If a therapy bot walks like a duck and talks like a duck then it is a medically regulated duck

作者：Max Ostermann, Oscar Freyer, Falk Gerrik Verhees, Jakob Nikolas Kather, Stephen Gilbert · 发表于：npj Digital Medicine · 年份：2025 · DOI：10.1038/s41746-025-02175-z · 被引用次数：8 · 研究领域：Digital Mental Health Interventions、Mental Health via Writing、Artificial Intelligence in Healthcare and Education

Large language models (LLMs) are increasingly used for mental health interactions, often mimicking therapeutic behaviour without regulatory oversight. Documented harms, including suicides, highlight the urgent need for stronger safeguards. This manuscript argues that LLMs providing therapy-like functions should be regulated as medical devices, with standards ensuring safety, transparency and accountability. Pragmatic regulation is essential to protect vulnerable users and maintain the credibility of digital health interventions.