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This page is an AI-assisted Turkish summary of the study presented at the 26th World Congress of Psychiatry. The study belongs to the presenting authors; please refer to the original source when citing it.

EV0475

Digital psychiatry and the European AI Act

DIGITAL PSYCHIATRY AND EUROPEAN AI ACT

The European AI Act may classify most clinical psychiatric AI systems as high-risk through both medical device classification and the emotion recognition rule, imposing extensive legal obligations.

The aim is to examine how the European Artificial Intelligence Act (AI Act) may apply to clinical psychiatric applications that increasingly rely on artificial intelligence (AI). Legal interpretation and business simulation methods were used, and data from Germany's Directory of Digital Health Applications (DiGA-Verzeichnis) were analysed for market validation. The Act's most consequential distinction is between high-risk AI systems, which are subject to extensive and complex legal obligations, and other systems, for which regulatory complexity remains relatively low. Both the general classification referring to the Medical Device Regulation (MDR) and the specific rule on emotion recognition systems may apply to clinical psychiatric AI systems. Whether an AI medical device is considered high-risk under the Act depends on its risk class under the MDR. Since mental health applications on the market vary in this classification, their status as high-risk systems also varies. In addition, emotion recognition based on biometric data may become increasingly common in mental health applications, and if an application is intended for use in emotion recognition, this alone may lead to a high-risk classification. The authors state that the Act will significantly affect many psychiatric AI systems; that even if the rules on medical devices are revised, the emotion recognition rules may continue to trigger the consequences of high-risk classification; that stakeholders should prepare for compliance; and that European legislators should reassess this regime in ongoing debates.

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