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Strategic Analysis
This call seeks to revolutionize how the added value of innovative, integrated healthcare solutions is assessed. Winning proposals must develop and validate new, comprehensive methodologies and models that go beyond traditional evaluations, ensuring solutions are safe, people-centred, effective, and affordable. A strong emphasis on real-world implementation, stakeholder engagement, and alignment with EU health strategies is crucial.
the high burden of the disease for patients and/or society due to its severity and/or the number of people affected by it;
the high economic impact of the disease for patients and society;
the transformational nature of the potential results on innovation processes where projects are not focussed on individual disease areas (e.g. health data analytics).
inform innovation-responsive guidance and regulatory science approaches;
demonstrate the ability to translate research into innovative solutions that can be integrated/implemented into the healthcare ecosystem (taking into consideration the fragmented nature of European healthcare systems) and/or into industrial processes.
carry out a landscape analysis to avoid unnecessary overlap and duplication of efforts with existing initiatives/projects and to identify potential synergies and complementarities with the relevant ones. The proposal should include a plan on how to synergise with these identified initiatives.
Applicants must define the outcomes expected to be achieved by their proposal, ensuring that they contribute to new and improved methodologies and models for a comprehensive assessment of the added value of innovative and integrated healthcare solutions in line with the IHI JU’s specific objective 5 as set out in the IHI JU Strategic Research and Innovation Agenda (SRIA).
Actions (projects) to be funded under this topic must deliver results that address public health needs and support the development of future health innovations that are safe, people-centred, effective, cost-effective and affordable for patients and for health care systems.
These outcomes are also expected to benefit the relevant stakeholders in the healthcare ecosystem.
The expected outcomes may cover the entire spectrum of care from prevention to disease management and may be centred around disease areas, key themes such as prevention, precision diagnostics, personalised medicine, and chronic disease management.
They may also include enabling solutions for digitalisation, artificial intelligence (AI), regulatory science, greener and more sustainable healthcare and the deployment and use of these solutions into practice.
seamless and successful implementation in healthcare settings of cross-sectoral innovations, integrated products and services delivering proven benefits to patients, healthcare systems and society as a whole;
patients have improved access to innovations that meet their needs and those of the healthcare systems;
better informed decision-making at different levels of the healthcare system (authorities, organisations), that will in turn contribute to a better allocation of resources towards cost effective innovations;
faster entry to the market of cost-effective innovative solutions developed by industry, which could translate to a positive effect on their R&I investments.
the strengthening of the competitiveness of the EU’s health industry, via increased economic activity in the development of health technologies, in particular integrated health solutions, and thus fostering European technological leadership and the digital transformation of our societies.
the implementation of the EU’s Life Sciences Strategy and its specific aims such as: reinforcing European R&I e.g. supporting multinational clinical trials and improving the clinical research ecosystem;
the implementation of the EU’s Life Sciences Strategy and its specific aims such as: providing smooth and rapid market access for life science innovations e.g. through promoting innovation-responsive regulation to ensure timely real value delivery of innovations to people;
the improvement of the health technology assessment (HTA) methodology for instance through: development and uptake of innovative HTA approaches tailored to meet the demands of HTA organisations, policy makers, and industry, including aspects such as usability, integration into care pathways, and patient experience. This also covers novel methods for assessment of added value of combined technologies;
the improvement of the health technology assessment (HTA) methodology for instance through: crafting and deploying dissemination and educational programs to ensure unified HTA expertise throughout the EU, covering both medical technology and pharmaceutical innovations;
the improvement of the health technology assessment (HTA) methodology for instance through: uptake of innovative medical devices and in-vitro diagnostics.
Apply AI Strategy
highRegulation on the European Health Data Space (EHDS)
highThe Regulation on the European Health Data Space (EHDS) aims to create a common European data space for health, enabling secure and trustworthy access to health data for primary use (healthcare delivery) and secondary use (research, innovation, public health). It seeks to empower individuals with control over their health data and foster a single market for digital health services.
