Risk Analysis Library

Business threat modeling analyses for AI-enabled medical devices and healthcare software. Performed using public data sources.

Diagnostic AI System

This risk analysis is an example of how Danny Lieberman worked with OpenCRO agents to create a risk analysis from publicly available data for an actual AI-enabled medical device cleared by FDA under the 510(K) regulatory pathway.

The device features integration of AI-driven diagnostic workflows in hospitals.

This example is deliberately limited to 2 threat scenarios.

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