AI Governance for Healthcare
Deploy AI for clinical decision support, diagnostics, and patient care with full HIPAA, FDA SaMD, and EU AI Act compliance. Generate audit-ready evidence for clinical oversight and regulators.
~45%
Reduction in manual review hours
100%
Clinical decision audit coverage
<10min
Evidence pack generation
24/7
Monitoring readiness
*Stats represent anonymized 2025 pilot outcomes (n=4). Directional only.
Healthcare Challenges
Healthcare AI must balance clinical safety, privacy, and regulatory compliance.
Prove clinical safety and performance
Document validation, risk controls, and post-market monitoring for AI in care.
Comply with HIPAA and data privacy
Protect PHI with auditable access controls, masking, and retention.
Meet FDA SaMD and MDR requirements
Maintain technical documentation, change control, and testing evidence for regulated software.
Enable human oversight in high-stakes decisions
Ensure clinicians can review, override, and document AI recommendations.
KLA Digital Solution
Purpose-built AI governance for clinical accountability and patient trust.
Clinical audit trails by default
Capture inputs, outputs, model versions, and overrides for each decision.
Automated documentation for FDA submissions
Generate evidence packs aligned to SaMD and MDR expectations.
Bias and drift monitoring
Detect performance changes across patient populations with alerts.
Secure, compliant data handling
PII masking, access controls, and integrity proofs built in.
Regulatory Coverage
Pre-configured compliance frameworks for healthcare regulations.
HIPAA
Protected health information compliance
FDA SaMD
Medical device software documentation
EU AI Act
High-risk AI system obligations
MDR
EU Medical Device Regulation alignment
GDPR
Automated decision transparency
Use Cases
AI governance for high-stakes clinical applications.
Clinical Decision Support
Explainable recommendations with oversight and audit logs.
Diagnostic Imaging
Model validation evidence and performance monitoring.
Patient Triage
Documented prioritization with bias checks.
Operational Automation
Workflow optimization with compliance controls.
Ready to deploy compliant AI in healthcare?
Book a demo tailored to your clinical workflows and regulatory requirements.