Article 14: Human Oversight
Article 14
Human Oversight
Updated on 31 July 2024 based on the version published in the Official Journal of the EU dated 12 July 2024 and entered into force on 1 August 2024.
1. High-risk AI systems shall be designed and developed in such a way, including with appropriate human-machine interface tools, that they can be effectively overseen by natural persons during the period in which they are in use.
2. Human oversight shall aim to prevent or minimise the risks to health, safety or fundamental rights that may emerge when a high-risk AI system is used in accordance with its intended purpose or under conditions of reasonably foreseeable misuse, in particular where such risks persist despite the application of other requirements set out in this Section.
3. The oversight measures shall be commensurate with the risks, level of autonomy and context of use of the high-risk AI system, and shall be ensured through either one or both of the following types of measures:
- measures identified and built, when technically feasible, into the high-risk AI system by the provider before it is placed on the market or put into service;
- measures identified by the provider before placing the high-risk AI system on the market or putting it into service and that are appropriate to be implemented by the deployer.
4. For the purpose of implementing paragraphs 1, 2 and 3, the high-risk AI system shall be provided to the deployer in such a way that natural persons to whom human oversight is assigned are enabled, as appropriate and proportionate:
- to properly understand the relevant capacities and limitations of the high-risk AI system and be able to duly monitor its operation, including in view of detecting and addressing anomalies, dysfunctions and unexpected performance;
- to remain aware of the possible tendency of automatically relying or over-relying on the output produced by a high-risk AI system (automation bias), in particular for high-risk AI systems used to provide information or recommendations for decisions to be taken by natural persons;
- to correctly interpret the high-risk AI system’s output, taking into account, for example, the interpretation tools and methods available;
- to decide, in any particular situation, not to use the high-risk AI system or to otherwise disregard, override or reverse the output of the high-risk AI system;
- to intervene in the operation of the high-risk AI system or interrupt the system through a ‘stop’ button or a similar procedure that allows the system to come to a halt in a safe state.
5. For high-risk AI systems referred to in point 1(a) of Annex III, the measures referred to in paragraph 3 of this Article shall be such as to ensure that, in addition, no action or decision is taken by the deployer on the basis of the identification resulting from the system unless that identification has been separately verified and confirmed by at least two natural persons with the necessary competence, training and authority.
The requirement for a separate verification by at least two natural persons shall not apply to high-risk AI systems used for the purposes of law enforcement, migration, border control or asylum, where Union or national law considers the application of this requirement to be disproportionate.
Table of Contents
Chapter III: High-Risk AI Systems
- Section 1: Classification of AI Systems as High-Risk
- Section 2: Requirements for High-Risk AI Systems
- Article 8: Compliance with the Requirements
- Article 9: Risk Management System
- Article 10: Data and Data Governance
- Article 11: Technical Documentation
- Article 12: Record-Keeping
- Article 13: Transparency and Provision of Information to Deployers
- Article 14: Human Oversight
- Article 15: Accuracy, Robustness and Cybersecurity
- Section 3: Obligations of Providers and Deployers of High-Risk AI Systems and Other Parties
- Article 16: Obligations of Providers of High-Risk AI Systems
- Article 17: Quality Management System
- Article 18: Documentation Keeping
- Article 19: Automatically Generated Logs
- Article 20: Corrective Actions and Duty of Information
- Article 21: Cooperation with Competent Authorities
- Article 22: Authorised Representatives of Providers of High-Risk AI Systems
- Article 23: Obligations of Importers
- Article 23a
- Article 24: Obligations of Distributors
- Article 25: Responsibilities along the AI Value Chain
