Cluster 1 - Health (Single stage - 2027/2)

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^[1].

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 to drive the development and adoption of innovative technologies and digital solutions to improve healthcare and health systems. This will ensure that the EU remains at the forefront of breakthrough health and medical technologies and can achieve open strategic autonomy in essential medical supplies and digital innovations.

In line with the Commission's Political Guidelines for 2024-2029^[2], this destination will support research and innovation in tools and technologies strengthening the competitiveness of European health industry and reinforcing EU autonomy. This effort will contribute to the completion of the European Health Union which aims to enhance the resilience of healthcare systems, facilitate access to innovative and affordable healthcare solutions, and ensure that all citizens have access to high-quality, equitable, inclusive and sustainable healthcare.

The development and use of innovative tools and technologies for biomedical research are the basis for prevention, early diagnosis, efficacious therapy and patient monitoring, essential components of efficient healthcare. These include enabling technologies, not least innovative biotechnological approaches, and emerging technologies like synthetic biology, digital tools including those based on Machine-Learning/Artificial Intelligence (ML/AI) and other data-driven approaches which will enable the development of more personalised medicine. Hence the combination of innovative tools, high-quality health data (incl. Real-World Data - RWD^[3]), digital technologies, modelling and AI tools holds great potential not only for advancing biomedical Research and Innovation but for developing health technologies that improve healthcare.

However, the implementation of these tools and technologies faces specific barriers such as scalability, regulatory frameworks and public acceptance and trust. To overcome these challenges cross-sectoral cooperation among stakeholders including researchers, regulatory bodies, policymakers, industry, healthcare providers and patients, is necessary. This collaboration will facilitate the design and development of innovative health products and services, tailored to specific population groups, ultimately improving patient outcomes and reducing health inequalities.

By taking a comprehensive and inclusive approach, this destination will prioritise the development of novel tools and technologies that address key considerations such as the rights of the individual, safety, effectiveness, appropriateness, accessibility, comparative value-added and fiscal sustainability while also ensuring ethical, legal and regulatory compliance.

In this Work Programme part, Destination “Developing and using new tools, technologies and digital solutions for a healthy society” is driven mainly by three key Commission policies, the “Biotechnology and Biomanufacturing Communication”^[4] the “Artificial Intelligence Strategy”^[5] and the “Strategy for European Life Sciences”^[6] and focuses on developing and applying innovative technologies to improve human health and healthcare systems. The topics under this destination cover efforts to develop AI based predictive biomarkers for disease prognosis and treatment response, advancing bio-printing of living cells for regenerative medicine, and integrating New Approach Methodologies (NAMs) to advance biomedical research, as well as developing virtual human twins for integrated clinical decision support.

To increase the impact of EU investments under Horizon Europe, the Commission encourages cooperation between EU-funded projects to enable cross-fertilisation and other synergies. For example, this cooperation could take the form of networking, to joint activities, such as the participation in joint workshops, exchange of knowledge, 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 different topics, Clusters or Pillars of Horizon Europe. Specifically, this could involve projects related to European health research infrastructures (under Pillar I of Horizon Europe), the EIC^[7] strategic challenges on health (under Pillar III of Horizon Europe) or with projects on themes that cut across the Clusters of Pillar II such as with Cluster “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, accessible 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)^[8].
• 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 AI supported decision-making, in a secure, ethical and inclusive 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.

Legal entities established in China are not eligible to participate in both Research and Innovation Actions (RIAs) and Innovation Actions (IAs) falling under this destination. For additional information please see “Restrictions on the participation of legal entities established in China” found in the Annex B of the General Annexes of this Work Programme.

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^[9] 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] https://research-and-innovation.ec.europa.eu/funding/funding-opportunities/funding-programmes-and-open-calls/horizon-europe/strategic-plan_en

[2] https://commission.europa.eu/about/commission-2024-2029_en

[3] EMA definition: “Real-World Data are routinely collected data relating to patient health status or the delivery of healthcare from a variety of sources other than traditional clinical trials (e.g. claims databases, hospital data, electronic health records, registries, mhealth data, etc.)”.

[4] 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

[5] 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

[6] 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

[7] https://eic.ec.europa.eu

[8] Commission Communication on the digital transformation of health and care; COM(2018) 233 final

[9] 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).

Expected Outcome:

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 that are directed at, tailored towards and contributing to all the following expected outcomes:

• Researchers and innovators benefit from an improved understanding of how to develop and use the next generation of frontier Artificial Intelligence (AI) models for healthcare, including how to leverage AI Factories and how to combine and expand the capabilities of existing foundation models towards inclusive and personalised medicine.
• 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, towards Artificial General Intelligence (AGI) 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. The next generation of frontier AI models are expected to make strides towards AGI, a type of AI capable of tackling highly complex and diverse tasks with proficiency comparable to that of humans. 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, towards AGI 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].

[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