Article 7

Article 7 — Amendments to Annex III

1. The Commission is empowered to adopt delegated acts to amend the list in Annex III by adding or modifying high-risk AI systems where both of the following conditions are fulfilled:
(a) the AI systems are intended to be used in any of the areas listed in points 1 to 8 of Annex III;
(b) the AI systems pose a risk of harm to the health, safety or fundamental rights of persons, taking into account the cumulative effect of the AI system with other AI systems.

2. When assessing the criteria in paragraph 1(b), the Commission shall take into account the following:
(a) the intended purpose of the AI system;
(b) the extent to which the AI system has been used or is likely to be used;
(c) the nature and amount of data processed and used by the AI system;
(d) the extent to which the AI system acts autonomously and the possibility for a human to override a decision or recommendation;
(e) the extent to which the use of the AI system has already caused harm to the health, safety or fundamental rights or has given rise to significant concerns in relation to the materialisation of such harm;
(f) the potential extent of such harm and its reversibility;
(g) the extent to which potentially harmed persons are in a position of vulnerability vis-a-vis the user of the AI system, in particular due to imbalances of power, knowledge, economic or social circumstances.