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Call key data
Call for proposals for health data for biotech innovation leveraging the European Health Data Space
Funding Program
EU4Health programme 2021-2027
Call number
EU4H-2026-SANTE-PJ-08
deadlines
Opening
23.09.2025
Deadline
06.01.2026 17:00
Funding rate
60%
Call budget
€ 14,386,810.00
Estimated EU contribution per project
€ 14,386,810.00
Link to the call
Link to the submission
Call content
short description
The general objective of this action is to accelerate the development and deployment of AI and digital solutions in the biotech sector driven by health data, ensuring its secure and responsible use through the EHDS and leveraging AI Factories to augment these efforts.
Call objectives
- Establish a multistakeholder platform/community of practice: create a platform that brings together biotech industry, research institutions, healthcare providers, patient organisations, and regulatory bodies and AI Factories to facilitate collaboration, knowledge-sharing among stakeholders, and the discussion of challenges in the use of AI in the biotechnology sector.
- Conduct a landscape analysis: map the current state of leveraging health data for AI in the biotech sector and identify the most relevant health datasets for the biotech sector, based on criteria such as potential impact on health outcomes, feasibility, and alignment with sectoral needs. Building on existing projects. Potentially incorporate also the AI Factories in this landscape analysis to also explore further application potential.
- Develop a strategic roadmap: create a 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. Promote the adoption of standardized data formats and frameworks that facilitate the role data and research infrastructure relevant to the biotech sector, taking into account AI Factory capabilities and building on existing projects and activities in this area.
- Pilot the roles for health data infrastructures under the EHDS frameworks: This activity involves analysing and piloting the roles, and the potential federation of, specific health data infrastructures (genomic, cancer imaging, and brain) within the EHDS frameworks, as well as access to computing resources, and other related data and support services, to support AI-driven biotech innovations. The analysis shall examine the current state of these infrastructures, identify gaps and limitations, and pilot their integration with the EHDS frameworks to enable seamless data sharing and access. The goal is to demonstrate the value of these infrastructures in supporting AI applications in the biotech sector and provide recommendations for integration of such infrastructures into the EHDS frameworks.
- Develop case studies: create case studies of successful AI applications in the biotech sector, and share them with stakeholders to promote best practices, pathways and knowledge-sharing, these case studies should focus on explainable AI.
- Integrate AI Factory Expertise: Incorporate AI Factory technological advancements in collaboration with the use of the EHDS infrastructure, for simulations and analytics to refine and optimise biotech AI solutions, ensuring alignment with healthcare needs.
- Monitor and evaluate progress: pilot a methodology and tools to monitor and evaluate progress towards the strategic roadmap objectives, to provide insights and adjustments needed for continuous improvement.
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Expected effects and impacts
The expected results and impact are:
- Increased collaboration and knowledge-sharing: establish an active network of stakeholders, encouraging collaboration and knowledge-sharing among biotech and healthcare sectors.
- Accelerate innovation in the Union’s biotech industry: support the development and deployment of effective digital / AI solutions in the biotech sector, driving innovation and competitiveness of the Union's biotech industry, including through AI Factoryenabled advancements.
- Enhanced health outcomes: facilitate the broader adoption of digital / AI solutions in the biotechnology sector enhancing patient care, diagnosis accuracy and treatment efficiency across the Union.
- Regulatory clarity: clarify regulatory requirements and standards/specifications for AI development and deployment relevant to the biotech sector and provide pathways for biotech stakeholders and for health data and research infrastructures integration into the EHDS frameworks.
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Expected results
- Create a multistakeholder platform that brings together the biotech industry, data holders, healthcare providers, patient organisations, regulatory bodies and AI Factories to exchange best practices on data access, AI applications, and innovation acceleration, facilitating collaboration, knowledge-sharing, and innovation in the biotechnology sector.
- Identify and prioritise the most promising digital / AI applications for the biotechnology sector, based on criteria such as potential impact on health outcomes, feasibility, technological maturity, and alignment with sectoral needs. Potentially, while also leveraging AI Factory resources for enhancement and validation, rapid prototyping and testing of AI-driven biotech solutions, enhancing the speed and efficiency of bringing innovations from concept to healthcare implementation.
- Analyse the challenges and barriers to the development and deployment of digital / AI solutions in the biotechnology sector, including data quality and availability, regulatory frameworks, ethical and privacy concerns, intellectual property ownership, technical barriers, and scientific validation, and identify potential solutions or strategies to address these challenges, guiding the effective utilization of the EHDS.
- Develop concrete recommendations to support the coordinated development of the EHDS for digital / AI solutions in the biotechnology sector, including for policymakers, industry leaders, and researchers, with a focus on fostering innovation, improving health outcomes, and enhancing the competitiveness of the Union’s biotechnology sector.
