Artificial intelligence (AI) has evolved over the past decade from a technological innovation into a key factor in social and legal transformations. The dynamic development of data processing algorithms, machine learning, and automated decision-making has necessitated new regulatory approaches to establish a balance between innovation and the protection of fundamental rights. The European Union recognized this need by adopting the AI Act, the first comprehensive legislative framework aimed at regulating the use of artificial intelligence based on the level of risk generated by such systems. This paper analyzes the main regulatory challenges in the field of AI, with a particular focus on the EU AI Act, its structure, implementation dynamics, as well as broader international implications and comparative regulatory models. The paper combines legal, technical, and ethical approaches to examine the complexity of balancing technological progress with social responsibility.