+6. pants Noteikumi klasificēšanai par augsta riska MI sistēmām
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---+Article 6 1a.
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6. pants Noteikumi klasificēšanai par augsta riska MI sistēmām

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1. Pārskats

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6. pants 1.

Neatkarīgi no tā, vai MI sistēmu laiž tirgū vai nodod ekspluatācijā neatkarīgi no a) un b) apakšpunktā minētajiem produktiem, minēto MI sistēmu uzskata par augsta riska sistēmu, ja ir izpildīti abi šie nosacījumi:

a) 

MI sistēmu paredzēts izmantot kā produkta drošības sastāvdaļu, vai MI sistēma pati par sevi ir produkts, uz kuru attiecas Savienības saskaņošanas tiesību akti, kas uzskaitīti I pielikumā;

b) 

produktam, kura drošības sastāvdaļa, ievērojot a) apakšpunktu, ir MI sistēma, vai pašai MI sistēmai kā produktam ir vajadzīgs trešās personas veikts atbilstības novērtējums, lai to varētu laist tirgū vai nodot ekspluatācijā saskaņā ar Savienības saskaņošanas tiesību aktiem, kas uzskaitīti I pielikumā.
Article 6 1a.
For the purposes of this Regulation, including paragraph 1 of this Article, AI systems that are solely used for non-safety related aspects of user assistance, performance optimisation, service efficiency, automation or convenience or quality control shall not qualify as safety components.
Article 6 1b.
Notwithstanding paragraph 1a, AI systems the failure or malfunctioning of which would endanger health and safety shall qualify as safety components.
Article 6 1c.
A product that is required to undergo a third-party conformity assessment solely due to risks other than risks to health and safety, in particular risks relating to the distribution of radio spectrum or electromagnetic interference that do not affect health and safety, shall not be considered as fulfilling the condition in paragraph 1, point (b).
6. pants 2.
Papildus 1. punktā minētajām augsta riska MI sistēmām par augsta riska sistēmām uzskata III pielikumā minētās MI sistēmas.
6. pants 3.
Atkāpjoties no 2. punkta, III pielikumā minēto MI sistēmu neuzskata par augsta riska sistēmu, ja tā nerada būtisku kaitējuma risku fizisku personu veselībai, drošībai vai pamattiesībām, tostarp būtiski neietekmē lēmumu pieņemšanas iznākumu.

Pirmo daļu piemēro, ja ir izpildīts jebkurš no šādiem nosacījumiem:

a) 

MI sistēma ir paredzēta šaura procedūras uzdevuma veikšanai;

b) 

MI sistēma ir paredzēta iepriekš pabeigtas cilvēka darbības rezultāta uzlabošanai;

c) 

MI sistēma ir paredzēta lēmumu pieņemšanas modeļu vai noviržu no iepriekšējiem lēmumu pieņemšanas modeļiem atklāšanai, un tā nav paredzēta, lai aizstātu vai ietekmētu iepriekš pabeigtu cilvēka veiktu novērtējumu, bez pienācīgas cilvēka veiktas pārskatīšanas; vai

d) 

MI sistēma ir paredzēta sagatavošanās uzdevuma veikšanai saistībā ar novērtējumu, kas ir būtisks III pielikumā uzskaitīto lietošanas gadījumu nolūkos.

Neatkarīgi no pirmās daļas III pielikumā minētu MI sistēmu vienmēr uzskata par augsta riska MI sistēmu, ja MI sistēma veic fizisku personu profilēšanu.
6. pants 4.
Nodrošinātājs, kas uzskata, ka III pielikumā minēta MI sistēma nav augsta riska sistēma, dokumentē tās novērtējumu pirms minētā sistēma tiek laista tirgū vai nodota ekspluatācijā. Uz šādu nodrošinātāju attiecas 49. panta 2. punktā paredzētais reģistrācijas pienākums. Pēc valsts kompetento iestāžu pieprasījuma nodrošinātājs uzrāda novērtējuma dokumentāciju.
6. pants 5.
Komisija pēc apspriešanās ar Eiropas Mākslīgā intelekta padomi (MI padomi) un ne vēlāk kā 2026. gada 2. februārī sniedz pamatnostādnes, kurās precizē šā panta praktisko īstenošanu saskaņā ar 96. pantu, kopā ar izsmeļošu sarakstu ar praktiskiem piemēriem par MI sistēmu, kuras ir augsta riska MI sistēmas, un to, kuras nav augsta riska MI sistēmas, lietošanas gadījumiem.
6. pants 6.
Komisija tiek pilnvarota pieņemt deleģētos aktus saskaņā ar 97. pantu, lai grozītu šā panta 3. punkta otro daļu, lai pievienotu jaunus nosacījumus tajā noteiktajiem nosacījumiem, vai grozītu tos, ja ir konkrēti un ticami pierādījumi, ka ir MI sistēmas, kas ietilpst III pielikuma tvērumā, bet nerada būtisku kaitējuma risku fizisku personu veselībai, drošībai vai pamattiesībām.
6. pants 7.
Komisija pieņem deleģētos aktus saskaņā ar 97. pantu, lai grozītu 3. punkta otro daļu, lai svītrotu jebkuru no tajā noteiktajiem nosacījumiem, ja ir konkrēti un ticami pierādījumi, ka tas ir vajadzīgs, lai uzturētu veselības, drošības un pamattiesību aizsardzības līmeni, ko paredz šī regula.
6. pants 8.
Neviens 3. punkta otrajā daļā paredzētais nosacījumu grozījums, kas pieņemts saskaņā ar šā panta 6. un 7. punktu, nemazina veselības, drošības un pamattiesību aizsardzības vispārējo līmeni, ko paredz šī regula un tas nodrošina saskanību ar deleģētajiem aktiem, kas pieņemti, ievērojot 7. panta 1. punktu, un ņem vērā tirgus norises un tehnoloģiju attīstību.

1.1 Atsauces

1.2 Identificētās prasības

1.3 Saistītie standarti

2. Identificētās prasības

Prasības

3. Saistītie standarti

Standarti
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 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.