Issued2026-07-01

Risk Categorization Tool v3

Risk Assessment ToolVoluntary

Summary

Provides a predeployment tool for categorizing healthcare AI systems as Low, Medium, or High risk using modifiers related to Life and Patient Safety and Technology and Data, with a supplemental mapping to the NIST AI Risk Management Framework and the EU AI Act.

Healthcare Implications

Health systems and governance teams can use the tool to triage review intensity before deployment, document the factors driving a risk designation, determine when enhanced validation and oversight are needed, and align later mitigation and monitoring activities with the system's risk profile.

Impact Level

Medium

Keywords

Transparency & Governance; Safety & Risk; Privacy & Data

Stakeholders

Providers & Health Systems; Payers & Purchasers; Developers & Vendors; Regulators & Government