1. The Commission is empowered to adopt delegated acts in accordance with Article 97 to amend Annex III by adding or modifying use-cases of high-risk AI systems where both of the following conditions are fulfilled:

(a) the AI systems are intended to be used in any of the areas listed in Annex III;

(b) the AI systems pose a risk of harm to health and safety, or an adverse impact on fundamental rightsfundamental rightsIncludes human dignity, right to life, prohibition of torture, protection of personal datapersonal dataAny information relating to an identified or identifiable natural person ('data subjectsubjectfor the purpose of real-world testing, means a natural person who participates in testing in real-world conditionsArticle 3(58)data subjectsubjectfor the purpose of real-world testing, means a natural person who participates in testing in real-world conditionsArticle 3(58)An identified or identifiable natural person to whom personal data relateGDPR Art. 4(1)'). Includes name, ID number, location data, online identifiers, or factors specific to physical, physiological, genetic, mental, economic, cultural or social identityGDPR Art. 4(1), freedom of expression, non-discrimination, equality between women and men, rights of the child, right to an effective remedy and fair trialCharter of Fundamental Rights Art. 1–54, and that risk is equivalent to, or greater than, the risk of harm or of adverse impact posed by the high-risk AI systems already referred to in Annex III.

2. When assessing the condition under paragraph 1, point (b), the Commission shall take into account the following criteria:

(a) the intended purposeintended purposemeans the use for which an AI systemAI systemmeans a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environmentsArticle 3(1) is intended by the providerprovidermeans a natural or legal person, public authority, agency or other body that develops an AI system or a general-purpose AI model or that has an AI system or a general-purpose AI model developed and places it on the market or puts the AI system into service under its own name or trademark, whether for payment or free of chargeArticle 3(3), including the specific context and conditions of use, as specified in the information supplied by the providerprovidermeans a natural or legal person, public authority, agency or other body that develops an AI system or a general-purpose AI model or that has an AI system or a general-purpose AI model developed and places it on the market or puts the AI system into service under its own name or trademark, whether for payment or free of chargeArticle 3(3) in the instructions for use, promotional or sales materials and statements, as well as in the technical documentationArticle 3(12) of the AI systemAI systemmeans a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environmentsArticle 3(1);

(b) the extent to which an AI systemAI systemmeans a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environmentsArticle 3(1) has been used or is likely to be used;

(c) the nature and amount of the data processed and used by the AI systemAI systemmeans a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environmentsArticle 3(1), in particular whether special categories of personal datapersonal dataAny information relating to an identified or identifiable natural person ('data subjectsubjectfor the purpose of real-world testing, means a natural person who participates in testing in real-world conditionsArticle 3(58)data subjectsubjectfor the purpose of real-world testing, means a natural person who participates in testing in real-world conditionsArticle 3(58)An identified or identifiable natural person to whom personal data relateGDPR Art. 4(1)'). Includes name, ID number, location data, online identifiers, or factors specific to physical, physiological, genetic, mental, economic, cultural or social identityGDPR Art. 4(1)special categories of personal datapersonal dataAny information relating to an identified or identifiable natural person ('data subjectsubjectfor the purpose of real-world testing, means a natural person who participates in testing in real-world conditionsArticle 3(58)data subjectsubjectfor the purpose of real-world testing, means a natural person who participates in testing in real-world conditionsArticle 3(58)An identified or identifiable natural person to whom personal data relateGDPR Art. 4(1)'). Includes name, ID number, location data, online identifiers, or factors specific to physical, physiological, genetic, mental, economic, cultural or social identityGDPR Art. 4(1)Racial or ethnic origin, political opinions, religious or philosophical beliefs, trade-union membership, genetic data, biometric databiometric datameans personal data resulting from specific technical processing relating to the physical, physiological or behavioural characteristics of a natural person, such as facial images or dactyloscopic dataArticle 3(34) for unique identification purposes, health data, sex life or sexual orientationGDPR Art. 9(1) are processed;

(d) the extent to which the AI systemAI systemmeans a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environmentsArticle 3(1) acts autonomously and the possibility for a human to override a decision or recommendations that may lead to potential harm;

(e) the extent to which the use of an AI systemAI systemmeans a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environmentsArticle 3(1) has already caused harm to health and safety, has had an adverse impact on fundamental rightsfundamental rightsIncludes human dignity, right to life, prohibition of torture, protection of personal datapersonal dataAny information relating to an identified or identifiable natural person ('data subjectsubjectfor the purpose of real-world testing, means a natural person who participates in testing in real-world conditionsArticle 3(58)data subjectsubjectfor the purpose of real-world testing, means a natural person who participates in testing in real-world conditionsArticle 3(58)An identified or identifiable natural person to whom personal data relateGDPR Art. 4(1)'). Includes name, ID number, location data, online identifiers, or factors specific to physical, physiological, genetic, mental, economic, cultural or social identityGDPR Art. 4(1), freedom of expression, non-discrimination, equality between women and men, rights of the child, right to an effective remedy and fair trialCharter of Fundamental Rights Art. 1–54 or has given rise to significant concerns in relation to the likelihood of such harm or adverse impact, as demonstrated, for example, by reports or documented allegations submitted to national competent authorities or by other reports, as appropriate;

