+Article 61 Informed consent to participate in testing in real world conditions outside AI regulatory sandboxes

Article 61 Informed consent to participate in testing in real world conditions outside AI regulatory sandboxes

Article 61

Informed consent to participate in testing in real world conditions outside AI regulatory sandboxes

1.   For the purpose of testing in real world conditions under Article 60, freely-given informed consent shall be obtained from the subjects of testing prior to their participation in such testing and after their having been duly informed with concise, clear, relevant, and understandable information regarding:

(a)

the nature and objectives of the testing in real world conditions and the possible inconvenience that may be linked to their participation;

(b)

the conditions under which the testing in real world conditions is to be conducted, including the expected duration of the subject or subjects’ participation;

(c)

their rights, and the guarantees regarding their participation, in particular their right to refuse to participate in, and the right to withdraw from, testing in real world conditions at any time without any resulting detriment and without having to provide any justification;

(d)

the arrangements for requesting the reversal or the disregarding of the predictions, recommendations or decisions of the AI system;

(e)

the Union-wide unique single identification number of the testing in real world conditions in accordance with Article 60(4) point (c), and the contact details of the provider or its legal representative from whom further information can be obtained.

2.   The informed consent shall be dated and documented and a copy shall be given to the subjects of testing or their legal representative.

1. Übersicht

1.1 Referenzen

1.2 Identifizierte Anforderungen

1.3 Related Standards

2. Identifizierte Anforderungen

Anforderungen

3. Related Standards

Standards
SCF Real World Testing of AI & Autonomous Technologies

Description

Mechanisms exist to obtain consent from the subjects of testing Artificial Intelligence (AI) and Autonomous Technologies (AAT):
(1) Prior to their participation in such testing; and
(2) After they have been provided with clear and concise information regarding the testing.

Possible Solutions & Considerations

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

∙ Obtain written consent before using individuals in AI testing

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

∙ Consent procedures for AI real-world testing participants

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

∙ Formal consent process for AI testing subjects
∙ Pre- and post-testing consent

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

∙ AI testing consent management program
∙ Ethics review for sensitive AI testing

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

∙ Enterprise AI testing ethics program
∙ Formal consent management platform
∙ Ethics review board
∙ Regulatory compliance for AI testing

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, risk assessments, etc.).
▪ 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, 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.

Level 3 Well Defined

Artificial Intelligence and Autonomous Technology (AAT) 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 AAT 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 AAT domain capabilities are well-documented and kept current by process owners.
▪ An Artificial Intelligence Governance (AIG) team, or similar function, is appropriately staffed and supported to implement and maintain AAT domain capabilities.
▪ Technology is leveraged to enhance the efficiency and accuracy of AI governance, risk management and compliance operations (e.g., dedicated AI governance 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 AAT 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 obtain consent from the subjects of testing AAT:
(1) Prior to their participation in such testing; and
(2) After they have been provided with clear and concise information regarding the testing.

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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