AI Governance for Healthcare
Enable clinical decision support, diagnostic assistance, and patient care optimization with full regulatory compliance. Generate audit-ready evidence for HIPAA, FDA, and EU AI Act requirements.
~55%
Reduction in documentation time
100%
Clinical override capture
HIPAA
Compliant by design
FDA-ready
Submission documentation
*Stats represent anonymized 2025 pilot outcomes (n=4). Directional only.
Industry Challenges
Healthcare AI must balance innovation with patient safety and regulatory requirements.
Ensure patient safety with AI recommendations
Prevent AI-driven recommendations that could harm patients without proper clinical oversight.
Meet FDA requirements for AI as medical device
Document AI systems that qualify as Software as a Medical Device (SaMD) under FDA regulations.
Maintain HIPAA compliance
Protect PHI while enabling AI-powered analysis with proper access controls and audit trails.
Document clinical validation
Provide evidence of AI system performance, validation studies, and ongoing monitoring.
KLA Digital Solution
Purpose-built AI governance for clinical workflows and medical device requirements.
Clinical override tracking and analysis
Record when clinicians override AI recommendations with reasoning, enabling continuous improvement.
FDA submission documentation
Generate technical documentation required for 510(k) submissions and post-market surveillance.
Patient consent management
Track consent for AI-assisted care and enable patient access to AI decision explanations.
Real-time clinician feedback loops
Capture clinician feedback on AI recommendations to improve model performance over time.
Regulatory Coverage
Pre-configured compliance frameworks for healthcare regulations.
HIPAA
PHI protection and audit trails
FDA SaMD
Software as Medical Device requirements
MDR
EU Medical Device Regulation
EU AI Act
High-risk AI system compliance
21 CFR Part 11
Electronic records compliance
Use Cases
AI governance for patient-critical healthcare decisions.
Clinical Decision Support
AI-assisted diagnosis and treatment recommendations with documented clinical reasoning and override tracking.
Diagnostic Assistance
Medical imaging analysis, pathology screening, and diagnostic suggestions with explainable AI.
Patient Triage
AI-powered prioritization with transparent decision criteria and human oversight checkpoints.
Drug Interaction Alerts
Automated medication safety checks with complete audit trails of alerts and clinician responses.
Ready to deploy compliant AI in healthcare?
Book a demo tailored to your clinical workflows and regulatory requirements.