Technical specification for Health Data Access Bodies on the implementation of the common IT infrastructure

This TEHDAS2 technical specification supports the implementation of the European Health Data Space (EHDS).Efficient and secure cross-border access to health data for secondary purposes such as research, innovation, policymaking, and improving patient safety is of strategic importance for the European Union. However, today, technical fragmentation and varied national frameworks hinder seamless secondary use of data among EU Member States. To overcome these challenges, Chapter IV of the European Health Data Space (EHDS) regulation introduces a dedicated common EU infrastructure: HealthData@EU. This infrastructure provides the necessary technical, functional, and security frameworks to enable secure and standardised secondary use of electronic health data across national borders. The HealthData@EU infrastructure and the HealthData@EU Central Platform, are defined as follows: HealthData@EU infrastructure: the infrastructure connecting national contact points for secondary use of electronic health data with the HealthData@EU Central Platform The HealthData@EU Central Platform for secondary use of electronic health data: the interoperability platform established by the European Commission to support and facilitate the exchange of information between national contact points for secondary use of electronic health data. The HealthData@EU infrastructure and central platform must be able to communicate securely with all authorised participants of HealthData@EU, as defined under article 75(2) of the EHDS Regulation. This communication is enabled by specialised software that ensure secure exchange of information between health data access bodies. The solutions guarantee that data is encrypted, access is authenticated and authorised, and compliance with data protection regulation sur as GDPR is maintained, thus protecting the confidentiality and integrity of health data. As specified in Article 75 of the EHDS Regulation, the European Commission holds the primary responsibility for developing, maintaining, and continuously improving the HealthData@EU infrastructure. This responsibility includes proposing robust interoperability standards, consistent data exchange protocols, and secure data-sharing mechanisms tailored to the secondary use context. At the national level, Member States contribute by deploying and managing national contact points for secondary use of electronic health data (NCPs), acting as connectors between their national data environments and the HealthData@EU infrastructure. NCPs ensure reliable national integration with relevant services such as the national dataset catalogue or the data access application management system, maintaining compliance with standards and facilitating secure data flows. Together, the HealthData@EU Central Platform, the HealthData@EU infrastructure (managed by the European Commission) and national implementations coordinated via NCPs establish a comprehensive, interoperable, and secure environment. This robust infrastructure, once fully operational, should significantly enhance the EU’s ability to leverage health data for secondary purposes, fostering cross-border collaboration and driving collective health research and policy advancements across Europe. This document provides the outcome of the task 7.3 under the TEHDAS2 Joint Action. It aims to present a policy-level overview of the proposed common IT infrastructure supporting the HealthData@EU infrastructure, with a focus on cross-border connectivity and system interoperability. The content is based on the technical specifications and architecture 1 developed by the European Commission. It has been adapted following public consultation of stakeholders (organized between the 30th of September and 30th of November 2025), as specified in Annex 2 – Public consultation summary, and prepare Member States for implementation in alignment with Chapter IV of the EHDS Regulation.