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White Paper

How to Build an Actionable AI Risk Framework in Healthcare

Clinicians and revenue operations rely on AI daily, yet traditional security controls fail to account for model degradation and clinical safety outcomes. Learn how Healthcare Delivery Organizations (HDOs) establish defensible boundaries around connected care infrastructure.

Claroty white paper cover: 'Finding the Acceptable Risk Level for AI in Healthcare,' featuring surgeons looking at digital displays in an operating room.

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Establish Defensible AI Boundaries Across Connected Care Infrastructure

HDO’s face immediate pressure to adopt artificial intelligence across diagnostic, operational, and administrative workflows. However, applying legacy IT controls to clinical machine learning models leaves patient safety exposed. Unlike standard software, clinical algorithms experience silent performance degradation over time without triggering standard security alerts.  

Establishing an acceptable risk level for AI in healthcare requires bridging the gap between cyber safety, clinical outcomes, and regulatory mandates. Security leaders must navigate opaque vendor supply chains while ensuring clinicians retain real-time override authority. Building a cross-functional healthcare AI governance committee structure allows security, clinical informatics, and legal teams to establish clear operational boundaries, catalog shadow deployments, and protect patient care continuity. 

Core Insights: 

  • Two-Stage Risk Classification: Categorize deployments by clinical impact, data sensitivity, and operational dependencies to drive pre-deployment validation standards.  

  • AI Software Supply Chain Visibility: Request a detailed software bill of materials for healthcare AI to uncover open-source dependencies and third-party model vulnerabilities before deployment.  

  • Vendor Agreement Protections: Secure contractual rights for data residency, model retrain boundaries, and notification protocols regarding algorithm updates.  

  • Production Monitoring Architecture: Implement continuous production monitoring for clinical AI models across performance metrics, data changes, and endpoint security.  Real-Time Accountability Protocols: Designate a named accountable human authority within the live decision path who holds immediate stop and override authority for active models. 

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