Establishment and composition
The idea of creating a community of practice with competent authorities for the secondary use of health data in the European Health Data Space (EHDS) started in the discussions while preparing the applications for the direct grants to set up Health Data Access Bodies (HDAB) [EU4H 2022 DI-g-22-22.01].
The competent authorities preparing the applications expressed their will to:
- create a community to discuss issues related to the design and implementation of HDABs services,
- share knowledge and best practices
- increase alignment and cost-effectiveness in setting up HDABs.
The HDABs community of practice (hereafter HDABs-CoP) stands as a testament to the collaborative commitment to navigate the complexities of secondary use of health data in the scope of the upcoming European Health Data Space Regulation.
The HDABs-CoP was created in January 2024 at the time of adoption of the working arrangements through an agreement between the competent authorities.
The HDABs-CoP comprises competent authorities and affiliated entities from EU Member States and EEA countries. Its members, involved in establishing the Health Data Access Bodies are responsible for the secondary use of health data within the European Health Data Space (EHDS) in their respective Member States, including holders of the direct grants for setting up HDABs.
The representatives of these competent authorities participate in the HDABs-CoP voluntarily. The HDABs-CoP serves as a temporary platform that enables collaboration between EU countries until the EHDS governance structure is formally established.
The European Commission supports the HDABs-CoP by co-chairing the General Assembly, serving as its secretariat as well as solution provider for the HealthData@EU infrastructure central services.
Mission and objectives
The HDABs-CoP mission is to foster collaboration and knowledge sharing among Competent Authorities and Affiliated Entities involved in establishing the HDABs and responsible for the secondary use of health data within the European Health Data Space (EHDS).
The HDABs-CoP aims to connect these authorities with initiatives such as Joint Actions, Coordination Support Actions, European projects (TEHDAS2, EHDS2Pilot, QUANTUM) and the relevant national projects for EHDS implementation.
The HDABs-CoP focus is to improve preparedness regarding the regulatory requirements for secondary use of health data within the EHDS, promoting the convergence of procedures while optimising the efficient use of resources.
The main objectives of the HDABs-CoP are:
- Support the establishment of HDABs,
- Strengthen cooperation inside and outside the HDABs-CoP,
- Establish a platform for sharing information and aligning strategies,
- Sharing of technical knowledge and expertise,
- Streamline Solutions and promote the 3Rs principle – Reduce, Reuse and Recycle,
- To increase capacity building,
- Foster harmonisation, standardisation and interoperability,
- Strategies for disseminating results.
Roles and responsibilities
The HDABs-CoP distribute its roles and responsibilities in the following way:
- General Assembly: Define the strategic vision, mission and objectives, adopt the annual work plan and approval of artefacts prepared by HDABs-CoP.
- Steering Board: Coordinate the work of subgroups, monitor progress, quality assure deliverables and report back to the General Assembly.
- Subgroups: teams specialised in specific domains or digital business capabilities:
- Subgroup 1 - Data Access Application systems: Focus on designing and developing data access application systems at national level.
- Subgroup 2 - Health Datasets Metadata Catalogue and Data Quality and Utility: Focus on designing and developing health datasets catalogues and contribute to data quality and utility at national level.
- Subgroup 3 - Secure Processing Environments: Focus on designing and developing secure processing environments at national level.
- Subgroup 4 - Cross-border Gateways: Focus on designing and developing the cross-border gateway at national level.
- Subgroup 5 - Deployment and Operations: Focus on coordinating deployment and operational aspects.
- Subgroup 6 - Stakeholders’ Fora: Focus on engaging with stakeholders.
HDABs-CoP meetings and documents
The HDABs-CoP General Assembly meets twice a year.
- Agendas, minutes from the meetings
- Key documents
