EU-Wide Advantages & Opportunities for “Leveraging artificial intelligence for pandemic preparedness and response” (HORIZON-HLTH-2025-01-DISEASE-04)

1. Unrestricted Access to the €16 trillion Single Market

• 450 + million potential users of AI-based pandemic tools (public-health authorities, hospitals, SMEs) enables rapid market uptake and commercial sustainability after the project.

• The Medical Device Regulation (MDR) and forthcoming AI Act create *one* conformity route for all Member States, avoiding 27 parallel authorisations and cutting time-to-market by an estimated 30-40 %.

• Alignment with the European Health Data Space (EHDS) ensures legal cross-border secondary use of health data—an asset that no single country can match in volume or diversity.

2. Deep Cross-Border Collaboration & Knowledge Exchange

• Consortium members can jointly tap EU-level data infrastructures (BBMRI-ERIC biobanks, ELIXIR, ECRIN, Euro-BioImaging) to train and validate AI models on truly pan-European cohorts—essential to minimise bias and strengthen external validity.

• Mandatory clustering with other funded projects plus synergies with HERA, ERA4Health, EIT Health, EIC Pathfinder/Transition create a built-in community of practice for continuous learning and technology transfer.

• Facilitates multi-language, multi-ethnic model development, satisfying the call’s bias-mitigation requirement and boosting model generalisability.

3. Direct Alignment with Flagship EU Strategies

• Digital Decade / Digital Europe Programme: project outcomes (trustworthy AI, high-value datasets) feed directly into twin digital-health goals.

• Green Deal & Fit-for-55: AI-optimised logistics reduce carbon footprint of medical supply chains during crises.

• EU Global Health Strategy: scalable tools strengthen the Union’s role as a global health security actor, facilitating international data reciprocity.

4. Regulatory Harmonisation & Ethics-by-Design

• The grant explicitly demands compliance with GDPR, NIS2, forthcoming AI Act, and the EHDS regulation—providing a single, predictable governance framework across all participating states.

• Early engagement with EMA, ECDC, EDPS and national ethics bodies via the project speeds future market authorisation and public-sector adoption.

• Incorporation of SSH expertise addresses societal acceptance, equity and gender/ethnicity bias from day one, reducing downstream litigation or public push-back.

5. Leveraging Europe’s World-Class Innovation Ecosystem

• Direct links to 13 European Digital Innovation Hubs for AI & Health, 24 EIT-Health Co-Location Centres, and supercomputing capacities (EuroHPC, LUMI, LEONARDO) provide unrivalled computational power and business-acceleration services.

• Encourages participation of start-ups and deep-tech SMEs, who can exploit the InvestEU SME window, EIC Accelerator, or InnovFund for scaling post-project.

6. Funding Synergies & Leverage Effect

• Combination with EU4Health (€5.3 bn) can finance post-R&I piloting in Member-State health systems.

• Structural funds (ERDF, ESF+) can bankroll regional deployments, while Digital Europe (€7.5 bn) can cover further data-space infrastructure.

• Participation unlocks preferential access to Joint Undertakings (e.g. Chips JU for edge-AI sensors, Clean Hydrogen JU for hospital energy resilience).

7. Scale & Impact Potential

• Pan-EU deployment enables real-time epidemiological dashboards covering >95 % of EU population, feeding into ECDC’s Early Warning and Response System.

• Harmonised AI enables faster coordinated response (e.g., common triage algorithms, cross-border ICU transfer optimisation) cutting morbidity and mortality during crises.

• EU visibility and standards-setting power position beneficiaries as global reference points, opening export markets and influencing WHO guidelines.

8. Strategic Competitive Edge for Participants

• Access to high-quality, FAIR, multi-country datasets gives a moat against global competitors limited to national data pools.

• IPR generated under Horizon rules (beneficiaries keep ownership, EU retains free licence for policy use) allows flexible commercial exploitation—licensing, spin-offs, or standard-essential patents.

• Consortium branding as an EU-funded, ethics-vetted project enhances trust among regulators, investors and the general public.

9. Recommended Actions to Maximise EU-Level Benefits

1. Build a consortium covering at least 10 Member States + 2 Associated Countries for dataset diversity.

2. Formal MoUs with EHDS pilot nodes and the EOSC Association to guarantee data interoperability.

3. Create an Advisory Board with HERA, ECDC, EMA, WHO-EURO, and civil-society groups to streamline future policy uptake.

4. Budget 5-7 % for joint clustering & communication to amplify EU-wide visibility and foster standardisation.

5. Map and apply for complementary funding (EIC Transition, Digital Europe, EU4Health) already during the project to secure a post-grant scaling pathway.

> Bottom line: Conducting this project at EU scale transforms isolated AI pilots into an integrated, regulation-ready, and market-shaping pandemic intelligence infrastructure—something no single country, company or dataset can deliver alone.