+Člen 12 Visokotvegani sistemi UI
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Člen 12 Visokotvegani sistemi UI

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1. Pregled

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Člen 12 1.

Brez poseganja v zahteve v zvezi s točnostjo in robustnostjo iz člena 15 Uredbe (EU) 2024/1689 se za izdelke z digitalnimi elementi, ki spadajo na področje uporabe te uredbe in so razvrščeni kot visokotvegani sistemi UI na podlagi člena 6 navedene uredbe šteje, da so skladni z zahtevami v zvezi s kibernetsko varnostjo iz člena 15 navedene uredbe, kadar:

(a) 

ti izdelki izpolnjujejo bistvene zahteve glede kibernetske varnosti iz dela I Priloge I;

(b) 

so procesi, ki jih je vzpostavil proizvajalec, skladni z bistvenimi zahtevami glede kibernetske varnosti iz dela II Priloge I ter

(c) 

se uresničitev ravni kibernetske zaščite, ki se zahteva na podlagi člena 15 Uredbe (EU) 2024/1689, izkaže v EU izjavi o skladnosti, izdani na podlagi te uredbe.
Člen 12 2.
Za izdelke z digitalnimi elementi in zahteve glede kibernetske varnosti iz odstavka 1 tega člena se uporablja ustrezni postopek ugotavljanja skladnosti, kot je določen v členu 43 Uredbe (EU) 2024/1689. Za namene tega ugotavljanja so priglašeni organi, ki so pristojni za nadzorovanje skladnosti visokotveganih sistemov UI na podlagi Uredbe (EU) 2024/1689, tudi pristojni za nadzorovanje skladnosti visokotveganih sistemov UI, ki spadajo na področje uporabe te uredbe, z zahtevami iz Priloge I k tej uredbi, če je bila skladnost teh priglašenih organov z zahtevami iz člena 39 te uredbe ocenjena v okviru postopka priglasitve na podlagi Uredbe (EU) 2024/1689.
Člen 12 3.
Z odstopanjem od odstavka 2 tega člena se za pomembne izdelke z digitalnimi elementi iz Priloge III k tej uredbi, za katere veljajo postopki ugotavljanja skladnosti iz člena 32(2), točki (a) in (b), ter člena 32(3) te uredbe, in kritične izdelke z digitalnimi elementi iz Priloge IV k tej uredbi, za katere je treba pridobiti evropski certifikat kibernetske varnosti na podlagi člena 8(1) te uredbe ali, v odsotnosti tega, za katere je treba uporabljati postopke ugotavljanja skladnosti iz člena 32(3) te uredbe ter ki so razvrščeni kot visoko tvegani sistemi UI na podlagi člena 6 Uredbe (EU) 2024/1689, za katere se uporablja postopek ugotavljanja skladnosti na podlagi notranje kontrole iz Priloge VI k Uredbi (EU) 2024/1689, v zvezi z bistvenimi zahtevami glede kibernetske varnosti iz te uredbe uporabljajo postopki ugotavljanja skladnosti, določeni v tej uredbi.
Člen 12 4.
Proizvajalci izdelkov z digitalnimi elementi iz odstavka 1 tega člena lahko sodelujejo v regulativnih peskovnikih za UI iz člena 57 Uredbe (EU) 2024/1689.

1.1 Sklici

1.2 Ugotovljene zahteve

1.3 Povezani standardi

2. Ugotovljene zahteve

Zahteve

3. Povezani standardi

Standardi
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 Statutory, Regulatory & Contractual Compliance

Description

Mechanisms exist to facilitate the identification and implementation of relevant statutory, regulatory and contractual controls.

Possible Solutions & Considerations

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

∙ SCF Security, Compliance & Resilience Management System (SCRMS)
∙ Governance, Risk and Compliance (GRC) solution (e.g., SCFConnect, SureCloud, Ostendio, SimpleRisk, Ignyte, ZenGRC, Galvanize, MetricStream, Archer, etc.)

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

∙ SCF Security, Compliance & Resilience Management System (SCRMS)
∙ Governance, Risk and Compliance (GRC) solution (e.g., SCFConnect, SureCloud, Ostendio, SimpleRisk, Ignyte, ZenGRC, Galvanize, MetricStream, Archer, etc.)

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

∙ SCF Security, Compliance & Resilience Management System (SCRMS)
∙ Governance, Risk and Compliance (GRC) solution (e.g., SCFConnect, SureCloud, Ostendio, SimpleRisk, Ignyte, ZenGRC, Galvanize, MetricStream, Archer, etc.)
∙ Steering committee

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

∙ SCF Security, Compliance & Resilience Management System (SCRMS)
∙ GRC solution (e.g., SCFConnect, Cyturus, SureCloud, SimpleRisk, Ignyte, ZenGRC, Galvanize, MetricStream, Archer, etc.)
∙ Steering committee

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

∙ SCF Security, Compliance & Resilience Management System (SCRMS)
∙ GRC solution (e.g., SCFConnect, Cyturus, SureCloud, SimpleRisk, Ignyte, ZenGRC, Galvanize, MetricStream, Archer, etc.)
∙ Steering committee

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

Compliance (CPL) domain capabilities are ad hoc and inconsistent. Capability criteria associated with this control may include:
▪ Policies, standards & procedures associated with CPL domain capabilities provide limited coverage due to the depth and breadth of the existing documentation.
▪ Compliance management-related activities are decentralized (e.g., a localized/regionalized function) and uses non-standardized methods to implement secure, resilient and compliant practices.
▪ Compliance efforts are narrowly-limited to certain compliance requirements.
▪ IT and/or cybersecurity personnel use an informal process to govern statutory, regulatory and contractual compliance obligations.

