Towards the next generation of frontier Artificial Intelligence models for healthcare

Researchers and innovators benefit from an improved understanding of how to leverage highly heterogeneous and multimodal health data spanning a range of anatomical scales (i.e. the micro to the macro level). Multidisciplinary stakeholders have access to a collaboratively created roadmap for developing the next generation of frontier AI models for healthcare. Scope: The AI Continent Action Plan [1] identifies the health sector, encompassing life sciences, medical devices and healthcare delivery, as one of the key strategic sectors. The action will contribute to making European life sciences [2] and healthcare more impactful and productive by fostering the full integration of advanced AI in the health sector and biomedical research, along the objectives of the AI in Science strategy [3] and Apply AI strategy [4] . Healthcare typically involves the combining of multimodal data, ranging from electronic health records through imaging and laboratory to molecular and omics data. This information combination is performed by specialists and is often challenging towards optimised patient care. In Europe, the growing amount of accessible multimodal health data, including via the forthcoming European Health Data Space (EHDS) [5] , combined with the increasing availability of high-performance computing facilities (e.g. AI Factories), presents a unique opportunity to develop the next generation of frontier AI models for healthcare. This action anticipates and operationalises the use of such federated infrastructures for research and innovation. Moreover, regulations such as the EHDS regulation and AI Act [6] steer the direction into building an ecosystem fostering ethical and safe innovation on AI in healthcare. AI models are becoming increasingly complex and able to tackle increasingly challenging tasks. This topic will lay the foundation for the development of the next generation of frontier AI models, paving the way for new, advanced AI-powered solutions to increase efficiency and efficacy in the health sector towards improved patient outcomes. It will leverage results, methodologies, data etc. of other relevant EU-funded projects. Proposals should include all the following coordination and support activities, ensuring multidisciplinary approaches and a broad representation of stakeholders in the consortium (e.g. healthcare professionals, patients, biomedical scientists, AI developers, data engineers, ethics experts): Community building: build a large-scale and diverse pan-European community of stakeholders with the multidisciplinary expertise united as required to develop the next generation of frontier AI models for healthcare, with a view to leveraging as a community the potential of AI Factories. Where relevant, this should build on and strengthen existing EU-funded communities and networks, and could pave the way for a formalised long-term collaboration under one of the available EU instruments. Roadmap creation: review previous research to identify the most promising AI models and model development approaches. In addition, risk assess and review evidence on safety and efficacy of existing AI models with reference to the AI Act, related regulatory provisions (including any jurisprudence) and ethical and security considerations, so that frontier AI model development can proceed on a well-informed basis. Finally, create a roadmap for developing the next generation of frontier AI models. Dataset identification, curation, expansion and use: i) identification: identify the most suitable existing datasets for the development of frontier AI models for healthcare, ii) curation: identify how to validate the datasets, ensure dataset interoperability, and convert datasets into formats suitable for frontier AI model development, iii) expansion: identify additional datasets and/or annotations required for frontier AI model development, especially to ensure that datasets are representative and iv) use: identify methods and required infrastructure to allow privacy-preserving use and further expansion of the datasets in alignment with and through the EHDS. Frontier AI model preparatory activities: mapping approaches for training and evaluating frontier AI models (e.g. approaches to combine foundation models for life sciences and healthcare delivery in order to develop more advanced and multidisciplinary models towards personalised medicine). The approaches should cover all trustworthy AI aspects [7] . This action should take into account the results of other relevant projects on AI in health, in particular in the two GenAI4EU topics HORIZON-HLTH-2025-01-CARE-01: “End user-driven application of Generative Artificial Intelligence models in healthcare (GenAI4EU)” and HORIZON-HLTH-2025-01-TOOL-03: “Leveraging multimodal data to advance Generative Artificial Intelligence applicability in biomedical research (GenAI4EU)”, and leverage the AI Factories and specialised health data infrastructures funded under the Digital Europe Programme [8] , biobanks, relevant ERICs [9] , as well as the data resources accessible through the EHDS infrastructure starting in 2029, funded under EU4Health Programme (2021-2027) [10] . This topic requires the effective contribution of social sciences and humanities (SSH) disciplines and the inclusion of relevant SSH expertise, in order to produce meaningful and significant effects enhancing the societal impact of the related research activities. [1] https://digital-strategy.ec.europa.eu/en/library/ai-continent-action-plan [2] https://research-and-innovation.ec.europa.eu/strategy/strategy-research-and-innovation/jobs-and-economy/towards-strategy-european-life-sciences_en ; https://ec.europa.eu/commission/presscorner/detail/en/ip_25_1686 [3] https://research-and-innovation.ec.europa.eu/research-area/industrial-research-and-innovation/artificial-intelligence-ai-science_en [4] https://digital-strategy.ec.europa.eu/en/consultations/commission-launches-public-consultation-and-call-evidence-apply-ai-strategy [5] https://health.ec.europa.eu/ehealth-digital-health-and-care/european-health-data-space-regulation-ehds_en [6] https://digital-strategy.ec.europa.eu/en/policies/regulatory-framework-ai , https://eur-lex.europa.eu/eli/reg/2024/1689/oj [7] https://digital-strategy.ec.europa.eu/en/library/ethics-guidelines-trustworthy-ai [8] https://digital-strategy.ec.europa.eu/en/activities/digital-programme [9] European Research Infrastructure Consortia: https://www.eric-forum.eu/the-eric-landscap [10] https://commission.europa.eu/funding-tenders/find-funding/eu-funding-programmes/eu4health_en

