+Artículo 7 Modificaciones del anexo III
---+Artículo 7 1.
---+Artículo 7 2.
---+Artículo 7 3.
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Artículo 7 Modificaciones del anexo III
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1. Resumen
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Regulación |
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Artículo 7 1.
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La Comisión estará facultada para adoptar actos delegados con arreglo al artículo 97 al objeto de modificar el anexo III mediante la adición o modificación de casos de uso de sistemas de IA de alto riesgo cuando se reúnan las dos condiciones siguientes:
a)
que los sistemas de IA estén destinados a ser utilizados en cualquiera de los ámbitos que figuran en el anexo III, y
b)
que los sistemas de IA planteen un riesgo de perjudicar la salud y la seguridad o de tener repercusiones negativas en los derechos fundamentales, y que dicho riesgo sea equivalente a, o mayor que, el riesgo de perjuicio o de repercusiones negativas que plantean los sistemas de IA de alto riesgo que ya se mencionan en el anexo III.
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Artículo 7 2.
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Cuando evalúe la condición prevista en el apartado 1, letra b), la Comisión tendrá en cuenta los criterios siguientes:
a)
la finalidad prevista del sistema de IA;
b)
la medida en que se haya utilizado o sea probable que se utilice un sistema de IA;
c)
la naturaleza y la cantidad de los datos tratados y utilizados por el sistema de IA, en particular si se tratan categorías especiales de datos personales;
d)
el grado de autonomía con el que actúa el sistema de IA y la posibilidad de que un ser humano anule una decisión o recomendaciones que puedan dar lugar a un perjuicio;
e)
la medida en que la utilización de un sistema de IA ya haya causado un perjuicio a la salud y la seguridad, haya tenido repercusiones negativas en los derechos fundamentales o haya dado lugar a problemas importantes en relación con la probabilidad de dicho perjuicio o dichas repercusiones negativas, según demuestren, por ejemplo, los informes o las alegaciones documentadas que se presenten a las autoridades nacionales competentes o cualquier otro informe, según proceda;
f)
el posible alcance de dicho perjuicio o dichas repercusiones negativas, en particular en lo que respecta a su intensidad y su capacidad para afectar a varias personas o afectar de manera desproporcionada a un determinado colectivo de personas;
g)
la medida en que las personas que podrían sufrir dicho perjuicio o dichas repercusiones negativas dependan del resultado generado por un sistema de IA, en particular porque, por motivos prácticos o jurídicos, no sea razonablemente posible renunciar a dicho resultado;
h)
la medida en que exista un desequilibrio de poder o las personas que podrían sufrir dicho perjuicio o dichas repercusiones negativas se encuentren en una posición de vulnerabilidad respecto del responsable del despliegue de un sistema de IA, en particular debido a su situación, autoridad, conocimientos, circunstancias económicas o sociales, o edad;
i)
la medida en que sea fácil corregir o revertir el resultado generado utilizando un sistema de IA, teniendo en cuenta las soluciones técnicas disponibles para corregirlo o revertirlo y sin que deba considerarse que los resultados que afectan negativamente a la salud, la seguridad o los derechos fundamentales son fáciles de corregir o revertir;
j)
la probabilidad de que el despliegue del sistema de IA resulte beneficioso para las personas, los colectivos o la sociedad en general, y la magnitud de este beneficio, incluidas posibles mejoras en la seguridad de los productos;
k)
la medida en que el Derecho de la Unión vigente establezca:
i)
vías de recurso efectivas en relación con los riesgos que plantea un sistema de IA, con exclusión de las acciones por daños y perjuicios,
ii)
medidas efectivas para prevenir o reducir notablemente esos riesgos.
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Artículo 7 3.
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La Comisión estará facultada para adoptar actos delegados con arreglo al artículo 97 al objeto de modificar la lista del anexo III mediante la supresión de sistemas de IA de alto riesgo cuando se reúnan las dos condiciones siguientes:
a)
que los sistemas de IA de alto riesgo de que se trate ya no planteen riesgos considerables para los derechos fundamentales, la salud o la seguridad, teniendo en cuenta los criterios enumerados en el apartado 2;
b)
que la supresión no reduzca el nivel general de protección de la salud, la seguridad y los derechos fundamentales con arreglo al Derecho de la Unión.
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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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High-Risk Technology Assets, Applications and/or Services (TAAS) Categorization
Description
Mechanisms exist to categorize Technology Assets, Applications and/or Services (TAAS) as "High Risk" if it poses a significant risk of harm to an individual's:
(1) Health;
(2) Safety; and/or
(3) Fundamental human rights.
