+Artikel 7 Änderungen des Anhangs III
---+Article 7 1.
---+Article 7 2.
---+Article 7 3.
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Artikel 7 Änderungen des Anhangs III
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1. Übersicht
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Regulierung |
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Article 7 1.
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The Commission is empowered to adopt delegated acts in accordance with Article 97 to amend Annex III by adding or modifying use-cases of high-risk AI systems where both of the following conditions are fulfilled:
(a)
the AI systems are intended to be used in any of the areas listed in Annex III;
(b)
the AI systems pose a risk of harm to health and safety, or an adverse impact on fundamental rights, and that risk is equivalent to, or greater than, the risk of harm or of adverse impact posed by the high-risk AI systems already referred to in Annex III.
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Article 7 2.
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When assessing the condition under paragraph 1, point (b), the Commission shall take into account the following criteria:
(a)
the intended purpose of the AI system;
(b)
the extent to which an AI system has been used or is likely to be used;
(c)
the nature and amount of the data processed and used by the AI system, in particular whether special categories of personal data are processed;
(d)
the extent to which the AI system acts autonomously and the possibility for a human to override a decision or recommendations that may lead to potential harm;
(e)
the extent to which the use of an AI system has already caused harm to health and safety, has had an adverse impact on fundamental rights or has given rise to significant concerns in relation to the likelihood of such harm or adverse impact, as demonstrated, for example, by reports or documented allegations submitted to national competent authorities or by other reports, as appropriate;
(f)
the potential extent of such harm or such adverse impact, in particular in terms of its intensity and its ability to affect multiple persons or to disproportionately affect a particular group of persons;
(g)
the extent to which persons who are potentially harmed or suffer an adverse impact are dependent on the outcome produced with an AI system, in particular because for practical or legal reasons it is not reasonably possible to opt-out from that outcome;
(h)
the extent to which there is an imbalance of power, or the persons who are potentially harmed or suffer an adverse impact are in a vulnerable position in relation to the deployer of an AI system, in particular due to status, authority, knowledge, economic or social circumstances, or age;
(i)
the extent to which the outcome produced involving an AI system is easily corrigible or reversible, taking into account the technical solutions available to correct or reverse it, whereby outcomes having an adverse impact on health, safety or fundamental rights, shall not be considered to be easily corrigible or reversible;
(j)
the magnitude and likelihood of benefit of the deployment of the AI system for individuals, groups, or society at large, including possible improvements in product safety;
(k)
the extent to which existing Union law provides for:
(i)
effective measures of redress in relation to the risks posed by an AI system, with the exclusion of claims for damages;
(ii)
effective measures to prevent or substantially minimise those risks.
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Article 7 3.
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The Commission is empowered to adopt delegated acts in accordance with Article 97 to amend the list in Annex III by removing high-risk AI systems where both of the following conditions are fulfilled:
(a)
the high-risk AI system concerned no longer poses any significant risks to fundamental rights, health or safety, taking into account the criteria listed in paragraph 2;
(b)
the deletion does not decrease the overall level of protection of health, safety and fundamental rights under Union law.
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1.1 Referenzen
1.2 Identifizierte Anforderungen
1.3 Zugehörige Standards
2. Identifizierte Anforderungen
Anforderungen
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Anforderung |
3. Zugehörige Standards
Standards
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Anforderung |
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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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