+Artikolu 6 Regoli ta' klassifikazzjoni għas-sistemi tal-IA b'riskju għoli
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Artikolu 6 Regoli ta' klassifikazzjoni għas-sistemi tal-IA b'riskju għoli
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1. Ħarsa ġenerali
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Regolamentazzjoni |
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Artikolu 6 1.
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Irrispettivament minn jekk sistema tal-IA tiġix introdotta fis-suq jew imqiegħda fis-servizz b'mod indipendenti mill-prodotti msemmija fil-punti (a) u (b), dik is-sistema tal-IA għandha titqies bħala riskju għoli jekk tkun tissodisfa ż-żewġ kundizzjonijiet li ġejjin:
(a)
is-sistema tal-IA hija maħsuba biex tintuża bħala komponent tas-sikurezza ta' prodott, jew is-sistema tal-IA tkun hi stess prodott, kopert bil-leġiżlazzjoni tal-Unjoni dwar l-armonizzazzjoni elenkata fl-Anness I;
(b)
il-prodott li l-komponent tas-sikurezza tiegħu skont il-punt (a) huwa s-sistema tal-IA, jew is-sistema tal-IA hi stess bħala prodott, jeħtieġ issirlu valutazzjoni tal-konformità minn parti terza, bil-ħsieb li dak il-prodott jiġi introdott fis-suq jew imqiegħed fis-servizz skont il-leġiżlazzjoni tal-Unjoni dwar l-armonizzazzjoni elenkata fl-Anness I.
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Artikolu 6 1a.
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Għall-finijiet ta’ dan ir-Regolament, inkluż il-paragrafu 1 ta’ dan l-Artikolu, is-sistemi tal-IA li jintużaw biss għal aspetti mhux relatati mas-sikurezza tal-assistenza lill-utenti, l-ottimizzazzjoni tal-prestazzjoni, l-effiċjenza tas-servizz, l-awtomatizzazzjoni jew il-konvenjenza jew il-kontroll tal-kwalità ma għandhomx jikkwalifikaw bħala komponenti tas-sikurezza.
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Artikolu 6 1b.
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Minkejja l-paragrafu 1a, is-sistemi tal-IA li l-falliment jew il-funzjonament ħażin tagħhom jipperikolaw is-saħħa u s-sikurezza għandhom jikkwalifikaw bħala komponenti tas-sikurezza.
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Artikolu 6 1c.
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Prodott li jkun meħtieġ li ssirlu valutazzjoni tal-konformità minn parti terza biss minħabba riskji għajr riskji għas-saħħa u għas-sikurezza, b’mod partikolari riskji relatati mad-distribuzzjoni tal-ispettru tar-radju jew mal-interferenza elettromanjetika li ma jaffettwawx is-saħħa u s-sikurezza, ma għandux jitqies li jissodisfa l-kundizzjoni fil-paragrafu 1, il-punt (b).
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Artikolu 6 2.
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Minbarra s-sistemi tal-IA b'riskju għoli msemmija fil-paragrafu 1, is-sistemi tal-IA msemmija fl-Anness III għandhom ukoll jitqiesu bħala b'riskju għoli.
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Artikolu 6 3.
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B'deroga mill-paragrafu 2, sistema tal-IA msemmija fl-Anness III ma għandhiex titqies bħala b'riskju għoli fejn ma toħloqx riskju sinifikanti ta' ħsara, għas-saħħa, għas-sikurezza jew għad-drittijiet fundamentali tal-persuni fiżiċi, inkluż billi ma tinfluwenzax materjalment l-eżitu tat-teħid tad-deċiżjonijiet. L-ewwel subparagrafu għandu japplika fejn tiġi ssodisfata kwalunkwe waħda mill-kundizzjonijiet li ġejjin:
(a)
is-sistema tal-IA hija maħsuba biex twettaq kompitu proċedurali ristrett;
(b)
is-sistema tal-IA hija maħsuba biex ittejjeb ir-riżultat ta' attività mill-bniedem li tkun tlestiet qabel;
(c)
is-sistema tal-IA hija maħsuba biex tikxef xejriet ta' teħid ta' deċiżjonijiet jew devjazzjonijiet minn xejriet ta' teħid ta' deċiżjonijiet preċedenti u mhijiex maħsuba biex tissostitwixxi jew tinfluwenza l-valutazzjoni mill-bniedem li tkun tlestiet qabel, mingħajr rieżami xieraq mill-bniedem; jew
(d)
is-sistema tal-IA hija maħsuba biex twettaq kompitu preparatorju għal valutazzjoni rilevanti għall-finijiet tal-każijiet ta' użu elenkati fl-Anness III.
