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:

• 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

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:

• Work strand 1: The consortium will provide guidance for public authorities and healthcare providers to deploy, upgrade and operate digital health services and systems that support the rights of citizens for primary use of their electronic health data and fulfil their obligations under the EHDS. The consortium will support, through the cascading funding mechanism, activities of public authorities and healthcare providers (e.g. hospitals, clinics, healthcare providers) to deploy digital health services and systems that support the rights of citizens included in the EHDS and the adoption of the EEHRxF, as well as to convert electronic health data into the EEHRxF. As part of the deployment, capacity building activities such as training for staff or reengineering processes can be included.
• Work strand 2: The consortium will develop a toolbox to support data holders in preparing electronic health data for secondary use in accordance with the EHDS. Through the cascading funding mechanism, it will support data holders to create and maintain dataset descriptions and, where applicable, data quality and utility labels for electronic health data falling within the scope of the EHDS. This strand will support data holders in publishing dataset descriptions and labels in the dataset catalogues operated by Health Data Access Bodies, thereby enabling data discoverability and access for secondary use. It will also support data holders in putting in place the necessary organisational and technical arrangements to make data available for secondary use under the EHDS, in line with applicable safeguards. Activities under this strand may include, where relevant, supporting data management practices, tooling and workflows, targeted IT deployment, staff training and process reengineering, insofar as these activities facilitate dataset description, cataloguing and secondary use readiness.
• Work strand 3: It will develop a training framework and conduct trainings for service providers to prepare them to support public authorities and healthcare providers to deploy digital health services and systems that support the rights of citizens included in the EHDS. It will also prepare them to convert health data held by public authorities and healthcare providers from various formats to the EEHRxF and vice-versa, and to deploy processes and services to enable such conversions, and to create and maintain dataset descriptions and the corresponding labelling for data quality and utility as foreseen in the EHDS for secondary uses of data.

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