+Άρθρο 49 Καταχώριση
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---+Άρθρο 49 2.
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Άρθρο 49 Καταχώριση
1. Επισκόπηση
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Κανονισμός |
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Άρθρο 49 1.
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Πριν από τη διάθεση στην αγορά ή τη θέση σε λειτουργία συστήματος ΤΝ υψηλού κινδύνου που απαριθμείται στο παράρτημα III, με την εξαίρεση συστημάτων ΤΝ υψηλού κινδύνου που αναφέρονται στο παράρτημα III σημείο 2, ο πάροχος ή, κατά περίπτωση, ο εξουσιοδοτημένος αντιπρόσωπος εγγράφεται και καταχωρίζει το σύστημά του στη βάση δεδομένων της ΕΕ που αναφέρεται στο άρθρο 71.
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Άρθρο 49 2.
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Πριν από τη διάθεση στην αγορά ή τη θέση σε λειτουργία συστήματος ΤΝ για το οποίο ο πάροχος έχει καταλήξει στο συμπέρασμα ότι δεν είναι υψηλού κινδύνου σύμφωνα με το άρθρο 6 παράγραφος 3, ο πάροχος ή, κατά περίπτωση, ο εξουσιοδοτημένος αντιπρόσωπος εγγράφεται και καταχωρίζει το εν λόγω σύστημα στη βάση δεδομένων της ΕΕ που αναφέρεται στο άρθρο 71.
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Άρθρο 49 3.
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Πριν από τη θέση σε λειτουργία ή τη χρήση συστήματος ΤΝ υψηλού κινδύνου που απαριθμείται στο παράρτημα III, με την εξαίρεση των συστημάτων ΤΝ υψηλού κινδύνου που απαριθμούνται στο παράρτημα III σημείο 2, οι φορείς εφαρμογής που είναι δημόσιες αρχές, θεσμικά και λοιπά όργανα ή οργανισμοί της Ένωσης ή πρόσωπα που ενεργούν για λογαριασμό τους εγγράφονται, επιλέγουν το σύστημα και καταχωρίζουν τη χρήση του στη βάση δεδομένων της ΕΕ που αναφέρεται στο άρθρο 71.
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Άρθρο 49 4.
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Για συστήματα ΤΝ υψηλού κινδύνου που αναφέρονται στο παράρτημα III σημεία 1, 6 και 7 στους τομείς της επιβολής του νόμου, της διαχείρισης της μετανάστευσης, του ασύλου και των συνοριακών ελέγχων, η καταχώριση που αναφέρεται στις παραγράφους 1, 2 και 3 του παρόντος άρθρου πραγματοποιείται σε ασφαλές μη δημόσιο τμήμα της βάσης δεδομένων της ΕΕ που αναφέρεται στο άρθρο 71 και περιλαμβάνει μόνο τις ακόλουθες πληροφορίες, κατά περίπτωση, που αναφέρονται στα εξής:
α)
παράρτημα VIII τμήμα Α σημεία 1 έως 10, με εξαίρεση τα σημεία 6, 8 και 9·
β)
παράρτημα VIII τμήμα Β σημεία 1 έως 5 και σημεία 8 και 9·
γ)
παράρτημα VIII τμήμα Γ σημεία 1 έως 3·
δ)
παράρτημα IX σημεία 1, 2, 3 και 5.
Μόνο η Επιτροπή και οι εθνικές αρχές που αναφέρονται στο άρθρο 74 παράγραφος 8 έχουν πρόσβαση στα αντίστοιχα τμήματα περιορισμένης πρόσβασης της βάσης δεδομένων της ΕΕ που απαριθμούνται στο πρώτο εδάφιο της παρούσας παραγράφου.
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Άρθρο 49 5.
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Τα συστήματα ΤΝ υψηλού κινδύνου που αναφέρονται στο παράρτημα III σημείο 2 καταχωρίζονται σε εθνικό επίπεδο.
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1.1 Παραπομπές
1.2 Εντοπισμένες απαιτήσεις
1.3 Σχετικά πρότυπα
2. Εντοπισμένες απαιτήσεις
3. Σχετικά πρότυπα
Πρότυπα
| Πηγή |
Απαίτηση |
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SCF
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AI & Autonomous Technologies Registration
Description
Mechanisms exist to maintain a current registration for Artificial Intelligence (AI) and Autonomous Technologies (AAT) with the appropriate governing body, as required by statutory or regulatory requirements.
