### (34) as regards the management and operation of critical infrastructure , it is appropriate to classify as high-risk the ai systems intended to be used as safety components in the management and operation of road traffic and the supply of water , gas , heating and electricity , since their failure or malfunctioning may put at risk the life and health of persons at large scale and lead to appreciable disruptions in the ordinary conduct of social and economic activities. ### (34) as regards the management and operation of critical infrastructure , it is appropriate to classify as high-risk the ai systems intended to be used as safety components in the management and operation of road , air and railway traffic and the supply of water , gas , heating and electricity , since their failure or malfunctioning may put at risk the life and health of persons at large scale and lead to appreciable disruptions in the ordinary conduct of social and economic activities.


### (37) another area in which the use of ai systems deserves special consideration is the access to and enjoyment of certain essential private and public services and benefits necessary for people to fully participate in society or to improve one’s standard of living. in particular , ai systems used to evaluate the credit score or creditworthiness of natural persons should be classified as high-risk ai systems , since they determine those persons’ access to financial resources or essential services such as housing , electricity , and telecommunication services. ai systems used for this purpose may lead to discrimination of persons or groups and perpetuate historical patterns of discrimination , for example based on racial or ethnic origins , disabilities , age , sexual orientation , or create new forms of discriminatory impacts. considering the very limited scale of the impact and the available alternatives on the market , it is appropriate to exempt ai systems for the purpose of creditworthiness assessment and credit scoring when put into service by small-scale providers for their own use. natural persons applying for or receiving public assistance benefits and services from public authorities are typically dependent on those benefits and services and in a vulnerable position in relation to the responsible authorities. if ai systems are used for determining whether such benefits and services should be denied , reduced , revoked or reclaimed by authorities , they may have a significant impact on persons’ livelihood and may infringe their fundamental rights , such as the right to social protection , non-discrimination , human dignity or an effective remedy. those systems should therefore be classified as high-risk. nonetheless , this regulation should not hamper the development and use of innovative approaches in the public administration , which would stand to benefit from a wider use of compliant and safe ai systems , provided that those systems do not entail a high risk to legal and natural persons. finally , ai systems used to dispatch or establish priority in the dispatching of emergency first response services should also be classified as high-risk since they make decisions in very critical situations for the life and health of persons and their property. ### (37) another area in which the use of ai systems deserves special consideration is the access to and enjoyment of certain essential private and public services and benefits necessary for people to fully participate in society or to improve one’s standard of living. in particular , ai systems used to evaluate the credit score or creditworthiness of natural persons should be classified as high-risk ai systems , since they determine those persons’ access to financial resources or essential services such as housing , electricity , and telecommunication services. ai systems used for this purpose may lead to discrimination of persons or groups and perpetuate historical patterns of discrimination , for example based on racial or ethnic origins , disabilities , age , sexual orientation , or create new forms of discriminatory impacts. considering the very limited scale of the impact and the available alternatives on the market , it is appropriate to exempt ai systems for the purpose of creditworthiness assessment and credit scoring when put into service by small-scale providers for their own use. due to the fact that ai systems related to low-value credits for the purchase of moveables does not cause high risk , it is proposed to exclude this category from the scope of high-risk ai category as well. natural persons applying for or receiving public assistance benefits and services from public authorities are typically dependent on those benefits and services and in a vulnerable position in relation to the responsible authorities. if ai systems are used for determining whether such benefits and services should be denied , reduced , revoked or reclaimed by authorities , they may have a significant impact on persons’ livelihood and may infringe their fundamental rights , such as the right to social protection , non-discrimination , human dignity or an effective remedy. those systems should therefore be classified as high-risk. nonetheless , this regulation should not hamper the development and use of innovative approaches in the public administration , which would stand to benefit from a wider use of compliant and safe ai systems , provided that those systems do not entail a high risk to legal and natural persons. finally , ai systems used to dispatch or establish priority in the dispatching of emergency first response services should also be classified as high-risk since they make decisions in very critical situations for the life and health of persons and their property.


### (43) requirements should apply to high-risk ai systems as regards the quality of data sets used , technical documentation and record-keeping , transparency and the provision of information to users , human oversight , and robustness , accuracy and cybersecurity. those requirements are necessary to effectively mitigate the risks for health , safety and fundamental rights , as applicable in the light of the intended purpose of the system , and no other less trade restrictive measures are reasonably available , thus avoiding unjustified restrictions to trade. ### (43) requirements should apply to high-risk ai systems as regards the quality of data sets used , technical documentation and record-keeping , transparency and the provision of information to users , human oversight , and robustness , accuracy and cybersecurity. those requirements are necessary to effectively mitigate the risks for health (threatening patient preference , and privacy) , safety and fundamental rights , as applicable in the light of the intended purpose of the system , and no other less trade restrictive measures are reasonably available , thus avoiding unjustified restrictions to trade.


### (48) high-risk ai systems should be designed and developed in such a way that natural persons can oversee their functioning. for this purpose , appropriate human oversight measures should be identified by the provider of the system before its placing on the market or putting into service. in particular , where appropriate , such measures should guarantee that the system is subject to in-built operational constraints that cannot be overridden by the system itself and is responsive to the human operator , and that the natural persons to whom human oversight has been assigned have the necessary competence , training and authority to carry out that role. ### (48) high-risk ai systems should be designed and developed in such a way that natural persons may , when appropriate , oversee their functioning. for this purpose , when it brings a proven added value to the protection of health , safety and fundamental rights , appropriate human oversight measures should be identified by the provider of the system before its placing on the market or putting into service. in particular , where appropriate , such measures should guarantee that the system is subject to in-built operational constraints that cannot be overridden by the system itself and is responsive to the human operator , and that the natural persons to whom human oversight has been assigned have the necessary competence , training and authority to carry out that role.


### (51) cybersecurity plays a crucial role in ensuring that ai systems are resilient against attempts to alter their use , behaviour , performance or compromise their security properties by malicious third parties exploiting the system’s vulnerabilities. cyberattacks against ai systems can leverage ai specific assets , such as training data sets (e.g. data poisoning) or trained models (e.g. adversarial attacks) , or exploit vulnerabilities in the ai system’s digital assets or the underlying ict infrastructure. to ensure a level of cybersecurity appropriate to the risks , suitable measures should therefore be taken by the providers of high-risk ai systems , also taking into account as appropriate the underlying ict infrastructure. ### (51) cybersecurity plays a crucial role in ensuring that ai systems are resilient against attempts to alter their use , behaviour , performance or compromise their security properties by malicious third parties exploiting the system’s vulnerabilities. cyberattacks against ai systems can leverage ai specific assets , such as training data sets (e.g. data poisoning) or trained models (e.g. adversarial attacks) , or exploit vulnerabilities in the ai system’s digital assets or the underlying ict infrastructure. to ensure a level of cybersecurity appropriate to the risks , suitable measures should therefore be taken by the providers of high-risk ai systems , as well as the notified bodies , competent national authorities and market surveillance authorities accessing the data of providers of high risk ai systems , also taking into account as appropriate the underlying ict infrastructure.


### (51) cybersecurity plays a crucial role in ensuring that ai systems are resilient against attempts to alter their use , behaviour , performance or compromise their security properties by malicious third parties exploiting the system’s vulnerabilities. cyberattacks against ai systems can leverage ai specific assets , such as training data sets (e.g. data poisoning) or trained models (e.g. adversarial attacks) , or exploit vulnerabilities in the ai system’s digital assets or the underlying ict infrastructure. to ensure a level of cybersecurity appropriate to the risks , suitable measures should therefore be taken by the providers of high-risk ai systems , also taking into account as appropriate the underlying ict infrastructure. ### (51) cybersecurity plays a crucial role in ensuring that ai systems are resilient against attempts to alter their use , behaviour , performance or compromise their security properties by malicious third parties exploiting the system’s vulnerabilities. cyberattacks against ai systems can leverage ai specific assets , such as training data sets (e.g. data poisoning) or trained models (e.g. adversarial attacks) , or exploit vulnerabilities in the ai system’s digital assets or the underlying ict infrastructure. to ensure a level of cybersecurity appropriate to the risks , suitable measures should therefore be taken by the providers of high-risk ai systems , as well as the notified bodies , competent national authorities and market surveillance authorities accessing the data of providers of high-risk ai systems , also taking into account as appropriate the underlying ict infrastructure.


