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Strategic Analysis
A winning proposal must center on established, trustworthy AI architectures applied to readily accessible, multimodal longitudinal datasets (molecular, imaging, digital, and RWD) to discover and prioritize robust predictive biomarkers for chronic non-communicable diseases. The strategy must avoid reinventing novel AI algorithms from scratch, emphasizing instead rigorous sex/gender stratification, multi-cohort clinical validation platforms led by EU/EFTA/AC teams, and proactive early engagement with regulatory qualification bodies (EMA/FDA).
Everything the call asks for, seen from the call's point of view. Each line shows what answers it, and which partner carries it.
This matrix lists everything the call asks for: outcomes, impacts, scope, the requirements buried in the call text, and policy alignment. Sign up free and GrantForge tracks each line against the concept you build.
| Requirement | Covered by | Carried | Status |
|---|---|---|---|
| Scope activities | |||
| SC1Set-up a multidisciplinary collaboration to map and evaluate the available information and data on biomarkers currently used in the clinical setting, candidate biomarkers from past and ongoing clinical studies, which are scientifically proven as clinically relevant to the disease progression and treatment response for the chronic non-communicable diseases under study. This should include stratification by biological sex, and where feasible, integration of gender-related variables and sociodemographic determinants that may modulate disease trajectories or treatment efficacy. | · | · | Sign up to track |
| SC2Adapt and apply of established AI methods rather than developing novel ones from scratch, to deliver novel predictive biomarkers of disease progression and treatment response, by integrating data of currently used and candidate biomarkers, with suitable data from available longitudinal and other relevant clinical studies, including RWD, as necessary. To guarantee a solid and fast optimisation and training of the AI tools, the applicants should provide information in their proposal that the appropriate high-quality clinical data are readily available, and when necessary generate small-scale new data for the AI optimisation needs. The biomarkers under study should be multimodal, covering for instance molecular, cellular, physiological, imaging, behavioural and digital markers, and/or their combinations. The applicants should justify why the development of the biomarkers proposed is imperative to tackle the unmet clinical needs of the chronic non-communicable diseases under study. | · | · | Sign up to track |
| SC3Use AI and, where needed, other relevant data and knowledge integration methods, to describe the relationships among different biomarkers and support the robust prioritisation of predictive biomarkers tailored to the characteristics of the patients’ and their disease stage and treatment response. Proposals should have strong emphasis on the AI trustworthiness [3] and develop the adequate performance metrics to assess their accuracy, reliability, reproducibility, including the assessment of possible inherent bias. Use of AI and dataset should comply with existing privacy-preserving legislation. Moreover, proposals should consider the development of user-friendly and fit-for-purpose visualisation and decision-support tools to guide clinicians in evaluating the clinical plausibility of the biomarkers under study across diverse patient groups. | · | · | Sign up to track |
| SC4Establish a biomarker validation platform to assess the clinical utility of the predictive biomarkers identified. To this end, the applicants should implement clinical validation studies in independent disease cohorts, RWD and exploratory clinical studies, as appropriate, to demonstrate their clinical value as prognostic and predictive indicators for more effective clinical research and better patient health outcomes as compared to the established clinical practice of chronic non-communicable diseases. Prospective clinical studies are expected to be led by entities in the EU/EFTA and/or Associated Countries. | · | · | Sign up to track |
| SC5Develop a comprehensive exploitation plan for the valorisation of the research outputs and a regulatory strategy to support the alignment to the regulatory requirements for the qualification of the biomarkers and/or AI tools and engage with the regulators in a timely manner. The applicants should prioritise the exploitation of their research results in the EU. Participation of small and medium-sized enterprises (SMEs) [4] is encouraged with the aim to strengthen the scientific and technological basis of SMEs and valorise their health innovations. | · | · | Sign up to track |
| Expected outcomes | |||
| EO1Clinical researchers and developers have access to novel predictive biomarkers to guide a more accurate assessment of disease progression and treatment response and tackle the unmet clinical needs of non-communicable chronic diseases. | · | · | Sign up to track |
| EO2Clinicians and healthcare professionals use clinically validated predictive biomarkers for implementing more effective clinical research and personalised medicine with better health outcomes in chronic non-communicable diseases. | · | · | Sign up to track |
| EO3Key stakeholders have access to trustworthy Artificial Intelligence (AI) tools to guide the development of multimodal predictive biomarkers of higher accuracy and clinical value when compared to the established practice. | · | · | Sign up to track |
