+Artículo 51 Reglas de clasificación de los modelos de IA de uso general como modelos de IA de uso general con riesgo sistémico
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---+Artículo 51 2.
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Artículo 51 Reglas de clasificación de los modelos de IA de uso general como modelos de IA de uso general con riesgo sistémico

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1. Resumen

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Artículo 51 1.

Un modelo de IA de uso general se clasificará como modelo de IA de uso general con riesgo sistémico si reúne alguna de las siguientes condiciones:

a) 

tiene capacidades de gran impacto evaluadas a partir de herramientas y metodologías técnicas adecuadas, como indicadores y parámetros de referencia;

b) 

con arreglo a una decisión de la Comisión, adoptada de oficio o a raíz de una alerta cualificada del grupo de expertos científicos, tiene capacidades o un impacto equivalente a los establecidos en la letra a), teniendo en cuenta los criterios establecidos en el anexo XIII.
Artículo 51 2.
Se presumirá que un modelo de IA de uso general tiene capacidades de gran impacto con arreglo al apartado 1, letra a), cuando la cantidad acumulada de cálculo utilizada para su entrenamiento, medida en operaciones de coma flotante, sea superior a 1025.
Artículo 51 3.
La Comisión adoptará actos delegados de conformidad con el artículo 97 para modificar los umbrales a que se refieren los apartados 1 y 2 del presente artículo, así como para complementar los parámetros de referencia e indicadores en función de los avances tecnológicos, como las mejoras algorítmicas o la mayor eficiencia del hardware, cuando sea necesario, para que los umbrales reflejen el estado actual de la técnica.

1.1 Referencias

1.2 Requisitos identificados

1.3 Estándares relacionados

2. Requisitos identificados

Requisitos

3. Estándares relacionados

Estándares
SCF AI & Autonomous Technologies High Risk Designations

Description

Mechanisms exist to designate Artificial Intelligence (AI) and Autonomous Technologies (AAT) "High Risk" if one (1), or more, of the following criteria are met:
(1) AAT is used as a safety component of a product or service;
(2) AAT poses a significant risk of harm to an individual's health, safety or fundamental rights; and/or
(3) AAT materially influences the outcome of an individual's decision making.

Possible Solutions & Considerations

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

∙ Document criteria for high-risk AI use and review before deployment

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

∙ AI risk classification checklist with high-risk criteria

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

∙ Formal AI risk classification policy
∙ High-risk designation process

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

∙ AI risk management framework with formal high-risk designation process
∙ Risk committee review

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

∙ Enterprise AI risk classification framework
∙ Automated risk scoring
∙ Legal/compliance review for high-risk AI
∙ Regulatory compliance mapping (e.g., EU AI Act)

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

SCR-CMM Level 1 criteria definitions are not available for this control:
▪ A reasonable person would conclude this control requires a structured process.
▪ At this level of maturity, the "ad hoc" nature of performing a capability informally would indicate the intent of the control is not met due to a lack of consistency and formality.

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.

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 designate AAT "High Risk" if one(1), or more, of the following criteria are met:
(1) AAT is used as a safety component of a product or service;
(2) AAT poses a significant risk of harm to an individual's health, safety or fundamental rights; and/or
(3) AAT materially influences the outcome of an individual's decision making.

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 High Risk Designations

Description

Mechanisms exist to designate Artificial Intelligence (AI) and Autonomous Technologies (AAT) "High Risk" if one (1), or more, of the following criteria are met:
(1) AAT is used as a safety component of a product or service;
(2) AAT poses a significant risk of harm to an individual's health, safety or fundamental rights; and/or
(3) AAT materially influences the outcome of an individual's decision making.

Possible Solutions & Considerations

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

∙ Document criteria for high-risk AI use and review before deployment

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

∙ AI risk classification checklist with high-risk criteria

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

∙ Formal AI risk classification policy
∙ High-risk designation process

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

∙ AI risk management framework with formal high-risk designation process
∙ Risk committee review

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

∙ Enterprise AI risk classification framework
∙ Automated risk scoring
∙ Legal/compliance review for high-risk AI
∙ Regulatory compliance mapping (e.g., EU AI Act)

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

SCR-CMM Level 1 criteria definitions are not available for this control:
▪ A reasonable person would conclude this control requires a structured process.
▪ At this level of maturity, the "ad hoc" nature of performing a capability informally would indicate the intent of the control is not met due to a lack of consistency and formality.

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.

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 designate AAT "High Risk" if one(1), or more, of the following criteria are met:
(1) AAT is used as a safety component of a product or service;
(2) AAT poses a significant risk of harm to an individual's health, safety or fundamental rights; and/or
(3) AAT materially influences the outcome of an individual's decision making.

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 High Risk Designations

Description

Mechanisms exist to designate Artificial Intelligence (AI) and Autonomous Technologies (AAT) "High Risk" if one (1), or more, of the following criteria are met:
(1) AAT is used as a safety component of a product or service;
(2) AAT poses a significant risk of harm to an individual's health, safety or fundamental rights; and/or
(3) AAT materially influences the outcome of an individual's decision making.

Possible Solutions & Considerations

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

∙ Document criteria for high-risk AI use and review before deployment

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

∙ AI risk classification checklist with high-risk criteria

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

∙ Formal AI risk classification policy
∙ High-risk designation process

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

∙ AI risk management framework with formal high-risk designation process
∙ Risk committee review

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

∙ Enterprise AI risk classification framework
∙ Automated risk scoring
∙ Legal/compliance review for high-risk AI
∙ Regulatory compliance mapping (e.g., EU AI Act)

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

SCR-CMM Level 1 criteria definitions are not available for this control:
▪ A reasonable person would conclude this control requires a structured process.
▪ At this level of maturity, the "ad hoc" nature of performing a capability informally would indicate the intent of the control is not met due to a lack of consistency and formality.

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.

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 designate AAT "High Risk" if one(1), or more, of the following criteria are met:
(1) AAT is used as a safety component of a product or service;
(2) AAT poses a significant risk of harm to an individual's health, safety or fundamental rights; and/or
(3) AAT materially influences the outcome of an individual's decision making.

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.