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

The GenAI4EU grant under Horizon Europe's Health Cluster focuses on advancing generative AI (GenAI) applications in biomedical research while adhering to EU ethical standards and regulations. The call targets startups and small to medium enterprises (SMEs) working on AI and health technologies, with potential involvement from universities and research institutions as collaborators.

This initiative is a Research and Innovation Action (HORIZON-RIA) which typically involves monetary support and requires forming consortia. The geographic eligibility encompasses EU member states and associated nations, and there are opportunities for participation from entities in the United States under specific conditions.

The primary sector targeted by this grant is healthcare, specifically about developing GenAI models that utilize multimodal biomedical data, such as medical imaging, genomics, and electronic health records. The emphasis is on creating ethical and trustworthy GenAI solutions focused on predictive and personalized medicine.

The funding amounts for projects are expected to range from one million to five million euros, based on similar grants within this domain, though specific amounts are not detailed in the call data. The application process is single-stage and is open for submissions until September 16, 2025.

Key outcomes include providing researchers with access to robust GenAI models, developing methodologies to assess these models’ ethical implications and effectiveness, and ensuring alignment with human values. Proposals are encouraged to build new or adapt existing GenAI models, demonstrating their clinical utility and addressing existing gaps in AI capabilities.

Projects should support fair data principles and be compliant with GDPR processes. Collaboration among various sectors and background areas, including the social sciences, is highly encouraged. The initiative aims to position Europe as a leader in the ethical application of AI in healthcare by fostering the development of tools that enable breakthrough scientific discoveries while addressing concerns such as transparency, inclusivity, and bias mitigation.

Successful projects may gain access to significant EU resources, including supercomputing capabilities and partnerships with industry leaders. The grant actively seeks to enhance multidisciplinary cooperation and leverage existing European data infrastructures, aligning with the broader objective of boosting AI capacities across key sectors.

This is a summary of a Horizon Europe funding opportunity focused on leveraging multimodal data to advance Generative Artificial Intelligence (AI) applicability in biomedical research, also known as GenAI4EU, under the call HORIZON-HLTH-2025-01-TOOL-03. It is a HORIZON Research and Innovation Action (RIA) with a budget of 50,000,000 EUR for the year 2025. The call is a single-stage process, opening on May 22, 2025, and closing on September 16, 2025, at 17:00 Brussels time. The expected contribution per project ranges from 15,000,000 to 17,000,000 EUR, with an indicative number of 3 grants to be awarded.

The primary goal of this funding opportunity is to support activities that contribute to the development and use of new tools, technologies, and digital solutions for a healthy society. The expected outcomes include:

Researchers, including clinical researchers, having access to robust, trustworthy, and ethical Generative AI models that can effectively advance biomedical research towards predictive and personalised medicine.

Researchers, including clinical researchers, knowing how to use Generative AI models to synthesise available scientific information and large-scale multimodal data, and how to apply necessary precautions to deliver new knowledge and breakthrough scientific discoveries.

The research community benefiting from advanced methodologies to assess the validity and application of accurate, transparent, traceable, and explainable Generative AI models.

The scope of the topic encompasses the development, evaluation, and ethical considerations surrounding the use of Generative AI in biomedical research. Proposals should address existing gaps related to Generative AI capabilities and limitations.

Key activities to be included in research actions are:

Developing new or repurposing existing Generative AI models for biomedical research across various medical fields and/or therapeutic indications. These models should be robust and based on large-scale, complex, and multimodal high-quality data, including but not limited to medical imaging, genomics, proteomics, other molecular data, electronic health records, laboratory results, unstructured health data, and available scientific and public information.

Developing 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. Active engagement of potential end-users in the development, adaptation, and testing of the models is required, considering sustainability aspects.

Developing or revising 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 Generative AI models. This includes:

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.

Metrics for model intelligibility, robustness, alignment with ethical principles, and approaches for ethical evaluation of AI trustworthiness.

Solutions to identify and mitigate potential bias and confounding of Generative AI models, including 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).

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

Proposals must adhere to the FAIR data principles and apply GDPR compliant processes for personal data protection. They should promote the highest standards of transparency and openness of models, going beyond documentation to include aspects such as assumptions, code, and FAIR data management.

Synergies with other relevant projects funded under Horizon Europe and/or Digital Europe Programmes are encouraged. Proposals should leverage knowledge/data platforms already developed by relevant Horizon Europe Partnerships or missions, such as the Virtual Platform of the European Joint Programme of Rare Diseases. Applicants are encouraged to leverage available and emerging European data infrastructures, such as the European Health Data Space, European Genomic Data Infrastructure, Cancer Image Europe, European Open Science Cloud, and EBRAINS. Adopting EOSC recommendations and services for high-quality software is also encouraged.

The effective contribution of social sciences and humanities (SSH) disciplines is required, including the involvement of SSH experts and institutions.

Successful proposals are encouraged to utilise the resources offered by the AI factories, when relevant.

Proposals should consider the involvement of the European Commission's Joint Research Centre (JRC) for providing an effective interface between research activities and pre-normative regulatory science.

Collaboration among selected projects is strongly encouraged, including participation in networking and joint activities, exchange of knowledge, and development of best practices. A budget for attendance to regular joint meetings should be included.

