About the European Health Data Space (EHDS)
The European Health Data Space (EHDS) aims to enable secure access to and use of electronic health data across the European Union (EU) for patients, healthcare professionals, researchers, policymakers, and other authorised users. It does so by establishing a shared legal, governance, and technical framework to connect national infrastructures and share data across borders. The EHDS distinguishes between primary and secondary use of health data.
Primary use refers to the use of personal electronic health data for healthcare provision, including diagnosis and treatment, as well as enabling citizens to access and share their own health data.
Secondary use concerns the reuse of health data for purposes such as research, innovation, and policymaking, under strict safeguards and access conditions. Within the EHDS framework, access for secondary use will be governed by national Health Data Access Bodies (HDABs), responsible for assessing data access applications, authorising permitted use in Secure Processing Environments (SPEs), and ensuring compliance with legal and security requirements.
The Second Joint Action Towards the EHDS (TEHDAS2)
TEHDAS2 aims to develop common guidelines and technical specifications to facilitate the access to health data for secondary purposes, such as research, innovation and policymaking. The European Member States and European Commission can use these documents to support the national implementation and development of implementing acts of the forthcoming European Health Data Space (EHDS) regulation. Ultimately, the Joint Action will contribute to more efficient European collaboration on data sharing to benefit the public health in Europe and foster the competitiveness of European researchers and innovators. The project started in May 2024, and will run until December 2026.
RIVM's role in TEHDAS2
RIVM participates in multiple TEHDAS2 work packages. For one, we co-coordinate work package 6 on access to data, which aims to enhance the common understanding about and the operationalisation of access to electronic health data. This work package will develop guidelines on making personal and non-personal/anonymous health data available, the requirements during the data application, issuing data permits and decisions on data requests, and technical specifications and/or requirements for the so-called Data Access Application Management Systems (DAAMS). In addition, RIVM contributes to the development of a guideline on international and third- country access to health data and a recommendation on informing natural persons about the use of health data through a Citizen Information Point.
Dutch Health Data Access Body (HDAB-NL) programme
The HDAB-NL programme was established to initiate and support the decision-making process leading to the creation of a Dutch Health Data Access Body (HDAB-NL). To fulfil its role effectively, HDAB-NL must be supported by a set of digital business capabilities that enable efficient, secure, and compliant operations. These capabilities include: a national Data Access Application Management System (DAAMs); a National Dataset Catalogue (NDC); support for the use of a Secure Processing Environment (SPE); and interoperability with the HealthData@EU infrastructure.
Within the programme, RIVM acts as work package leader for Work Package 3 (Evaluation), a horizontal work package that assesses the implementation of the HDAB-NL programme, with particular attention to the development and performance of the digital business capabilities. RIVM is also responsible for Work Package 4 (Sustainability), which aims to ensure that these digital business capabilities are underpinned by a sustainability plan. In addition, RIVM leads Work Package 9 (Data Quality), which focuses on strengthening data quality for secondary use.