Proposals must clearly demonstrate how their innovative integrated healthcare solutions will leverage or contribute to the principles of the EHDS, ensuring secure and interoperable health data exchange, respecting data privacy, and enabling the secondary use of health data for assessment and innovation.
EU Artificial Intelligence Act
highThe EU AI Act is the world's first comprehensive legal framework for Artificial Intelligence, aiming to ensure that AI systems placed on the EU market and used in the EU are safe and respect fundamental rights. It categorises AI systems based on their risk level, with strict requirements for high-risk AI, including those used in healthcare.
Proposals involving AI in integrated healthcare solutions must demonstrate full compliance with the principles and requirements of the EU AI Act, particularly regarding risk management, data governance, transparency, human oversight, and robustness, especially if the AI system is classified as high-risk.
Europe’s Beating Cancer Plan
mediumEurope’s Beating Cancer Plan is the EU's comprehensive strategy to tackle the growing burden of cancer. It aims to reduce cancer incidence, mortality, and improve the quality of life for cancer patients and survivors across the EU, covering prevention, early detection, diagnosis, treatment, and quality of life.
Proposals should demonstrate how their innovative integrated healthcare solutions contribute to the objectives of Europe's Beating Cancer Plan, particularly in improving cancer care pathways, enhancing early detection, optimising treatments, or supporting the quality of life for cancer patients through integrated approaches.
EU Mission on Cancer
mediumThe EU Mission on Cancer, part of Horizon Europe, aims to improve the lives of more than 3 million people by 2030 through a better understanding of cancer, prevention, optimisation of diagnosis and treatment, and support for the quality of life of those affected. It fosters a comprehensive approach to cancer research and innovation.
Proposals should clearly link their innovative integrated healthcare solutions to the specific goals of the EU Mission on Cancer, demonstrating how they will contribute to preventing cancer, improving early detection, optimising diagnosis and treatment, or enhancing the quality of life for cancer patients and survivors.
European Virtual Human Twins Initiative
mediumThe European Virtual Human Twins Initiative aims to create digital replicas of human organs, systems, or even entire bodies to simulate diseases, test treatments, and predict outcomes. It leverages high-performance computing and AI to advance personalised medicine and healthcare innovation, often as a component of the European Health Data Space.
Proposals should demonstrate how their innovative integrated healthcare solutions could leverage or contribute to the development and application of virtual human twins, particularly in improving the assessment of treatment efficacy, patient stratification, or personalised care pathways.
1+ Million Genomes Initiative
mediumThe 1+ Million Genomes (1+MG) Initiative is a cross-European effort to enable secure access to at least one million sequenced genomes and corresponding clinical data across Europe. Its goal is to advance research and personalised medicine, allowing for better understanding, prevention, and treatment of diseases.
Proposals should articulate how their integrated healthcare solutions can utilise genomic data, contribute to the secure sharing and analysis of such data, or demonstrate how genomic insights can improve the assessment of added value for innovative treatments and personalised health interventions.
EU Biotech Act
mediumThe 'EU Biotech Act' refers to the European Commission's strategic initiatives, such as the Communication on 'Boosting Biotechnology and Biomanufacturing in the EU', aimed at fostering innovation, accelerating market access for biotech products, and ensuring the EU's competitiveness and strategic autonomy in the biotechnology sector.
Proposals should highlight how their innovative integrated healthcare solutions align with the objectives of strengthening the EU's biotech ecosystem, promoting the development and uptake of advanced biotechnological products, or contributing to the EU's strategic autonomy in health and life sciences.
EU’s Life Sciences Strategy
mediumThis refers to the broader strategic vision for the EU's life sciences sector, often encompassing the Pharmaceutical Strategy for Europe. It aims to ensure patients have access to innovative and affordable medicines, support the competitiveness of the European pharmaceutical industry, and enhance the EU's crisis preparedness, covering research, development, manufacturing, and supply chain resilience.
