Transforming Clinical Silos into Economic Assets. Business Models for European Digital Health Research Networks
Extended Abstract — CIDE 2025
Author: Fabio Liberti University of the Italian Chambers of Commerce (Universitas Mercatorum) & Bambino Gesù Children's Hospital, IRCCS
This paper proposes a theoretical framework examining how federated learning architectures, integrated with OHDSI's OMOP Common Data Model and HL7-FHIR standards, could enable sustainable business models within the European Health Data Space (EHDS) regulatory context.
- Infrastructure reuse — Explore how existing OHDSI/FHIR investments can be repurposed for federated architectures, reducing adoption barriers
- Business model design — Define theoretical models balancing economic sustainability with EHDS privacy requirements
- Trade-off analysis — Analyze the interplay between technical complexity, privacy guarantees, and economic viability
| Dimension | Approach |
|---|---|
| Technical | Hub-and-spoke federated topology leveraging OMOP CDM v5.4 + FHIR R5 APIs, with differential privacy (ε = 0.1–10) and O(n log n) communication complexity |
| Economic | Three conceptual business models: Data Cooperative, Platform-as-a-Service, Innovation Marketplace |
| Privacy | Privacy-utility trade-off analysis mapping EHDS Article 50 requirements to technical capabilities |
- Non-IID data distributions across institutions
- Byzantine fault tolerance for untrusted environments
- Bandwidth constraints in healthcare networks
- FHIR-to-OMOP resource mapping (Patient, Observation, Condition)
- Leveraging existing OMOP implementations could reduce integration costs vs. proprietary approaches
- Minimum viable network: 10–20 institutions for operational sustainability
- Initial investment: EUR 150–300K per institution (estimated)
- Moderate privacy settings (ε = 1.0) yield ~5% accuracy degradation while enabling new business models
- Federated approaches become economically favorable beyond 20 participants
| Model | Strengths | Challenges |
|---|---|---|
| Data Cooperative | Risk-sharing, collective ownership | Governance complexity |
| Platform-as-a-Service | Better scalability | Concentrates economic benefits |
| Innovation Marketplace | Highest potential returns | Two-sided market bootstrapping |
- Practitioners: Existing OHDSI/FHIR investments can be leveraged for federated paradigms
- Policymakers: EHDS regulation can be designed to encourage innovation, not just compliance
- Researchers: Critical empirical questions identified for future investigation
Pilot implementations to validate technical assumptions and economic hypotheses, transforming this conceptual framework into actionable insights for the European health data economy.
Federated Learning OMOP Common Data Model HL7-FHIR European Health Data Space (EHDS) Differential Privacy Healthcare Interoperability Digital Health Business Models Clinical Research Networks
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This repository contains materials related to the CIDE 2025 conference submission.