+Artikkel 25 Vastutus tehisintellekti väärtusahelas
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Artikkel 25 Vastutus tehisintellekti väärtusahelas

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1. Ülevaade

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Artikkel 25 1.

Turustajat, importijat, juurutajat või muud kolmandat isikut käsitatakse käesoleva määruse kohaldamisel suure riskiga tehisintellektisüsteemi pakkujana ning tema suhtes kohaldatakse artiklist 16 tulenevaid pakkuja kohustusi mis tahes järgmisel juhul:

a) 

ta lisab juba turule lastud või kasutusele võetud suure riskiga tehisintellektisüsteemile oma nime või kaubamärgi, ilma et see piiraks selliste lepinguliste kokkulepete kohaldamist, milles sätestatakse, et kohustused on muul viisil jaotatud;

b) 

nad teevad suure riskiga tehisintellektisüsteemi, mis on juba turule lastud või kasutusele võetud, olulise muudatuse viisil, et see jääb suure riskiga tehisintellektisüsteemiks vastavalt artiklile 6;

c) 

nad muudavad tehisintellektisüsteemi, sealhulgas üldotstarbelisse tehisintellektisüsteemi, mida ei ole liigitatud suure riskiga tehisintellektisüsteemiks ja mis on juba turule lastud või kasutusele võetud, sihtotstarvet, nii et asjaomasest tehisintellektisüsteemist saab suure riskiga tehisintellektisüsteem vastavalt artiklile 6.
Artikkel 25 2.
Lõikes 1 osutatud asjaolude ilmnemise korral ei käsitata tehisintellektisüsteemi algselt turule lasknud või kasutusele võtnud pakkujat enam käesoleva määruse kohaldamisel selle konkreetse tehisintellektisüsteemi pakkujana.

Kõnealune algne pakkuja teeb tihedat koostööd uute pakkujatega ning teeb kättesaadavaks vajaliku teabe ja annab mõistlikult eeldatava tehnilise juurdepääsu ja osutab muud abi, mida on vaja käesolevas määruses sätestatud kohustuste täitmiseks, eelkõige seoses suure riskiga tehisintellektisüsteemide vastavushindamise järgimisega.

Teises lõigus sätestatud kohustus, kui see on selles täpsustatud eesmärkidel asjakohane, hõlmab eelkõige järgmist:

a) 

teha kättesaadavaks artiklis 16 sätestatud nõuetele vastavuse hindamiseks piisav tehniline dokumentatsioon;

b) 

teavitada uusi pakkujaid teadaolevatest piirangutest ja tõrkeviisidest ning

c) 

anda uutele pakkujatele sihipärane tehniline juurdepääs, sealhulgas testimiseks ja valideerimiseks.

Käesolevat lõiget ei kohaldata juhul, kui algne pakkuja on selgelt täpsustanud, et tema tehisintellektisüsteemi ei tohi muuta suure riskiga tehisintellektisüsteemiks, ja seetõttu ei kohaldata tema suhtes uute pakkujatega koostöö tegemise ja dokumentatsiooni üleandmise kohustust.
Artikkel 25 3.

Suure riskiga tehisintellektisüsteemide puhul, mis on selliste toodete turvakomponendid, mille suhtes kohaldatakse I lisa A jaos loetletud liidu ühtlustamisõigusakte, käsitatakse nende toodete valmistajat suure riskiga tehisintellektisüsteemi pakkujana ja ta peab täitma artikli 16 kohaseid kohustusi ühel järgmistest juhtudest:

a) 

suure riskiga tehisintellektisüsteem lastakse turule koos tootega toote valmistaja nime või kaubamärgi all;

b) 

suure riskiga tehisintellektisüsteem võetakse kasutusele toote valmistaja nime või kaubamärgi all pärast toote turule laskmist.
Artikkel 25 4.
Suure riskiga tehisintellektisüsteemi pakkuja ja kolmas isik, kes tarnib tehisintellektisüsteemi, tehisintellektimudelit, vahendeid, teenuseid, komponente või protsesse, mida kasutatakse suure riskiga tehisintellektisüsteemis või mis on sellesse integreeritud, määravad tehnika üldtunnustatud tasemele tuginedes kirjaliku kokkuleppega kindlaks vajaliku teabe, võimed, tehnilise juurdepääsu ja või muu abi, et võimaldada suure riskiga tehisintellektisüsteemi pakkujal täielikult täita käesolevast määrusest tulenevaid kohustusi. Käesolevat lõiget ei kohaldata kolmandate isikute suhtes, kes teevad vaba ja avatud lähtekoodi litsentsi alusel avalikele vahenditele, teenustele, protsessidele või komponentidele kättesaadavaks muud kui üldotstarbelised tehisintellektimudelid.

