding the requirements for the cross-border exchange of personal health data, represents a highly significant development for healthcare systems, professionals and patients across Europe.

Dear Sir or Madam, Please find attached a PDF document containing an opinion in relation to the Public Consultations European Health Data Space: Requirements for Cross-Border Exchange of Personal Health Data (MyHealth@EU).

Response on behalf of ActiZ, Dutch Association in elderly care, home care, and rehabilitation. ActiZ supports the objectives of MyHealth@EU. However we would like to bring up some points of attention. The national contact points will become the data controllers for cross-border data exchange. In the Netherlands, healthcare providers are the data holders (source holders).

The European Association of E-Pharmacies (EAEP) welcomes the opportunity to provide input to the public consultation on the implementing act related to the cross-border exchange of personal health data under the European Health Data Space (EHDS), in particular through the MyHealth@EU infrastructure.

Please find attached our review comments of the Implementing act on the requirements for the cross-border gateway. The review was performed by a group of colleagues. Our comments are mainly specification questions (mainly on responsibilities) or language suggestions.

Since the European Health Data Space (EHDS) Regulation aims to empower patients and citizens and enable the secondary use of health data for research purposes, the draft implementing acts should include additional provisions on requirements for cross-border exchange to further reflect this.

Article 3 clause 4 describes that national contact points should map codes and can use a central terminology server to help with that. This seems to contradict the purpose of the regulation requiring EHRs to contain an interoperability component to allow for data exchange in a standardized format.

Response on behalf of NVZ Dutch Hospital Association to the EU consultation on the Commission Implementing Regulation on MyHealth@EU NVZ (Dutch Hospital Association) supports the objectives of MyHealth@EU and welcomes the detailed provisions in this draft Implementing Regulation on technical, operational and governance aspects of cross border exchange of electronic health data.

IS Consulting is a Polish cybersecurity consultancy and coordinator of the ASCLEPIUS consortium (EU Digital Europe Programme, Grant 101127583), focused on cybersecurity preparedness for the European healthcare sector. We submit this opinion as an independent expert contribution, vendor-agnostic and grounded in operational implementation experience. Overall assessment.

European Health Data Space Infrastructure set up (MyHealth@EU) Perspective of dbb beamtenbund und tarifunion (Germany) The dbb beamtenbund und tarifunion welcomes the objectives of the European Health Data Space (EHDS) to strengthen cross border healthcare, enhance patients rights over their data and improve interoperability within the EU.

Clinical interoperability as a complement to data interoperability in MyHealth@EU The proposed implementing regulation establishes a robust framework for the secure and interoperable cross-border exchange of personal electronic health data under MyHealth@EU.