+Artikel 72 Monitoring door aanbieders na het in de handel brengen en plan voor monitoring na het in de handel brengen voor AI-systemen met een hoog risico
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Artikel 72 Monitoring door aanbieders na het in de handel brengen en plan voor monitoring na het in de handel brengen voor AI-systemen met een hoog risico

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1. Overzicht

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Titel Regelgeving
Artikel 72 1.
Aanbieders moeten een systeem voor monitoring na het in de handel brengen vaststellen en documenteren op een manier die evenredig is aan de aard van de AI-technologieën en de risico’s van het AI-systeem met een hoog risico.
Artikel 72 2.
Het systeem voor monitoring na het in de handel brengen verzamelt, documenteert en analyseert actief en systematisch relevante data die door gebruiksverantwoordelijken kunnen zijn verstrekt of via andere bronnen kunnen zijn verzameld, over de prestaties van AI-systemen met een hoog risico gedurende hun hele levensduur, en die de aanbieder in staat stellen na te gaan of AI-systemen blijvend voldoen aan de in hoofdstuk III, afdeling 2, vermelde voorschriften. In voorkomend geval omvat de monitoring na het in de handel brengen een analyse van de interactie met andere AI-systemen. Deze verplichting geldt niet voor gevoelige operationele gegevens van gebruiksverantwoordelijken die rechtshandhavingsinstanties zijn.
Artikel 72 3.
Het systeem voor monitoring na het in de handel brengen, is gebaseerd op een plan voor monitoring na het in de handel brengen. Het plan voor monitoring na het in de handel brengen, maakt deel uit van de in bijlage IV bedoelde technische documentatie. De Commissie stelt uiterlijk op 2 september 2027 richtsnoeren vast, met inbegrip van een model, voor het plan voor monitoring na het in de handel brengen en houdt daarbij zoveel mogelijk rekening met het advies van de AI-board.
Artikel 72 4.
Voor AI-systemen met een hoog risico die onder de in afdeling A van bijlage I vermelde harmonisatiewetgeving van de Unie vallen, hebben aanbieders, indien er krachtens die wetgeving reeds een systeem en een plan voor monitoring na het in de handel brengen zijn vastgesteld, ten behoeve van de consistentie, ter vermijding van doublures en om extra lasten tot een minimum te beperken, de keuze om de noodzakelijke in de leden 1, 2 en 3 beschreven elementen te integreren, met gebruikmaking van het in lid 3 bedoelde model, in systemen en plannen die reeds bestaan op grond van die wetgeving, mits dat een gelijkwaardig beschermingsniveau garandeert.

De eerste alinea van dit lid is ook van toepassing op in punt 5 van bijlage III bedoelde aI-systemen met een hoog risico die in de handel worden gebracht of in gebruik worden gesteld door financiële instellingen waarvoor krachtens het Unierecht inzake financiële diensten vereisten met betrekking tot hun interne governance, regelingen of processen gelden.

1.1 Referenties

1.2 Geïdentificeerde eisen

1.3 Gerelateerde standaarden

2. Geïdentificeerde eisen

Eisen
Bron Eis

3. Gerelateerde standaarden

Standaarden
Bron Eis
SCF AI & Autonomous Technologies Production Monitoring

Description

Mechanisms exist to monitor the functionality and behavior of the deployed Artificial Intelligence (AI) and Autonomous Technologies (AAT).

Possible Solutions & Considerations

Micro-Small Business (<10 staff) / BLS Firm Size Classes 1-2

∙ Formal product management practices
∙ Artificial Intelligence (AI) / autonomous technologies governance program

Small Business (10-49 staff) / BLS Firm Size Classes 3-4

∙ Formal product management practices
∙ Artificial Intelligence (AI) / autonomous technologies governance program

Medium Business (50-249 staff) / BLS Firm Size Classes 5-6

∙ Formal product management practices
∙ Artificial Intelligence (AI) / autonomous technologies governance program

Large Business (250-999 staff) / BLS Firm Size Classes 7-8

∙ Formal product management practices
∙ Artificial Intelligence (AI) / autonomous technologies governance program

Enterprise (> 1,000 staff) / BLS Firm Size Class 9

∙ Formal product management practices
∙ Artificial Intelligence (AI) / autonomous technologies governance program

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 and risk assessments).
▪ 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 and 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 monitor the functionality and behavior of the deployed 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.
SCF AI & Autonomous Technologies Production Monitoring

Description

Mechanisms exist to monitor the functionality and behavior of the deployed Artificial Intelligence (AI) and Autonomous Technologies (AAT).

