%% VaultMesh GenAI Health โ€” Federated Learning + Governance Flow %% Proposal: โ‚ฌ3M HORIZON-HLTH-2025-CARE-01 %% Partners: VaultMesh (IE), DFKI (DE), UMC Utrecht (NL), Philips Healthcare (NL) graph TB subgraph DataSources["๐Ÿฅ Federated Data Sources (Privacy-Preserving)"] HOSPITAL1[Hospital A
Electronic Health Records
Germany โ€” 10k patients] HOSPITAL2[Hospital B
Wearable + Lab Data
Netherlands โ€” 8k patients] HOSPITAL3[Hospital C
Imaging + Genomics
France โ€” 5k patients] CLINIC[Primary Care Clinics
Long-Term Health Monitoring
Multi-Country โ€” 20k patients] end subgraph Privacy["๐Ÿ”’ Privacy & Anonymization Layer"] ANON[Data Anonymization
Differential Privacy (ฮต=0.1)
K-Anonymity (kโ‰ฅ10)] ENCRYPT[Homomorphic Encryption
Computation on Encrypted Data
SEAL/Palisade Library] CONSENT[Consent Management
GDPR Art. 7 & 9 Compliance
Dynamic Consent Updates] WP2_PRIVACY[WP2: Privacy Infrastructure
Lead: DFKI
M1-12] end subgraph FederatedML["๐Ÿค– Federated Machine Learning"] LOCAL_TRAIN1[Local Training โ€” Site A
No Raw Data Leaves Hospital
Model Gradients Only] LOCAL_TRAIN2[Local Training โ€” Site B
Secure Aggregation Protocol
Encrypted Weight Updates] LOCAL_TRAIN3[Local Training โ€” Site C
Edge Computing
GPU Clusters On-Premise] AGGREGATOR[Secure Aggregator
Federated Averaging (FedAvg)
Byzantine-Robust] GLOBAL_MODEL[Global Model
Disease Prediction (Diabetes, CVD)
Treatment Recommendation] WP3_ML[WP3: Federated Learning
Lead: UMC Utrecht
M4-18] end subgraph Governance["โš–๏ธ AI Act Governance & Human-in-the-Loop"] PSI[ฮจ-Field Oversight
Collective Sensing of Model Drift
Bias Detection & Alerts] ETHICS_BOARD[Ethics Review Board
Continuous Monitoring
IRB Integration] HUMAN_REVIEW[Human-in-the-Loop
Clinician Review of High-Risk Decisions
AI Act Art. 14 Compliance] EXPLAINABLE[Explainability Layer
SHAP/LIME for Model Interpretation
Clinician-Facing Dashboard] WP4_GOV[WP4: Governance & Compliance
Lead: VaultMesh
M6-24] end subgraph VaultMesh["๐Ÿ›๏ธ VaultMesh Proof Infrastructure"] RECEIPTS[Receipt Engine
Every Training Round = Cryptographic Receipt
Provenance Trail] LAWCHAIN[LAWCHAIN
Model Version History
Immutable Audit Log] FEDERATION[Federation Router
Hospital-to-Hospital Secure Channel
mTLS + Capability Exchange] TREASURY[Treasury Subsystem
Computation Cost Tracking
Fair Resource Allocation] WP1[WP1: Core Integration
Lead: VaultMesh
M1-6] end subgraph Deployment["๐Ÿš€ Clinical Deployment Pipeline"] VALIDATION[Clinical Validation
Retrospective Study (n=5000)
Prospective Trial (n=500)] REGULATORY[Regulatory Pathway
CE Mark (MDR)
FDA Pre-Cert if US expansion] INTEGRATION[EHR Integration
HL7 FHIR API
Philips IntelliSpace] PILOT[๐Ÿงช UMC Utrecht Pilot
Diabetes Risk Prediction
12-Month Trial โ€” M12-24] WP5_PILOT[WP5: Pilots & Validation
Lead: UMC Utrecht
M12-24] end subgraph Policy["๐Ÿ‡ช๐Ÿ‡บ EU Policy & Standards Compliance"] AI_ACT[AI Act (Reg 2024/1689)
Art. 10: High-Risk System Data Governance
Art. 14: Human Oversight] GDPR[GDPR (Art. 9)
Special Category Health Data
Explicit Consent + Safeguards] MDR[Medical Device Reg (MDR)
Class IIa/IIb Risk Classification
Clinical Evidence Requirements] EHDS[European Health Data Space
Data Altruism + Secondary Use
Cross-Border Access] end subgraph Outcomes["๐Ÿ“Š Expected Outcomes & KPIs"] KPI1[20% Diagnostic Accuracy Improvement
vs. Current Clinical Baselines] KPI2[30% Reduction in Data Collection Time
