guidance

High-risk § 2.1

The role of human involvement and high-risk classification

Official source ↗

(70)

To assess whether an AI system qualifies as high-risk under Article 6(2) AI Act, the only relevant determinant is whether the intended purpose of the system includes one of the use cases listed in Annex III AI Act. Since human involvement cannot change the purpose and area in which a system is intended to be used, it has no effect on the classification of the system as high-risk under Article 6(2) AI Act. Rather, human oversight is a prerequisite for compliance with the rules for high-risk AI systems pursuant to Article 14 AI Act and a necessary requirement for systems classified as high-risk.

(71)

If the intended purpose of an AI system is covered by a use case listed in Annex III AI Act, the provider may exempt the system from high-risk classification pursuant to Article 6(3) AI Act, provided that it can demonstrate that at least one of the four conditions of that provision are met and provided the system does not perform profiling. To determine whether any of those conditions are met, the provider must consider which tasks the system is intended to perform, which again relates to the intended purpose of the system , including its context and the conditions of use (see Section II.2.). The type and degree of human involvementduring the deployment of the systemmay therefore play a role in the classification of an AI system as high-risk, but only to demonstrate that the tasks the system is intended to perform are narrow procedural tasks or preparatory in nature, or that the system is only intended to improve a previously completed human activity. The provider cannot exempt and categorise an AI system as ‘low risk’ simply by adding to it a requirement for human involvement (see in more detail Section 2.7 below).