Call: Setting up a European Electronic Health Record Exchange Format (EEHRxF) Ecosystem

Expected Outcome

• Individuals, researchers, health services and the workforce across borders in the EU Digital Single Market use significantly improved and interoperable cross-border digital health solutions thanks to sophisticated ICT toolbox, representative use case applications, a Pan-European ecosystem of early adopters, and a framework for sustainability and exploitation. These will also contribute to the European Health Data Space.
• Individuals have an improved level of accessibility, control and portability of health data, including donation for research across Europe and jurisdictions.
• Policy makers and members of the eHealth Network are better informed and advised regarding potential evolutions of the EEHRxF and its extension to other uses cases.
• Different target populations such as designers, developers, health care professionals, and individuals have access to exploitation and capacity building support, such as training material, dedicated tools, guidelines, mentorship and collaboration programs.

Scope:

Interoperability of Electronic Health Record is key for the exchange and the portability of health data in view of better health outcomes and treatments. The EU has supported projects to ensure cross-border sharing of health data and, in 2019, adopted a Recommendation on EEHRxF. There is a need to continue supporting the uptake of new use cases (i.e. laboratory results, medical imaging and reports, and hospital discharge reports) and take on board possible new requirements, and ultimately to bring together policy actors and stakeholders.

Applicants should propose activities in all of the following areas:

• Building on the outcomes of activities and projects related to the EEHRxF Recommendation, establishing and sustaining a scalable public infrastructure for digital health innovation based on the EEHRxF principles and the functional and technical specifications of its information domains (i.e. medical imaging, discharge letters, laboratory results, etc.). This infrastructure must provide a REST API to third-party developers, which should comprise a coherent set of functionality that significantly improve the development and deployment of interoperable cross-border digital health solutions. It should specifically allow individuals accessing and providing their own (electronic) health records across national borders. The infrastructure must ensure compliance with the General Data Protection Regulation, the Network and Information Systems Directive and the operation in a European Digital Single Market.
• Demonstrating feasibility of real-life interoperable digital solutions for use by individuals, researchers, health services and the workforce across borders in the EU Digital Single Market by leveraging the above EEHRxF-based infrastructure. Emphasis should be given to specific fields of high societal relevance and high prevalence. Omics type of information associated to the use and exchange of health datasets and artificial intelligence should be strongly considered with special regard to analysis and corresponding further health-related data. Integration with population-based patient registries such as cardiovascular disease, congenital anomalies, diabetes, rare diseases, and cancer are highly recommended. Relevant activities of the eHealth Network should be taken into account. For all relevant data (e.g. from hospitals, doctors or user-generated) ethics and legal issues should be considered appropriately. Local, regional, national and cross-border aspects (to cover e.g. differences in languages and terminologies) should be given adequate consideration.
• Establishing and sustaining a Pan-European ecosystem of digital health stakeholders by promoting and ensuring adoption of the EEHRxF-based infrastructure, involving both supply and demand sides, reinforcing collaboration and networking between the different actors working on digital health innovation across Europe around that infrastructure, and more particularly ensuring strong involvement and coordination at the governance level with the national authorities and Ministries represented in the eHealth Network and the eHealth agencies underneath it. The latter should include innovation initiatives related to a coherent selection of the following: clinical research, clinical trial integration, outcomes-based research, monitoring or decision aids for individuals, and business analytics, as well as application designers and developers, SMEs, innovation hubs, professionals networks e.g. rare disease network, health professionals and patient associations, and standardisation bodies.
• Creating and validating a framework for enabling further exploitation of the public infrastructure for digital health innovation, including its terms of reference, governance and operations rules and procedures, as well as support for capacity building such as training material, guidelines, mentorship and collaboration/twinning programs for designers, developers, health care professionals, policymakers, SMEs, etc.

In this topic the integration of the gender dimension (sex and gender analysis) in research and innovation content is not a mandatory requirement.

eligible non-EU countries:

• countries associated to Horizon Europe

• low-and middle-income countries

Legal entities which are established in countries not listed above will be eligible for funding if provided for in the specific call conditions, or if their participation is considered essential for implementing the action by the granting authority.

Specific cases:

• Affiliated entities - Affiliated entities are eligible for funding if they are established in one of the countries listed above.
• EU bodies - Legal entities created under EU law may also be eligible to receive funding, unless their basic act states otherwise.
• International organisations - International European research organisations are eligible to receive funding. Unless their participation is considered essential for implementing the action by the granting authority, other international organisations are not eligible to receive funding. International organisations with headquarters in a Member State or Associated Country are eligible to receive funding for ‘Training and mobility’actions and when provided for in the specific call conditions.

Unless otherwise provided for in the specific call conditions , legal entities forming a consortium are eligible to participate in actions provided that the consortium includes:

• at least one independent legal entity established in a Member State;and
• at least two other independent legal entities, each established in different Member States or Associated Countries.

In recognition of the opening of the US National Institutes of Health’s programmes to European researchers, any legal entity established in the United States of America is eligible to receive Union funding to support its participation in projects funded under the Health cluster.

Proposal page limits and layout:

The application form will have two parts:

• Part A to be filled in directly online  (administrative information, summarised budget, call-specific questions, etc.)
• Part B to be downloaded from the Portal submission system, completed and re-uploaded as a PDF in the system

Page limit - Part B: 30 pages