Three further implementing regulations provide more detail on the EHDS.

Implementation of the European Health Data Space (EHDS) is moving forward. On 21 and 22 September, three implementing regulations were published in the Official Journal of the European Union. They set out more detailed rules for the secure and interoperable exchange of health data across borders and for making datasets easier to find for research, innovation and health policy planning. This brings the total number of EHDS implementing regulations adopted and published to four.

MyHealth@EU

Implementing Regulation (EU) 2026/2083 governs the cross-border exchange of personal electronic health data through MyHealth@EU. Its aim is to make relevant health information available when patients receive treatment in another Member State.

The regulation includes requirements on interoperability, data protection, cybersecurity and the operation of MyHealth@EU. It also sets out the conditions under which national contact points can connect to the infrastructure and the technical and regular compliance checks required. The regulation applies from 26 March 2027. Patient summaries, electronic prescriptions and information on the dispensing of medicines must be available for cross-border exchange from 26 March 2029. Medical images, laboratory results and discharge reports will follow from 26 March 2031.

Secure identification

Implementing Regulation (EU) 2026/2099 governs the secure identification of patients, health professionals and healthcare providers when health data is exchanged across borders. This is intended to ensure that health data can be reliably attributed to the right person and protected against unauthorised access.

By 26 March 2028, Member States must specify which information will be used to identify patients. In future, this information may also be provided through the European Digital Identity Wallet. Use of the wallet will remain voluntary. The regulation generally applies from 26 March 2027. The provisions on issuing and recognising digital identification information across borders through the European Digital Identity Wallet apply from 26 March 2029.

Common descriptions for health datasets

Implementing Regulation (EU) 2026/2098 concerns the secondary use of electronic health data, for example in research and health policy decisions on the provision of care. It specifies what information health data holders must provide to national health data access bodies when describing their datasets.

This includes, for example, information on the content and purpose of a dataset, the responsible data holder, the number of records or people covered, the period covered, the coding systems used, and the legal and technical conditions for access. A common European standard is intended to make national dataset catalogues standardised and machine-readable, and to allow them to be linked through the future EU dataset catalogue. The regulation applies from 26 March 2029.

Implementation in Germany

Germany is also preparing to implement the EHDS. The draft Act on Data and Digital Innovation in Healthcare (GeDIG), approved by the Federal Cabinet in July, aims to connect the electronic patient record to MyHealth@EU and reorganise the structures for the secondary use of health data.

The draft provides, among other things, for a coordinating health data access body based at the Federal Institute for Drugs and Medical Devices (BfArM), additional access bodies for specific domains, and a uniform research identifier to link different datasets. The bill is currently going through the national parliamentary process.