+AI & Autonomous Technologies Risk Management Decisions
---+AI & Autonomous Technologies Impact Assessment
---+AI & Autonomous Technologies Likelihood & Impact Risk Analysis
---+AI & Autonomous Technologies Continuous Improvements
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AI & Autonomous Technologies Risk Management Decisions
Description
Mechanisms exist to leverage decision makers from a diversity of demographics, disciplines, experience, expertise and backgrounds for mapping, measuring and managing Artificial Intelligence (AI) and Autonomous Technologies (AAT)-related risks.
Possible Solutions & Considerations
Micro-Small Business (<10 staff) / BLS Firm Size Classes 1-2
∙ AI risk management decisions documented (accept, mitigate, avoid, transfer)
∙ AI governance program
∙ NIST AI RMF Manage function
Small Business (10-49 staff) / BLS Firm Size Classes 3-4
∙ Formal AI risk management decision process
∙ AI governance program
∙ NIST AI RMF Manage function
Medium Business (50-249 staff) / BLS Firm Size Classes 5-6
∙ Structured AI risk management decisions aligned to NIST AI RMF Manage function
∙ AI risk register with decision audit trail
∙ AI governance program
Large Business (250-999 staff) / BLS Firm Size Classes 7-8
∙ Enterprise AI risk management decision framework
∙ NIST AI RMF Manage function
∙ Executive AI risk acceptance and treatment decisions documented
∙ AI risk decisions integrated with GRC platform
Enterprise (> 1,000 staff) / BLS Firm Size Class 9
∙ Enterprise AI risk management governance (NIST AI RMF, ISO 42001)
∙ Board-level AI risk acceptance and treatment decisions
∙ AI risk decisions integrated with ERM and GRC platforms
∙ NIST AI RMF Manage function at enterprise scale
SCR-CMM
Level 0 Not Performed
Practices are non-existent, based on the inability to demonstrate an implemented and operational capability. A reasonable person would conclude the control is not being performed.
Level 1 Performed Informally
Artificial Intelligence and Autonomous Technology (AAT) domain capabilities are ad hoc and inconsistent. Capability criteria associated with this control may include:
▪ Policies, standards & procedures associated with AAT domain capabilities provide limited coverage due to the depth and breadth of the existing documentation.
▪ AAT-related processes are expected to follow the organization's existing processes (e.g., incident response, asset management, change control, risk assessments, etc.).
▪ No formal Governance, Risk & Compliance (GRC) team exists to provide AAT oversight, where the Chief Information Officer (CIO), or similar function, governs technology decisions what is acceptable for AAT within the organization.
Level 2 Planned Tracked
Artificial Intelligence and Autonomous Technology (AAT) capabilities are requirements-driven, but are not standardized across the entity (e.g., local/regional level consistency). Capability criteria associated with this control reasonably expect the following criteria to exist:
▪ Policies and standards associated with AAT domain capabilities are formally documented and centrally-managed by the entity.
▪ Standardized Operating Procedures (SOP) associated with AAT domain capabilities are documented and maintained by process owners.
▪ IT and/or cybersecurity personnel work with business stakeholders and process owners to appropriately scope and reasonably implement cybersecurity and data protection controls associated with AAT domain capabilities to address applicable statutory, regulatory and/or contractual requirements for Technology Assets, Applications, Services and/or Data (TAASD).
▪ Artificial Intelligence (AI)-related controls are primarily administrative and preventative in nature (e.g., policies, standards, procedures & guidelines).
▪ Asset management may be a defined function (e.g., team or department) or assigned as an additional duty to existing IT and/or cybersecurity personnel.
▪ AAT is regarded as a technology and governed by the entity's existing IT governance practices.
▪ No formal Governance, Risk & Compliance (GRC) team exists to provide oversight of AAT-related activities. GRC functions are assigned to existing IT and/or cybersecurity personnel.
Level 3 Well Defined
Artificial Intelligence and Autonomous Technology (AAT) capabilities are standardized across the entity for applicability to People, Processes, Technologies, Data and/or Facilities (PPTDF) to ensure consistency for Technology Assets, Applications, Services and/or Data (TAASD). Capability criteria associated with this control reasonably expect the following criteria to exist:
▪ Policies and standards associated with AAT domain capabilities are formally documented and centrally-managed by the entity's Governance, Risk & Compliance (GRC) team, or similar function.
▪ Standardized Operating Procedures (SOP) associated with AAT domain capabilities are well-documented and kept current by process owners.
