
New regulations released, shaping the future implementation of the EHDS:
- Commission Implementing Regulation (EU) 2026/2099 of 21 September 2026 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
- Commission Implementing Regulation (EU) 2026/2083 of 18 September 2026 on MyHealth@EU
- Commission Implementing Regulation (EU) 2026/2098 of 18 September 2026 laying down the minimum metadata elements and their characteristics to be provided by health data holders for dataset descriptions for the secondary use of electronic health data under Article 77(4) of Regulation (EU) 2025/327 establishing the European Health Data Space
Let’s not forget the draft under public scrutiny (feedback open until September 29th) for the Implementing Decision setting out the technical and functional framework for the HealthData@EU infrastructure, which will enable secure and interoperable cross-border access to electronic health data for secondary use; it also sets out the specifications of the IT tool for enforcement transparency, facilitating cooperation and information exchange between health data access bodies on enforcement measures.