### (54) the provider should establish a sound quality management system , ensure the accomplishment of the required conformity assessment procedure , draw up the relevant documentation and establish a robust post-market monitoring system. public authorities which put into service high-risk ai systems for their own use may adopt and implement the rules for the quality management system as part of the quality management system adopted at a national or regional level , as appropriate , taking into account the specificities of the sector and the competences and organisation of the public authority in question. ### (54) the provider should establish a sound quality management system , ensure the accomplishment of the required conformity assessment procedure , draw up the relevant documentation in the language of the member state concerned and establish a robust post-market monitoring system. all elements , from design to future development , must be transparent for the user. public authorities which put into service high-risk ai systems for their own use may adopt and implement the rules for the quality management system as part of the quality management system adopted at a national or regional level , as appropriate , taking into account the specificities of the sector and the competences and organisation of the public authority in question.


### (73) in order to promote and protect innovation , it is important that the interests of small-scale providers and users of ai systems are taken into particular account. to this objective , member states should develop initiatives , which are targeted at those operators , including on awareness raising and information communication. moreover , the specific interests and needs of small-scale providers shall be taken into account when notified bodies set conformity assessment fees. translation costs related to mandatory documentation and communication with authorities may constitute a significant cost for providers and other operators , notably those of a smaller scale. member states should possibly ensure that one of the languages determined and accepted by them for relevant providers’ documentation and for communication with operators is one which is broadly understood by the largest possible number of cross-border users. ### (73) in order to promote and protect innovation , it is important that the interests of small-scale providers and users of ai systems are taken into particular account. to this objective , ai solutions and services designed to combat fraud and protect consumers against fraudulent activities should not be considered high risk , nor prohibited. as a matter of substantial public interest , it is vital that this regulation does not undermine the incentive of the industry to create and roll out solutions designed to combat fraud across the european union. furthermore , member states should develop initiatives , which are targeted at those operators , including on awareness raising and information communication. moreover , the specific interests and needs of small-scale providers shall be taken into account when notified bodies set conformity assessment fees. translation costs related to mandatory documentation and communication with authorities may constitute a significant cost for providers and other operators , notably those of a smaller scale. member states should possibly ensure that one of the languages determined and accepted by them for relevant providers’ documentation and for communication with operators is one which is broadly understood by the largest possible number of cross-border users


### 3. this regulation shall not apply to ai systems developed or used exclusively for military purposes. ### 3. this regulation shall not apply to ai systems specially designed , modified , developed or used exclusively for military purposes.


### 3. this regulation shall not apply to ai systems developed or used exclusively for military purposes. ### 3. this regulation shall not apply to ai systems designed , modified , developed or used exclusively for military purposes.


### 3. this regulation shall not apply to ai systems developed or used exclusively for military purposes. ### 3. this regulation shall not apply to ai systems developed or used for military purposes.


### (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) ‘artificial intelligence system’ (ai system) means software that display intelligent behaviour by analysing their environment and taking actions – with some degree of autonomy – to achieve specific goals , which:


### (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) ‘artificial intelligence system’ (ai system) refers to systems designed by humans that , given a complex goal , act in the physical or digital world by perceiving their environment , interpreting the collected structured or unstructured data , reasoning on the knowledge derived from this data and deciding the best action(s) to take (according to pre-defined parameters) to achieve the given goal. ai systems can also be designed to learn to adapt theirbehaviour by analysing how the environment is affected by their previous actions. as a scientific discipline , ai includes several approaches and techniques , such as machine learning (of which deep learning and reinforcement learning are specific examples) , machine reasoning (which includes planning , scheduling , knowledge representation and reasoning , search , and optimization) , and robotics(which includes control , perception , sensors and actuators , as well as the integration of all other techniques into cyber-physical systems);


### (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) ‘artificial intelligence system’ (ai system) means a machine-based system that can , for a given set of human-defined objectives , make predictions , recommendations , or decisions real or virtual environments


### (2) ‘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; ### (2) ‘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 and places that system on the market or puts it into service under its own name or trademark , whether for payment or free of charge;


### (4) ‘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; ### (4) ‘deployer’ 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;


### (4) ‘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; ### (4) ‘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 , this includes research activities to the extent that they are conducted in accordance with generally accepted ethical standards;


### (11) ‘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; ### (11) ‘putting into service’ means the supply of an ai system for first use directly to the user or the end-user for its intended purpose;


### (12) ‘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; ### (12) ‘intended purpose’ means the specific 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; general purpose ai systems shall not be considered as having an intended purpose within the meaning of this regulation;


### (12) ‘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; ### (12) ‘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; general purpose ai systems shall not be considered as having an intended purpose within the meaning of this regulation;


### (13) ‘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; ### (13) ‘reasonably foreseeable misuse’ means the use of an ai system in a way that is not in accordance with its purpose as indicated in instruction for use or technical specification , but which may result from reasonably foreseeable human behaviour or interaction with other systems;


### (14) ‘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; ### (14) ‘safety component of a product or system’ means a component of a product or of a system the failure or malfunctioning of which endangers the health and safety of persons or property;


### (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 user of the ai system whether the person will be present and can be identified ; ### (36) ‘remote biometric identification system’ means an ai system for the purpose of identifying natural persons at a physical distance through a one-to-many’ comparison where the persons identified do not claim to have a particular identity but where that identity is otherwise established – without the conscious cooperation of these persons or against their will – by matching live templates with templates stored in a template database


### (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 user of the ai system whether the person will be present and can be identified ; ### (36) ‘remote biometric identification system’ means an ai system for the purpose of identifying natural persons at a physical 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 ;


### the placing on the market , putting into service or use of an ai system that deploys subliminal techniques beyond a person’s consciousness in order to materially distort a person’s behaviour in a manner that causes or is likely to cause that person or another person physical or psychological harm; ### the placing on the market , putting into service or use of an ai system that deploys subliminal techniques beyond a person’s consciousness in order to materially distort a person’s behaviour in a manner intended to cause that person or another person physical or psychological harm;


### detrimental or unfavourable treatment of certain natural persons or whole groups thereof in social contexts which are unrelated to the contexts in which the data was originally generated or collected; ### preferential , detrimental or unfavourable treatment of certain natural persons or groups thereof in social contexts which are unrelated to the contexts in which the data was originally generated or collected;


### detrimental or unfavourable treatment of certain natural persons or whole groups thereof in social contexts which are unrelated to the contexts in which the data was originally generated or collected; ### deleted


### detrimental or unfavourable treatment of certain natural persons or whole groups thereof in social contexts which are unrelated to the contexts in which the data was originally generated or collected; ### detrimental or unfavourable treatment affecting the fundamental rights of certain natural persons or whole groups thereof in social contexts which are unrelated to the contexts in which the data was originally generated or collected;


### detrimental or unfavourable treatment of certain natural persons or whole groups thereof in social contexts which are unrelated to the contexts in which the data was originally generated or collected; ### preferential , detrimental or unfavourable treatment of certain natural persons or whole groups thereof in social contexts which are unrelated to the contexts in which the data was originally generated or collected;


### (ii) detrimental or unfavourable treatment of certain natural persons or whole groups thereof that is unjustified or disproportionate to their social behaviour or its gravity; ### (ii) preferential , detrimental or unfavourable treatment of certain natural persons or groups thereof that is unjustified or disproportionate to their social behaviour or its gravity;


### (ii) detrimental or unfavourable treatment of certain natural persons or whole groups thereof that is unjustified or disproportionate to their social behaviour or its gravity; ### deleted


### (ii) detrimental or unfavourable treatment of certain natural persons or whole groups thereof that is unjustified or disproportionate to their social behaviour or its gravity; ### (ii) preferential , detrimental or unfavourable treatment of certain natural persons or whole groups thereof that is unjustified or disproportionate to their social behaviour or its gravity;


### the targeted search for specific potential victims of crime , including missing children; ### the targeted search for specific potential victims of crime;


