HEALTHCARE
AI Governance for Healthcare
Diagnostic support, triage, and clinical decision support—with dual-regulation compliance.
Healthcare AI has the fastest growth (29% CAGR) and the highest regulatory complexity. CleanAim® provides infrastructure that satisfies both the EU AI Act and Medical Device Regulation simultaneously.
REGULATORY CONTEXT
The dual compliance challenge
Healthcare AI often falls under both the EU AI Act and the Medical Device Regulation (MDR)—creating overlapping requirements that documentation-only platforms cannot address.
| Standard | Requirement | AI Challenge |
|---|---|---|
| Risk Management (Art. 9) | Clinical risk assessment for AI decisions | MDR Annex I cross-reference |
| Automatic Logging (Art. 12) | Complete audit trail of diagnostic recommendations | Post-market surveillance |
| Transparency (Art. 13) | Explainable clinical decision support | Clinical evidence requirements |
| Human Oversight (Art. 14) | Clinician review requirements | Vigilance reporting |
| Accuracy & Robustness (Art. 15) | Bias monitoring across patient populations | Technical documentation standards |
US regulatory requirements also apply:
HIPAA for protected health information. FDA SaMD classification for Software as Medical Device. 21 CFR Part 11 for electronic records. Plus varying state privacy laws by jurisdiction.
THE CHALLENGE
Your clinical AI touches patient safety. Can you prove it's working as intended?
Clinical AI creates unique challenges that go beyond typical compliance requirements.
Patient safety concerns
- How do you know the AI isn't developing blind spots for certain patient populations?
- What happens when a diagnostic recommendation is wrong—can you replay exactly what the system saw?
- Are clinicians meaningfully reviewing AI recommendations, or has automation bias crept in?
Dual regulation complexity
- EU AI Act and MDR have overlapping but distinct requirements
- Documentation must satisfy both frameworks simultaneously
- Post-market monitoring requirements compound
Privacy constraints
- Learning from outcomes while protecting PHI
- Audit trails that don't compromise patient confidentiality
- Cross-institution learning without data sharing
THE SOLUTION
Infrastructure-level compliance for clinical AI
HIPAA-Aware Logging
Complete audit trail without exposing protected health information.
- Prediction-outcome pairing without PHI in learning data
- Configurable de-identification rules
- Audit logs that satisfy Article 12 without HIPAA exposure
- Consent-aware learning when PHI is needed
Clinical Decision Support Workflows
Human-in-the-loop workflows designed for clinical environments.
- Role-based escalation (nurse → physician → specialist)
- Time-sensitive routing for urgent findings
- Integration with clinical communication systems
- Documentation of clinician review and decision rationale
Dual-Regulation Documentation
Single source of truth for EU AI Act and MDR compliance.
- Technical documentation that satisfies both frameworks
- Mapping between AI Act articles and MDR requirements
- Post-market surveillance integration
- Incident reporting workflows
Per-Population Accuracy Monitoring
Ensure your AI performs equitably across patient demographics.
- Accuracy disaggregated by age, gender, ethnicity, comorbidity
- Alerts when performance gaps emerge
- Trend analysis for long-term equity monitoring
- Clinical validity evidence generation
Automation Bias Detection for Clinicians
Prove your clinical team isn't over-relying on AI recommendations.
- Engagement scoring for clinician reviews
- Detection of rubber-stamping patterns
- Intervention recommendations when oversight degrades
- Evidence for regulatory inspection
INTEGRATION
Built for clinical infrastructure
EHR Integration
- Epic
- Cerner (Oracle Health)
- Meditech
- CPSI
- Custom EHR systems via HL7/FHIR
Clinical Communication
- Secure messaging platforms
- Alert routing to on-call systems
- PACS integration for imaging AI
Healthcare Deployment
- BYOC: AWS HIPAA, Azure HIPAA, GCP Healthcare
- Air-Gapped: Completely isolated deployment
- PrivateLink: Traffic never touches public internet
USE CASES
Healthcare applications
Diagnostic Decision Support
AI-assisted diagnosis with complete audit trail, clinician oversight verification, and per-population accuracy monitoring.
Triage Prioritization
Automated patient prioritization with doubt-based routing for uncertain cases and human override documentation.
Treatment Recommendations
Clinical decision support with explainable recommendations and deterministic replay for clinical review.
Resource Allocation
AI-assisted scheduling and resource optimization with fairness monitoring across patient populations.
Documentation Automation
Clinical documentation AI with audit trail and quality verification.
Population Health Analytics
Risk stratification and care gap identification with bias monitoring and outcome tracking.
PROVEN ARCHITECTURE
Built on validated infrastructure
CleanAim's healthcare capabilities are built on the same architecture that powers our core platform—proven across 1.1 million lines of production code.
Capture rate
Transfer efficiency
Error reduction
Audit score
Clinical AI governance starts with infrastructure.
Learn how CleanAim® provides dual-regulation compliance, HIPAA-aware logging, and EHR integration.
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