Level 2 Planned Tracked

Compliance (CPL) 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 CPL domain capabilities are formally documented and centrally-managed by the entity.
▪ Standardized Operating Procedures (SOP) associated with CPL 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 CPL domain capabilities to address applicable statutory, regulatory and/or contractual requirements for Technology Assets, Applications, Services and/or Data (TAASD).
▪ Compliance management controls-related controls are primarily administrative and preventative in nature (e.g., policies, standards and procedures & guidelines).
▪ Compliance management may be a defined function (e.g., team or department) or assigned as an additional duty to existing IT and/or cybersecurity personnel.
▪ External compliance requirements for cybersecurity and data privacy are identified and documented, based on applicable laws, regulations and contractual obligations.
▪ IT and/or cybersecurity perform an informal annual review of existing compliance requirements and research evolving or new requirements.

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 facilitate the identification and implementation of relevant statutory, regulatory and contractual controls.

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 Conformity Assessment

Description

Mechanisms exist to conduct assessments to demonstrate security, compliance and/or resilience capability conformity with applicable cybersecurity and data protection laws, regulations and/or contractual obligations.

Possible Solutions & Considerations

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

∙ Document applicable regulatory requirements in a checklist

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

∙ Compliance checklist
∙ Annual compliance review

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

∙ Compliance management program
∙ Regulatory mapping
∙ Compliance calendar

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

∙ GRC solution (e.g., SCFConnect, Cyturus, SureCloud, SimpleRisk, Ignyte, ZenGRC, Galvanize, MetricStream, Archer, etc.)
∙ Compliance team

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

∙ GRC solution (e.g., SCFConnect, Cyturus, SureCloud, SimpleRisk, Ignyte, ZenGRC, Galvanize, MetricStream, Archer, etc.)
∙ Dedicated compliance team
∙ Automated compliance monitoring

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

Compliance (CPL) 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 CPL domain capabilities are formally documented and centrally-managed by the entity.
▪ Standardized Operating Procedures (SOP) associated with CPL 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 CPL domain capabilities to address applicable statutory, regulatory and/or contractual requirements for Technology Assets, Applications, Services and/or Data (TAASD).
▪ Compliance management controls-related controls are primarily administrative and preventative in nature (e.g., policies, standards and procedures & guidelines).
▪ Compliance management may be a defined function (e.g., team or department) or assigned as an additional duty to existing IT and/or cybersecurity personnel.
▪ External compliance requirements for cybersecurity and data privacy are identified and documented, based on applicable laws, regulations and contractual obligations.
▪ IT and/or cybersecurity personnel work with business stakeholders and process owners to assigned cybersecurity and/or data protection controls to comply with specific compliance requirements.

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 conduct assessments to demonstrate security, compliance and/or resilience capability conformity with applicable cybersecurity and data protection laws, regulations and/or contractual obligations.

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 Declaration of Conformity

Description

Mechanisms exist to generate a declaration of conformity for each conformity assessment, where the document:
(1) Is concise;
(2) Unambiguously reflects the current status;
(3) Is physically or electronically signed; and
(4) Where possible, is machine readable.

Possible Solutions & Considerations

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

∙ Document applicable regulatory requirements in a checklist

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

∙ Compliance checklist
∙ Annual compliance review

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

∙ Compliance management program
∙ Regulatory mapping
∙ Compliance calendar

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

∙ GRC solution (e.g., SCFConnect, Cyturus, SureCloud, SimpleRisk, Ignyte, ZenGRC, Galvanize, MetricStream, Archer, etc.)
∙ Compliance team

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

∙ GRC solution (e.g., SCFConnect, Cyturus, SureCloud, SimpleRisk, Ignyte, ZenGRC, Galvanize, MetricStream, Archer, etc.)
∙ Dedicated compliance team
∙ Automated compliance monitoring

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

Compliance (CPL) 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 CPL domain capabilities are formally documented and centrally-managed by the entity.
▪ Standardized Operating Procedures (SOP) associated with CPL 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 CPL domain capabilities to address applicable statutory, regulatory and/or contractual requirements for Technology Assets, Applications, Services and/or Data (TAASD).
▪ Compliance management controls-related controls are primarily administrative and preventative in nature (e.g., policies, standards and procedures & guidelines).
▪ Compliance management may be a defined function (e.g., team or department) or assigned as an additional duty to existing IT and/or cybersecurity personnel.
▪ External compliance requirements for cybersecurity and data privacy are identified and documented, based on applicable laws, regulations and contractual obligations.
▪ A formal report is generated for each security assessment/audit with sufficient details to understand the organization's ability to demonstrate conformity with its requirements.

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 generate a declaration of conformity for each conformity assessment, where the document:
(1) Is concise;
(2) Unambiguously reflects the current status;
(3) Is physically or electronically signed; and
(4) Where possible, is machine readable.

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.