A European flagship initiative leveraging AI and health data for cardiovascular health and related non-communicable diseases: Advancing Risk Prediction, Prevention, Treatments, Personalised Care and Rehabilitation

Grant Purpose and Target

• Core Objective: This flagship initiative aims to leverage Artificial Intelligence (AI) and health data to accelerate the early detection, prediction, personalised prevention, and integrated management of cardiovascular diseases (CVDs) and related non-communicable diseases (NCDs) like diabetes and obesity. The goal is to establish a European model of AI-enabled care by federating high-quality health data and deploying mature AI solutions in real-world clinical settings.

• Funding Organization: European Health and Digital Executive Agency (HaDEA), on behalf of the European Commission.

• Target Recipients: A wide range of legal entities can apply. This includes networks of experts (like ERNs), professional societies, civil society organizations (associations, foundations, NGOs), private entities (both for-profit and not-for-profit), public authorities (e.g., ministries of health), and other established networks in public health.

• Sector Focus: SECTOR-SPECIFIC, with a primary focus on Healthcare, Artificial Intelligence, and Health Data management. Projects must address cardiovascular health and related non-communicable diseases.

• Geographic Scope: Applicants must be established in EU Member States (including Overseas Countries and Territories), listed EEA countries (Iceland, Norway), or countries associated with the EU4Health Programme (such as Ukraine, Moldova, Montenegro, and Bosnia and Herzegovina).

• Key Filtering Criteria:

  • Project Scale: This is a large-scale initiative with an indicative budget of €20,000,000 for a single project.
  • Consortium Requirement: A consortium of at least 5 beneficiaries from 5 different eligible countries is mandatory.
  • Project Focus: The project must focus on piloting, validating, and scaling up mature AI applications, not on the development of new AI technologies from scratch.

Financial Structure

• Funding Range: The total budget for this topic is €20,000,000. It is expected that only one grant will be awarded, making the indicative project budget €20,000,000.

• Co-financing: The funding rate (i.e., the percentage of eligible costs covered by the grant) is not specified in the provided grant materials. Applicants will need to co-finance the remaining project costs from other sources.

• Eligible Costs: Costs must be actually incurred during the project, necessary for its implementation, and recorded in the beneficiary's accounts. Eligible direct costs include:

  • Personnel costs: Salaries and social security contributions for staff assigned to the project. This can also include costs for SME owners not receiving a salary, calculated as a unit cost.
  • Subcontracting costs: Costs for tasks outsourced to third parties, provided it is justified and follows best value for money principles.
  • Purchase costs: Including travel and subsistence, equipment (normally as depreciation costs), and other goods, works, and services (e.g., consumables, publications, translations).
  • Financial support to third parties: This is an eligible cost category for this call. The maximum amount of financial support to a single third party is capped at €60,000. Clear, transparent, and objective procedures must be in place for awarding this support.
  • Indirect costs: A flat rate of 7% of the total eligible direct costs is provided to cover general overheads (e.g., office rent, utilities).

• Ineligible Costs: Standard ineligible costs apply, including:

  • Debt and debt service charges.
  • Provisions for future losses or debts.
  • Interest owed.
  • Currency exchange losses.
  • Deductible VAT.
  • Costs declared in another EU grant.

• Payment & Reporting: Payments are tied to reporting periods. The structure typically includes:

  • An initial pre-financing payment at the start of the project.
  • Interim payments upon submission and approval of periodic reports.
  • A final payment (payment of the balance) after the submission and approval of the final project report.

Eligibility Requirements

• Formal Criteria:

  • Consortium Composition: Proposals must be submitted by a consortium of at least 5 legal entities established in at least 5 different eligible countries.
  • Legal Status: Applicants must be legally established entities, such as public bodies or private companies. Natural persons are not eligible to apply as beneficiaries.
  • Eligible Countries: Applicants (beneficiaries and affiliated entities) must be established in an EU Member State (including OCTs) or a country associated with the EU4Health Programme or a listed EEA country.
  • Registration: All applicants must be registered and validated in the EU's Participant Register and have a Participant Identification Code (PIC) before the grant agreement is signed.

• Organizational Status: The call is open to a broad range of organizations, including:

  • Public authorities (e.g., ministries of health, regional agencies).
  • Private entities (both for-profit and not-for-profit).
  • Non-governmental organizations (NGOs), associations, and foundations.
  • Networks of experts, such as European Reference Networks (ERNs) and European societies in cardiology and public health.

• Technical Expertise: While not explicitly quantified, applicants must demonstrate they possess the necessary qualifications, know-how, and resources to implement the project successfully. This is assessed based on:

  • The profiles and CVs of the core project team.
  • The description of the consortium, showing complementary expertise in AI, health data management, cardiovascular health, clinical practice, and large-scale project management.
  • A list of previous relevant projects undertaken by the participants.

• Exclusion Criteria: Applicants will be excluded if they are in situations such as bankruptcy, have been convicted of an offence concerning their professional conduct, are guilty of grave professional misconduct, have not fulfilled obligations relating to the payment of social security contributions or taxes, or have been found to have committed fraud or corruption. Applicants must submit a declaration of honour confirming they are not in any of these situations.

