+Article 18 Documentation keeping
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Article 18 Documentation keeping
Article 18
1. The provider shall, for a period ending 10 years after the high-risk AI system has been placed on the market or put into service, keep at the disposal of the national competent authorities:
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(a)
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the technical documentation referred to in Article 11;
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(b)
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the documentation concerning the quality management system referred to in Article 17;
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(c)
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the documentation concerning the changes approved by notified bodies, where applicable;
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(d)
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the decisions and other documents issued by the notified bodies, where applicable;
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(e)
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the EU declaration of conformity referred to in Article 47.
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2. Each Member State shall determine conditions under which the documentation referred to in paragraph 1 remains at the disposal of the national competent authorities for the period indicated in that paragraph for the cases when a provider or its authorised representative established on its territory goes bankrupt or ceases its activity prior to the end of that period.
3. Providers that are financial institutions subject to requirements regarding their internal governance, arrangements or processes under Union financial services law shall maintain the technical documentation as part of the documentation kept under the relevant Union financial services law.
1. Übersicht
1.1 Referenzen
1.2 Identifizierte Anforderungen
1.3 Related Standards
2. Identifizierte Anforderungen
Anforderungen
| Source |
Anforderung |
3. Related Standards
Standards
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Anforderung |
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SCF
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Media & Data Retention
Description
Mechanisms exist to retain media and data in accordance with applicable statutory, regulatory and contractual obligations.
Possible Solutions & Considerations
Micro-Small Business (<10 staff) / BLS Firm Size Classes 1-2
∙ Data retention program
∙ Data classification program
Small Business (10-49 staff) / BLS Firm Size Classes 3-4
∙ Data retention program
∙ Data classification program
Medium Business (50-249 staff) / BLS Firm Size Classes 5-6
∙ Data retention program
∙ Data classification program
Large Business (250-999 staff) / BLS Firm Size Classes 7-8
∙ Data retention program
∙ Data classification program
∙ Data governance program
Enterprise (> 1,000 staff) / BLS Firm Size Class 9
∙ Data retention program
∙ Data classification program
∙ Data governance program
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
Data Classification & Handling (DCH) domain capabilities are ad hoc and inconsistent. Capability criteria associated with this control may include:
▪ Policies, standards & procedures associated with DCH domain capabilities provide limited coverage due to the depth and breadth of the existing documentation.
▪ Data management-related activities are decentralized (e.g., a localized/regionalized function) and uses non-standardized methods to implement secure, resilient and compliant practices.
▪ Data protection controls are primarily administrative in nature (e.g., policies & standards) to classify, protect and dispose of systems and data, including storage media.
▪ A manual data retention process exists.
▪ Media is securely stored until it is destroyed or sanitized using approved equipment, techniques and procedures.
Level 2 Planned Tracked
Data Classification & Handling (DCH) 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 DCH domain capabilities are formally documented and centrally-managed by the entity.
▪ Standardized Operating Procedures (SOP) associated with DCH 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 DCH domain capabilities to address applicable statutory, regulatory and/or contractual requirements for Technology Assets, Applications, Services and/or Data (TAASD).
▪ Data classification and handling-related controls are primarily administrative and preventative in nature (e.g., policies, standards, procedures & guidelines).
▪ Data classification and handling management may be a defined function (e.g., team or department) or assigned as an additional duty to existing IT and/or cybersecurity personnel.
▪ A formalized data classification scheme exists to identify categories of data, based on protection requirements from applicable laws, regulations and/or contractual obligations.
▪ The data retention process is manual and IT and/or cybersecurity personnel work with business stakeholders and process owners to manage the process.
▪ IT and/or cybersecurity personnel work with business stakeholders and process owners to dispose of, destroy, erase, and/or anonymize sensitive/regulated data.
Level 3 Well Defined
Data Classification & Handling (DCH) 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 DCH 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 DCH domain capabilities are well-documented and kept current by process owners.
▪ A Governance, Risk & Compliance (GRC) team, or similar function, is appropriately staffed and supported to implement and maintain DCH domain capabilities.
▪ Technology is leveraged to enhance the efficiency and accuracy of data classification and handling operations (e.g., GRC platform).
▪ The entity's Governance, Risk & Compliance (GRC) team, or similar function, works with business stakeholders and process owners to appropriately scope and reasonably implement cybersecurity and data protection controls associated with DCH 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 retain media and data in accordance with applicable statutory, regulatory and contractual obligations.
Level 4 Quantitatively Controlled
Data Classification & Handling (DCH) capabilities, in addition to being standardized across the entity and centrally managed to ensure consistency across Technology Assets, Applications, Services and/or Data (TAASD), efforts are metrics driven to provide sufficient insight for decision makers to predict optimal performance, ensure continued operations and/or identify areas for improvement. Capability criteria associated with this control reasonably expect the following criteria to exist:
▪ Applicable SCR-CMM Level 3 (Well Defined) capabilities are implemented and operational.
▪ Metrics reporting includes quantitative analysis of Key Performance Indicators (KPIs).
▪ Metrics reporting includes quantitative analysis of Key Risk Indicators (KRIs).
▪ Scope of metrics, KPIs and KRIs covers organization-wide cybersecurity and data protection controls, including functions performed by third-parties.
▪ Organizational leadership maintains a formal process to objectively review and respond to metrics, KPIs and KRIs (e.g., monthly or quarterly review).
▪ Based on metrics analysis, process improvement recommendations are submitted for review and are handled in accordance with change control processes.
▪ Business and technical stakeholders are involved in reviewing and approving proposed changes to evolve capabilities.
Level 5 Continuously Improving
Utilize SCR-CMM Level 3 or Level 4 (if available) criteria definitions:
▪ There are no defined Level 5 criteria, since it is reasonable to assume a continuously-improving process is not necessary to operationalize this control.
▪ Level 5 capabilities should be considered “world-class” where the control builds on Level 4 capabilities, but are continuously improving through Artificial Intelligence (AI) and/or Machine Learning (ML) technologies.
▪ While it may be possible to develop responsive capabilities for this control through the use of AI and/or ML technologies, the criteria would be organization-specific to define.
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