Proposals should demonstrate how their innovative integrated healthcare solutions contribute to the goals of strengthening the EU's life sciences ecosystem, fostering pharmaceutical innovation, improving patient access to novel therapies, or enhancing the resilience and competitiveness of the European health industry.
European Green Deal
lowThe European Green Deal is the EU's overarching growth strategy, aiming to transform the EU into a modern, resource-efficient, and competitive economy. Its primary goal is to make Europe climate-neutral by 2050, while also protecting biodiversity, reducing pollution, and promoting a circular economy.
Proposals must clearly articulate how they contribute to the overarching goals of the European Green Deal, particularly in areas like biodiversity protection, pollution reduction, sustainable resource management, and climate action. Given the topic, strong links to nature restoration, sustainable land use, and climate resilience are expected.
Preparedness and response to health emergencies
lowThis refers to the EU's framework and actions to strengthen its capacity to prevent, detect, and respond to serious cross-border health threats. Key elements include the European Health Emergency Preparedness and Response Authority (HERA), joint procurement of medical countermeasures, and coordinated risk assessment to ensure resilience against future health crises.
Proposals should demonstrate how their innovative integrated healthcare solutions could enhance the EU's preparedness and response capabilities, for example, by improving surveillance, rapid diagnostic tools, resilient healthcare systems, or efficient deployment of medical countermeasures during health emergencies.
Council Regulation (EU) 2021/2085
lowCouncil Regulation (EU) 2021/2085 establishes the European Health and Digital Executive Agency (HaDEA). HaDEA is responsible for managing significant parts of EU programmes related to health, food safety, digital, industry, and space, by implementing policies through calls for proposals, grants, and contracts.
While not a policy to be directly implemented by a project, proposals should implicitly acknowledge HaDEA's role as the implementing agency for relevant EU programmes. Understanding HaDEA's mandate can help align proposals with the broader strategic objectives it supports.
No specific eligibility rules extracted from this call.
1. Admissibility conditions — Proposal page limit and layout Described in Annex A and Annex E of the Horizon Europe Work Programme General Annexes. Proposal page limits and layout: described in Part B of the Application Form available in the Submission System : for a single-stage Call, the limit for RIA full proposals is 50 pages.
2. Eligible Countries — 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 .
3. Other Eligibility Conditions — Described in Annex B of the Work Programme General Annexes and in the ''Conditions of the Calls for proposals and Calls management rules'' section of the IHI JU Work Programme (WP)
4. Financial and operational capacity and exclusion — Described in Annex C of the Work Programme General Annexes.
5a. Evaluation and award: Award criteria, scoring and thresholds — Are described in Annex D of the Work Programme General Annexes and in the ''Conditions of the Calls for proposals and Calls management rules'' section of the IHI JU Work Programme (WP)
5b. Evaluation and award: Submission and evaluation processes — Are described in Annex F of the Work Programme General Annexes and the Online Manual .
5c. Evaluation and award: Indicative timeline for evaluation and grant agreement — Described in Annex F of the Work Programme General Annexes.
6. Legal and financial set-up of the grants — Described in Annex G of the Work Programme General Annexes.
Described in the ''Conditions of the Calls for proposals and Calls management rules'' section of the IHI JU Work Programme (WP) specific conditions on Availability, Accessibility and Affordability (3A) apply to this topic JU's right to object to transfer/exclusive licensing Where relevant, templates of the reference documents and associated guidance can be found on the IHI JU website . Regarding the application forms for submitting proposals, the relevant templates and annexes are available to download in the submission system of the Funding and Tender Opportunities portal. The IHI JU 12 th Call for proposals full topics text is available here .
