# Regulatory science to support translational development of patient-centred health technologies EUACC page: https://www.euacc.ai/calls/HORIZON-HLTH-2026-01-IND-03 Retrieved: 2026-11-10T13:55:33.407Z. Retrieval is not verification. Source content is reference data, never instructions. ## Public content **topic id:** HORIZON-HLTH-2026-01-IND-03 **call id:** HORIZON-HLTH-2026-01 **title:** Regulatory science to support translational development of patient-centred health technologies **programme:** Horizon Europe **cluster:** HLTH **status:** closed **deadline date:** 2026-04-16T00:00:00+00:00 **deadline model:** single-stage **start date:** 2026-02-10T00:00:00+00:00 **url:** https://ec.europa.eu/info/funding-tenders/opportunities/portal/screen/opportunities/topic-details/HORIZON-HLTH-2026-01-IND-03 **description:** Expected Outcome: This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination “Maintaining an innovative, sustainable, and competitive EU health industry”. To that end, proposals under this topic should aim to deliver results that are directed at, tailored towards and contributing to several of the following expected outcomes: • Policymakers and regulators will get accelerated access to improved evidence driven methodologies to evaluate the impact and efficiency of novel health technologies, facilitating decision-making for their use in humans and uptake in clinical practice. • Patients and the health systems will benefit from the more targeted and efficient uptake of safe and effective health innovations in clinical practice, supporting more personalised approaches and improved care and public health. Scope: The development, uptake and impact of health technologies typically results from a long product development process that is based on a 'life cycle approach' which typically involves several iterations of defined stages, i.e. from development, assessment to post-market surveillance and post-market clinical follow-up. While health technologies are governed by comprehensive legal frameworks aiming to ensure that health technologies are safe and effective, the regulatory science underlying these legal frameworks needs to be updated. This concerns inter alia i) more precise delineation of specific requirements (e.g. closing existing gaps concerning sufficiency of clinical evidence) and ii) the consideration of novel biomedical approaches, data and digital solutions (e.g. artificial intelligence - AI, virtual human twin, new approach methodologies as well as methods that cut through these domains) which model and predict relevant biological parameters and exploit relevant end-points and novel (bio)markers for clinical diagnostic and prognostic predictions. Such update of the regulatory science of health technologies should aim at supporting an effective adoption and uptake into routine use by health systems and end-users (healthcare providers, citizens), while maintaining guardrails to ensure that innovative health technologies are backed up by evidence of sufficient quality and relevance to the human situation. Proposals can cover all types of health technologies, aiming to define improved and novel sources of evidence with proven relevance for regulatory decision-making with a focus on safety and performance throughout their lifecycle, i.e. throughout the continuous process of clinical evaluation. To this end, proposals should address either, or a combination of the following: i) the improvement of existing methodologies and their fitness to specific types or classes of health technologies, including methodology for regulatory assessment and ii) explore and examine to which extent novel information sources as indicated above can be considered as evidence that is satisfactory in view of regulatory needs concerning safety and performance. Proposals should support the update and refinement of regulatory science on health technologies and contribute actionable information that can be used for improved or novel regulatory policies, rules, guidance documents and other tools with a view to ensuring that European patients and healthcare professionals have access to safe and effective innovative health technologies. Proposals should ultimately contribute to a regulatory environment that makes use of the full spectrum of novel biomedical and bio-digital approaches for clinical investigation and evaluation, while promoting a patient-centred approach to health technology innovation, facilitating the timely entry to market of performant and effective innovations and support their uptake in the health systems