| EO4The citizens benefit of better health outcomes thanks to improved clinical guidelines and the implementation of effective biomarker-guided clinical research and personalised healthcare. | · | · | Sign up to track |
| Other requirements | |||
| REQ1Sex and gender stratification and sociodemographic determinant integrationCollaborations must include stratification by biological sex, and where feasible, integration of gender-related variables and sociodemographic determinants modulating disease trajectories or treatment efficacy. | · | · | Sign up to track |
| REQ2Adherence to trustworthy AI principles and privacy-preserving legislationProposals must emphasize AI trustworthiness (accuracy, reliability, reproducibility, and assessment of inherent bias) adhering to EC Ethics Guidelines for Trustworthy AI and comply with privacy-preserving legislation. | · | · | Sign up to track |
| REQ3GDPR compliance for personal data protectionProposals should apply good practices for General Data Protection Regulation (GDPR) compliant personal data protection. | · | · | Sign up to track |
| REQ4Leadership of prospective clinical studies by EU/EFTA/AC entitiesProspective clinical studies to assess biomarker clinical utility are expected to be led by entities established in EU Member States, EFTA, and/or Associated Countries. | · | · | Sign up to track |
| REQ5Regulatory engagement and exploitation prioritized within the EUApplicants must develop an exploitation plan prioritising results in the EU and establish a regulatory strategy to engage timely with regulators for biomarker/AI tool qualification. | · | · | Sign up to track |
| REQ6Encouraged participation of SMEsParticipation of small and medium-sized enterprises (SMEs) is encouraged to strengthen their scientific and technological base and valorise health innovations. | · | · | Sign up to track |
| REQ7Synergies with European research and Digital Europe data infrastructuresProposals are encouraged, where relevant, to exploit available data services, expertise, and digital tools provided by ESFRI European research infrastructures and health data infrastructures funded under Digital Europe. | · | · | Sign up to track |
| REQ8Mandatory budget allocation for networking and inter-project joint activitiesProjects are strongly encouraged to participate in joint workshops and networking with other Horizon Europe or EU-programme projects (such as Digital Europe), allocating sufficient budget for these activities. | · | · | Sign up to track |
| REQ9Mandatory clinical studies annex templateApplicants are strongly encouraged to detail clinical study protocols in the dedicated submission annex using the official template provided in the submission system. | · | · | Sign up to track |
| REQ10Mandatory use of Copernicus and Galileo/EGNOS space dataIf projects use satellite-based earth observation, positioning, navigation, or timing data/services, beneficiaries must make use of Copernicus and/or Galileo/EGNOS. | · | · | Sign up to track |
| REQ11Restrictions concerning high-risk suppliers of mobile communication equipmentEntities assessed as high-risk suppliers of mobile network communication equipment (under the EU 5G cybersecurity toolbox) are not eligible to participate as beneficiaries, affiliated entities, or associated partners. | · | · | Sign up to track |
| Expected impacts | |||
| EI1Europe’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. | · | · | Sign up to track |
| EI2Citizens 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). | · | · | Sign up to track |
| EI3The EU gains high visibility and leadership in terms of health technology development, including through international cooperation. | · | · | Sign up to track |
| EI4The 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. | · | · | Sign up to track |
| EI5Both 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. | · | · | Sign up to track |
| EI6Citizens trust and support the opportunities offered by innovative technologies for healthcare, based on expected health outcomes and potential risks involved. | · | · | Sign up to track |
| Underlying policies | |||
| POL1general data protection regulationThe General Data Protection Regulation (Regulation (EU) 2016/679) establishes the legal framework for the processing of personal data across the EU. It enforces core principles including lawfulness, fairness, purpose limitation, data minimisation, and data security, with strict safeguards for special category data such as health and genetic information. | · | · | Sign up to track |
| POL2ethics guidelines for trustworthy aiDeveloped by the High-Level Expert Group on AI, these guidelines establish seven key requirements for ethical, lawful, and robust artificial intelligence systems. The framework highlights human agency, technical robustness, privacy and data governance, transparency, diversity, societal well-being, and accountability. | · | · | Sign up to track |
| POL3artificial intelligence strategyThe European AI Strategy aims to make the EU a world-class hub for AI while ensuring technology is human-centric and trustworthy. Coordinated with Member States, it mobilises public and private investment to boost research excellence, digital infrastructure, and AI deployment across strategic sectors like healthcare. | · | · | Sign up to track |
The binding rules of this call. Items marked auto are verified by GrantForge from the call and the template. The others are yours to confirm.
