+Artículo 49 Registro
---+Artículo 49 1.
---+Artículo 49 2.
---+Artículo 49 3.
---+Artículo 49 4.
---+Artículo 49 5.
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Artículo 49 Registro
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1. Resumen
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Regulación |
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Artículo 49 1.
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Antes de introducir en el mercado o de poner en servicio un sistema de IA de alto riesgo enumerado en el anexo III, con excepción de los sistemas de IA de alto riesgo mencionados en el anexo III, punto 2, el proveedor o, en su caso, el representante autorizado, registrarán su sistema y a ellos mismos en la base de datos de la UE a que se refiere el artículo 71.
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Artículo 49 2.
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Antes de introducir en el mercado o poner en servicio un sistema de IA sobre el que el proveedor haya llegado a la conclusión de que no es de alto riesgo de conformidad con el artículo 6, apartado 3, dicho proveedor o, en su caso, el representante autorizado, registrarán ese sistema y a ellos mismos en la base de datos de la UE a que se refiere el artículo 71.
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Artículo 49 3.
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Antes de poner en servicio o utilizar un sistema de IA de alto riesgo enumerado en el anexo III, con excepción de los sistemas de IA de alto riesgo mencionados en el anexo III, punto 2, los responsables del despliegue de sistemas de IA de alto riesgo que sean autoridades públicas, instituciones, órganos u organismos de la Unión, o personas que actúen en su nombre, se registrarán, seleccionarán el sistema y registrarán su utilización en la base de datos de la UE a que se refiere el artículo 71.
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Artículo 49 4.
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En el caso de los sistemas de IA de alto riesgo mencionados en el anexo III, puntos 1, 6 y 7, en los ámbitos de la garantía del cumplimiento del Derecho, la migración, el asilo y la gestión del control fronterizo, el registro a que se refieren los apartados 1, 2 y 3 del presente artículo se efectuará en una sección segura no pública de la base de datos de la UE a que se refiere el artículo 71 e incluirá únicamente la información, según proceda, a la que se hace referencia en:
a)
el anexo VIII, sección A, puntos 1 a 10, con excepción de los puntos 6, 8 y 9;
b)
el anexo VIII, sección B, puntos 1 a 5 y puntos 8 y 9;
c)
el anexo VIII, sección C, puntos 1 a 3;
d)
el anexo IX, puntos 1, 2, 3 y 5.
Únicamente la Comisión y las autoridades nacionales a que se refiere el artículo 74, apartado 8, tendrán acceso a las secciones restringidas respectivas de la base de datos de la UE enumeradas en el párrafo primero del presente apartado.
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Artículo 49 5.
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Los sistemas de IA de alto riesgo a que se refiere el anexo III, punto 2, se registrarán a nivel nacional.
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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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AI & Autonomous Technologies Registration
Description
Mechanisms exist to maintain a current registration for Artificial Intelligence (AI) and Autonomous Technologies (AAT) with the appropriate governing body, as required by statutory or regulatory requirements.
Possible Solutions & Considerations
Micro-Small Business (<10 staff) / BLS Firm Size Classes 1-2
∙ Determine whether any AI use requires registration (e.g., EU AI Act high-risk systems)
Small Business (10-49 staff) / BLS Firm Size Classes 3-4
∙ Track AI registration obligations by jurisdiction in compliance checklist
Medium Business (50-249 staff) / BLS Firm Size Classes 5-6
∙ Register high-risk AI systems with relevant authorities as required
Large Business (250-999 staff) / BLS Firm Size Classes 7-8
∙ AI registration compliance program
∙ Track registration requirements by jurisdiction
Enterprise (> 1,000 staff) / BLS Firm Size Class 9
∙ Enterprise AI regulatory compliance platform
∙ Automated registration tracking
∙ EU AI Act database registration compliance
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
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 maintain a current registration for AAT with the appropriate governing body, as required by statutory or regulatory requirements.
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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AI & Autonomous Technologies Registration
Description
Mechanisms exist to maintain a current registration for Artificial Intelligence (AI) and Autonomous Technologies (AAT) with the appropriate governing body, as required by statutory or regulatory requirements.
Possible Solutions & Considerations
Micro-Small Business (<10 staff) / BLS Firm Size Classes 1-2
∙ Determine whether any AI use requires registration (e.g., EU AI Act high-risk systems)
Small Business (10-49 staff) / BLS Firm Size Classes 3-4
∙ Track AI registration obligations by jurisdiction in compliance checklist
Medium Business (50-249 staff) / BLS Firm Size Classes 5-6
∙ Register high-risk AI systems with relevant authorities as required
Large Business (250-999 staff) / BLS Firm Size Classes 7-8
∙ AI registration compliance program
∙ Track registration requirements by jurisdiction
Enterprise (> 1,000 staff) / BLS Firm Size Class 9
∙ Enterprise AI regulatory compliance platform
∙ Automated registration tracking
∙ EU AI Act database registration compliance
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
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 maintain a current registration for AAT with the appropriate governing body, as required by statutory or regulatory requirements.
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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AI & Autonomous Technologies Registration
Description
Mechanisms exist to maintain a current registration for Artificial Intelligence (AI) and Autonomous Technologies (AAT) with the appropriate governing body, as required by statutory or regulatory requirements.
Possible Solutions & Considerations
Micro-Small Business (<10 staff) / BLS Firm Size Classes 1-2
∙ Determine whether any AI use requires registration (e.g., EU AI Act high-risk systems)
Small Business (10-49 staff) / BLS Firm Size Classes 3-4
∙ Track AI registration obligations by jurisdiction in compliance checklist
Medium Business (50-249 staff) / BLS Firm Size Classes 5-6
∙ Register high-risk AI systems with relevant authorities as required
Large Business (250-999 staff) / BLS Firm Size Classes 7-8
∙ AI registration compliance program
∙ Track registration requirements by jurisdiction
Enterprise (> 1,000 staff) / BLS Firm Size Class 9
∙ Enterprise AI regulatory compliance platform
∙ Automated registration tracking
∙ EU AI Act database registration compliance
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
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 maintain a current registration for AAT with the appropriate governing body, as required by statutory or regulatory requirements.
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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