AI Compliance for Healthcare & Pharma
Healthcare AI faces dual regulation under the EU AI Act and MDR/IVDR. Diagnostic AI, treatment recommendations, and patient triage require rigorous compliance documentation. Governum simplifies this complexity.
Healthcare AI Compliance Challenges
Medical AI faces the most complex regulatory landscape
Dual Regulation
Medical device AI must comply with both EU AI Act and MDR/IVDR requirements simultaneously.
Health Data
GDPR Article 9 special category data requires explicit consent and strict governance.
Clinical Oversight
Human oversight by qualified healthcare professionals is mandatory for high-risk systems.
Vigilance
Serious incident reporting within 15 days with EUDAMED integration requirements.
Healthcare AI Use Cases
Comprehensive compliance for every medical AI application
Diagnostic AI Systems
AI-assisted diagnosis in radiology, pathology, dermatology, and ophthalmology is classified as high-risk under both Annex I (medical devices) and Annex III. Requires CE marking under MDR and full EU AI Act compliance.
Governum Features
- Clinical evaluation docs
- PMCF tracking
- MDR + Annex IV alignment
- Performance metrics
Clinical Decision Support
AI systems recommending treatments, drug dosages, or clinical pathways directly impact patient safety. Requires robust risk management and human oversight to ensure clinicians maintain final decision authority.
Governum Features
- Clinical evidence mgmt
- HCP oversight tracking
- Explanation logging
- Alert fatigue monitoring
Patient Triage & Prioritization
AI systems prioritizing patients for emergency care, surgery scheduling, or resource allocation are high-risk under Annex III as they affect access to essential healthcare services. FRIA mandatory.
Governum Features
- Fairness testing
- Bias detection
- Override mechanisms
- FRIA documentation
Drug Discovery & R&D
AI for drug discovery, molecular simulation, and preclinical research is typically minimal risk as it doesn't directly impact patients. Good documentation supports FDA/EMA submissions.
Governum Features
- Model validation docs
- Data provenance
- Reproducibility records
- GxP compliance
EU AI Act + MDR/IVDR Alignment
Medical device AI faces the most complex regulatory landscape in Europe. Governum helps you maintain unified documentation across both frameworks.
SaMD Classification
Determine MDR class alongside AI Act risk level automatically.
Unified Technical File
Single source of truth for MDR and AI Act documentation.
Notified Body Ready
Export-ready documentation for NB audits and inspections.
Documentation Synergies
| MDR Requirement | AI Act Equivalent |
|---|---|
| Technical Documentation | Annex IV Documentation |
| Risk Management (ISO 14971) | Article 9 Risk Mgmt |
| Clinical Evaluation | Testing & Validation |
| Post-Market Surveillance | Post-Market Monitoring |
| Instructions for Use | Article 13 Transparency |
Built for Healthcare
Enterprise features for medical AI governance
Health Data Governance
GDPR Article 9 special category data management. Anonymization, pseudonymization, and cross-border transfer documentation.
Continuous Learning
Change management for AI systems learning from new patient data. Model update documentation and performance baselines.
Vigilance Integration
EUDAMED-ready incident reporting workflows. Automatic 15-day deadline tracking with escalation procedures.
Multi-Site Deployment
Track AI across multiple hospitals. Population-specific validation, site performance monitoring, and local compliance.
AI Literacy Training
Article 4 compliance for healthcare staff. Training program documentation and competency tracking for clinicians.
Multi-Jurisdiction
Navigate EU, FDA, and other frameworks. Documentation supporting multi-jurisdictional regulatory submissions.
Leading European Hospital Network
"Governum enabled us to achieve dual MDR and EU AI Act compliance for our diagnostic AI portfolio. We reduced documentation time by 70% and passed our Notified Body audit with zero non-conformities on AI-related requirements."
Chief Medical Information Officer
University Hospital Group
Ready to Simplify Healthcare AI Compliance?
Join leading healthcare organizations using Governum to navigate EU AI Act and MDR requirements.