Building capacity to deploy the EEHRxF and digital health services and systems to support the rights of citizens and reuse of health data under EHDS -

Expected Outcome:

Expected outcomes and deliverables are:

Work strand 1:

Work strand 2:

Work strand 3:

1 - https://hadea.ec.europa.eu/calls-tenders/capacity-building-secondary-uses-health-data-european-health-data-space_en

2 - https://quantumproject.eu/

Objective:

Regulation (EU) 2025/327 of the European Parliament and of the Council (‘The European Health Data Space (EHDS) Regulation’) [1] reinforces the rights for citizens to access and control their personal electronic health data and supports their freedom of movement by improving the cross-border exchange of such data to ensure continuity of healthcare. These rights include the right of natural persons or their representatives to access their personal electronic health data through electronic health data access services, the right to insert information in their own electronic health record (EHR), the right to rectification, the right to portability and the right to restrict access to their electronic health data. The rights also contribute to the achievement of the target of 100% of Union citizens having access to their electronic health records by 2030, as set in the Digital Decade policy programme.

For primary use, implementing these rights under the EHDS Regulation requires concrete action, capacity-building and training, to support the digital health community, particularly public authorities, healthcare providers, and service providers, particularly Small and Medium-sized Enterprises (SMEs), in the deployment of digital health services and systems that support these rights (across all the priority data categories) and that adopt the EEHRxF (European Electronic Health Record Exchange Format), taking into account the specific circumstances of different categories of stakeholders involved.

For secondary use, the EHDS Regulation requires health data holders, including public authorities and healthcare providers, to create and maintain a dataset description, following a health extension of the DCAT Application Profile [2] (currently under development), and, where applicable, a dedicated labelling for data quality and utility (also under development. These datasets descriptions and labels will need to be made available in the datasets catalogue of health data access bodies (HDABs).

The action is divided in three objectives, each to be achieved through a separate work strand:

a) to build capacity of public authorities, healthcare providers to deploy services and systems that support the rights of natural persons under Chapter II of the European Health Data Space (EHDS) Regulation (primary use);

b) to build capacity of health data holders to improve quality of data, create the datasets description and label for electronic health data they hold and that is within the scope of the EHDS for secondary use;

c) to train service providers, particularly Small and Medium-sized Enterprises (SMEs), to support public authorities, healthcare providers and data holders in the implementation of the requirements set by the EHDS.

These objectives will be implemented through three work strands of a single project that will provide cascading funding to the third parties through a single call.

This action will foster a more efficient and interconnected healthcare ecosystem, supporting early adopters including at least public authorities, healthcare providers, health data holders and service providers to advance the implementation of the primary and secondary use requirements in the EHDS.

1 Regulation - EU - 2025/327 - EN - EUR-Lex

2 HealthDCAT-AP Release 5

Scope:

The selected project will manage a portfolio of individual grants across the three work strands by cascading funding mechanism, through financial support to third parties with the maximum amount of up to 120.000 euro per third party. The project consortium will be responsible for selecting, coordinating and monitoring the portfolio of cascaded grants across the three work strands and will ensure their coherent execution in line with the objectives, scope and deliverables defined in the Digital Europe Work Programme 2025-2027 without prejudice to the roles and responsibilities assigned to Health Data Access Bodies under the EHDS Regulation. Therefore, the consortium must demonstrate the ability to develop and execute this type of funding mechanism by involving participants with profound previous experience in this field.

The work of these projects will be implemented through three main work strands:

This action is aimed at providing the necessary support, tools, and incentives in complementarity with other associated projects under Digital Europe Programme, EU4Health and Horizon Europe, such as i2X, MyHealth@MyHands, Xt-EHR, TEHDAS2, x-Share, SHAIPED. It should cover a large number of Member States and be deployed supporting all the priority data categories under EHDS. The action contributes to the eHealth Target of the Digital Decade Policy programme established by Decision (EU) 2022/2481 of the European Parliament and of the Council (the ‘DDPP Decision’) [1] through the implementation of EHR systems and digital health services and systems enabling access of citizens to their EHRs as well as contributing to the implementation of the European Data Union Strategy by increasing data discoverability and improved data quality.

1 https://eur-lex.europa.eu/eli/dec/2022/2481/oj

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