Artificial Intelligence in Mental Health Landscape – Legal and Regulatory Challenges

Sovilj, Ranko (2025) Artificial Intelligence in Mental Health Landscape – Legal and Regulatory Challenges. In: Challenges and perspectives of the development of legal systems in the XXI century” Conference Proceedings. Faculty of Law, University of Banja Luka., Banja Luka, pp. 113-128. ISBN 978-99976-54-33-5

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Abstract

Mental health diseases are increasingly prevalent in contemporary society, affecting millions of individuals globally in the post-industrial era. In addition, post-COVID-19 impact, lack of interpersonal contact, and economic concern have caused new cases of major depression and anxiety disorders and other stress-related disorders. Artificial intelligence (AI) offers new perspectives in the mental healthcare sector, ranging from clinical decision support tools to new treatment strategies or alternative patient remote monitoring, accurate prognostic assessments, and self-managed support systems, all of which can significantly improve the efficiency and structure of mental health services. However, while the introduction of AI in mental healthcare presents certain advantages, it also introduces specific challenges. As an innovative technology, artificial intelligence is associated with certain barriers, limitations, and challenges for appropriate integration in medical practice. To avoid potential risks and harms to patient safety, and ensure their well-being, it is necessary to establish a comprehensive legal and regulatory framework to guide healthcare professionals in their AI adoption in clinical practice. By adopting the Artificial Intelligence Act, the European Union offers a new legal framework for the development and application of AI systems. However, these new regulatory concepts may be obscure for healthcare professionals. Therefore, the aim of this paper is to examine the legal and regulatory framework governing the AI application in mental health, with a particular focus on recently enacted legal documents, primarily adopted in some US states, AI Act, and other relevant international legal documents, as well as to consider the potential risks associated with the implementation of artificial intelligence in relation to patient safety.

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