What changed between the plenary report and the adopted text

Article 3 – paragraph 1 – point 15: (15) ‘instructions for use’ means the information provided by the provider to inform the deployer of in particular an AI system’s intended purpose and proper use, as well as information on any precautions to be taken; inclusive of the specific geographical, behavioural or functional setting within which the high-risk AI system is intended to be used;

Article 3 – paragraph 1 – point 16: (16) ‘recall of an AI system’ means any measure aimed at achieving the return to the provider of an AI system that has been made available to deployers;

Article 3 – paragraph 1 – point 20: (20) ‘conformity assessment’ means the process of demonstrating whether the requirements set out in Title III, Chapter 2 of this Regulation relating to an AI system have been fulfilled;

Article 3 – paragraph 1 – point 22: (22) ‘notified body’ means a conformity assessment body notified in accordance with this Regulation and other relevant Union harmonisation legislation;

Article 3 – paragraph 1 – point 23: (23) ‘substantial modification’ means a modification or a series of modifications of the AI system after its placing on the market or putting into service which is not foreseen or planned in the initial risk assessment by the provider and as a result of which the compliance of the AI system with the requirements set out in Title III, Chapter 2 of this Regulation is affected or results in a modification to the intended purpose for which the AI system has been assessed;

Article 3 – paragraph 1 – point 24: (24) ‘CE marking of conformity’ (CE marking) means a physical or digital marking by which a provider indicates that an AI system or a product with an embedded AI system is in conformity with the requirements set out in Title III, Chapter 2 of this Regulation and other applicable Union legislation harmonising the conditions for the marketing of products (‘Union harmonisation legislation’) providing for its affixing;

Article 3 – paragraph 1 – point 29: (29) ‘training data’ means data used for training an AI system through fitting its learnable parameters;

Article 3 – paragraph 1 – point 30: (30) ‘validation data’ means data used for providing an evaluation of the trained AI system and for tuning its non-learnable parameters and its learning process, among other things, in order to prevent underfitting or overfitting; whereas the validation dataset is a separate dataset or part of the training dataset, either as a fixed or variable split;

Article 3 – paragraph 1 – point 33: (33) ‘biometric data’ means biometric data as defined in Article 4, point (14) of Regulation (EU) 2016/679;

Article 3 – paragraph 1 – point 34: (34) ‘emotion recognition system’ means an AI system for the purpose of identifying or inferring emotions, thoughts, states of mind or intentions of individuals or groups on the basis of their biometric and biometric-based data;

Article 3 – paragraph 1 – point 35: (35) ‘biometric categorisation means assigning natural persons to specific categories, or inferring their characteristics and attributes on the basis of their biometric or biometric-based data, or which can be inferred from such data;

Article 3 – paragraph 1 – point 36: (36) ‘remote biometric identification system’ means an AI system for the purpose of identifying natural persons at a distance through the comparison of a person’s biometric data with the biometric data contained in a reference database, and without prior knowledge of the deployer of the AI system whether the person will be present and can be identified, excluding verification systems;

Article 3 – paragraph 1 – point 37: (37) ‘‘real-time’ remote biometric identification system’ means a remote biometric identification system whereby the capturing of biometric data, the comparison and the identification all occur without a significant delay. This comprises not only instant identification, but also limited delays in order to avoid circumvention;

Article 3 – paragraph 1 – point 39: (39) ‘publicly accessible space’ means any publicly or privately owned physical place accessible to the public, regardless of whether certain conditions for access may apply, and regardless of the potential capacity restrictions;

Article 3 – paragraph 1 – point 41: (41) ‘law enforcement’ means activities carried out by law enforcement authorities or on their behalf for the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, including the safeguarding against and the prevention of threats to public security;

Article 3 – paragraph 1 – point 42: (42) ‘national supervisory authority’ means a public (AM 69) authority to which a Member State assigns the responsibility for the implementation and application of this Regulation, for coordinating the activities entrusted to that Member State, for acting as the single contact point for the Commission, and for representing the Member State in the management Board of the AI Office;

Article 3 – paragraph 1 – point 43: (43) ‘national competent authority’ means any of the national authorities which are responsible for the enforcement of this Regulation;

Article 4: deleted / (deleted) / (deleted)

