A Complete Guide to the EU AI Act: Summary, Timeline and Impact

A Complete Guide to the EU AI Act: Summary, Timeline and Impact

17 min read

Introduction to the EU Artificial Intelligence Act

Understanding the World's First Comprehensive AI Law

The European Union stands at the forefront of regulating artificial intelligence (AI) through its pioneering Artificial Intelligence Act. This legislation represents a significant milestone, aiming to harmonize AI rules across member states while ensuring AI development is human-centric, trustworthy, and aligned with fundamental rights and safety.

The Objectives of the EU AI Act

At its core, the AI Act seeks to establish a balanced framework that fosters innovation and technological advancement without compromising ethical standards and individual protections. It introduces specific regulations for high-risk AI applications, mandates transparency, and sets forth governance structures to oversee AI deployment within the EU.

The EU's Digital Strategy and AI

Benefits of Regulating AI: From Healthcare to Energy

The regulation underscores the myriad benefits that controlled AI development can bring across sectors such as healthcare, transportation, and energy. By setting clear guidelines, the EU aims to leverage AI for societal good, enhancing efficiency, safety, and sustainability.

The Path to Regulation: The European Commission's Proposal

Initiated by the European Commission, the AI Act is part of a broader digital strategy to position the EU as a global leader in the digital age. This proposal outlines a risk-based approach to AI governance, ensuring that systems are developed and deployed under stringent ethical and safety standards.

What the EU Parliament Wants in AI Legislation

Ensuring Safety, Transparency, and Environmental Friendliness

The European Parliament advocates for AI systems that prioritize safety, transparency, and environmental sustainability. The legislation emphasizes the need for AI to be understandable and under human oversight, ensuring that technology serves the public interest without adverse impacts.

The Call for a Uniform Definition of AI

A crucial aspect of the AI Act is its attempt to establish a uniform, technology-neutral definition of AI. This is intended to ensure that the regulation remains relevant and adaptable to future technological advancements, providing a solid foundation for AI governance.

AI Act: Categorizing Risks and Setting Rules

The AI Act introduces a novel classification system for AI applications based on the level of risk they pose. This framework is designed to apply a proportionate level of regulatory scrutiny, from minimal to high-risk AI systems, ensuring that higher-risk applications undergo rigorous assessment. Below is a summary of what risk levels there are, their regulatory requirements and classification criteria with examples:

  • Unacceptable Risk – Full Scope Prohibitions – Art.5
    • Highest level, system with clear encroachments on fundamental rights.
    • e.g.real time monitoring by law enforcement agencies, social scoring
  • High Risk – Comprehensive Regulation – Art.6
    • Systems with potential to cause significant harm (health, safety, fundamental rights) in case of failure or misuse
    • e.g. AI in recruiting/ HR or in law enforcement,
  • Limited Risk– Transparency Obligations – Art.52
    • Systems with a risk of manipulation or deceit, in non-critical areas
    • e.g. chatbots in customer service, emotion recognition systems
    • Users must be informed about any interaction with AI
  • Minimal Risk – Codes of Conduct – Art.69
    • Systems with low or lower risk of causing any potential harm
    • e.g. spam filter, content ranking
    • No additional restrictions of deployment

EU AI Act: Risk based system classification

Specific Prohibitions: Unacceptable Risk AI Systems

The regulation identifies certain AI practices as unacceptable risks, thereby prohibiting them. These include real-time biometric identification in public spaces and manipulative AI that exploits individual vulnerabilities, reflecting the EU's commitment to safeguarding citizens' rights and safety. In summary, the following practices are prohibited:

  • Subliminal Techniques: Placing on the market, putting into service, or using AI systems that deploy subliminal techniques beyond a person’s consciousness or purposefully manipulative or deceptive techniques with the intent or effect of materially distorting a person's behavior, causing significant harm.
  • Exploitation of Vulnerabilities: Exploiting any of the vulnerabilities of a person or a specific group of persons due to their age, disability, or a specific social or economic situation in a manner that materially distorts their behavior and causes or is likely to cause significant harm.
  • Social Scoring: Using AI systems for the evaluation or classification of natural persons or groups based on their social behavior or personal characteristics, leading to detrimental or unfavorable treatment, particularly if it results in unjustified or disproportionate outcomes.
  • Real-Time Remote Biometric Identification: The use of 'real-time' remote biometric identification systems in publicly accessible spaces for the purpose of law enforcement, except under narrowly defined situations where it is strictly necessary to achieve a substantial public interest.
  • Risk Assessments Based on Profiling: Making risk assessments of natural persons in order to assess or predict the risk of them committing a criminal offense, based solely on profiling or assessing their personality traits and characteristics.
  • Untargeted Facial Image Scraping: Creating or expanding facial recognition databases through untargeted scraping of facial images from the internet or CCTV footage.
  • Emotion Recognition in Sensitive Areas: Inferring or detecting emotions or intentions of natural persons based on their biometric data for purposes such as employment, education, or public security, except in cases where it is intended for medical or safety reasons.