### (iii) the detection , localisation , identification or prosecution of a perpetrator or suspect of a criminal offence referred to in article 2(2) of council framework decision 2002/584/jha62 and punishable in the member state concerned by a custodial sentence or a detention order for a maximum period of at least three years , as determined by the law of that member state. ### deleted


### the ai system is intended to be used as a safety component of a product , or is itself a product , covered by the union harmonisation legislation listed in annex ii; ### the ai system is intended to be used as main safety component of a product , or is itself a product , covered by the union harmonisation legislation listed in annex ii;


### the ai systems pose a risk of harm to the health and safety , or a risk of adverse impact on fundamental rights , that is , in respect of its severity and probability of occurrence , 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. ### the ai systems pose a risk of harm to the health , natural environment and safety , or a risk of adverse impact on fundamental rights , that is , in respect of its severity and probability of occurrence , 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 for the purposes of paragraph 1 whether an ai system poses a risk of harm to the health and safety or a risk of adverse impact on fundamental rights that is equivalent to or greater than the risk of harm posed by the high-risk ai systems already referred to in annex iii , the commission shall take into account the following criteria: ### 2. when assessing for the purposes of paragraph 1 whether an ai system poses a risk of harm to the health , natural environment and safety or a risk of adverse impact on fundamental rights that is equivalent to or greater than the risk of harm posed by the high-risk ai systems already referred to in annex iii , the commission shall take into account the following criteria:


### the extent to which the use of an ai system has already caused harm to the health and safety or adverse impact on the fundamental rights or has given rise to significant concerns in relation to the materialisation of such harm or adverse impact , as demonstrated by reports or documented allegations submitted to national competent authorities; ### the extent to which the use of an ai system has already caused harm to the health , natural environment and safety or adverse impact on the fundamental rights or has given rise to significant concerns in relation to the materialisation of such harm or adverse impact , as demonstrated by reports or documented allegations submitted to national competent authorities;


### 4. the risk management measures referred to in paragraph 2 , point (d) shall be such that any residual risk associated with each hazard as well as the overall residual risk of the high-risk ai systems is judged acceptable , provided that the high-risk ai system is used in accordance with its intended purpose or under conditions of reasonably foreseeable misuse. those residual risks shall be communicated to the user. ### 4. the risk management measures referred to in paragraph 2 , point (d) shall be such that any residual risk associated with each hazard as well as the overall residual risk of the high-risk ai systems is judged acceptable , provided that the high-risk ai system is used in accordance with its intended purpose or under conditions of reasonably foreseeable misuse , subject to terms , conditions as made available by the provider , and contractual and license restrictions. those residual risks shall be communicated to the user


### 4. the risk management measures referred to in paragraph 2 , point (d) shall be such that any residual risk associated with each hazard as well as the overall residual risk of the high-risk ai systems is judged acceptable , provided that the high-risk ai system is used in accordance with its intended purpose or under conditions of reasonably foreseeable misuse. those residual risks shall be communicated to the user. ### 4. the risk management measures referred to in paragraph 2 , point (d) shall be such that the overall residual risk of the high-risk ai systems is reasonably judged to be acceptable , having regard to the benefits that the high-risk ai system is reasonably expected to deliver and , provided that the high-risk ai system is used in accordance with its intended purpose or under conditions of reasonably foreseeable misuse , subject to terms , conditions as made available by the provider , and contractual and license restrictions. those residual risks shall be communicated to the user.


### 4. the risk management measures referred to in paragraph 2 , point (d) shall be such that any residual risk associated with each hazard as well as the overall residual risk of the high-risk ai systems is judged acceptable , provided that the high-risk ai system is used in accordance with its intended purpose or under conditions of reasonably foreseeable misuse. those residual risks shall be communicated to the user. ### 4. the risk management measures referred to in paragraph 2 , point (d) shall be such that any residual risk associated with each hazard as well as the overall residual risk of the high-risk ai systems is judged acceptable , provided that the high-risk ai system is used in accordance with its intended purpose or under conditions of reasonably foreseeable misuse , subject to terms , conditions as made available by the provider , and contractual and license restrictions. those residual risks shall be communicated to the user.


### 4. the risk management measures referred to in paragraph 2 , point (d) shall be such that any residual risk associated with each hazard as well as the overall residual risk of the high-risk ai systems is judged acceptable , provided that the high-risk ai system is used in accordance with its intended purpose or under conditions of reasonably foreseeable misuse. those residual risks shall be communicated to the user. ### 4. the risk management measures referred to in paragraph 2 , point (d) shall be such that any residual risk associated with each hazard as well as the overall residual risk of the high-risk ai systems is judged acceptable , provided that the high-risk ai system is used in accordance with its intended purpose or under conditions of reasonably foreseeable misuse. those residual risks shall be communicated to the user or end-user when applicable.


### 1. high-risk ai systems which make use of techniques involving the training of models with data shall be developed on the basis of training , validation and testing data sets that meet the quality criteria referred to in paragraphs 2 to 5. ### 1. high-risk ai systems which make use of techniques involving the training of models with data shall be developed , to the extent technically feasible , on the basis of training , validation and testing data sets that meet the quality criteria referred to in paragraphs 2 to 5.


### 2. training , validation and testing data sets shall be subject to appropriate data governance and management practices. those practices shall concern in particular , ### 2. training , validation and testing data sets shall be subject to appropriate data governance and management practices. where relevant to appropriate risk management measures , those practices shall concern in particular ,


### 2. training , validation and testing data sets shall be subject to appropriate data governance and management practices. those practices shall concern in particular , ### 2. to the extent technically feasible , training , validation and testing data sets shall be subject to appropriate data governance and management practices. those practices shall concern in particular ,


### a prior assessment of the availability , quantity and suitability of the data sets that are needed; ### an assessment of the availability , quantity and suitability of the data sets that are needed;


### examination in view of possible biases; ### examination in view of possible biases , that are likely to affect health and safety of persons or lead to discrimination prohibited by union law;


### examination in view of possible biases; ### examination in view of possible biases , in particular deviations that could affect health and safety of people or lead to discrimination;


### examination in view of possible biases; ### examination in view of possible biases , in particular biases that are likely to affect health and safety of persons or lead to prohibited discrimination;


### the identification of any possible data gaps or shortcomings , and how those gaps and shortcomings can be addressed. ### the identification of any other data gaps or shortcomings that materially increase the risks of harm to the health , natural environment and safety or the fundamental rights of persons , and how those gaps and shortcomings can be addressed.


### the identification of any possible data gaps or shortcomings , and how those gaps and shortcomings can be addressed. ### the identification of possible data gaps or shortcomings and , where practicable , how those gaps and shortcomings can be addressed.


### 3. training , validation and testing data sets shall be relevant , representative , free of errors and complete. they shall have the appropriate statistical properties , including , where applicable , as regards the persons or groups of persons on which the high-risk ai system is intended to be used. these characteristics of the data sets may be met at the level of individual data sets or a combination thereof. ### 3. training , validation and testing data sets shall be relevant , sufficiently diverse to mitigate bias , and , to the best extent possible , representative , free of errors and complete. they shall have the appropriate statistical properties , including , where applicable , as regards the persons or groups of persons on which the high-risk ai system is intended to be used. these characteristics of the data sets may be met at the level of individual data sets or a combination thereof.


### 3. training , validation and testing data sets shall be relevant , representative , free of errors and complete. they shall have the appropriate statistical properties , including , where applicable , as regards the persons or groups of persons on which the high-risk ai system is intended to be used. these characteristics of the data sets may be met at the level of individual data sets or a combination thereof. ### 3. training , validation and testing data sets must be as relevant , representative , free of errors and complete as possible in order to fulfil the purpose of the ai system. in particular , they shall have the appropriate statistical properties , including , where applicable , as regards the persons or groups of persons on which the high-risk ai system is intended to be used. these characteristics of the data sets may be met at the level of individual data sets or a combination thereof.


### 4. training , validation and testing data sets shall take into account , to the extent required by the intended purpose , the characteristics or elements that are particular to the specific geographical , behavioural or functional setting within which the high-risk ai system is intended to be used. ### 4. training , validation and testing data sets shall be sufficiently diverse to accurately capture , to the extent required by the intended purpose , the characteristics or elements that are particular to the specific geographical , behavioural or functional setting within which the high-risk ai system is intended to be used.


