European Health Data Space identification management

In order to achieve the objectives pursued by the Regulation on an interoperable, cross-border identification and authentication mechanism for natural persons, healthcare professionals and healthcare providers for the purposes of the cross border exchange of personal electronic health data from the outsetnamely, ensuring access to electronic health data while safeguarding the secure processing of such data and…

We have reviewed the draft implementing regulation Ares (2026) 3673210 regarding an interoperable, cross-border identification and authentication mechanism. We propose to (1) remove the Annex and all references to it, as these technical specifications not only duplicate but also conflict with the technical specifications set forth in MyHealth@EU.

Stichting MedMij is the Dutch foundation that provides the national trust framework for Personal Health Environments/PHRs in the Netherlands. The framework defines interoperable, legally binding agreements between citizens, healthcare providers, and ICT suppliers, enabling citizens to access their health data securely and reliably.

Cancer Patients Europe (CPE) welcomes the draft Commission Implementing Regulation on an interoperable, cross-border identification and authentication mechanism for natural persons, health professionals and healthcare providers for the cross-border exchange of personal electronic health data. While CPE supports its objectives, we highlight some implementation considerations from a patient perspective.

1. Introduction The Jérôme Lejeune Foundation welcomes the establishment of a European identification and interoperable authentication mechanism under the European Health Data Space (EHDS). As actors involved in the management and research of intellectual disabilities of genetic origin, we process particularly sensitive health data, often in cross-border contexts.

Filed in French · English published by the European Commission

he Portuguese Pharmaceutical Society welcomes the objective of the draft Implementing Regulation to ensure reliable cross-border identification and authentication for personal electronic health data. For pharmacists, these rules are particularly relevant at the point of care: they must identify the patient, verify their professional authorisation, and access only the data necessary for safe dispensing and patient…

SNOMED International welcomes the initiative and offers to act as a strategic partner to the European Commission. Health professional role: recommended use of ISCO-08 as a cross-border anchor for routing and audit, with explicit acknowledgement of its limited granularity. SNOMED International does not recommend binding this attribute to the international SNOMED CT hierarchy (223366009).

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 Health Information and Quality Authority (HIQA), welcomes the opportunity to provide input on Regulation (EU) 2025/327. HIQA has a legal remit to set national standards for health information in Ireland and assess compliance with those standards.

This initiative sets out the requirements for an interoperable, cross-border identification and authentication mechanism for individuals and health professionals, in line with the eIDAS Regulation. These requirements will be key to allow EU countries and the Commission to implement the mechanism in MyHealth@EU, which supports the cross-border exchange of personal electronic health data without the possibility of…

Filed in Italian · English published by the European Commission

The Council of European Dentists (CED) welcomes the European Commission's draft implementing regulation as a significant step towards establishing a secure and interoperable identification mechanism for cross-border health data exchange.

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.

The success of the cross-border identification and authentication mechanism is a direct precondition for the value MyHealth@EU is intended to deliver to patients and clinicians. If patients cannot be reliably identified across borders, and if healthcare professionals cannot be securely authenticated in a way that works in clinical practice, the framework will not deliver its intended benefits.

Response on behalf of ActiZ, Dutch Association in elderly care, home care, and rehabilitation. ActiZ supports the objectives of Identity Management. However we would like to bring up some points of attention. The long-term care sector is the largest healthcare sector in the Netherlands. Within this sector, a substantial share of the workforce consists of external hires and other forms of flexible deployment.

The Dutch Association of Hospitals has taken note with interest of the Draft Implementing Regulation on an interoperable, cross-border identification and authentication mechanism for natural persons, health professionals and healthcare providers for the purposes of the cross-border exchange of personal electronic health data (“Draft Implementing Regulation”).

Filed in Dutch · English published by the European Commission

PGEU welcomes the aim of the draft Implementing Regulation to make cross-border identification and authentication reliable for personal electronic health data. For community pharmacies, these rules matter at the point of care: pharmacists must identify the patient, prove professional authorisation for access to his/her data and limit such access only to the data needed for safe dispensing and care.

Comments to the Commission Implementing Regulation (EU) on annex on an interoperable, cross-border identification and authentication mechanism for natural persons, health professionals and healthcare providers for the purposes of the cross-border exchange of personal electronic health data: 1. List of mandatory data is not sufficient to properly define scope and structure of data being shared.

The implementing act states that in proxy situations, the health professional or healthcare provider shall identify the natural person and verify that the authorised natural person or legal representative satisfies the necessary requirements to act in that capacity.

The European Association of E-Pharmacies (EAEP) welcomes the opportunity to provide input to the public consultation on the implementing act related to identity management under the European Health Data Space (EHDS).

Dear reader, Please find attached our review comments of the Implementing act on Identity management. The review was performed by a group of colleagues. Our comments are mainly specification questions or language suggestions. Kind Regards Marije van [name removed], the Netherlands

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 identity management to further reflect this.

The draft implementing act specifies that the identification data used in the Member State a request is sent to, are to be provided for cross-border requests (recital 2, articles 3 and 4). However, no means seem to be provided for EHR's to provide this data to an NCPeH or to even request information from an NCPeH about what identification data is needed for a request to a specific Member State.

In Ireland we have two health numbers: PRSI and IHI. The PRSI number is government owned (for those with a government account), old in design and cannot be validated on provision. The IHI number is health service owned, sits within the numbering system of the United Kingdom, and is validated at source alongside other demographics: name, date of birth, gender on passport, postcode, PRSI - and is probablistically…

IS Consulting Executive Summary Opinion on the Draft Commission Implementing Regulation on Interoperable Cross-Border Identification and Authentication for the Purposes of the Cross-Border Exchange of Personal Electronic Health Data Ref.

Subject: Identity-enabled access and the need for clinically consistent data use The proposed implementing regulation establishes an important foundation for the reliable identification and authentication of natural persons, health professionals and healthcare providers in the context of cross-border exchange of electronic health data.