LMIC entities auto-eligible
Low/middle-income country entities are automatically eligible for funding.
Page limit Stage 1
Part B Section 1+2+3 combined is typically capped at 10 pages at Stage 1. Pages exceeding the limit are invisible to evaluators.
Consortium continuity
The consortium declared at Stage 1 is expected to submit Stage 2. Substantial changes must be justified.
EU space data infrastructures
If the project uses satellite-based Earth observation, positioning, navigation or timing data/services, beneficiaries must use Copernicus and/or Galileo/EGNOS.
Civil applications only
Exclusive military or dual-use applications are excluded.
US entities eligible for funding
Any legal entity established in the United States of America is eligible to receive Union funding.
Exclusion of entities established in China
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.
Exclusion of high-risk network suppliers
Entities that are assessed as high-risk suppliers of mobile network communication equipment (and any entities they own or control) are not eligible to participate as beneficiaries, affiliated entities and associated partners.
5 key insights you must internalise before writing. Each is grounded in the call text and tells you what evaluators will actually look for. Share these with your consortium before drafting.
Evaluators are bound by strict blind evaluation rules in Stage 1. Any inclusion of participant names, acronyms, or logos in the abstract or Part B will result in immediate disqualification. Applicants must construct a compelling 10-page narrative that proves consortium excellence and data readiness without revealing institutional identities.
Source: Evaluation_pre_award
A proposal that attempts to develop novel AI algorithms from scratch will fail the scope requirements. The strategy must focus exclusively on adapting established, trustworthy AI architectures to integrate multimodal data. Evaluators will score based on explainability, bias mitigation, and GDPR compliance rather than theoretical algorithmic novelty.
Source: Scope
Proposals relying on long, unstarted prospective data generation will be penalized. Applicants must provide absolute proof that high-quality, pre-existing longitudinal clinical cohorts and Real-World Data (RWD) are immediately available for AI training. Small-scale new data generation is only permitted for specific AI optimization needs.
Source: Evaluation_pre_award
While US entities are exceptionally eligible for funding, the core clinical validation platform must remain European-led. The call mandates that any prospective clinical studies be led by entities established in the EU, EFTA, or Associated Countries. Furthermore, legal entities established in China are strictly excluded from participation at any level.
Source: Eligibility rules
Treating sex and gender as a generic ethics checkbox will severely damage the proposal's score. The methodology must explicitly integrate biological sex stratification and socio-demographic determinants into the disease trajectory and treatment response models. Evaluators expect concrete variables that modulate biomarker efficacy across diverse patient groups.
Source: Scope
Specific requirements
Page limit Stage 1
Part B Section 1+2+3 combined is typically capped at 10 pages at Stage 1. Pages exceeding the limit are invisible to evaluators.
Consortium continuity
The consortium declared at Stage 1 is expected to submit Stage 2. Substantial changes must be justified.
EU space data infrastructures
If the project uses satellite-based Earth observation, positioning, navigation or timing data/services, beneficiaries must use Copernicus and/or Galileo/EGNOS.
Civil applications only
Exclusive military or dual-use applications are excluded.
US entities eligible for funding
Any legal entity established in the United States of America is eligible to receive Union funding.
Exclusion of entities established in China
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.
Exclusion of high-risk network suppliers
Entities that are assessed as high-risk suppliers of mobile network communication equipment (and any entities they own or control) are not eligible to participate as beneficiaries, affiliated entities and associated partners.
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Applicants submitting a proposal for a blind evaluation (see General Annex F) must not disclose their organisation names, acronyms, logos nor names of personnel in the proposal abstract and Part B of their first-stage application (see General Annex E).
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.
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.
In recognition of the opening of the US National Institutes of Health’s programmes to European researchers, any legal entity established in the United States of America is eligible to receive Union funding.
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).
Subject to restrictions for the protection of European communication networks.
