+Članak 7. Izmjene Priloga III.
---+Članak 7. 1.
---+Članak 7. 2.
---+Članak 7. 3.

Članak 7. Izmjene Priloga III.

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1. Pregled

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Naslov Regulativa
Članak 7. 1.

Komisija je ovlaštena za donošenje delegiranih akata u skladu s člankom 97. radi izmjene Priloga III. dodavanjem ili prilagodbom slučajeva upotrebe visokorizičnih UI sustava ako su ispunjena oba sljedeća uvjeta:

(a) 

UI sustavi namijenjeni su za korištenje u bilo kojem od područja iz Priloga III.;

(b) 

UI sustavi predstavljaju rizik od štete za zdravlje i sigurnost ili rizik od nepovoljnog utjecaja na temeljna prava, a taj je rizik jednakovrijedan riziku ili veći od rizika od štete ili nepovoljnog utjecaja koji predstavljaju visokorizični UI sustavi već navedeni u Prilogu III.

Članak 7. 2.

Pri procjeni uvjeta iz stavka 1. točke (b) Komisija uzima u obzir sljedeće kriterije:

(a) 

namjenu UI sustava;

(b) 

stupanj u kojem se UI sustav upotrebljava ili će se vjerojatno upotrebljavati;

(c) 

prirodu i količinu podataka koje obrađuje i upotrebljava UI sustav, a posebice obrađuju li se posebne kategorije osobnih podataka;

(d) 

stupanj u kojem UI sustav djeluje autonomno i mogućnost da čovjek nadjača odluku ili preporuke koje bi mogle prouzročiti štetu;

(e) 

stupanj u kojem je upotreba UI sustava već prouzročila štetu za zdravlje ili sigurnost ili imala nepovoljan utjecaj na temeljna prava ili izazvala ozbiljnu zabrinutost da bi mogla prouzročiti takvu štetu ili nepovoljan utjecaj, kako je, primjerice, potvrđeno u izvješćima ili dokumentiranim navodima koji su podneseni nacionalnim nadležnim tijelima ili u drugim izvješćima, ovisno o slučaju;

(f) 

potencijalne razmjere takve štete ili takvog nepovoljnog utjecaja, osobito u smislu intenziteta i mogućnosti da pogodi više osoba ili da nerazmjerno pogodi određenu skupinu osoba;

(g) 

stupanj u kojem potencijalno oštećene osobe ili osobe izložene nepovoljnom utjecaju ovise o ishodu upotrebe UI sustava, osobito ako taj ishod nije razumno moguće ne prihvatiti zbog praktičnih ili pravnih razloga;

(h) 

stupanj u kojem postoji neravnoteža moći ili su potencijalno oštećene osobe ili osobe izložene nepovoljnom utjecaju u ranjivu položaju u odnosu na subjekt koji uvodi UI sustav, osobito zbog statusa, autoriteta, znanja, ekonomskih ili socijalnih okolnosti ili dobi;

(i) 

stupanj u kojem je ishod nastao upotrebom UI sustava lako ispravljiv ili poništiv, uzimajući u obzir tehnička rješenja dostupna za njegovo ispravljanje ili poništenje, pri čemu se smatra da ishodi koji nepovoljno utječu na zdravlje, sigurnost ili temeljna prava nisu lako ispravljivi ili poništivi;

(j) 

razmjer i vjerojatnost koristi od uvođenja UI sustava za pojedince, skupine ili društvo u cjelini, uključujući moguća poboljšanja sigurnosti proizvoda;

(k) 

stupanj u kojem se postojećim pravom Unije predviđaju:

i. 

djelotvorne mjere pravne zaštite od rizika koji predstavlja UI sustav, uz iznimku zahtjevâ za naknadu štete;

ii. 

djelotvorne mjere za sprečavanje ili što veće smanjenje tih rizika.

Članak 7. 3.

Komisija je ovlaštena za donošenje delegiranih akata u skladu s člankom 97. radi izmjene popisa iz Priloga III. uklanjanjem visokorizičnih UI sustava ako su ispunjena oba sljedeća uvjeta:

(a) 

dotični visokorizični UI sustav više ne predstavlja znatan rizik za temeljna prava, zdravlje ili sigurnost, uzimajući u obzir kriterije navedene u stavku 2.;

(b) 

brisanjem se ne smanjuje ukupna razina zaštite zdravlja, sigurnosti i temeljnih prava na temelju prava Unije.

1.1 Reference

1.2 Utvrđeni zahtjevi

1.3 Povezani standardi

2. Utvrđeni zahtjevi

Zahtjevi
Izvor Zahtjev

3. Povezani standardi

Standardi
Izvor Zahtjev
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.