▪ An Artificial Intelligence Governance (AIG) team, or similar function, is appropriately staffed and supported to implement and maintain AAT domain capabilities.
▪ Technology is leveraged to enhance the efficiency and accuracy of AI governance, risk management and compliance operations (e.g., dedicated AI governance platform).
▪ The entity's Governance, Risk & Compliance (GRC) team, or similar function, works with business stakeholders and process owners to appropriately scope and reasonably implement cybersecurity and data protection controls associated with AAT domain capabilities to address Minimum Compliance Requirements (MCR) (e.g., applicable statutory, regulatory and/or contractual requirements) and Discretionary Security Requirements (DSR) (e.g., entity-required controls).
▪ An implemented and operational capability exists to leverage decision makers from a diversity of demographics, disciplines, experience, expertise and backgrounds for mapping, measuring and managing AAT-related risks.
Level 4 Quantitatively Controlled
Utilize SCR-CMM Level 3 criteria definitions:
▪ There are no defined Level 4 criteria, since it is reasonable to assume a quantitatively-controlled process is not necessary to operationalize this control.
▪ While it may be possible to develop “metrics-driven” capabilities for this control, the criteria would be organization-specific to define.
Level 5 Continuously Improving
Utilize SCR-CMM Level 3 or Level 4 (if available) criteria definitions:
▪ There are no defined Level 5 criteria, since it is reasonable to assume a continuously-improving process is not necessary to operationalize this control.
▪ Level 5 capabilities should be considered “world-class” where the control builds on Level 4 capabilities, but are continuously improving through Artificial Intelligence (AI) and/or Machine Learning (ML) technologies.
▪ While it may be possible to develop responsive capabilities for this control through the use of AI and/or ML technologies, the criteria would be organization-specific to define.
1. Übersicht
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Standard |
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AI & Autonomous Technologies Impact Assessment
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Description
Mechanisms exist to assess the impact(s) of proposed Artificial Intelligence (AI) and Autonomous Technologies (AAT) on individuals, groups, communities, organizations and society (e.g., Fundamental Rights Impact Assessment (FRIA)).
Possible Solutions & Considerations
Micro-Small Business (<10 staff) / BLS Firm Size Classes 1-2
∙ Basic AI impact assessment (documented impact on people, processes, decisions)
∙ AI governance program
∙ NIST AI RMF Map function
Small Business (10-49 staff) / BLS Firm Size Classes 3-4
∙ Formal AI impact assessment for each deployed system
∙ AI governance program
∙ NIST AI RMF Map function
Medium Business (50-249 staff) / BLS Firm Size Classes 5-6
∙ AI impact assessment process aligned to NIST AI RMF
∙ AI governance program
∙ Algorithmic Impact Assessment (AIA) for higher-risk systems
Large Business (250-999 staff) / BLS Firm Size Classes 7-8
∙ Formal AI impact assessment program with independent review for high-risk systems
∙ NIST AI RMF Map function
∙ Algorithmic Impact Assessment (AIA) process
∙ EU AI Act conformity assessment requirements (if applicable)
Enterprise (> 1,000 staff) / BLS Firm Size Class 9
∙ Enterprise AI impact assessment framework (NIST AI RMF, EU AI Act)
∙ Third-party conformity assessments for high-risk AI (EU AI Act Article 43)
∙ Algorithmic Impact Assessment (AIA) program
∙ Board-level AI impact reporting
SCR-CMM
Level 0 Not Performed
Practices are non-existent, based on the inability to demonstrate an implemented and operational capability. A reasonable person would conclude the control is not being performed.
Level 1 Performed Informally
Artificial Intelligence and Autonomous Technology (AAT) domain capabilities are ad hoc and inconsistent. Capability criteria associated with this control may include:
▪ Policies, standards & procedures associated with AAT domain capabilities provide limited coverage due to the depth and breadth of the existing documentation.
▪ AAT-related processes are expected to follow the organization's existing processes (e.g., incident response, asset management, change control, risk assessments, etc.).
▪ No formal Governance, Risk & Compliance (GRC) team exists to provide AAT oversight, where the Chief Information Officer (CIO), or similar function, governs technology decisions what is acceptable for AAT within the organization.
Level 2 Planned Tracked
Artificial Intelligence and Autonomous Technology (AAT) capabilities are requirements-driven, but are not standardized across the entity (e.g., local/regional level consistency). Capability criteria associated with this control reasonably expect the following criteria to exist:
▪ Policies and standards associated with AAT domain capabilities are formally documented and centrally-managed by the entity.
