Understanding the Implications of the AI Act for Businesses

Risk & Governance Legal Newsletter (February 2025)

On July 12, 2024, the EU officially published Regulation (EU) 2024/1689, known as the Artificial Intelligence Act (the “AI Act”). This regulation marks the world’s first comprehensive legal framework governing AI.

Discussions on the AI Act had been ongoing since the European Commission initially proposed the legislation on April 21, 2021. The rapid advancement of generative AI and other technologies necessitated continuous updates to the proposal. Ultimately, the AI Act was formally adopted after receiving approval from the Council of the EU on May 21, 2024.

The AI Act entered into force on August 1, 2024, with most of its provisions set to take effect from August 2, 2026. Certain provisions, however, will be enforced at different times as appropriate. The AI Act applies not only to companies within the EU but also broadly to businesses providing AI systems and related services within the EU. As a result, businesses outside the EU cannot overlook the implications of this regulation.

1. Step 1: Identification of AI System

The AI Act primarily regulates AI Systems and general-purpose AI models. Their respective definitions are as follows:

AI System (Article 3(1)): A machine-based system that is designed to operate with varying levels of autonomy and may exhibit adaptiveness after deployment, inferring outputs such as predictions, content, recommendations, or decisions from the input it receives.

General-purpose AI model (Article 3(63)): An AI model capable of competently performing a wide range of tasks, trained with a large amount of data using self-supervision at scale, except for AI models used for research, development, or prototyping activities before they are placed on the market.

2. Step 2: Identification of Regulated Persons

The AI Act applies to various stakeholders involved with AI systems. The primary regulated parties are:

  • Providers: Entities placing AI systems on the market or putting them into service in the EU, regardless of their location.
  • Deployers: Entities using AI systems within the EU.

Businesses must identify which category of regulated parties they fall under and verify where the AI systems are being developed, placed on the market, or used.

3. Step 3: Exemption Eligibility

The AI Act provides exemption provisions for certain AI systems. If a system qualifies for an exemption, it will not be subject to regulation. Exemptions primarily include:

  • AI systems used exclusively for military, defense, or national security purposes.
  • AI systems developed for scientific research and development.
  • Deployers who are natural persons using AI systems in a personal non-professional capacity.

4. Step 4: Categorization of AI Systems

The AI Act adopts a risk-based approach, categorizing AI systems based on the risks they pose:

  • Prohibited AI Practice: Systems that could cause significant harm to individuals.
  • High-risk AI System: Regulated systems that require compliance obligations.
  • AI System with Limited Risk: Systems subject to transparency obligations.
  • Other AI Systems: Not subject to regulation under the AI Act.

5. Step 5: Identification of Applicable Regulations

Operators need to take different approaches based on the categories classified in Step 4:

  • Prohibited AI Practice: Banned from being placed on the market, subject to penalties.
  • High-risk AI System: Must comply with several obligations, including risk management and data governance.
  • AI System with Limited Risk: Subject to transparency obligations.

6. Step 6: Preparations for Implementation

The AI Act came into effect on August 1, 2024, with provisions enforcing sequentially. Key dates include:

  • Chapter 1 and Chapter 2: February 1, 2025.
  • High-risk AI system: August 2, 2027.
  • General-purpose AI model: August 2, 2025.

In conclusion, the AI Act establishes a framework intended to ensure that AI technologies are developed and used safely and responsibly within the EU, while also impacting businesses worldwide. It is crucial for companies to understand their obligations under this new regulation to ensure compliance and safeguard their operations.

More Insights

Balancing Innovation and Ethics in AI Engineering

Artificial Intelligence has rapidly advanced, placing AI engineers at the forefront of innovation as they design and deploy intelligent systems. However, with this power comes the responsibility to...

Harnessing the Power of Responsible AI

Responsible AI is described by Dr. Anna Zeiter as a fundamental imperative rather than just a buzzword, emphasizing the need for ethical frameworks as AI reshapes the world. She highlights the...

Integrating AI: A Compliance-Driven Approach for Businesses

The Cloud Security Alliance (CSA) highlights that many AI adoption efforts fail because companies attempt to integrate AI into outdated processes that lack the necessary transparency and adaptability...

Preserving Generative AI Outputs: Legal Considerations and Best Practices

Generative artificial intelligence (GAI) tools raise legal concerns regarding data privacy, security, and the preservation of prompts and outputs for litigation. Organizations must develop information...

Embracing Responsible AI: Principles and Practices for a Fair Future

Responsible AI refers to the creation and use of artificial intelligence systems that are fair, transparent, and accountable. It emphasizes the importance of ethical considerations in AI development...

Building Trustworthy AI for Sustainable Business Growth

As businesses increasingly rely on artificial intelligence (AI) for critical decision-making, the importance of building trust and governance around these technologies becomes paramount. Organizations...

Spain’s Trailblazing AI Regulatory Framework

Spain is leading in AI governance by establishing Europe’s first AI regulator, AESIA, and implementing a draft national AI law that aligns with the EU AI Act. The country is also creating a regulatory...

Global AI Regulation: Trends and Challenges

This document discusses the current state of AI regulation in Israel, highlighting the absence of specific laws directly regulating AI. It also outlines the government's efforts to promote responsible...

AI and Regulatory Challenges in the Gambling Industry

The article discusses the integration of Artificial Intelligence (AI) in the gambling industry, emphasizing the balance between technological advancements and regulatory compliance. It highlights the...