COMPLIANCE

Compliance & Trust Center

Built for regulated healthcare from day one — not bolted on as an afterthought

Last Updated: February 25, 2026

HIPAA

Compliant

PHI protection, Business Associate Agreements, encryption at rest and in transit, immutable audit trails

SOC 2 Type II

In Progress

Trust services criteria for security, availability, processing integrity, confidentiality, and privacy

FDA

De Novo Pathway

Clinical validation for AI-assisted dermatology diagnostics, De Novo classification pathway

EU AI Act

Compliant

High-risk AI system requirements, transparency obligations, human oversight provisions

GDPR

Compliant

Data protection for EU/EEA subjects, lawful processing basis, international transfer safeguards

CCPA / State Privacy

Compliant

California Consumer Privacy Act and applicable US state privacy law compliance

Data Encryption

  • AES-256-GCM encryption for all Protected Health Information at rest
  • TLS 1.2 or higher enforced for all data in transit, with TLS 1.3 preferred
  • Per-tenant encryption keys managed through Cloud Key Management Service
  • Automatic key rotation on 90-day cycles
  • Encryption context includes tenant identifier and data classification metadata

Access Controls

  • Role-based access control (RBAC) with principle of least privilege
  • Multi-factor authentication required for all accounts accessing PHI
  • 15-minute idle session timeout and 8-hour absolute session limit
  • Emergency access (“break-glass”) procedures with enhanced audit logging and immediate supervisor notification
  • Unique user identification for every account — shared credentials are prohibited

Audit Logging

  • Immutable, append-only audit trails for all PHI access events
  • Hash-chain integrity verification for tamper detection
  • Six-year retention period per HIPAA requirements
  • Every access event logged with who, what, when, where, and why
  • Automated suspicious access pattern detection and alerting
  • Daily integrity verification runs across the full audit chain

AI Fairness & Bias Auditing

Equitable AI is not a compliance checkbox — it is the foundation of OSAZ's mission. Our bias auditing practices go beyond regulatory requirements.

  • Continuous bias detection and monitoring across Fitzpatrick skin types I through VI
  • Published fairness metrics for all diagnostic models
  • Enforced training data diversity requirements
  • Model transparency reporting available to clinical partners
  • Performance parity monitoring across demographic groups
  • Regular third-party fairness audits

Infrastructure Security

  • Deployed on Google Cloud Platform using only HIPAA-eligible services under a signed BAA
  • Network isolation with private VPCs and strict firewall rules
  • Container security scanning integrated into the CI/CD pipeline
  • Regular penetration testing conducted by independent third-party security firms
  • Continuous vulnerability scanning and timely patch management
  • Software Bill of Materials (SBOM) generation for supply chain transparency

Business Associate Agreements

  • BAAs available for all covered entities and business associates
  • Subcontractor BAA chain maintained for all downstream data processors
  • Breach notification procedures compliant with HIPAA's 60-day timeline
  • BAA verification required before any PHI processing begins
  • Standard BAA template available upon request

Data Residency & Sovereignty

  • Primary data processing and storage in the United States
  • EU/EEA data transfers secured through Standard Contractual Clauses (SCCs) and Data Processing Agreements
  • Data residency options available for enterprise customers with specific jurisdictional requirements
  • Lagos, Nigeria operations do not process PHI without appropriate cross-border data transfer safeguards
  • Adequacy decision references applied where applicable

Incident Response

  • Dedicated incident response team with defined roles and escalation procedures
  • Continuous monitoring and anomaly detection for breach identification
  • HIPAA-compliant breach notification within 60 days of discovery
  • Affected individual notification with clear, actionable information
  • Post-incident review, root cause analysis, and remediation documentation
  • Annual incident response drills and tabletop exercises

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