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Call key data

Better integration and use of health-related real-world and research data, including genomics, for improved clinical outcomes

Funding ProgramHorizon Europe - Cluster 1 - Destination 5: Unlocking the full potential of new tools, technologies and digital solutions for a healthy society
Call numberHORIZON-HLTH-2023-TOOL-05-04
deadlinesOpening
12.01.2023		Deadline
13.04.2023 17:00
Funding rate100%
Call budget € 35,000,000.00
Estimated EU contribution per projectbetween € 8,000,000.00 and € 10,000,000.00
Link to the callec.europa.eu
Link to the submissionec.europa.eu

Call content

short description

Health data bear vast information potential in many disease areas, to significantly improve the outcomes and efficiency of healthcare delivery, unlock new research and innovation avenues, and inform public health policy across Europe. There is a huge need of integration, use and deployment of health data from multiple sources for effectively addressing the challenges of medical research underpinning diagnostics, therapy guidance and implementation decisions on new therapies. Such integration requires linking data of different types, disease areas and provenance which are scattered in repositories and databases across Europe.

Call objectives

This topic aims to support proposals focusing on the integration of health data from multiple sources (e.g. electronic health records, genomics, medical imaging, laboratory and diagnostic results, pathogen data, public health registries and other clinical research data) by linking real-world and clinical research data. The data integration should be exemplified in several use-cases, i.e. well-justified groups of diseases (excluding cancer), within and/or across medical domains, and pave the way towards improved health outcomes. At least one of those use cases should build on the use of whole genome sequence data.

The consortium should ensure wide coverage of EU and associated countries, contributing significantly to health data standardisation, while catering for the diversity of health data sources.

To enhance synergies and avoid overlaps of activities, the proposals are expected to align with and complement the relevant European initiatives, in particular the European Health Data Space (EHDS), the 1+Million Genomes initiative (1+MG) and the European Open Science Cloud.

The applicants have to demonstrate that the necessary data sources are, or will be, effectively, timely and legally available for the proposed research activities.

The proposals should address all of the following activities:

  • Identification of the barriers to health data integration and access as needed for the selected use cases, and of specific existing tools, technological solutions and coordination and standardisation agreements addressing those barriers. Issues to be covered include semantic ontologies, data standards and formats, data quality, data storage, management and access modalities, as well as enhanced findability of relevant datasets through improved metadata standards and data catalogues.
  • New approaches to assemble large, easily findable and lawfully accessible high-quality datasets integrating multiple types of health data leading to improved clinical outcomes (e.g. new care solutions, personalised disease management, advanced diagnostic tools), taking into account data FAIRification and inter-operability needs.
  • New techniques, support tools, mechanisms and modalities to enable GDPR compliant access to sensitive personal data, including genomics, allowing for their re-use across borders and integration of different types of data relevant to human health. Legal and ethical frameworks should duly consider the heterogeneity in national and sectorial rules and procedures for data access and re-use.
  • Data management approaches for cross-border distributed data storage and processing, enabling remote collaboration, electronic consent management, data provenance tracking, and scalability of data management resources, ensuring data privacy and security, and resulting in robust support to advanced, innovative clinical workflows. Joint data governance is expected to be piloted among several clinical centres across Europe.
  • Development of a data analytics platform applying distributed learning and artificial intelligence approaches to query and aggregate efficiently, effectively and securely data from multiple sources for multiple use cases (groups of diseases), to monitor patients' health status, analyse causal inference, support diagnosis and health policymakers, and establish recommendations for patients and other stakeholders.

The proposals should adhere to the FAIR data principles and build on existing and justified tools and harmonisation efforts, such as widely used standards for encoding the different types of health data and inter-operability for cross-sector collaborations. Also the data collection, management and/or modelling should build on ongoing EU and international efforts to avoid possible duplication of efforts and fragmentation. In particular, projects are expected to take into account the legislation, if available, on the EHDS, so as to align project activities with pertinent EHDS infrastructure efforts that provide for the secondary use of health data as regards e.g. cross-border access to data, cross-border infrastructures, data quality and utility labelling. The achievements of the relevant past and ongoing EU-funded projects and initiatives, and good practices developed by the European research infrastructures, should be duly considered and used. Close involvement of patients and end-users is crucial to ensure that the project outcomes are relevant, widely accepted and feasible in real-world settings.