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Eligibility Criteria
Regions / countries for funding
Moldova (Moldova), Bosnia and Herzegovina (Bosna i Hercegovina / Босна и Херцеговина), Iceland (Ísland), Montenegro (Црна Гора), Norway (Norge), Ukraine (Україна)
eligible entities
Education and training institution, International organization, Non-Profit Organisation (NPO) / Non-Governmental Organisation (NGO), Other, Private institution, incl. private company (private for profit), Public Body (national, regional and local; incl. EGTCs), Research Institution incl. University, Small and medium-sized enterprise (SME)
Mandatory partnership
Yes
Project Partnership
In order to be eligible, the applicants (beneficiaries and affiliated entities) must:
- be legal entities (public or private bodies)
- be established in one of the eligible countries, i.e.:
- EU Member States (including overseas countries and territories (OCTs))
- listed EEA countries and countries associated to the EU4Health Programme (list of participating countries)
Proposals must be submitted by a consortium of at least 5 beneficiaries from 5 different eligible countries.
other eligibility criteria
Specific cases
- Natural persons are NOT eligible (with the exception of self-employed persons, i.e. sole traders, where the company does not have legal personality separate from that of the natural person).
- International organisations are eligible. The rules on eligible countries do not apply to them.
- Entities which do not have legal personality under their national law may exceptionally participate, provided that their representatives have the capacity to undertake legal obligations on their behalf, and offer guarantees for the protection of the EU financial interests equivalent to that offered by legal persons
- EU bodies (with the exception of the European Commission Joint Research Centre) can NOT be part of the consortium.
- Associations and interest groupings - entities composed of members may participate as ‘sole beneficiaries’ or ‘beneficiaries without legal personality’. Please note that if the action will be implemented by the members, they should also participate (either as beneficiaries or as affiliated entities, otherwise their costs will NOT be eligible).
- European Reference Networks (ERNs) — These cover networks between healthcare providers and centres of expertise in the Member States to reinforce healthcare cooperation, in particular in the area of rare diseases, in line with the objectives set out in Article 12 of Directive 2011/24.
- Countries currently negotiating association agreements — Beneficiaries from countries with ongoing negotiations for participation in the programme (see list of participating countries) may participate in the call and can sign grants if the negotiations are concluded before grant signature and if the association covers the call (i.e. is retroactive and covers both the part of the programme and the year when the call was launched).
- EU restrictive measures — Special rules apply for entities subject to EU restrictive measures under Article 29 of the Treaty on the European Union (TEU) and Article 215 of the Treaty on the Functioning of the EU (TFEU). Such entities are not eligible to participate in any capacity, including as beneficiaries, affiliated entities, associated partners, subcontractors or recipients of financial support to third parties (if any).
- EU conditionality measures — Special rules apply for entities subject to measures adopted on the basis of EU Regulation 2020/209214. Such entities are not eligible to participate in any funded role (beneficiaries, affiliated entities, subcontractors, recipients of financial support to third parties, etc). Currently such measures are in place for Hungarian public interest trusts established under the Hungarian Act IX of 2021 or any entity they maintain (see Council Implementing Decision (EU) 2022/2506, as of 16 December 2022).
Additional information
Topics
Relevance for EU Macro-Region
EUSAIR - EU Strategy for the Adriatic and Ionian Region, EUSALP - EU Strategy for the Alpine Space, EUSBSR - EU Strategy for the Baltic Sea Region, EUSDR - EU Strategy for the Danube Region
UN Sustainable Development Goals (UN-SDGs)
project duration
between 24 and 36 months
Additional Information
Proposals must be submitted electronically via the Funding & Tenders Portal Electronic Submission System. Paper submissions are NOT possible.
Proposals must be complete and contain all the requested information and all required annexes and supporting documents:
- Application Form Part A — contains administrative information about the participants (future coordinator, beneficiaries and affiliated entities) and the summarised budget for the project (to be filled in directly online)
- Application Form Part B — contains the technical description of the project (template to be downloaded from the Portal Submission System, completed, assembled and re-uploaded)
- mandatory annexes and supporting documents (templates to be downloaded from the Portal Submission System, completed, assembled and re-uploaded):
- detailed budget table/calculator
- CVs (standard) of core project team
- list of previous projects (key projects for the last 4 years) (template available in Part B)
Proposals are limited to maximum 70 pages (Part B).
Financial support to third parties is allowed for grants or similar forms of support under the following conditions:
- the calls must be open, published widely and conform to EU standards concerning transparency, equal treatment, conflict of interest and confidentiality
- the calls must remain open for at least two months
- the outcome of the call must be published on the participants’ websites, including a description of the selected projects, award dates, project durations, and final recipient legal names and countries
- the calls must have a clear European dimension.
Call documents
Call Document EU4H-2026-SANTE-PJCall Document EU4H-2026-SANTE-PJ(1036kB)
Contact
Website
HaDEA- EU4 Health
HaDEA-HP-CALLS@ec.europa.eu
Website
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