Possible Solutions & Considerations
Micro-Small Business (<10 staff) / BLS Firm Size Classes 1-2
∙ Determine whether any AI use requires registration (e.g., EU AI Act high-risk systems)
Small Business (10-49 staff) / BLS Firm Size Classes 3-4
∙ Track AI registration obligations by jurisdiction in compliance checklist
Medium Business (50-249 staff) / BLS Firm Size Classes 5-6
∙ Register high-risk AI systems with relevant authorities as required
Large Business (250-999 staff) / BLS Firm Size Classes 7-8
∙ AI registration compliance program
∙ Track registration requirements by jurisdiction
Enterprise (> 1,000 staff) / BLS Firm Size Class 9
∙ Enterprise AI regulatory compliance platform
∙ Automated registration tracking
∙ EU AI Act database registration compliance
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
Artificial Intelligence and Autonomous Technology (AAT) domain capabilities are ad hoc and inconsistent. Capability criteria associated with this control may include:
▪ Policies, standards & procedures associated with AAT domain capabilities provide limited coverage due to the depth and breadth of the existing documentation.
▪ AAT-related processes are expected to follow the organization's existing processes (e.g., incident response, asset management, change control and risk assessments).
▪ No formal Governance, Risk & Compliance (GRC) team exists to provide AAT oversight, where the Chief Information Officer (CIO), or similar function, governs technology decisions what is acceptable for AAT within the organization.
Level 2 Planned Tracked
Artificial Intelligence and Autonomous Technology (AAT) 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 AAT domain capabilities are formally documented and centrally-managed by the entity.
▪ Standardized Operating Procedures (SOP) associated with AAT 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 AAT domain capabilities to address applicable statutory, regulatory and/or contractual requirements for Technology Assets, Applications, Services and/or Data (TAASD).
▪ Artificial Intelligence (AI)-related controls are primarily administrative and preventative in nature (e.g., policies, standards and procedures & guidelines).
▪ Asset management may be a defined function (e.g., team or department) or assigned as an additional duty to existing IT and/or cybersecurity personnel.
▪ AAT is regarded as a technology and governed by the entity's existing IT governance practices.
▪ No formal Governance, Risk & Compliance (GRC) team exists to provide oversight of AAT-related activities. GRC functions are assigned to existing IT and/or cybersecurity personnel.
Level 3 Well Defined
Compliance (CPL) capabilities are standardized across the entity for applicability to People, Processes, Technologies, Data and/or Facilities (PPTDF) to ensure consistency for Technology Assets, Applications, Services and/or Data (TAASD). Capability criteria associated with this control reasonably expect the following criteria to exist:
▪ Policies and standards associated with CPL domain capabilities are formally documented and centrally-managed by the entity's Governance, Risk & Compliance (GRC) team, or similar function.
▪ Standardized Operating Procedures (SOP) associated with CPL domain capabilities are well-documented and kept current by process owners.
▪ A Governance, Risk & Compliance (GRC) team, or similar function, is appropriately staffed and supported to implement and maintain CPL domain capabilities.
▪ Technology is leveraged to enhance the efficiency and accuracy of governance, risk management and compliance operations (e.g., GRC platform).
▪ The entity's Governance, Risk & Compliance (GRC) team, or similar function, works with business stakeholders and process owners to appropriately scope and reasonably implement cybersecurity and data protection controls associated with CPL domain capabilities to address Minimum Compliance Requirements (MCR) (e.g., applicable statutory, regulatory and/or contractual requirements) and Discretionary Security Requirements (DSR) (e.g., entity-required controls).
▪ An implemented and operational capability exists to maintain a current registration for AAT with the appropriate governing body, as required by statutory or regulatory requirements.
Level 4 Quantitatively Controlled
Utilize SCR-CMM Level 3 criteria definitions:
▪ There are no defined Level 4 criteria, since it is reasonable to assume a quantitatively-controlled process is not necessary to operationalize this control.
▪ While it may be possible to develop “metrics-driven” capabilities for this control, the criteria would be organization-specific to define.
Level 5 Continuously Improving
Utilize SCR-CMM Level 3 or Level 4 (if available) criteria definitions:
▪ There are no defined Level 5 criteria, since it is reasonable to assume a continuously-improving process is not necessary to operationalize this control.
▪ Level 5 capabilities should be considered “world-class” where the control builds on Level 4 capabilities, but are continuously improving through Artificial Intelligence (AI) and/or Machine Learning (ML) technologies.
▪ While it may be possible to develop responsive capabilities for this control through the use of AI and/or ML technologies, the criteria would be organization-specific to define.
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SCF
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AI & Autonomous Technologies Registration
Description
Mechanisms exist to maintain a current registration for Artificial Intelligence (AI) and Autonomous Technologies (AAT) with the appropriate governing body, as required by statutory or regulatory requirements.