Eligibility and submission conditions

"> General conditions 1. Admissibility Conditions, proposal page limit and layout Admissibility conditions are described in Annex A and Annex E of the Horizon Europe Work Programme General Annexes. Proposal page limits and layout are described in Part B of the Application Form available in the Submission System. 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 Eligibility Conditions In order to achieve the expected outcomes, and safeguard the Union’s strategic assets, interests, autonomy, or security, it is important to avoid a situation of technological dependency on a non-EU source, in a global context that requires the EU to take action to build on its strengths, and to carefully assess and address any strategic weaknesses, vulnerabilities and high-risk dependencies which put at risk the attainment of its ambitions. For this reason, participation is limited to legal entities established in Member States and Associated Countries. Proposals including entities established in countries outside the scope specified in the topic will be ineligible. For the duly justified and exceptional reasons listed in the paragraph above, in order to guarantee the protection of the strategic interests of the Union and its Member States, entities established in an eligible country listed above, but which are directly or indirectly controlled by a non-eligible country or by a non-eligible country entity, may not participate in the action unless it can be demonstrated, by means of guarantees positively assessed by their eligible country of establishment, that their participation to the action would not negatively impact the Union’s strategic assets, interests, autonomy, or security. Entities established in an eligible country, but which are directly or indirectly controlled by China or by a legal entity established in China cannot submit guarantees.[[The guarantees shall in particular substantiate that, for the purpose of the action, measures are in place to ensure that: a) control over the applicant legal entity is not exercised in a manner that retrains or restricts its ability to carry out the action and to deliver results, that imposes restrictions concerning its infrastructure, facilities, assets, resources, intellectual property or know-how needed for the purpose of the action, or that undermines its capabilities and standards necessary to carry out the action; b) access by a non-eligible country or by a non-eligible country entity to sensitive information relating to the action is prevented; and the employees or other persons involved in the action have a national security clearance issued by an eligible country, where appropriate; c) ownership of the intellectual property arising from, and the results of, the action remain within the recipient during and after completion of the action, are not subject to control or restrictions by non-eligible countries or non-eligible country entity, and are not exported outside the eligible countries, nor is access to them from outside the eligible countries granted, without the approval of the eligible country in which the legal entity is established.]] 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). Other eligibility 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 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. 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 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 Eligible costs will take the form of a lump sum as defined in the Decision of 7 July 2021 authorising the use of lump sum contributions under the Horizon Europe Programme – the Framework Programme for Research and Innovation (2021-2027) – and in actions under the Research and Training Programme of the European Atomic Energy Community (2021-2025) [This [decision is available on the Funding and Tenders Portal, in the reference documents section for Horizon Europe, under ‘Simplified costs decisions’ or through this link: https://ec.europa.eu/info/funding-tenders/opportunities/docs/2021-2027/horizon/guidance/ls-decision_he_en.pdf ]]. 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 CSA) - the application form specific to this call is available in the Submission System. Standard evaluation form (HE CSA) - will be used with the necessary adaptations. Guidance HE Programme Guide Model Grant Agreement (MGA) Lump Sum MGA Call-specific instructions Detailed budget table (HE LS) Guidance: "Lump sums - what do I need to know?" Ownership control declaration Additional documents HE Main Work Programme 2026-2027 – 1. General Introduction HE Main Work Programme 2026-2027 – 4. Health HE Main Work Programme 2026-2027 – 15. General Annexes HE Programme Guide 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 Funding & Tenders Portal Terms and Conditions Funding & Tenders Portal Privacy Statement

Hivatkozott dokumentumok

Annex A Horizon Europe Programme Guide Online Manual [This [decision Standard application form (HE CSA) Standard evaluation form (HE CSA) Lump Sum MGA Detailed budget table (HE LS) Guidance: "Lump sums - what do I need to know?" Ownership control declaration HE Main Work Programme 2026-2027 – 1. General Introduction HE Main Work Programme 2026-2027 – 4. Health Rules for Legal Entity Validation, LEAR Appointment and Financial Capacity Assessment EU Grants AGA — Annotated Model Grant Agreement Funding & Tenders Portal Terms and Conditions