Setting up a European Electronic Health Record Exchange Format (EEHRxF) Ecosystem
HORIZON Coordination and Support Actions
Basic Information
- Identifier
- HORIZON-HLTH-2022-IND-13-05
- Programme
- A competitive health-related industry (2022)
- Programme Period
- 2021 - 2027
- Status
- Closed (31094503)
- Opening Date
- October 5, 2021
- Deadline
- April 20, 2022
- Deadline Model
- single-stage
- Budget
- €2,000,000
- Min Grant Amount
- €2,000,000
- Max Grant Amount
- €2,000,000
- Expected Number of Grants
- 1
- Keywords
- HORIZON-HLTH-2022-IND-13-05HORIZON-HLTH-2022-IND-13
Description
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[1] 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
Destination & Scope
Calls for proposals under this destination are directed towards the Key Strategic Orientation KSO-A ‘Promoting an open strategic autonomy by leading the development of key digital, enabling and emerging technologies, sectors and value chains’ of Horizon Europe’s Strategic Plan 2021-2024. Research and innovation supported under this destination should contribute to the impact area ‘A competitive and secure data-economy’ and in particular to the following expected impact, set out in the Strategic Plan for the health cluster: ‘EU health industry is innovative, sustainable and globally competitive thanks to improved up-take of breakthrough technologies and innovations, which makes the EU with its Member States more resilient and less dependent from imports with regard to the access to and supply of critical health technologies’. In addition, research and innovation supported under this destination could also contribute to the following impact areas: ‘Industrial leadership in key and emerging technologies that work for people’, ‘High quality digital services for all’, and ‘Good health and high-quality accessible health care’.
The health industry is a key driver for growth and has the capacity to provide health technologies to the benefit of patients and providers of health care services. The relevant value chains involve a broad variety of key players from supply, demand and regulatory sides. In addition, the path of innovation in health is long and complex. The development of novel health technologies is generally associated with uncertainties and market barriers due to expensive and risky development (e.g. attrition rate in pharmaceutical development), high quality and security requirements (e.g. clinical performance, safety, data privacy and cybersecurity) and market specificities (e.g. strong regulation, pricing and reimbursement issues). In addition, the growing concern about environmental issues is putting more pressure on this industry. Therefore, there is a need for research and innovation integrating various stakeholders to facilitate market access of innovative health technologies (medical technologies, pharmaceuticals, biotechnologies, digital health technologies).
In order to address these challenges, in particular green and digital transitions and proper supply of health technologies and products, destination 6 will focus on research and innovation activities that aim at:
- Production of pharmaceuticals in compliance with the objectives of the European Green Deal.
- Methodologies, guidelines and standards, assessment studies, and structuring activities adapted to digital solutions and interventions for GDPR compliant translation into health care practice, including inter-operability, cyber-security and data confidentiality.
- Public authorities supported with better methodologies and interdisciplinary approaches to assess and value new health technologies and interventions.
- Development of pharmaceutical products meeting unmet medical needs in the context of market failures.
In view of increasing the impact of EU investments under Horizon Europe, the European Commission welcomes and supports cooperation between EU-funded projects to enable cross-fertilisation and other synergies. This could range from networking to joint activities such as the participation in joint workshops, the exchange of knowledge, the development and adoption of best practices, or joint communication activities. Opportunities for potential synergies exist between projects funded under the same topic but also between other projects funded under another topic, cluster or pillar of Horizon Europe (but also with ongoing projects funded under Horizon 2020). In particular, this could involve projects related to European health research infrastructures (under pillar I of Horizon Europe), the EIC strategic challenges on health and EIT-KIC Health (under pillar III of Horizon Europe), or in areas cutting across the health and other clusters (under pillar II of Horizon Europe). For instance, with cluster 4 “Digital, Industry and Space” such as on industrial research and innovation infrastructures (pilot plants, testing and simulation facilities, open innovation hubs); additive manufacturing (3D/4D printing) and other production technologies (incl. bio manufacturing); safe, smart and sustainable materials.
Expected Impacts:
Proposals for topics under this destination should set out a credible pathway to contributing to maintaining an innovative, sustainable and globally competitive health industry, and more specifically to one or several of the following expected impacts:
- Health industry in the EU is more competitive and sustainable, assuring European leadership in breakthrough health technologies and strategic autonomy in essential medical supplies and digital technologies, contributing to job creation and economic growth, in particular with small- and medium-sized enterprises (SMEs).
- Health industry is working more efficiently along the value chain from the identification of needs to the scale-up and take-up of solutions at national, regional or local level, including through early engagement with patients, health care providers, health authorities and regulators ensuring suitability and acceptance of solutions.
