+Artikel 40 Harmoniserede standarder og standardiseringsdokumentation
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Artikel 40 Harmoniserede standarder og standardiseringsdokumentation
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1. Oversigt
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Regulering |
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Artikel 40 1.
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Højrisiko-AI-systemer eller AI-modeller til almen brug, som er i overensstemmelse med harmoniserede standarder eller dele heraf, hvis referencer er offentliggjort i Den Europæiske Unions Tidende i overensstemmelse med forordning (EU) nr. 1025/2012, formodes at være i overensstemmelse med kravene i dette kapitels afdeling 2 eller, alt efter hvad der er relevant, med forpligtelserne i nærværende forordnings kapitel V, afdeling 2 og 3, for så vidt de nævnte standarder omfatter disse krav eller forpligtelser.
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Artikel 40 2.
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I overensstemmelse med artikel 10 i forordning (EU) nr. 1025/2012 fremsætter Kommissionen uden unødigt ophold standardiseringsanmodninger, der dækker alle kravene i dette kapitels afdeling 2, og, alt efter hvad der er relevant, standardiseringsanmodninger, der dækker forpligtelserne i nærværende forordnings kapitel V, afdeling 2 og 3. I standardiseringsanmodningen anmodes der også om dokumentation vedrørende rapporterings- og dokumentationsprocesser med henblik på at forbedre AI-systemernes ressourceydeevne såsom reduktion af højrisiko-AI-systemets forbrug af energi og af andre ressourcer i løbet af dets livscyklus og vedrørende energieffektiv udvikling af AI-modeller til almen brug. I forbindelse med udarbejdelsen af en standardiseringsanmodning hører Kommissionen AI-udvalget og relevante interessenter, herunder det rådgivende forum. Når Kommissionen fremsætter en standardiseringsanmodning til de europæiske standardiseringsorganisationer, præciserer den, at standarderne skal være klare, overensstemmende, herunder med de standarder, der er udviklet i de forskellige sektorer for produkter, der er omfattet af den gældende EU-harmoniseringslovgivning, som er opført i bilag I, og søge at sikre, at højrisiko-AI-systemer eller AI-modeller til almen brug, som bringes i omsætning eller tages i brug i Unionen, opfylder de relevante krav eller forpligtelser i nærværende forordning. Kommissionen anmoder de europæiske standardiseringsorganisationer om at dokumentere deres bedste indsats for at nå de mål, der er omhandlet i dette stykkes første og andet afsnit, i overensstemmelse med artikel 24 i forordning (EU) nr. 1025/2012. Kommissionen anmoder i overensstemmelse med Europa-Parlamentets og Rådets forordning (EU) nr. 1025/2012 (
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) og uden unødigt ophold de europæiske standardiseringsorganisationer om at udarbejde standardiseringspublikationer, herunder, hvis det er relevant, harmoniserede standarder, for at lette den fælles overholdelse af og formodning om overensstemmelse med de krav eller forpligtelser, der er fastsat i nærværende forordnings kapitel III, afdeling 2 og 3, og de relevante krav og forpligtelser, der er fastsat i den EU-harmoniseringslovgivning, der er opført i bilag I til nærværende forordning.
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Artikel 40 3.
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Deltagerne i standardiseringsprocessen skal søge at fremme investering og innovation inden for AI, herunder gennem øget retssikkerhed, samt EU-markedets konkurrenceevne og vækst, at bidrage til at styrke globalt samarbejde om standardisering og tage højde for eksisterende internationale standarder inden for kunstig intelligens, som stemmer overens med Unionens værdier, grundlæggende rettigheder og interesser, og at styrke multiinteressentforvaltning, der sikrer en afbalanceret repræsentation af interesser og effektiv deltagelse af alle relevante interessenter i overensstemmelse med artikel 5, 6 og 7 i forordning (EU) nr. 1025/2012.
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1.1 Referencer
1.2 Identificerede krav
1.3 Relaterede standarder
2. Identificerede krav
3. Relaterede standarder
Standarder
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Krav |
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SCF
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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.
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