EU-Wide Advantages and Opportunities for the call HORIZON-HLTH-2025-01-CARE-01 (GenAI4EU)

1. Single Market Access

- Immediate addressable market of more than 450 million citizens and 11 million healthcare professionals.

- One CE-mark and conformity with the Medical Device Regulation (MDR) and the upcoming AI Act unlock sales in all 27 Member States rather than repeating 27 national approvals.

- Multilingual training mandated by the topic ("different EU languages") turns a regulatory requirement into a competitive advantage for rapid roll-out in every national health system.

2. Cross-Border Collaboration & Knowledge Exchange

- Mandatory multinational consortia let applicants tap the best clinical datasets (oncology in France, radiology in Germany, rare diseases in Italy, etc.) while respecting data residency through federated learning.

- The call encourages use of EU data infrastructures (EHDS, EOSC, Cancer Image Europe, EBRAINS) – giving free or subsidised access to petabytes of harmonised data that are unavailable to single-country projects.

- Joint activities budget line obliges all funded projects under the destination to network, creating a self-reinforcing EU community of GenAI for healthcare.

3. Alignment with Flagship EU Policies

- Digital decade targets: accelerates secure electronic health record exchange and AI uptake.

- AI Act & Coordinated Plan on AI: project becomes an early real-world demonstrator of trustworthy, high-risk medical AI compliant with forthcoming legislation.

- European Care Strategy & Green Deal: more efficient, home-based care reduces hospital resource use and carbon footprint.

4. Regulatory Harmonisation Benefits

- Single dialogue with EMA, HMA, HTA bodies and JRC instead of fragmented national pathways, cutting time-to-market by 12-18 months.

- Common EU guidelines on bias, ethics, and liability (GDPR, AI Act, Ethics Guidelines for Trustworthy AI) provide one compliance framework; lessons are transferable EU-wide.

5. Access to Europe’s Innovation Ecosystem

- Synergies with AI Factories, EIT Health, EIC Accelerator, European Digital Innovation Hubs and 23 Health-related European Research Infrastructures.

- Ability to recruit talent across the EU under free movement rules; secondments between hospitals, SMEs and universities supported by Horizon Europe mobility budgets.

- Visibility in European Partnership on Transforming Health and Care Systems and Mission Cancer accelerates adoption by regional authorities that control 70 % of EU health spending.

6. Funding & Investment Leverage

- Horizon RIA covers up to 100 % of eligible costs; success rate typically 8–12 %, far above national AI calls.

- Results can unlock follow-on instruments:

• Digital Europe Programme for large-scale deployment pilots (75 % co-funding).

• InvestEU and Cohesion Funds for procurement by hospitals.

• EIC Transition/Accelerator for commercialisation up to 17.5 M €.

- Blending with EU4Health Joint Actions or ERDF regional innovation schemes enables public purchase of validated solutions.

7. Scale and Impact Potential

- Two mandatory clinical use cases in different medical fields create proof-points that can be replicated in 3 700 acute hospitals and 140 000 primary care centres EU-wide.

- Federated governance models pioneered here become blueprints for secure secondary use of data under the European Health Data Space, influencing future standard-setting.

- Open-source orientation amplifies uptake by SMEs and public providers, maximising socioeconomic return on EU investment.

8. Practical EU-Level Opportunities for Applicants

1. Combine Nordic structured EHR data quality with Southern Europe’s large image biobanks for multimodal model superiority.

2. Exploit language diversity to fine-tune LLMs in 24 official EU languages, a barrier to US competitors.

3. Engage the JRC’s newly launched AI Testing and Experimentation Facility for Health for pre-certification benchmarking at no cost.

4. Align early with the new EU HTA Regulation (2025) via EUnetHTA21 to secure reimbursement recommendations valid in all Member States.

5. Pilot ethical oversight boards using the ALLEA/EC guidelines, positioning the consortium as thought-leader for Responsible AI in healthcare.

9. Strategic Value of Operating at EU Scale

- Critical mass of diversified data mitigates algorithmic bias far more effectively than any single-country dataset.

- Pooling clinical validation across health systems with different care pathways yields stronger external validity, a prerequisite for global FDA/TGA submissions.

- Demonstrated pan-European cost-effectiveness strengthens the business case for joint procurement under the EU cross-border healthcare directive.

10. Recommended Next Steps

- Identify at least three Member States representing diverse regulatory and clinical environments for pilots (e.g. DE, ES, FI).

- Secure letters of support from national HTA bodies and data permit authorities to evidence feasibility.

- Map complementarity with ongoing Horizon projects (e.g. TEF-Health, 1M Genomes, iHelp) to demonstrate added value and avoid duplication.

- Allocate ≥5 % of budget for joint clustering activities to fulfil networking expectations and maximise EU visibility.

*Conclusion*: Pursuing GenAI4EU under Horizon Europe offers a uniquely integrated playground—common market, common rules, shared infrastructure and multiple follow-on funding streams—that no national scheme can match. A well-structured consortium can convert these EU-wide advantages into faster innovation cycles, deeper trust and continent-wide market penetration for generative AI assistants in healthcare.