### 4. training , validation and testing data sets shall take into account , to the extent required by the intended purpose , the characteristics or elements that are particular to the specific geographical , behavioural or functional setting within which the high-risk ai system is intended to be used. ### 4. training , validation and testing data sets shall take into account , to the extent technically feasible and required by the intended purpose , the characteristics or elements that are particular to the specific geographical , behavioural or functional setting within which the high-risk ai system is intended to be used.


### 2. the logging capabilities shall ensure a level of traceability of the ai system’s functioning throughout its lifecycle that is appropriate to the intended purpose of the system. ### 2. the logging capabilities shall ensure a level of traceability of the ai system’s functioning while the ai system is used within its lifecycle that is appropriate to the intended purpose of the system.


### 2. high-risk ai systems shall be accompanied by instructions for use in an appropriate digital format or otherwise that include concise , complete , correct and clear information that is relevant , accessible and comprehensible to users. ### 2. high-risk ai systems shall be accompanied by instructions for use in an appropriate digital format or made otherwise available , that include concise , complete , correct and clear information that is reasonably relevant , accessible and comprehensible to users to assist them in operating and maintaining the ai system , taking into consideration the system’s intended purpose and the expected audience for the instructions.


### the characteristics , capabilities and limitations of performance of the high-risk ai system , including: ### the characteristics , capabilities and limitations of performance of the high-risk ai system , that are relevant to the material risks associated with the intended purpose , including where appropriate , including:


### (ii) the level of accuracy , robustness and cybersecurity referred to in article 15 against which the high-risk ai system has been tested and validated and which can be expected , and any known and foreseeable circumstances that may have an impact on that expected level of accuracy , robustness and cybersecurity; ### (ii) the level of accuracy , robustness and cybersecurity referred to in article 15 against which the high-risk ai system has been tested and validated and which can be expected , and any known and reasonably foreseeable circumstances that could materially impact that expected level of accuracy , robustness and cybersecurity;


### the expected lifetime of the high-risk ai system and any necessary maintenance and care measures to ensure the proper functioning of that ai system , including as regards software updates. ### the expected lifetime of the high-risk ai system , the description of the procedure of withdrawing it from use and any necessary maintenance and care measures to ensure the proper functioning of that ai system , including as regards software updates.


### 2. human oversight shall aim at preventing or minimising the risks to health , safety or fundamental rights that may emerge when a high-risk ai system is used in accordance with its intended purpose or under conditions of reasonably foreseeable misuse , in particular when such risks persist notwithstanding the application of other requirements set out in this chapter. ### 2. human oversight shall aim at preventing or minimising the risks to health , safety or fundamental rights that may emerge when a high-risk ai system is used in accordance with its intended purpose or under conditions of reasonably foreseeable misuse , in particular when such risks persist notwithstanding the application of other requirements set out in this chapter. human oversight requirements shall only apply when appropriate , proportionate and justified by a proven added value to the protection of health , safety and fundamental rights , such justification residing in an improved accuracy measured in the outcomes and results delivered by high-risk ai systems.


### 4. the measures referred to in paragraph 3 shall enable the individuals to whom human oversight is assigned to do the following , as appropriate to the circumstances: ### 4. the measures referred to in paragraph 3 shall enable the individuals to whom human oversight is assigned to do the following , as appropriate and proportionate to the circumstances:


### fully understand the capacities and limitations of the high-risk ai system and be able to duly monitor its operation , so that signs of anomalies , dysfunctions and unexpected performance can be detected and addressed as soon as possible; ### understand the capacities and limitations of the high-risk ai system and be able to duly monitor its operation , so that signs of anomalies , dysfunctions and unexpected performance can be detected and addressed as soon as possible;


### fully understand the capacities and limitations of the high-risk ai system and be able to duly monitor its operation , so that signs of anomalies , dysfunctions and unexpected performance can be detected and addressed as soon as possible; ### sufficiently understand the capacities and limitations of the high-risk ai system and be able to duly monitor its operation , so that signs of anomalies , dysfunctions and unexpected performance can be detected and addressed as soon as possible;


### be able to intervene on the operation of the high-risk ai system or interrupt the system through a “stop” button or a similar procedure. ### interrupt the ai system through a “stop” button or a similar procedure.


### 5. for high-risk ai systems referred to in point 1(a) of annex iii , the measures referred to in paragraph 3 shall be such as to ensure that , in addition , no action or decision is taken by the user on the basis of the identification resulting from the system unless this has been verified and confirmed by at least two natural persons. ### 5. for high-risk ai systems referred to in point 1(a) of annex iii and for which human oversight is effectively justified by a proven end value to the protection of health , safety and fundamental rights , the measures referred to in paragraph 3 shall be such as to ensure that , in addition , no action or decision is taken by the user on the basis of the identification resulting from the system unless this has been separately verified and confirmed by at least two natural persons.


### 3. high-risk ai systems shall be resilient as regards errors , faults or inconsistencies that may occur within the system or the environment in which the system operates , in particular due to their interaction with natural persons or other systems. ### 3. providers and deployers should take all appropriate and feasible technical and organizational measures to ensure that high-risk ai systems are resilient as regards errors , faults or inconsistencies that may occur within the system or the environment in which the system operates , in particular due to their interaction with natural persons or other systems.


### 3. high-risk ai systems shall be resilient as regards errors , faults or inconsistencies that may occur within the system or the environment in which the system operates , in particular due to their interaction with natural persons or other systems. ### 3. sufficient and technically feasible measures shall be taken to ensure that high-risk ai systems shall be resilient as regards errors , faults or inconsistencies that may occur within the system or the environment in which the system operates , in particular due to their interaction with natural persons or other systems.


### 1. users of high-risk ai systems shall use such systems in accordance with the instructions of use accompanying the systems , pursuant to paragraphs 2 and 5. ### 1. users shall bear sole responsibility in case of any use of the ai system that is not in accordance with the instructions of use accompanying the systems.


### 2. notified bodies shall satisfy the organisational , quality management , resources and process requirements that are necessary to fulfil their tasks. ### 2. notified bodies shall satisfy the minimum cybersecurity requirements set out for public administration entities identified as operators of essential services pursuant to directive (…) on measures for a high common level of cybersecurity across the union , repealing directive (eu) 2016/1148;


### 6. notified bodies shall have documented procedures in place ensuring that their personnel , committees , subsidiaries , subcontractors and any associated body or personnel of external bodies respect the confidentiality of the information which comes into their possession during the performance of conformity assessment activities , except when disclosure is required by law. the staff of notified bodies shall be bound to observe professional secrecy with regard to all information obtained in carrying out their tasks under this regulation , except in relation to the notifying authorities of the member state in which their activities are carried out. ### 6. notified bodies shall have documented procedures in place ensuring that their personnel , committees , subsidiaries , subcontractors and any associated body or personnel of external bodies respect the confidentiality of the information which comes into their possession during the performance of conformity assessment activities , except when disclosure is required by law. the staff of notified bodies shall be bound to observe professional secrecy with regard to all information obtained in carrying out their tasks under this regulation , except in relation to the notifying authorities of the member state in which their activities are carried out. any information and documentation obtained by notified bodies pursuant to the provisions of this article shall be treated in compliance with the confidentiality obligations set out in article 70.


### 2. the commission , when preparing the common specifications referred to in paragraph 1 , shall gather the views of relevant bodies or expert groups established under relevant sectorial union law. ### 2. the commission , when preparing the common specifications referred to in paragraph 1 , shall gather the views of applicable stakeholders , including industry representatives , smes as well as other relevant bodies or expert groups established under relevant sectorial union law.


### 1. providers shall ensure that ai systems intended to interact with natural persons are designed and developed in such a way that natural persons are informed that they are interacting with an ai system , unless this is obvious from the circumstances and the context of use. this obligation shall not apply to ai systems authorised by law to detect , prevent , investigate and prosecute criminal offences , unless those systems are available for the public to report a criminal offence. ### 1. providers shall ensure that ai systems intended to interact with natural persons are designed and developed in such a way that natural persons are informed that they are interacting with an ai system. this obligation shall not apply to ai systems authorised by law to detect , prevent , investigate and prosecute criminal offences , unless those systems are available for the public to report a criminal offence.


