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The document is a proposal for a regulation of the European Parliament and the Council on harmonised rules on artificial intelligence (AI). The main content of the document can be summarised as follows:
- The document explains the purpose, scope and definitions of the proposed regulation, which aims to improve the functioning of the internal market, promote the uptake of trustworthy AI, and ensure a high level of protection of health, safety, fundamental rights and environmental protection against harmful effects of AI systems.
- The document identifies certain AI practices that are prohibited or subject to specific conditions, such as those that violate human dignity, manipulate human behaviour, exploit vulnerabilities, or pose a clear threat to safety or fundamental rights.
- The document establishes a risk-based approach to regulate AI systems according to their intended purpose and potential impact. It defines high-risk AI systems as those that are used in certain sectors or contexts where significant risks are likely to occur, such as health, education, law enforcement, justice, transport, energy, and public administration. It also sets out the criteria and procedures for identifying other high-risk AI systems that are not covered by the predefined list.
- The document lays down the requirements and obligations for providers, importers, distributors, authorised representatives and deployers of high-risk AI systems, such as ensuring conformity assessment, technical documentation, risk management, quality management, data governance, transparency, human oversight, accuracy, robustness, security, and post-market monitoring. It also specifies the rights and obligations of users and affected persons, such as the right to information, explanation, redress, and human intervention.
- The document provides for the establishment of a European Artificial Intelligence Board, composed of representatives of national competent authorities and the Commission, to facilitate the consistent implementation of the regulation, issue opinions and guidance, and monitor the developments and impacts of AI.
- The document sets out the tasks and powers of national competent authorities and the Commission to ensure the effective enforcement and supervision of the regulation, such as conducting market surveillance, inspections, audits, investigations, and imposing corrective measures or administrative fines. It also establishes a cooperation mechanism among national competent authorities and the Commission to exchange information, coordinate actions, and resolve disputes.
- The document introduces transparency obligations for providers and users of certain AI systems that are not high-risk but may pose specific risks of impersonation or deception, such as those that interact with natural persons, generate or manipulate content, or categorise or recognise emotions or biometrics. It also requires providers of general-purpose AI models to respect Union copyright law and disclose the content used for training the models.
- The document outlines the measures to support innovation and the development of the AI ecosystem in the Union, such as facilitating access to data and testing facilities, establishing regulatory sandboxes, providing guidance and assistance, promoting AI literacy and skills, and fostering international cooperation.
Overview of the titles of the European Articifial Intelligence Act:
- Title I: General provisions. This title defines the scope, objectives, and key concepts of the regulation, such as artificial intelligence, high-risk AI systems, and providers and deployers of AI systems.
- Title II: Prohibitions. This title prohibits certain AI practices that are considered to violate fundamental rights and values of the Union, such as social scoring, subliminal manipulation, and exploitation of vulnerabilities of children or persons with disabilities.
- Title III: Requirements for high-risk AI systems. This title lays down the requirements that providers and deployers of high-risk AI systems have to comply with, such as risk management, data quality, transparency, human oversight, and accuracy. It also establishes the conformity assessment procedures and the obligations of the operators along the AI value chain.
- Title IV: Transparency obligations for providers and deployers of certain AI systems and GPAI models. This title sets out the transparency obligations for providers and deployers of AI systems that interact with humans, generate or manipulate content, or provide emotion recognition or biometric categorization. It also introduces the concept of GPAI models, which are AI models that are trained on personal data and may pose significant risks to the rights and freedoms of individuals. Providers and deployers of GPAI models have to comply with specific requirements, such as data protection, data minimization, and data quality.
- Title V: Voluntary codes of conduct. This title encourages and facilitates the drawing up of codes of conduct for the voluntary application of some or all of the requirements of Title III to AI systems other than high-risk AI systems, or for the application of specific requirements to all AI systems, such as ethical principles, environmental sustainability, AI literacy, and diversity and inclusion.
- Title VI: Governance and coordination. This title establishes the European Artificial Intelligence Board, which is a body composed of representatives of the Member States and the Commission, and which is responsible for providing guidance, advice, and recommendations on the implementation and development of the regulation. It also creates the AI Office, which is a unit within the Commission that is in charge of supporting the Board, maintaining the EU database of AI systems, and facilitating the exchange of information and best practices among the Member States and the stakeholders.
- Title VII: Notification and market surveillance. This title sets out the rules for the notification and designation of notified bodies, which are entities that are authorized to carry out the conformity assessment of high-risk AI systems. It also establishes the market surveillance and control measures that the national competent authorities have to apply to ensure the compliance of AI systems with the regulation, and the cooperation mechanisms among the authorities and with the Commission.
- Title VIII: Post-market monitoring, information sharing, market surveillance. This title requires providers of high-risk AI systems to establish and document a post-market monitoring system, which is a system that collects, analyses, and evaluates data on the performance and compliance of the AI systems throughout their lifetime. It also obliges providers and deployers of high-risk AI systems to register them in the EU database of AI systems, which is a public and user-friendly database that contains information on the characteristics, capabilities, and limitations of the AI systems, as well as the identity and contact details of the providers and deployers.
- Title IX: Confidentiality and penalties. This title lays down the rules for the protection of confidential information that is obtained or exchanged in the context of the application of the regulation, and the sanctions and remedies that may be imposed for the infringement of the regulation, including administrative fines, injunctions, and compensation for damages.
- Title X: Amendments to existing Union legislation. This title amends several existing Union legal acts that are related to the safety and performance of products and services that may incorporate or use AI systems, such as machinery, toys, vehicles, railways, and maritime equipment. The amendments aim to ensure the consistency and coherence of the regulation with those legal acts, and to take into account the specific requirements for AI systems that are set out in Title III, Chapter 2 of the regulation.
- Title XI: Delegated acts and implementing acts. This title empowers the Commission to adopt delegated acts and implementing acts to supplement or amend certain non-essential elements of the regulation, such as the criteria for the identification of high-risk AI systems, the common
specifications for the conformity assessment procedures, and the template for the post-market monitoring plan.
- Title XII: Final provisions. This title contains the final provisions of the regulation, such as the entry into force, the application, and the transitional and review clauses. It also specifies the committee procedure that applies to the adoption of the implementing acts by the Commission.
Here is an overview of annex II to annex IX of the document:
- Annex II: Lists the existing Union harmonisation legislation that applies to high-risk AI systems related to products, such as medical devices, machinery, toys, etc.
- Annex III: Lists the use cases of AI systems that are considered high-risk, such as biometric identification, credit scoring, recruitment, etc.
- Annex IV: Specifies the elements to be included in the technical documentation of high-risk AI systems, such as description, intended purpose, risk assessment, etc.
- Annex V: Specifies the elements to be included in the instructions for use of high-risk AI systems, such as information on data sources, accuracy, limitations, etc.
- Annex VI: Describes the conformity assessment procedure based on internal control for high-risk AI systems, which involves self-assessment and declaration of conformity by the provider.
- Annex VII: Describes the conformity assessment procedure based on assessment of the quality management system and assessment of the technical documentation, with the involvement of a notified body, for high-risk AI systems.
- Annex VIII: Specifies the information to be submitted upon the registration of high-risk AI systems in the EU database, such as identification number, provider details, description, etc.
- Annex VIIIa: Specifies the information to be submitted upon the registration of high-risk AI systems for testing in real world conditions in the EU database, such as testing plan, users involved, etc.
- Annex IX: Lists the Union legislation on large-scale IT systems in the area of freedom, security and justice, such as Schengen Information System, Visa Information System, Eurodac, etc.