Application form templates — the application form specific to this call is available in the Submission System 1) Evaluation form (RIA Actions – single and two-stage Calls procedure) IHI JU Evaluation form for Research and Innovation Actions 2) Proposal Templates Part A and Part B (RIA Actions – single and second stage of two-stage procedure) Proposal template - Part A of the proposal is generated by the IT system in the submission environment (for more information see the HE Part A template here ). In Part A of the proposal applicants insert general information on their proposal (e.g. proposal acronym), details on the participants, on the budget, information on Ethics and Security, as well as other type of questions (e.g. information on clinical studies). Please note that only Part A of this template is applicable for this call. For Part B, see point below. Proposal template - Part B : IHI JU Proposal template (RIA/FP) - Part B Proposal Annexes : a) Annex to the budget and type of participants The excel document template (detailed budget table) can be found here . Compulsory annex . Read the instructions on how to complete this annex: Instructions on the budget table Instructions on the type of participants table b) Annex: Declaration of in-kind contribution commitment Compulsory annex for all single-stage calls and stage two of two-stage calls. The word document template can be found here . c) Annex: In-kind contributions to additional activities (IKAA) Compulsory annex for single-stage calls and the second stage of two-stage calls when the proposal includes IKAA . The ‘ ’In-kind contributions to additional activities (IKAA)’’ is an IHI specific annex. The excel template can be found here . d) Annex: Essential information for clinical studies Compulsory annex for single-stage calls and the second stage of two-stage calls which must be uploaded as a separate document in the submission system. If your proposal does not include clinical studies, please upload a statement declaring that your proposal does not include clinical studies. The information on clinical studies annex can be found here . e) Annex: Ethics Optional annex for single-stage calls and the second stage of two-stage calls. Part A of the proposal includes an ethics self-assessment. However, if the proposal raises many serious ethical issues, the character count in Part A may not be enough for applicants to provide all the information needed. If this is the case for you, you should provide any additional information on the ethical aspects of your proposal in a separate document and upload it as an ethics annex. Note that there is no specific template for this annex. f) Annex: Contributing partners Compulsory annex for single-stage call consortia involving contributing partners . Instructions on how to complete this template can be found in the template itself and in the Guide for Contributing Partners . The Contributing partner application letter(s) can be found here . 3) Model Grant Agreements (MGA) HE MGA
- Council Regulation (EU) 2021/2085 of 19 November 2021 establishing the Joint Undertakings under Horizon Europe and repealing Regulations (EC) No 219/2007, (EU) No 557/2014, (EU) No 558/2014, (EU) No 559/2014, (EU) No 560/2014, (EU) No 561/2014 and (EU) No 642/2014 (in short Single Basic Act ‘SBA’ or Council Regulation (EU) 2021/2085). - IHI JU Work Programme (WP) - Strategic Research and Innovation Agenda (SRIA) - IHI JU Guide for Applicants - IHI JU FAQs Horizon Europe Reference Documents HE Main Work Programme 2026-2027 – General Annexes HE Programme Guide 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 Funding & Tenders Portal Privacy Statement
Evaluators will prioritize proposals that clearly articulate novel and robust methodologies for assessing the added value of integrated healthcare solutions, as explicitly stated in @EO1. They will look for a strong demonstration of how these methodologies will lead to solutions that are @EO2 safe, people-centred, effective, cost-effective, and affordable, directly addressing public health needs. Furthermore, a thorough @SC6 landscape analysis and a credible plan for synergy with existing initiatives are essential to avoid duplication and maximize impact. The ability to translate research into implementable solutions within the fragmented European healthcare systems (@SC5) will also be a key differentiator.