High-Risk AI Systems Explained

Categories of High-Risk AI Applications

High-risk AI systems are defined within the regulation to include applications that impact critical sectors such as healthcare, transportation, and public services. These systems are subject to stringent requirements, including data governance, technical documentation, and transparency, to mitigate risks and ensure accountability.

Obligations and Assessments for High-Risk Systems

The Act mandates comprehensive obligations for high-risk AI systems, focusing on aspects such as human oversight, accuracy, and cybersecurity. These requirements aim to ensure that high-risk AI applications are safe, reliable, and aligned with EU values and standards. In summary, here are the requirements set for high-risk systems:

  • Risk Management System: Establishing a continuous, iterative process to identify and mitigate risks to health, safety, and fundamental rights associated with the AI system throughout its lifecycle.
  • Quality and Relevance of Data Sets: Ensuring that datasets used for training, validation, and testing are of high quality, relevant, sufficiently representative, and as free from errors as possible, considering the intended purpose of the AI system.
  • Technical Documentation: Maintaining up-to-date technical documentation that provides information necessary to assess compliance with the regulation and facilitates post-market monitoring.
  • Record-Keeping: Ensuring that the AI system can automatically generate logs (events) throughout its operational lifetime, which should be kept for a period appropriate to the system's purpose.
  • Transparency and Information Provision: Designing high-risk AI systems to be sufficiently transparent for deployers to understand their operation and providing them with clear and comprehensive instructions for use.
  • Human Oversight: Implementing appropriate human oversight measures to ensure that the AI system's functioning can be effectively overseen by natural persons during its use.
  • Accuracy, Robustness, and Cybersecurity: Ensuring that high-risk AI systems achieve an appropriate level of accuracy, robustness, and cybersecurity, and perform consistently in these respects throughout their lifecycle.
  • Conformity Assessment: Undergoing the relevant conformity assessment procedure before placing the AI system on the market or putting it into service.
  • CE Marking: Affixing the CE marking to the AI system to indicate conformity with the regulation.
  • Registration: Registering the AI system in the EU database before making it available on the market or putting it into service.
  • Accessibility Requirements: Complying with accessibility requirements for products and services and the accessibility of the websites and mobile applications of public sector bodies.

Transparency Requirements for AI Systems

Generative AI and the Need for Transparency

Generative AI systems, while not classified as high-risk, are required to comply with transparency obligations. This includes the need to disclose when content is AI-generated, thereby enabling users to make informed decisions and maintain trust in digital content.

Labeling AI-Generated Content

The AI Act emphasizes the importance of clearly labeling AI-generated content, such as deepfakes or synthetic media. This measure aims to ensure user awareness and prevent misinformation, fostering a digital environment where users can discern between AI-generated and authentic content.

Detailed Transparency Requirements

  • Interaction with Natural Persons: Providers must ensure that AI systems designed to directly interact with natural persons clearly inform users that they are interacting with an AI system, unless it is obvious from the context and the user's level of knowledge and awareness.
  • Synthetic Content Generation: Providers of AI systems that generate synthetic audio, images, video, or text content must mark the outputs in a machine-readable format and ensure the content is detectable as artificially generated or manipulated. The technical solutions implemented must be effective, interoperable, robust, and reliable to the extent technically feasible.
  • Emotion Recognition and Biometric Categorization Systems: Deployers of systems used for emotion recognition or biometric categorization must inform individuals about the operation of these systems and process personal data in compliance with relevant data protection regulations.
  • Deepfakes (Manipulated Content): Deployers of AI systems that generate or manipulate content that could be considered "deepfakes" must disclose that the content has been artificially created or manipulated. This does not apply if the content is part of a creative, satirical, artistic, or fictional work, or if the AI-generated content has undergone human review or editorial control.
  • Public Interest Text Generation: Deployers of AI systems that generate text for the purpose of informing the public on matters of public interest must disclose that the text has been artificially generated or manipulated, unless there is human review or editorial control and editorial responsibility for the content.
  • Clear and Distinguishable Information: The information provided to natural persons must be presented in a clear and distinguishable manner, respecting accessibility requirements.
  • Registration of High-Risk AI Systems: Providers and deployers of high-risk AI systems must register themselves and their systems in an EU database before placing the system on the market or putting it into service.

