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      {
        "article": "16",
        "title": "Obligations of providers of high-risk AI systems",
        "duty": "Meet the provider obligations for high-risk AI systems.",
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          "label": "Article 16",
          "title": "Obligations of providers of high-risk AI systems",
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            "Providers of high-risk AI systems shall:",
            "(a) ensure that their high-risk AI systems are compliant with the requirements set out in Section 2;",
            "(b) indicate on the high-risk AI system or, where that is not possible, on its packaging or its accompanying documentation, as applicable, their name, registered trade name or registered trade mark, the address at which they can be contacted;",
            "(c) have a quality management system in place which complies with Article 17;",
            "(d) keep the documentation referred to in Article 18;",
            "(e) when under their control, keep the logs automatically generated by their high-risk AI systems as referred to in Article 19;",
            "(f) ensure that the high-risk AI system undergoes the relevant conformity assessment procedure as referred to in Article 43, prior to its being placed on the market or put into service;",
            "(g)"
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        "article": "9",
        "title": "Risk management system",
        "duty": "Establish and maintain a risk management system.",
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        "source_text": {
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          "label": "Article 9",
          "title": "Risk management system",
          "paragraphs": [
            "1. A risk management system shall be established, implemented, documented and maintained in relation to high-risk AI systems.",
            "2. The risk management system shall be understood as a continuous iterative process planned and run throughout the entire lifecycle of a high-risk AI system, requiring regular systematic review and updating. It shall comprise the following steps:",
            "(a) the identification and analysis of the known and the reasonably foreseeable risks that the high-risk AI system can pose to health, safety or fundamental rights when the high-risk AI system is used in accordance with its intended purpose;",
            "(b) the estimation and evaluation of the risks that may emerge when the high-risk AI system is used in accordance with its intended purpose, and under conditions of reasonably foreseeable misuse;",
            "(c) the evaluation of other risks possibly arising, based on the analysis of data gathered from the post-market monitoring system referred to in Article 72;",
            "(d) the adoption of appropriate and targeted risk management measures designed to address the risks identified pursuant to point (a).",
            "3. The risks referred to in this Article shall concern only those which may be reasonably mitigated or eliminated through the development or design of the high-risk AI system, or the provision of adequate technical information.",
            "4. The risk management measures referred to in paragraph 2, point (d), shall give due consideration to the effects and possible interaction resulting from the combined application of the requirements set out in this Section, with a view to minimising risks more effectively while achieving an appropriate balance in implementing the measures to fulfil those requirements.",
            "5. The risk management measures referred to in paragraph 2, point (d), shall be such that the relevant residual risk associated with each hazard, as well as the overall residual risk of the high-risk AI systems is judged to be acceptable.",
            "In identifying the most appropriate risk management measures, the following shall be ensured:"
          ],
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      {
        "article": "10",
        "title": "Data and data governance",
        "duty": "Apply data and data governance requirements to training, validation and testing data.",
        "page": "https://legal.exploreworldai.com/eu/rattsakter/ai-act-2024-1689/artikel-10",
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          "label": "Article 10",
          "title": "Data and data governance",
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            "1. High-risk AI systems which make use of techniques involving the training of AI 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 whenever such data sets are used.",
            "2. Training, validation and testing data sets shall be subject to data governance and management practices appropriate for the intended purpose of the high-risk AI system. Those practices shall concern in particular:",
            "(a) the relevant design choices;",
            "(b) data collection processes and the origin of data, and in the case of personal data, the original purpose of the data collection;",
            "(c) relevant data-preparation processing operations, such as annotation, labelling, cleaning, updating, enrichment and aggregation;",
            "(d) the formulation of assumptions, in particular with respect to the information that the data are supposed to measure and represent;",
            "(e) an assessment of the availability, quantity and suitability of the data sets that are needed;",
            "(f) examination in view of possible biases that are likely to affect the health and safety of persons, have a negative impact on fundamental rights or lead to discrimination prohibited under Union law, especially where data outputs influence inputs for future operations;"
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        "article": "11",
        "title": "Technical documentation",
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          "label": "Article 11",
          "title": "Technical documentation",
          "paragraphs": [
            "1. The technical documentation of a high-risk AI system shall be drawn up before that system is placed on the market or put into service and shall be kept up-to date.",
            "The technical documentation shall be drawn up in such a way as to demonstrate that the high-risk AI system complies with the requirements set out in this Section and to provide national competent authorities and notified bodies with the necessary information in a clear and comprehensive form to assess the compliance of the AI system with those requirements. It shall contain, at a minimum, the elements set out in Annex IV. SMEs, including start-ups, may provide the elements of the technical documentation specified in Annex IV in a simplified manner. To that end, the Commission shall establish a simplified technical documentation form targeted at the needs of small and microenterprises. Where an SME, including a start-up, opts to provide the information required in Annex IV in a simplified manner, it shall use the form referred to in this paragraph. Notified bodies shall accept the form for the purposes of the conformity assessment.",
            "2. Where a high-risk AI system related to a product covered by the Union harmonisation legislation listed in Section A of Annex I is placed on the market or put into service, a single set of technical documentation shall be drawn up containing all the information set out in paragraph 1, as well as the information required under those legal acts.",
            "3. The Commission is empowered to adopt delegated acts in accordance with Article 97 in order to amend Annex IV, where necessary, to ensure that, in light of technical progress, the technical documentation provides all the information necessary to assess the compliance of the system with the requirements set out in this Section."