Possible Solutions & Considerations

Micro-Small Business (<10 staff) / BLS Firm Size Classes 1-2

∙ Formal product management practices
∙ Artificial Intelligence (AI) / autonomous technologies governance program

Small Business (10-49 staff) / BLS Firm Size Classes 3-4

∙ Formal product management practices
∙ Artificial Intelligence (AI) / autonomous technologies governance program

Medium Business (50-249 staff) / BLS Firm Size Classes 5-6

∙ Formal product management practices
∙ Artificial Intelligence (AI) / autonomous technologies governance program

Large Business (250-999 staff) / BLS Firm Size Classes 7-8

∙ Formal product management practices
∙ Artificial Intelligence (AI) / autonomous technologies governance program

Enterprise (> 1,000 staff) / BLS Firm Size Class 9

∙ Formal product management practices
∙ Artificial Intelligence (AI) / autonomous technologies governance program

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 and risk assessments).
▪ 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 and 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 monitor the functionality and behavior of the deployed 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.
SCF AI & Autonomous Technologies Production Monitoring

Description

Mechanisms exist to monitor the functionality and behavior of the deployed Artificial Intelligence (AI) and Autonomous Technologies (AAT).

Possible Solutions & Considerations

Micro-Small Business (<10 staff) / BLS Firm Size Classes 1-2

∙ Formal product management practices
∙ Artificial Intelligence (AI) / autonomous technologies governance program

Small Business (10-49 staff) / BLS Firm Size Classes 3-4

∙ Formal product management practices
∙ Artificial Intelligence (AI) / autonomous technologies governance program

Medium Business (50-249 staff) / BLS Firm Size Classes 5-6

∙ Formal product management practices
∙ Artificial Intelligence (AI) / autonomous technologies governance program

Large Business (250-999 staff) / BLS Firm Size Classes 7-8

∙ Formal product management practices
∙ Artificial Intelligence (AI) / autonomous technologies governance program

Enterprise (> 1,000 staff) / BLS Firm Size Class 9

∙ Formal product management practices
∙ Artificial Intelligence (AI) / autonomous technologies governance program

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 and risk assessments).
▪ 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 and 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 monitor the functionality and behavior of the deployed 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.
SCF AI & Autonomous Technologies Production Monitoring

Description

Mechanisms exist to monitor the functionality and behavior of the deployed Artificial Intelligence (AI) and Autonomous Technologies (AAT).

Possible Solutions & Considerations

Micro-Small Business (<10 staff) / BLS Firm Size Classes 1-2

∙ Formal product management practices
∙ Artificial Intelligence (AI) / autonomous technologies governance program

Small Business (10-49 staff) / BLS Firm Size Classes 3-4

∙ Formal product management practices
∙ Artificial Intelligence (AI) / autonomous technologies governance program

Medium Business (50-249 staff) / BLS Firm Size Classes 5-6

∙ Formal product management practices
∙ Artificial Intelligence (AI) / autonomous technologies governance program

Large Business (250-999 staff) / BLS Firm Size Classes 7-8

∙ Formal product management practices
∙ Artificial Intelligence (AI) / autonomous technologies governance program

Enterprise (> 1,000 staff) / BLS Firm Size Class 9

∙ Formal product management practices
∙ Artificial Intelligence (AI) / autonomous technologies governance program

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 and risk assessments).
▪ 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 and 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 monitor the functionality and behavior of the deployed 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.