The tools developed by the projects are expected to be widely accessible and amenable to necessary updates after the project’s end for further use by interested parties. Datasets generated during the project should be accessible to researchers and innovators. For example, genomic data and linked patient level data are expected to be made accessible for secondary use through the 1+MG data infrastructure.

This topic requires an effective contribution of social sciences and humanities (SSH) disciplines and the involvement of SSH experts, in order to produce meaningful and significant effects enhancing the societal impact of the related research activities.

All projects funded under this topic are strongly encouraged to participate in networking and joint activities. These networking and joint activities could, for example, involve the participation in joint workshops, the exchange of knowledge, the development and adoption of best practices, or joint communication activities. This could also involve networking and joint activities with projects funded under other clusters and pillars of Horizon Europe, or other EU programmes. Therefore, proposals are expected to include a budget for the attendance to regular joint meetings and may consider covering the costs of any other potential joint activities without the prerequisite to detail concrete joint activities at this stage. The details of these joint activities will be defined during the grant agreement preparation phase. In this regard, the Commission may take on the role of facilitator for networking and exchanges, including with relevant stakeholders.

Applicants envisaging to include clinical studies should provide details of their clinical studies in the dedicated annex using the template provided in the submission system. See definition of clinical studies in the introduction to this work programme part.

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Expected effects and impacts
Expected results
  • Researchers, innovators and healthcare professionals benefit from better linkage of health data from various sources, including genomics, based on harmonised approaches related to data structure, format and quality, applicable across certain disease areas and across national borders.
  • Researchers, innovators, healthcare professionals and health policymakers have access to advanced digital tools for the integration, management and analysis of various health data re-used in a secure, cost-effective and clinically meaningful way enabling the improvement of health outcomes.
  • By linking and using effectively more data and new methods and tools, including artificial intelligence, researchers, innovators and healthcare professionals are able to advance our understanding of the risk factors, causes, development and optimal treatment in disease areas where genomics integrated with other health data, spanning from clinical to e.g. lifestyle, offer potential for novel and more comprehensive information.
  • Healthcare professionals and health policymakers benefit from data-driven solutions and reinforced evidence base for decisions addressing health and care challenges.
  • Citizens can be offered data-driven patient-focused health interventions, resulting in improved disease prevention, diagnosis, treatment and monitoring towards better patient outcomes and well-being.
  • Citizens’ trust in the sharing and re-use of health data for research and healthcare increases due to the application of advanced technologies and data governance preserving data privacy and security.

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Regions / countries for fundingEU Member States, Overseas Countries and Territories (OCT)
Moldova (Moldova), Albania (Shqipëria), Armenia (Հայաստան), Bosnia and Herzegovina (Bosna i Hercegovina / Босна и Херцеговина), Faeroes (Føroyar / Færøerne), Georgia (საქართველო), Island (Ísland), Israel (ישראל / إِسْرَائِيل), Kosovo (Kosova/Kosovë / Косово), Montenegro (Црна Гора), Morocco (المغرب), North Macedonia (Северна Македонија), Norway (Norge), Serbia (Srbija/Сpбија), Tunisia (تونس /Tūnis), Türkiye, Ukraine (Україна), United Kingdom
eligible entitiesEU Body, Education and training institution, International organization, Natural Person, Non-Profit Organisation (NPO) / Non-Governmental Organisation (NGO), Other, Private institution, incl. private company (private for profit), Public Body (national, regional and local; incl. EGTCs), Research Institution incl. University, Small and medium-sized enterprise (SME)
Mandatory partnershipYes
Project Partnership

To be eligible for funding, applicants must be established in one of the following countries:

  • the Member States of the European Union, including their outermost regions
  • the Overseas Countries and Territories (OCTs) linked to the Member States
  • third countries associated to Horizon Europe - see list of particpating countries

Applications may be submitted by one or more legal entities, which may be established in a Member State, Associated Country or, in exceptional cases and if provided for in the specific call conditions, in another third country. 

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.

Any legal entity, regardless of its place of establishment, including legal entities from non-associated third countries or international organisations (including international European research organisations) is eligible to participate (whether it is eligible for funding or not), provided that the conditions laid down in the Horizon Europe Regulation have been met, along with any other conditions laid down in the specific call topic.

A ‘legal entity’ means any natural or legal person created and recognised as such under national law, EU law or international law, which has legal personality and which may, acting in its own name, exercise rights and be subject to obligations, or an entity without legal personality.