▪ Standardized Operating Procedures (SOP) associated with AAT domain capabilities are documented and maintained by process owners.
▪ IT and/or cybersecurity personnel work with business stakeholders and process owners to appropriately scope and reasonably implement cybersecurity and data protection controls associated with AAT domain capabilities to address applicable statutory, regulatory and/or contractual requirements for Technology Assets, Applications, Services and/or Data (TAASD).
▪ Artificial Intelligence (AI)-related controls are primarily administrative and preventative in nature (e.g., policies, standards, procedures & guidelines).
▪ Asset management may be a defined function (e.g., team or department) or assigned as an additional duty to existing IT and/or cybersecurity personnel.
Level 3 Well Defined
Artificial Intelligence and Autonomous Technology (AAT) capabilities are standardized across the entity for applicability to People, Processes, Technologies, Data and/or Facilities (PPTDF) to ensure consistency for Technology Assets, Applications, Services and/or Data (TAASD). Capability criteria associated with this control reasonably expect the following criteria to exist:
▪ Policies and standards associated with AAT domain capabilities are formally documented and centrally-managed by the entity's Governance, Risk & Compliance (GRC) team, or similar function.
▪ Standardized Operating Procedures (SOP) associated with AAT domain capabilities are well-documented and kept current by process owners.
▪ An Artificial Intelligence Governance (AIG) team, or similar function, is appropriately staffed and supported to implement and maintain AAT domain capabilities.
▪ Technology is leveraged to enhance the efficiency and accuracy of AI governance, risk management and compliance operations (e.g., dedicated AI governance platform).
▪ The entity's Governance, Risk & Compliance (GRC) team, or similar function, works with business stakeholders and process owners to appropriately scope and reasonably implement cybersecurity and data protection controls associated with AAT domain capabilities to address Minimum Compliance Requirements (MCR) (e.g., applicable statutory, regulatory and/or contractual requirements) and Discretionary Security Requirements (DSR) (e.g., entity-required controls).
▪ An implemented and operational capability exists to assess the impact(s) of proposed AAT on individuals, groups, communities, organizations and society (e.g., Fundamental Rights Impact Assessment (FRIA)).
Level 4 Quantitatively Controlled
Utilize SCR-CMM Level 3 criteria definitions:
▪ There are no defined Level 4 criteria, since it is reasonable to assume a quantitatively-controlled process is not necessary to operationalize this control.
▪ While it may be possible to develop “metrics-driven” capabilities for this control, the criteria would be organization-specific to define.
Level 5 Continuously Improving
Utilize SCR-CMM Level 3 or Level 4 (if available) criteria definitions:
▪ There are no defined Level 5 criteria, since it is reasonable to assume a continuously-improving process is not necessary to operationalize this control.
▪ Level 5 capabilities should be considered “world-class” where the control builds on Level 4 capabilities, but are continuously improving through Artificial Intelligence (AI) and/or Machine Learning (ML) technologies.
▪ While it may be possible to develop responsive capabilities for this control through the use of AI and/or ML technologies, the criteria would be organization-specific to define.
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AI & Autonomous Technologies Likelihood & Impact Risk Analysis
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Description
Mechanisms exist to define the potential likelihood and impact of each identified risk based on expected use and past uses of Artificial Intelligence (AI) and Autonomous Technologies (AAT) in similar contexts.
Possible Solutions & Considerations
Micro-Small Business (<10 staff) / BLS Firm Size Classes 1-2
∙ Basic AI likelihood and impact risk analysis (qualitative)
∙ AI governance program
∙ NIST AI RMF Measure function
Small Business (10-49 staff) / BLS Firm Size Classes 3-4
∙ AI likelihood and impact risk analysis for each system
∙ AI governance program
∙ NIST AI RMF Measure function
Medium Business (50-249 staff) / BLS Firm Size Classes 5-6
∙ Structured AI likelihood and impact risk analysis
∙ AI risk scoring aligned to NIST AI RMF Measure function
∙ AI governance program
Large Business (250-999 staff) / BLS Firm Size Classes 7-8
∙ Quantitative/qualitative AI risk analysis (likelihood x impact)
∙ NIST AI RMF Measure function
∙ AI risk scoring integrated with organizational risk register
Enterprise (> 1,000 staff) / BLS Firm Size Class 9
∙ Enterprise AI risk quantification (NIST AI RMF Measure function, FAIR methodology)
∙ Automated AI risk scoring and monitoring
∙ Board-level AI risk reporting with likelihood and impact metrics
SCR-CMM
Level 0 Not Performed
Practices are non-existent, based on the inability to demonstrate an implemented and operational capability. A reasonable person would conclude the control is not being performed.
