AI Governance for HealthTech & HIPAA Compliance

• •Manual control mapping across HIPAA Security, Privacy, and Breach Rules
• •Evidence collection scattered across EMR, audit logs, and spreadsheets
• •Compliance audits take 6–9 months to prepare for
• •No automated demonstration of PII protection measures

Deploy AI-powered HIPAA control mapping and audit evidence generation for rapid compliance validation.

• Automated HIPAA control mapping and compliance dashboard
• Real-time evidence collection from all systems
• Breach risk detection and incident response automation
• Audit-ready documentation export (45 CFR 164.308–316)

• •AI models for diagnosis/treatment require FDA oversight (21 CFR Part 11)
• •No model versioning or change control for clinical decisions
• •Bias in training data affects patient outcomes and liability
• •Explainability required for clinical adoption and regulatory approval

Deploy model governance, bias detection, and explainability for clinical AI with audit trails.

• Model registry with version control and FDA 21 CFR Part 11 compliance
• Real-time bias detection in clinical predictions
• Explainability for clinical decision support systems
• Automated adverse event reporting