laredoyin/eu-ai-act huggingface dataset:
As signatories to the United Nations Convention on the Rights of Persons with Disabilities, the Union and the  Member States are legally obliged to protect persons with disabilities from discrimination and promote their equality,  to ensure that persons with disabilities have access, on an equal basis with others, to information and  communications technologies and systems, and to ensure respect for privacy for persons with disabilities. Given the  growing importance and use of AI systems, the application of universal design principles to all new technologies and  services should ensure full and equal access for everyone potentially affected by or using AI technologies, including  persons with disabilities, in a way that takes full account of their inherent dignity and diversity. It is therefore  essential that providers ensure full compliance with accessibility requirements, including Directive (EU) 2016/2102  of the European Parliament and of the Council (38) and Directive (EU) 2019/882. Providers should ensure  compliance with these requirements by design. Therefore, the necessary measures should be integrated as much as  possible into the design of the high-risk AI system.
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. Providers of high-risk AI systems that are subject to obligations regarding quality management  systems under relevant sectoral Union law should have the possibility to include the elements of the quality  management system provided for in this Regulation as part of the existing quality management system provided for  in that other sectoral Union law. The complementarity between this Regulation and existing sectoral Union law  should also be taken into account in future standardisation activities or guidance adopted by the Commission. 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 concerned.
To enable enforcement of this Regulation and create a level playing field for operators, and, taking into account the  different forms of making available of digital products, it is important to ensure that, under all circumstances,  a person established in the Union can provide authorities with all the necessary information on the compliance of an  AI system. Therefore, prior to making their AI systems available in the Union, providers established in third  countries should, by written mandate, appoint an authorised representative established in the Union. This authorised  representative plays a pivotal role in ensuring the compliance of the high-risk AI systems placed on the market or  put into service in the Union by those providers who are not established in the Union and in serving as their contact  person established in the Union.
In light of the nature and complexity of the value chain for AI systems and in line with the New Legislative  Framework, it is essential to ensure legal certainty and facilitate the compliance with this Regulation. Therefore, it is  necessary to clarify the role and the specific obligations of relevant operators along that value chain, such as  importers and distributors who may contribute to the development of AI systems. In certain situations those  operators could act in more than one role at the same time and should therefore fulfil cumulatively all relevant  obligations associated with those roles. For example, an operator could act as a distributor and an importer at the  same time.
To ensure legal certainty, it is necessary to clarify that, under certain specific conditions, any distributor, importer,  deployer or other third-party should be considered to be a provider of a high-risk AI system and therefore assume all  the relevant obligations. This would be the case if that party puts its name or trademark on a high-risk AI system  already placed on the market or put into service, without prejudice to contractual arrangements stipulating that the  obligations are allocated otherwise. This would also be the case if that party makes a substantial modification to  a high-risk AI system that has already been placed on the market or has already been put into service in a way that it  remains a high-risk AI system in accordance with this Regulation, or if it modifies the intended purpose of an AI  system, including a general-purpose AI system, which has not been classified as high-risk and has already been  placed on the market or put into service, in a way that the AI system becomes a high-risk AI system in accordance  with this Regulation. Those provisions should apply without prejudice to more specific provisions established in  certain Union harmonisation legislation based on the New Legislative Framework, together with which this Regulation should apply. For example, Article 16(2) of Regulation (EU) 2017/745, establishing that certain changes  should not be considered to be modifications of a device that could affect its compliance with the applicable  requirements, should continue to apply to high-risk AI systems that are medical devices within the meaning of that  Regulation.
General-purpose AI systems may be used as high-risk AI systems by themselves or be components of other high-risk  AI systems. Therefore, due to their particular nature and in order to ensure a fair sharing of responsibilities along the  AI value chain, the providers of such systems should, irrespective of whether they may be used as high-risk AI  systems as such by other providers or as components of high-risk AI systems and unless provided otherwise under  this Regulation, closely cooperate with the providers of the relevant high-risk AI systems to enable their compliance  with the relevant obligations under this Regulation and with the competent authorities established under this  Regulation.
