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AI risk and lifecycle management
Defining and documenting AI system requirements
AI governance
AI risk and lifecycle management

Defining and documenting AI system requirements

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Task description

Defining and documenting AI system requirements

The organization should establish a clear process for defining and documenting all relevant requirements for newly developed AI systems or significant upgrades to existing ones. This includes functional, non-functional, technical, security, and ethical requirements.

The process should involve relevant stakeholders and incorporate considerations such as the intended purpose, potential risks, and impacts of the AI system. Documented requirements should serve as a foundational basis for the design, development, testing, and deployment phases of the AI system's lifecycle.

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Policy
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Conducting and documenting AI system impact assessments
Top management's commitment to the AI management system
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Top management's commitment to the AI management system
Documentation of high-risk AI system characteristics and intended purpose
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Implementing, verifying, and updating the AI risk treatment plan
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Implementation and verification of responsible AI development controls
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Implementing operational controls for the AI management system
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Establishing and maintaining an AI management system
Change management for the AI management system
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Change management for the AI management system
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AI system design and development lifecycle process
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Critical
High
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Critical
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Maintaining a log of monitoring activities of deployed high-risk AI systems
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AI risk and lifecycle management
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High
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Fundamental rights assessment -report publishing, informing and maintenance
Critical
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AI risk and lifecycle management
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Examples of other requirements this task affects

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Article 9.4: Considerations for risk management measures
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Evaluation of AI risk management measures in the risk management phase
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Critical
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AI risk and lifecycle management
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Acceptance of overall residual AI risk
Mitigation and control measures for AI risks
Critical
High
Normal
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AI risk and lifecycle management
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Article 9.5: Risk management measures
AI Act (Base)
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Mitigation and control measures for AI risks
Testing plan for high-risk AI systems
Critical
High
Normal
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AI risk and lifecycle management
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Testing plan for high-risk AI systems
Documentation of AI system design and development
Critical
High
Normal
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AI risk and lifecycle management
2
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Article 10.2: Management of training, validation and testing data sets
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Documentation of AI system design and development
Logging capabilities for high-risk AI systems
Critical
High
Normal
Low
AI risk and lifecycle management
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Examples of other requirements this task affects

Article 12: Record-keeping (logs)
AI Act (Base)
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Logging capabilities for high-risk AI systems
Amount, competence and adequacy of human oversight personnel
Critical
High
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Low
AI risk and lifecycle management
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Amount, competence and adequacy of human oversight personnel
Management of AI-specific cybersecurity risks
Critical
High
Normal
Low
AI risk and lifecycle management
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Article 15.5: Cybersecurity and resilience against manipulation attempts
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Management of AI-specific cybersecurity risks
AI cybersecurity incident response plan
Critical
High
Normal
Low
AI risk and lifecycle management
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requirements

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Article 15.5: Cybersecurity and resilience against manipulation attempts
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Verification process for imported high-risk AI systems
Critical
High
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AI risk and lifecycle management
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Examples of other requirements this task affects

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Verification process for imported high-risk AI systems
Handling non-conformities in imported high-risk AI systems
Critical
High
Normal
Low
AI risk and lifecycle management
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requirements

Examples of other requirements this task affects

Article 23: Declaration of conformity for importers of high-risk AI systems
AI Act (Base)
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Handling non-conformities in imported high-risk AI systems
Internal control procedure for conformity assessment
Critical
High
Normal
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AI risk and lifecycle management
1
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Examples of other requirements this task affects

Article 43.1: Conformity assessment procedure for providers of high-risk AI systems
AI Act (Base)
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Internal control procedure for conformity assessment
Internal conformity assessment procedure for high-risk AI systems
Critical
High
Normal
Low
AI risk and lifecycle management
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Examples of other requirements this task affects

Article 43.2: Conformity assessment procedure for providers of high-risk AI systems listed in Annex III
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Internal conformity assessment procedure for high-risk AI systems
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Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

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Article 43.4: Conditions for high-risk AI systems to undergo a new conformity assessment procedure
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Process for managing substantial modifications to AI systems
Policy on CE marking responsibility and usage for high-risk AI systems
Critical
High
Normal
Low
AI risk and lifecycle management
1
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Article 48: CE markings for high-risk AI systems
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Policy on CE marking responsibility and usage for high-risk AI systems
Management of serious incidents during real-world AI testing
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