Other eligibility conditions are described in Annex B of the Work Programme General Annexes.
Financial and operational capacity and exclusion are described in Annex C of the Work Programme General Annexes.
The first-stage proposals of this topic will be evaluated blindly.
Award criteria, scoring and thresholds are described in Annex D of the Work Programme General Annexes.
For the first stage, the thresholds for each criterion will be 4 (Excellence) and 4 (Impact). The overall threshold applying to the sum of the two individual scores will be set at a level that ensures the total requested budget of proposals admitted to stage 2 is as close as possible to four times the available budget, and not less than three and a half times the available budget.
For the second stage, 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.
Indicative timeline for evaluation and grant agreement are described in Annex F of the Work Programme General Annexes.
The granting authority may, up to 4 years after the end of the action, object to a transfer of ownership or to the exclusive licensing of results, as set out in the specific provision of Annex 5.
Legal and financial set-up of the grants are described in Annex G of the Work Programme General Annexes.
Specific conditions are described in the specific topic of the Work Programme.
Application and evaluation form templates
Standard application form (HE RIA IA Stage 1 BLIND) - the application form specific to this call is available in the Submission System
Standard application form (HE RIA, IA) - the application form specific to this call is available in the Submission System
Standard evaluation form (HE RIA, IA and CSA Stage 1 BLIND) - will be used with the necessary adaptations
Standard evaluation form (HE RIA, IA) - will be used with the necessary adaptations
Guidance
Model Grant Agreement (MGA)
Call-specific instructions
Information on clinical studies (HE)
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 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
Evaluators are bound by strict blind evaluation rules in Stage 1 (any mention of participant names, acronyms, or logos is strictly disqualifying) and a harsh 10-page limit. Key scoring priorities include:
TRL 2 → 6
Based on programme defaults
Set-up a multidisciplinary collaboration to map and evaluate the available information and data on biomarkers currently used in the clinical setting, candidate biomarkers from past and ongoing clinical studies, which are scientifically proven as clinically relevant to the disease progression and treatment response for the chronic non-communicable diseases under study. This should include stratification by biological sex, and where feasible, integration of gender-related variables and sociodemographic determinants that may modulate disease trajectories or treatment efficacy.
Adapt and apply of established AI methods rather than developing novel ones from scratch, to deliver novel predictive biomarkers of disease progression and treatment response, by integrating data of currently used and candidate biomarkers, with suitable data from available longitudinal and other relevant clinical studies, including RWD, as necessary. To guarantee a solid and fast optimisation and training of the AI tools, the applicants should provide information in their proposal that the appropriate high-quality clinical data are readily available, and when necessary generate small-scale new data for the AI optimisation needs. The biomarkers under study should be multimodal, covering for instance molecular, cellular, physiological, imaging, behavioural and digital markers, and/or their combinations. The applicants should justify why the development of the biomarkers proposed is imperative to tackle the unmet clinical needs of the chronic non-communicable diseases under study.
Use AI and, where needed, other relevant data and knowledge integration methods, to describe the relationships among different biomarkers and support the robust prioritisation of predictive biomarkers tailored to the characteristics of the patients’ and their disease stage and treatment response. Proposals should have strong emphasis on the AI trustworthiness [3] and develop the adequate performance metrics to assess their accuracy, reliability, reproducibility, including the assessment of possible inherent bias. Use of AI and dataset should comply with existing privacy-preserving legislation. Moreover, proposals should consider the development of user-friendly and fit-for-purpose visualisation and decision-support tools to guide clinicians in evaluating the clinical plausibility of the biomarkers under study across diverse patient groups.
Establish a biomarker validation platform to assess the clinical utility of the predictive biomarkers identified. To this end, the applicants should implement clinical validation studies in independent disease cohorts, RWD and exploratory clinical studies, as appropriate, to demonstrate their clinical value as prognostic and predictive indicators for more effective clinical research and better patient health outcomes as compared to the established clinical practice of chronic non-communicable diseases. Prospective clinical studies are expected to be led by entities in the EU/EFTA and/or Associated Countries.
Develop a comprehensive exploitation plan for the valorisation of the research outputs and a regulatory strategy to support the alignment to the regulatory requirements for the qualification of the biomarkers and/or AI tools and engage with the regulators in a timely manner. The applicants should prioritise the exploitation of their research results in the EU. Participation of small and medium-sized enterprises (SMEs) [4] is encouraged with the aim to strengthen the scientific and technological basis of SMEs and valorise their health innovations.
