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

About this call

Expected Outcome:

Expected outcomes and deliverables are:

Work strand 1:

Guidance for public authorities and healthcare providers to deploy, upgrade and operate digital health services and systems that support the rights of citizens and fulfil their obligations under the EHDS.

Maintenance and expansion of a community of public authorities and healthcare providers based on common guidance for services and systems aligned with the objectives of the EHDS. The community should build upon one or more existing communities.

Large-scale deployment of and/or capacity building for digital health services and systems that support the EEHRxF and the rights of citizens included in the EHDS.

Work strand 2:

A toolbox for data holders to support dataset description, data quality and utility labelling, and secondary use readiness in alignment with the EHDS.

Establishment or expansion of existing community of data holders with the objective of supporting peer exchange, reuse of good practices and alignment of approaches for the creation and maintenance of dataset descriptions and data quality and utility labels for secondary use under the EHDS.

Creation of dataset descriptions and data quality and utility labelling by data holders, such as public authorities and healthcare providers.

Integration of datasets descriptions in the datasets catalogues of health data access bodies.

Support to data holders in putting in place the organisational and technical arrangements required to make electronic health data available for secondary use under the EHDS, in line with applicable safeguards.

Work strand 3:

A training framework and training sessions to prepare service providers to support public authorities, healthcare providers and data holders in the implementation of the EHDS as described above, complementing and aligning with the work of the EEHRxF Support Centre, i2X Capacity Building for Secondary Use [1], and QUANTUM [2] .

A business model, including the uptake strategy, for service providers that can support the adoption of the EEHRxF, the uptake of services and systems compatible with the EHDS and the creation and maintenance of dataset descriptions and data quality and utility labels.

A community of trained service providers trained to support public authorities, healthcare providers and data holders in fulfilling requirements of the EHDS.

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