Examples of other requirements this task affects

Article 60.7: Reporting of serious incidents connected to real-world testing of high-risk AI systems
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Management of serious incidents during real-world AI testing
Registration of AI systems before market placement
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

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Article 49: Registration of AI systems
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Registration of AI systems before market placement
Considering AI risks in the ISMS
Critical
High
Normal
Low
AI risk and lifecycle management
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Examples of other requirements this task affects

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Considering AI risks in the ISMS
AI risk assessment process establishment and management
Critical
High
Normal
Low
AI risk and lifecycle management
3
requirements

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Article 9.2: Risk management system planning, processes and maintenance
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AI risk assessment process establishment and management
Adopting a code of practice for general-purpose AI models
Critical
High
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Low
AI risk and lifecycle management
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Examples of other requirements this task affects

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Adopting a code of practice for general-purpose AI models
Appointment of an authorised representative for GPAI model providers from outside the EU
Critical
High
Normal
Low
AI risk and lifecycle management
1
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Examples of other requirements this task affects

Article 54: Authorised representatives of providers of general-purpose AI models
AI Act (GPAI)
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Appointment of an authorised representative for GPAI model providers from outside the EU
Evaluating and managing systemic risk in GPAI models
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

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Article 55: Obligations for providers of general-purpose AI models with systemic risk
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Evaluating and managing systemic risk in GPAI models
Process for cooperating with competent authorities
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

Examples of other requirements this task affects

Article 52.3: Cooperation with competent authorities for providers of general purpose AI models
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Process for cooperating with competent authorities
Support for authorised representatives of GPAI model providers
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

Examples of other requirements this task affects

Article 54: Authorised representatives of providers of general-purpose AI models
AI Act (GPAI)
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Support for authorised representatives of GPAI model providers
AI system operational procedures and monitoring
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

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AI system operational procedures and monitoring
Integrating customer expectations into AI development and usage
Critical
High
Normal
Low
AI risk and lifecycle management
1
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Integrating customer expectations into AI development and usage
Consideration of technical, societal, and legal environment in AI impact assessments
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

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Consideration of technical, societal, and legal environment in AI impact assessments
Defining objectives for responsible AI
Critical
High
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AI risk and lifecycle management
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Defining objectives for responsible AI
Secure storage of AI system impact assessment documentation
Critical
High
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Low
AI risk and lifecycle management
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Secure storage of AI system impact assessment documentation
AI policy
Critical
High
Normal
Low
AI risk and lifecycle management
1
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AI policy
AI personnel competence management
Critical
High
Normal
Low
AI risk and lifecycle management
1
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AI personnel competence management
AI supplier management procedure
Critical
High
Normal
Low
AI risk and lifecycle management
1
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AI supplier management procedure
Documentation of AI system resources and activities
Critical
High
Normal
Low
AI risk and lifecycle management
1
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Documentation of AI system resources and activities
AI risk and opportunity management
Critical
High
Normal
Low
AI risk and lifecycle management
1
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AI risk and opportunity management
Documenting personnel skills and roles in AI system life cycle
Critical
High
Normal
Low
AI risk and lifecycle management
1
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Documenting personnel skills and roles in AI system life cycle
AI system deployment plan
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

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AI system deployment plan
AI policy review and validation
Critical
High
Normal
Low
AI risk and lifecycle management
2
requirements

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AI policy review and validation
Defining and documenting AI system requirements
Critical
High
Normal
Low
AI risk and lifecycle management
2
requirements

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Defining and documenting AI system requirements
Identifying specific risks of harm in AI fundamental rights impact assessment
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

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Identifying specific risks of harm in AI fundamental rights impact assessment
Review of AI management system resource sufficiency
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

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Review of AI management system resource sufficiency
Process for AI risk treatment and control implementation
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

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Process for AI risk treatment and control implementation
AI management system resource management
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

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AI management system resource management
Maintaining an inventory of AI system tools
Critical
High
Normal
Low
AI risk and lifecycle management
1
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Maintaining an inventory of AI system tools
Societal impact assessment for AI systems
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

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Societal impact assessment for AI systems
Assessment of foreseeable AI system abuses
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