Tehisintellektiamet võib välja töötada ja soovitada vabatahtlikke näidis-lepingutingimusi kasutamiseks suure riskiga tehisintellektisüsteemide pakkujate ja kolmandate isikute vahel, kes pakuvad suure riskiga tehisintellektisüsteemides kasutatavaid või integreeritud vahendeid, teenuseid, komponente või protsesse. Vabatahtlike näidistingimuste väljatöötamisel peaks tehisintellektiamet arvesse võtma konkreetsetes sektorites või ärimudelites kohaldatavaid võimalikke lepingulisi nõudeid. Vabatahtlikud näidistingimused avaldatakse ja tehakse tasuta kättesaadavaks kergesti kasutatavas elektroonilises vormingus.
Artikkel 25 5.
Lõiked 2 ja 3 ei piira vajadust järgida ja kaitsta intellektuaalomandi õigusi, konfidentsiaalset äriteavet ja ärisaladusi kooskõlas liidu ja siseriikliku õigusega.

1.1 Viited

1.2 Tuvastatud nõuded

1.3 Seotud standardid

2. Tuvastatud nõuded

Nõuded

3. Seotud standardid

Standardid
SCF Product Conformity Governance

Description

Mechanisms exist to ensure developed Technology Assets, Applications and/or Services (TAAS) conform to applicable statutory and regulatory requirements, based on the product's and/or service's:
(1) Use case(s); and
(2) Geographic markets.

Possible Solutions & Considerations

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

∙ Identify laws/regulations applicable to any developed products (e.g., privacy, accessibility)

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

∙ Regulatory requirements checklist for product development
∙ Legal review before release

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

∙ Product compliance requirements defined at project start
∙ Compliance validation before release
∙ Regulatory conformity records

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

∙ Product conformity governance program (statutory, regulatory, certification requirements)
∙ Compliance gates in release management
∙ Conformity documentation (e.g., declarations of conformity)

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

∙ Enterprise product compliance program covering statutory/regulatory conformity (e.g., EU CRA, FDA, UL 2900)
∙ Regulatory affairs and product security integration
∙ Conformity assessment and certification management

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

Technology Development & Acquisition (TDA) 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 TDA domain capabilities are formally documented and centrally-managed by the entity.
▪ Standardized Operating Procedures (SOP) associated with TDA 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 TDA domain capabilities to address applicable statutory, regulatory and/or contractual requirements for Technology Assets, Applications, Services and/or Data (TAASD).
▪ Technology development and acquisition-related controls are primarily administrative and preventative in nature (e.g., policies, standards and procedures & guidelines).
▪ Technology development and acquisition management may be a defined function (e.g., team or department) or assigned as an additional duty to existing IT and/or cybersecurity personnel.
▪ Secure development practices mostly conform to industry-recognized standards for secure engineering of Technology Assets, Applications and/or Services (TAAS) (e.g., OWASP, NIST SP 800-218 and NIST SP 800-160).
▪ An application development team, or similar function, uses a structured process to design, build and maintain secure configurations for test, development, staging and production environments.

Level 3 Well Defined

Technology Development & Acquisition (TDA) 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 TDA 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 TDA domain capabilities are well-documented and kept current by process owners.
▪ A software development team, or similar function, is appropriately staffed and supported to implement and maintain TDA domain capabilities.
▪ Technology is leveraged to enhance the efficiency and accuracy of technology development and acquisition management (e.g., project management software, software escrow solution and software testing tools).
▪ 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 TDA 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 ensure developed Technology Assets, Applications and/or Services (TAAS) conform to applicable statutory and regulatory requirements, based on the product's and/or service's:
(1) Use case(s); and
(2) Geographic markets.

