Packages

The project is divided into eight work packages led by organisations from different countries.  Work packages 1–3 are linked to execution of the joint action and 4–8 are thematic work packages linked to the secondary use of health data.

1 Management and coordination

Co-ordinates and manages the project and its implementation.
Lead: The Finnish Innovation Fund Sitra, Finland

2 Communication

Communicates the project results and deliverables.
Lead: The Finnish Innovation Fund Sitra, Finland

3 Evaluation

Assesses whether the project is reaching its objectives.
Lead: Croatian Institute of Public Health, CIPH (HR)

4 Collaboration models

Creates guidelines for fees and penalties to facilitate organisational implementation of the EHDS for Health Data Access Bodies (HDABs) in the EU. Ensures engagement from the European ecosystem relevant for the implementation for EHDS and increasing knowledge sharing and awareness of future EHDS regulatory requirements. Creates operational models and guidelines for collaboration on the implementation of the EHDS, including international collaboration (third country access).

5 Data discovery

Facilitates the discovery and enrichment of datasets for secondary use purposes. Provides guidelines for data holders to fulfil their duties towards data description. Develops guidelines for common policies for Health Data Access Bodies (HDABs) on limitations in relation to the purposes that are enlisted for secondary use according to EHDS and technical specifications on the national metadata catalogue. Establishes guidance for data holders and HDABs on data enrichment capabilities.

6 Access to data

Advances both the common understanding about access to electronic health data, and putting it into practice. Develops guidelines for data holders on making personal and non-personal electronic health data available for reuse. Provides guideline for data users on good application and access practice as well as guideline for Health Data Access Bodies on the procedures and formats for data access. Develops technical specifications for health data access bodies about Data Access Application Management System (DAAMS).

7 Safe and secure processing

Gives clear guidelines and technical specifications about Secure Processing Environments (SPEs) and de-identification of data. Provides guidance to users about their responsibilities while analysing data in an SPE. Develops technical specifications for Health Data Access Bodies on data minimisation and de-identification. Develops specifications for implementation of common IT infrastructure, defines common security requirements applicable to all SPEs and specifies functional and technical services to ensure interoperability.

8 Serving citizens

Strengthens the engagement of citizens towards the EHDS regarding the secondary use of health data. Develops guidelines on data altruism and provides guidelines for Health Data Access Bodies to inform citizens and involve them in the understanding of how their health data is utilised and for which secondary use purpose. Provides guidance on key responsibilities of data users on research outcomes derived from secondary use of data.