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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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Call key data

End user-driven application of Generative Artificial Intelligence models in healthcare (GenAI4EU)

Funding Program

Horizon Europe: Cluster 1 - Health

Call number

HORIZON-HLTH-2025-01-CARE-01

deadlines

Opening
22.05.2025

Deadline
16.09.2025 17:00

Funding rate

100%

Call budget

€ 40,000,000.00

Estimated EU contribution per project

between € 15,000,000.00 and 20,000,000.00

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 “Ensuring equal access to innovative, sustainable, and high-quality healthcare”. 

Call objectives

Healthcare professionals face important challenges related to efficiency, patient safety and provision of quality care with limited health systems’ resources. Multimodality of health data combined with the available high-performance computing capabilities have the potential to empower effective and accurate use of trustworthy and ethical Generative AI-based solutions, augmented by other AI tools to address these challenges. Generative AI may benefit patients, healthcare professionals and health systems.

This topic will contribute to advancing and generating research to better understand and improve Generative AI-based virtual assistant solutions and their applicability in healthcare settings by improving patient health outcomes, fostering personalised healthcare and support the resilience, sustainability, and efficiency of the healthcare systems. In addition, the topic aims to also cover the understanding and mitigation of possible shortcomings (biases) and frameworks for monitoring and overseeing these solutions’ use.

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, patients):

  • Develop virtual assistant solutions based on new or optimised trustworthy and ethical Generative AI models, augmented by other AI tools to support healthcare professionals. The models should leverage extensive and diverse multimodal health and research data, public knowledge, and reliable healthcare systems information relevant for healthcare settings. Examples can include electronic health records, medical imaging, genomics, proteomics, molecular data, laboratory results, patient information (including on safety), and/or unstructured health data (the applicants may choose any type of available large-scale data). The development and training of the models should take place in multinational consortia and federated governance approaches should be considered. The applicants should demonstrate how the project goes beyond combining existing data and generates new specific knowledge to improve clinical decision making.
  • Demonstrate the added-value and clinical utility of the virtual assistant solutions in at least two healthcare use cases in different medical fields and unmet needs showing e.g. improved care management and efficiency, prediction of potential patient-specific therapeutic strategies and outcomes, etc. The applicants should provide evidence of high maturity technology for the use cases and assess the relative effectiveness of the solutions compared with standard of care, including on why these solutions would be superior to other AI tools and would deliver better outcomes. They should actively engage healthcare professionals as end users, and other stakeholders such as patients, caregivers in the development and testing of the solutions, ensuring that diverse perspectives and intersectional considerations are integrated throughout the process. Training and education activities for healthcare professionals should be organised.
  • Develop a regulatory strategy/interaction plan with regulators (including in the area of Health Technology Assessment) for generating evidence, where relevant, in a timely manner. Consider also the potential for future regulatory impact of the results and sustainability aspects.
  • Develop or adapt existing methodologies for continuous assessment of the developed solutions. The methodologies should demonstrate technical robustness, healthcare utility and trustworthiness of the Generative AI-based solutions, by adopting:
    • Appropriate metrics for evaluating alignment with human values, ethical principles and the intended purposes of Generative AI models, performance including testing their technical robustness and clinical utility, as well as their model intelligibility, in view of ensuring AI trustworthiness.
    • Appropriate solutions to identify and mitigate potential bias of the models (e.g. representativeness of the data, bias of the trainer, bias of training and validation data, algorithmic discrimination and bias including gender bias etc.).
    • Appropriate techniques to discover and demonstrate explainability of model reasoning, increase users’ trust, and address the black box element, thus further enhancing transparency, model explainability and alignment.
    • Methods to systematically address and assess ELSI (Ethical, Legal and Societal Implications), including data privacy concerns and risk of discrimination/bias (not limited to sex, gender, age, disability, race or ethnicity, religion, belief, minority and/or vulnerable groups). The implication of medical errors originated from AI-assisted decision-making and the effects on potential legal liability for healthcare professionals should be explored.

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

The proposals should adhere to the FAIR data principles and apply GDPR compliant processes for personal data protection based on good practices of 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.

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Expected effects and impacts

Proposals are encouraged to exploit potential synergies with the projects funded under the topic HORIZON-CL4-2021-HUMAN-01-24, as well as with other projects funded under Horizon Europe and Digital Europe Programmes. When the use cases are relevant to diseases covered by specific Horizon Europe Partnerships or missions (e.g., European Partnership on Rare Diseases, European Partnership on transforming health and care systems, the Cancer Mission, etc.), the proposals should adopt the federated data-management and data access recommendations already developed. Moreover, the applicants are encouraged to leverage available and emerging data infrastructures (e.g., European Health Data Space, European Genomic Data Infrastructure, Cancer Image Europe, European Open Science Cloud, EBRAINS etc.), whenever relevant. Adopting EOSC recommendations and services for high-quality software is also encouraged. The expansion of health data and/or existing or under development AI infrastructures is not in the scope of this topic.

When possible, the developed models should be trained with multimodal data in different EU languages, to ensure accessibility and inclusivity.

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.

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, to produce meaningful and significant effects enhancing the societal impact of the related research activities. The active engagement of healthcare professionals as end users, patients, and their caregivers is central to achieving targeted outcomes in the development and testing of the Generative AI virtual assistant solutions.

Proposals should consider the involvement of the European Commission's Joint Research Centre (JRC) based on its experience and with respect to the value it could bring in providing an effective interface between research activities and preliminary regulatory science as well as strategies and frameworks that address fit for 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 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

To that end, proposals under this topic should aim to deliver results directed towards and contributing to all the following expected outcomes:

  • Healthcare professionals, at all stages of healthcare provision, have access to user-centric, robust and trustworthy virtual assistant solutions based on Generative Artificial Intelligence (AI) models and other AI tools to support them towards the provision of safer, more efficient and personalised care.
  • Healthcare professionals benefit from cross-country applicable methodologies with the aim to facilitate acceptability, healthcare uptake and public trust of virtual assistant tools based on Generative AI models.
  • Patients benefit from enhanced outcomes, more personalised care, and increased engagement with their healthcare professionals, leading to improved safety, quality of care, access to appropriate healthcare information and patient-doctor communication.
  • Healthcare systems benefit from improved cost-effective patient outcomes, superior to standard of care in terms of accuracy, safety, and quality, and from cost-savings through advancements in highly accurate, transparent, traceable, and explainable solutions.

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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

Administration & Governance, Institutional Capacity & Cooperation, 
Digitalisation, Digital Society, ICT, 
Health, Social Services, Sports

Relevance for EU Macro-Region

EUSAIR - 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

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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