5-Layer Governance Framework
Every workflow operates within mandatory governance controls—no autonomous clinical decisions, full audit trail, human oversight required.
Five Layers of Protection
Each layer works together to ensure safe, transparent, and compliant AI operations in healthcare settings.
Risk-Tiered Human-in-Loop Gates
Mandatory human approval at defined risk thresholds—no autonomous clinical decisions
Example: Medication reminders (low) → Care plan changes (medium) → Cognitive alerts (high) → Emergency escalations (critical)
Full HIPAA-Compliant Audit Trail
Complete chain of custody for every patient interaction, decision, and outcome
Example: Who accessed what data, when, why, and what actions were taken—fully reconstructible for any audit
Role-Based Access Control
Granular permissions based on clinical role and facility-specific compliance rules
Example: CNAs see vitals logging, RNs see care plans, DONs see facility-wide analytics—each role sees only what they need
Fallback & Escalation Logic
Automated escalation paths when AI confidence is low or edge cases are detected
Example: Unclear patient response → flag for nurse review. No response within 30 seconds → escalate to charge nurse
Bias & Drift Monitoring
Continuous monitoring for model drift, bias detection, and anomaly alerting
Example: If cognitive screening shows 10% variance across demographics, alert triggers immediate review and recalibration
HIPAA-Compliant Audit Trail
Every interaction, decision, and outcome is logged with complete chain of custody. Fully reconstructible for any regulatory audit or quality review.
Real-time Logging
Every interaction captured as it happens
Immutable Storage
Cryptographically verified records
Encrypted at Rest
AES-256 encryption for all data
Access Tracking
Complete user activity history
What Gets Logged
Compliance & Certifications
Meeting the highest standards for healthcare AI governance and data protection.
HIPAA Compliant
Full compliance with healthcare data protection standards
SOC 2 Type II
Final phase of third-party security audit
FDA 510(k) Registered
Gia™ Cognitive Index™ medical device registration
Samsung Knox Integrated
Enterprise-grade device security
See Governance in Action
The governance dashboard provides real-time visibility into all five layers—human reviews, audit completeness, escalations, and bias alerts.
Governance Framework FAQ
Common questions about healthcare AI governance and compliance.
Ready to See Governance in Practice?
Schedule a demo to explore how the 5-layer governance framework ensures safe, compliant AI deployment for your facility.