Setting Up a European Electronic Health Record Exchange Format (EEHRxF) Ecosystem

This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination 6 “Maintaining an innovative, sustainable and globally competitive health industry”. To that end, proposals under this topic should aim for delivering results that are directed, tailored towards and contributing to all of the following expected outcomes:

• 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^[1] 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.

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^[2]. 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^[3] 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^[4] 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^[5], the Network and Information Systems Directive^[6] 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^[7] 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.

[1]https://ec.europa.eu/health/ehealth/policy/network_en

[2]https://ec.europa.eu/digital-single-market/en/news/recommendation-european-electronic-health-record-exchange-format

[3]E.g. from the H2020 topics PHC 34 – 2014, HCO-14-2016, HCO-15-2016, SC1-DTH-08-2018, SC1-HCC-07-2020.

[4]https://joinup.ec.europa.eu/collection/api4dt

[5]Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation): http://eur-lex.europa.eu/eli/reg/2016/679/oj

[6]Directive (EU) 2016/1148 of the European Parliament and of the Council of 6 July 2016 concerning measures for a high common level of security of network and information systems across the Union: http://eur-lex.europa.eu/eli/dir/2016/1148/oj

[7]https://ec.europa.eu/health/ehealth/policy/network_en