- Art. 6Classification rules for high-risk AI systems
- Art. 7Amendments to Annex III
- Art. 8Compliance with the requirements
- Art. 9Risk management system
- Art. 10Data and data governance
- Art. 11Technical documentation
- Art. 12Record-keeping
- Art. 13Transparency and provision of information to deployers
- Art. 14Human oversight
- Art. 15Accuracy, robustness and cybersecurity
- Art. 16Obligations of providers of high-risk AI systems
- Art. 17Quality management system
- Art. 18Documentation keeping
- Art. 19Automatically generated logs
- Art. 20Corrective actions and duty of information
- Art. 21Cooperation with competent authorities
- Art. 22Authorised representatives of providers of high-risk AI systems
- Art. 23Obligations of importers
- Art. 24Obligations of distributors
- Art. 25Responsibilities along the AI value chain
- Art. 26Obligations of deployers of high-risk AI systems
- Art. 27Fundamental rights impact assessment for high-risk AI systems
- Art. 28Notifying authorities
- Art. 29Application of a conformity assessment body for notification
- Art. 30Notification procedure
- Art. 31Requirements relating to notified bodies
- Art. 32Presumption of conformity with requirements relating to notified bodies
- Art. 33Subsidiaries of notified bodies and subcontracting
- Art. 34Operational obligations of notified bodies
- Art. 35Identification numbers and lists of notified bodies
- Art. 36Changes to notifications
- Art. 37Challenge to the competence of notified bodies
- Art. 38Coordination of notified bodies
- Art. 39Conformity assessment bodies of third countries
- Art. 40Harmonised standards and standardisation deliverables
- Art. 41Common specifications
- Art. 42Presumption of conformity with certain requirements
- Art. 43Conformity assessment
- Art. 44Certificates
- Art. 45Information obligations of notified bodies
- Art. 46Derogation from conformity assessment procedure
- Art. 47EU declaration of conformity
- Art. 48CE marking
- Art. 49Registration
- Art. 51Classification of general-purpose AI models as general-purpose AI models with systemic risk
- Art. 52Procedure
- Art. 53Obligations for providers of general-purpose AI models
- Art. 54Authorised representatives of providers of general-purpose AI models
- Art. 55Obligations of providers of general-purpose AI models with systemic risk
- Art. 56Codes of practice
- Art. 57AI regulatory sandboxes
- Art. 58Detailed arrangements for, and functioning of, AI regulatory sandboxes
- Art. 59Further processing of personal data for developing certain AI systems in the public interest in the AI regulatory sandbox
- Art. 60Testing of high-risk AI systems in real world conditions outside AI regulatory sandboxes
- Art. 60aTesting of high-risk AI systems covered by Union harmonisation legislation listed in Section B of Annex I in real-world conditions outside AI regulatory sandboxes
- Art. 61Informed consent to participate in testing in real world conditions outside AI regulatory sandboxes
- Art. 62Measures for providers and deployers, in particular SMEs, including start-ups
- Art. 63Derogations for specific operators
- Art. 64AI Office
- Art. 65Establishment and structure of the European Artificial Intelligence Board
- Art. 66Tasks of the Board
- Art. 67Advisory forum
- Art. 68Scientific panel of independent experts
- Art. 69Access to the pool of experts by the Member States
- Art. 70Designation of national competent authorities and single points of contact
- Art. 72Post-market monitoring by providers and post-market monitoring plan for high-risk AI systems
- Art. 73Reporting of serious incidents
- Art. 74Market surveillance and control of AI systems in the Union market
- Art. 75Market surveillance and control of AI systems and mutual assistance
- Art. 75aSupervisory and enforcement powers of the AI Office
- Art. 75bCommitments
- Art. 75cNon-compliance, fines and periodic penalty payments
- Art. 75dSafeguards and further specification
- Art. 76Supervision of testing in real world conditions by market surveillance authorities
- Art. 77Powers of authorities protecting fundamental rights and cooperation with market surveillance authorities
- Art. 78Confidentiality
- Art. 79Procedure at national level for dealing with AI systems presenting a risk
- Art. 80Procedure for dealing with AI systems classified by the provider as non-high-risk in application of Annex III
- Art. 81Union safeguard procedure
- Art. 82Compliant AI systems which present a risk
- Art. 83Formal non-compliance
- Art. 84Union AI testing support structures
- Art. 85Right to lodge a complaint with a market surveillance authority
- Art. 86Right to explanation of individual decision-making
- Art. 87Reporting of infringements and protection of reporting persons
- Art. 88Enforcement of the obligations of providers of general-purpose AI models
- Art. 89Monitoring actions
- Art. 90Alerts of systemic risks by the scientific panel
- Art. 91Power to request documentation and information
- Art. 92Power to conduct evaluations
- Art. 93Power to request measures
- Art. 94Procedural rights of economic operators of the general-purpose AI model
- Art. 102Amendment to Regulation (EC) No 300/2008
- Art. 103Amendment to Regulation (EU) No 167/2013
- Art. 104Amendment to Regulation (EU) No 168/2013
- Art. 105Amendment to Directive 2014/90/EU
- Art. 106Amendment to Directive (EU) 2016/797
- Art. 107Amendment to Regulation (EU) 2018/858
- Art. 108Amendments to Regulation (EU) 2018/1139
- Art. 109Amendment to Regulation (EU) 2019/2144
- Art. 110Amendment to Directive (EU) 2020/1828
- Art. 111AI systems already placed on the market or put into service and general-purpose AI models already placed on the marked
- Art. 112Evaluation and review
- Art. 113Entry into force and application
AI Act 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 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.
3.
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.
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 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.
5.
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.
