+Article 80 Procédure applicable aux systèmes d’IA classés par le fournisseur comme n’étant pas à haut risque en application de l’annexe III
---+Article 80 1.
---+Article 80 2.
---+Article 80 3.
---+Article 80 4.
---+Article 80 5.
---+Article 80 6.
---+Article 80 7.
---+Article 80 8.
|
Article 80 Procédure applicable aux systèmes d’IA classés par le fournisseur comme n’étant pas à haut risque en application de l’annexe III
-
1. Vue d’ensemble
| Intitulé |
Réglementation |
|
Article 80 1.
|
Lorsqu’une autorité de surveillance du marché a des raisons suffisantes de considérer qu’un système d’IA classé par le fournisseur comme n’étant pas à haut risque en application de l’article 6, paragraphe 3, est en réalité à haut risque, elle procède à une évaluation du système d’IA concerné quant à la question de sa classification en tant que système d’IA à haut risque sur la base des conditions énoncées à l’article 6, paragraphe 3, et dans les lignes directrices de la Commission.
|
|
Article 80 2.
|
Lorsque, au cours de cette évaluation, l’autorité de surveillance du marché constate que le système d’IA concerné est à haut risque, elle demande sans retard injustifié au fournisseur concerné de prendre toutes les mesures nécessaires pour mettre le système d’IA en conformité avec les exigences et obligations énoncées dans le présent règlement, ainsi que de prendre les mesures correctives appropriées dans un délai que l’autorité de surveillance du marché peut prescrire.
|
|
Article 80 3.
|
Lorsque l’autorité de surveillance du marché considère que l’utilisation du système d’IA concerné n’est pas limitée à son territoire national, elle informe la Commission et les autres États membres, sans retard injustifié, des résultats de l’évaluation et des mesures qu’elle a exigées du fournisseur.
|
|
Article 80 4.
|
Le fournisseur veille à ce que toutes les mesures nécessaires soient prises pour mettre le système d’IA en conformité avec les exigences et obligations énoncées dans le présent règlement. Lorsque le fournisseur d’un système d’IA concerné ne met pas le système d’IA en conformité avec ces exigences et obligations dans le délai visé au paragraphe 2 du présent article, il fait l’objet d’amendes conformément à l’article 99.
|
|
Article 80 5.
|
Le fournisseur s’assure que toutes les mesures correctives appropriées sont prises pour tous les systèmes d’IA concernés qu’il a mis à disposition sur le marché de l’Union.
|
|
Article 80 6.
|
Lorsque le fournisseur du système d’IA concerné ne prend pas de mesures correctives adéquates dans le délai visé au paragraphe 2 du présent article, l’article 79, paragraphe 5 à 9, s’applique.
|
|
Article 80 7.
|
Lorsque, au cours de l’évaluation prévue au paragraphe 1 du présent article, l’autorité de surveillance du marché établit que le système d’IA a été classé à tort par le fournisseur comme n’étant pas à haut risque afin de contourner l’application des exigences figurant au chapitre III, section 2, le fournisseur fait l’objet d’amendes conformément à l’article 99.
|
|
Article 80 8.
|
Dans l’exercice de leur pouvoir de contrôle de l’application du présent article, et conformément à l’article 11 du règlement (UE) 2019/1020, les autorités de surveillance du marché peuvent effectuer des contrôles appropriés, en tenant compte notamment des informations stockées dans la base de données de l’UE visée à l’article 71 du présent règlement.
|
,
1.1 Références
1.2 Exigences identifiées
1.3 Normes associées
2. Exigences identifiées
Exigences
| Source |
Exigence |
3. Normes associées
Normes
| Source |
Exigence |
|
SCF
|
Non-Conformity Corrective Action
Description
Mechanisms exist to implement corrective action to remediate instances of non-conformity with applicable statutory, regulatory, and/or contractual compliance obligations.
Possible Solutions & Considerations
Micro-Small Business (<10 staff) / BLS Firm Size Classes 1-2
∙ Corrective action log (spreadsheet)
∙ Documented remediation plans for audit findings
Small Business (10-49 staff) / BLS Firm Size Classes 3-4
∙ Corrective action register with remediation tracking
∙ Management review of open findings
Medium Business (50-249 staff) / BLS Firm Size Classes 5-6
∙ Formal corrective action plan process
∙ GRC platform for finding tracking and remediation
∙ Management review of open findings
Large Business (250-999 staff) / BLS Firm Size Classes 7-8
∙ Enterprise corrective action management program
∙ GRC platform with workflow-driven remediation tracking
∙ Executive reporting on open findings
Enterprise (> 1,000 staff) / BLS Firm Size Class 9
∙ Enterprise GRC platform for corrective action management
∙ Automated finding tracking and escalation workflows
∙ Board-level reporting on material findings
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
Compliance (CPL) domain capabilities are ad hoc and inconsistent. Capability criteria associated with this control may include:
▪ Policies, standards & procedures associated with CPL domain capabilities provide limited coverage due to the depth and breadth of the existing documentation.
