EU-Wide Advantages & Opportunities for the IHI Call 11 Topic

1. Single Market Access (450+ million citizens)

- One data-rich market for precision CNS health: Harmonised GDPR rules and the upcoming European Health Data Space (EHDS) enable lawful secondary use of health data from 27 Member States—critical for the large, multimodal datasets required by the call.

- Pan-EU deployment of novel biomarkers & endpoints: Once qualified by EMA, transdiagnostic markers can be commercialised simultaneously across all EU/EEA countries through centralised regulatory procedures, accelerating time-to-market versus fragmented national roll-outs.

- Unified procurement channels: EU joint procurement (e.g., via EU4Health) can speed adoption of new diagnostic frameworks and digital platforms in national health systems, creating an immediate, addressable market worth €2+ trillion in healthcare expenditure.

2. Cross-Border Collaboration & Knowledge Exchange

- Mandatory public–private partnerships (PPPs): Horizon-JU-RIA actions oblige industry, academia, SMEs, hospitals, and patient groups from at least three Member States/Assoc. countries to co-create; this ensures critical mass of neuro-imaging centres, biobanks, and AI expertise that no single country possesses.

- Access to flagship EU infrastructures:

- European Platform for Neurodegenerative Diseases (EPND)

- Brain imaging nodes of the European Research Infrastructure for Imaging Technologies in Biology and Medicine (Euro-BioImaging)

- ELIXIR for -omics data standards

- Researcher mobility schemes (MSCA, ERC Proof-of-Concept) can be layered, giving partners staff-exchange budgets and PhD pipelines aligned with the project.

3. Alignment with Key EU Policies & Strategies

| EU Policy | Direct Relevance | Project Opportunity |

|-----------|-----------------|----------------------|

| European Health Data Space (EHDS) | Legal basis for federated data access & AI analysis | Shape secondary-use ‘code of conduct’, stress-test data altruism clauses, position platform as EHDS reference node |

| EU Artificial Intelligence Act | Risk-management & transparency for medical AI | Early compliance creates first-mover advantage, higher investor confidence |

| European Mental Health Strategy (2023) & "Healthier Together" NCD Initiative | Calls for integrated care & digital innovation | Provide evidence for new care pathways, help Commission draft implementation toolkits |

| Digital Europe Programme & High-Performance Computing (EuroHPC) | Petascale compute for multimodal analytics | Apply for EuroHPC access to run federated learning workloads |

| European Green Deal / Twin Transition | Digital health reduces travel & resource waste | Demonstrate healthcare decarbonisation via reduced hospitalisations |

4. Regulatory Harmonisation Benefits

- EMA centralised qualification of biomarkers: One scientific advice process replaces 27 national ones, cutting cost and time for validation of transdiagnostic markers.

- HTA Regulation (2025+) introduces joint clinical assessments; project can deliver evidence dossiers acceptable EU-wide, smoothing reimbursement.

- GDPR Codes of Conduct & EDPB guidelines give legal certainty for cross-border data federation, lowering compliance overhead.

5. Access to Europe’s Innovation Ecosystem

- Over 3,000 hospitals in the European University Hospital Alliance & EIT Health network provide clinical trial sites for the pilot studies described in Objective 3.

- Digital Innovation Hubs & AI Testing and Experimentation Facilities (TEFs) can act as sandboxes for federated-learning algorithms, shortening iteration cycles.

- Clusters of Excellence in Brain Research (e.g., Human Brain Project legacy nodes) bring cutting-edge neuro-informatics tools that fit the platform mandate.

6. Funding Synergies

- Blending with other EU instruments:

- European Innovation Council (EIC) Transition & Accelerator for spin-offs that commercialise validated biomarkers.

- ERDF & REACT-EU funds for regional hospital IT upgrades to adopt the new platform.

- Digital Europe grants for AI cloud infrastructure that can host the federated nodes.

- Cascade funding mechanisms within the IHI project can issue small grants to SMEs in Member States otherwise under-represented in health PPPs, boosting cohesion.

7. Scale, Impact & Long-Term Sustainability

- Standardisation at EU scale creates a de-facto global benchmark for transdiagnostic CNS diagnostics, positioning EU industry as world leader and attracting foreign direct investment.

- Economies of scale in data curation and AI model training: pooling datasets from >10 million potential patients across Europe increases statistical power and robustness, directly improving probability-of-success (PoS) in drug discovery.

- Socio-economic ROI: Even a 5 % reduction in misdiagnosis across the EU could free €4-6 billion annually in avoidable healthcare costs—evidence that resonates with EU budgetary authorities and Council health ministers.

- Sustainable business models: Federated platform can pivot to paid data-as-a-service (DaaS) offerings under the EHDS secondary-use framework, ensuring post-grant longevity.

8. Unique Strategic Value of Operating at EU Level

1. Critical diversity: Access to heterogeneous genotypes, lifestyles, and healthcare systems across 27 countries enhances generalisability of biomarkers—unachievable at a national scale.

2. Policy influence: Consortium becomes a trusted advisor for upcoming delegated acts under EHDS and the AI Act; national-only projects lack this leverage.

3. Risk sharing: €510 million total indicative envelope for IHI Call 11 spreads financial risk across EU and industry, enabling bolder R&D bets than any single Member State could fund.

4. Reputation & talent magnet: EU-branded flagship attracts world-class neuroscientists and AI engineers, reinforcing Europe’s brain health leadership in the global arena.

Bottom Line: Leveraging an EU-wide framework multiplies scientific robustness, market reach, regulatory efficiency, and societal impact—turning the proposed precision-medicine platform into a continental asset that no national initiative could replicate.