Boosting innovation for better assessment of the added value of innovative integrated healthcare solutions

The Innovative Health Initiative (IHI) Call 12 Topic 5 presents a comprehensive funding opportunity focusing on health technology assessment (HTA) innovation as part of the Horizon Europe framework. The core aim is to enhance methodologies for evaluating the added value of innovative healthcare solutions, such as medicines, medical devices, and digital health tools. This initiative encourages the assembly of collaborative public-private partnership consortia that combine a diverse mix of expertise, involving research institutions, universities, pharmaceutical companies, healthcare providers, and regulatory organizations.

Funding will be provided through HORIZON Action Grants, specifically for Research and Innovation Actions (RIA), with a grant range of €5 million to €9.8 million per project. The total budget allocated for this call is approximately €163.1 million, with up to two grants expected to be awarded under this topic. The required geographic scope includes EU member states and associated countries, with Canada and the UK eligible for participation.

This opportunity emphasizes pre-competitive research addressing unmet public health needs and includes a strong expectation for co-funding, wherein consortia must demonstrate that at least 45% of total eligible costs are covered by contributions from participants, primarily from industry partners. The application process will be single-stage, opening on January 15, 2026, and closing on April 21, 2026, at 17:00 Brussels time.

The expected outcomes include the creation of integrated frameworks for assessing health innovations, faster evidence-based market access, and improved methodologies for assessing clinical effectiveness, cost-effectiveness, and patient experiences. Projects should also address regulatory impacts and promote open access to research outputs, ultimately fostering significant transformations in European health systems.

Applicants are encouraged to focus on projects that are innovative, patient-centered, and capable of accelerating the uptake of evidence-based practices. A streamlined application process, specific eligibility criteria, mandatory in-kind contributions, and detailed guidelines for proposal submission are outlined to facilitate participation. The IHI aims to strengthen the European health industry's competitiveness and contributes to the overarching EU Life Sciences Strategy.

This is a summary of the Innovative Health Initiative (IHI) Joint Undertaking (JU) Call 12, specifically focusing on the topic "Boosting innovation for better assessment of the added value of innovative integrated healthcare solutions." This call falls under the Horizon Europe (HORIZON) program and aims to fund Research and Innovation Actions (RIA).

The call is structured as a single-stage submission process with the opening date set for January 15, 2026, and a deadline of April 21, 2026, at 17:00 Brussels time. The total budget allocated for this call is 110,000,000 EUR, distributed across several topics with varying contribution ranges and indicative numbers of grants.

The expected impact of the funded actions includes: seamless implementation of cross-sectoral innovations in healthcare, improved patient access to innovations, better informed decision-making in healthcare resource allocation, and faster market entry for cost-effective solutions. These actions are also expected to contribute to strengthening the EU's health industry competitiveness, implementing the EU's Life Sciences Strategy, and improving health technology assessment (HTA) methodologies.

The expected outcomes involve contributing to new and improved methodologies and models for assessing the added value of innovative and integrated healthcare solutions, addressing public health needs, and supporting the development of safe, people-centered, effective, cost-effective, and affordable health innovations. These outcomes should benefit all relevant stakeholders in the healthcare ecosystem.

The scope of the call focuses on funding pre-competitive research and innovation for novel tools, methods, and technologies that will foster the development of health innovations for disease prevention, interception, diagnosis, treatment, management, and efficient recovery. Applicants are required to form collaborative public-private partnership consortia that can address the challenges and scope of IHI JU’s Specific Objective 5, which is to enable the development of new and improved methodologies and models for a comprehensive assessment of the added value of innovative and integrated healthcare solutions.

Proposals should address an unmet public health need, inform innovation-responsive guidance and regulatory science approaches, demonstrate the ability to translate research into innovative solutions for integration into the healthcare ecosystem and/or industrial processes, and carry out a landscape analysis to identify potential synergies and complementarities with existing initiatives. Patient-centricity and consideration of demographic trends are also encouraged.

