Legal and Ethical Implications of Mental Health Chatbots in the Light of the European Union Medical Device Regulation and the Artificial Intelligence Act

The master's thesis provides a comprehensive exploration of the legal and ethical aspects concerning Artificial Intelligence-assisted chatbots in the diagnosis and treatment of mental disorders in the European Union with special focus on the European Artificial Intelligence Act and the Medical Device Regulation.

The escalating mental health crisis in the European Union, intensified by global disruptions such as wars, climate change, the COVID-19 pandemic, and rising living costs, highlights the critical need for effective and innovative solutions. Mental health chatbots have emerged as a significant advancement in this regard, offering accessible, cost-effective, and personalized therapeutic interactions. However, the integration of these technologies also introduces substantial legal and ethical challenges, including concerns over data protection, potential discrimination, transparency issues, and the reliability of health advice provided by the chatbots.

Within the EU, the deployment of mental health chatbots is primarily regulated by two significant legislative frameworks: the Artificial Intelligence Act and the Medical Device Regulation. This thesis aims to resolve the complexities and ambiguities associated with these regulations, focusing particularly on how chatbots are classified under these laws and the subsequent legal implications of these classifications.

The central research question of this thesis examines the extent to which mental health chatbots align with the Artificial Intelligence Act and the Medical Device Regulation, their risk classification under these regulations, and the resultant legal consequences.

Furthermore, the thesis delves into the ethical aspects of employing mental health chatbots. It critically examines whether the use of Artificial Intelligence-assisted chatbots in sensitive mental health support settings can be ethically justified. It explores ethical issues and establishes boundaries for the application.

Methodologically, this thesis employs a literature-based legal doctrine approach, using a deductive framework to analyze the Artificial Intelligence Act and the Medical Device Regulation through statutory texts, appendices, and leading legal opinions. It also incorporates an analysis of ethical frameworks to assess the ethical standards applicable to Artificial Intelligence-assisted mental health chatbots.

Anticipated to be completed by July 2024, this master’s thesis aims to lay the groundwork for the development of guidelines and best practices.

Publication History

Article published online:
05 December 2024