+Artikolu 111 Sistemi tal-IA diġà introdotti fis-suq jew imqiegħda fis-servizz u mudeli tal-IA bi skop ġenerali diġà introdotti fis-suq
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Artikolu 111 Sistemi tal-IA diġà introdotti fis-suq jew imqiegħda fis-servizz u mudeli tal-IA bi skop ġenerali diġà introdotti fis-suq

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1. Ħarsa ġenerali

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Artikolu 111 1.
Mingħajr preġudizzju għall-applikazzjoni tal-Artikolu 5 kif imsemmi fl-Artikolu 113(3), il-punt (a), is-sistemi tal-IA li huma komponenti tas-sistemi tal-IT fuq skala kbira stabbiliti bl-atti legali elenkati fl-Anness X li jkunu ġew introdotti fis-suq jew tqiegħdu fis-servizz qabel it-2 ta’ Awwissu 2027 għandhom jinġiebu f'konformità ma' dan ir-Regolament sal-31 ta' Diċembru 2030.

Ir-rekwiżiti stabbiliti f'dan ir-Regolament għandhom jitqiesu fl-evalwazzjoni ta' kull sistema tal-IT fuq skala kbira stabbilita bl-atti legali elenkati fl-Anness X li għandha titwettaq kif previst f'dawk l-atti legali u meta dawk l-atti legali jiġu sostitwiti jew emendati.
Artikolu 111 2.
Mingħajr preġudizzju għall-applikazzjoni tal-Artikolu 5 kif imsemmi fl-Artikolu 113, it-tielet paragrafu, il-punt (a), dan ir-Regolament għandu japplika għall-operaturi tas-sistemi tal-IA b’riskju għoli, ħlief għas-s-sistemi imsemmija fil-paragrafu 1 ta’ dan l-Artikolu,li ġew introdotti fis-suq jew li tqiegħdu fis-servizz qabel id-data tal-applikazzjoni tal-Kapitolu III msemmija fl-Artikolu 113, biss jekk minn dik id-data dawk is-sistemi jkunu soġġetti għal bidliet sinifikanti fid-disinni tagħhom. Fi kwalunkwe każ, il-fornituri u l-implimentaturi tas-sistemi tal-IA b’riskju għoli maħsuba biex jintużaw mill-awtoritajiet pubbliċi għandhom jieħdu l-passi neċessarji biex jikkonformaw mar-rekwiżiti u l-obbligi stabbiliti f’dan ir-Regolament sat-2 ta’ Awwissu 2030.
Artikolu 111 3.
Il-fornituri ta' mudelli tal-IA bi skop ġenerali li ġew introdotti fis-suq qabel it-2 ta’ Awwissu 2025 għandhom jieħdu l-passi meħtieġa biex jikkonformaw mal-obbligi stabbiliti f'dan ir-Regolament sat-2 ta’ Awwissu 2027.
Artikolu 111 4.
Il-fornituri tas-sistemi tal-IA, inkluż tas-sistemi tal-IA bi skop ġenerali, li jiġġeneraw kontenut sintetiku ta’ awdjo, immaġni, video jew test, u li jkunu ġew introdotti fis-suq qabel it-2 ta’ Awwissu 2026 għandhom jieħdu l-passi neċessarji biex jikkonformaw mal-Artikolu 50(2) sat-2 ta’ Diċembru 2026.

1.1 Referenzi

1.2 Rekwiżiti identifikati

1.3 Standards relatati

2. Rekwiżiti identifikati

Rekwiżiti

3. Standards relatati

Standards
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.