Call for proposals for health data for biotech innovation leveraging the European Health Data Space

The EU funding opportunity under the EU4Health Programme is titled "Call for proposals for health data for biotech innovation leveraging the European Health Data Space." It is referenced as EU4H-2026-SANTE-PJ-08. The call is set to open on September 23, 2025, and will close on January 6, 2026. A total budget of €14,386,810 is allocated for this initiative.

The primary objective is to accelerate the development and deployment of artificial intelligence and digital solutions within the biotechnology sector by leveraging health data sourced from the European Health Data Space (EHDS). This initiative aims to establish a multistakeholder platform that includes various stakeholders such as the biotech industry, research institutions, healthcare providers, patient organizations, regulatory bodies, and AI Factories.

Eligible applicants for this grant include secondary or higher education institutions, research organizations, hospitals, healthcare institutions, NGOs, developers, and private or public entities with expertise in diagnostics and biotech innovation. A consortium approach is highly encouraged, considering the need for diverse expertise to address the comprehensive scope of the objectives outlined in the call.

The expected project outcomes include increased collaboration, enhanced health data utilization, and improved health outcomes. Specific goals involve the identification of promising AI applications, an analysis of barriers to digital innovation in biotechnology, and the development of strategic recommendations to support the coordinated growth of the EHDS.

The application process will be a single-stage submission, where full proposals must be submitted by the deadline. While co-funding is likely to be required, specific details will be provided in the official documentation. Successful projects are expected to be at various stages, ranging from development to demonstration.

The call aligns with the European strategy to enhance the competitiveness of the biotech sector, aiming to strengthen Europe’s position in global biotech and digital health innovations.

This EU funding opportunity is part of the EU4Health Programme (EU4H) and falls under the EU4H SANTE Action Grants 2025 (EU4H-2026-SANTE-PJ) call. It is categorized as an EU4H Project Grant (EU4H-PJG) and utilizes an EU4H Action Grant Budget-Based [EU4H-AG] Model Grant Agreement (MGA). The call follows a single-stage submission process. The planned opening date for submissions is September 23, 2025, and the deadline for submissions is January 6, 2026, at 17:00:00 Brussels time.

The primary objective of this action is to accelerate the development and deployment of AI and digital solutions within the biotech sector, leveraging health data in a secure and responsible manner through the European Health Data Space (EHDS), and utilizing AI Factories to enhance these efforts.

The expected impact includes: Increased collaboration and knowledge-sharing by establishing an active network of stakeholders across the biotech and healthcare sectors. Accelerated innovation in the Union’s biotech industry through the support of effective digital and AI solutions, driving competitiveness with AI Factory-enabled advancements. Enhanced health outcomes by facilitating the broader adoption of digital and AI solutions in biotechnology, improving patient care, diagnosis accuracy, and treatment efficiency. Regulatory clarity by defining requirements and standards for AI development and deployment in the biotech sector, providing pathways for stakeholders and integrating health data and research infrastructures into EHDS frameworks.

The specific objectives of this call are to: Create a multistakeholder platform involving the biotech industry, data holders, healthcare providers, patient organizations, regulatory bodies, and AI Factories to exchange best practices on data access, AI applications, and innovation acceleration. Identify and prioritize promising digital and AI applications for the biotech sector based on their potential impact on health outcomes, feasibility, technological maturity, and alignment with sectoral needs, potentially leveraging AI Factory resources for enhancement and validation. Analyze challenges and barriers to the development and deployment of digital and AI solutions in the biotech sector, including data quality, regulatory frameworks, ethical and privacy concerns, intellectual property ownership, technical barriers, and scientific validation, and identify solutions to address these challenges, guiding the effective utilization of the EHDS. Develop concrete recommendations to support the coordinated development of the EHDS for digital and AI solutions in the biotech sector, targeting policymakers, industry leaders, and researchers, with a focus on fostering innovation, improving health outcomes, and enhancing the competitiveness of the Union’s biotechnology sector.

