+Článek 80 Postup nakládání se systémy AI, které nejsou při použití přílohy III poskytovatelem klasifikovány jako vysoce rizikové
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Článek 80 Postup nakládání se systémy AI, které nejsou při použití přílohy III poskytovatelem klasifikovány jako vysoce rizikové
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1. Přehled
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Regulace |
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Článek 80 1.
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Pokud má orgán dozoru nad trhem dostatečný důvod se domnívat, že systém AI klasifikovaný poskytovatelem jako nikoliv vysoce rizikový podle čl. 6 odst. 3 ve skutečnosti vysoce rizikový je, provede hodnocení dotčeného systému AI ohledně jeho klasifikace jako vysoce rizikového systému AI, a to na základě podmínek stanovených v čl. 6 odst. 3 a v pokynech Komise.
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Článek 80 2.
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Pokud v průběhu tohoto hodnocení orgán dozoru nad trhem zjistí, že dotčený systém AI vysoce rizikový je, vyzve bez zbytečného odkladu příslušného poskytovatele, aby přijal veškerá nezbytná opatření k uvedení systému AI do souladu s požadavky a povinnostmi stanovenými v tomto nařízení a aby ve lhůtě, kterou může orgán dozoru nad trhem stanovit, přijal vhodná nápravná opatření.
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Článek 80 3.
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Domnívá-li se orgán dozoru nad trhem, že použití dotčeného systému AI není omezeno pouze na území jeho členského státu, informuje o výsledcích hodnocení a o opatřeních, která má poskytovatel na jeho žádost přijmout, neprodleně Komisi a ostatní členské státy.
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Článek 80 4.
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Poskytovatel zajistí, aby byla přijata veškerá nezbytná opatření k uvedení dotyčného systému AI do souladu s požadavky a povinnostmi stanovenými v tomto nařízení. Pokud dotčený poskytovatel systému AI neuvede systém AI do souladu s těmito požadavky a povinnostmi ve lhůtě uvedené v odstavci 2 tohoto článku, uloží se mu pokuty v souladu s článkem 99.
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Článek 80 5.
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Poskytovatel zajistí, aby byla přijata veškerá vhodná nápravná opatření ohledně všech dotčených systémů AI, které dodal na trh v Unii.
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Článek 80 6.
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Pokud poskytovatel dotčeného systému AI ve lhůtě uvedené v odstavci 2 tohoto článku přiměřená nápravná opatření nepřijme, použije se čl. 79 odst. 5 až 9.
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Článek 80 7.
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Pokud v průběhu hodnocení podle odstavce 1 tohoto článku orgán dozoru nad trhem zjistí, že poskytovatel daný systém AI nesprávně klasifikoval jako nikoliv vysoce rizikový s cílem obejít uplatňování požadavků uvedených v kapitole III oddíle 2, uloží se poskytovateli pokuty v souladu s článkem 99.
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Článek 80 8.
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Při výkonu své pravomoci monitorovat uplatňování tohoto článku a v souladu s článkem 11 nařízení (EU) 2019/1020 mohou orgány dozoru nad trhem provádět vhodné kontroly, zejména s přihlédnutím k informacím uloženým v databázi EU uvedené v článku 71 tohoto nařízení.
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1.1 Odkazy
1.2 Identifikované požadavky
1.3 Související standardy
2. Identifikované požadavky
Požadavky
| Zdroj |
Požadavek |
3. Související standardy
Standardy
| Zdroj |
Požadavek |
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SCF
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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.
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SCF
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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.
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