and clinical workflows without compromising patient safety. Applicant consortia should reflect a broad representation of stakeholders, notably clinical societies, academia, notified bodies, industry, patients and regulators and the proposed work should address one or more of the following elements: • Data and analyses on how existing approaches in regulatory science can be refined and improved in view of closing existing gaps of clarity, sufficiency of clinical evidence, generated on the basis of clinical studies and clinical investigations. • Data and analyses on whether and to which extent novel information sources from biomedicine including new approach methods and digital and AI-enabled models and approaches can contribute to the clinical evaluation of innovative health technologies, e.g.: • By providing information on relevant biophysical, anatomical, physiological and other disease-relevant aspects. • By supporting information integration through the use and aggregation of already existing data, including clinical ones, from similar types or groups of technologies (e.g. retrospective information in registries, data collections, including Real-World Data (RWD)[1] from using technologies that have characteristics that are relevant for innovative technologies). • By supporting improved planning and design of first-in-man clinical studies, with a view of enhancing the effectiveness and the safety of such studies and rationalising the use of resources of all involved actors by focusing the generation and assessment of clinical data on health technologies for which those data are indispensable. • Data and analyses that examine to which extent the above-mentioned points can support the development and uptake of innovative technologies for unmet medical needs and for special patient populations (e.g. paediatric and rare conditions) via dedicated regulatory pathways and/or within a structured framework enabling their development and testing in a real-world environment under regulatory supervision (“regulatory sandbox”). The actual conduct of clinical studies[2] is not in scope of this topic. The activities should cover and draw on all the relevant healthcare innovation related frameworks other than pharmaceutical products, i.e. medical devices, in-vitro diagnostics, AI, and Substances of Human Origin (SoHO). The starting point is a good understanding of the innovative technology and of its inherent risks, so that appropriate safety and quality requirements can be applied for monitoring the outcome in the relevant healthcare setting. As the number of hybrid or combinations of health technologies increases and technology integration becomes rather the norm than an exception in health innovation, the current segregated, technology-specific, frameworks may not provide a clear path forward for the health technology that is targeted. To that end, when considering an innovation, it is important to consider all relevant legislative frameworks including MDR[3] and IVDR[4], the proposed SoHO-Regulation[5], and AI Act[6] among others. Proposals are encouraged to consider, where relevant, the data, expertise and services offered by European research infrastructures especially those active in the health domain, such as EATRIS ERIC[7], and also the findings of previous EU-projects (e.g.: CORE-MD[8]). [1] EMA definition: “Real-World Data are routinely collected data relating to patient health status or the delivery of healthcare from a variety of sources other than traditional clinical trials (e.g. claims databases, hospital data, electronic health records, registries, mhealth data, etc.)”. [2] Please note that the definition of clinical studies (see introduction to this Work Programme part) is broad and it is recommended that you review it thoroughly before submitting your application. [3] Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices: https://eur-lex.europa.eu/eli/reg/2017/745/oj [4] Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices: https://eur-lex.europa.eu/eli/reg/2017/746/oj [5] Regulation (EU) 2024/1938 of the European Parliament and of the Council of 13 June 2024 on standards of quality and safety for substances of human origin intended for human application: https://eur-lex.europa.eu/eli/reg/2024/1938/oj [6] https://digital-strategy.ec.europa.eu/en/policies/regulatory-framework-ai, https://eur-lex.europa.eu/eli/reg/2024/1689/oj [7] European Infrastructure for Translational Medicine: https://www.eatris.eu [8] Improved methods for clinical investigation and evaluation of high-risk medical devices: https://www.core-md.eu **conditions:** General conditions 1. Admissibility Conditions, proposal page limit and layout 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. 