The European Commission has launched a consultation on a draft implementing regulation setting out the technical and functional framework for HealthData@EU, the cross-border infrastructure for accessing electronic health data for secondary use under Regulation (EU) 2025/327. The draft sets out the infrastructure’s architecture, central platform services, interoperability, security and data protection requirements. It also specifies the responsibilities of the Commission and connected entities, the conditions and compliance checks for joining and remaining connected, and the procedures for temporary disconnection and definitive exclusion. The draft would also establish an Enforcement Information Exchange Tool through which health data access bodies could record and exchange information on enforcement measures, including periodic penalty payments, the revocation of data permits and exclusions. Commission adoption is planned for the fourth quarter of 2026 and the regulation would apply from 26 March 2029. The consultation closes on 29 September 2026.