Governance and Enforcement

A pivotal aspect of the regulation is the establishment of a governance structure centered around the AI Office, which plays a crucial role in supporting the implementation and enforcement of the Act. An EU-wide database for high-risk AI systems will be created to facilitate oversight and compliance. The regulation also delineates the roles of national competent authorities, market surveillance authorities, and the European Data Protection Supervisor, ensuring a coordinated approach to AI governance. Here is a summary of the governance of enforcement of the EU AI Act:

  • AI Office: The establishment of the AI Office to contribute to the implementation, monitoring, and supervision of AI systems, general-purpose AI models, and AI governance. The AI Office is responsible for coordinating support for joint investigations, providing guidance on the implementation of the regulation, and ensuring that classification rules and procedures are up to date.
  • European Artificial Intelligence Board: The creation of a board composed of representatives from Member States, a scientific panel for technical support, and an advisory forum for stakeholder input. The Board is tasked with advising and assisting the Commission and Member States in the application of the regulation, issuing opinions and recommendations, and facilitating the development of common criteria and understanding among market operators.
  • National Competent Authorities: Each Member State is required to designate at least one notifying authority and one market surveillance authority to oversee the application and enforcement of the regulation at the national level. These authorities are responsible for ensuring that AI systems comply with the regulation's requirements and for taking appropriate measures in case of non-compliance.
  • Market Surveillance: Market surveillance authorities are tasked with monitoring the market for AI systems, taking measures to ensure compliance, and proposing joint activities, including investigations, to address non-compliance or serious risks across Member States.
  • Compliance Assessment: The AI Office, in collaboration with national competent authorities, is responsible for evaluating compliance with the regulation, including through the assessment of technical documentation and the monitoring of AI systems' performance.
  • Reporting and Documentation: Providers of high-risk AI systems are required to submit reports and maintain documentation related to their systems, which may be subject to review by the AI Office and national competent authorities.
  • Support Structures: The Commission is tasked with designating EU AI testing support structures to provide technical or scientific advice and assistance in the enforcement of the regulation.
  • Confidentiality and Data Protection: All parties involved in the enforcement of the regulation are required to respect the confidentiality of information obtained in the course of their duties, protecting intellectual property rights, personal data, and ensuring the security of AI systems.
  • Periodic Evaluations and Reviews: The Commission is required to evaluate and review the regulation periodically, taking into account technological developments, the state of the internal market, and the protection of fundamental rights.

Penalties and Fines

The regulation provides for the imposition of penalties and fines for non-compliance with its provisions, including administrative fines based on the total worldwide annual turnover of the offending entity or a fixed amount, depending on the nature and severity of the non-compliance.

  • For breaches of the prohibition of certain AI practices as referred to in Article 5, the administrative fine can be up to €35,000,000 or 7% of the total worldwide annual turnover of the preceding financial year, whichever is higher.
  • For non-compliance with other provisions related to operators or notified bodies, the administrative fines can be up to €15,000,000 or 3% of the total worldwide annual turnover of the preceding financial year, whichever is higher.
  • For providing incorrect, incomplete, or misleading information to notified bodies and national competent authorities, the administrative fines can be up to €7,500,000 or 1% of the total worldwide annual turnover of the preceding financial year, whichever is higher.
  • For SMEs, including start-ups, the fines mentioned above will be reduced to the lower of the two percentages or amounts mentioned, taking into account their economic viability.

Supporting Innovation and SMEs

Providing a Testing Environment for AI Development

To promote innovation and support small and medium-sized enterprises (SMEs), the AI Act requires national authorities to offer testing environments for AI development. This initiative is designed to simulate real-world conditions, enabling startups and SMEs to refine and test AI models before public release, ensuring that emerging technologies can thrive within a regulated framework.

The AI Act: Key Provisions and Next Steps

Timeline for Implementation and Applicability

The timeline of the EU AI Act's development and implementation is marked by significant milestones:

  • April 2021: The European Commission published a proposal to regulate artificial intelligence in the EU, marking the inception of the EU AI Act
  • Throughout 2022: The year saw numerous developments, including the adoption of a common position by the Council of the EU in December, proposals for harmonizing national liability rules for AI, and the circulation of various compromise texts and amendments
  • 2023: Key events included the European Parliament adopting its negotiating position on the AI Act in June and reaching a provisional agreement with the Council in December
  • 2024: The timeline includes the unanimous endorsement of the AI Act by the EU’s 27 member states and the approval of the AI Act's result of negotiations by the Internal Market and Civil Liberties Committees in February. Additionally, the European Artificial Intelligence Office was launched in February to support the implementation of the AI Act, particularly concerning general-purpose AI. On March 13, 2024, the European Parliament voted to approve the European Union's Artificial Intelligence Act.