Applicants are expected to perform at-scale activities that consider the innovation cycles of the pharmaceutical and medical technology industries, driving concrete and transformational outcomes. Integrated pre-competitive activities, including demonstration pilots, are welcomed to accelerate and improve the uptake of evidence-based practice and research outcomes into regular use.

Consideration of the potential regulatory impact of project outputs is expected, with the development of a regulatory strategy and interaction plan for engaging with relevant regulatory bodies. Open access to project-generated outputs, such as standards, data sets, and research results, is strongly encouraged.

The general conditions for participation include admissibility conditions related to proposal page limits and layout, eligible countries, and other eligibility criteria. Financial and operational capacity and exclusion criteria are also specified. Evaluation and award processes, including award criteria, scoring, thresholds, submission, evaluation processes, and indicative timelines, are detailed in the relevant annexes and work program sections.

Specific conditions include adherence to Availability, Accessibility, and Affordability (3A) principles and the JU's right to object to transfer/exclusive licensing. Templates and guidance documents are available on the IHI JU website, and application forms and annexes can be downloaded from the Funding and Tender Opportunities portal.

Required annexes include: Annex to the budget and type of participants, Declaration of in-kind contribution commitment, In-kind contributions to additional activities (IKAA), Essential information for clinical studies, Ethics (optional), and Contributing partners (if applicable).

The call is supported by various reference documents, including the Council Regulation (EU) 2021/2085, IHI JU Work Programme, Strategic Research and Innovation Agenda (SRIA), IHI JU Guide for Applicants, IHI JU FAQs, Horizon Europe Reference Documents, EU Financial Regulation 2024/2509, Rules for Legal Entity Validation, LEAR Appointment and Financial Capacity Assessment, EU Grants AGA, Funding & Tenders Portal Online Manual, Funding & Tenders Portal Terms and Conditions, and Funding & Tenders Portal Privacy Statement.

Support services are available through the Online Manual, Horizon Europe Programme Guide, Funding & Tenders Portal FAQ, Research Enquiry Service, National Contact Points (NCPs), Enterprise Europe Network, IT Helpdesk, European IPR Helpdesk, and CEN-CENELEC/ETSI Research Helpdesks.

In essence, this funding opportunity aims to foster collaborative research and innovation projects that develop novel tools, methods, and technologies to improve the assessment of the added value of integrated healthcare solutions. It encourages applicants to address unmet public health needs, consider regulatory impacts, and promote open access to research outputs, ultimately contributing to a more competitive and innovative European health industry.

The budget overview indicates that the total budget for the call is 110,000,000 EUR. The opening date for the call is January 15, 2026, and the deadline for submission is April 21, 2026. The indicative number of grants to be awarded is 324. The contribution amounts range from 8,000,000 to 30,000,000 EUR, 8,000,000 to 20,000,000 EUR, and 15,000,000 to 60,000,000 EUR.

There are also other topics with their own budget and grant numbers:

HORIZON-JU-IHI-2026-12-SINGLE-STAGE-04 - HORIZON-JU-RIA HORIZON JU Research and Innovation Actions has a budget of 43,300,000 EUR, with contributions ranging from 8,000,000 to 43,300,000 EUR, and an indicative number of 5 grants.

HORIZON-JU-IHI-2026-12-SINGLE-STAGE-05 - HORIZON-JU-RIA HORIZON JU Research and Innovation Actions has a budget of 9,800,000 EUR, with contributions ranging from 5,000,000 to 9,800,000 EUR, and an indicative number of 2 grants.

There are partner search announcements available, and applicants can start the submission process through the Funding & Tenders Portal.

Eligible Applicant Types: The opportunity requires a collaborative public-private partnership consortium. This suggests that eligible applicants could include a mix of public sector organizations (e.g., universities, research institutions, government bodies) and private sector entities (e.g., startups, SMEs, large enterprises, pharmaceutical companies, medical technology companies). The consortium should reflect the integrative and cross-sectoral nature of the IHI JU. Contributing partners are also mentioned, suggesting a broader range of eligible entities.