### 3. users of an ai system that generates or manipulates image , audio or video content that appreciably resembles existing persons , objects , places or other entities or events and would falsely appear to a person to be authentic or truthful (‘deep fake’) , shall disclose that the content has been artificially generated or manipulated. ### 3. users of an ai system that generates or manipulates text , image , audio or video content that appreciably resembles existing persons , objects , places or other entities or events and would falsely appear to a person to be authentic or truthful (‘deep fake’) , shall disclose that the content has been artificially generated or manipulated.


### 3. users of an ai system that generates or manipulates image , audio or video content that appreciably resembles existing persons , objects , places or other entities or events and would falsely appear to a person to be authentic or truthful (‘deep fake’) , shall disclose that the content has been artificially generated or manipulated. ### 3. users of an ai system that generates or manipulates image , audio or video content that appreciably resembles existing persons , objects , places or other entities or events and would falsely appear to a person to be authentic or truthful (‘deep fake’) , shall disclose that the content has been artificially generated or manipulated. users shall be able to opt out of such disclosure notifications.


### 1. ai regulatory sandboxes established by one or more member states competent authorities or the european data protection supervisor shall provide a controlled environment that facilitates the development , testing and validation of innovative ai systems for a limited time before their placement on the market or putting into service pursuant to a specific plan. this shall take place under the direct supervision and guidance by the competent authorities with a view to ensuring compliance with the requirements of this regulation and , where relevant , other union and member states legislation supervised within the sandbox. ### 1. ai regulatory sandboxes established by one or more member states competent authorities or the european data protection supervisor shall provide a controlled environment that facilitates the development , testing and validation of innovative ai systems before their placement on the market or putting into service pursuant to a specific plan. this shall take place under the direct supervision and guidance by the competent authorities with a view to ensuring compliance with the requirements of this regulation and , where relevant , other union and member states legislation supervised within the sandbox.


### 5. member states’ competent authorities that have established ai regulatory sandboxes shall coordinate their activities and cooperate within the framework of the european artificial intelligence board. they shall submit annual reports to the board and the commission on the results from the implementation of those scheme , including good practices , lessons learnt and recommendations on their setup and , where relevant , on the application of this regulation and other union legislation supervised within the sandbox. ### 5. member states’ competent authorities that have established ai regulatory sandboxes shall cooperate within the framework of the european artificial intelligence board. they shall submit annual reports to the board and the commission on the results from the implementation of those scheme , including good practices , lessons learnt and recommendations on their setup and , where relevant , on the application of this regulation and other union legislation supervised within the sandbox.


### measures for small-scale providers and users ### measures for smes and users


### provide small-scale providers and start-ups with priority access to the ai regulatory sandboxes to the extent that they fulfil the eligibility conditions; ### provide smes and start-ups with priority access to the ai regulatory sandboxes to the extent that they fulfil the eligibility conditions;


### organise specific awareness raising activities about the application of this regulation tailored to the needs of the small-scale providers and users; ### organise specific awareness raising activities about the application of this regulation tailored to the needs of the smes and users;


### where appropriate , establish a dedicated channel for communication with small-scale providers and user and other innovators to provide guidance and respond to queries about the implementation of this regulation. ### where appropriate , establish a dedicated channel for communication with smes and user and other innovators to provide guidance and respond to queries about the implementation of this regulation.


### 1. the board shall be composed of the national supervisory authorities , who shall be represented by the head or equivalent high-level official of that authority , and the european data protection supervisor. other national authorities may be invited to the meetings , where the issues discussed are of relevance for them. ### 1. the board shall be composed of the national supervisory authorities , who shall be represented by the head or equivalent high-level official of that authority , the european data protection supervisor , ai ethics experts and industry representatives. other national authorities may be invited to the meetings , where the issues discussed are of relevance for them.


### 1. the board shall be composed of the national supervisory authorities , who shall be represented by the head or equivalent high-level official of that authority , and the european data protection supervisor. other national authorities may be invited to the meetings , where the issues discussed are of relevance for them. ### 1. the board shall be composed of the national supervisory authorities , who shall be represented by the head or equivalent high-level official of that authority , and the european data protection supervisor. other national or international authorities and relevant stakeholders , including from the private sector , shall be invited to the meetings , where the issues discussed are of relevance for them.


### 1. the board shall be composed of the national supervisory authorities , who shall be represented by the head or equivalent high-level official of that authority , and the european data protection supervisor. other national authorities may be invited to the meetings , where the issues discussed are of relevance for them. ### 1. the board shall be composed of the national supervisory authorities , who shall be represented by the head or equivalent high-level official of that authority , and the european data protection supervisor , ai ethics experts and industry representatives. other national authorities may be invited to the meetings , where the issues discussed are of relevance for them.


### 3. the board shall be chaired by the commission. the commission shall convene the meetings and prepare the agenda in accordance with the tasks of the board pursuant to this regulation and with its rules of procedure. the commission shall provide administrative and analytical support for the activities of the board pursuant to this regulation. ### 3. the board shall be co-chaired by the commission and representative chosen from among the delegates of the member states. the commission shall convene the meetings and prepare the agenda in accordance with the tasks of the board pursuant to this regulation and with its rules of procedure. the commission shall provide administrative and analytical support for the activities of the board pursuant to this regulation.


### 3. the board shall be chaired by the commission. the commission shall convene the meetings and prepare the agenda in accordance with the tasks of the board pursuant to this regulation and with its rules of procedure. the commission shall provide administrative and analytical support for the activities of the board pursuant to this regulation. ### 3. the board shall be co-chaired by the commission and a representative chosen from among the delegates of the member states. the commission shall convene the meetings and prepare the agenda in accordance with the tasks of the board pursuant to this regulation and with its rules of procedure. the commission shall provide administrative and analytical support for the activities of the board pursuant to this regulation.


### 7. national competent authorities may provide guidance and advice on the implementation of this regulation , including to small-scale providers. whenever national competent authorities intend to provide guidance and advice with regard to an ai system in areas covered by other union legislation , the competent national authorities under that union legislation shall be consulted , as appropriate. member states may also establish one central contact point for communication with operators. ### 7. national competent authorities may provide guidance and advice on the implementation of this regulation , including to small-scale providers. whenever national competent authorities intend to provide guidance and advice with regard to an ai system in areas covered by other union legislation , the competent national authorities under that union legislation shall be consulted , as appropriate. member states shall also establish one central contact point for communication with operators. in addition , the central contact point of each member state should be contactable through electronic communications means.


### 4. the eu database shall contain personal data only insofar as necessary for collecting and processing information in accordance with this regulation. that information shall include the names and contact details of natural persons who are responsible for registering the system and have the legal authority to represent the provider. ### 4. the eu database shall not contain any confidential business information or trade secrets of a natural or legal person , including source code.


### 2. the post-market monitoring system shall actively and systematically collect , document and analyse relevant data provided by users or collected through other sources on the performance of high-risk ai systems throughout their lifetime , and allow the provider to evaluate the continuous compliance of ai systems with the requirements set out in title iii , chapter 2. ### 2. the post-market monitoring system shall actively and systematically collect , document and analyse relevant data provided by users and end-users or collected through other sources on the performance of high-risk ai systems throughout their lifetime , and allow the provider to evaluate the continuous compliance of ai systems with the requirements set out in title iii , chapter 2.


### 1. access to data and documentation in the context of their activities , the market surveillance authorities shall be granted full access to the training , validation and testing datasets used by the provider , including through application programming interfaces (‘api’) or other appropriate technical means and tools enabling remote access. ### 1. access to data and documentation in the context of their activities , the market surveillance authorities shall be granted adequate access to the training , validation and testing datasets used by the provider , including through application programming interfaces (‘api’) or other appropriate technical means and tools enabling remote access , taking into account the scope of access agreed with the relevant data subjects or data holders.


### 1. access to data and documentation in the context of their activities , the market surveillance authorities shall be granted full access to the training , validation and testing datasets used by the provider , including through application programming interfaces (‘api’) or other appropriate technical means and tools enabling remote access. ### 1. upon reasoned request access to data and documentation in the context of their activities , the market surveillance authorities shall be granted full access to the training , validation and testing datasets used by the provider , including through application programming interfaces (‘api’) or other appropriate technical means and tools enabling remote access.