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 Product Conformity Governance

Description

Mechanisms exist to ensure developed Technology Assets, Applications and/or Services (TAAS) conform to applicable statutory and regulatory requirements, based on the product's and/or service's:
(1) Use case(s); and
(2) Geographic markets.

Possible Solutions & Considerations

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

∙ Identify laws/regulations applicable to any developed products (e.g., privacy, accessibility)

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

∙ Regulatory requirements checklist for product development
∙ Legal review before release

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

∙ Product compliance requirements defined at project start
∙ Compliance validation before release
∙ Regulatory conformity records

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

∙ Product conformity governance program (statutory, regulatory, certification requirements)
∙ Compliance gates in release management
∙ Conformity documentation (e.g., declarations of conformity)

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

∙ Enterprise product compliance program covering statutory/regulatory conformity (e.g., EU CRA, FDA, UL 2900)
∙ Regulatory affairs and product security integration
∙ Conformity assessment and certification management

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

Technology Development & Acquisition (TDA) 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 TDA domain capabilities are formally documented and centrally-managed by the entity.
▪ Standardized Operating Procedures (SOP) associated with TDA 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 TDA domain capabilities to address applicable statutory, regulatory and/or contractual requirements for Technology Assets, Applications, Services and/or Data (TAASD).
▪ Technology development and acquisition-related controls are primarily administrative and preventative in nature (e.g., policies, standards and procedures & guidelines).
▪ Technology development and acquisition management may be a defined function (e.g., team or department) or assigned as an additional duty to existing IT and/or cybersecurity personnel.
▪ Secure development practices mostly conform to industry-recognized standards for secure engineering of Technology Assets, Applications and/or Services (TAAS) (e.g., OWASP, NIST SP 800-218 and NIST SP 800-160).
▪ An application development team, or similar function, uses a structured process to design, build and maintain secure configurations for test, development, staging and production environments.

Level 3 Well Defined

Technology Development & Acquisition (TDA) 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 TDA 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 TDA domain capabilities are well-documented and kept current by process owners.
▪ A software development team, or similar function, is appropriately staffed and supported to implement and maintain TDA domain capabilities.
▪ Technology is leveraged to enhance the efficiency and accuracy of technology development and acquisition management (e.g., project management software, software escrow solution and software testing tools).
▪ 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 TDA 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 ensure developed Technology Assets, Applications and/or Services (TAAS) conform to applicable statutory and regulatory requirements, based on the product's and/or service's:
(1) Use case(s); and
(2) Geographic markets.

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 Product Conformity Governance

Description

Mechanisms exist to ensure developed Technology Assets, Applications and/or Services (TAAS) conform to applicable statutory and regulatory requirements, based on the product's and/or service's:
(1) Use case(s); and
(2) Geographic markets.

Possible Solutions & Considerations

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

∙ Identify laws/regulations applicable to any developed products (e.g., privacy, accessibility)

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

∙ Regulatory requirements checklist for product development
∙ Legal review before release

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

∙ Product compliance requirements defined at project start
∙ Compliance validation before release
∙ Regulatory conformity records

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

∙ Product conformity governance program (statutory, regulatory, certification requirements)
∙ Compliance gates in release management
∙ Conformity documentation (e.g., declarations of conformity)

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

∙ Enterprise product compliance program covering statutory/regulatory conformity (e.g., EU CRA, FDA, UL 2900)
∙ Regulatory affairs and product security integration
∙ Conformity assessment and certification management

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

Technology Development & Acquisition (TDA) 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 TDA domain capabilities are formally documented and centrally-managed by the entity.
▪ Standardized Operating Procedures (SOP) associated with TDA 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 TDA domain capabilities to address applicable statutory, regulatory and/or contractual requirements for Technology Assets, Applications, Services and/or Data (TAASD).
▪ Technology development and acquisition-related controls are primarily administrative and preventative in nature (e.g., policies, standards and procedures & guidelines).
▪ Technology development and acquisition management may be a defined function (e.g., team or department) or assigned as an additional duty to existing IT and/or cybersecurity personnel.
▪ Secure development practices mostly conform to industry-recognized standards for secure engineering of Technology Assets, Applications and/or Services (TAAS) (e.g., OWASP, NIST SP 800-218 and NIST SP 800-160).
▪ An application development team, or similar function, uses a structured process to design, build and maintain secure configurations for test, development, staging and production environments.