Funding Type: The primary financial mechanism is a grant, specifically a HORIZON Action Grant Budget-Based [HORIZON-AG] for Research and Innovation Actions (RIA).

Consortium Requirement: A consortium of multiple applicants is required. The text explicitly states that applicants must assemble a collaborative public-private partnership consortium.

Beneficiary Scope (Geographic Eligibility): The primary geographic eligibility appears to be EU member states and associated countries, as indicated by the reference to Horizon Europe and the IHI JU. However, the text also mentions that 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.

Target Sector: The program targets the health sector, with a focus on health technologies, integrated health solutions, pharmaceutical innovations, medical devices, in-vitro diagnostics, digital health, artificial intelligence (AI) in healthcare, regulatory science, and health technology assessment (HTA). It also touches on areas like cancer research, personalized medicine, and sustainable healthcare.

Mentioned Countries: The opportunity is focused on the EU and associated countries. The European Medicines Agency (EMA) is mentioned, as are EU national competent authorities. 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.

Project Stage: The projects should be at the pre-competitive research and innovation stage, with a focus on developing novel tools, methods, and technologies. The program also supports demonstration pilots and activities that can accelerate the uptake of evidence-based practice and research outcomes into regular use, suggesting a development and piloting stage.

Funding Amount: The funding amounts vary depending on the specific topic within the call:
HORIZON-JU-IHI-2026-12-SINGLE-STAGE-01, HORIZON-JU-IHI-2026-12-SINGLE-STAGE-03, HORIZON-JU-IHI-2026-12-SINGLE-STAGE-02: €8,000,000 to €30,000,000, €8,000,000 to €20,000,000 and €15,000,000 to €60,000,000 respectively.
HORIZON-JU-IHI-2026-12-SINGLE-STAGE-04: €8,000,000 to €43,300,000
HORIZON-JU-IHI-2026-12-SINGLE-STAGE-05: €5,000,000 to €9,800,000

Application Type: The application type is an open call, specifically a single-stage call.

Nature of Support: Beneficiaries will receive money in the form of a grant to support their research and innovation activities.

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

Success Rates: The success rates are not explicitly mentioned.

Co-funding Requirement: The text mentions "in-kind contribution commitment" and "in-kind contributions to additional activities (IKAA)", suggesting that co-funding or in-kind contributions may be required or encouraged.

Summary:

This is a call for proposals under the Horizon Europe program, specifically the Innovative Health Initiative (IHI) Joint Undertaking (JU). The call aims to boost innovation in the health sector by funding research and innovation actions that contribute to the development and assessment of innovative and integrated healthcare solutions. The focus is on projects that can improve health outcomes, strengthen the competitiveness of the EU health industry, and contribute to the implementation of the EU's Life Sciences Strategy.

The call is structured around several topics, each with a specific budget and expected number of grants. Applicants must form a collaborative public-private partnership consortium to address the challenges and scope of the IHI JU's Specific Objective 5, which focuses on enabling the development of new and improved methodologies and models for a comprehensive assessment of the added value of innovative and integrated healthcare solutions.

Projects should address unmet public health needs, inform regulatory science approaches, demonstrate the ability to translate research into innovative solutions, and carry out a landscape analysis to identify synergies and complementarities with existing initiatives. The call encourages projects that consider patient-centricity, perform at-scale activities, and consider the potential regulatory impact of their outputs. Open access to project outputs is also strongly encouraged.

The application process is a single-stage call, and proposals must adhere to specific page limits and layout guidelines. A variety of annexes and templates are required as part of the application, including a budget table, declaration of in-kind contribution commitment, and information on clinical studies (if applicable). The call is open to a wide range of applicants from both the public and private sectors, primarily from the EU and associated countries, although some non-EU/non-associated countries may also be eligible.