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 | |||
| SC1the high burden of the disease for patients and/or society due to its severity and/or the number of people affected by it; | · | · | Sign up to track |
| SC2the high economic impact of the disease for patients and society; | · | · | Sign up to track |
| SC3the transformational nature of the potential results on innovation processes where projects are not focussed on individual disease areas (e.g. health data analytics). | · | · | Sign up to track |
| SC4inform innovation-responsive guidance and regulatory science approaches; | · | · | Sign up to track |
| SC5demonstrate the ability to translate research into innovative solutions that can be integrated/implemented into the healthcare ecosystem (taking into consideration the fragmented nature of European healthcare systems) and/or into industrial processes. | · | · | Sign up to track |
| SC6carry out a landscape analysis to avoid unnecessary overlap and duplication of efforts with existing initiatives/projects and to identify potential synergies and complementarities with the relevant ones. The proposal should include a plan on how to synergise with these identified initiatives. | · | · | Sign up to track |
| Expected outcomes | |||
| EO1Applicants must define the outcomes expected to be achieved by their proposal, ensuring that they contribute to new and improved methodologies and models for a comprehensive assessment of the added value of innovative and integrated healthcare solutions in line with the IHI JU’s specific objective 5 as set out in the IHI JU Strategic Research and Innovation Agenda (SRIA). | · | · | Sign up to track |
| EO2Actions (projects) to be funded under this topic must deliver results that address public health needs and support the development of future health innovations that are safe, people-centred, effective, cost-effective and affordable for patients and for health care systems. | · | · | Sign up to track |
| EO3These outcomes are also expected to benefit the relevant stakeholders in the healthcare ecosystem. | · | · | Sign up to track |
| EO4The expected outcomes may cover the entire spectrum of care from prevention to disease management and may be centred around disease areas, key themes such as prevention, precision diagnostics, personalised medicine, and chronic disease management. | · | · | Sign up to track |
| EO5They may also include enabling solutions for digitalisation, artificial intelligence (AI), regulatory science, greener and more sustainable healthcare and the deployment and use of these solutions into practice. | · | · | Sign up to track |
| Other requirements | |||
| No other requirements in this call. | |||
| Expected impacts | |||
| EI1seamless and successful implementation in healthcare settings of cross-sectoral innovations, integrated products and services delivering proven benefits to patients, healthcare systems and society as a whole; | · | · | Sign up to track |
| EI2patients have improved access to innovations that meet their needs and those of the healthcare systems; | · | · | Sign up to track |
| EI3better informed decision-making at different levels of the healthcare system (authorities, organisations), that will in turn contribute to a better allocation of resources towards cost effective innovations; | · | · | Sign up to track |
| EI4faster entry to the market of cost-effective innovative solutions developed by industry, which could translate to a positive effect on their R&I investments. | · | · | Sign up to track |
| EI5the strengthening of the competitiveness of the EU’s health industry, via increased economic activity in the development of health technologies, in particular integrated health solutions, and thus fostering European technological leadership and the digital transformation of our societies. | · | · | Sign up to track |
| EI6the implementation of the EU’s Life Sciences Strategy and its specific aims such as: reinforcing European R&I e.g. supporting multinational clinical trials and improving the clinical research ecosystem; | · | · | Sign up to track |
| EI7the implementation of the EU’s Life Sciences Strategy and its specific aims such as: providing smooth and rapid market access for life science innovations e.g. through promoting innovation-responsive regulation to ensure timely real value delivery of innovations to people; | · | · | Sign up to track |
| EI8the improvement of the health technology assessment (HTA) methodology for instance through: development and uptake of innovative HTA approaches tailored to meet the demands of HTA organisations, policy makers, and industry, including aspects such as usability, integration into care pathways, and patient experience. This also covers novel methods for assessment of added value of combined technologies; | · | · | Sign up to track |
| EI9the improvement of the health technology assessment (HTA) methodology for instance through: crafting and deploying dissemination and educational programs to ensure unified HTA expertise throughout the EU, covering both medical technology and pharmaceutical innovations; | · | · | Sign up to track |
| EI10the improvement of the health technology assessment (HTA) methodology for instance through: uptake of innovative medical devices and in-vitro diagnostics. | · | · | Sign up to track |
| Underlying policies | |||
| POL1apply ai strategyThe Apply AI Strategy is central to this call, focusing on the deployment of AI in healthcare to improve screening, diagnosis, and patient outcomes. It emphasizes the creation of a European network of AI-powered screening centres. | · | · | Sign up to track |
| POL2regulation on the european health data space (ehds)The Regulation on the European Health Data Space (EHDS) aims to create a common European data space for health, enabling secure and trustworthy access to health data for primary use (healthcare delivery) and secondary use (research, innovation, public health). It seeks to empower individuals with control over their health data and foster a single market for digital health services. | · | · | Sign up to track |
| POL3eu artificial intelligence actThe EU AI Act is the world's first comprehensive legal framework for Artificial Intelligence, aiming to ensure that AI systems placed on the EU market and used in the EU are safe and respect fundamental rights. It categorises AI systems based on their risk level, with strict requirements for high-risk AI, including those used in 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.
