AI Act: A New Era of Regulation in Europe

The AI Act: Landmark Regulation Comes into Force

The AI Act, a significant regulatory framework for artificial intelligence, officially came into force on August 1, 2024, with the European Commission releasing new guidelines on prohibited AI practices on February 4, 2025. This comprehensive regulation aims to address the myriad risks associated with AI technologies while promoting innovation.

AI Action Summit

The AI Action Summit, held in Paris on February 10/11, 2025, brought together heads of state, leaders of international organizations, and CEOs to discuss the future of AI regulation. With participation from nearly 100 countries and over 1,000 representatives from the private sector and civil society, the summit provided a platform for critical discussions on the balance between regulation and innovation.

Debates during the summit highlighted that while regulation is necessary to mitigate risks, ignoring potential dangers in AI development may hinder true innovation. The conversation also touched upon the ongoing challenges within the European market, including market fragmentation and a lack of venture capital.

Risk-Based Framework

The AI Act introduces a four-tier risk-based system to categorize AI systems:

  • Unacceptable risk: This category includes AI systems that pose a clear threat to societal safety. Examples include:
    • Harmful AI-based manipulation and deception
    • Social scoring
    • Real-time biometric identification for law enforcement in public spaces
  • Provisions banning these practices took effect on February 2, 2025, with penalties of up to EUR35 million or 7% of global annual revenues for non-compliance.
  • High-risk: This category encompasses AI systems that could significantly impact health, safety, or fundamental rights. Examples include:
    • AI used in critical infrastructure (e.g., transport)
    • AI solutions in educational institutions that affect access to education
  • While not banned, these systems are subject to legal obligations such as risk assessment and detailed documentation.
  • Minimal or no risk: This level entails lighter transparency requirements, ensuring users are aware they are interacting with AI, particularly in applications like chatbots and deepfakes.

International Reactions

The summit also underscored the differing approaches to AI regulation globally. The US criticized the European stance, with both the US and the UK declining to sign the summit’s declaration on ‘inclusive’ AI. This division raises concerns about the potential for a disjointed global approach to AI governance.

Some companies, including OpenAI, expressed concerns that the AI Act could stifle commercial development in Europe, emphasizing the need for balanced regulation that does not hinder progress.

Emerging Players and Initiatives

Amid these regulatory discussions, new players like DeepSeek and Mistral AI are making significant strides in the AI landscape. DeepSeek’s recent open-weight model, R1, challenges existing US dominance in AI. Meanwhile, Mistral AI has partnered with various organizations to enhance its offerings and announced the InvestAI initiative, a EUR200-billion investment plan aimed at establishing four AI gigafactories.

This initiative reflects a broader strategy within the EU to foster collaborative development of advanced AI models while navigating the regulatory landscape.

More Insights

CII Advocates for Strong AI Accountability in Financial Services

The Chartered Insurance Institute (CII) has urged for clear accountability frameworks and a skills strategy for the use of artificial intelligence (AI) in financial services. They emphasize the...

Regulating AI in APAC MedTech: Current Trends and Future Directions

The regulatory landscape for AI-enabled MedTech in the Asia Pacific region is still developing, with existing frameworks primarily governing other technologies. While countries like China, Japan, and...

New York’s AI Legislation: Key Changes Employers Must Know

In early 2025, New York proposed the NY AI Act and the AI Consumer Protection Act to regulate the use of artificial intelligence, particularly addressing algorithmic discrimination in employment...

Managing AI Risks: Effective Frameworks for Safe Implementation

This article discusses the importance of AI risk management frameworks to mitigate potential risks associated with artificial intelligence systems. It highlights various types of risks, including...

Essential Insights on the EU Artificial Intelligence Act for Tech Companies

The European Union has introduced the Artificial Intelligence Act (AI Act), which aims to manage the risks and opportunities associated with AI technologies across Europe. This landmark regulation...

South Korea’s Landmark AI Basic Act: A New Era of Regulation

South Korea has established itself as a leader in AI regulation in Asia with the introduction of the AI Basic Act, which creates a comprehensive legal framework for artificial intelligence. This...

EU AI Act and DORA: Mastering Compliance in Financial Services

The EU AI Act and DORA are reshaping how financial entities manage AI risk by introducing new layers of compliance that demand transparency, accountability, and quantifiable risk assessments...

AI Governance: Bridging the Transatlantic Divide

Artificial intelligence (AI) is rapidly reshaping economies, societies, and global governance, presenting both significant opportunities and risks. This chapter examines the divergent approaches of...

EU’s Ambitious Plan to Boost AI Development

The EU Commission is launching a new strategy to reduce barriers for the deployment of artificial intelligence (AI) across Europe, aiming to enhance the region's competitiveness on a global scale. The...