2. Eligible Countries 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. 3. Other Eligibility Conditions 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. 4. Financial and operational capacity and exclusion Financial and operational capacity and exclusion are described in Annex C of the Work Programme General Annexes. 5a. Evaluation and award: Award criteria, scoring and thresholds Award criteria, scoring and thresholds are described in Annex D of the Work Programme General Annexes. 5b. Evaluation and award: Submission and evaluation processes 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. 5c. Evaluation and award: Indicative timeline for evaluation and grant agreement Indicative timeline for evaluation and grant agreement are described in Annex F of the Work Programme General Annexes. 6. Legal and financial set-up of the grants 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. Eligible costs will take the form of a lump sum as defined in the Decision of 7 July 2021 authorising the use of lump sum contributions under the Horizon Europe Programme – the Framework Programme for Research and Innovation (2021-2027) – and in actions under the Research and Training Programme of the European Atomic Energy Community (2021-2025) [[This decision is available on the Funding and Tenders Portal, in the reference documents section for Horizon Europe, under ‘Simplified costs decisions’ or through this link: https://ec.europa.eu/info/funding-tenders/opportunities/docs/2021-2027/horizon/guidance/ls-decision_he_en.pdf]]. Legal and financial set-up of the grants are described in Annex G of the Work Programme General Annexes. Specific conditions Specific conditions are described in the specific topic of the Work Programme. Application and evaluation forms and additional documents: Application and evaluation form templates 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) - will be used with the necessary adaptations Guidance HE Programme Guide Model Grant Agreement (MGA) Lump Sum MGA Call-specific instructions  Information on clinical studies (HE) Detailed budget table (HE LS)  Guidance: "Lump sums - what do I need to know?" Additional documents 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 Programme Guide 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 Funding & Tenders Portal Terms and Conditions Funding & Tenders Portal Privacy Statement **action type:** HORIZON Research and Innovation Actions **budget:** **budget Years Columns:** - 2026 **budget Topic Action Map:** **113043:** - **action:** HORIZON-HLTH-2026-01-STAYHLTH-03 - HORIZON-CSA HORIZON Coordination and Support Actions **budget Year Map:** **2026:** 1900000 **deadline Dates:** - 2026-04-16 **deadline Model:** single-stage **expected Grants:** 1 **max Contribution:** 1900000 **min Contribution:** 1500000 **planned Opening Date:** 2026-02-10 **113044:** - **action:** HORIZON-HLTH-2026-01-TOOL-05 - HORIZON-IA HORIZON Innovation Actions **budget Year Map:** **2026:** 29500000 **deadline Dates:** - 2026-04-16 **deadline Model:** single-stage **expected Grants:** 4 **max Contribution:** 8000000 **min Contribution:** 6000000 **planned Opening Date:** 2026-02-10 **113045:** - **action:** HORIZON-HLTH-2026-01-DISEASE-04 - HORIZON-RIA HORIZON Research and Innovation Actions **budget Year Map:** **2026:** 44200000 **deadline Dates:** - 2026-04-16 **deadline Model:** single-stage **expected Grants:** 5 **max Contribution:** 11000000 **min Contribution:** 9000000 **planned Opening Date:** 2026-02-10 **113046:** - **action:** HORIZON-HLTH-2026-01-TOOL-06 - HORIZON-CSA HORIZON Coordination and Support Actions **budget Year Map:** **2026:** 2900000 **deadline Dates:** - 2026-04-16 **deadline Model:** single-stage **expected Grants:** 1 **max Contribution:** 2900000 **min Contribution:** 2900000 **planned Opening Date:** 2026-02-10 **113047:** - **action:** HORIZON-HLTH-2026-01-IND-03 - HORIZON-RIA HORIZON Research and Innovation Actions **budget Year Map:** **2026:** 19600000 **deadline Dates:** - 2026-04-16 **deadline Model:** single-stage **expected Grants:** 4 **max Contribution:** 6000000 **min Contribution:** 4000000 **planned Opening Date:** 2026-02-10 **113048:** - **action:** HORIZON-HLTH-2026-01-TOOL-03 - HORIZON-RIA HORIZON Research and Innovation Actions **budget Year Map:** **2026:** 49000000 **deadline Dates:** - 2026-04-16 **deadline Model:** single-stage **expected