Where, under the conditions laid down in this Regulation, the provider that initially placed the AI system on the  market or put it into service should no longer be considered to be the provider for the purposes of this Regulation,  and when that provider has not expressly excluded the change of the AI system into a high-risk AI system, the  former provider should nonetheless closely cooperate and make available the necessary information and provide the  reasonably expected technical access and other assistance that are required for the fulfilment of the obligations set  out in this Regulation, in particular regarding the compliance with the conformity assessment of high-risk AI  systems.
Along the AI value chain multiple parties often supply AI systems, tools and services but also components or  processes that are incorporated by the provider into the AI system with various objectives, including the model  training, model retraining, model testing and evaluation, integration into software, or other aspects of model  development. Those parties have an important role to play in the value chain towards the provider of the high-risk  AI system into which their AI systems, tools, services, components or processes are integrated, and should provide  by written agreement this provider with the necessary information, capabilities, technical access and other assistance  based on the generally acknowledged state of the art, in order to enable the provider to fully comply with the  obligations set out in this Regulation, without compromising their own intellectual property rights or trade secrets.
Third parties making accessible to the public tools, services, processes, or AI components other than  general-purpose AI models, should not be mandated to comply with requirements targeting the responsibilities  along the AI value chain, in particular towards the provider that has used or integrated them, when those tools,  services, processes, or AI components are made accessible under a free and open-source licence. Developers of free  and open-source tools, services, processes, or AI components other than general-purpose AI models should be  encouraged to implement widely adopted documentation practices, such as model cards and data sheets, as a way to  accelerate information sharing along the AI value chain, allowing the promotion of trustworthy AI systems in the  Union.
Given the nature of AI systems and the risks to safety and fundamental rights possibly associated with their use,  including as regards the need to ensure proper monitoring of the performance of an AI system in a real-life setting, it  is appropriate to set specific responsibilities for deployers. Deployers should in particular take appropriate technical  and organisational measures to ensure they use high-risk AI systems in accordance with the instructions of use and  certain other obligations should be provided for with regard to monitoring of the functioning of the AI systems and  with regard to record-keeping, as appropriate. Furthermore, deployers should ensure that the persons assigned to  implement the instructions for use and human oversight as set out in this Regulation have the necessary  competence, in particular an adequate level of AI literacy, training and authority to properly fulfil those tasks. Those  obligations should be without prejudice to other deployer obligations in relation to high-risk AI systems under  Union or national law.
This Regulation is without prejudice to obligations for employers to inform or to inform and consult workers or  their representatives under Union or national law and practice, including Directive 2002/14/EC of the European  Parliament and of the Council (39), on decisions to put into service or use AI systems. It remains necessary to ensure  information of workers and their representatives on the planned deployment of high-risk AI systems at the  workplace where the conditions for those information or information and consultation obligations in other legal  instruments are not fulfilled. Moreover, such information right is ancillary and necessary to the objective of  protecting fundamental rights that underlies this Regulation. Therefore, an information requirement to that effect  should be laid down in this Regulation, without affecting any existing rights of workers.
Whilst risks related to AI systems can result from the way such systems are designed, risks can as well stem from  how such AI systems are used. Deployers of high-risk AI systems therefore play a critical role in ensuring that  fundamental rights are protected, complementing the obligations of the provider when developing the AI system.  Deployers are best placed to understand how the high-risk AI system will be used concretely and can therefore  identify potential significant risks that were not foreseen in the development phase, due to a more precise knowledge  of the context of use, the persons or groups of persons likely to be affected, including vulnerable groups. Deployers  of high-risk AI systems listed in an annex to this Regulation also play a critical role in informing natural persons and  should, when they make decisions or assist in making decisions related to natural persons, where applicable, inform  the natural persons that they are subject to the use of the high-risk AI system. This information should include the  intended purpose and the type of decisions it makes. The deployer should also inform the natural persons about  their right to an explanation provided under this Regulation. With regard to high-risk AI systems used for law  enforcement purposes, that obligation should be implemented in accordance with Article 13 of Directive (EU)  2016/680.