### 1. access to data and documentation in the context of their activities , the market surveillance authorities shall be granted full access to the training , validation and testing datasets used by the provider , including through application programming interfaces (‘api’) or other appropriate technical means and tools enabling remote access. ### 1. access to data and documentation in the context of their activities , the market surveillance authorities shall be granted sufficient access to the training , validation and testing datasets used by the provider , including through application programming interfaces (‘api’) or other appropriate technical means and tools enabling remote access , taking into account the scope of access agreed with the relevant data subjects or data holders.


### 2. where necessary to assess the conformity of the high-risk ai system with the requirements set out in title iii , chapter 2 and upon a reasoned request , the market surveillance authorities shall be granted access to the source code of the ai system. ### 2. where necessary to assess the conformity of the high-risk ai system with the requirements set out in title iii , chapter 2 and upon a reasoned request. ai providers or deployers should support market surveillance authorities with the necessary facilities to carry out testing to confirm compliance.


### 2. where necessary to assess the conformity of the high-risk ai system with the requirements set out in title iii , chapter 2 and upon a reasoned request , the market surveillance authorities shall be granted access to the source code of the ai system. ### 2. where necessary to assess the conformity of the high-risk ai system with the requirements set out in title iii , chapter 2 and upon a reasoned request. ai providers or deployers shall support market surveillance authorities with the necessary facilities to carry out testing to confirm compliance.


### 1. national competent authorities and notified bodies involved in the application of this regulation shall respect the confidentiality of information and data obtained in carrying out their tasks and activities in such a manner as to protect , in particular: ### 1. national competent authorities , market surveillance authorities and notified bodies involved in the application of this regulation shall respect the confidentiality of information and data obtained in carrying out their tasks and activities in such a manner as to protect , in particular:


### the nature , gravity and duration of the infringement and of its consequences; ### the nature , gravity and duration of the infringement and of its consequences , taking into account the number of subjects affected and the level of damage suffered by them;


### in article 5 of regulation (eu) 2018/858 the following paragraph is added: ### in article 5 of regulation (eu) 2018/858 the following paragraphs are added:


### in article 11 of regulation (eu) 2019/2144 , the following paragraph is added: ### in article 11 of regulation(eu) 2019/2144 , the following paragraphs are added:


### 1. the commission shall assess the need for amendment of the list in annex iii once a year following the entry into force of this regulation. ### deleted


### 2. by [three years after the date of application of this regulation referred to in article 85(2)] and every four years thereafter , the commission shall submit a report on the evaluation and review of this regulation to the european parliament and to the council. the reports shall be made public. ### 2. by [two years after the date of application of this regulation referred to in article 85(2)] and every three years thereafter , the commission shall submit a report on the evaluation and review of this regulation to the european parliament and to the council. the reports shall be made public.


### artificial intelligence techniques and approachesreferred to in article 3 , point 1 ### artificial intelligence techniques and approaches referred to in article 3 , point 1


### statistical approaches , bayesian estimation , search and optimization methods. ### statistical approaches , bayesian estimation , , forecasting , search and optimization methods.


### statistical approaches , bayesian estimation , search and optimization methods. ### statistical approaches , bayesian estimation , if they are used to extract decisions from data in an automated way and search.


### statistical approaches , bayesian estimation , search and optimization methods. ### statistical approaches , bayesian estimation , forecasting , search and optimization methods.


### ai systems intended to be used for the ‘real-time’ and ‘post’ remote biometric identification of natural persons; ### ai systems intended to be used for the ‘real-time’ and ‘post’ remote biometric identification of natural persons without their consent of being identified;


### ai systems intended to be used for the ‘real-time’ and ‘post’ remote biometric identification of natural persons; ### ai biometric identification systems intended to be used for the ‘real time’ and ‘post’ remote biometric identification of natural persons without their agreement;


### ai systems intended to be used for the ‘real-time’ and ‘post’ remote biometric identification of natural persons; ### ai systems used for the ‘real-time’ and ‘post’ biometric identification of natural persons;


### ai systems intended to be used as safety components in the management and operation of road traffic and the supply of water , gas , heating and electricity. ### ai systems intended to be used as safety components in the management and operation of road , air , railway traffic and the supply of water , gas , heating and electricity , whose failure or malfunctioning would directly cause significant harm to the health , natural environment or safety of natural persons.


### ai systems intended to be used as safety components in the management and operation of road traffic and the supply of water , gas , heating and electricity. ### ai systems intended to be used as safety components in the management and operation of road traffic and the supply of water , gas , heating and electricity , whose failure or malfunctioning would directly cause significant harm to the health , natural environment or safety of natural persons.


### ai systems intended to be used for recruitment or selection of natural persons , notably for advertising vacancies , screening or filtering applications , evaluating candidates in the course of interviews or tests; ### ai systems intended to be used for the sole purpose of recruitment or selection of natural persons , notably for advertising vacancies , screening or filtering applications , evaluating candidates in the course of interviews or tests;


### ai intended to be used for making decisions on promotion and termination of work-related contractual relationships , for task allocation and for monitoring and evaluating performance and behavior of persons in such relationships. ### ai systems intended to be used to make decisions on promotion and termination of work-related contractual relationships , based on individual behaviour or personal traits or characteristics , and for monitoring and evaluating performance and behaviour of persons in such relationships that have a likelihood of causing harm to the physical health and safety or adversely impact on the fundamental rights or have given rise to significant concerns in relation to the materialisation of such harm or adverse impact.


### the methods and steps performed for the development of the ai system , including , where relevant , recourse to pre-trained systems or tools provided by third parties and how these have been used , integrated or modified by the provider; ### provided that no confidential information or trade secrets are disclosed , the methods and steps performed for the development of the ai system , including , where relevant , recourse to pre-trained systems or tools provided by third parties and how these have been used , integrated or modified by the provider;


### the design specifications of the system , namely the general logic of the ai system and of the algorithms; the key design choices including the rationale and assumptions made , also with regard to persons or groups of persons on which the system is intended to be used; the main classification choices; what the system is designed to optimise for and the relevance of the different parameters; the decisions about any possible trade-off made regarding the technical solutions adopted to comply with the requirements set out in title iii , chapter 2; ### provided that no confidential information or trade secrets are disclosed , the design specifications of the system , namely the general logic of the ai system and of the algorithms; the key design choices including the rationale and assumptions made , also with regard to persons or groups of persons on which the system is intended to be used; the main classification choices; what the system is designed to optimise for and the relevance of the different parameters; the decisions about any possible trade-off made regarding the technical solutions adopted to comply with the requirements set out in title iii , chapter 2;


### (2) artificial intelligence systems (ai systems) can be easily deployed in multiple sectors of the economy and society , including cross border , and circulate throughout the union. certain member states have already explored the adoption of national rules to ensure that artificial intelligence is safe and is developed and used in compliance with fundamental rights obligations. differing national rules may lead to fragmentation of the internal market and decrease legal certainty for operators that develop or use ai systems. a consistent and high level of protection throughout the union should therefore be ensured , while divergences hampering the free circulation of ai systems and related products and services within the internal market should be prevented , by laying down uniform obligations for operators and guaranteeing the uniform protection of overriding reasons of public interest and of rights of persons throughout the internal market based on article 114 of the treaty on the functioning of the european union (tfeu). to the extent that this regulation contains specific rules on the protection of individuals with regard to the processing of personal data concerning restrictions of the use of ai systems for ‘real-time’ remote biometric identification in publicly accessible spaces for the purpose of law enforcement , it is appropriate to base this regulation , in as far as those specific rules are concerned , on article 16 of the tfeu. in light of those specific rules and the recourse to article 16 tfeu , it is appropriate to consult the european data protection board. ### (2) artificial intelligence systems (ai systems) can be easily deployed in multiple sectors of the economy and society , including cross border , and circulate throughout the union. certain member states have already explored the adoption of national rules to ensure that artificial intelligence is safe and is developed and used in compliance with fundamental rights obligations. differing national rules may lead to fragmentation of the internal market and decrease legal certainty for operators that develop or use ai systems. a consistent and high level of protection throughout the union should therefore be ensured , while divergences hampering the free circulation , innovation , deployment and uptake of ai systems and related products and services within the internal market should be prevented , by laying down uniform obligations for operators and guaranteeing the uniform protection of overriding reasons of public interest and of rights of persons throughout the internal market based on article 114 of the treaty on the functioning of the european union (tfeu). to the extent that this regulation contains specific rules on the protection of individuals with regard to the processing of personal data concerning restrictions of the use of ai systems for ‘real-time’ remote biometric identification in publicly accessible spaces for the purpose of law enforcement , it is appropriate to base this regulation , in as far as those specific rules are concerned , on article 16 of the tfeu. in light of those specific rules and the recourse to article 16 tfeu , it is appropriate to consult the european data protection board.