Specific cases:

  • Affiliated entities — Affiliated entities (i.e. entities with a legal or capital link to a beneficiary which participate in the action with similar rights and obligations to the beneficiaries, but which do not sign the grant agreement and therefore do not become beneficiaries themselves) are allowed, if they are eligible for participation and funding.
  • Associated partners — Associated partners (i.e. entities which participate in the action without signing the grant agreement, and without the right to charge costs or claim contributions) are allowed, subject to any conditions regarding associated partners set out in the specific call conditions.
  • Entities without legal personality — Entities which do not have legal personality under their national law may exceptionally participate, provided that their representatives have the capacity to undertake legal obligations on their behalf, and offer guarantees to protect the EU’s financial interests equivalent to those offered by legal persons.
  • EU bodies — Legal entities created under EU law including decentralised agencies may be part of the consortium, unless provided for otherwise in their basic act.
  • Joint Research Centre (‘JRC’)— Where provided for in the specific call conditions, applicants may include in their proposals the possible contribution of the JRC but the JRC will not participate in the preparation and submission of the proposal. Applicants will indicate the contribution that the JRC could bring to the project based on the scope of the topic text. After the evaluation process, the JRC and the consortium selected for funding may come to an agreement on the specific terms of the participation of the JRC. If an agreement is found, the JRC may accede to the grant agreement as beneficiary requesting zero funding or participate as an associated partner, and would accede to the consortium as a member.
  • Associations and interest groupings — Entities composed of members (e.g. European research infrastructure consortia (ERICs)) may participate as ‘sole beneficiaries’ or ‘beneficiaries without legal personality’. However, if the action is in practice implemented by the individual members, those members should also participate (either as beneficiaries or as affiliated entities, otherwise their costs will NOT be eligible.
other eligibility criteria

If projects use satellite-based earth observation, positioning, navigation and/or related timing data and services, beneficiaries must make use of Copernicus and/or Galileo/EGNOS (other data and services may additionally be used).

Additional information

Topics
Competitiveness of Enterprises, Employment/Labour Market, SME & entrepreneurship, 
Digitalisation, Digital Society, ICT, 
Health, Social Services, Sports
Relevance for EU Macro-RegionEUSAIR - EU Strategy for the Adriatic and Ionian Region, EUSALP - EU Strategy for the Alpine Space, EUSBSR - EU Strategy for the Baltic Sea Region, EUSDR - EU Strategy for the Danube Region
UN Sustainable Development Goals (UN-SDGs)
Additional Information

All proposals must be submitted electronically via the Funders & Tenders Portal electronic submission system (accessible via the topic page in the Search Funding & Tenders section). Paper submissions are NOT possible.

Proposals must be complete and contain all parts and mandatory annexes and supporting documents, e.g. plan for the exploitation and dissemination of the results including communication activities, etc.

The application form will have two parts:

  • Part A (to be filled in directly online) contains administrative information about the applicant organisations (future coordinator and beneficiaries and affiliated entities), the summarised budget for the proposal and call-specific questions;
  • Part B (to be downloaded from the Portal submission system, completed and then assembled and re-uploaded as a PDF in the system) contains the technical description of the project.

Annexes and supporting documents will be directly available in the submission system and must be uploaded as PDF files (or other formats allowed by the system).

The limit for a full application (Part B) is 45 pages.

The award criteria are described in General Annex D. The following exceptions apply: The thresholds for each criterion will be 4 (Excellence), 4 (Impact) and 3 (Implementation). The cumulative threshold will be 12.

The rules for the legal and financial set-up of the grant agreements are described in General Annex G. The following exceptions apply: In order to optimise synergies and increase the impact of the projects, all projects selected for funding from this topic will form a cluster and be required to participate in common networking and joint activities (and in determining modalities for their implementation and the specific responsibilities of projects). Depending on the scope of proposals selected for funding, these activities may include:

  • Attendance of regular joint meetings (e.g., common kick-off meeting and annual meetings). 
  • Periodic report of joint activities (delivered at each reporting period). 
  • Common dissemination and communication activities (which may include, for example: a common dissemination and communication strategy, web portal and visual identity, brochure, newsletters). 
  • Common Data Management Strategy and Common Policy Strategy (including joint policy briefs). 
  • Thematic workshops/trainings on issues of common interest. 
  • Working groups on topics of common interest (e.g. data management, communication and dissemination, science-policy link, scientific synergies)
Call documents HE-Work Programme 2023-2024, Cluster 1, Destination 5 (481kB)
ContactNational Contact Points for Horizon Europe
Website

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