Compliance by design for EU healthcare.

Built from the ground up to meet the stringent regulatory requirements of European healthcare and AI governance.

EU AI Act (High-Risk) Readiness

Comprehensive compliance framework for high-risk AI systems in healthcare

Compliance Checklist
Risk Management SystemReady
Data Governance FrameworkReady
Technical DocumentationReady
Logging and MonitoringReady
Human Oversight ProtocolsReady
Accuracy and Robustness TestingIn Progress
Post-Market MonitoringIn Progress

GDPR & Security

Comprehensive data protection and security measures for healthcare data

Data Protection Agreement (DPA)

Standard templates for healthcare data processing

DPIA Templates

Data Protection Impact Assessment frameworks

Encryption at Rest & Transit

AES-256 encryption for all data handling

Data Minimization

Process only necessary data for AI explanations

Access Controls

Role-based permissions and audit logging

Model Cards & Audit Trails

Comprehensive documentation and traceability for all AI models and decisions

Model Documentation
  • Structured model cards with performance metrics
  • Version control and change tracking
  • Training data provenance and lineage
  • Bias and fairness assessment reports
Audit Capabilities
  • Complete decision audit trails
  • User interaction logging
  • Export to PDF, CSV, and JSON formats
  • Regulatory reporting automation

Frequently Asked Questions

Common questions about compliance, security, and regulatory requirements

Request our compliance pack

Get detailed documentation, templates, and guidance for implementing compliant AI systems in your healthcare organization.