Level 1 Performed Informally
Artificial Intelligence and Autonomous Technology (AAT) domain capabilities are ad hoc and inconsistent. Capability criteria associated with this control may include:
▪ Policies, standards & procedures associated with AAT domain capabilities provide limited coverage due to the depth and breadth of the existing documentation.
▪ AAT-related processes are expected to follow the organization's existing processes (e.g., incident response, asset management, change control, risk assessments, etc.).
▪ No formal Governance, Risk & Compliance (GRC) team exists to provide AAT oversight, where the Chief Information Officer (CIO), or similar function, governs technology decisions what is acceptable for AAT within the organization.
Level 2 Planned Tracked
Artificial Intelligence and Autonomous Technology (AAT) capabilities are requirements-driven, but are not standardized across the entity (e.g., local/regional level consistency). Capability criteria associated with this control reasonably expect the following criteria to exist:
▪ Policies and standards associated with AAT domain capabilities are formally documented and centrally-managed by the entity.
▪ Standardized Operating Procedures (SOP) associated with AAT domain capabilities are documented and maintained by process owners.
▪ IT and/or cybersecurity personnel work with business stakeholders and process owners to appropriately scope and reasonably implement cybersecurity and data protection controls associated with AAT domain capabilities to address applicable statutory, regulatory and/or contractual requirements for Technology Assets, Applications, Services and/or Data (TAASD).
▪ Artificial Intelligence (AI)-related controls are primarily administrative and preventative in nature (e.g., policies, standards, procedures & guidelines).
▪ Asset management may be a defined function (e.g., team or department) or assigned as an additional duty to existing IT and/or cybersecurity personnel.
Level 3 Well Defined
Artificial Intelligence and Autonomous Technology (AAT) capabilities are standardized across the entity for applicability to People, Processes, Technologies, Data and/or Facilities (PPTDF) to ensure consistency for Technology Assets, Applications, Services and/or Data (TAASD). Capability criteria associated with this control reasonably expect the following criteria to exist:
▪ Policies and standards associated with AAT domain capabilities are formally documented and centrally-managed by the entity's Governance, Risk & Compliance (GRC) team, or similar function.
▪ Standardized Operating Procedures (SOP) associated with AAT domain capabilities are well-documented and kept current by process owners.
▪ An Artificial Intelligence Governance (AIG) team, or similar function, is appropriately staffed and supported to implement and maintain AAT domain capabilities.
▪ Technology is leveraged to enhance the efficiency and accuracy of AI governance, risk management and compliance operations (e.g., dedicated AI governance platform).
▪ The entity's Governance, Risk & Compliance (GRC) team, or similar function, works with business stakeholders and process owners to appropriately scope and reasonably implement cybersecurity and data protection controls associated with AAT domain capabilities to address Minimum Compliance Requirements (MCR) (e.g., applicable statutory, regulatory and/or contractual requirements) and Discretionary Security Requirements (DSR) (e.g., entity-required controls).
▪ An implemented and operational capability exists to define the potential likelihood and impact of each identified risk based on expected use and past uses of AAT in similar contexts.
Level 4 Quantitatively Controlled
Utilize SCR-CMM Level 3 criteria definitions:
▪ There are no defined Level 4 criteria, since it is reasonable to assume a quantitatively-controlled process is not necessary to operationalize this control.
▪ While it may be possible to develop “metrics-driven” capabilities for this control, the criteria would be organization-specific to define.
Level 5 Continuously Improving
Utilize SCR-CMM Level 3 or Level 4 (if available) criteria definitions:
▪ There are no defined Level 5 criteria, since it is reasonable to assume a continuously-improving process is not necessary to operationalize this control.
▪ Level 5 capabilities should be considered “world-class” where the control builds on Level 4 capabilities, but are continuously improving through Artificial Intelligence (AI) and/or Machine Learning (ML) technologies.
▪ While it may be possible to develop responsive capabilities for this control through the use of AI and/or ML technologies, the criteria would be organization-specific to define.
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AI & Autonomous Technologies Continuous Improvements
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Description
Mechanisms exist to continuously improve Artificial Intelligence (AI) and Autonomous Technologies (AAT) capabilities to maximize benefits and minimize negative impacts associated with AAT.