Possible Solutions & Considerations
Micro-Small Business (<10 staff) / BLS Firm Size Classes 1-2
∙ Determine whether any AI use requires registration (e.g., EU AI Act high-risk systems)
Small Business (10-49 staff) / BLS Firm Size Classes 3-4
∙ Track AI registration obligations by jurisdiction in compliance checklist
Medium Business (50-249 staff) / BLS Firm Size Classes 5-6
∙ Register high-risk AI systems with relevant authorities as required
Large Business (250-999 staff) / BLS Firm Size Classes 7-8
∙ AI registration compliance program
∙ Track registration requirements by jurisdiction
Enterprise (> 1,000 staff) / BLS Firm Size Class 9
∙ Enterprise AI regulatory compliance platform
∙ Automated registration tracking
∙ EU AI Act database registration compliance
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
Artificial Intelligence and Autonomous Technology (AAT) domain capabilities are ad hoc and inconsistent. Capability criteria associated with this control may include:
▪ Policies, standards & procedures associated with AAT domain capabilities provide limited coverage due to the depth and breadth of the existing documentation.
▪ AAT-related processes are expected to follow the organization's existing processes (e.g., incident response, asset management, change control and risk assessments).
▪ No formal Governance, Risk & Compliance (GRC) team exists to provide AAT oversight, where the Chief Information Officer (CIO), or similar function, governs technology decisions what is acceptable for AAT within the organization.
Level 2 Planned Tracked
Artificial Intelligence and Autonomous Technology (AAT) 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 AAT domain capabilities are formally documented and centrally-managed by the entity.
▪ Standardized Operating Procedures (SOP) associated with AAT 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 AAT domain capabilities to address applicable statutory, regulatory and/or contractual requirements for Technology Assets, Applications, Services and/or Data (TAASD).
▪ Artificial Intelligence (AI)-related controls are primarily administrative and preventative in nature (e.g., policies, standards and procedures & guidelines).
▪ Asset management may be a defined function (e.g., team or department) or assigned as an additional duty to existing IT and/or cybersecurity personnel.
▪ AAT is regarded as a technology and governed by the entity's existing IT governance practices.
▪ No formal Governance, Risk & Compliance (GRC) team exists to provide oversight of AAT-related activities. GRC functions are assigned to existing IT and/or cybersecurity personnel.
Level 3 Well Defined
Compliance (CPL) capabilities are standardized across the entity for applicability to People, Processes, Technologies, Data and/or Facilities (PPTDF) to ensure consistency for Technology Assets, Applications, Services and/or Data (TAASD). Capability criteria associated with this control reasonably expect the following criteria to exist:
▪ Policies and standards associated with CPL domain capabilities are formally documented and centrally-managed by the entity's Governance, Risk & Compliance (GRC) team, or similar function.
▪ Standardized Operating Procedures (SOP) associated with CPL domain capabilities are well-documented and kept current by process owners.
▪ A Governance, Risk & Compliance (GRC) team, or similar function, is appropriately staffed and supported to implement and maintain CPL domain capabilities.
▪ Technology is leveraged to enhance the efficiency and accuracy of governance, risk management and compliance operations (e.g., GRC platform).
▪ The entity's Governance, Risk & Compliance (GRC) team, or similar function, works with business stakeholders and process owners to appropriately scope and reasonably implement cybersecurity and data protection controls associated with CPL domain capabilities to address Minimum Compliance Requirements (MCR) (e.g., applicable statutory, regulatory and/or contractual requirements) and Discretionary Security Requirements (DSR) (e.g., entity-required controls).
▪ An implemented and operational capability exists to maintain a current registration for AAT with the appropriate governing body, as required by statutory or regulatory requirements.
Level 4 Quantitatively Controlled
Utilize SCR-CMM Level 3 criteria definitions:
▪ There are no defined Level 4 criteria, since it is reasonable to assume a quantitatively-controlled process is not necessary to operationalize this control.
▪ While it may be possible to develop “metrics-driven” capabilities for this control, the criteria would be organization-specific to define.
Level 5 Continuously Improving
Utilize SCR-CMM Level 3 or Level 4 (if available) criteria definitions:
▪ There are no defined Level 5 criteria, since it is reasonable to assume a continuously-improving process is not necessary to operationalize this control.
▪ Level 5 capabilities should be considered “world-class” where the control builds on Level 4 capabilities, but are continuously improving through Artificial Intelligence (AI) and/or Machine Learning (ML) technologies.
▪ While it may be possible to develop responsive capabilities for this control through the use of AI and/or ML technologies, the criteria would be organization-specific to define.
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SCF
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AI & Autonomous Technologies Registration
Description
Mechanisms exist to maintain a current registration for Artificial Intelligence (AI) and Autonomous Technologies (AAT) with the appropriate governing body, as required by statutory or regulatory requirements.