(f) the potential extent of such harm or such adverse impact, in particular in terms of its intensity and its ability to affect multiple persons or to disproportionately affect a particular group of persons;

(g) the extent to which persons who are potentially harmed or suffer an adverse impact are dependent on the outcome produced with an AI systemAI systemmeans a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environmentsArticle 3(1), in particular because for practical or legal reasons it is not reasonably possible to opt-out from that outcome;

(h) the extent to which there is an imbalance of power, or the persons who are potentially harmed or suffer an adverse impact are in a vulnerable position in relation to the deployerdeployermeans a natural or legal person, public authority, agency or other body using an AI system under its authority except where the AI system is used in the course of a personal non-professional activityArticle 3(4) of an AI systemAI systemmeans a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environmentsArticle 3(1), in particular due to status, authority, knowledge, economic or social circumstances, or age;

(i) the extent to which the outcome produced involving an AI systemAI systemmeans a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environmentsArticle 3(1) is easily corrigible or reversible, taking into account the technical solutions available to correct or reverse it, whereby outcomes having an adverse impact on health, safety or fundamental rightsfundamental rightsIncludes human dignity, right to life, prohibition of torture, protection of personal datapersonal dataAny information relating to an identified or identifiable natural person ('data subjectsubjectfor the purpose of real-world testing, means a natural person who participates in testing in real-world conditionsArticle 3(58)data subjectsubjectfor the purpose of real-world testing, means a natural person who participates in testing in real-world conditionsArticle 3(58)An identified or identifiable natural person to whom personal data relateGDPR Art. 4(1)'). Includes name, ID number, location data, online identifiers, or factors specific to physical, physiological, genetic, mental, economic, cultural or social identityGDPR Art. 4(1), freedom of expression, non-discrimination, equality between women and men, rights of the child, right to an effective remedy and fair trialCharter of Fundamental Rights Art. 1–54, shall not be considered to be easily corrigible or reversible;

(j) the magnitude and likelihood of benefit of the deployment of the AI systemAI systemmeans a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environmentsArticle 3(1) for individuals, groups, or society at large, including possible improvements in product safety;

(k) the extent to which existing Union law provides for:

(i) effective measures of redress in relation to the risks posed by an AI systemAI systemmeans a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environmentsArticle 3(1), with the exclusion of claims for damages;

(ii) effective measures to prevent or substantially minimise those risks.

3. The Commission is empowered to adopt delegated acts in accordance with Article 97 to amend the list in Annex III by removing high-risk AI systems where both of the following conditions are fulfilled:

(a) the high-risk AI systemAI systemmeans a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environmentsArticle 3(1) concerned no longer poses any significant risks to fundamental rightsfundamental rightsIncludes human dignity, right to life, prohibition of torture, protection of personal datapersonal dataAny information relating to an identified or identifiable natural person ('data subjectsubjectfor the purpose of real-world testing, means a natural person who participates in testing in real-world conditionsArticle 3(58)data subjectsubjectfor the purpose of real-world testing, means a natural person who participates in testing in real-world conditionsArticle 3(58)An identified or identifiable natural person to whom personal data relateGDPR Art. 4(1)'). Includes name, ID number, location data, online identifiers, or factors specific to physical, physiological, genetic, mental, economic, cultural or social identityGDPR Art. 4(1), freedom of expression, non-discrimination, equality between women and men, rights of the child, right to an effective remedy and fair trialCharter of Fundamental Rights Art. 1–54, health or safety, taking into account the criteria listed in paragraph 2;

(b) the deletion does not decrease the overall level of protection of health, safety and fundamental rightsfundamental rightsIncludes human dignity, right to life, prohibition of torture, protection of personal datapersonal dataAny information relating to an identified or identifiable natural person ('data subjectsubjectfor the purpose of real-world testing, means a natural person who participates in testing in real-world conditionsArticle 3(58)data subjectsubjectfor the purpose of real-world testing, means a natural person who participates in testing in real-world conditionsArticle 3(58)An identified or identifiable natural person to whom personal data relateGDPR Art. 4(1)'). Includes name, ID number, location data, online identifiers, or factors specific to physical, physiological, genetic, mental, economic, cultural or social identityGDPR Art. 4(1), freedom of expression, non-discrimination, equality between women and men, rights of the child, right to an effective remedy and fair trialCharter of Fundamental Rights Art. 1–54 under Union law.