+Artikel 7 Ändringar av Bilaga III
---+Artikel 7 1.
---+Artikel 7 2.
---+Artikel 7 3.

Artikel 7 Ändringar av Bilaga III

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1. Översikt

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Artikel 7 1.

Kommissionen ges befogenhet att anta delegerade akter i enlighet med artikel 97 med avseende på att ändra bilaga III genom att lägga till eller ändra användningsfall för AI-system med hög risk om båda följande villkor är uppfyllda:

a) 

AI-systemen är avsedda att användas inom något av de områden som förtecknas i bilaga III.

b) 

AI-systemen utgör en risk för skada på hälsa och säkerhet, eller för negativ inverkan på grundläggande rättigheter, och denna risk är likvärdig med eller större än den risk för skada eller negativ inverkan som förorsakas av de AI-system med hög risk som redan anges i bilaga III.
Artikel 7 2.

Vid bedömningen av villkoret i punkt 1 b ska kommissionen beakta följande kriterier:

a) 

Det avsedda ändamålet med AI-systemet.

b) 

I vilken utsträckning ett AI-system har använts eller sannolikt kommer att användas.

c) 

Typen och mängden data som behandlas och används av AI-systemet, i synnerhet huruvida särskilda kategorier av personuppgifter behandlas.

d) 

I vilken utsträckning AI-systemet agerar självständigt och om det är möjligt för en människa att åsidosätta ett beslut eller rekommendationer som kan leda till potentiell skada.

e) 

I vilken utsträckning användningen av ett AI-system redan har orsakat skada på hälsa och säkerhet, har haft negativ inverkan på grundläggande rättigheter eller har gett upphov till betydande farhågor när det gäller sannolikheten för sådan skada eller negativ inverkan, vilket till exempel framgår av rapporter eller dokumenterade anklagelser som lämnats till nationella behöriga myndigheter, eller, i förekommande fall, av andra rapporter.

f) 

Den potentiella omfattningen av sådan skada eller sådan negativ inverkan, särskilt i fråga om intensitet och förmåga att påverka en stor mängd personer eller att i oproportionerlig utsträckning påverka en viss grupp av personer.

g) 

I vilken utsträckning potentiellt skadade eller negativt påverkade personer är beroende av det resultat som producerats med ett AI-system, särskilt till följd av att det av praktiska eller juridiska skäl inte rimligen är möjligt att undantas från detta resultat.

h) 

I vilken utsträckning det föreligger en obalans i fråga om makt, eller potentiellt skadade eller negativt påverkade personer befinner sig i ett utsatt läge i förhållande till tillhandahållaren av ett AI-system, särskilt på grund av status, auktoritet, kunskap, ekonomiska eller sociala omständigheter eller ålder.

i) 

I vilken utsträckning det resultat som produceras med medverkan av ett AI-system är lätt att korrigera eller upphäva, med beaktande av tillgängliga tekniska lösningar som möjliggör dess korrigering eller upphävande, varvid resultat med en negativ påverkan på hälsa, säkerhet eller grundläggande rättigheter inte ska anses vara lätta att korrigera eller upphäva.

j) 

Omfattningen av och sannolikheten för nyttan med införandet av AI-systemet för enskilda personer, grupper eller samhället i stort, inbegripet eventuella förbättringar av produktsäkerheten.

k) 

I vilken utsträckning befintlig unionsrätt föreskriver

i) 

effektiva åtgärder för rättslig prövning med hänsyn till de risker som ett AI-system medför, med undantag för skadeståndsanspråk,

ii) 

effektiva åtgärder för att förebygga eller avsevärt minimera dessa risker.
Artikel 7 3.

Kommissionen ges befogenhet att anta delegerade akter i enlighet med artikel 97 med avseende på att ändra förteckningen i bilaga III genom att låta AI-system med hög risk utgå om båda följande villkor är uppfyllda:

a) 

Det berörda AI-systemet medför inte längre någon betydande risk för grundläggande rättigheter, hälsa eller säkerhet, med beaktande av kriterierna i punkt 2.

b) 

Strykningen sänker inte den övergripande nivån på skyddet för hälsa, säkerhet och grundläggande rättigheter enligt unionsrätten.

1.1 Referenser

1.2 Identifierade krav

1.3 Relaterade standarder

2. Identifierade krav

Krav

3. Relaterade standarder

Standarder
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.
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.