Minkejja l-ewwel subparagrafu, sistema tal-IA msemmija fl-Anness III għandha dejjem titqies bħala b'riskju għoli meta s-sistema tal-IA twettaq tfassil tal-profili ta' persuni fiżiċi.
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Artikolu 6 4.
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Fornitur li jqis li sistema tal-IA msemmija fl-Anness III mhix b'riskju għoli għandu jiddokumenta l-valutazzjoni tiegħu qabel ma dik is-sistema tiġi introdotta fis-suq jew titqiegħed fis-servizz. Tali fornitur għandu jkun soġġett għall-obbligu ta' reġistrazzjoni stipulat fl-Artikolu 49(2). Fuq talba tal-awtoritajiet nazzjonali kompetenti, il-fornitur għandu jipprovdi d-dokumentazzjoni tal-valutazzjoni.
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Artikolu 6 5.
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Il-Kummissjoni għandha, wara li tikkonsulta lill-Bord Ewropew għall-Intelliġenza Artifiċjali (il-“Bord”), u mhux aktar tard mit-2 ta’ Frar 2026, tipprovdi linji gwida li jispeċifikaw l-implimentazzjoni prattika ta' dan l-Artikolu f'konformità mal-Artikolu 96 flimkien ma' lista komprensiva ta' eżempji prattiċi ta' każijiet ta' użu ta' sistemi tal-IA b'riskju għoli u mingħajr riskju għoli.
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Artikolu 6 6.
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Il-Kummissjoni għandha tadotta atti delegati f'konformità mal-Artikolu 97 biex temenda l-kundizzjonijiet stabbiliti fil-paragrafu 3, l-ewwel subparagrafu, ta' dan l-Artikolu. Il-Kummissjoni tingħata s-setgħa li tadotta atti delegati f'konformità mal-Artikolu 97 sabiex temenda l-paragrafu 3, it-tieni subparagrafu, ta’ dan l-Artikolu billi żżid kundizzjonijiet ġodda ma' dawk stabbiliti fih, jew billi timmodifikahom, meta jkun hemm evidenza konkreta u affidabbli tal-eżistenza ta' sistemi tal-IA li jaqgħu fil-kamp ta' applikazzjoni tal-Anness III iżda li ma joħolqux riskju sinifikanti ta' ħsara għas-saħħa, għas-sikurezza jew għad-drittijiet fundamentali ta' persuni fiżiċi.
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Artikolu 6 7.
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Il-Kummissjoni għandha tadotta atti delegati f'konformità mal-Artikolu 97 sabiex temenda l-paragrafu 3, it-tieni subparagrafu, ta’ dan l-Artikolu billi tħassar kwalunkwe waħda mill-kundizzjonijiet stabbiliti fih, fejn ikun hemm evidenza konkreta u affidabbli li dan ikun meħtieġ biex jinżamm il-livell ta' protezzjoni tas-saħħa, tas-sikurezza u tad-drittijiet fundamentali previsti f’dan ir-Regolament.
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Artikolu 6 8.
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Kwalunkwe emenda għall-kundizzjonijiet stabbiliti fil-paragrafu 3, it-tieni subparagrafu, adottati f’konformità mal-paragrafi 6 u 7 ta’ dan l-Artikolu, ma għandhiex tnaqqas il-livell ġenerali ta' protezzjoni tas-saħħa, tas-sikurezza u tad-drittijiet fundamentali previsti f’dan ir-Regolament u għandha tiżgura konsistenza mal-atti delegati adottati skont l-Artikolu 7(1), u tqis l-iżviluppi teknoloġiċi u tas-suq.
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1.1 Referenzi
1.2 Rekwiżiti identifikati
1.3 Standards relatati
2. Rekwiżiti identifikati
3. Standards relatati
Standards
| Sors |
Rekwiżit |
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SCF
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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.
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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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