▪ Compliance management-related activities are decentralized (e.g., a localized/regionalized function) and uses non-standardized methods to implement secure, resilient and compliant practices.
▪ Compliance efforts are narrowly-limited to certain compliance requirements.
▪ IT and/or cybersecurity personnel use an informal process to govern statutory, regulatory and contractual compliance obligations.
Level 2 Planned Tracked
Compliance (CPL) 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 CPL domain capabilities are formally documented and centrally-managed by the entity.
▪ Standardized Operating Procedures (SOP) associated with CPL 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 CPL domain capabilities to address applicable statutory, regulatory and/or contractual requirements for Technology Assets, Applications, Services and/or Data (TAASD).
▪ Compliance management controls-related controls are primarily administrative and preventative in nature (e.g., policies, standards and procedures & guidelines).
▪ Compliance management may be a defined function (e.g., team or department) or assigned as an additional duty to existing IT and/or cybersecurity personnel.
▪ External compliance requirements for cybersecurity and data privacy are identified and documented, based on applicable laws, regulations and contractual obligations.
Level 3 Well Defined
Compliance (CPL) 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 CPL 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 CPL domain capabilities are well-documented and kept current by process owners.
▪ A Governance, Risk & Compliance (GRC) team, or similar function, is appropriately staffed and supported to implement and maintain CPL domain capabilities.
▪ Technology is leveraged to enhance the efficiency and accuracy of governance, risk management and compliance operations (e.g., GRC 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 CPL 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 take corrective action to remediate instances of non-conformity with applicable statutory, regulatory, and/or contractual compliance obligations.
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
|
Non-Conformity Corrective Action
Description
Mechanisms exist to implement corrective action to remediate instances of non-conformity with applicable statutory, regulatory, and/or contractual compliance obligations.
Possible Solutions & Considerations
Micro-Small Business (<10 staff) / BLS Firm Size Classes 1-2
∙ Corrective action log (spreadsheet)
∙ Documented remediation plans for audit findings
Small Business (10-49 staff) / BLS Firm Size Classes 3-4
∙ Corrective action register with remediation tracking
∙ Management review of open findings
Medium Business (50-249 staff) / BLS Firm Size Classes 5-6
∙ Formal corrective action plan process
∙ GRC platform for finding tracking and remediation
∙ Management review of open findings
Large Business (250-999 staff) / BLS Firm Size Classes 7-8
∙ Enterprise corrective action management program
∙ GRC platform with workflow-driven remediation tracking
∙ Executive reporting on open findings
Enterprise (> 1,000 staff) / BLS Firm Size Class 9
∙ Enterprise GRC platform for corrective action management
∙ Automated finding tracking and escalation workflows
∙ Board-level reporting on material findings
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
Compliance (CPL) domain capabilities are ad hoc and inconsistent. Capability criteria associated with this control may include:
▪ Policies, standards & procedures associated with CPL domain capabilities provide limited coverage due to the depth and breadth of the existing documentation.
▪ Compliance management-related activities are decentralized (e.g., a localized/regionalized function) and uses non-standardized methods to implement secure, resilient and compliant practices.
▪ Compliance efforts are narrowly-limited to certain compliance requirements.
▪ IT and/or cybersecurity personnel use an informal process to govern statutory, regulatory and contractual compliance obligations.
Level 2 Planned Tracked
Compliance (CPL) 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 CPL domain capabilities are formally documented and centrally-managed by the entity.
▪ Standardized Operating Procedures (SOP) associated with CPL 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 CPL domain capabilities to address applicable statutory, regulatory and/or contractual requirements for Technology Assets, Applications, Services and/or Data (TAASD).
▪ Compliance management controls-related controls are primarily administrative and preventative in nature (e.g., policies, standards and procedures & guidelines).
▪ Compliance management may be a defined function (e.g., team or department) or assigned as an additional duty to existing IT and/or cybersecurity personnel.
▪ External compliance requirements for cybersecurity and data privacy are identified and documented, based on applicable laws, regulations and contractual obligations.
Level 3 Well Defined
Compliance (CPL) 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 CPL 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 CPL domain capabilities are well-documented and kept current by process owners.
▪ A Governance, Risk & Compliance (GRC) team, or similar function, is appropriately staffed and supported to implement and maintain CPL domain capabilities.
▪ Technology is leveraged to enhance the efficiency and accuracy of governance, risk management and compliance operations (e.g., GRC 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 CPL 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 take corrective action to remediate instances of non-conformity with applicable statutory, regulatory, and/or contractual compliance obligations.
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.
|
|