The Regulation lays down rules on cybersecurity, technical and semantic interoperability, and operations and service management for MyHealth@EU, the central interoperability platform for digital health established by Article 23 of the EHDS Regulation (EU) 2025/327. It defines the Commission's role as processor and national contact points for digital health as joint controllers. Under Article 3, the Commission provides four central services: a reference implementation, a central terminology service for coding mappings, a secure communication network, and a central configuration service. Article 4 requires a requirements catalogue and technical specifications, distinguishing major from minor releases. Articles 7-13 set authorisation procedures for national contact points to start, upgrade, or resume data exchange, based on compliance checks and technical tests, plus a 24-hour notification regime for significant incidents. Articles 14-17 limit processed personal data to the priority and additional categories under Article 14 of Regulation (EU) 2025/327, and set the joint controllers' and processor's GDPR responsibilities. It applies from 26 March 2027.
Author: European Commission
Status: Adopted / Published
Adoption date: 2026-09-18
Last updated: 17 Oct 2026
Category: Relevant legislation
Subcategory: Implementing Regulation