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      {
        "article": "12",
        "title": "Record-keeping",
        "duty": "Enable automatic recording of events (logging).",
        "page": "https://legal.exploreworldai.com/eu/rattsakter/ai-act-2024-1689/artikel-12",
        "obligation_id": "obligation:eu:ai-act-art-12-provider",
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          "label": "Article 12",
          "title": "Record-keeping",
          "paragraphs": [
            "1. High-risk AI systems shall technically allow for the automatic recording of events (logs) over the lifetime of the system.",
            "2. In order to ensure a level of traceability of the functioning of a high-risk AI system that is appropriate to the intended purpose of the system, logging capabilities shall enable the recording of events relevant for:",
            "(a) identifying situations that may result in the high-risk AI system presenting a risk within the meaning of Article 79(1) or in a substantial modification;",
            "(b) facilitating the post-market monitoring referred to in Article 72; and",
            "(c) monitoring the operation of high-risk AI systems referred to in Article 26(5).",
            "3. For high-risk AI systems referred to in point 1 (a), of Annex III, the logging capabilities shall provide, at a minimum:",
            "(a) recording of the period of each use of the system (start date and time and end date and time of each use);",
            "(b) the reference database against which input data has been checked by the system;",
            "(c)"
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      {
        "article": "17",
        "title": "Quality management system",
        "duty": "Operate a quality management system.",
        "page": "https://legal.exploreworldai.com/eu/rattsakter/ai-act-2024-1689/artikel-17",
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        "source_text": {
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          "label": "Article 17",
          "title": "Quality management system",
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            "1. Providers of high-risk AI systems shall put a quality management system in place that ensures compliance with this Regulation. That system shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions, and shall include at least the following aspects:",
            "(a) a strategy for regulatory compliance, including compliance with conformity assessment procedures and procedures for the management of modifications to the high-risk AI system;",
            "(b) techniques, procedures and systematic actions to be used for the design, design control and design verification of the high-risk AI system;",
            "(c) techniques, procedures and systematic actions to be used for the development, quality control and quality assurance of the high-risk AI system;",
            "(d) examination, test and validation procedures to be carried out before, during and after the development of the high-risk AI system, and the frequency with which they have to be carried out;",
            "(e) technical specifications, including standards, to be applied and, where the relevant harmonised standards are not applied in full or do not cover all of the relevant requirements set out in Section 2, the means to be used to ensure that the high-risk AI system complies with those requirements;",
            "(f) systems and procedures for data management, including data acquisition, data collection, data analysis, data labelling, data storage, data filtration, data mining, data aggregation, data retention and any other operation regarding the data that is performed before and for the purpose of the placing on the market or the putting into service of high-risk AI systems;",
            "(g)"
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      {
        "article": "43",
        "title": "Conformity assessment",
        "duty": "Carry out the applicable conformity assessment before placing on the market.",
        "page": "https://legal.exploreworldai.com/eu/rattsakter/ai-act-2024-1689/artikel-43",
        "obligation_id": "obligation:eu:ai-act-art-43-provider",
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        "duty_kind": "summary",
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          "label": "Article 43",
          "title": "Conformity assessment",
          "paragraphs": [
            "1. For high-risk AI systems listed in point 1 of Annex III, where, in demonstrating the compliance of a high-risk AI system with the requirements set out in Section 2, the provider has applied harmonised standards referred to in Article 40, or, where applicable, common specifications referred to in Article 41, the provider shall opt for one of the following conformity assessment procedures based on:",
            "(a) the internal control referred to in Annex VI; or",
            "(b) the assessment of the quality management system and the assessment of the technical documentation, with the involvement of a notified body, referred to in Annex VII.",
            "In demonstrating the compliance of a high-risk AI system with the requirements set out in Section 2, the provider shall follow the conformity assessment procedure set out in Annex VII where:",
            "(a) harmonised standards referred to in Article 40 do not exist, and common specifications referred to in Article 41 are not available;",
            "(b) the provider has not applied, or has applied only part of, the harmonised standard;",
            "(c) the common specifications referred to in point (a) exist, but the provider has not applied them;",
            "(d) one or more of the harmonised standards referred to in point (a) has been published with a restriction, and only on the part of the standard that was restricted."
