+25. pants Pienākumi MI vērtības ķēdē
---+25. pants 1.
---+25. pants 2.
---+25. pants 3.
---+25. pants 4.
---+25. pants 5.

25. pants Pienākumi MI vērtības ķēdē

-

1. Pārskats

,
25. pants 1.

Katru izplatītāju, importētāju, uzturētāju vai citu trešo personu šajā regulā uzskata par augsta riska MI sistēmas nodrošinātāju, un uz to attiecas 16. pantā paredzētie nodrošinātāja pienākumi jebkuros no šiem apstākļiem:

a) 

tie uzliek savu nosaukumu/vārdu vai preču zīmi augsta riska MI sistēmai, kura jau laista tirgū vai nodota ekspluatācijā, neskarot līgumiskas vienošanās, kas paredz, ka pienākumi tiek sadalīti citādi;

b) 

tie veic būtisku modifikāciju augsta riska MI sistēmā, kura jau ir laista tirgū vai jau ir nodota ekspluatācijā, tādā veidā, ka tā joprojām paliek augsta riska MI sistēma, ievērojot 6. pantu;

c) 

tie veic modifikāciju MI sistēmai paredzētajā nolūkā, tostarp vispārīga lietojuma MI sistēmai, kas nav klasificēta kā augsta riska sistēma un kas jau ir laista tirgū vai nodota ekspluatācijā, tādā veidā, ka attiecīgā MI sistēma kļūst par augsta riska MI sistēmu saskaņā ar 6. pantu.
25. pants 2.
Ja iestājas 1. punktā minētie apstākļi, nodrošinātājs, kas MI sistēmu sākotnēji laidis tirgū vai nodevis ekspluatācijā, vairs netiek uzskatīts par minētās konkrētās MI sistēmas nodrošinātāju šīs regulas nolūkos.

Minētais sākotnējais nodrošinātājs cieši sadarbojas ar jauniem nodrošinātājiem un dara pieejamu nepieciešamo informāciju un nodrošina saprātīgi sagaidāmu tehnisko piekļuvi un citu palīdzību, kas vajadzīga, lai izpildītu šajā regulā paredzētās prasības, jo īpaši attiecībā uz atbilsmi augsta riska MI sistēmu atbilstības novērtējumam.

Jo īpaši, īstenojot otrajā daļā noteikto pienākumu, ja tas ir būtiski tajā norādītajiem nolūkiem:

a) 

dara pieejamu tehnisko dokumentāciju, kas ir pietiekama, lai novērtētu atbilstību 16. pantā noteiktajām prasībām;

b) 

informē jaunos pakalpojumu sniedzējus par zināmiem ierobežojumiem un atteices veidiem; un

c) 

nodrošina jaunajiem pakalpojumu sniedzējiem mērķorientētu tehnisko piekļuvi, tostarp testēšanas un validēšanas nolūkā.

Šo punktu nepiemēro gadījumos, kad sākotnējais nodrošinātājs ir skaidri norādījis, ka tā MI sistēma nav pārveidojama par augsta riska MI sistēmu un tādējādi uz to neattiecas pienākums sadarboties ar jaunajiem nodrošinātājiem un nodot dokumentāciju.
25. pants 3.

Gadījumos, kad augsta riska MI sistēmas ir tādu produktu drošības sastāvdaļas, uz kuriem attiecas I pielikuma A iedaļā uzskaitītie Savienības saskaņošanas tiesību akti, produkta ražotāju uzskata par augsta riska MI sistēmas nodrošinātāju un uz to attiecas 16. pantā noteiktie pienākumi kādos no šādiem apstākļiem:

a) 

augsta riska MI sistēma tiek laista tirgū kopā ar produktu ar produkta ražotāja nosaukumu/vārdu vai preču zīmi;

b) 

augsta riska MI sistēma tiek nodota ekspluatācijā ar produkta ražotāja nosaukumu/vārdu vai preču zīmi pēc produkta laišanas tirgū.
25. pants 4.
Pamatojoties uz vispāratzītiem jaunākajiem sasniegumiem, augsta riska MI sistēmas nodrošinātājs un trešā persona, kas piegādā MI sistēmu, MI modeli, rīkus, pakalpojumus, sastāvdaļas vai procesus, kuri tiek izmantoti vai integrēti augsta riska MI sistēmā, ar rakstisku vienošanos precizē nepieciešamo informāciju, spējas, tehnisko piekļuvi un citu palīdzību, lai augsta riska MI sistēmas nodrošinātājs varētu pilnībā izpildīt šajā regulā noteiktos pienākumus. Šo punktu nepiemēro trešām personām, kas dara pieejamus publiskus rīkus, pakalpojumus, procesus vai sastāvdaļas, kas nav vispārīga lietojuma MI modeļi ar bezmaksas un atvērtas piekļuves licenci.

MI birojs var izstrādāt un ieteikt brīvprātīgus paraugnoteikumus līgumiem starp augsta riska MI sistēmu nodrošinātājiem un trešām personām, kuras piegādā rīkus, pakalpojumus, sastāvdaļas vai procesus, ko izmanto vai integrē augsta riska MI sistēmās. Izstrādājot minētos brīvprātīgos līguma paraugnoteikumus, MI birojs ņem vērā iespējamās līgumiskās prasības, kas piemērojamas konkrētās nozarēs vai uzņēmējdarbības gadījumos. Brīvprātīgos paraugnoteikumus publicē, un tie ir bez maksas pieejami viegli lietojamā elektroniskā formātā.
25. pants 5.
Šā panta 2. un 3. punkts neskar nepieciešamību ievērot un aizsargāt intelektuālā īpašuma tiesības, konfidenciālu uzņēmējdarbības informāciju un komercnoslēpumus saskaņā ar Savienības un valsts tiesību aktiem.

1.1 Atsauces

1.2 Identificētās prasības

1.3 Saistītie standarti

2. Identificētās prasības

Prasības

3. Saistītie standarti

Standarti
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.