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  1. An institution, body, office or agency established by or based on the Treaty on European Union and the Treaties establishing the European Communities.

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    An intergovernmental organization having legal personality under public international law or a specialized agency established by such an international organization. An international organization, the majority of whose members are Member States or Associated Countries and whose main objective is to promote scientific and technological cooperation in Europe, is an International Organization of European Interest.

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Call key data

Leveraging multimodal data to advance Generative Artificial Intelligence applicability in biomedical research (GenAI4EU)

Funding Program

Horizon Europe: Cluster 1 - Health

Call number

HORIZON-HLTH-2025-01-TOOL-03

deadlines

Opening
22.05.2025

Deadline
16.09.2025 17:00

Funding rate

100%

Call budget

€ 50,000,000.00

Estimated EU contribution per project

between € 15,000,000.00 and € 17,000,000.00

Link to the call

ec.europa.eu

Link to the submission

ec.europa.eu

Call content

short description

This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination “Developing and using new tools, technologies and digital solutions for a healthy society”.

Call objectives

The availability of large-scale multimodal health data, scientific information, and novel Generative AI models, combined with high-performance computing capacities offer an unprecedented opportunity for researchers to achieve breakthroughs in our understanding of disease development and to develop new predictive models for disease management, personalised treatment solutions and personalised care pathways. The European Commission recognises this potential and considers health research and healthcare, among the priority sectors for building the Union’s strategic leadership [COM(2024) 28 final].

This topic will contribute to advancing research and providing new evidence on how these models contribute to and support biomedical research and its applicability towards more predictive and personalised medicine, while also defining use conditions, usability requirements and training needs of the researchers. It aims to cover existing gaps related to Generative AI in biomedical research, addressing both capabilities and existing limitations.

Research actions under this topic should include all the following activities, ensuring multidisciplinary approaches and a broad representation of stakeholders in the consortia (e.g. industry, academia, healthcare professionals):

  • Develop new or re-purpose existing Generative AI models for biomedical research across various medical fields and/or therapeutic indications. The models should be robust, based on the use of large-scale, complex, and multimodal high-quality data (real and/or synthetic data), such as but not limited to medical imaging, genomics, proteomics, other molecular data, electronic health records, laboratory results, unstructured health data and/or available scientific and public information relevant to biomedical research. The applicants may choose any type of available large-scale biomedical data and/or their combinations and justify their relevance for training and optimisation of the Generative AI tools.
  • Develop a proof of concept with at least two use cases relevant for predictive and personalised medicine in different medical fields to demonstrate the scientific added value compared to currently used methods and/or potential future clinical utility of the Generative AI models in biomedical research. The applicants should actively engage potential end users in the development, adaptation and testing of the new/repurposed models, considering sustainability aspects.
  • Develop or revise existing methodologies to assess alignment with human values and the use cases of developed and/or repurposed Generative AI models, their applicability, performance, limitations and added value in biomedical research. These methodologies should demonstrate the technical, scientific, and potential future clinical utility, robustness and trustworthiness of the developed or repurposed Generative AI models, in particular:
    • Appropriate performance metrics for continuous evaluation and testing of scientific, technical robustness and relevance of the Generative AI models, as well as risks from misalignment of training data (which may degrade performance, e.g. through including but not limited to hallucinations or confabulations of these models).
    • Appropriate metrics for model intelligibility, robustness, alignment with ethical principles and approaches for ethical evaluation of AI trustworthiness.
    • Appropriate solutions to identify and mitigate potential bias and confounding of Generative AI models and include examples from different perspectives (e.g., representativeness of the data, bias of the trainer, bias of training and validation data, algorithmic discrimination and bias including gender bias etc.).
    • Methods to systematically address and assess ELSI (Ethical, Legal, and Societal Implications) aspects, including data privacy, risk of discrimination/bias (not limited to sex, gender, age, disability, race or ethnicity, religion, belief, minority and/or vulnerable groups).
    • Appropriate techniques to ensure explainability of the model in order to increase users’ trust.
    • Approaches and metrics (where feasible) for the usability of Generative AI models for researchers.

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Expected effects and impacts

All proposals should demonstrate EU added value by developing and/or using trustworthy and ethical Generative AI models developed in the EU and Associated countries, involving in the consortium EU industrial developers of Generative AI solutions, including leading-edge startups when possible. An open-source approach is encouraged when technically and economically feasible.

The proposals should adhere to the FAIR data principles and apply GDPR compliant processes for personal data protection based on good practices developed by the European research infrastructures, where relevant. The proposals should promote the highest standards of transparency and openness of models, as much as possible going well beyond documentation and extending to aspects such as assumptions, code and FAIR data management.

Proposals are encouraged to exploit potential synergies with other relevant projects funded under Horizon Europe and/or Digital Europe Programmes. When the use cases are relevant to diseases covered by specific Horizon Europe Partnerships or missions (e.g., the European Partnership on Rare Diseases, the Cancer Mission, etc.), the proposals should leverage the knowledge/data platforms already developed, such as the Virtual Platform of the European Joint Programme of Rare Diseases etc. Moreover, the applicants are encouraged to leverage available and emerging European data infrastructures (e.g., the European Health Data Space, European Genomic Data Infrastructure[8], Cancer Image Europe, European Open Science Cloud, EBRAINS etc.), whenever relevant. In addition, adopting EOSC recommendations and services for high-quality software is also encouraged, if applicable. The creation and expansion of health data and/or AI infrastructures or large-data curation initiatives, existing or under development, are not in the scope of this topic.

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

Successful proposals are encouraged to utilise the resources offered by the AI factories, when relevant and in accordance with the specific access terms and conditions.

