A significant risk is defined as:
A risk of harm to health, safety or fundamental rights of natural person or the environment. A significant risk is determined by the combination of its severity, intensity, probability of occurrence, duration of effects, and its potential to impact individuals, groups, or specific categories of people.
An AI system does not pose a significant risk if one of the following criteria is fulfilled:
- The AI system is intended to perform a narrow procedural task;
- The AI system is intended to improve the result of a previously completed human activity;
- The AI system is intended to detect decision-making patterns or deviations from prior decision-making patterns and is not meant to replace or influence the previously completed human assessment, without proper human review; or
- The AI system is intended to perform a preparatory task to an assessment relevant for the purpose of the use cases listed in Annex III.
An AI system shall always be considered high-risk if the AI system performs profiling of natural persons.
Article 6 AI Act