- European standards, including for operations involving health data, ensure patient safety and quality of healthcare services as well as effectiveness and interoperability of health innovation and productivity of innovators.
- Citizens, health care providers and health systems benefit from a swift uptake of innovative health technologies and services offering significant improvements in health outcomes, while health industry in the EU benefits from decreased time-to-market.
- Health security in the EU benefits from reliable access to key manufacturing capacity, including timely provision of essential medical supplies of particularly complex or critical supply and distribution chains, such as regards vaccines or medical radioisotopes.
Eligibility & Conditions
General conditions
2. Eligible countries: described in Annex B of the Work Programme General Annexes.
A number of non-EU/non-Associated Countries that are not automatically eligible for funding have made specific provisions for making funding available for their participants in Horizon Europe projects. See the information in the Horizon Europe Programme Guide.
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.
3. Other eligibility conditions: described in Annex B of the Work Programme General Annexes.
4. Financial and operational capacity and exclusion: described in Annex C of the Work Programme General Annexes.
Award criteria, scoring and thresholds are described in Annex D of the Work Programme General Annexes.
Submission and evaluation processes are described in Annex F of the Work Programme General Annexes and the Online Manual.
Indicative timeline for evaluation and grant agreement: described in Annex F of the Work Programme General Annexes.
6. Legal and financial set-up of the grants: described in Annex G of the Work Programme General Annexes.
Specific conditions
7. Specific conditions: described in the specific topic of the Work Programme.
Documents
Call documents:
Standard application form (HE CSA) — call-specific application form is available in the Submission System
Standard evaluation form (HE CSA) — will be used with the necessary adaptations
HE General MGA v1.0
Essential Information for Clinical Studies
Additional documents:
HE Main Work Programme 2021–2022 – 1. General Introduction
HE Main Work Programme 2021–2022 – 4. Health
HE Main Work Programme 2021–2022 – 13. General Annexes
HE Programme Guide
EU Financial Regulation
Rules for Legal Entity Validation, LEAR Appointment and Financial Capacity Assessment
EU Grants AGA — Annotated Model Grant Agreement
Funding & Tenders Portal Online Manual
Funding & Tenders Portal Terms and Conditions
Funding & Tenders Portal Privacy Statement
Support & Resources
Online Manual is your guide on the procedures from proposal submission to managing your grant.
Horizon Europe Programme Guidecontains the detailed guidance to the structure, budget and political priorities of Horizon Europe.
Funding & Tenders Portal FAQ – find the answers to most frequently asked questions on submission of proposals, evaluation and grant management.
Research Enquiry Service – ask questions about any aspect of European research in general and the EU Research Framework Programmes in particular.
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The European Charter for Researchers and the Code of Conduct for their recruitment– consult the general principles and requirements specifying the roles, responsibilities and entitlements of researchers, employers and funders of researchers.
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National Contact Points (NCP) – contact your NCP for further assistance.
Latest Updates
We recently informed the applicants about the evaluation results for their proposals submitted under this call. The results of the evaluation are as follows:
- Number of proposals submitted (including proposals transferred from or to other calls): 88
- Number of inadmissible proposals: 3
- Number of ineligible proposals: 3
- Number of above-threshold proposals: 62
- Total budget requested for above-threshold proposals: 333,100,753 EUR
We recently informed the applicants about the evaluation results for their proposals submitted under this call. The results of the evaluation are as follows:
- Number of proposals submitted (including proposals transferred from or to other calls): 88
- Number of inadmissible proposals: 3
- Number of ineligible proposals: 3
- Number of above-threshold proposals: 62
- Total budget requested for above-threshold proposals: 333,100,753 EUR
Call HORIZON-HLTH-2022-IND-13 closed on 21 April 2022. 89 proposals were submitted. The breakdown per topic is:
- HORIZON-HLTH-2022-IND-13-01: 31 proposals
- HORIZON-HLTH-2022-IND-13-02: 35 proposals
- HORIZON-HLTH-2022-IND-13-03: 5 proposals
- HORIZON-HLTH-2022-IND-13-04: 15 proposals
- HORIZON-HLTH-2022-IND-13-05: 3 proposals
Evaluation results are expected to be communicated on Friday 5 August 2022 at the earliest.
Call HORIZON-HLTH-2022-IND-13 closed on 21 April 2022. 89 proposals were submitted. The breakdown per topic is:
- HORIZON-HLTH-2022-IND-13-01: 31 proposals
- HORIZON-HLTH-2022-IND-13-02: 35 proposals
- HORIZON-HLTH-2022-IND-13-03: 5 proposals
- HORIZON-HLTH-2022-IND-13-04: 15 proposals
- HORIZON-HLTH-2022-IND-13-05: 3 proposals
Evaluation results are expected to be communicated on Friday 5 August 2022 at the earliest.