+Artículo 80 Procedimiento aplicable a los sistemas de IA clasificados por el proveedor como no de alto riesgo en aplicación del anexo III
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Artículo 80 Procedimiento aplicable a los sistemas de IA clasificados por el proveedor como no de alto riesgo en aplicación del anexo III
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1. Resumen
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Regulación |
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Artículo 80 1.
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Cuando una autoridad de vigilancia del mercado tenga motivos suficientes para considerar que un sistema de IA que el proveedor haya clasificado como no de alto riesgo con arreglo al artículo 6, apartado 3, sí lo es, dicha autoridad realizará una evaluación del sistema de IA de que se trate por cuanto se refiere a su clasificación como sistema de IA de alto riesgo en función de las condiciones establecidas en el artículo 6, apartado 3, y las directrices de la Comisión.
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Artículo 80 2.
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Cuando, al realizar dicha evaluación, la autoridad de vigilancia del mercado constate que el sistema de IA afectado es de alto riesgo, pedirá sin demora indebida al proveedor correspondiente que adopte todas las medidas necesarias para que el sistema de IA cumpla los requisitos y obligaciones establecidos en el presente Reglamento, así como que adopte las medidas correctoras adecuadas en el plazo que la autoridad de vigilancia del mercado podrá determinar.
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Artículo 80 3.
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Cuando la autoridad de vigilancia del mercado considere que la utilización del sistema de IA afectado no se circunscribe a su territorio nacional, informará a la Comisión y a los demás Estados miembros sin demora indebida de los resultados de la evaluación y de las medidas que haya exigido al proveedor que adopte.
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Artículo 80 4.
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El proveedor se asegurará de que se adopten todas las medidas necesarias para que el sistema de IA cumpla los requisitos y obligaciones que se establecen en el presente Reglamento. Cuando el proveedor de un sistema de IA afectado no haga lo necesario para que cumpla dichos requisitos y obligaciones en el plazo a que se refiere el apartado 2 del presente artículo, se le impondrán multas de conformidad con el artículo 99.
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Artículo 80 5.
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El proveedor se asegurará de que se adopten todas las medidas correctoras adecuadas para todos los sistemas de IA afectados que haya comercializado en toda la Unión.
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Artículo 80 6.
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Cuando el proveedor del sistema de IA afectado no adopte las medidas correctoras adecuadas en el plazo a que se refiere el apartado 2 del presente artículo, se aplicará el artículo 79, apartados 5 a 9.
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Artículo 80 7.
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Cuando, al realizar la evaluación con arreglo al apartado 1 del presente artículo, la autoridad de vigilancia del mercado determine que el proveedor había clasificado erróneamente el sistema de IA como de no alto riesgo con el fin de eludir la aplicación de los requisitos establecidos en el capítulo III, sección 2, se impondrán multas al proveedor de conformidad con el artículo 99.
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Artículo 80 8.
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En el ejercicio de su facultad de supervisión de la aplicación del presente artículo, y de conformidad con el artículo 11 del Reglamento (UE) 2019/1020, las autoridades de vigilancia del mercado podrán realizar los controles pertinentes, teniendo en cuenta, en particular, la información almacenada en la base de datos de la UE a que se refiere el artículo 71 del presente Reglamento.
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1.1 Referencias
1.2 Requisitos identificados
1.3 Estándares relacionados
2. Requisitos identificados
Requisitos
| Fuente |
Requisito |
3. Estándares relacionados
Estándares
| Fuente |
Requisito |
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SCF
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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.
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SCF
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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.
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