European Union Artifical Intelligence Act (EU AI ACT): Implications for Digital Health and Care

Abstract

The rapidly advancing development of artificial intelligence (AI) brings both opportunities and challenges, particularly in the healthcare sector and the broader medical environment, including research. With the aim of promoting innovation, removing barriers, and simultaneously ensuring safety, trust, and ethical standards, the European Union has introduced the AI Act. This Act, alongside other regulations that remain unaffected, represents the first comprehensive, risk-based legal framework for AI applications. According to Article 3 No. 1 of the EU AI Act, an AI system is defined by whether it operates in a machine-assisted manner, is designed for autonomous operation and adaptability, and has the capability to generate new outputs (such as recommendations) from received inputs. AI systems are also characterized by their reliance on data inputs throughout their development, training, and actual use phases. This chapter aims to explore, analyze, and evaluate the significance of the AI Act and its implications for the digital health sector, including the concrete benefits for all stakeholders and patients in the areas of diagnosis, therapy, and administration.

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