Application Practical Information

• Deadlines:

  • Call opening: 23 September 2025
  • Submission deadline: 06 January 2026, 17:00:00 Brussels time (CET)
  • Evaluation period: January – March 2026
  • Information on results: April – May 2026
  • Grant agreement signature: September – October 2026

• Required Documents: The application must be submitted electronically and consists of:

  • Part A (Administrative Forms): To be filled out directly in the submission system, containing information on the participants, legal declarations, and budget overview.
  • Part B (Technical Description): A narrative document describing the project in detail (relevance, quality, impact, work plan). This must be uploaded as a PDF file and is limited to 70 pages.
  • Mandatory Annexes:
    • A detailed budget table/calculator.
    • CVs of the core project team.
    • A list of previous relevant projects for each participating organization.

• Application Process:

  • Proposals must be submitted electronically via the EU Funding & Tenders Portal.
  • The submission process is a single-stage procedure.
  • Applicants can submit multiple versions before the deadline; the last version submitted overwrites all previous ones.

• Support:

  • Financial Support: The grant provides funding up to the specified amount.
  • Application Support: For questions related to the call, applicants can contact [email protected]. For technical issues with the portal, an IT Helpdesk is available.

• Post-Award Obligations:

  • Implementation: Projects are expected to have a duration of 24 to 36 months.
  • Reporting: Beneficiaries must submit continuous reports on progress (e.g., deliverables, milestones) and periodic reports (technical and financial) to trigger payments.
  • Record-keeping: Records and supporting documents must be kept for 5 years after the final payment for potential audits.
  • Specific Deliverables: The project must produce mandatory deliverables, including a strategic roadmap, technical specifications for datasets, a blueprint for AI integration, and evidence-based guidelines.

Evaluation Criteria

Proposals are evaluated and scored out of 100 points against a set of weighted criteria. To be considered for funding, proposals must achieve a minimum score for each criterion and an overall minimum score of 70 points.

• Scoring Factors:

  • Relevance (Maximum 30 points; minimum pass score of 21)

    • How the project aligns with the call's background, general objectives, and priorities.
    • Clarity and achievability of the project's specific objectives, based on a sound needs analysis.
    • The project's innovative aspects, complementarity with other actions, and its European added value (e.g., trans-national impact).

  • Quality — Project design and implementation (Maximum 30 points; minimum pass score of 21)

    • Suitability of the proposed concept and methodology.
    • Effectiveness of the project management, quality assurance, monitoring, and evaluation strategies.
    • Cost-effectiveness and soundness of the financial management plan.
    • Robustness of the risk management plan, identifying critical risks and proposing mitigation measures.

  • Quality — Project team and cooperation arrangements (Maximum 30 points; minimum pass score of 21)

    • Quality of the consortium, including how participants' expertise is complementary and their roles are clearly defined.
    • Expertise of the proposed project teams and staff.
    • Clarity and effectiveness of consortium management structures and decision-making mechanisms.

  • Impact (Maximum 10 points; minimum pass score of 7)

    • The project's expected short, medium, and long-term effects on target groups.
    • Ambition of the project and its potential to create significant change or innovation beyond the state-of-the-art.
    • Quality of the communication, dissemination, and visibility plan to maximize impact and ensure awareness of EU funding.
    • Sustainability of the project's impact and results after the EU funding ends.

• Innovation & Impact: The project should demonstrate how it will advance the adoption of AI in healthcare, leading to improved health outcomes, greater equity in care, and increased efficiency of health systems. Impact is assessed based on the project's potential to generate tangible, scalable results and establish a trusted European data ecosystem for health innovation.

• Project Quality: Evaluated based on the clarity of the methodology, the coherence of the work plan, the quality assurance measures, and the soundness of the financial and risk management strategies.

• Strategic Fit: A high score in the 'Relevance' criterion indicates strong strategic fit. The project must directly address the call's objectives of federating health data under the EHDS framework and deploying mature AI solutions for cardiovascular health.

• Cross-cutting Themes: The proposal should consider the needs of diverse population groups, addressing socio-economic and gender differences, and aim to include data from underrepresented populations to promote health equity. These aspects are part of the 'Relevance' and 'Impact' evaluation.

Compliance and Special Requirements

• Regulatory Compliance:

  • Projects must comply with all relevant EU legal frameworks, including the AI Act, the European Health Data Space (EHDS) Regulation, the Medical Devices Regulation (MDR), and the General Data Protection Regulation (GDPR).
  • Activities must adhere to the highest ethical standards. An ethics self-assessment is part of the application, and any identified ethics issues must be addressed.

• IP Policy:

  • Ownership: The results of the project are owned by the beneficiaries who generate them.
  • Rights of Use: The EU is granted a royalty-free, non-exclusive, and irrevocable license to use project materials and results for communication, dissemination, and policy-making purposes. This includes the right to edit, translate, and distribute the materials.
  • Background IPR: Beneficiaries must grant each other and other participants access to any background intellectual property needed to carry out the project.

• Unique Aspects:

  • Flagship Initiative: This is a high-profile, large-scale action with a significant budget, intended to have a major impact on cardiovascular care in Europe.
  • Focus on Mature AI: The grant is for deploying and scaling up existing, mature AI solutions, rather than funding early-stage research and development.
  • EHDS Integration: A core component is the creation of a federated data infrastructure aligned with the principles and technical framework of the European Health Data Space.
  • Financial Support to Third Parties: The project is explicitly permitted to provide financial support (grants or similar) to third parties, with a cap of €60,000 per recipient, to support activities like targeted data collection.

• Industry-Specific Rules: As the project operates in the healthcare sector, it must adhere to strict rules regarding patient data privacy, clinical validation standards for AI tools, and interoperability standards for health information systems. Compliance with medical device regulations may be necessary if the AI tools fall under that definition.