Proposals should consider the involvement of the European Commission's Joint Research Centre (JRC) with respect to the value it could bring in providing an effective interface between research activities and pre-normative regulatory science as well as strategies and frameworks that address regulatory requirements. In that respect, the JRC will consider collaborating with any successful proposal and this collaboration, when relevant, should be established after the proposal’s approval.

All proposals selected for funding under this topic are strongly encouraged to collaborate, for example by participating in networking and joint activities, exchange of knowledge, developing, and adopting best practices, as appropriate. 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.

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.

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Expected results

Proposals under this topic should aim to deliver results directed towards and contributing to all the following expected outcomes:

  • Researchers, including clinical researchers, have access to robust, trustworthy and ethical Generative Artificial Intelligence (AI) models able to effectively advance biomedical research towards predictive and personalised medicine.
  • Researchers, including clinical researchers, know how to use Generative AI models to synthesise the available scientific information and large-scale multimodal data and how to apply the necessary precautions, in order to deliver new knowledge and breakthrough scientific discoveries.
  • Research community benefits from advanced methodologies to assess the validity and application of accurate, transparent, traceable, and explainable Generative AI models.

Eligibility Criteria

Regions / countries for funding

EU Member States, Overseas Countries and Territories (OCT)
Moldova (Moldova), Albania (Shqipëria), Armenia (Հայաստան), Bosnia and Herzegovina (Bosna i Hercegovina / Босна и Херцеговина), Canada, Faeroes (Føroyar / Færøerne), Georgia (საქართველო), Iceland (Ísland), Israel (ישראל / إِسْرَائِيل), Kosovo (Kosova/Kosovë / Косово), Montenegro (Црна Гора), New Zealand (Aotearoa), North Macedonia (Северна Македонија), Norway (Norge), Serbia (Srbija/Сpбија), Tunisia (تونس /Tūnis), Türkiye, Ukraine (Україна), United Kingdom

eligible entities

EU Body, Education and training institution, 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 partnership

Yes

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
  • countries associated to Horizon Europe - see list of particpating countries

Only legal entities forming a consortium are eligible to participate in actions provided that the consortium includes, as beneficiaries, three legal entities independent from each other and each established in a different country as follows:

  • 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.

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.

other eligibility criteria

Specific cases:

  • 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 (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 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.
  • Legal entities created under EU law (EU bodies) including decentralised agencies may be part of the consortium, unless provided for otherwise in their basic act.
  • International European research organisations are 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 or when provided for in the specific call/topic conditions. Other international organisations are not eligible to receive funding, unless provided for in the specific call/topic conditions, or if their participation is considered essential for implementing the action by the granting authority.
  • 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.
  • EU restrictive measures — Entities subject to EU restrictive measures under Article 29 of the Treaty on the European Union (TEU) and Article 215 of the Treaty on the Functioning of the EU (TFEU) as well as Article 75 TFEU, are not eligible to participate in any capacity, including as beneficiaries, affiliated entities, associated partners, third parties giving in-kind contributions, subcontractors or recipients of financial support to third parties (if any).
  • Legal entities established in Russia, Belarus, or in non-government controlled territories of Ukraine — Given the illegal invasion of Ukraine by Russia and the involvement of Belarus, there is currently no appropriate context allowing the implementation of the actions foreseen in this programme with legal entities established in Russia, Belarus, or in non-government controlled territories of Ukraine. Therefore, even where such entities are not subject to EU restrictive measures, such legal entities are not eligible to participate in any capacity. This includes participation as beneficiaries, affiliated entities, associated partners, third parties giving in-kind contributions, subcontractors or recipients of financial support to third parties (if any). Exceptions may be granted on a case-by-case basis for justified reasons.
    With specific regard to measures addressed to Russia, following the adoption of the Council Regulation (EU) 2024/1745 of 24 June 2024 (amending Council Regulation (EU) No 833/2014 of 31 July 2014) concerning restrictive measures in view of Russia’s actions destabilising the situation in Ukraine, legal entities established outside Russia but whose proprietary rights are directly or indirectly owned for more than 50% by a legal person, entity or body established in Russia are also not eligible to participate in any capacity.
  • Measures for the protection of the Union budget against breaches of the principles of the rule of law in Hungary — Following the Council Implementing Decision (EU) 2022/2506, as of 16 December 2022, no legal commitments can be entered into with Hungarian public interest trusts established under the Hungarian Act IX of 2021 or any entity they maintain. Affected entities may continue to apply to calls for proposals and can participate without receiving EU funding, as associated partners, if allowed by the call conditions. However, as long as the Council measures are not lifted, such entities are not eligible to participate in any funded role (beneficiaries, affiliated entities, subcontractors, recipients of financial support to third parties, etc.).In case of multi-beneficiary grant calls, applicants will be invited to remove or replace that entity in any funded role and/or to change its status into associated partner. Tasks and budget may be redistributed accordingly.

Additional information

Topics

Digitalisation, Digital Society, ICT, 
Health, Social Services, Sports

Relevance for EU Macro-Region

EUSDR - EU Strategy for the Danube Region, EUSBSR - EU Strategy for the Baltic Sea Region, EUSALP - EU Strategy for the Alpine Space, EUSAIR - EU Strategy for the Adriatic and Ionian Region

UN Sustainable Development Goals (UN-SDGs)

Additional Information

Applications 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.

Applications must be submitted using the forms provided inside the electronic submission system (not the templates available on the topic page, which are only for information). The structure and presentation must correspond to the instructions given in the forms.

Applications must be complete and contain all parts and mandatory annexes and supporting documents.

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.

Call documents

Horizon Europe Work Programme 2025 Cluster 1 - HealthHorizon Europe Work Programme 2025 Cluster 1 - Health(1200kB)

Contact

National Contact Points for Horizon Europe
Website

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