Any processing of biometric data involved in the use of AI systems for biometric identification for the purpose of  law enforcement needs to comply with Article 10 of Directive (EU) 2016/680, that allows such processing only  where strictly necessary, subject to appropriate safeguards for the rights and freedoms of the data subject, and where  authorised by Union or Member State law. Such use, when authorised, also needs to respect the principles laid down  in Article 4(1) of Directive (EU) 2016/680 including lawfulness, fairness and transparency, purpose limitation,  accuracy and storage limitation.
Without prejudice to applicable Union law, in particular Regulation (EU) 2016/679 and Directive (EU) 2016/680,  considering the intrusive nature of post-remote biometric identification systems, the use of post-remote biometric  identification systems should be subject to safeguards. Post-remote biometric identification systems should always be  used in a way that is proportionate, legitimate and strictly necessary, and thus targeted, in terms of the individuals to  be identified, the location, temporal scope and based on a closed data set of legally acquired video footage. In any  case, post-remote biometric identification systems should not be used in the framework of law enforcement to lead  to indiscriminate surveillance. The conditions for post-remote biometric identification should in any case not  provide a basis to circumvent the conditions of the prohibition and strict exceptions for real time remote biometric  identification.
In order to efficiently ensure that fundamental rights are protected, deployers of high-risk AI systems that are bodies  governed by public law, or private entities providing public services and deployers of certain high-risk AI systems  listed in an annex to this Regulation, such as banking or insurance entities, should carry out a fundamental rights  impact assessment prior to putting it into use. Services important for individuals that are of public nature may also  be provided by private entities. Private entities providing such public services are linked to tasks in the public interest  such as in the areas of education, healthcare, social services, housing, administration of justice. The aim of the  fundamental rights impact assessment is for the deployer to identify the specific risks to the rights of individuals or  groups of individuals likely to be affected, identify measures to be taken in the case of a materialisation of those risks.  The impact assessment should be performed prior to deploying the high-risk AI system, and should be updated when the deployer considers that any of the relevant factors have changed. The impact assessment should identify  the deployer’s relevant processes in which the high-risk AI system will be used in line with its intended purpose, and  should include a description of the period of time and frequency in which the system is intended to be used as well  as of specific categories of natural persons and groups who are likely to be affected in the specific context of use. The  assessment should also include the identification of specific risks of harm likely to have an impact on the  fundamental rights of those persons or groups. While performing this assessment, the deployer should take into  account information relevant to a proper assessment of the impact, including but not limited to the information  given by the provider of the high-risk AI system in the instructions for use. In light of the risks identified, deployers  should determine measures to be taken in the case of a materialisation of those risks, including for example  governance arrangements in that specific context of use, such as arrangements for human oversight according to the  instructions of use or, complaint handling and redress procedures, as they could be instrumental in mitigating risks  to fundamental rights in concrete use-cases. After performing that impact assessment, the deployer should notify the  relevant market surveillance authority. Where appropriate, to collect relevant information necessary to perform the  impact assessment, deployers of high-risk AI systems, in particular when AI systems are used in the public sector,  could involve relevant stakeholders, including the representatives of groups of persons likely to be affected by the AI  system, independent experts, and civil society organisations in conducting such impact assessments and designing  measures to be taken in the case of materialisation of the risks. The European Artificial Intelligence Office (AI Office)  should develop a template for a questionnaire in order to facilitate compliance and reduce the administrative burden  for deployers.
