High-risk AI system
Also known as: Critical AI systems, Regulated AI (context-dependent)
An AI system that poses significant threats to health, safety, or fundamental rights if it malfunctions or is biased. These systems are typically used in critical sectors such as healthcare, law enforcement, and employment. Because of their potential impact, they are subject to stricter regulatory requirements and mandatory oversight than low-risk applications.
In practice
An auditor first reviews the system's intended purpose against a regulatory classification list (such as those in the EU AI Act) to determine if it qualifies as high-risk. Once identified, the practitioner verifies evidence of specific controls, including detailed technical documentation, data quality governance, and human-in-the-loop mechanisms.