### (2) artificial intelligence systems (ai systems) can be easily deployed in multiple sectors of the economy and society , including cross border , and circulate throughout the union. certain member states have already explored the adoption of national rules to ensure that artificial intelligence is safe and is developed and used in compliance with fundamental rights obligations. differing national rules may lead to fragmentation of the internal market and decrease legal certainty for operators that develop or use ai systems. a consistent and high level of protection throughout the union should therefore be ensured , while divergences hampering the free circulation of ai systems and related products and services within the internal market should be prevented , by laying down uniform obligations for operators and guaranteeing the uniform protection of overriding reasons of public interest and of rights of persons throughout the internal market based on article 114 of the treaty on the functioning of the european union (tfeu). to the extent that this regulation contains specific rules on the protection of individuals with regard to the processing of personal data concerning restrictions of the use of ai systems for ‘real-time’ remote biometric identification in publicly accessible spaces for the purpose of law enforcement , it is appropriate to base this regulation , in as far as those specific rules are concerned , on article 16 of the tfeu. in light of those specific rules and the recourse to article 16 tfeu , it is appropriate to consult the european data protection board. ### (2) artificial intelligence systems (ai systems) can be easily deployed in multiple sectors of the economy and society , including cross border , and circulate throughout the union. certain member states have already explored the adoption of national rules to ensure that artificial intelligence is safe and is developed and used in compliance with fundamental rights obligations. differing national rules may lead to fragmentation of the internal market and decrease legal certainty for operators that develop or use ai systems. a consistent and high level of protection throughout the union should therefore be ensured , while divergences hampering the free circulation of ai systems and related products and services within the internal market should be prevented , by laying down uniform obligations for operators and guaranteeing the uniform protection of overriding reasons of public interest and of rights of persons throughout the internal market based on article 114 of the treaty on the functioning of the european union (tfeu). to the extent that this regulation contains specific rules on the protection of individuals with regard to the processing of personal data concerning restrictions of the use of ai systems for ‘real-time’ remote biometric identification in publicly accessible spaces for the purpose of law enforcement , it is appropriate to base this regulation , in as far as those specific rules are concerned , on article 16 of the tfeu and to align it with relevant eu legislation such as the gdpr and the eudpr. in light of those specific rules and the recourse to article 16 tfeu , it is appropriate to consult the european data protection board and to take into consideration the edpb-edps joint opinion 5/2021.


### (3) artificial intelligence is a fast evolving family of technologies that can contribute to a wide array of economic and societal benefits across the entire spectrum of industries and social activities. by improving prediction , optimising operations and resource allocation , and personalising digital solutions available for individuals and organisations , the use of artificial intelligence can provide key competitive advantages to companies and support socially and environmentally beneficial outcomes , for example in healthcare , farming , education and training , infrastructure management , energy , transport and logistics , public services , security , justice , resource and energy efficiency , and climate change mitigation and adaptation. ### (3) artificial intelligence is a fast evolving family of technologies that can contribute and is already contributing to a wide array of economic and societal benefits across the entire spectrum of industries and social activities. by establishing an accommodative framework which entails improving prediction , optimising operations and resource allocation , and personalising digital solutions available for individuals and organisations , the use of artificial intelligence can provide key competitive advantages to companies and entire industries , and support socially and environmentally beneficial outcomes , for example in healthcare , farming , education and training , media , sports , infrastructure management , energy , transport and logistics , public services , security , justice , resource and energy efficiency , and climate change mitigation and adaptation.


### (8) the notion of remote biometric identification system as used in this regulation should be defined functionally , as an ai system intended for the identification of 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 whether the targeted person will be present and can be identified , irrespectively of the particular technology , processes or types of biometric data used. considering their different characteristics and manners in which they are used , as well as the different risks involved , a distinction should be made between ‘real-time’ and ‘post’ remote biometric identification systems. in the case of ‘real-time’ systems , the capturing of the biometric data , the comparison and the identification occur all instantaneously , near-instantaneously or in any event without a significant delay. in this regard , there should be no scope for circumventing the rules of this regulation on the ‘real-time’ use of the ai systems in question by providing for minor delays. ‘real-time’ systems involve the use of ‘live’ or ‘near-‘live’ material , such as video footage , generated by a camera or other device with similar functionality. in the case of ‘post’ systems , in contrast , the biometric data have already been captured and the comparison and identification occur only after a significant delay. this involves material , such as pictures or video footage generated by closed circuit television cameras or private devices , which has been generated before the use of the system in respect of the natural persons concerned. ### (8) the notion of remote biometric identification system as used in this regulation should be defined functionally , as an ai system intended for the identification of natural persons at a distance through the comparison of a person’s biometric data with the biometric data contained in a database data repository , excluding verification/authentication systems whose sole purpose is to confirm that a specific natural person is the person he or she claims to be , and systems that are used to confirm the identity of a natural person for the sole purpose of having access to a service , a device or premises , and without prior knowledge whether the targeted person will be present and can be identified , irrespectively of the particular technology , processes or types of biometric data used. considering their different characteristics and manners in which they are used , as well as the different risks involved , a distinction should be made between ‘real-time’ and ‘post’ remote biometric identification systems. in the case of ‘real-time’ systems , the capturing of the biometric data , the comparison and the identification occur all instantaneously , near-instantaneously or in any event without a significant delay. in this regard , there should be no scope for circumventing the rules of this regulation on the ‘real-time’ use of the ai systems in question by providing for minor delays. ‘real-time’ systems involve the use of ‘live’ or ‘near-‘live’ material , such as video footage , generated by a camera or other device with similar functionality. in the case of ‘post’ systems , in contrast , the biometric data have already been captured and the comparison and identification occur only after a significant delay. this involves material , such as pictures or video footage generated by closed circuit television cameras or private devices , which has been generated before the use of the system in respect of the natural persons concerned.


### (9) for the purposes of this regulation the notion of publicly accessible space should be understood as referring to any physical place that is accessible to the public , irrespective of whether the place in question is privately or publicly owned. therefore , the notion does not cover places that are private in nature and normally not freely accessible for third parties , including law enforcement authorities , unless those parties have been specifically invited or authorised , such as homes , private clubs , offices , warehouses and factories. online spaces are not covered either , as they are not physical spaces. however , the mere fact that certain conditions for accessing a particular space may apply , such as admission tickets or age restrictions , does not mean that the space is not publicly accessible within the meaning of this regulation. consequently , in addition to public spaces such as streets , relevant parts of government buildings and most transport infrastructure , spaces such as cinemas , theatres , shops and shopping centres are normally also publicly accessible. whether a given space is accessible to the public should however be determined on a case-by-case basis , having regard to the specificities of the individual situation at hand. ### (9) for the purposes of this regulation the notion of publicly accessible space should be understood as referring to any physical place that is accessible to the public , irrespective of whether the place in question is privately or publicly owned. therefore , the notion does not cover places that are private in nature and normally not freely accessible for third parties , including law enforcement authorities , unless those parties have been specifically invited or authorised , such as homes , private clubs , offices , warehouses , factories and other private spaces. online spaces , whether publicly accessible or not , are not covered either , as they are not physical spaces. however , the mere fact that certain conditions for accessing a particular space may apply , such as admission tickets or age restrictions , does not mean that the space is not publicly accessible within the meaning of this regulation. consequently , in addition to public spaces such as streets , relevant parts of government buildings and most transport infrastructure , spaces such as cinemas , theatres , shops and shopping centres are normally also publicly accessible. whether a given space is accessible to the public should however be determined on a case-by-case basis , having regard to the specificities of the individual situation at hand.


