The Artificial Intelligence Act (AIA) was accepted in August 2024, setting the foundation for regulating AI systems within the European Union. The Act introduces a comprehensive framework aimed at ensuring that AI systems operating in the EU are trustworthy, legally compliant, and ethically sound. It emphasizes the classification of AI systems based on risk, focusing particularly on high-risk AI systems, which are subject to stricter rules concerning safety, transparency, and risk management. These high-risk systems include those used in areas such as law enforcement, recruitment, and healthcare.
The AI Act mandates a certification process for AI systems, ensuring that they meet these requirements before being deployed in the market. However, one significant challenge the Act presents is the absence of detailed practical guidelines on how organizations can comply with these rules. This is where CapAI, a conformity assessment procedure developed by the University of Oxford, comes into play. CapAI offers structured guidance, particularly in addressing how organizations can navigate the AI lifecycle, which is crucial for aligning with the Act’s requirements.
Figure 1. Machine learning life cycle stages in relation with AI act, source: CapAI 2022
The machine learning (ML) lifecycle forms the core structure for AI system development, comprising distinct stages that guide the process from inception to eventual deactivation. Each stage is crucial for ensuring that AI systems are compliant with legal, ethical, and technical standards, especially in light of the AI Act (AIA). The lifecycle includes:
This lifecycle, supported by Articles 10 and 15 of the AI Act, provides a structured framework for ensuring that AI systems adhere to the required compliance and risk management standards throughout their entire lifecycle. The accompanying figure visualizes this process, highlighting the transitions between stages and the environments in which development and operation occur.
The integration of this figure offers a clearer view of how AI systems evolve through these stages, from initial design to retirement, emphasizing the continuous monitoring required for compliance with the AI Act. CapAI addresses each of these stages by providing an internal review protocol (IRP) that helps organizations ensure that their systems adhere to ethical standards, legal norms, and technical robustness at every stage of the AI lifecycle. For example, during the design phase, CapAI recommends identifying the ethical values that will guide development, while in the evaluation phase, it emphasizes rigorous testing to ensure the AI system is fair and unbiased.
Figure 2. AI system risk classification and conformity recommendations, source: CapAI 2022.
Furthermore, the AI Act introduces a risk classification system, dividing AI systems into three levels:
This risk classification, visualized in Figure 2, helps to clarify which AI systems are subject to stricter regulatory scrutiny. For more details on how the ML lifecycle aligns with the AI Act. While the AI Act provides a robust regulatory framework, tools like CapAI are essential for offering organizations the practical guidance they need to comply, ensuring their AI systems are both ethical and technically sound throughout the ML lifecycle.
The governance framework of the AI Act is designed to ensure a harmonized implementation across the European Union through both supranational and national authorities. At the supranational level, the European Commission plays a central role, supported by the AI Office and the AI Board. The governance structure is further supported by two advisory bodies: the Advisory Forum and the Scientific Panel, both appointed by the Commission to provide expertise and recommendations for the Act’s implementation.
At the national level, each EU Member State is required to establish several authorities to implement and enforce the AI Act:
The national implementation of the AI Act in Lithuania is built on a structure of key institutions assigned to oversee the conformity, regulation, and market surveillance of AI systems. These institutions are responsible for ensuring that AI systems, particularly those classified as high-risk, comply with both national and EU regulations. Lithuania has established a framework of authorities to provide conformity assessments, oversee market practices, and support companies in aligning with the AI Act.
In addition to these key bodies, several sector-specific authorities will regulate AI systems within particular industries:
These institutions collectively provide a comprehensive national governance structure to support the responsible development and deployment of AI systems. The combination of notifying authorities, conformity bodies, market surveillance, and sector-specific regulators ensures that AI systems in Lithuania meet the highest standards of safety, transparency, and ethical compliance. Organizations are also encouraged to adopt the ISO AI management system to further reduce risks and ensure adherence to global standards.
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Dr. Valentas Gružauskas is an expert in AI governance, conformity assessment, and ethical AI applications. As an Associate Professor at Vilnius University and CEO of AI Conformity & Research Consulting, he leads initiatives in AI regulation and ISO standards. He actively participates in AI governance through the Horizon Europe Programme and various standardization committees. Dr. Gružauskas has made significant contributions to fields like machine learning, deep learning, and agent-based modeling, with a focus on AI ethics and data depersonalization. His work is widely published in esteemed journals, reflecting his impact and recognition in the AI community.