+Artigo 7.o Alterações ao anexo III
---+Artigo 7.o 1.
---+Artigo 7.o 2.
---+Artigo 7.o 3.
|
Artigo 7.o Alterações ao anexo III
-
1. Visão geral
| Título |
Regulamentação |
|
Artigo 7.o 1.
|
A Comissão fica habilitada a adotar atos delegados nos termos do artigo 97.o para alterar o anexo III, aditando ou modificando casos de utilização de sistemas de IA de risco elevado sempre que estejam preenchidas ambas as seguintes condições:
a)
Os sistemas de IA destinam-se a ser utilizados em qualquer um dos domínios enumerados no anexo III;
b)
Os sistemas de IA representam um risco de danos para a saúde e a segurança ou de repercussões negativas nos direitos fundamentais, e esse risco é equivalente ou superior ao risco de danos ou repercussões negativas representado pelos sistemas de IA de risco elevado já referidos no anexo III.
|
|
Artigo 7.o 2.
|
Ao avaliar a condição prevista no n.o 1, alínea b), a Comissão tem em conta os seguintes critérios:
a)
A finalidade prevista do sistema de IA;
b)
O grau de utilização efetiva ou a probabilidade de utilização de um sistema de IA;
c)
A natureza e a quantidade dos dados tratados e utilizados pelo sistema de IA e, em particular, o facto de serem tratadas categorias especiais de dados pessoais;
d)
A medida em que o sistema de IA atua de forma autónoma e a possibilidade de um ser humano anular decisões ou recomendações que possam causar danos;
e)
A medida em que a utilização de um sistema de IA já tenha causado danos para a saúde e a segurança, tenha tido repercussões negativas nos direitos fundamentais ou tenha suscitado preocupações significativas quanto à probabilidade de esses danos ou essas repercussões negativas ocorrerem, conforme demonstrado, por exemplo, por relatórios ou alegações documentadas apresentados às autoridades nacionais competentes, ou por outros relatórios, consoante o caso;
f)
A potencial dimensão desses danos ou dessas repercussões negativas, nomeadamente em termos de intensidade e de capacidade para afetar várias pessoas, ou para afetar de forma desproporcionada um determinado grupo de pessoas;
g)
A medida em que as pessoas que sofreram potenciais danos ou repercussões negativas dependem dos resultados produzidos por um sistema de IA, em especial se, por razões práticas ou jurídicas, não lhes for razoavelmente possível autoexcluir-se desse resultado;
h)
A medida em que existe um desequilíbrio em termos de poder ou em que as pessoas que sofreram potenciais danos ou repercussões negativas se encontram numa posição vulnerável em relação ao responsável pela implantação de um sistema de IA, em particular por motivos relacionados com o estatuto, a autoridade, o conhecimento, as circunstâncias económicas ou sociais, ou a idade;
i)
A medida em que os resultados produzidos com o envolvimento de um sistema de IA são facilmente corrigíveis ou reversíveis, tendo em conta as soluções técnicas disponíveis para os corrigir ou reverter, sendo que os resultados com uma repercussão negativa na saúde, na segurança ou nos direitos fundamentais não podem ser considerados como facilmente corrigíveis ou reversíveis;
j)
A magnitude e a probabilidade dos benefícios da implantação do sistema de IA para as pessoas, os grupos ou a sociedade em geral, incluindo possíveis melhorias na segurança dos produtos;
k)
A medida em que o direito da União em vigor prevê:
i)
medidas de reparação eficazes em relação aos riscos representados por um sistema de IA, com exclusão de pedidos de indemnização,
ii)
medidas eficazes para prevenir ou minimizar substancialmente esses riscos.
|
|
Artigo 7.o 3.
|
A Comissão fica habilitada a adotar atos delegados nos termos do artigo 97.o para alterar a lista do anexo III suprimindo sistemas de IA de risco elevado sempre que estejam preenchidas ambas as seguintes condições:
a)
O sistema de IA de risco elevado em causa deixa de representar um risco significativo para os direitos fundamentais, a saúde ou a segurança, tendo em conta os critérios enumerados no n.o 2;
b)
A supressão não diminui o nível geral de proteção da saúde, da segurança e dos direitos fundamentais ao abrigo do direito da União.
|
,
1.1 Referências
1.2 Requisitos identificados
1.3 Normas relacionadas
2. Requisitos identificados
Requisitos
| Fonte |
Requisito |
3. Normas relacionadas
Normas
| Fonte |
Requisito |
|
SCF
|
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.
|
|
SCF
|
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.
|
|