Leveraging multimodal data to advance Generative Artificial Intelligence applicability in biomedical research (GenAI4EU)
HORIZON Research and Innovation Actions
Basic Information
- Identifier
- HORIZON-HLTH-2025-01-TOOL-03
- Programme
- Cluster 1 - Health (Single stage - 2025)
- Programme Period
- 2021 - 2027
- Status
- Closed (31094503)
- Opening Date
- May 22, 2025
- Deadline
- September 16, 2025
- Deadline Model
- single-stage
- Budget
- €40,000,000
- Min Grant Amount
- €6,000,000
- Max Grant Amount
- €8,000,000
- Expected Number of Grants
- 5
- Keywords
- HORIZON-HLTH-2025-01-TOOL-03HORIZON-HLTH-2025-01BiomarkersBiomedical engineeringBiomedical softwareClinical analysisClinical dataClinical informationDiagnosticsEthics in medical sciencesHealth dataHealth informationHealth-related biotechnologyImaging, image and data processingMedical biotechnology related ethicsSoftware validationTechnologies involving identifying the functioning of DNA, proteins and enzymes and how they influence the onset of disease and maintenance of well-being (gene-based diagnostics and therapeutic interventions (pharmacogenomics, gene-based
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”. To that end, 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)[1] 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.
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[2].
- Appropriate solutions to identify and mitigate potential bias and confounding[3] 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.
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[4] data principles and apply GDPR[5] 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[6] etc. Moreover, the applicants are encouraged to leverage available and emerging European data infrastructures (e.g., the European Health Data Space[7], European Genomic Data Infrastructure[8], Cancer Image Europe[9], European Open Science Cloud[10], EBRAINS[11] 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[12], 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[13] should provide details of their clinical studies in the dedicated annex using the template provided in the submission system.
[1] Generative AI is a type of AI technology that can generate various forms of new content such as text, images, sounds, and even code, such as for programming or gene sequencing (https://ec.europa.eu/newsroom/dae/redirection/document/101621).
[2] Ethics Guidelines for Trustworthy AI, published by the European Commission’s High Level Expert Group on Artificial Intelligence: https://ec.europa.eu/futurium/en/ai-alliance-consultation.1.html
[3] Guidelines on the responsible use of Generative AI in research developed by the European Research Area Forum: https://research-and-innovation.ec.europa.eu/news/all-research-and-innovation-news/guidelines-responsible-use-generative-ai-research-developed-european-research-area-forum-2024-03-20_en
[4] See definition of FAIR data in the introduction to this work programme part.
[5] General Data Protection Regulation: https://commission.europa.eu/law/law-topic/data-protection_en
[6] https://www.ejprarediseases.org/what-is-the-virtual-platform
[7] https://health.ec.europa.eu/ehealth-digital-health-and-care/european-health-data-space_en
[8] https://gdi.onemilliongenomes.eu
[12] https://digital-strategy.ec.europa.eu/en/policies/ai-factories
[13] Please note that the definition of clinical studies (see introduction to this work programme part) is broad and it is recommended that you review it thoroughly before submitting your application.
Destination & Scope
Topics under this destination are directed towards the Key Strategic Orientation 2 “The Digital Transition” and Key Strategic Orientation 3 “A More Resilient, Competitive, Inclusive, and Democratic Europe” of Horizon Europe’s strategic plan 2025-2027.
Research and Innovation supported under this destination should contribute to the following expected impact, set out in the strategic plan impact summary for the Health Cluster: “Health technologies, data, new tools, and digital solutions are applied effectively thanks to their inclusive, ethically sound, secure and sustainable delivery, integration and deployment in health policies and in health and care systems.”
The Health Cluster will continue work to develop and stimulate the uptake of new technologies and digital solutions to improve healthcare and health systems. This includes using technology to help people better understand and use health information, promote healthier lifestyles, improve pandemic/epidemic preparedness, prevent diseases, provide better diagnoses and more personalised treatments and care solutions, and improve access to health and care systems while making sure that even groups with limited access to good healthcare can benefit. The Cluster will help the EU ensure leadership in breakthrough health and medical technologies and achieve open strategic autonomy in essential medical supplies and digital innovations. By collecting and analysing health data across borders and creating human-centred health technologies, including the use of Artificial Intelligence (AI), research can improve and personalise medical care for different patients, increasing patient safety and leading to better health outcomes and wellbeing.
