In short
The TEHDAS2 joint action prepares the ground for the harmonised implementation of the secondary use of health data in the European Health Data Space (EHDS). The secondary use of health data refers to the reuse of information, in a different context than for primary (clinical) use, for research, innovation, policy-making and regulatory activities.
Project description
The TEHDAS2 joint action will build on the work of the previous TEHDAS1 and other European projects. TEHDAS2 is carried out by 29 European countries and co-ordinated by the Finnish Innovation Fund, Sitra. It is based on the European Commission’s EU4Health Programme.
TEHDAS2 produces concrete guidelines and technical specifications for the European Commission and member states to ensure a harmonised implementation of the European Health Data Space (EHDS) regulation. Member states can use TEHDAS2 results to support their implementation efforts at the national level, while at the same time, the work will support the European Commission, for instance, in the drafting of the implementing acts defined in the EHDS regulation.
The specific objectives are to:
- Facilitate the discovery of datasets and enrichment of description of datasets for secondary use purposes;
- Advance both the common understanding about and the operationalisation of access to health data, from the point of view of different key players along a data lifecycle and user journey;
- Create a technical framework for safe and secure processing of health data through Secure Processing Environments and de-identification of data;
- Strengthen the involvement of citizens towards the European Health Data Space regarding the secondary use of health data;
- Create operational and collaboration models in implementing the EHDS as well as promote knowledges haring and best practices via stakeholder engagement.
Sciensano is leading Work Package (WP) 5 on Data Discovery and is involved in WP4 on Stakeholder collaboration models, WP7 on Secure Processing Environments and WP8 on Serving citizens. More specifically, Sciensano will contribute to the project in the following tasks:
- Develop common guidelines for collaboration and engagement with relevant stakeholders
- Build a unique set of requirements at the European scale towards data holders to fulfil their duties for data description
- Define common security requirements applicable to all Secure Processing Environments (SPEs) and specify functional and technical services that should be proposed by all SPEs, mainly to ensure interoperabilityEstablish a framework for recognising and acknowledging citizens involvement in EHDS and in voluntary data sharing initiatives including potential incentives
- Provide guidance on key responsibilities of data users regarding research outcomes derived from secondary use of data