- Article 26: Obligations of Deployers of High-Risk AI Systems
- Article 27: Fundamental Rights Impact Assessment for High-Risk AI Systems
- Section 4: Notifying Authorities and Notified Bodies
- Article 28: Notifying Authorities
- Article 29: Application of a Conformity Assessment Body for Notification
- Article 30: Notification Procedure
- Article 31: Requirements Relating to Notified Bodies
- Article 32: Presumption of Conformity with Requirements Relating to Notified Bodies
- Article 33: Subsidiaries of Notified Bodies and Subcontracting
- Article 34: Operational Obligations of Notified Bodies
- Article 35: Identification Numbers and Lists of Notified Bodies
- Article 36: Changes to Notifications
- Article 37: Challenge to the Competence of Notified Bodies
- Article 38: Coordination of Notified Bodies
- Article 39: Conformity Assessment Bodies of Third Countries
- Section 5: Standards, Conformity Assessment, Certification, Registration
- Article 40: Harmonised Standards and Standardisation Deliverables
- Article 41: Common Specifications
- Article 42: Presumption of Conformity with Certain Requirements
- Article 43: Conformity Assessment
- Article 44: Certificates
- Article 45: Information Obligations of Notified Bodies
- Article 46: Derogation from Conformity Assessment Procedure
- Article 47: EU Declaration of Conformity
- Article 48: CE Marking
- Article 49: Registration
Chapter V: General-Purpose AI Models
Chapter VI: Measures in Support of Innovation
- Article 57: AI Regulatory Sandboxes
- Article 58: Detailed Arrangements for, and Functioning of, AI Regulatory Sandboxes
- Article 59: Further Processing of Personal Data for Developing Certain AI Systems in the Public Interest in the AI Regulatory Sandbox
- Article 60: Testing of High-Risk AI Systems in Real World Conditions Outside AI Regulatory Sandboxes
- Article 61: Informed Consent to Participate in Testing in Real World Conditions Outside AI Regulatory Sandboxes
- Article 62: Measures for Providers and Deployers, in Particular SMEs, including Start-Ups
- Article 63: Derogations for Specific Operators
Chapter VII: Governance
Chapter IX: Post-Market Monitoring, Information Sharing and Market Surveillance
- Section 1: Post-Market Monitoring
- Section 2: Sharing of Information on Serious Incidents
- Section 3: Enforcement
- Article 74: Market Surveillance and Control of AI Systems in the Union Market
- Article 75: Mutual Assistance, Market Surveillance and Control of General-Purpose AI Systems
- Article 76: Supervision of Testing in Real World Conditions by Market Surveillance Authorities
- Article 77: Powers of Authorities Protecting Fundamental Rights
- Article 78: Confidentiality
- Article 80: Procedure for Dealing with AI Systems Classified by the Provider as Non-High-Risk in Application of Annex III
- Article 81: Union Safeguard Procedure
- Article 82: Compliant AI Systems which Present a Risk
- Article 82a
- Article 83: Formal Non-Compliance
- Article 84: Union AI Testing Support Structures
- Article 79: Procedure at National Level for Dealing with AI Systems Presenting a Risk
- Section 4: Remedies
- Section 5: Supervision, Investigation, Enforcement and Monitoring in Respect of Providers of General-Purpose AI Models
- Article 88: Enforcement of the Obligations of Providers of General-Purpose AI Models
- Article 89: Monitoring Actions
- Article 90: Alerts of Systemic Risks by the Scientific Panel
- Article 91: Power to Request Documentation and Information
- Article 92: Power to Conduct Evaluations
- Article 93: Power to Request Measures
- Article 94: Procedural Rights of Economic Operators of the General-Purpose AI Model
Chapter XIII: Final Provisions
- Article 102: Amendment to Regulation (EC) No 300/2008
- Article 103: Amendment to Regulation (EU) No 167/2013
- Article 104: Amendment to Regulation (EU) No 168/2013
- Article 105: Amendment to Directive 2014/90/EU
- Article 106: Amendment to Directive (EU) 2016/797
- Article 107: Amendment to Regulation (EU) 2018/858
- Article 108: Amendment to Regulation (EU) 2018/1139
- Article 109: Amendment to Regulation (EU) 2019/2144
- Article 110: Amendment to Directive (EU) 2020/1828
- Article 111: AI Systems Already Placed on the Market or Put into Service and General-Purpose AI Models Already Placed on the Marked
- Article 112: Evaluation and Review
- Article 113: Entry into Force and Application