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      {
        "article": "72",
        "title": "Post-market monitoring by providers and post-market monitoring plan for high-risk AI systems",
        "duty": "Run post-market monitoring of the system in use.",
        "page": "https://legal.exploreworldai.com/eu/rattsakter/ai-act-2024-1689/artikel-72",
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          "label": "Article 72",
          "title": "Post-market monitoring by providers and post-market monitoring plan for high-risk AI systems",
          "paragraphs": [
            "1. Providers shall establish and document a post-market monitoring system in a manner that is proportionate to the nature of the AI technologies and the risks of the high-risk AI system.",
            "2. The post-market monitoring system shall actively and systematically collect, document and analyse relevant data which may be provided by deployers or which may be collected through other sources on the performance of high-risk AI systems throughout their lifetime, and which allow the provider to evaluate the continuous compliance of AI systems with the requirements set out in Chapter III, Section 2. Where relevant, post-market monitoring shall include an analysis of the interaction with other AI systems. This obligation shall not cover sensitive operational data of deployers which are law-enforcement authorities.",
            "3. The post-market monitoring system shall be based on a post-market monitoring plan. The post-market monitoring plan shall be part of the technical documentation referred to in Annex IV. The Commission shall adopt an implementing act laying down detailed provisions establishing a template for the post-market monitoring plan and the list of elements to be included in the plan by 2 February 2026. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 98(2).",
            "4. For high-risk AI systems covered by the Union harmonisation legislation listed in Section A of Annex I, where a post-market monitoring system and plan are already established under that legislation, in order to ensure consistency, avoid duplications and minimise additional burdens, providers shall have a choice of integrating, as appropriate, the necessary elements described in paragraphs 1, 2 and 3 using the template referred in paragraph 3 into systems and plans already existing under that legislation, provided that it achieves an equivalent level of protection.",
            "The first subparagraph of this paragraph shall also apply to high-risk AI systems referred to in point 5 of Annex III placed on the market or put into service by financial institutions that are subject to requirements under Union financial services law regarding their internal governance, arrangements or processes."
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      {
        "article": "73",
        "title": "Reporting of serious incidents",
        "duty": "Report serious incidents to the market surveillance authority.",
        "page": "https://legal.exploreworldai.com/eu/rattsakter/ai-act-2024-1689/artikel-73",
        "obligation_id": "obligation:eu:ai-act-art-73-provider",
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        "duty_kind": "summary",
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          "label": "Article 73",
          "title": "Reporting of serious incidents",
          "paragraphs": [
            "1. Providers of high-risk AI systems placed on the Union market shall report any serious incident to the market surveillance authorities of the Member States where that incident occurred.",
            "2. The report referred to in paragraph 1 shall be made immediately after the provider has established a causal link between the AI system and the serious incident or the reasonable likelihood of such a link, and, in any event, not later than 15 days after the provider or, where applicable, the deployer, becomes aware of the serious incident.",
            "The period for the reporting referred to in the first subparagraph shall take account of the severity of the serious incident.",
            "3. Notwithstanding paragraph 2 of this Article, in the event of a widespread infringement or a serious incident as defined in Article 3, point (49)(b), the report referred to in paragraph 1 of this Article shall be provided immediately, and not later than two days after the provider or, where applicable, the deployer becomes aware of that incident.",
            "4. Notwithstanding paragraph 2, in the event of the death of a person, the report shall be provided immediately after the provider or the deployer has established, or as soon as it suspects, a causal relationship between the high-risk AI system and the serious incident, but not later than 10 days after the date on which the provider or, where applicable, the deployer becomes aware of the serious incident.",
            "5. Where necessary to ensure timely reporting, the provider or, where applicable, the deployer, may submit an initial report that is incomplete, followed by a complete report.",
            "6. Following the reporting of a serious incident pursuant to paragraph 1, the provider shall, without delay, perform the necessary investigations in relation to the serious incident and the AI system concerned. This shall include a risk assessment of the incident, and corrective action.",
            "The provider shall cooperate with the competent authorities, and where relevant with the notified body concerned, during the investigations referred to in the first subparagraph, and shall not perform any investigation which involves altering the AI system concerned in a way which may affect any subsequent evaluation of the causes of the incident, prior to informing the competent authorities of such action.",
            "7. Upon receiving a notification related to a serious incident referred to in Article 3, point (49)(c), the relevant market surveillance authority shall inform the national public authorities or bodies referred to in Article 77(1). The Commission shall develop dedicated guidance to facilitate compliance with the obligations set out in paragraph 1 of this Article. That guidance shall be issued by 2 August 2025, and shall be assessed regularly.",
            "8. The market surveillance authority shall take appropriate measures, as provided for in Article 19 of Regulation (EU) 2019/1020, within seven days from the date it received the notification referred to in paragraph 1 of this Article, and shall follow the notification procedures as provided in that Regulation.",
            "9. For high-risk AI systems referred to in Annex III that are placed on the market or put into service by providers that are subject to Union legislative instruments laying down reporting obligations equivalent to those set out in this Regulation, the notification of serious incidents shall be limited to those referred to in Article 3, point (49)(c).",
            "10. For high-risk AI systems which are safety components of devices, or are themselves devices, covered by Regulations (EU) 2017/745 and (EU) 2017/746, the notification of serious incidents shall be limited to those referred to in Article 3, point (49)(c) of this Regulation, and shall be made to the national competent authority chosen for that purpose by the Member States where the incident occurred.",
            "11. National competent authorities shall immediately notify the Commission of any serious incident, whether or not they have taken action on it, in accordance with Article 20 of Regulation (EU) 2019/1020."
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