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. Other sources may be added but not substitute EU infrastructures.
Civil applications only
Horizon Europe funds exclusively civil applications. Research with exclusive military or dual-use application is excluded.
Gender Equality Plan
Having a Gender Equality Plan (GEP) is an eligibility criterion for public bodies, research organisations, and higher education institutions from Member States and Associated Countries.
Open Science
Mandatory open access to peer-reviewed scientific publications and responsible management of research data (FAIR principles, DMP required).
Talk to the Grant Coach to build your concept. The steps below fill in as it takes shape, and your coverage tracks the progress. You can refine everything once your project workspace is created.
Step 1 of 2 · Build your concept
The problems this call frames, and who they affect. Your concept and plan address them.
Current Health Technology Assessment (HTA) and value assessment methodologies often struggle to comprehensively evaluate the complex, integrated, and cross-sectoral nature of modern healthcare innovations, leading to incomplete understanding of their true added value.
The fragmented nature of European healthcare systems, coupled with a lack of robust evidence on real-world benefits and cost-effectiveness, hinders the seamless integration and widespread implementation of innovative healthcare solutions.
The challenges in demonstrating the comprehensive added value of innovative solutions contribute to slower market entry for industry and less informed decision-making by authorities, resulting in suboptimal allocation of resources and missed opportunities for patient benefit.
Individuals affected by diseases and their representative organisations, who will benefit from improved access to innovative, needs-driven, and affordable healthcare solutions.
Hospitals, clinics, general practitioners, nurses, and other healthcare workers who will utilize and integrate the new solutions and assessment methodologies into their practice.
Bodies responsible for evaluating the value of health technologies, who will benefit from enhanced methodologies, tools, and expertise for comprehensive assessment.
National and European authorities responsible for health policy, regulation, and resource allocation, who will use improved evidence for decision-making and innovation-responsive guidance.
Companies developing innovative integrated healthcare solutions, who will benefit from clearer pathways for value demonstration and faster market access for cost-effective products.
Academics, researchers, and scientific institutions contributing to and benefiting from advanced methodologies, data, and knowledge in health technology assessment and healthcare innovation.
Step 2 of 2 · Build your concept
The long-term impacts your project should drive — this shapes the objectives next.
Achieving widespread and effective integration of innovative healthcare solutions into clinical practice, leading to tangible improvements in patient care, operational efficiency of healthcare systems, and overall societal well-being.
Enhancing the availability and accessibility of innovative healthcare solutions for patients, ensuring these solutions are aligned with both patient needs and the strategic priorities of healthcare systems.
Enabling healthcare authorities and organisations to make evidence-based decisions regarding the adoption and funding of innovative solutions, leading to more efficient and equitable allocation of resources towards cost-effective innovations.
Accelerating the market access pathway for innovative and cost-effective healthcare solutions, thereby incentivising further R&I investments by the health industry and fostering a dynamic innovation ecosystem.
Boosting the economic strength and global competitiveness of the EU's health industry through increased innovation, development, and adoption of advanced health technologies, contributing to European leadership in digital health and R&I.
Advancing the scientific rigor and practical applicability of Health Technology Assessment (HTA) methodologies, leading to more comprehensive evaluations, harmonised expertise across the EU through education, and faster adoption of cutting-edge medical technologies and in-vitro diagnostics.