+Articolo 80 Procedura per i sistemi di IA classificati dal fornitore come non ad alto rischio in applicazione dell'allegato III
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Articolo 80 Procedura per i sistemi di IA classificati dal fornitore come non ad alto rischio in applicazione dell'allegato III

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1. Panoramica

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Articolo 80 1.
Se ha motivi sufficienti per ritenere che un sistema di IA classificato dal fornitore come non ad alto rischio a norma dell'articolo 6, paragrafo 3, sia in realtà ad alto rischio, l'autorità di vigilanza del mercato effettua una valutazione del sistema di IA interessato in relazione alla sua classificazione come sistema di IA ad alto rischio sulla base delle condizioni di cui all'articolo 6, paragrafo 3, e degli orientamenti della Commissione.
Articolo 80 2.
Se, nel corso di tale valutazione, ritiene che il sistema di IA interessato sia ad alto rischio, l'autorità di vigilanza del mercato chiede senza indebito ritardo al fornitore pertinente di adottare tutte le misure necessarie per rendere il sistema di IA conforme ai requisiti e agli obblighi di cui al presente regolamento, nonché di adottare le opportune misure correttive entro un termine che l'autorità di vigilanza del mercato può prescrivere.
Articolo 80 3.
Se ritiene che l'uso del sistema di IA interessato non sia limitato al territorio nazionale, l'autorità di vigilanza del mercato informa la Commissione e gli altri Stati membri senza indebito ritardo dei risultati della valutazione e delle misure che ha chiesto al fornitore di adottare.
Articolo 80 4.
Il fornitore garantisce che siano adottate tutte le misure necessarie per rendere il sistema di IA conforme ai requisiti e agli obblighi di cui al presente regolamento. Qualora il fornitore di un sistema di IA interessato non renda il sistema di IA conforme a tali requisiti e obblighi entro il termine di cui al paragrafo 2 del presente articolo, il fornitore è soggetto a sanzioni pecuniarie conformemente all'articolo 99.
Articolo 80 5.
Il fornitore garantisce che siano adottate tutte le opportune misure correttive nei confronti di tutti i sistemi di IA interessati che ha messo a disposizione sul mercato dell'Unione.
Articolo 80 6.
Se il fornitore del sistema di IA in questione non adotta misure correttive adeguate entro il periodo di cui al paragrafo 2 del presente articolo, si applica l'articolo 79, paragrafi da 5 a 9.
Articolo 80 7.
Qualora, nel corso della valutazione di cui al paragrafo 1 del presente articolo, l'autorità di vigilanza del mercato stabilisca che il sistema di IA è stato classificato erroneamente dal fornitore come non ad alto rischio al fine di eludere l'applicazione dei requisiti di cui al capo III, sezione 2, il fornitore è soggetto a sanzioni pecuniarie conformemente all'articolo 99.
Articolo 80 8.
Nell'esercizio del loro potere di monitorare l'applicazione del presente articolo e in conformità dell'articolo 11 del regolamento (UE) 2019/1020, le autorità di vigilanza del mercato possono eseguire i controlli del caso, tenendo conto in particolare delle informazioni conservate nella banca dati dell'UE di cui all'articolo 71 del presente regolamento.

1.1 Riferimenti

1.2 Requisiti identificati

1.3 Standard correlati

2. Requisiti identificati

Requisiti

3. Standard correlati

Standard
SCF Non-Conformity Corrective Action

Description

Mechanisms exist to implement corrective action to remediate instances of non-conformity with applicable statutory, regulatory, and/or contractual compliance obligations.

Possible Solutions & Considerations

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

∙ Corrective action log (spreadsheet)
∙ Documented remediation plans for audit findings

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

∙ Corrective action register with remediation tracking
∙ Management review of open findings

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

∙ Formal corrective action plan process
∙ GRC platform for finding tracking and remediation
∙ Management review of open findings

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

∙ Enterprise corrective action management program
∙ GRC platform with workflow-driven remediation tracking
∙ Executive reporting on open findings

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

∙ Enterprise GRC platform for corrective action management
∙ Automated finding tracking and escalation workflows
∙ Board-level reporting on material findings

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.

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 take corrective action to remediate instances of non-conformity with applicable statutory, regulatory, and/or contractual compliance 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 Non-Conformity Corrective Action

Description

Mechanisms exist to implement corrective action to remediate instances of non-conformity with applicable statutory, regulatory, and/or contractual compliance obligations.

Possible Solutions & Considerations

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

∙ Corrective action log (spreadsheet)
∙ Documented remediation plans for audit findings

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

∙ Corrective action register with remediation tracking
∙ Management review of open findings

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

∙ Formal corrective action plan process
∙ GRC platform for finding tracking and remediation
∙ Management review of open findings

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

∙ Enterprise corrective action management program
∙ GRC platform with workflow-driven remediation tracking
∙ Executive reporting on open findings

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

∙ Enterprise GRC platform for corrective action management
∙ Automated finding tracking and escalation workflows
∙ Board-level reporting on material findings

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.

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 take corrective action to remediate instances of non-conformity with applicable statutory, regulatory, and/or contractual compliance 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.