Clinical researchers and developers have access to novel predictive biomarkers to guide a more accurate assessment of disease progression and treatment response and tackle the unmet clinical needs of non-communicable chronic diseases.
Clinicians and healthcare professionals use clinically validated predictive biomarkers for implementing more effective clinical research and personalised medicine with better health outcomes in chronic non-communicable diseases.
Key stakeholders have access to trustworthy Artificial Intelligence (AI) tools to guide the development of multimodal predictive biomarkers of higher accuracy and clinical value when compared to the established practice.
The citizens benefit of better health outcomes thanks to improved clinical guidelines and the implementation of effective biomarker-guided clinical research and personalised healthcare.
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).
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.
General Data Protection Regulation
highThe General Data Protection Regulation (Regulation (EU) 2016/679) establishes the legal framework for the processing of personal data across the EU. It enforces core principles including lawfulness, fairness, purpose limitation, data minimisation, and data security, with strict safeguards for special category data such as health and genetic information.
Evaluators expect a robust Data Management Plan detailing lawful bases for secondary health data processing, data anonymisation or pseudonymisation protocols, and technical and organisational security measures. Proposals should explicitly demonstrate compliance with GDPR requirements when handling sensitive patient cohorts and multi-centre clinical datasets.
Ethics Guidelines for Trustworthy AI
highDeveloped by the High-Level Expert Group on AI, these guidelines establish seven key requirements for ethical, lawful, and robust artificial intelligence systems. The framework highlights human agency, technical robustness, privacy and data governance, transparency, diversity, societal well-being, and accountability.
Evaluators expect applicants to demonstrate how their predictive AI models ensure explainability, prevent algorithmic bias across diverse patient demographics, and integrate human-in-the-loop validation for clinical decision support. Proposals must show clear protocols for model verification, reproducibility, and risk mitigation against false predictions.
Artificial Intelligence Strategy
highThe European AI Strategy aims to make the EU a world-class hub for AI while ensuring technology is human-centric and trustworthy. Coordinated with Member States, it mobilises public and private investment to boost research excellence, digital infrastructure, and AI deployment across strategic sectors like healthcare.
Evaluators expect proposals to leverage cutting-edge AI architectures while maintaining alignment with European digital sovereignty and open science principles. Applications should outline clear valorisation strategies for AI tools and demonstrate alignment with emerging European AI testing and validation standards.
Strategy for European Life Sciences
mediumEuropean strategic initiatives in life sciences focus on fostering multidisciplinary research, integrating biological data platforms, and advancing personalised medicine across Europe. They prioritise cross-border collaboration, interoperability of health research infrastructures, and sustainable translation of scientific breakthroughs into clinical applications.
Evaluators expect to see clear synergies with existing European life sciences research infrastructures and shared biological databases. Proposals should demonstrate multidisciplinary cooperation spanning computational biology, clinical practice, and biomarker development for personalised patient management.
European Health Union
mediumThe European Health Union initiative focuses on strengthening EU crisis preparedness, improving healthcare resilience, and ensuring equal access to innovative treatments. Key pillars include the creation of the European Health Data Space (EHDS), pharmaceutical legislation reform, and targeted initiatives to manage chronic and non-communicable diseases.
Evaluators expect proposals to explain how diagnostic and predictive tools will support long-term healthcare system resilience and reduce the burden of chronic diseases. Demonstrating data readiness and interoperability in alignment with European Health Data Space standards is highly valued.
Biotechnology and Biomanufacturing Communication
lowThe Communication on Building the future with nature: Boosting Biotechnology and Biomanufacturing in the EU (COM(2024) 137) outlines measures to foster innovation and scale up biotechnology solutions across healthcare and industrial sectors. It emphasizes accelerating translation from lab to market, simplifying regulatory pathways, and supporting advanced therapies and diagnostics.
Evaluators look for clear commercialisation and translation roadmaps showing how identified biomarkers and diagnostic tools can be scaled and integrated into healthcare delivery. Demonstrating industrial engagement, technology transfer feasibility, and standardisation pathways aligns strongly with this communication.
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