Source: OJ L, 2024/1689, 12.7.2024 · Consolidated text

Article 27 Fundamental rights impact assessment for high-risk AI systems

Summary What does Article 27 of the AI act regulation say?

This article imposes a fundamental rights impact assessment obligation on a specific subset of deployers before they put certain high-risk AI systems into use.

It applies to public law bodies, private entities providing public services, and deployers of specific employment and credit-related high-risk AI systems listed in Annex III.

The assessment must cover the deployment context, affected persons, foreseeable risks, human oversight arrangements, and contingency measures.

The article also addresses how the obligation interacts with existing data protection impact assessments under GDPR and Directive (EU) 2016/680, allowing cross-referencing to avoid duplication.

Results must be notified to the market surveillance authority, and the AI Office is tasked with developing a standardised template to support compliance.

Important points:

Specific deployers (public law bodies, private entities providing public services, and those deploying certain Annex III systems) must conduct a fundamental rights impact assessment before first use of qualifying high-risk AI systems.
The assessment obligation applies once at first use, but deployers must update it if relevant circumstances change during deployment.
The AI Office is required to develop a questionnaire template to help deployers meet this obligation, including the option to incorporate relevant sections from existing data protection impact assessments.

Springlex's summary of the article is a reading aid, not a substitute for the legal text.

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:
  1. a description of the deployer’s processes in which the high-risk AI system will be used in line with its intended purpose;
  2. a description of the period of time within which, and the frequency with which, each high-risk AI system is intended to be used;
  3. the categories of natural persons and groups likely to be affected by its use in the specific context;
  4. 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;
  5. a description of the implementation of human oversight measures, according to the instructions for use;
  6. the measures to be taken in the case of the materialisation of those risks, including the arrangements for internal governance and complaint mechanisms.
1. 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.
1. Once the assessment referred 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 referred to in paragraph 5 of this Article as part of the notification. In the case referred to in Article 46(1), deployers may be exempt from that obligation to notify.
▼M1ModificationReplacedParagraph 4 replaced by Regulation (EU) 2026/1744, Article 1(13)(a). Published in the Official Journal 24 July 2026.
1. 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 deployer may, when conducting the fundamental rights impact assessment referred to in paragraph 1 of this Article, include cross-references to the relevant sections of that data protection impact assessment or include relevant parts thereof in the fundamental rights impact assessment.
▼M1ModificationReplacedParagraph 5 replaced by Regulation (EU) 2026/1744, Article 1(13)(b). Published in the Official Journal 24 July 2026.▲
1. The AI Office shall develop a template for a questionnaire, including through an automated tool, to facilitate deployers in complying with their obligations under this Article in a simplified manner. This template shall, where relevant, give deployers the possibility to include cross-references to the relevant sections of the data protection impact assessment or include relevant parts thereof in the fundamental rights impact assessment pursuant to paragraph 4.

Relevant recitals

Recital 93 Role of deployers in ensuring that fundamental rights are protected

Whilst risks related to AI systems can result from the way such systems are designed, risks can as well stem from how such AI systems are used. Deployers of high-risk AI system therefore play a critical role in ensuring that fundamental rights are protected, complementing the obligations of the provider when developing the AI system. Deployers are best placed to understand how the high-risk AI system will be used concretely and can therefore identify potential significant risks that were not foreseen in the development phase, due to a more precise knowledge of the context of use, the persons or groups of persons likely to be affected, including vulnerable groups. Deployers of high-risk AI systems listed in an annex to this Regulation also play a critical role in informing natural persons and should, when they make decisions or assist in making decisions related to natural persons, where applicable, inform the natural persons that they are subject to the use of the high-risk AI system. This information should include the intended purpose and the type of decisions it makes. The deployer should also inform the natural persons about their right to an explanation provided under this Regulation. With regard to high-risk AI systems used for law enforcement purposes, that obligation should be implemented in accordance with Article 13 of Directive (EU) 2016/680.

Recital 96 Fundamental rights impact assessment

In order to efficiently ensure that fundamental rights are protected, deployers of high-risk AI systems that are bodies governed by public law, or private entities providing public services and deployers of certain high-risk AI systems listed in an annex to this Regulation, such as banking or insurance entities, should carry out a fundamental rights impact assessment prior to putting it into use. Services important for individuals that are of public nature may also be provided by private entities. Private entities providing such public services are linked to tasks in the public interest such as in the areas of education, healthcare, social services, housing, administration of justice. The aim of the fundamental rights impact assessment is for the deployer to identify the specific risks to the rights of individuals or groups of individuals likely to be affected, identify measures to be taken in the case of a materialisation of those risks. The impact assessment should be performed prior to deploying the high-risk AI system, and should be updated when the deployer considers that any of the relevant factors have changed. The impact assessment should identify the deployer’s relevant processes in which the high-risk AI system will be used in line with its intended purpose, and should include a description of the period of time and frequency in which the system is intended to be used as well as of specific categories of natural persons and groups who are likely to be affected in the specific context of use. The assessment should also include the identification of specific risks of harm likely to have an impact on the fundamental rights of those persons or groups. While performing this assessment, the deployer should take into account information relevant to a proper assessment of the impact, including but not limited to the information given by the provider of the high-risk AI system in the instructions for use. In light of the risks identified, deployers should determine measures to be taken in the case of a materialisation of those risks, including for example governance arrangements in that specific context of use, such as arrangements for human oversight according to the instructions of use or, complaint handling and redress procedures, as they could be instrumental in mitigating risks to fundamental rights in concrete use-cases. After performing that impact assessment, the deployer should notify the relevant market surveillance authority. Where appropriate, to collect relevant information necessary to perform the impact assessment, deployers of high-risk AI system, in particular when AI systems are used in the public sector, could involve relevant stakeholders, including the representatives of groups of persons likely to be affected by the AI system, independent experts, and civil society organisations in conducting such impact assessments and designing measures to be taken in the case of materialisation of the risks. The European Artificial Intelligence Office (AI Office) should develop a template for a questionnaire in order to facilitate compliance and reduce the administrative burden for deployers.

Table of contents

Springlex and this text is meant purely as a documentation tool and has no legal effect. No liability is assumed for its content. The authentic version of this act is the one published in the Official Journal of the European Union.