The Act becomes applicable after 24 months concerning most parts of the regulation. However, shorter deadlines apply to prohibited AI (6 months), and longer deadlines apply to AI systems already regulated by EU law (36 months).

The EU AI Act sets forth a comprehensive timeline for implementation, including the immediate applicability of Titles I (GENERAL PROVISIONS) and II (PROHIBITED ARTIFICIAL INTELLIGENCE PRACTICES) after six months, preparation of codes of practice within nine months, and the operational readiness of at least one regulatory sandbox per member state by the 24-month mark. It further outlines the compliance requirements for high-risk AI systems and components used in large-scale IT systems in the area of freedom, security, and justice by the end of 2030.

Comparative Analysis with Other Digital Measures

The AI Act does not exist in isolation but is part of a broader suite of EU initiatives aimed at regulating the digital space. This legislation is designed to complement existing measures, such as the General Data Protection Regulation (GDPR), by addressing the unique challenges posed by AI technologies and ensuring a cohesive regulatory framework.

Practical Guidance for Compliance

Steps for AI System Providers and Users

For AI system providers and users, the regulation sets out clear steps to achieve compliance, from conducting risk assessments to designing systems with ethical considerations in mind. These guidelines are crucial for entities to navigate the regulatory requirements and integrate responsible AI practices into their operations.

Designing Risk Management and Quality Systems for High-Risk AI

For high-risk AI systems, the regulation mandates the establishment of robust risk management and quality systems. These systems are essential for ensuring that AI applications are developed and deployed in a manner that minimizes risks and upholds the highest standards of safety and reliability.

Impact on Various Sectors

Case Studies from Healthcare, Manufacturing, and Financial Services

The AI Act is expected to have a significant impact across multiple sectors, with healthcare, manufacturing, and financial services poised to experience profound transformations. By ensuring that AI systems in these sectors are developed and used responsibly, the Act aims to enhance efficiency, innovation, and trust.

The Role of AI in Future EU Legislation

The Evolving Landscape of AI Regulation

As AI technologies continue to evolve, so too will the regulatory landscape. The AI Act represents a critical step in this evolution, establishing a foundation for future legislation to build upon. It reflects the EU's proactive approach to shaping a future where AI technologies are harnessed responsibly and ethically.

Preparing for the AI Act: A Checklist

From Risk Assessment to Ethical Design

Entities involved in the development and deployment of AI systems must undertake comprehensive risk assessments and integrate ethical considerations into their design processes. This checklist serves as a roadmap for aligning AI practices with the Act's requirements, fostering a culture of responsibility and innovation.

The AI Act imposes significant penalties for non-compliance, underscoring the importance of adhering to its provisions. These penalties are designed to ensure that entities take their obligations seriously, contributing to a safer and more trustworthy AI ecosystem.

Conclusion: Embracing AI with Responsibility

The EU AI Act is a landmark piece of legislation that sets a global standard for the regulation of artificial intelligence. By prioritizing human oversight, transparency, and robustness, the Act aims to ensure that AI technologies are developed and deployed in a manner that benefits society while safeguarding individual rights and safety. As we stand on the cusp of a new era in AI regulation, the Act offers a blueprint for balancing innovation with ethical considerations, heralding a future where AI serves the common good under a framework of trust and accountability.


Q1: What constitutes a high-risk AI system under the EU AI Act? A1: High-risk AI systems are those that pose significant risks to the public's safety, rights, and freedoms. Examples include AI applications in critical infrastructure, education, employment, and law enforcement. These systems are subject to stringent regulatory requirements, including transparency, accuracy, and data governance.

Q2: How does the AI Act affect small and medium-sized enterprises (SMEs)? A2: The AI Act recognizes the importance of innovation and provides support for SMEs through the establishment of testing environments for AI development. It aims to balance regulatory requirements with the need to foster innovation, ensuring that SMEs can compete and innovate within the AI space.

Q3: Can AI systems still use biometric identification under the AI Act? A3: The AI Act prohibits real-time biometric identification in public spaces for law enforcement purposes, except under specific, stringent conditions. However, other applications of biometric identification may be permissible, provided they comply with the Act's provisions and respect fundamental rights and privacy.

Q4: What role does transparency play in the AI Act? A4: Transparency is a cornerstone of the AI Act, requiring providers to disclose when content or decisions are generated by AI. This transparency aims to empower users, enabling informed decision-making and fostering trust in AI technologies.

Q5: How will the AI Act be enforced across EU member states? A5: The AI Act establishes a governance structure, including the AI Office and national competent authorities, to oversee its implementation and enforcement. Penalties for non-compliance include substantial fines, ensuring that entities take their regulatory obligations seriously.

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