Applicants planning to include clinical studies should provide details in a dedicated annex.

The call is a single-stage submission process. Admissibility conditions, proposal page limits, eligible countries, and other conditions are detailed in the Horizon Europe Work Programme General Annexes and Programme Guide. The evaluation criteria include Excellence, Impact, and Implementation, each with a threshold of 4, and a cumulative threshold of 12.

The legal and financial setup of the grants is described in Annex G of the Work Programme General Annexes. Specific conditions are described in the specific topic of the Work Programme.

Application and evaluation form templates, the HE Programme Guide, Model Grant Agreements (MGA), and call-specific instructions are available in the Submission System and through provided links.

The Funding & Tenders Portal provides access to an Online Manual, FAQs, a Research Enquiry Service, National Contact Points (NCPs), the Enterprise Europe Network, and an IT Helpdesk for support.

In summary, this Horizon Europe call aims to foster the development and responsible use of Generative AI in biomedical research to advance predictive and personalised medicine. It encourages collaborative, multidisciplinary projects that address ethical considerations, data quality, and the practical application of AI models in various medical fields. The call seeks to bridge the gap between AI technology and biomedical research, ultimately benefiting researchers, clinicians, and patients across Europe and associated countries.

Eligible Applicant Types: The eligible applicant types are broad, including industry (including leading-edge startups), academia, and healthcare professionals. The call emphasizes multidisciplinary approaches and a broad representation of stakeholders in the consortia. Legal entities established in the United States of America are also eligible to receive Union funding. The Joint Research Centre (JRC) may participate as a member of the consortium.

Funding Type: The funding type is primarily a grant, specifically a HORIZON Research and Innovation Action (RIA) and HORIZON Innovation Action (IA) under the Horizon Europe program. There are also Coordination and Support Actions (CSA). The grants are budget-based.

Consortium Requirement: The opportunity requires a consortium of multiple applicants. The call specifies ensuring multidisciplinary approaches and a broad representation of stakeholders in the consortia, including industry, academia, and healthcare professionals.

Beneficiary Scope (Geographic Eligibility): The geographic eligibility includes the EU and Associated countries. Non-EU/non-Associated Countries may also be eligible if they have made specific provisions for funding their participants in Horizon Europe projects. Legal entities established in the United States of America are also eligible.

Target Sector: The program targets the health sector, specifically biomedical research, predictive and personalized medicine, and the development and use of new tools, technologies, and digital solutions for a healthy society. It focuses on Generative AI, medical imaging, genomics, proteomics, electronic health records, and related areas.

Mentioned Countries: United States of America, EU, Associated countries

Project Stage: The expected maturity of the project is research, development, and demonstration, with a focus on developing new or repurposing existing Generative AI models, developing proofs of concept, and revising existing methodologies. The projects should demonstrate scientific added value and potential future clinical utility.

Funding Amount: The funding amounts vary depending on the specific topic within the call. Some examples include:
HORIZON-HLTH-2025-01-CARE-01: EUR 15,000,000 to EUR 20,000,000
HORIZON-HLTH-2025-01-DISEASE-01: Around EUR 15,000,000
HORIZON-HLTH-2025-01-TOOL-03: EUR 15,000,000 to EUR 17,000,000
HORIZON-HLTH-2025-01-TOOL-05: EUR 4,000,000 to EUR 8,000,000
HORIZON-HLTH-2025-01-DISEASE-05: Around EUR 2,000,000
HORIZON-HLTH-2025-01-IND-02: Around EUR 4,000,000
The total budget allocated to the call is EUR 486,000,000.

Application Type: The application type is an open call with a single-stage submission process.

Nature of Support: Beneficiaries will receive money in the form of grants to support their research and innovation activities.

Application Stages: The application process is a single-stage process.

Success Rates: The success rates are not explicitly mentioned, but the indicative number of grants for each topic provides some insight. For example, HORIZON-HLTH-2025-01-TOOL-05 aims to award 10 grants, while HORIZON-HLTH-2025-01-DISEASE-05 aims to award only 1 grant.

Co-funding Requirement: The information does not explicitly state a co-funding requirement.

Summary:
This Horizon Europe call, specifically under Cluster 1 Health, focuses on "Leveraging multimodal data to advance Generative Artificial Intelligence applicability in biomedical research (GenAI4EU)". The call aims to fund research and innovation actions that develop and utilize trustworthy and ethical Generative AI models to advance biomedical research and personalized medicine. The European Commission recognizes the potential of Generative AI combined with large-scale health data and high-performance computing to revolutionize disease understanding, predictive models, and personalized treatment.

The call encourages multidisciplinary consortia involving industry, academia, and healthcare professionals from the EU and Associated countries, with some opportunities for US entities. Projects should focus on developing new or repurposing existing Generative AI models, demonstrating their value through proofs of concept in different medical fields, and developing methodologies to assess their applicability, performance, and ethical implications. Open-source approaches, adherence to FAIR data principles and GDPR, and leveraging existing European data infrastructures are highly encouraged. The call includes various topics with different budget allocations and expected outcomes, ranging from research and innovation actions (RIA) to coordination and support actions (CSA). The application process is a single-stage submission, with a deadline of September 16, 2025.