Leveraging ISO 42001 and NIST AI RMF for EU AI Act Compliance

Utilizing ISO 42001 & NIST AI RMF for Compliance with the EU AI Act

The adoption of artificial intelligence (AI) technologies has dramatically increased in recent years. In 2019, 58% of organizations used AI for at least one business function; by 2024, that figure surged to 72%. Notably, the use of generative AI nearly doubled from 33% in 2023 to 65% in 2024.

Understanding the EU AI Act

The European Union Artificial Intelligence Act (AI Act), Regulation (EU) 2024/1689, establishes a comprehensive regulatory framework for AI within the EU. It came into effect on August 1, 2024 and applies to all AI types across various sectors, excluding systems used solely for military, national security, research, and non-professional purposes.

The landmark AI Act is designed to balance innovation and safety in the realm of AI. It provides guidelines for risk management, ongoing system monitoring, and human supervision, thereby establishing a foundation for trustworthy AI systems.

This act safeguards fundamental rights, such as privacy, and ensures that AI systems do not engage in unfair discrimination. Crucially, it offers AI developers and companies a unified regulatory framework, aiding them in innovating confidently while protecting consumer interests.

Who Will Be Affected?

Organizations that utilize AI and operate within the EU, as well as those outside the EU developing or using AI systems for business in the EU, will be impacted by the AI Act.

Who Will Not Be Affected?

It is essential to note that military and national security applications, whether developed by public or private entities, are excluded from the AI Act’s scope. Furthermore, AI systems dedicated purely to scientific research and development are exempt, allowing researchers the freedom to innovate without regulatory constraints. The Act only applies when AI systems are deployed or commercialized; during development, these rules remain inactive.

EU AI Act Fines

Organizations face significant penalties for non-compliance:

  • Fines up to EUR 35,000,000 or 7% of worldwide annual turnover for non-compliance with prohibited AI practices, whichever is higher.
  • Fines up to EUR 15,000,000 or 3% of worldwide annual turnover for non-compliance with high-risk AI system requirements, whichever is higher.
  • Fines up to EUR 7,500,000 or 1% of worldwide annual turnover for supplying incorrect, incomplete, or misleading information to authorities, whichever is higher.

Key Players Under the EU AI Act

The Act addresses various stakeholders in the AI ecosystem, ensuring all parties understand their responsibilities and compliance requirements.

EU AI Act Risk-Based Approach

The Act categorizes AI systems into four risk levels:

1. Unacceptable Risks:

AI systems that enable manipulation, exploitation, and social control practices are deemed unacceptable risks. Examples include:

  • Deploying subliminal or manipulative techniques.
  • Exploiting vulnerabilities related to age, disability, or socio-economic circumstances.
  • Social scoring and real-time remote biometric identification (RBI).

Such systems are prohibited in the EU market.

2. High Risks:

AI systems that negatively impact safety or fundamental rights are classified as high risk. Examples include:

  • Biometric systems.
  • Critical infrastructure applications, such as water supply management.
  • Law enforcement and judicial processes.

High-risk AI systems can only be deployed in the EU market after implementing adequate risk mitigation strategies.

3. Limited Risks:

Some AI systems, such as chatbots and deepfakes, may present risks of impersonation or deception but do not qualify as high risk. These systems are subject to lighter transparency obligations and must ensure that end-users are aware they are interacting with AI. They can be deployed with appropriate human oversight and monitoring activities.

4. Minimal Risks:

This category includes AI systems not classified elsewhere, such as AI-enabled video games or spam filters. These systems are unregulated in the EU market and can be deployed without restrictions.

Understanding NIST AI Risk Management Framework (RMF) & ISO/IEC 42001

The NIST AI Risk Management Framework (RMF) and ISO/IEC 42001 provide structured approaches to managing risks associated with AI technologies. These frameworks assure the responsible, ethical, and trustworthy development, deployment, and use of AI systems.

What is ISO/IEC 42001:2023?

ISO/IEC 42001 is an international standard that outlines requirements for establishing, implementing, maintaining, and continually improving an Artificial Intelligence Management System (AIMS) within organizations. It is applicable to entities involved in developing or utilizing AI-based products or services across all industries, ensuring responsible development and usage.

Mapped Requirements

Organizations must adhere to the mapped requirements to ensure compliance with the AI Act and other relevant standards.

More Insights

US Rejects UN’s Call for Global AI Governance Framework

U.S. officials rejected the establishment of a global AI governance framework at the United Nations General Assembly, despite broad support from many nations, including China. Michael Kratsios of the...

Agentic AI: Managing the Risks of Autonomous Systems

As companies increasingly adopt agentic AI systems for autonomous decision-making, they face the emerging challenge of agentic AI sprawl, which can lead to security vulnerabilities and operational...

AI as a New Opinion Gatekeeper: Addressing Hidden Biases

As large language models (LLMs) become increasingly integrated into sectors like healthcare and finance, a new study highlights the potential for subtle biases in AI systems to distort public...

AI Accountability: A New Era of Regulation and Compliance

The burgeoning world of Artificial Intelligence (AI) is at a critical juncture as regulatory actions signal a new era of accountability and ethical deployment. Recent events highlight the shift...

Choosing Effective AI Governance Tools for Safer Adoption

As generative AI continues to evolve, so do the associated risks, making AI governance tools essential for managing these challenges. This initiative, in collaboration with Tokio Marine Group, aims to...

UN Initiatives for Trustworthy AI Governance

The United Nations is working to influence global policy on artificial intelligence by establishing an expert panel to develop standards for "safe, secure and trustworthy" AI. This initiative aims to...

Data-Driven Governance: Shaping AI Regulation in Singapore

The conversation between Thomas Roehm from SAS and Frankie Phua from United Overseas Bank at the SAS Innovate On Tour in Singapore explores how data-driven regulation can effectively govern rapidly...

Preparing SMEs for EU AI Compliance Challenges

Small and medium-sized enterprises (SMEs) must navigate the complexities of the EU AI Act, which categorizes many AI applications as "high-risk" and imposes strict compliance requirements. To adapt...

Draft Guidance on Reporting Serious Incidents Under the EU AI Act

On September 26, 2025, the European Commission published draft guidance on serious incident reporting requirements for high-risk AI systems under the EU AI Act. Organizations developing or deploying...