+7 straipsnis III priedo daliniai pakeitimai
---+7 straipsnis 1.
---+7 straipsnis 2.
---+7 straipsnis 3.
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7 straipsnis III priedo daliniai pakeitimai
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1. Apžvalga
| Pavadinimas |
Reguliavimas |
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7 straipsnis 1.
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Komisijai suteikiami įgaliojimai pagal 97 straipsnį priimti deleguotuosius aktus, kuriais iš dalies keičiamas III priedas įtraukiant arba pakeičiant didelės rizikos DI sistemų naudojimo atvejus, jei tenkinamos abi šios sąlygos:
a)
DI sistemos yra skirtos naudoti bet kurioje iš III priede išvardytų sričių;
b)
DI sistemos kelia riziką, susijusią su žala sveikatai ir saugai arba neigiamu poveikiu pagrindinėms teisėms, ir ta rizika yra lygiavertė III priede jau nurodytų didelės rizikos DI sistemų keliamai rizikai, susijusiai su žala ar neigiamu poveikiu, arba yra už ją didesnė.
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7 straipsnis 2.
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Vertindama 1 dalies b punkte pateiktą sąlygą, Komisija atsižvelgia į šiuos kriterijus:
a)
numatytąją DI sistemos paskirtį;
b)
kokiu mastu DI sistema buvo arba, tikėtina, bus naudojama;
c)
DI sistemos tvarkomų ir naudojamų duomenų pobūdį ir kiekį, visų pirma tai, ar tvarkomi specialių kategorijų asmens duomenys;
d)
kokiu mastu DI sistema veikia autonomiškai ir galimybę žmogui panaikinti sprendimą ar rekomendacijas, dėl kurių gali būti padaryta žala;
e)
kokiu mastu DI sistemos naudojimas jau padarė žalą sveikatai ir saugai arba neigiamą poveikį pagrindinėms teisėms arba sukėlė didelį susirūpinimą dėl tokios žalos ar neigiamo poveikio tikimybės, kaip matyti, pavyzdžiui, iš nacionalinėms kompetentingoms institucijoms pateiktų pranešimų arba dokumentais pagrįstų įtarimų, arba atitinkamai iš kitų pranešimų;
f)
galimą tokios žalos arba tokio neigiamo poveikio mastą, visų pirma atsižvelgiant į jų dydį ir galėjimą paveikti daugelį asmenų arba padaryti neproporcingą poveikį tam tikrai asmenų grupei;
g)
kiek asmenys, kuriems gali būti padaryta žala arba kurie gali nukentėti dėl neigiamo poveikio, priklauso nuo DI sistemos generuotų išvedinių, visų pirma todėl, kad dėl praktinių ar teisinių priežasčių tų išvedinių nėra pagrįstai įmanoma išvengti;
h)
kokiu mastu egzistuoja galios disbalansas arba kiek asmenys, kuriems gali būti padaryta žala arba kurie gali nukentėti dėl neigiamo poveikio, yra pažeidžiami DI sistemos diegėjo požiūriu, visų pirma dėl statuso, įgaliojimų, žinių, ekonominių ar socialinių aplinkybių arba amžiaus;
i)
kaip lengvai generuotus išvedinius, susijusius su DI sistema, galima ištaisyti ar atšaukti, atsižvelgiant į esamus techninius sprendimus tiems išvediniams ištaisyti ar atšaukti (išvediniai, darantys neigiamą poveikį sveikatai, saugai ar pagrindinėms teisėms, nėra laikomi lengvai ištaisomais ar atšaukiamais);
j)
naudos asmenims, grupėms ar plačiajai visuomenei, gaunamos įdiegus DI sistemą, įskaitant galimą gaminių saugos pagerinimą, dydį ir tikimybę;
k)
kiek esamuose Sąjungos teisės aktuose numatyta:
i)
veiksmingų teisių gynimo priemonių, susijusių su DI sistemos keliama rizika, išskyrus reikalavimus atlyginti žalą;
ii)
veiksmingų priemonių, kuriomis galima išvengti tokios rizikos arba ją iš esmės sumažinti.
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7 straipsnis 3.
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Komisijai suteikiami įgaliojimai pagal 97 straipsnį priimti deleguotuosius aktus, kuriais III priede pateikiamas sąrašas iš dalies pakeičiamas iš jo išbraukiant didelės rizikos DI sistemas, jei tenkinamos abi šios sąlygos:
a)
atitinkama didelės rizikos DI sistema nebekelia jokios didelės rizikos pagrindinėms teisėms, sveikatai ar saugai, atsižvelgiant į 2 dalyje išvardytus kriterijus;
b)
išbraukus tokią sistemą nesumažėja bendras sveikatos, saugos ir pagrindinių teisių apsaugos lygis pagal Sąjungos teisę.
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1.1 Nuorodos
1.2 Nustatyti reikalavimai
1.3 Susiję standartai
2. Nustatyti reikalavimai
Reikalavimai
| Šaltinis |
Reikalavimas |
3. Susiję standartai
Standartai
| Šaltinis |
Reikalavimas |
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SCF
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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.
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SCF
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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.
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