+Artikolu 40 Standards armonizzati u strumenti ta’ standardizzazzjoni
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Artikolu 40 Standards armonizzati u strumenti ta’ standardizzazzjoni

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1. Ħarsa ġenerali

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Artikolu 40 1.
Is-sistemi tal-IA b’riskju għoli jew il-mudelli tal-IA bi skop ġenerali li jkunu konformi ma’ standards armonizzati jew ma’ partijiet minnhom, li r-referenzi tagħhom ikunu ġew ippubblikati f’Il-Ġurnal Uffiċjali tal-Unjoni Ewropea f’konformità mar-Regolament (UE) Nru 1025/2012 għandhom ikunu preżunti li huma konformi mar-rekwiżiti stipulati fit-Taqsima 2 ta’ dan il-Kapitolu jew, kif applikabbli, mal-obbligi stipulati fl-Kapitolu V, it-Taqsimiet 2 u 3 ta’ dan ir-Regolament, sa fejn dawk l-istandards ikopru dawk ir-rekwiżiti jew obbligi.
Artikolu 40 2.
F’konformità mal-Artikolu 10 tar-Regolament (UE) Nru 1025/2012, il-Kummissjoni għandha toħroġ, mingħajr dewmien żejjed, talbiet għall-istandardizzazzjoni li jkopru r-rekwiżiti kollha stipulati fit-Taqsima 2 ta’ dan il-Kapitolu u, kif applikabbli, talbiet għall-istandardizzazzjoni li jkopru l-obbligi stipulati fil-Kapitolu V, it-Taqsimiet 2 u 3 ta’ dan ir-Regolament’. It-talba ta’ standardizzazzjoni għandha titlob ukoll strumenti għall-proċessi ta’ rappurtar u ta’ dokumentazzjoni biex tittejjeb il-prestazzjoni tar-riżorsi tas-sistemi tal-IA, bħat-tnaqqis fil-konsum tal-enerġija u ta’ riżorsi oħra tas-sistema tal-IA b’riskju għoli matul iċ-ċiklu tal-ħajja tagħha, u dwar l-iżvilupp tal-effiċjenza fl-użu tal-enerġija tal-mudelli tal-IA bi skop ġenerali. Meta tħejji talba ta’ standardizzazzjoni, il-Kummissjoni għandha tikkonsulta lill-Bord u lill-partijiet ikkonċernati rilevanti, inkluż il-forum konsultattiv.

Meta toħroġ talba ta’ standardizzazzjoni lill-organizzazzjonijiet Ewropej tal-istandardizzazzjoni, il-Kummissjoni għandha tispeċifika li l-istandards iridu jkunu ċari, konsistenti, inkluż mal-istandards żviluppati fid-diversi setturi għall-prodotti koperti mil-leġiżlazzjoni eżistenti tal-Unjoni dwar l-armonizzazzjoni elenkata fl-Anness I, u bil-għan li jiżguraw li s-sistemi tal-IA b’riskju għoli jew il-mudelli tal-IA bi skop ġenerali introdotti fis-suq jew imqiegħda fis-servizz fl-Unjoni jissodisfaw ir-rekwiżiti rilevanti jew l-obbligi stabbiliti f’dan ir-Regolament.

Il-Kummissjoni għandha titlob lill-organizzazzjonijiet Ewropej tal-istandardizzazzjoni biex jipprovdu evidenza tal-aħjar sforzi tagħhom biex jissodisfaw l-objettivi msemmija fl-ewwel u t-tieni subparagrafu ta’ dan il-paragrafu f’konformità mal-Artikolu 24 tar-Regolament (UE) 1025/2012.

Il-Kummissjoni għandha titlob, f’konformità mar-Regolament (UE) Nru 1025/2012 tal-Parlament Ewropew u tal-Kunsill ( 1 ) u mingħajr dewmien żejjed, lill-organizzazzjonijiet Ewropej tal-istandardizzazzjoni biex jiżviluppaw strumenti ta’ standardizzazzjoni, inkluż, kif xieraq, standards armonizzati, biex jiffaċilitaw il-konformità konġunta u l-preżunzjoni ta’ konformità mar-rekwiżiti jew l-obbligi stabbiliti fil-Kapitolu III, it-Taqsimiet 2 u 3 ta’ dan ir-Regolament, u r-rekwiżiti u l-obbligi rilevanti stabbiliti fil-leġiżlazzjoni tal-Unjoni dwar l-armonizzazzjoni elenkata fl-Anness I ta’ dan ir-Regolament.
Artikolu 40 3.
Il-parteċipanti fil-proċess ta’ standardizzazzjoni għandhom ifittxu li jippromwovu l-investiment u l-innovazzjoni fl-IA, inkluż permezz ta’ żieda fiċ-ċertezza legali, kif ukoll il-kompetittività u t-tkabbir tas-suq tal-Unjoni, li jikkontribwixxu għat-tisħiħ tal-kooperazzjoni globali dwar l-istandardizzazzjoni u filwaqt li jqisu l-istandards internazzjonali eżistenti fil-qasam tal-IA li huma konsistenti mal-valuri, id-drittijiet fundamentali u l-interessi tal-Unjoni, u li jtejbu l-governanza b’diversi partijiet ikkonċernati li tiżgura rappreżentanza bbilanċjata tal-interessi u l-parteċipazzjoni effettiva tal-partijiet ikkonċernati rilevanti kollha f’konformità mal-Artikoli 5, 6 u 7 tar-Regolament (UE) Nru 1025/2012.