### (14) in order to introduce a proportionate and effective set of binding rules for ai systems , a clearly defined risk-based approach should be followed. that approach should tailor the type and content of such rules to the intensity and scope of the risks that ai systems can generate. it is therefore necessary to prohibit certain artificial intelligence practices , to lay down requirements for high-risk ai systems and obligations for the relevant operators , and to lay down transparency obligations for certain ai systems. ### (14) in order to introduce a proportionate and effective set of binding rules for ai systems , a clearly defined risk-based approach should be followed. that approach should tailor the type and content of such rules to the intensity and scope of the risks that ai systems can generate. it is therefore necessary to prohibit certain artificial intelligence practices , to lay down requirements for high-risk ai systems and obligations for the relevant operators , and to lay down transparency obligations for certain ai systems. however , it is important to distinguish between the parties who develop and make the system and those who promote or market the product.


### (14) in order to introduce a proportionate and effective set of binding rules for ai systems , a clearly defined risk-based approach should be followed. that approach should tailor the type and content of such rules to the intensity and scope of the risks that ai systems can generate. it is therefore necessary to prohibit certain artificial intelligence practices , to lay down requirements for high-risk ai systems and obligations for the relevant operators , and to lay down transparency obligations for certain ai systems. ### (14) in order to introduce a proportionate and effective set of binding rules for ai systems , a clearly defined risk-based approach should be followed. that approach should tailor the type and content of such rules to the intensity and scope of the risks that ai systems can generate. it is therefore necessary to prohibit certain artificial intelligence practices , to lay down requirements for high-risk ai systems and obligations for the relevant operators , and to lay down transparency obligations for certain ai systems. however , it is important to distinguish both categories between the person who develops and makes the system available and the person who deploys the ai-system.


### (28) ai systems could produce adverse outcomes to health and safety of persons , in particular when such systems operate as components of products. consistently with the objectives of union harmonisation legislation to facilitate the free movement of products in the internal market and to ensure that only safe and otherwise compliant products find their way into the market , it is important that the safety risks that may be generated by a product as a whole due to its digital components , including ai systems , are duly prevented and mitigated. for instance , increasingly autonomous robots , whether in the context of manufacturing or personal assistance and care should be able to safely operate and performs their functions in complex environments. similarly , in the health sector where the stakes for life and health are particularly high , increasingly sophisticated diagnostics systems and systems supporting human decisions should be reliable and accurate. the extent of the adverse impact caused by the ai system on the fundamental rights protected by the charter is of particular relevance when classifying an ai system as high-risk. those rights include the right to human dignity , respect for private and family life , protection of personal data , freedom of expression and information , freedom of assembly and of association , and non-discrimination , consumer protection , workers’ rights , rights of persons with disabilities , right to an effective remedy and to a fair trial , right of defence and the presumption of innocence , right to good administration. in addition to those rights , it is important to highlight that children have specific rights as enshrined in article 24 of the eu charter and in the united nations convention on the rights of the child (further elaborated in the uncrc general comment no. 25 as regards the digital environment) , both of which require consideration of the children’s vulnerabilities and provision of such protection and care as necessary for their well-being. the fundamental right to a high level of environmental protection enshrined in the charter and implemented in union policies should also be considered when assessing the severity of the harm that an ai system can cause , including in relation to the health and safety of persons. ### (28) ai systems could produce adverse outcomes to health and safety of persons , in particular when such systems operate as components of products. consistently with the objectives of union harmonisation legislation to facilitate the free movement of products in the internal market and to ensure that only safe and otherwise compliant products find their way into the market , it is important that the safety risks that may be generated by a product as a whole due to its digital components , including ai systems , are duly prevented and mitigated. for instance , increasingly autonomous robots , whether in the context of manufacturing or personal assistance and care should be able to safely operate and performs their functions in complex environments. similarly , in the health sector where the stakes for life and health are particularly high , increasingly sophisticated diagnostics systems and systems supporting human decisions should be reliable and accurate. digital health should not dehumanise care nor diminish the doctor-patient relationship , but should provide doctors with assistance in diagnosing and/or treating patients more effectively , all the while keeping in mind the necessary human oversight and abiding by relevant data protection rules. the extent of the adverse impact caused by the ai system on the fundamental rights protected by the charter is of particular relevance when classifying an ai system as high-risk. those rights include the right to human dignity , respect for private and family life , protection of personal data , freedom of expression and information , freedom of assembly and of association , and non-discrimination , consumer protection , workers’ rights , rights of persons with disabilities , right to an effective remedy and to a fair trial , right of defence and the presumption of innocence , right to good administration. in addition to those rights , it is important to highlight that children have specific rights as enshrined in article 24 of the eu charter and in the united nations convention on the rights of the child (further elaborated in the uncrc general comment no. 25 as regards the digital environment) , both of which require consideration of the children’s vulnerabilities and provision of such protection and care as necessary for their well-being. the fundamental right to a high level of environmental protection enshrined in the charter and implemented in union policies should also be considered when assessing the severity of the harm that an ai system can cause , including in relation to the health and safety of persons.


### (35) ai systems used in education or vocational training , notably for determining access or assigning persons to educational and vocational training institutions or to evaluate persons on tests as part of or as a precondition for their education should be considered high-risk , since they may determine the educational and professional course of a person’s life and therefore affect their ability to secure their livelihood. when improperly designed and used , such systems may violate the right to education and training as well as the right not to be discriminated against and perpetuate historical patterns of discrimination. ### (35) ai systems used in education or vocational training for determining access or assigning persons to educational and vocational training institutions or to evaluate persons on tests as part of or as a precondition for their education should be considered high-risk , since poorly designed ai systems may negatively determine the educational and professional course of a person’s life and therefore affect their ability to secure their livelihood. when improperly designed and used , such systems may violate the right to education and training as well as the right not to be discriminated against and perpetuate historical patterns of discrimination. all other applications of ai systems in education and training , such as systems used to monitor students during tests , should by default be considered minimal risk.


### (35) ai systems used in education or vocational training , notably for determining access or assigning persons to educational and vocational training institutions or to evaluate persons on tests as part of or as a precondition for their education should be considered high-risk , since they may determine the educational and professional course of a person’s life and therefore affect their ability to secure their livelihood. when improperly designed and used , such systems may violate the right to education and training as well as the right not to be discriminated against and perpetuate historical patterns of discrimination. ### (35) ai systems used in education or vocational training , notably for determining access or assigning persons to educational and vocational training institutions or to evaluate persons on tests as part of or as a precondition for their education should be considered high-risk , since they may determine the educational and professional course of a person’s life and therefore affect their ability to secure their livelihood. it requires appropriate training and preparation for health and administrative personnel to prevent a digital divide , specifically bearing in mind our ageing societies and potential challenges to healthcare systems in the post-pandemic world. when improperly designed and used , such systems may violate the right to education and training as well as the right not to be discriminated against and perpetuate historical patterns of discrimination.


### (40) certain ai systems intended for the administration of justice and democratic processes should be classified as high-risk , considering their potentially significant impact on democracy , rule of law , individual freedoms as well as the right to an effective remedy and to a fair trial. in particular , to address the risks of potential biases , errors and opacity , it is appropriate to qualify as high-risk ai systems intended to assist judicial authorities in researching and interpreting facts and the law and in applying the law to a concrete set of facts. such qualification should not extend , however , to ai systems intended for purely ancillary administrative activities that do not affect the actual administration of justice in individual cases , such as anonymisation or pseudonymisation of judicial decisions , documents or data , communication between personnel , administrative tasks or allocation of resources. ### (40) certain ai systems intended for the administration of justice and democratic processes should be classified as high-risk , considering their potentially significant impact on democracy , rule of law , individual freedoms as well as the right to an effective remedy and to a fair trial. in particular , to address the risks of potential biases , errors and opacity , it is appropriate to qualify as high-risk ai systems intended to assist judicial authorities in researching facts and the law. such qualification should not extend , however , to ai systems intended for purely ancillary administrative activities that do not affect the actual administration of justice in individual cases , such as anonymisation or pseudonymisation of judicial decisions , documents or data , communication between personnel , administrative tasks or allocation of resources.