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AI-Regulation (Proposal)
Article 3

Article 3 — Definitions

For the purpose of this Regulation, the following definitions apply:

  1. artificial intelligence system (AI system) means software that is developed with one or more of the techniques and approaches listed in Annex I and can, for a given set of human-defined objectives, generate outputs such as content, predictions, recommendations, or decisions influencing the environments they interact with;
  1. (1)provider means a natural or legal person, public authority, agency or other body that develops an AI system or that has an AI system developed with a view to placing it on the market or putting it into service under its own name or trademark, whether for payment or free of charge;
    1. small-scale provider means a provider that is a micro or small enterprise within the meaning of Commission Recommendation 2003/361/EC 61;
    2. user means any 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 activity;
    3. authorised representative means any natural or legal person established in the Union who has received a written mandate from a provider of an AI system to, respectively, perform and carry out on its behalf the obligations and procedures established by this Regulation;
    4. importer means any natural or legal person established in the Union that places on the market or puts into service an AI system that bears the name or trademark of a natural or legal person established outside the Union;
    5. distributor means any natural or legal person in the supply chain, other than the provider or the importer, that makes an AI system available on the Union market without affecting its properties;
    6. operator means the provider, the user, the authorised representative, the importer and the distributor;
    7. placing on the market means the first making available of an AI system on the Union market;
    8. making available on the market means any supply of an AI system for distribution or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge;
    9. putting into service means the supply of an AI system for first use directly to the user or for own use on the Union market for its intended purpose;
    10. intended purpose means the use for which an AI system is intended by the provider, including the specific context and conditions of use, as specified in the information supplied by the provider in the instructions for use, promotional or sales materials and statements, as well as in the technical documentation;
    11. reasonably foreseeable misuse means the use of an AI system in a way that is not in accordance with its intended purpose, but which may result from reasonably foreseeable human behaviour or interaction with other systems;
    12. safety component of a product or system means a component of a product or of a system which fulfils a safety function for that product or system or the failure or malfunctioning of which endangers the health and safety of persons or property;
    13. instructions for use means the information provided by the provider to inform the user of in particular an AI system’s intended purpose and proper use, inclusive of the specific geographical, behavioural or functional setting within which the high-risk AI system is intended to be used;
    14. recall of an AI system means any measure aimed at achieving the return to the provider of an AI system made available to users;
    15. withdrawal of an AI system means any measure aimed at preventing the distribution, display and offer of an AI system;
    16. performance of an AI system means the ability of an AI system to achieve its intended purpose;
    17. notifying authority means the national authority responsible for setting up and carrying out the necessary procedures for the assessment, designation and notification of conformity assessment bodies and for their monitoring;
    18. conformity assessment means the process of verifying whether the requirements set out in Title III, Chapter 2 of this Regulation relating to an AI system have been fulfilled;
    19. conformity assessment body means a body that performs third-party conformity assessment activities, including testing, certification and inspection;
    20. notified body means a conformity assessment body designated in accordance with this Regulation and other relevant Union harmonisation legislation;
    21. substantial modification means a change to the AI system following its placing on the market or putting into service which affects the compliance of the AI system with the requirements set out in Title III, Chapter 2 of this Regulation or results in a modification to the intended purpose for which the AI system has been assessed;
    22. CE marking of conformity (CE marking) means a marking by which a provider indicates that an 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;
    23. post-market monitoring means all activities carried out by providers of AI systems to proactively collect and review experience gained from the use of AI systems they place on the market or put into service for the purpose of identifying any need to immediately apply any necessary corrective or preventive actions;
    24. market surveillance authority means the national authority carrying out the activities and taking the measures pursuant to Regulation (EU) 2019/1020;
    25. harmonised standard means a European standard as defined in Article 2(1)(c) of Regulation (EU) No 1025/2012;
    26. common specifications means a document, other than a standard, containing technical solutions providing a means to, comply with certain requirements and obligations established under this Regulation;
    27. training data means data used for training an AI system through fitting its learnable parameters, including the weights of a neural network;
    28. 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 overfitting; whereas the validation dataset can be a separate dataset or part of the training dataset, either as a fixed or variable split;
    29. testing data means data used for providing an independent evaluation of the trained and validated AI system in order to confirm the expected performance of that system before its placing on the market or putting into service;
    30. input data means data provided to or directly acquired by an AI system on the basis of which the system produces an output;
    31. biometric data means personal data resulting from specific technical processing relating to the physical, physiological or behavioural characteristics of a natural person, which allow or confirm the unique identification of that natural person, such as facial images or dactyloscopic data;
    32. emotion recognition system means an AI system for the purpose of identifying or inferring emotions or intentions of natural persons on the basis of their biometric data;
    33. biometric categorisation system means an AI system for the purpose of assigning natural persons to specific categories, such as sex, age, hair colour, eye colour, tattoos, ethnic origin or sexual or political orientation, on the basis of their biometric data;
    34. 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 user of the AI system whether the person will be present and can be identified ;
    35. 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 short delays in order to avoid circumvention.
    36. post remote biometric identification system’ means a remote biometric identification system other than a real-time remote biometric identification system;
    37. publicly accessible space means any physical place accessible to the public, regardless of whether certain conditions for access may apply;
    38. law enforcement authority means:
      1. any public authority competent 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; or
      2. any other body or entity entrusted by Member State law to exercise public authority and public powers for the purposes of 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;
    39. law enforcement means activities carried out by law enforcement authorities 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;
    40. national supervisory authority means the 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 at the European Artificial Intelligence Board;
    41. national competent authority means the national supervisory authority, the notifying authority and the market surveillance authority;
    42. serious incident means any incident that directly or indirectly leads, might have led or might lead to any of the following:
      1. the death of a person or serious damage to a person’s health, to property or the environment,
      2. a serious and irreversible disruption of the management and operation of critical infrastructure.