Support for Research and Innovation is needed on the large spectrum of tools and technologies for biomedical research, prevention, diagnosis, therapy and health monitoring. This includes enabling technologies not least innovative biotechnological approaches. The emergence of the European Health Data Space will create an additional boost to cross-border, data-driven approaches and innovation, e.g. for personalised medicine or patient safety. High-quality health data (incl. real world data) combined with digital technologies, modelling and AI tools, have a high potential for advancing biomedical Research and Innovation. Emerging and disruptive technologies using tools like new genomic techniques and AI tools, offer big opportunities for transforming healthcare, but also depend on the capacity to collect, integrate and interpret large amounts of data and on their compatibility with appropriate regulatory frameworks. Such technologies can provide better and more cost-efficient solutions with high societal impact, tailored to the specific healthcare needs of the individual. However, novel tools, technologies and digital approaches face specific barriers and hurdles in piloting, implementing and scaling-up before reaching the patient, encountering additional challenges such as public acceptance and trust. The development and uptake of new technologies for high-quality healthcare will need to draw on multiple disciplines and require cross-sectoral cooperation among all those concerned, including end-users (patients, healthcare providers and workforce, researchers, regulatory bodies, policymakers, and funders). These interactions will help address unmet needs via integrated tools, hybrid health technologies and digital solutions (including those with limited commercial interest). It will also support the design and development of health products and services tailored to the needs of specific population groups, thereby improving patient outcomes and reducing health inequalities.
This destination aims to promote the development of novel tools, technologies and digital solutions for prevention, diagnosis and therapy with the goal to improve health outcomes, while taking into consideration the rights of the individual, safety, effectiveness, appropriateness, accessibility, comparative value-added and fiscal sustainability as well as issues of ethical, legal and regulatory nature.
In this work programme part, Destination “Developing and using new tools, technologies and digital solutions for a healthy society” is driven by two key Commission policies, the “Biotechnology and Biomanufacturing Strategy[1]” and the “Artificial Intelligence Strategy[2]” and will focus on the development and use of innovative biotechnological tools for the improvement of the therapeutic arsenal of healthcare against diseases where there are currently no or only insufficient therapeutic strategies, on the development of Generative Artificial Intelligence models to help researchers in their activities to deliver new knowledge for advancing biomedical research and on the technology transfer of biotechnology-derived therapeutics from discovery to approved products. In particular, the topics under this destination will support activities aiming at: cellular and cell-free therapeutic approaches employing either genetic modifications or more classical techniques for improving the safety and therapeutic performance of these therapies, including their testing in clinical studies; development of generative AI models based on large-scale multi-modal health data for better understanding of diseases and their management thanks to the enhancement of biomedical discoveries and more personalised treatment solutions; bridging the gap between pre-clinical and clinical development stages of therapeutics developed through biotechnological methods and giving special emphasis on small and medium-sized enterprises (SMEs). In this context, specific attention is given to support the objectives of the Strategic Technologies for Europe Platform (STEP), adopted by the Commission in March 2024, which aims to boost investments in critical technologies in Europe (see introduction to this work programme part).
Under this destination, actions will support interdisciplinary Research and Innovation activities involving a broad spectrum of actors from different sectors, who will strive for the convergence of health technologies, combining medical technologies, pharmaceuticals, Advanced Therapy Medicinal Products (ATMPs) and digital health technologies, that will lead to integrated health solutions for the benefit of healthcare providers and patients.
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 such activities and 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, the European Innovation Ecosystems (EIE) interregional networks 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), like, for instance, with Cluster 4 “Digital, Industry and Space” on digitalisation of the health sector or key enabling technologies.
Expected Impacts:
Proposals for topics under this destination should set out a credible pathway towards the development and use of new tools, technologies and digital solutions for a healthy society, and more specifically to one or several of the following impacts:
- Europe’s scientific and technological expertise and know-how, its capabilities for innovation in new tools, technologies and digital solutions, and its ability to take-up, scale-up and integrate innovation in healthcare is world-class.
- Citizens benefit from targeted and faster research resulting in safer, more sustainable, efficient, cost-effective and affordable tools, technologies and digital solutions for improved (personalised) disease prevention, diagnosis, treatment and monitoring for better patient outcome and wellbeing, in particular through increasingly shared health resources (interoperable data, infrastructure, expertise, citizen/patient driven co-creation)[3].
- The EU gains high visibility and leadership in terms of health technology development, including through international cooperation.
- The burden of diseases in the EU and worldwide is reduced through the development and integration of innovative diagnostic and therapeutic approaches, personalised medicine approaches, digital and other people-centred solutions for healthcare.
- Both the productivity of health Research and Innovation, and the quality and outcome of healthcare is improved thanks to the use of health data and innovative analytical tools, such as artificial intelligence (AI) supported decision-making, in a secure and ethical manner, respecting individual integrity and underpinned with public acceptance and trust.
- Citizens trust and support the opportunities offered by innovative technologies for healthcare, based on expected health outcomes and potential risks involved.
The protection of European communication networks has been identified as an important security interest of the Union and its Member States. Entities that are assessed as high-risk suppliers[4] of mobile network communication equipment (and any entities they own or control) are not eligible to participate as beneficiaries, affiliated entities and associated partners to topics identified as “subject to restrictions for the protection of European communication networks”. Please refer to the Annex B of the General Annexes of this Work Programme for further details.