The notion of general-purpose AI models should be clearly defined and set apart from the notion of AI systems to  enable legal certainty. The definition should be based on the key functional characteristics of a general-purpose AI  model, in particular the generality and the capability to competently perform a wide range of distinct tasks. These  models are typically trained on large amounts of data, through various methods, such as self-supervised,  unsupervised or reinforcement learning. General-purpose AI models may be placed on the market in various ways,  including through libraries, application programming interfaces (APIs), as direct download, or as physical copy.  These models may be further modified or fine-tuned into new models. Although AI models are essential  components of AI systems, they do not constitute AI systems on their own. AI models require the addition of further  components, such as for example a user interface, to become AI systems. AI models are typically integrated into and  form part of AI systems. This Regulation provides specific rules for general-purpose AI models and for  general-purpose AI models that pose systemic risks, which should apply also when these models are integrated or  form part of an AI system. It should be understood that the obligations for the providers of general-purpose AI  models should apply once the general-purpose AI models are placed on the market. When the provider of  a general-purpose AI model integrates an own model into its own AI system that is made available on the market or  put into service, that model should be considered to be placed on the market and, therefore, the obligations in this  Regulation for models should continue to apply in addition to those for AI systems. The obligations laid down for  models should in any case not apply when an own model is used for purely internal processes that are not essential  for providing a product or a service to third parties and the rights of natural persons are not affected. Considering  their potential significantly negative effects, the general-purpose AI models with systemic risk should always be  subject to the relevant obligations under this Regulation. The definition should not cover AI models used before their  placing on the market for the sole purpose of research, development and prototyping activities. This is without  prejudice to the obligation to comply with this Regulation when, following such activities, a model is placed on the  market.
Providers of general-purpose AI models have a particular role and responsibility along the AI value chain, as the  models they provide may form the basis for a range of downstream systems, often provided by downstream  providers that necessitate a good understanding of the models and their capabilities, both to enable the integration of  such models into their products, and to fulfil their obligations under this or other regulations. Therefore,  proportionate transparency measures should be laid down, including the drawing up and keeping up to date of  documentation, and the provision of information on the general-purpose AI model for its usage by the downstream  providers. Technical documentation should be prepared and kept up to date by the general-purpose AI model  provider for the purpose of making it available, upon request, to the AI Office and the national competent  authorities. The minimal set of elements to be included in such documentation should be set out in specific annexes  to this Regulation. The Commission should be empowered to amend those annexes by means of delegated acts in  light of evolving technological developments.
Software and data, including models, released under a free and open-source licence that allows them to be openly  shared and where users can freely access, use, modify and redistribute them or modified versions thereof, can  contribute to research and innovation in the market and can provide significant growth opportunities for the Union  economy. General-purpose AI models released under free and open-source licences should be considered to ensure  high levels of transparency and openness if their parameters, including the weights, the information on the model  architecture, and the information on model usage are made publicly available. The licence should be considered to be  free and open-source also when it allows users to run, copy, distribute, study, change and improve software and data,  including models under the condition that the original provider of the model is credited, the identical or comparable  terms of distribution are respected.
Free and open-source AI components covers the software and data, including models and general-purpose AI  models, tools, services or processes of an AI system. Free and open-source AI components can be provided through  different channels, including their development on open repositories. For the purposes of this Regulation, AI  components that are provided against a price or otherwise monetised, including through the provision of technical  support or other services, including through a software platform, related to the AI component, or the use of  personal data for reasons other than exclusively for improving the security, compatibility or interoperability of the  software, with the exception of transactions between microenterprises, should not benefit from the exceptions  provided to free and open-source AI components. The fact of making AI components available through open  repositories should not, in itself, constitute a monetisation.
The providers of general-purpose AI models that are released under a free and open-source licence, and whose  parameters, including the weights, the information on the model architecture, and the information on model usage,  are made publicly available should be subject to exceptions as regards the transparency-related requirements  imposed on general-purpose AI models, unless they can be considered to present a systemic risk, in which case the  circumstance that the model is transparent and accompanied by an open-source license should not be considered to  be a sufficient reason to exclude compliance with the obligations under this Regulation. In any case, given that the  release of general-purpose AI models under free and open-source licence does not necessarily reveal substantial  information on the data set used for the training or fine-tuning of the model and on how compliance of copyright  law was thereby ensured, the exception provided for general-purpose AI models from compliance with the  transparency-related requirements should not concern the obligation to produce a summary about the content used  for model training and the obligation to put in place a policy to comply with Union copyright law, in particular to  identify and comply with the reservation of rights pursuant to Article 4(3) of Directive (EU) 2019/790 of the  European Parliament and of the Council (40).