Possible Solutions & Considerations
Micro-Small Business (<10 staff) / BLS Firm Size Classes 1-2
∙ Identify systems that could harm people if misused (e.g., safety devices, sensitive personal data)
Small Business (10-49 staff) / BLS Firm Size Classes 3-4
∙ High-risk categorization field in asset inventory
∙ Criteria for high-risk classification
Medium Business (50-249 staff) / BLS Firm Size Classes 5-6
∙ High-risk TAAS categorization in CMDB based on potential harm to individuals or society
∙ Enhanced controls for high-risk assets
Large Business (250-999 staff) / BLS Firm Size Classes 7-8
∙ Formal high-risk categorization criteria (e.g., aligned with EU AI Act, safety impact)
∙ Risk-based control baselines for high-risk TAAS
Enterprise (> 1,000 staff) / BLS Firm Size Class 9
∙ Enterprise high-risk asset categorization program integrated with risk management and regulatory obligations
∙ Enhanced assurance for high-risk TAAS
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
Asset Management (AST) 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 AST domain capabilities are formally documented and centrally-managed by the entity.
▪ Standardized Operating Procedures (SOP) associated with AST 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 AST domain capabilities to address applicable statutory, regulatory and/or contractual requirements for Technology Assets, Applications, Services and/or Data (TAASD).
▪ Asset management-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.
▪ The IT department establishes, maintains and updates an inventory that contains a listing of all organizational-owned TAASD, at a minimum covering common devices (e.g., laptops, workstations and servers).
Level 3 Well Defined
Asset Management (AST) 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 AST 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 AST domain capabilities are well-documented and kept current by process owners.
▪ An IT Asset Management (ITAM) team, or similar function, is appropriately staffed and supported to implement and maintain AST domain capabilities.
▪ Technology is leveraged to enhance the efficiency and accuracy of ITAM operations (e.g., ITAM platform, (e.g., Configuration Management Database (CMBD) Asset Management solution).
▪ 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 AST 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 categorize a system and/or service as "High Risk" if it poses a significant risk of harm to an individual's:
(1) Health;
(2) Safety; and/or
(3) Fundamental human rights.
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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High-Risk Technology Assets, Applications and/or Services (TAAS) Categorization
Description
Mechanisms exist to categorize Technology Assets, Applications and/or Services (TAAS) as "High Risk" if it poses a significant risk of harm to an individual's:
(1) Health;
(2) Safety; and/or
(3) Fundamental human rights.
Possible Solutions & Considerations
Micro-Small Business (<10 staff) / BLS Firm Size Classes 1-2
∙ Identify systems that could harm people if misused (e.g., safety devices, sensitive personal data)
Small Business (10-49 staff) / BLS Firm Size Classes 3-4
∙ High-risk categorization field in asset inventory
∙ Criteria for high-risk classification
Medium Business (50-249 staff) / BLS Firm Size Classes 5-6
∙ High-risk TAAS categorization in CMDB based on potential harm to individuals or society
∙ Enhanced controls for high-risk assets
Large Business (250-999 staff) / BLS Firm Size Classes 7-8
∙ Formal high-risk categorization criteria (e.g., aligned with EU AI Act, safety impact)
∙ Risk-based control baselines for high-risk TAAS
Enterprise (> 1,000 staff) / BLS Firm Size Class 9
∙ Enterprise high-risk asset categorization program integrated with risk management and regulatory obligations
∙ Enhanced assurance for high-risk TAAS
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
Asset Management (AST) 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 AST domain capabilities are formally documented and centrally-managed by the entity.
▪ Standardized Operating Procedures (SOP) associated with AST 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 AST domain capabilities to address applicable statutory, regulatory and/or contractual requirements for Technology Assets, Applications, Services and/or Data (TAASD).
▪ Asset management-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.
▪ The IT department establishes, maintains and updates an inventory that contains a listing of all organizational-owned TAASD, at a minimum covering common devices (e.g., laptops, workstations and servers).
Level 3 Well Defined
Asset Management (AST) 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 AST 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 AST domain capabilities are well-documented and kept current by process owners.
▪ An IT Asset Management (ITAM) team, or similar function, is appropriately staffed and supported to implement and maintain AST domain capabilities.
▪ Technology is leveraged to enhance the efficiency and accuracy of ITAM operations (e.g., ITAM platform, (e.g., Configuration Management Database (CMBD) Asset Management solution).
▪ 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 AST 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 categorize a system and/or service as "High Risk" if it poses a significant risk of harm to an individual's:
(1) Health;
(2) Safety; and/or
(3) Fundamental human rights.
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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