Article 4 a (new): Article 4 a / General principles applicable to all AI systems / 1. All operators falling under this Regulation shall make their best efforts to develop and use AI systems or foundation models in accordance with the following general principles establishing a high-level framework that promotes a coherent human-centric European approach to ethical and trustworthy Artificial Intelligence, which is fully in line with the Charter as well as the values on which the Union is founded: / a) ‘human agency and oversight’ means that AI systems shall be developed and used as a tool that serves people, respects human dignity and personal autonomy, and that is functioning in a way that can be appropriately controlled and overseen by humans; / b) ‘technical robustness and safety’ means that AI systems shall be developed and used in a way to minimize unintended and unexpected harm as well as being robust in case of unintended problems and being resilient against attempts to alter the use or performance of the AI system so as to allow unlawful use by malicious third parties; / c) ‘privacy and data governance’ means that AI systems shall be developed and used in compliance with existing privacy and data protection rules, while processing data that meets high standards in terms of quality and integrity; / d) ‘transparency’ means that AI systems shall be developed and used in a way that allows appropriate traceability and explainability, while making humans aware that they communicate or interact…

Article 4 b (new): Article 4 b / AI literacy / 1. When implementing this Regulation, the Union and the Member States shall promote measures for the development of a sufficient level of AI literacy, across sectors and taking into account the different needs of groups of providers, deployers and affected persons concerned, including through education and training, skilling and reskilling programmes and while ensuring proper gender and age balance, in view of allowing a democratic control of AI systems / 2. Providers and deployers of AI systems shall take measures to ensure a sufficient level of AI literacy of their staff and other persons dealing with the operation and use of AI systems on their behalf, taking into account their technical knowledge, experience, education and training and the context the AI systems are to be used in, and considering the persons or groups of persons on which the AI systems are to be used. / 3. Such literacy measures shall consist, in particular, of the teaching of basic notions and skills about AI systems and their functioning, including the different types of products and uses, their risks and benefits. / 4. A sufficient level of AI literacy is one that contributes, as necessary, to the ability of providers and deployers to ensure compliance and enforcement of this Regulation.

Article 5 – paragraph 1 – point a: (a) the placing on the market, putting into service or use of an AI system that deploys subliminal techniques beyond a person’s consciousness or purposefully manipulative or deceptive techniques, with the objective to or the effect of materially distorting a person’s or a group of persons’ behaviour by appreciably impairing the person’s ability to make an informed decision, thereby causing the person to take a decision that that person would not have otherwise taken in a manner that causes or is likely to cause that person, another person or group of persons significant harm; / The prohibition of AI system that deploys subliminal techniques referred to in the first sub-paragraph shall not apply to AI systems intended to be used for approved therapeutical purposes on the basis of specific informed consent of the individuals that are exposed to them or, where applicable, of their legal guardian;

Article 5 – paragraph 1 – point b: (b) the placing on the market, putting into service or use of an AI system that exploits any of the vulnerabilities of a person or a specific group of persons, including characteristics of such person’s or a such group’s known or predicted personality traits or social or economic situation age, physical or mental ability with the objective or to the effect of materially distorting the behaviour of that person or a person pertaining to that group in a manner that causes or is likely to cause that person or another person significant harm;;

Article 5 – paragraph 1 – point b a (new): (b a) the placing on the market, putting into service or use of biometric categorisation systems that categorise natural persons according to sensitive or protected attributes or characteristics or based on the inference of those attributes or characteristics. This prohibition shall not apply to AI systems intended to be used for approved therapeutical purposes on the basis of specific informed consent of the individuals that are exposed to them or, where applicable, of their legal guardian.

Article 5 – paragraph 1 – point c – introductory part: (c) the placing on the market, putting into service or use of AI systems for the social scoring evaluation or classification of natural persons or groups thereof over a certain period of time based on their social behaviour or known, inferred or predicted personal or personality characteristics, with the social score leading to either or both of the following:

Article 5 – paragraph 1 – point c – point i: (i) detrimental or unfavourable treatment of certain natural persons or whole groups thereof in social contexts that are unrelated to the contexts in which the data was originally generated or collected;

Article 5 – paragraph 1 – point d – introductory part: (d) the use of ‘real-time’ remote biometric identification systems in publicly accessible spaces;