EU regulatory register · AI Act
Article 27Fundamental rights impact assessment for high-risk AI systems
CELEX 32024R1689 · Read on 2026-08-18 · Chapter III
Official text
Read from the EU Publications Office for this CELEX number. The wording stands as published; nothing here is rewritten or summarised.
1. Prior to deploying a high-risk AI system referred to in Article 6(2), with the exception of high-risk AI systems intended to be used in the area listed in point 2 of Annex III, deployers that are bodies governed by public law, or are private entities providing public services, and deployers of high-risk AI systems referred to in points 5 (b) and (c) of Annex III, shall perform an assessment of the impact on fundamental rights that the use of such system may produce. For that purpose, deployers shall perform an assessment consisting of:
(a)
a description of the deployer’s processes in which the high-risk AI system will be used in line with its intended purpose;
(b)
a description of the period of time within which, and the frequency with which, each high-risk AI system is intended to be used;
(c)
the categories of natural persons and groups likely to be affected by its use in the specific context;
(d)
the specific risks of harm likely to have an impact on the categories of natural persons or groups of persons identified pursuant to point (c) of this paragraph, taking into account the information given by the provider pursuant to Article 13;
(e)
a description of the implementation of human oversight measures, according to the instructions for use;
(f)
the measures to be taken in the case of the materialisation of those risks, including the arrangements for internal governance and complaint mechanisms.
2. The obligation laid down in paragraph 1 applies to the first use of the high-risk AI system. The deployer may, in similar cases, rely on previously conducted fundamental rights impact assessments or existing impact assessments carried out by provider. If, during the use of the high-risk AI system, the deployer considers that any of the elements listed in paragraph 1 has changed or is no longer up to date, the deployer shall take the necessary steps to update the information.
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