Article 27: Fundamental Rights Impact Assessment for High-Risk AI Systems
Official Statutory Text
Article 27 FUNDAMENTAL rights impact assessment for high-risk AI systems 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 refer red to in points 5 (b) and (c) of Annex III, shall performan assessmentof the impacton fundamental rights that the use of such system may produce. For that pur pose, deployers shall performan 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 pur pose; (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) thecategories of natural persons and groups likely to be affected by its use in the specific context ; (d) the specific risks of harm likely to havean impacton thecategories 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 betaken in the case of the materialisation of those risks, including the arrangements for internal governanceand complaint mec hanisms. 2. The obligation laid down in paragraph 1 applies to the first use of the high-risk AI system. The deployermay , 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. 3. Once the assessment refer red to in paragraph 1 of this Article has been performed, the deployer shall notify the market surveillance authority of its results, submitting the filled- out template refer red to in paragraph 5 of this Article as par tof the notification. In the case refer red to in Article 46(1), deployers maybe exempt from thatobligation to notify . 4. If any of the obligations laid down in this Article is already met through the data protection impact assessment conducted pursuant to Article 35 of Regulation (EU) 2016/679 or Article 27 of Directive (EU) 2016/680, the fundamental rights impact assessment referred to in paragraph 1 of this Article shall complement that data protection impact assessment. 5. The AI Office shall develop atemplate for a questionnaire, including through an automated tool, tofacilitat e deployers incomplying with their obligations under this Article in a simplified manner . SECTION 4 Notifying authorities and notified bodies
European Parliament & Council (Regulation 2024/1689)
View Official EUR-Lex Publication- Perform a Fundamental Rights Impact Assessment (FRIA): Before deploying a high-risk AI system (except those in Annex III, point 2), if you are a body governed by public law, a private entity providing public services, or a deployer of systems referred to in Annex III, points 5(b) and (c), conduct an assessmentof the impacton fundamental rights.
- The FRIA must include:
- A description of the deployer's processes where the high-risk AI system will be used, aligned with its intended purpose.
- A description of the period and frequency of the system's intended use.
- The categories of natural persons and groups likely to be affected by its use in the specific context.
- Specific risks of harm likely to impact those identified persons/groups, taking into account information from the provider (Art. 13).
- A description of the implementation of human oversight measures, according to instructions for use.
- Measures to be taken if risks materialise, including internal governance and complaint mechanisms.
- This obligation applies to the first use of the high-risk AI system. For similar cases, you may rely on previously conducted FRIAs or existing impact assessments by the provider.
- Update the FRIA if any elements of the assessment change or become outdated during the use of the system.
- Notify the market surveillance authority of the FRIA results by submitting the filled-out template (to be developed by the AI Office) as partof the notification, unless exempted by Article 46(1).
- Ensure the FRIA complements any Data Protection Impact Assessment (DPIA) already conducted pursuant to GDPR (Art. 35) or Directive (EU) 2016/680 (Art. 27), covering any overlapping obligations.
- Utilize the template/automated tool developed by the AI Office to simplify compliance with your FRIA obligations.
Applies directly across all 27 EU Member States with phased entry into force from 2025 to 2026.