Possible Solutions & Considerations
Micro-Small Business (<10 staff) / BLS Firm Size Classes 1-2
∙ AI improvement tracking (document lessons learned and updates)
∙ AI governance program
∙ NIST AI RMF Govern function
Small Business (10-49 staff) / BLS Firm Size Classes 3-4
∙ Formal AI continuous improvement process
∙ AI governance program
∙ NIST AI RMF Govern function
Medium Business (50-249 staff) / BLS Firm Size Classes 5-6
∙ AI continuous improvement program aligned to NIST AI RMF
∙ AI performance monitoring with improvement triggers
∙ AI governance program
Large Business (250-999 staff) / BLS Firm Size Classes 7-8
∙ Enterprise AI continuous improvement program
∙ AI performance monitoring platform (e.g., Arize AI, WhyLabs)
∙ NIST AI RMF Govern and Improve functions
∙ AI lessons learned integration
Enterprise (> 1,000 staff) / BLS Firm Size Class 9
∙ Enterprise AI continuous improvement and MLOps program
∙ AI model retraining and improvement pipelines
∙ NIST AI RMF full implementation with continuous improvement loop
∙ Board-level AI improvement reporting
SCR-CMM
Level 0 Not Performed
Practices are non-existent, based on the inability to demonstrate an implemented and operational capability. A reasonable person would conclude the control is not being performed.
Level 1 Performed Informally
Artificial Intelligence and Autonomous Technology (AAT) domain capabilities are ad hoc and inconsistent. Capability criteria associated with this control may include:
▪ Policies, standards & procedures associated with AAT domain capabilities provide limited coverage due to the depth and breadth of the existing documentation.
▪ AAT-related processes are expected to follow the organization's existing processes (e.g., incident response, asset management, change control, risk assessments, etc.).
▪ No formal Governance, Risk & Compliance (GRC) team exists to provide AAT oversight, where the Chief Information Officer (CIO), or similar function, governs technology decisions what is acceptable for AAT within the organization.
Level 2 Planned Tracked
Artificial Intelligence and Autonomous Technology (AAT) capabilities are requirements-driven, but are not standardized across the entity (e.g., local/regional level consistency). Capability criteria associated with this control reasonably expect the following criteria to exist:
▪ Policies and standards associated with AAT domain capabilities are formally documented and centrally-managed by the entity.
▪ Standardized Operating Procedures (SOP) associated with AAT domain capabilities are documented and maintained by process owners.
▪ IT and/or cybersecurity personnel work with business stakeholders and process owners to appropriately scope and reasonably implement cybersecurity and data protection controls associated with AAT domain capabilities to address applicable statutory, regulatory and/or contractual requirements for Technology Assets, Applications, Services and/or Data (TAASD).
▪ Artificial Intelligence (AI)-related controls are primarily administrative and preventative in nature (e.g., policies, standards, procedures & guidelines).
▪ Asset management may be a defined function (e.g., team or department) or assigned as an additional duty to existing IT and/or cybersecurity personnel.
Level 3 Well Defined
Artificial Intelligence and Autonomous Technology (AAT) capabilities are standardized across the entity for applicability to People, Processes, Technologies, Data and/or Facilities (PPTDF) to ensure consistency for Technology Assets, Applications, Services and/or Data (TAASD). Capability criteria associated with this control reasonably expect the following criteria to exist:
▪ Policies and standards associated with AAT domain capabilities are formally documented and centrally-managed by the entity's Governance, Risk & Compliance (GRC) team, or similar function.
▪ Standardized Operating Procedures (SOP) associated with AAT domain capabilities are well-documented and kept current by process owners.
▪ An Artificial Intelligence Governance (AIG) team, or similar function, is appropriately staffed and supported to implement and maintain AAT domain capabilities.
▪ Technology is leveraged to enhance the efficiency and accuracy of AI governance, risk management and compliance operations (e.g., dedicated AI governance platform).
▪ The entity's Governance, Risk & Compliance (GRC) team, or similar function, works with business stakeholders and process owners to appropriately scope and reasonably implement cybersecurity and data protection controls associated with AAT domain capabilities to address Minimum Compliance Requirements (MCR) (e.g., applicable statutory, regulatory and/or contractual requirements) and Discretionary Security Requirements (DSR) (e.g., entity-required controls).
