Abstract

The digitization of mental health enables significant shifts in clinical practice by harnessing vast amounts of data derived from the use of apps and wearables to enhance medical research, patient care, and health system efficiency. However, this process brings forth pertinent ethical and legal risks. Ethically, concerns primarily revolve around safeguarding the privacy and confidentiality of sensitive data, alongside the transformation of the doctor-patient relationship through technological interaction. Within the regulatory realm, issues encompass the classification of these tools as medical products, ensuring normative assurance of effective protection of mental health data, and addressing potential legal risks within this domain. This article aims to provide an overarching view of this landscape, serving as a catalyst for the technological, ethical, and legal discourse necessitated by digital mental health.

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