Possible Solutions & Considerations
Micro-Small Business (<10 staff) / BLS Firm Size Classes 1-2
∙ Determine whether any AI use requires registration (e.g., EU AI Act high-risk systems)
Small Business (10-49 staff) / BLS Firm Size Classes 3-4
∙ Track AI registration obligations by jurisdiction in compliance checklist
Medium Business (50-249 staff) / BLS Firm Size Classes 5-6
∙ Register high-risk AI systems with relevant authorities as required
Large Business (250-999 staff) / BLS Firm Size Classes 7-8
∙ AI registration compliance program
∙ Track registration requirements by jurisdiction
Enterprise (> 1,000 staff) / BLS Firm Size Class 9
∙ Enterprise AI regulatory compliance platform
∙ Automated registration tracking
∙ EU AI Act database registration compliance
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
Artificial Intelligence and Autonomous Technology (AAT) domain capabilities are ad hoc and inconsistent. Capability criteria associated with this control may include:
▪ Policies, standards & procedures associated with AAT domain capabilities provide limited coverage due to the depth and breadth of the existing documentation.
▪ AAT-related processes are expected to follow the organization's existing processes (e.g., incident response, asset management, change control and risk assessments).
▪ No formal Governance, Risk & Compliance (GRC) team exists to provide AAT oversight, where the Chief Information Officer (CIO), or similar function, governs technology decisions what is acceptable for AAT within the organization.
Level 2 Planned Tracked
Artificial Intelligence and Autonomous Technology (AAT) 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 AAT domain capabilities are formally documented and centrally-managed by the entity.
▪ Standardized Operating Procedures (SOP) associated with AAT 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 AAT domain capabilities to address applicable statutory, regulatory and/or contractual requirements for Technology Assets, Applications, Services and/or Data (TAASD).
▪ Artificial Intelligence (AI)-related controls are primarily administrative and preventative in nature (e.g., policies, standards and procedures & guidelines).
▪ Asset management may be a defined function (e.g., team or department) or assigned as an additional duty to existing IT and/or cybersecurity personnel.
▪ AAT is regarded as a technology and governed by the entity's existing IT governance practices.
▪ No formal Governance, Risk & Compliance (GRC) team exists to provide oversight of AAT-related activities. GRC functions are assigned to existing IT and/or cybersecurity personnel.
Level 3 Well Defined
Compliance (CPL) capabilities are standardized across the entity for applicability to People, Processes, Technologies, Data and/or Facilities (PPTDF) to ensure consistency for Technology Assets, Applications, Services and/or Data (TAASD). Capability criteria associated with this control reasonably expect the following criteria to exist:
▪ Policies and standards associated with CPL domain capabilities are formally documented and centrally-managed by the entity's Governance, Risk & Compliance (GRC) team, or similar function.
▪ Standardized Operating Procedures (SOP) associated with CPL domain capabilities are well-documented and kept current by process owners.
▪ A Governance, Risk & Compliance (GRC) team, or similar function, is appropriately staffed and supported to implement and maintain CPL domain capabilities.
▪ Technology is leveraged to enhance the efficiency and accuracy of governance, risk management and compliance operations (e.g., GRC platform).
▪ The entity's Governance, Risk & Compliance (GRC) team, or similar function, works with business stakeholders and process owners to appropriately scope and reasonably implement cybersecurity and data protection controls associated with CPL domain capabilities to address Minimum Compliance Requirements (MCR) (e.g., applicable statutory, regulatory and/or contractual requirements) and Discretionary Security Requirements (DSR) (e.g., entity-required controls).
▪ An implemented and operational capability exists to maintain a current registration for AAT with the appropriate governing body, as required by statutory or regulatory requirements.
Level 4 Quantitatively Controlled
Utilize SCR-CMM Level 3 criteria definitions:
▪ There are no defined Level 4 criteria, since it is reasonable to assume a quantitatively-controlled process is not necessary to operationalize this control.
▪ While it may be possible to develop “metrics-driven” capabilities for this control, the criteria would be organization-specific to define.
Level 5 Continuously Improving
Utilize SCR-CMM Level 3 or Level 4 (if available) criteria definitions:
▪ There are no defined Level 5 criteria, since it is reasonable to assume a continuously-improving process is not necessary to operationalize this control.
▪ Level 5 capabilities should be considered “world-class” where the control builds on Level 4 capabilities, but are continuously improving through Artificial Intelligence (AI) and/or Machine Learning (ML) technologies.
▪ While it may be possible to develop responsive capabilities for this control through the use of AI and/or ML technologies, the criteria would be organization-specific to define.
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