The scope of the projects should include: Establishing a multistakeholder platform/community of practice that brings together the biotech industry, research institutions, healthcare providers, patient organizations, regulatory bodies, and AI Factories to facilitate collaboration, knowledge-sharing, and discussion of challenges in the use of AI in the biotechnology sector. Conducting a landscape analysis to map the current state of leveraging health data for AI in the biotech sector and identify the most relevant health datasets, building on existing projects and potentially incorporating AI Factories to explore further application potential. Developing a strategic roadmap for the development, deployment, and scale-up of effective AI solutions in the biotech sector, including recommendations for policy-makers, industry leaders, and researchers, promoting the adoption of standardized data formats and frameworks, taking into account AI Factory capabilities. Piloting the roles for health data infrastructures under the EHDS frameworks, analyzing and piloting the roles and potential federation of specific health data infrastructures (genomic, cancer imaging, and brain) within the EHDS frameworks, as well as access to computing resources and related data and support services, to support AI-driven biotech innovations. Developing case studies of successful AI applications in the biotech sector, focusing on explainable AI, and sharing them with stakeholders to promote best practices and knowledge-sharing. Integrating AI Factory expertise by incorporating AI Factory technological advancements in collaboration with the use of the EHDS infrastructure, for simulations and analytics to refine and optimize biotech AI solutions, ensuring alignment with healthcare needs. Monitoring and evaluating progress by piloting a methodology and tools to monitor and evaluate progress towards the strategic roadmap objectives, to provide insights and adjustments needed for continuous improvement.

The admissibility conditions include proposal page limits and layout, which are described in section 5 of the call document and Part B of the Application Form available in the Submission System. Eligible countries are described in section 6 of the call document, as are other eligible conditions. Financial and operational capacity and exclusion criteria are detailed in section 7 of the call document. The submission and evaluation processes are described in section 8 of the call document and the Online Manual. Award criteria, scoring, and thresholds are described in section 9 of the call document. The indicative timeline for evaluation and grant agreement is described in section 4 of the call document. The legal and financial set-up of the grants is described in section 10 of the call document.

The call document and annexes include: The call document itself. Application form templates, including the standard application form (EU4H) available in the Submission System and a detailed budget table (EU4H). Model Grant Agreements (MGA), specifically the EU4H MGA. Additional documents such as the EU4H Work Programme, EU4H Regulation 2021/522, EU Financial Regulation 2024/2509, 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, and Funding & Tenders Portal Privacy Statement.

The budget overview for the year 2025 includes the following topics: EU4H-2026-SANTE-PJ-01 EU4H Project Grants with a budget of 3,000,000 EUR, EU4H-2026-SANTE-PJ-02 EU4H Project Grants with a budget of 7,440,000 EUR, EU4H-2026-SANTE-PJ-03 EU4H Project Grants with a budget of 7,440,000 EUR, EU4H-2026-SANTE-PJ-04 EU4H Project Grants with a budget of 20,000,000 EUR, EU4H-2026-SANTE-PJ-05 EU4H Project Grants with a budget of 2,000,000 EUR, EU4H-2026-SANTE-PJ-06 EU4H Project Grants with a budget of 750,000 EUR, EU4H-2026-SANTE-PJ-07 EU4H Project Grants with a budget of 1,200,000 EUR, EU4H-2026-SANTE-PJ-08 EU4H Project Grants with a budget of 14,386,810 EUR, and EU4H-2026-SANTE-PJ-09 EU4H Project Grants with a budget of 600,000 EUR. All topics are single-stage, have a planned opening date of September 23, 2025, and a deadline of January 6, 2026.

Partner search announcements are available for those looking to collaborate on this topic. LEARs, Account Administrators, and self-registrants can publish partner requests on the Funding & Tenders Portal.

The submission system is planned to open on the date stated on the topic header.

For support, applicants are advised to read all provisions carefully before preparing their application. For help related to this call, contact HaDEA-HP-CALLS@ec.europa.eu. Additional support resources include the Funding & Tenders Portal FAQ, the IT Helpdesk for technical issues, and the Online Manual for a step-by-step guide through the Portal processes.