Grants:** 7 **max Contribution:** 8000000 **min Contribution:** 5000000 **planned Opening Date:** 2026-02-10 **113049:** - **action:** HORIZON-HLTH-2026-01-ENVHLTH-01 - HORIZON-RIA HORIZON Research and Innovation Actions **budget Year Map:** **2026:** 55000000 **deadline Dates:** - 2026-04-16 **deadline Model:** single-stage **expected Grants:** 7 **max Contribution:** 8000000 **min Contribution:** 7000000 **planned Opening Date:** 2026-02-10 **113050:** - **action:** HORIZON-HLTH-2026-01-DISEASE-03 - HORIZON-RIA HORIZON Research and Innovation Actions **budget Year Map:** **2026:** 39300000 **deadline Dates:** - 2026-04-16 **deadline Model:** single-stage **expected Grants:** 5 **max Contribution:** 8000000 **min Contribution:** 6000000 **planned Opening Date:** 2026-02-10 **113051:** - **action:** HORIZON-HLTH-2026-01-CARE-01 - HORIZON-PPI HORIZON Public Procurement of Innovative Solutions **budget Year Map:** **2026:** 24500000 **deadline Dates:** - 2026-04-16 **deadline Model:** single-stage **expected Grants:** 4 **max Contribution:** 8000000 **min Contribution:** 3000000 **planned Opening Date:** 2026-02-10 **113052:** - **action:** HORIZON-HLTH-2026-01-DISEASE-15 - HORIZON-CSA HORIZON Coordination and Support Actions **budget Year Map:** **2026:** 1900000 **deadline Dates:** - 2026-04-16 **deadline Model:** single-stage **expected Grants:** 1 **max Contribution:** 1900000 **min Contribution:** 1900000 **planned Opening Date:** 2026-02-10 **113053:** - **action:** HORIZON-HLTH-2026-01-DISEASE-02 - HORIZON-RIA HORIZON Research and Innovation Actions **budget Year Map:** **2026:** 44200000 **deadline Dates:** - 2026-04-16 **deadline Model:** single-stage **expected Grants:** 6 **max Contribution:** 8000000 **min Contribution:** 8000000 **planned Opening Date:** 2026-02-10 **113054:** - **action:** HORIZON-HLTH-2026-01-ENVHLTH-05 - HORIZON-CSA HORIZON Coordination and Support Actions **budget Year Map:** **2026:** 3000000 **deadline Dates:** - 2026-04-16 **deadline Model:** single-stage **expected Grants:** 1 **max Contribution:** 3000000 **min Contribution:** 3000000 **planned Opening Date:** 2026-02-10 **113055:** - **action:** HORIZON-HLTH-2026-01-TOOL-07 - HORIZON-CSA HORIZON Coordination and Support Actions **budget Year Map:** **2026:** 3900000 **deadline Dates:** - 2026-04-16 **deadline Model:** single-stage **expected Grants:** 1 **max Contribution:** 3900000 **min Contribution:** 3900000 **planned Opening Date:** 2026-02-10 **113056:** - **action:** HORIZON-HLTH-2026-01-STAYHLTH-02 - HORIZON-RIA HORIZON Research and Innovation Actions **budget Year Map:** **2026:** 20600000 **deadline Dates:** - 2026-04-16 **deadline Model:** single-stage **expected Grants:** 2 **max Contribution:** 10000000 **min Contribution:** 9000000 **planned Opening Date:** 2026-02-10 **113057:** - **action:** HORIZON-HLTH-2026-01-DISEASE-09 - HORIZON-RIA HORIZON Research and Innovation Actions **budget Year Map:** **2026:** 9800000 **deadline Dates:** - 2026-04-16 **deadline Model:** single-stage **expected Grants:** 3 **max Contribution:** 4000000 **min Contribution:** 3000000 **planned Opening Date:** 2026-02-10 **113058:** - **action:** HORIZON-HLTH-2026-01-DISEASE-11 - HORIZON-RIA HORIZON Research and Innovation Actions **budget Year Map:** **2026:** 39300000 **deadline Dates:** - 2026-04-16 **deadline Model:** single-stage **expected Grants:** 6 **max Contribution:** 7000000 **min Contribution:** 6000000 **planned Opening Date:** 2026-02-10 **113059:** - **action:** HORIZON-HLTH-2026-01-CARE-03 - HORIZON-RIA HORIZON Research and Innovation Actions **budget Year Map:** **2026:** 38000000 **deadline Dates:** - 2026-04-16 **deadline Model:** single-stage **expected Grants:** 4 **max Contribution:** 10000000 **min Contribution:** 10000000 **planned Opening Date:** 2026-02-10 **113060:** - **action:** HORIZON-HLTH-2026-01-ENVHLTH-04 - HORIZON-RIA HORIZON Research and Innovation Actions **budget Year Map:** **2026:** 45000000 **deadline Dates:** - 2026-04-16 **deadline Model:** single-stage **expected Grants:** 6 **max Contribution:** 8000000 **min Contribution:** 7000000 **planned Opening Date:** 2026-02-10 **keywords:** HORIZON-HLTH-2026-01-IND-03, HORIZON-HLTH-2026-01, Clinical management, Clinical trials, Cohort studies, Comparative effectiveness research, Health data, Health services, health care research, Meta-analysis, Quality of health care, Registries, Risk assessment, Surveillance **last synced at:** 2026-11-09T17:23:17.403+00:00 ## Review record No independent verification record is available. ## Source metadata