Why the HORIZON-HLTH-2025-01-CARE-01 call on generative AI in healthcare matters now
18th June 2025 at 3:40 pm
Generative AI (GenAI) is transforming digital industries, and its potential and challenges are highly relevant to healthcare. The Horizon Europe call HORIZON-HLTH-2025-01-CARE-01 invites robust, end-user-driven solutions that apply GenAI models in clinical settings. The goal is to both improve care quality and system efficiency and build trust, address legal concerns and reduce inequalities in access. With a deadline on 16 September 2025, this pivotal call topic aligns cutting-edge GenAI development with new EU regulations, data infrastructure initiatives and urgent health system needs for safer, more efficient and personalised care. Below, we explore the strategic urgency of this call and what successful Horizon Europe Health proposals are expected to deliver.
1. GenAI in healthcare: a political and clinical inflection point
AI policy is maturing fast, and so is GenAI’s potential. The European Health Data Space Regulation (EHDS), the EU AI Act, and multiple Digital Europe initiatives are aligning to support ethical, high-performance AI systems in health. This call reflects that policy momentum. Proposals must:
- Develop of trustworthy and ethical GenAI models developed in the EU or Associated Countries.
- Demonstrate the added value and clinical utility of the virtual assistant solutions.
- Clinical and cost-effectiveness evidence beyond existing AI tools.
- Develop a clearly defined regulatory strategy, including early engagement with Health Technology Assessment (HTA) bodies.
- Develop or adapt existing methodologies for the continuous assessment of the developed solutions
Pro tip: Anchoring your proposal in EU policy milestones, referencing the AI Act, the European Health Data Space or relevant Digital Europe initiatives signals alignment with long-term EU priorities and strengthens your credibility with evaluators.
2. From hype to health outcomes: what the EC wants to see
PhaProposals must test GenAI-driven virtual assistants in at least two healthcare use cases in different medical fields. What the EC wants:
- Demonstrated added value and superiority over standard of care.
- A high maturity technology and evidence that these solutions are superior to other AI tools.
- The development or revision of existing methodologies to assess alignment with human values and the use cases developed.
Pro tip: Select use cases where multimodal data is available and where clinician engagement is high. Make sure models are trained with data in multiple EU languages, when relevant.
3. Addressing bias, transparency, and liability head-on
EU regulators and healthcare users need to trust that GenAI systems won’t systematically disadvantage certain groups. To do so, your proposal should:
- Show how you will identify and mitigate bias and confounding (e.g., representativeness of the data, bias of the trainer, bias of training and validation data, algorithmic discrimination and bias including gender bias etc.).
- Include explainability techniques that make GenAI reasoning transparent.
- Include methods to systematically address and assess ELSI (Ethical, Legal, and Societal Implications) aspects, including data privacy and risk of discrimination/bias.
- Promote the highest standards of transparency and openness of models, as much as possible going well beyond documentation and extending to aspects such as assumptions, code and FAIR data management.
Pro tip: Make ethics and social science expertise central to your approach. This is a requirement, not a recommendation and it strengthens your evaluation score.
4. Building public trust through stakeholder co-creation
GenAI in health will not be adopted if it is seen as opaque or unaccountable. Horizon Europe expects applicants to:
- Actively involve healthcare professionals, patients and caregivers in development and testing,
- Offer training and education activities for healthcare professionals.
- Develop models aligned with ethical and societal values, not just technical metrics
Pro tip: Involve all stakeholders from the beginning and detail in your proposal how you plan to incorporate them in the different stages of the project and their role.
5. Proposal essentials: technical excellence meets EU alignment
To stay competitive, your Horizon Europe Health proposal should also:
- Commit to open-source approaches and FAIR data principles, where feasible
- Allocate budget for collaboration with other funded projects and participation in joint networking activities
- Show how your project will interface with the European Commission’s JRC and other relevant agencies
Changes in the new Part B template
Please note the following when getting started with your proposal preparation: As of the latest updates to the Horizon Europe RIA/IA proposal template (Part B, v4.0 from December 2024), several noteworthy adjustments have been made. The guidance notes under Section 1.2 Methodology concerning the Do No Significant Harm (DNSH) principle and the technical robustness of AI have been removed. Additionally, the requirements on data management have been simplified: the dedicated Research Data Management chapter has been eliminated and, instead, a brief reference to the Data Management Plan (DMP) has been integrated under the Open science practices section, streamlining the treatment of research data. On a positive note, the template now includes a new, direct link to the EU’s sex and gender reference documentation, making it easier for applicants to ensure appropriate integration of sex/gender dimensions in their research. These changes reflect a simplification and targeted focus in the current template structure.
For more information or general advice on the call topic, please consult your National Contact Point.
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Since our foundation, we have been collaborating with more than 1,000 organisations in Europe and beyond. At accelopment, we support consortia driving innovation at the intersection of health, AI and systems change. Our experience includes Horizon Europe and Horizon 2020 projects on digital health, brain disease diagnostics, health technology assessment and AI-enabled tools. Projects like AI-Mind and EDiHTA reflect our hands-on expertise in these fields and are in addition to our other successful Research and Innovation Actions (RIAs and IAs) HORIZON Health projects EXPOSIM, EU PAL-COPD, GLIOMATCH, COVend, GENEGUT and MyPath. We are also actively involved in Horizon 2020 Health projects still running such as EXIMIOUS and VANGUARD. Additionally, our support extends to many more health-focused Innovative Training and Doctoral Networks, including MITGEST and MobiliTraIN, as well as Pathfinder-Open projects related to health, such as POLINA and BoneOscopy
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