A. Background
On March 25, 2025, Regulation (EU) 2025/327 of the European Parliament and of the Council of February 11, 2025, on the EHDS (EHDS Regulation) entered into force and, pursuant to Article 105 of the EHDS Regulation, generally applies as of March 26, 2027. In exceptional cases, transition periods of four, six, and ten years apply. Specifically, for EHR systems, phased-in transitional provisions apply pursuant to Article 105(3) and (4) of the EHDS Regulation, which take effect in March 2029 and March 2031, respectively. The EHDS Regulation distinguishes between primary use and secondary use. Primary use pertains in particular to individuals’ access to their electronic health data. Secondary use enables, among other things, the processing of health data for purposes of public interest, policymaking and regulation, scientific research, and development and innovation in the healthcare sector—and thus also for commercial research.
B. Regulation (EU) 2026/2083
Implementing Regulation (EU) 2026/2083 establishes, pursuant to Article 3, the technical, organizational, security, and data protection framework for MyHealth@EU.
I. Subject Matter
Implementing Regulation (EU) 2026/2083 is primarily addressed to the Commission, as the provider of central services, and to the national contact points for digital health. For the authorized participants referred to in Article 24(2) and (3) of the EHDS Regulation (such as services or infrastructures in the fields of health, long-term care, or social security), certain provisions apply accordingly pursuant to Article 1(2) of the Implementing Regulation.
MyHealth@EU, as the central interoperability platform for digital health, is intended to enable the exchange of electronic health data between national contact points (see Article 23(1) of the EHDS Regulation). MyHealth@EU sets requirements not only for the technical transmission of health data but also for semantic interoperability, particularly the translation and mapping of coding systems and values. A product can therefore be technically “connected” and yet still fail to meet semantic or organizational requirements.
II. Effective Date
Pursuant to Article 19 of Implementing Regulation 2026/2083, this Regulation enters into force on October 11, 2026, and applies as of March 26, 2027. However, pursuant to Article 18, the obligations regarding data exchange via MyHealth@EU will be phased in (see Recital 24):
- Effective March 26, 2029: Exchange of patient summaries, electronic prescriptions, and dispensing of medications.
- Effective March 26, 2031: Exchange of medical imaging and related imaging-based findings, results of medical examinations—including laboratory and other diagnostic results and related reports—as well as discharge summaries.
C. Regulation (EU) 2026/2098
Implementing Regulation (EU) 2026/2098 implements Article 77(4) of the EHDS Regulation. It specifies the minimum metadata elements that health data holders must provide to the Health Data Access Point for descriptions of their datasets when these datasets are made available for the secondary use of electronic health data (see also Art. 60(3) of the EHDS Regulation).
The Regulation also applies to authorized participants in HealthData@EU, to the extent that they provide dataset descriptions in accordance with the EHDS Regulation.
I. Subject Matter
The HealthDCAT Application Profile (HealthDCAT-AP), developed and maintained by the Commission, is intended to serve as a metadata framework. It builds on the general DCAT Application Profile and is specifically designed to serve as a basis for describing health datasets made available for the secondary use of electronic health data.
In practice, this means: health data holders should not record the minimum metadata in their own arbitrary structures, but rather use the terms, structure, cardinalities, and controlled vocabularies of the HealthDCAT-AP. This information is incorporated into the public, standardized, and machine-readable data set catalogs that access points are required to maintain under Article 77(1) of the EHDS Regulation. HealthDCAT-AP standardizes the description of the data sets, not the health data itself.
The complete list of metadata elements and their characteristics can be found in Part B of the Annex to the Regulation.
II. Update of Data Set Descriptions
Pursuant to Article 60(3) of the EHDS Regulation, the health data controller must verify at least once a year whether its description of the data set in the national data set catalog is accurate and up to date. This is more than just a one-time cataloging requirement: metadata must be integrated into ongoing data, quality, and governance processes.
III. Effective Date
Pursuant to Article 4, the Implementing Regulation enters into force on October 11, 2026, and applies as of March 26, 2029.
Do you have any questions about this news item, or would you like to discuss it with the author? Please feel free to contact: Prof. Dr. Boris Handorn or Anna Christ