▪ An implemented and operational capability exists to continuously improve AAT capabilities to maximize benefits and minimize negative impacts associated with AAT.
Level 4 Quantitatively Controlled
Utilize SCR-CMM Level 3 criteria definitions:
▪ There are no defined Level 4 criteria, since it is reasonable to assume a quantitatively-controlled process is not necessary to operationalize this control.
▪ While it may be possible to develop “metrics-driven” capabilities for this control, the criteria would be organization-specific to define.
Level 5 Continuously Improving
Utilize SCR-CMM Level 3 or Level 4 (if available) criteria definitions:
▪ There are no defined Level 5 criteria, since it is reasonable to assume a continuously-improving process is not necessary to operationalize this control.
▪ Level 5 capabilities should be considered “world-class” where the control builds on Level 4 capabilities, but are continuously improving through Artificial Intelligence (AI) and/or Machine Learning (ML) technologies.
▪ While it may be possible to develop responsive capabilities for this control through the use of AI and/or ML technologies, the criteria would be organization-specific to define.
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1.1 Referenzen
1.2 Identifizierte Anforderungen
1.3 Related Regulations
2. Identifizierte Anforderungen
Anforderungen
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Anforderung |
3. Related Regulations
Regulations
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Regulierung |
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EULAW
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Article 9 Risk management system
Article 9
1. A risk management system shall be established, implemented, documented and maintained in relation to high-risk AI systems.
2. The risk management system shall be understood as a continuous iterative process planned and run throughout the entire lifecycle of a high-risk AI system, requiring regular systematic review and updating. It shall comprise the following steps:
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(a)
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the identification and analysis of the known and the reasonably foreseeable risks that the high-risk AI system can pose to health, safety or fundamental rights when the high-risk AI system is used in accordance with its intended purpose;
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(b)
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the estimation and evaluation of the risks that may emerge when the high-risk AI system is used in accordance with its intended purpose, and under conditions of reasonably foreseeable misuse;
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(c)
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the evaluation of other risks possibly arising, based on the analysis of data gathered from the post-market monitoring system referred to in Article 72;
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(d)
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the adoption of appropriate and targeted risk management measures designed to address the risks identified pursuant to point (a).
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3. The risks referred to in this Article shall concern only those which may be reasonably mitigated or eliminated through the development or design of the high-risk AI system, or the provision of adequate technical information.
4. The risk management measures referred to in paragraph 2, point (d), shall give due consideration to the effects and possible interaction resulting from the combined application of the requirements set out in this Section, with a view to minimising risks more effectively while achieving an appropriate balance in implementing the measures to fulfil those requirements.
5. The risk management measures referred to in paragraph 2, point (d), shall be such that the relevant residual risk associated with each hazard, as well as the overall residual risk of the high-risk AI systems is judged to be acceptable.
In identifying the most appropriate risk management measures, the following shall be ensured:
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(a)
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elimination or reduction of risks identified and evaluated pursuant to paragraph 2 in as far as technically feasible through adequate design and development of the high-risk AI system;
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(b)
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where appropriate, implementation of adequate mitigation and control measures addressing risks that cannot be eliminated;
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(c)
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provision of information required pursuant to Article 13 and, where appropriate, training to deployers.
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With a view to eliminating or reducing risks related to the use of the high-risk AI system, due consideration shall be given to the technical knowledge, experience, education, the training to be expected by the deployer, and the presumable context in which the system is intended to be used.
6. High-risk AI systems shall be tested for the purpose of identifying the most appropriate and targeted risk management measures. Testing shall ensure that high-risk AI systems perform consistently for their intended purpose and that they are in compliance with the requirements set out in this Section.
7. Testing procedures may include testing in real-world conditions in accordance with Article 60.
8. The testing of high-risk AI systems shall be performed, as appropriate, at any time throughout the development process, and, in any event, prior to their being placed on the market or put into service. Testing shall be carried out against prior defined metrics and probabilistic thresholds that are appropriate to the intended purpose of the high-risk AI system.
9. When implementing the risk management system as provided for in paragraphs 1 to 7, providers shall give consideration to whether in view of its intended purpose the high-risk AI system is likely to have an adverse impact on persons under the age of 18 and, as appropriate, other vulnerable groups.
10. For providers of high-risk AI systems that are subject to requirements regarding internal risk management processes under other relevant provisions of Union law, the aspects provided in paragraphs 1 to 9 may be part of, or combined with, the risk management procedures established pursuant to that law.
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Linked Issues
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