In summary, this EU4Health Programme call aims to foster the integration of AI and digital solutions within the biotech sector by promoting collaboration, addressing challenges, and developing strategic recommendations. It seeks to leverage health data through the EHDS and AI Factories to drive innovation, improve health outcomes, and enhance the competitiveness of the EU's biotechnology sector. The call encourages the establishment of a multistakeholder platform, landscape analysis, strategic roadmap development, piloting of health data infrastructures, and the creation of case studies, all while integrating AI Factory expertise and monitoring progress towards strategic objectives.

Eligible Applicant Types: The call targets a broad range of stakeholders including the biotech industry, data holders, healthcare providers, patient organizations, regulatory bodies, research institutions, and AI Factories. This suggests eligibility for various entity types such as startups, SMEs, large enterprises, universities, research institutes, nonprofits, and potentially governmental bodies involved in healthcare and biotech innovation.

Funding Type: The primary financial mechanism is a grant, specifically identified as EU4H Project Grants (EU4H-PJG) under the EU4Health Programme. The Model Grant Agreement (MGA) is an EU4H Action Grant Budget-Based [EU4H-AG].

Consortium Requirement: The call encourages collaboration and knowledge-sharing among various stakeholders, suggesting that a consortium approach is favored, although the specific requirement for a consortium versus a single applicant is not explicitly stated. Given the need for a multistakeholder platform, a consortium is highly probable.

Beneficiary Scope (Geographic Eligibility): The call is part of the EU4Health Programme, which generally targets entities within the European Union. The explicit geographic eligibility is described in section 6 of the call document.

Target Sector: The program targets the biotech sector, with a focus on leveraging health data, artificial intelligence (AI), and digital solutions. Specific areas include AI applications, health data infrastructures (genomic, cancer imaging, and brain), and the European Health Data Space (EHDS).

Mentioned Countries: No specific countries are mentioned, but the focus is on the European Union, as the call is part of the EU4Health Programme and aims to enhance the competitiveness of the Union’s biotechnology sector.

Project Stage: The projects are expected to be in the development and deployment stage, focusing on accelerating the implementation of AI and digital solutions. This includes rapid prototyping, testing, and scaling up of AI solutions in the biotech sector, suggesting a maturity level ranging from development to demonstration and potentially early commercialization.

Funding Amount: The funding amounts vary across different topics within the call, ranging from €600,000 to €20,000,000. The specific breakdown is as follows:
EU4H-2026-SANTE-PJ-01: €3,000,000
EU4H-2026-SANTE-PJ-02: €7,440,000
EU4H-2026-SANTE-PJ-03: €7,440,000
EU4H-2026-SANTE-PJ-04: €20,000,000
EU4H-2026-SANTE-PJ-05: €2,000,000
EU4H-2026-SANTE-PJ-06: €750,000
EU4H-2026-SANTE-PJ-07: €1,200,000
EU4H-2026-SANTE-PJ-08: €14,386,810
EU4H-2026-SANTE-PJ-09: €600,000

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 projects.

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

Success Rates: The indicative number of grants is not specified, making it impossible to assess success rates.

Co-funding Requirement: The need for co-funding is not explicitly mentioned in the provided text.

Summary:
This EU4Health Programme call (EU4H SANTE Action Grants 2025) aims to accelerate the development and deployment of AI and digital solutions in the biotech sector, leveraging health data and AI Factories within the European Health Data Space (EHDS). The call encourages the creation of a multistakeholder platform involving biotech industry, healthcare providers, patient organizations, regulatory bodies, and AI Factories. The objectives include identifying promising AI applications, analyzing challenges to AI deployment, and developing recommendations for the coordinated development of the EHDS. The scope covers establishing a community of practice, conducting landscape analysis, developing a strategic roadmap, piloting roles for health data infrastructures, creating case studies, integrating AI Factory expertise, and monitoring progress. The call is structured as a single-stage application process, with funding amounts varying from €600,000 to €20,000,000 depending on the specific topic. The call opens on September 23, 2025, and closes on January 6, 2026. This initiative seeks to enhance collaboration, drive innovation, improve health outcomes, and provide regulatory clarity for AI in the biotech sector across the European Union.