[1] Commission Communication on Building the future with nature: Boosting Biotechnology and Biomanufacturing in the EU; COM(2024) 137 final: https://research-and-innovation.ec.europa.eu/document/download/47554adc-dffc-411b-8cd6-b52417514cb3_en
[2] Commission Communication on Artificial Intelligence for Europe; COM(2018) 237 final: https://digital-strategy.ec.europa.eu/en/policies/european-approach-artificial-intelligence; https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=COM:2018:237:FIN
[3] Commission Communication on the digital transformation of health and care; COM(2018) 233 final
[4] Entities assessed as “high-risk suppliers”, are currently set out in the second report on Member States’ progress in implementing the EU toolbox on 5G cybersecurity of 2023 (NIS Cooperation Group, Second report on Member States’ progress in implementing the EU Toolbox on 5G Cybersecurity, June 2023) and the related Communication on the implementation of the 5G cybersecurity toolbox of 2023 (Communication from the Commission: Implementation of the 5G cybersecurity Toolbox, Brussels, 15.6.2023 C(2023) 4049 final).
Eligibility & Conditions
General conditions
1. Admissibility Conditions, Proposal page limit and layout
2. Eligible Countries
Eligible Countries are 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.
3. Other Eligible Conditions
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.
The Joint Research Centre (JRC) may participate as member of the consortium selected for funding.
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).
The following exceptions apply: subject to restrictions for the protection of European communication networks.
Other Eligible Conditions are described in Annex B of the Work Programme General Annexes.
4. Financial and operational capacity and exclusion
Financial and operational capacity and exclusion are described in Annex C of the Work Programme General Annexes.
5a. Evaluation and award: Award criteria, scoring and thresholds
Evaluation and award: Award criteria, scoring and thresholds are described in Annex D of the Work Programme General Annexes.
5b. Evaluation and award: Submission and evaluation processes
The thresholds for each criterion will be 4 (Excellence), 4 (Impact) and 4 (Implementation). The cumulative threshold will be 12.
Evaluation and award: Submission and evaluation processes are described in Annex F of the Work Programme General Annexes and the Online Manual.
5c. Evaluation and award: Indicative timeline for evaluation and grant agreement
Evaluation and award: Indicative timeline for evaluation and grant agreement are described in Annex F of the Work Programme General Annexes.
6. Legal and financial set-up of the grants
Legal and financial set-up of the grants are described in Annex G of the Work Programme General Annexes.
Specific conditions
Specific conditions are described in the specific topic of the Work Programme.
Application and evaluation forms and additional documents:
Application and evaluation form templates
Standard application form (HE RIA, IA) - the application form specific to this call is available in the Submission System
Standard evaluation form (HE RIA, IA) - will be used with the necessary adaptations
Guidance
Model Grant Agreements (MGA)
Call-specific instructions
Additional documents
HE Main Work Programme 2025 – 1. General Introduction
HE Main Work Programme 2025 – 4. Health
HE Main Work Programme 2025 – 14. General Annexes
HE Framework Programme 2021/695
HE Specific Programme Decision 2021/764
EU Financial Regulation 2024/2509
Decision authorising the use of lump sum contributions under the Horizon Europe Programme
Rules for Legal Entity Validation, LEAR Appointment and Financial Capacity Assessment
EU Grants AGA — Annotated Model Grant Agreement
Funding & Tenders Portal Online Manual
Support & Resources
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Horizon Europe Programme Guide contains 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.
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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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Latest Updates
Call HORIZON-HLTH-2025-01 closed on 16 September 2025. 749 proposals were submitted. The breakdown per topic is:
- HORIZON-HLTH-2025-01-DISEASE-01: 30 proposals
- HORIZON-HLTH-2025-01-DISEASE-03: 15 proposals
- HORIZON-HLTH-2025-01-DISEASE-04: 76 proposals
- HORIZON-HLTH-2025-01-DISEASE-05: 7 proposals
- HORIZON-HLTH-2025-01-DISEASE-06: 158 proposals
- HORIZON-HLTH-2025-01-DISEASE-07: 83 proposals
- HORIZON-HLTH-2025-01-CARE-01: 118 proposals
- HORIZON-HLTH-2025-01-TOOL-01: 57 proposals
- HORIZON-HLTH-2025-01-TOOL-02: 35 proposals
- HORIZON-HLTH-2025-01-TOOL-03: 82 proposals
- HORIZON-HLTH-2025-01-TOOL-05: 25 proposals
- HORIZON-HLTH-2025-01-IND-01: 58 proposals
- HORIZON-HLTH-2025-01-IND-02: 5 proposals
Evaluation results are expected to be communicated on Wednesday 21 January 2026 at the earliest.
Please note that due to a technical issue, during the first days of publication of this call, the topic page did not display the description of the corresponding destination. This problem is now solved. In addition to the information published in the topic page, you can always find a full description of the relevant destination in the Work Programme 2025 part for "Health". Please select from the work programme the destination relevant to your topic and take into account the description and expected impacts of that destination for the preparation of your proposal.