+Člen 7 Spremembe Priloge III
---+Člen 7 1.
---+Člen 7 2.
---+Člen 7 3.
|
Člen 7 Spremembe Priloge III
-
1. Pregled
| Naslov |
Regulativa |
|
Člen 7 1.
|
Na Komisijo se prenese pooblastilo za sprejemanje delegiranih aktov v skladu s členom 97 za spremembo Priloge III z dodajanjem primerov uporabe visokotveganih sistemov UI ali spreminjanjem njihove uporabe, kadar sta izpolnjena oba naslednja pogoja:
(a)
sistemi UI so namenjeni uporabi na katerem koli področju iz Priloge III;
(b)
sistemi UI predstavljajo tveganje škode za zdravje in varnost ali škodljivega vpliva na temeljne pravice in to tveganje je enakovredno ali večje od tveganja škode ali škodljivega vpliva visokotveganih sistemov UI, ki so že navedeni v Prilogi III.
|
|
Člen 7 2.
|
Komisija pri ocenjevanju pogoja iz odstavka 1, točka (b), upošteva naslednja merila:
(a)
predvideni namen sistema UI;
(b)
obseg, v katerem se sistem UI uporablja ali se bo verjetno uporabljal;
(c)
naravo in količino podatkov, ki se obdelujejo in uporabljajo v sistemu UI, in zlasti to, ali se obdelujejo posebne vrste osebnih podatkov;
(d)
obseg, v katerem sistem UI deluje samostojno, in možnost, da človek razveljavi odločitev ali priporočila, ki bi lahko povzročila morebitno škodo;
(e)
obseg, v katerem je uporaba sistema UI že povzročila škodo za zdravje in varnost, negativno vplivala na temeljne pravice ali povzročila resno zaskrbljenost v zvezi z verjetnostjo take škode ali škodljivega vpliva, kot je razvidno na primer iz poročil ali dokumentiranih trditev, predloženih pristojnim nacionalnim organom, ali drugih poročil, kot je ustrezno;
(f)
morebitni obseg take škode ali takega škodljivega vpliva, zlasti v smislu njune intenzivnosti in zmožnosti, da vplivata na več oseb ali nesorazmerno vplivata na določeno skupino ljudi;
(g)
obseg, v katerem so potencialno oškodovane osebe ali osebe, ki bi lahko trpele zaradi škodljivega vpliva, odvisne od izida, ustvarjenega s sistemom UI, zlasti ker iz praktičnih ali pravnih razlogov ni mogoče razumno odstopiti od tega izida;
(h)
obseg, v katerem obstaja neravnovesje moči ali v katerem so potencialno oškodovane osebe ali osebe, ki bi lahko trpele zaradi škodljivega vpliva, v ranljivem položaju v odnosu do uvajalca sistema UI, zlasti zaradi statusa, avtoritete, znanja, ekonomskih ali socialnih okoliščin ali starosti;
(i)
obseg, v katerem je rezultat, ki vključuje sistem UI, zlahka popravljiv ali izničljiv, ob upoštevanju razpoložljivih tehničnih rešitev za njegovo popravljanje ali izničenje, pri čemer rezultati, ki škodljivo vplivajo na zdravje, varnost ali temeljne pravice, ne štejejo za zlahka popravljive ali izničljive;
(j)
razsežnost in verjetnost, da bo uvedba sistema UI koristila posameznikom, skupinam ali družbi na splošno, vključno z možnimi izboljšavami glede varnosti proizvodov;
(k)
obseg, v katerem so v obstoječem pravu Unije določeni:
(i)
učinkoviti ukrepi sodnega varstva v zvezi s tveganji, ki jih predstavlja sistem UI, razen odškodninskih zahtevkov;
(ii)
učinkoviti ukrepi za preprečevanje ali bistveno zmanjšanje teh tveganj.
|
|
Člen 7 3.
|
Na Komisijo se prenese pooblastilo za sprejemanje delegiranih aktov v skladu s členom 97 za spremembo seznama iz Priloge III z umikom visokotveganih sistemov UI, kadar sta izpolnjena oba naslednja pogoja:
(a)
zadevni visokotvegani sistem UI ob upoštevanju meril iz odstavka 2 ne predstavlja več večjih tveganj za temeljne pravice, zdravje ali varnost;
(b)
črtanje ne zmanjšuje splošne ravni varovanja zdravja, varnosti in temeljnih pravic na podlagi prava Unije.
|
,
1.1 Sklici
1.2 Ugotovljene zahteve
1.3 Povezani standardi
2. Ugotovljene zahteve
3. Povezani standardi
Standardi
| Vir |
Zahteva |
|
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.
|
|