Level 3 Well Defined

Technology Development & Acquisition (TDA) 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 TDA 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 TDA domain capabilities are well-documented and kept current by process owners.
▪ A software development team, or similar function, is appropriately staffed and supported to implement and maintain TDA domain capabilities.
▪ Technology is leveraged to enhance the efficiency and accuracy of technology development and acquisition management (e.g., project management software, software escrow solution and software testing tools).
▪ 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 TDA 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 ensure developed Technology Assets, Applications and/or Services (TAAS) conform to applicable statutory and regulatory requirements, based on the product's and/or service's:
(1) Use case(s); and
(2) Geographic markets.

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 Product Conformity Governance

Description

Mechanisms exist to ensure developed Technology Assets, Applications and/or Services (TAAS) conform to applicable statutory and regulatory requirements, based on the product's and/or service's:
(1) Use case(s); and
(2) Geographic markets.

Possible Solutions & Considerations

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

∙ Identify laws/regulations applicable to any developed products (e.g., privacy, accessibility)

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

∙ Regulatory requirements checklist for product development
∙ Legal review before release

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

∙ Product compliance requirements defined at project start
∙ Compliance validation before release
∙ Regulatory conformity records

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

∙ Product conformity governance program (statutory, regulatory, certification requirements)
∙ Compliance gates in release management
∙ Conformity documentation (e.g., declarations of conformity)

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

∙ Enterprise product compliance program covering statutory/regulatory conformity (e.g., EU CRA, FDA, UL 2900)
∙ Regulatory affairs and product security integration
∙ Conformity assessment and certification management

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

Technology Development & Acquisition (TDA) 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 TDA domain capabilities are formally documented and centrally-managed by the entity.
▪ Standardized Operating Procedures (SOP) associated with TDA 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 TDA domain capabilities to address applicable statutory, regulatory and/or contractual requirements for Technology Assets, Applications, Services and/or Data (TAASD).
▪ Technology development and acquisition-related controls are primarily administrative and preventative in nature (e.g., policies, standards and procedures & guidelines).
▪ Technology development and acquisition management may be a defined function (e.g., team or department) or assigned as an additional duty to existing IT and/or cybersecurity personnel.
▪ Secure development practices mostly conform to industry-recognized standards for secure engineering of Technology Assets, Applications and/or Services (TAAS) (e.g., OWASP, NIST SP 800-218 and NIST SP 800-160).
▪ An application development team, or similar function, uses a structured process to design, build and maintain secure configurations for test, development, staging and production environments.

Level 3 Well Defined

Technology Development & Acquisition (TDA) 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 TDA 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 TDA domain capabilities are well-documented and kept current by process owners.
▪ A software development team, or similar function, is appropriately staffed and supported to implement and maintain TDA domain capabilities.
▪ Technology is leveraged to enhance the efficiency and accuracy of technology development and acquisition management (e.g., project management software, software escrow solution and software testing tools).
▪ 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 TDA 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 ensure developed Technology Assets, Applications and/or Services (TAAS) conform to applicable statutory and regulatory requirements, based on the product's and/or service's:
(1) Use case(s); and
(2) Geographic markets.

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 Product Conformity Governance

Description

Mechanisms exist to ensure developed Technology Assets, Applications and/or Services (TAAS) conform to applicable statutory and regulatory requirements, based on the product's and/or service's:
(1) Use case(s); and
(2) Geographic markets.