Federated vs. Centralized] KPI3[5+ Hospital Network
Cross-Border Federation Active] KPI4[0 Privacy Breaches
Differential Privacy Guarantees] KPI5[10+ Publications
Top-Tier Medical AI Venues] end %% Data โ†’ Privacy Flow HOSPITAL1 --> ANON HOSPITAL2 --> ANON HOSPITAL3 --> ANON CLINIC --> ANON ANON --> ENCRYPT ENCRYPT --> CONSENT CONSENT -.->|"Audit Trail"| RECEIPTS %% Privacy โ†’ Federated ML CONSENT --> LOCAL_TRAIN1 CONSENT --> LOCAL_TRAIN2 CONSENT --> LOCAL_TRAIN3 LOCAL_TRAIN1 -->|"Encrypted Gradients"| AGGREGATOR LOCAL_TRAIN2 -->|"Encrypted Gradients"| AGGREGATOR LOCAL_TRAIN3 -->|"Encrypted Gradients"| AGGREGATOR AGGREGATOR --> GLOBAL_MODEL %% Federated ML โ†’ Governance GLOBAL_MODEL -->|"Model Artifact"| PSI GLOBAL_MODEL -->|"Prediction Requests"| HUMAN_REVIEW PSI -->|"Drift Alerts"| ETHICS_BOARD ETHICS_BOARD -->|"Review Decision"| HUMAN_REVIEW HUMAN_REVIEW --> EXPLAINABLE EXPLAINABLE -.->|"Clinician Feedback"| GLOBAL_MODEL %% VaultMesh Integration RECEIPTS -->|"Training Receipt"| AGGREGATOR RECEIPTS -->|"Governance Decision Receipt"| HUMAN_REVIEW LAWCHAIN -->|"Model Version Chain"| GLOBAL_MODEL LAWCHAIN -->|"Audit Queries"| ETHICS_BOARD FEDERATION -->|"Hospital Network"| AGGREGATOR TREASURY -->|"Computation Metering"| LOCAL_TRAIN1 TREASURY -->|"Computation Metering"| LOCAL_TRAIN2 TREASURY -->|"Computation Metering"| LOCAL_TRAIN3 %% Deployment Pipeline GLOBAL_MODEL --> VALIDATION VALIDATION --> REGULATORY REGULATORY --> INTEGRATION INTEGRATION --> PILOT PILOT -.->|"Clinical Feedback"| GLOBAL_MODEL %% Policy Compliance CONSENT -->|"GDPR Art. 9"| GDPR PSI -->|"AI Act Art. 14"| AI_ACT HUMAN_REVIEW -->|"AI Act Art. 14"| AI_ACT VALIDATION -->|"MDR Evidence"| MDR FEDERATION -->|"EHDS Cross-Border"| EHDS ANON -->|"GDPR Art. 25 (Privacy by Design)"| GDPR %% Work Package Dependencies WP1 --> RECEIPTS WP1 --> LAWCHAIN WP1 --> FEDERATION WP2_PRIVACY --> ANON WP2_PRIVACY --> ENCRYPT WP2_PRIVACY --> CONSENT WP3_ML --> AGGREGATOR WP3_ML --> GLOBAL_MODEL WP4_GOV --> PSI WP4_GOV --> ETHICS_BOARD WP4_GOV --> HUMAN_REVIEW WP5_PILOT --> PILOT WP5_PILOT --> VALIDATION %% ฮจ-Field Collective Intelligence PSI -.->|"Cross-Site Anomaly Patterns"| AGGREGATOR LOCAL_TRAIN1 -.->|"Site A Metrics"| PSI LOCAL_TRAIN2 -.->|"Site B Metrics"| PSI LOCAL_TRAIN3 -.->|"Site C Metrics"| PSI %% Outcomes Tracking GLOBAL_MODEL -->|"Accuracy Metrics"| KPI1 AGGREGATOR -->|"Training Efficiency"| KPI2 FEDERATION -->|"Network Growth"| KPI3 ENCRYPT -->|"Privacy Guarantees"| KPI4 VALIDATION -->|"Research Output"| KPI5 classDef data fill:#e3f2fd,stroke:#01579b,stroke-width:2px classDef privacy fill:#f3e5f5,stroke:#6a1b9a,stroke-width:2px classDef ml fill:#c8e6c9,stroke:#2e7d32,stroke-width:2px classDef governance fill:#fff9c4,stroke:#f57f17,stroke-width:3px classDef vaultmesh fill:#ffccbc,stroke:#bf360c,stroke-width:2px classDef deployment fill:#b2dfdb,stroke:#004d40,stroke-width:2px classDef policy fill:#e1bee7,stroke:#4a148c,stroke-width:2px classDef outcomes fill:#ffe0b2,stroke:#e65100,stroke-width:2px class HOSPITAL1,HOSPITAL2,HOSPITAL3,CLINIC data class ANON,ENCRYPT,CONSENT privacy class LOCAL_TRAIN1,LOCAL_TRAIN2,LOCAL_TRAIN3,AGGREGATOR,GLOBAL_MODEL ml class PSI,ETHICS_BOARD,HUMAN_REVIEW,EXPLAINABLE governance class RECEIPTS,LAWCHAIN,FEDERATION,TREASURY vaultmesh class VALIDATION,REGULATORY,INTEGRATION,PILOT deployment class AI_ACT,GDPR,MDR,EHDS policy class KPI1,KPI2,KPI3,KPI4,KPI5 outcomes