1.1 Referenzi

1.2 Rekwiżiti identifikati

1.3 Standards relatati

2. Rekwiżiti identifikati

Rekwiżiti

3. Standards relatati

Standards
SCF Statutory, Regulatory & Contractual Compliance

Description

Mechanisms exist to facilitate the identification and implementation of relevant statutory, regulatory and contractual controls.

Possible Solutions & Considerations

Micro-Small Business (<10 staff) / BLS Firm Size Classes 1-2

∙ SCF Security, Compliance & Resilience Management System (SCRMS)
∙ Governance, Risk and Compliance (GRC) solution (e.g., SCFConnect, SureCloud, Ostendio, SimpleRisk, Ignyte, ZenGRC, Galvanize, MetricStream, Archer, etc.)

Small Business (10-49 staff) / BLS Firm Size Classes 3-4

∙ SCF Security, Compliance & Resilience Management System (SCRMS)
∙ Governance, Risk and Compliance (GRC) solution (e.g., SCFConnect, SureCloud, Ostendio, SimpleRisk, Ignyte, ZenGRC, Galvanize, MetricStream, Archer, etc.)

Medium Business (50-249 staff) / BLS Firm Size Classes 5-6

∙ SCF Security, Compliance & Resilience Management System (SCRMS)
∙ Governance, Risk and Compliance (GRC) solution (e.g., SCFConnect, SureCloud, Ostendio, SimpleRisk, Ignyte, ZenGRC, Galvanize, MetricStream, Archer, etc.)
∙ Steering committee

Large Business (250-999 staff) / BLS Firm Size Classes 7-8

∙ SCF Security, Compliance & Resilience Management System (SCRMS)
∙ GRC solution (e.g., SCFConnect, Cyturus, SureCloud, SimpleRisk, Ignyte, ZenGRC, Galvanize, MetricStream, Archer, etc.)
∙ Steering committee

Enterprise (> 1,000 staff) / BLS Firm Size Class 9

∙ SCF Security, Compliance & Resilience Management System (SCRMS)
∙ GRC solution (e.g., SCFConnect, Cyturus, SureCloud, SimpleRisk, Ignyte, ZenGRC, Galvanize, MetricStream, Archer, etc.)
∙ Steering committee

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

Compliance (CPL) domain capabilities are ad hoc and inconsistent. Capability criteria associated with this control may include:
▪ Policies, standards & procedures associated with CPL domain capabilities provide limited coverage due to the depth and breadth of the existing documentation.
▪ Compliance management-related activities are decentralized (e.g., a localized/regionalized function) and uses non-standardized methods to implement secure, resilient and compliant practices.
▪ Compliance efforts are narrowly-limited to certain compliance requirements.
▪ IT and/or cybersecurity personnel use an informal process to govern statutory, regulatory and contractual compliance obligations.

Level 2 Planned Tracked

Compliance (CPL) 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 CPL domain capabilities are formally documented and centrally-managed by the entity.
▪ Standardized Operating Procedures (SOP) associated with CPL 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 CPL domain capabilities to address applicable statutory, regulatory and/or contractual requirements for Technology Assets, Applications, Services and/or Data (TAASD).
▪ Compliance management controls-related controls are primarily administrative and preventative in nature (e.g., policies, standards and procedures & guidelines).
▪ Compliance management may be a defined function (e.g., team or department) or assigned as an additional duty to existing IT and/or cybersecurity personnel.
▪ External compliance requirements for cybersecurity and data privacy are identified and documented, based on applicable laws, regulations and contractual obligations.
▪ IT and/or cybersecurity perform an informal annual review of existing compliance requirements and research evolving or new requirements.

Level 3 Well Defined

Compliance (CPL) 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 CPL 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 CPL domain capabilities are well-documented and kept current by process owners.
▪ A Governance, Risk & Compliance (GRC) team, or similar function, is appropriately staffed and supported to implement and maintain CPL domain capabilities.
▪ Technology is leveraged to enhance the efficiency and accuracy of governance, risk management and compliance operations (e.g., GRC 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 CPL 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 facilitate the identification and implementation of relevant statutory, regulatory and contractual controls.

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.