Possible Solutions & Considerations

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

∙ Identify laws/regulations applicable to any developed products (e.g., privacy, accessibility)

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

∙ Regulatory requirements checklist for product development
∙ Legal review before release

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

∙ Product compliance requirements defined at project start
∙ Compliance validation before release
∙ Regulatory conformity records

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

∙ Product conformity governance program (statutory, regulatory, certification requirements)
∙ Compliance gates in release management
∙ Conformity documentation (e.g., declarations of conformity)

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

∙ Enterprise product compliance program covering statutory/regulatory conformity (e.g., EU CRA, FDA, UL 2900)
∙ Regulatory affairs and product security integration
∙ Conformity assessment and certification management

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

Technology Development & Acquisition (TDA) 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 TDA domain capabilities are formally documented and centrally-managed by the entity.
▪ Standardized Operating Procedures (SOP) associated with TDA 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 TDA domain capabilities to address applicable statutory, regulatory and/or contractual requirements for Technology Assets, Applications, Services and/or Data (TAASD).
▪ Technology development and acquisition-related controls are primarily administrative and preventative in nature (e.g., policies, standards and procedures & guidelines).
▪ Technology development and acquisition management may be a defined function (e.g., team or department) or assigned as an additional duty to existing IT and/or cybersecurity personnel.
▪ Secure development practices mostly conform to industry-recognized standards for secure engineering of Technology Assets, Applications and/or Services (TAAS) (e.g., OWASP, NIST SP 800-218 and NIST SP 800-160).
▪ An application development team, or similar function, uses a structured process to design, build and maintain secure configurations for test, development, staging and production environments.

Level 3 Well Defined

Technology Development & Acquisition (TDA) 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 TDA 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 TDA domain capabilities are well-documented and kept current by process owners.
▪ A software development team, or similar function, is appropriately staffed and supported to implement and maintain TDA domain capabilities.
▪ Technology is leveraged to enhance the efficiency and accuracy of technology development and acquisition management (e.g., project management software, software escrow solution and software testing tools).
▪ 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 TDA 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 ensure developed Technology Assets, Applications and/or Services (TAAS) conform to applicable statutory and regulatory requirements, based on the product's and/or service's:
(1) Use case(s); and
(2) Geographic markets.

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 Product Conformity Governance

Description

Mechanisms exist to ensure developed Technology Assets, Applications and/or Services (TAAS) conform to applicable statutory and regulatory requirements, based on the product's and/or service's:
(1) Use case(s); and
(2) Geographic markets.

Possible Solutions & Considerations

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

∙ Identify laws/regulations applicable to any developed products (e.g., privacy, accessibility)

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

∙ Regulatory requirements checklist for product development
∙ Legal review before release

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

∙ Product compliance requirements defined at project start
∙ Compliance validation before release
∙ Regulatory conformity records

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

∙ Product conformity governance program (statutory, regulatory, certification requirements)
∙ Compliance gates in release management
∙ Conformity documentation (e.g., declarations of conformity)

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

∙ Enterprise product compliance program covering statutory/regulatory conformity (e.g., EU CRA, FDA, UL 2900)
∙ Regulatory affairs and product security integration
∙ Conformity assessment and certification management

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

Technology Development & Acquisition (TDA) 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 TDA domain capabilities are formally documented and centrally-managed by the entity.
▪ Standardized Operating Procedures (SOP) associated with TDA 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 TDA domain capabilities to address applicable statutory, regulatory and/or contractual requirements for Technology Assets, Applications, Services and/or Data (TAASD).
▪ Technology development and acquisition-related controls are primarily administrative and preventative in nature (e.g., policies, standards and procedures & guidelines).
▪ Technology development and acquisition management may be a defined function (e.g., team or department) or assigned as an additional duty to existing IT and/or cybersecurity personnel.
▪ Secure development practices mostly conform to industry-recognized standards for secure engineering of Technology Assets, Applications and/or Services (TAAS) (e.g., OWASP, NIST SP 800-218 and NIST SP 800-160).
▪ An application development team, or similar function, uses a structured process to design, build and maintain secure configurations for test, development, staging and production environments.

Level 3 Well Defined

Technology Development & Acquisition (TDA) 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 TDA 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 TDA domain capabilities are well-documented and kept current by process owners.
▪ A software development team, or similar function, is appropriately staffed and supported to implement and maintain TDA domain capabilities.
▪ Technology is leveraged to enhance the efficiency and accuracy of technology development and acquisition management (e.g., project management software, software escrow solution and software testing tools).
▪ 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 TDA 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 ensure developed Technology Assets, Applications and/or Services (TAAS) conform to applicable statutory and regulatory requirements, based on the product's and/or service's:
(1) Use case(s); and
(2) Geographic markets.

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.