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Assessment of foreseeable AI system abuses
AI system impact assessment documentation
Critical
High
Normal
Low
AI risk and lifecycle management
3
requirements

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AI system impact assessment documentation
AI system use verification
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

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AI system use verification
Establishing documented processes for the responsible use of AI systems
Critical
High
Normal
Low
AI risk and lifecycle management
3
requirements

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Establishing documented processes for the responsible use of AI systems
AI-related concern reporting mechanism
Critical
High
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Low
AI risk and lifecycle management
1
requirements

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AI-related concern reporting mechanism
Defining responsibilities for AI system lifecycle management
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

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Defining responsibilities for AI system lifecycle management
AI objectives and organizational policies
Critical
High
Normal
Low
AI risk and lifecycle management
2
requirements

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AI objectives and organizational policies
AI system impact assessment on individuals and groups
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

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AI system impact assessment on individuals and groups
Transparency in the AI development lifecycle
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

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Transparency in the AI development lifecycle
Awareness and mitigation of automation bias in AI system use
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

Examples of other requirements this task affects

Article 4: Ensuring personnel have a sufficient level of AI literacy
AI Act (Base)
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Awareness and mitigation of automation bias in AI system use
Unit or role-specific AI literacy program
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

Examples of other requirements this task affects

Article 4: Ensuring personnel have a sufficient level of AI literacy
AI Act (Base)
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Unit or role-specific AI literacy program
Implementing changes to AI system classifications
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

Examples of other requirements this task affects

Article 25.3: Manufacturer conditions for AI systems as safety components of products
AI Act (Base)
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Implementing changes to AI system classifications
Code of conduct for organisations deploying or providing AI systems
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

Examples of other requirements this task affects

Article 95.3: Code of conduct for providers or deployers of AI systems and their organisations
AI Act (Base)
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Code of conduct for organisations deploying or providing AI systems
Process for managing classification changes for AI systems
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

Examples of other requirements this task affects

Article 25.1-2: Conditions to be considered a provider of high-risk AI systems
AI Act (Base)
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Process for managing classification changes for AI systems
Automatic log-generation for high-risk AI systems
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

Examples of other requirements this task affects

Article 16: Obligations for providers of high-risk AI systems
AI Act (Base)
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Automatic log-generation for high-risk AI systems
Cooperation with national competent authorities for providers of high-risk AI systems
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

Examples of other requirements this task affects

Article 16: Obligations for providers of high-risk AI systems
AI Act (Base)
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Cooperation with national competent authorities for providers of high-risk AI systems
Termination clause in the authorised representative's mandate
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

Examples of other requirements this task affects

Article 22: Authorised representatives of high-risk AI system providers
AI Act (Base)
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Termination clause in the authorised representative's mandate
Appointment and responsibilities of the authorised representative of providers of high-risk AI systems
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

Examples of other requirements this task affects

Article 22: Authorised representatives of high-risk AI system providers
AI Act (Base)
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Appointment and responsibilities of the authorised representative of providers of high-risk AI systems
Secure storage and transport of distributed high-risk AI systems
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

Examples of other requirements this task affects

Article 24: Declaration of conformity for distributors of high-risk AI systems
AI Act (Base)
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Secure storage and transport of distributed high-risk AI systems
Notification procedure for risks in distributed high-risk AI systems
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

Examples of other requirements this task affects

Article 24: Declaration of conformity for distributors of high-risk AI systems
AI Act (Base)
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Notification procedure for risks in distributed high-risk AI systems
Incident reporting for deployed high-risk AI systems
Critical
High
Normal
Low
AI risk and lifecycle management
1
requirements

Examples of other requirements this task affects

Article 26.5: Monitoring the operation of deployed high-risk AI systems
AI Act (Base)
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Incident reporting for deployed high-risk AI systems
Monitoring equivalencies for high-risk AI systems deployed by financial institutions
Critical
High
Normal
Low
AI risk and lifecycle management
2
requirements

Examples of other requirements this task affects

Article 26.5: Monitoring the operation of deployed high-risk AI systems
AI Act (Base)
Article 26.6: Minimum log retention periods in deployed high-risk AI systems
AI Act (Base)
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Monitoring equivalencies for high-risk AI systems deployed by financial institutions

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