Cybersecurity and Privacy Risks of Generative AI Mental-Health Chatbots: A Systematic Review and Regulatory Framework.
PMID: 42212181 ·
Suhila Sawesi, Hemalatha Sabbineni, Rajashekhar Reddy Shagamreddy, Budur Rashrash
Abstract
Large language models (LLMs) and other generative artificial intelligence systems are increasingly used in mental health care for psychoeducation, emotional support, screening, and crisis-related interactions. To our knowledge, this is the first structured synthesis explicitly mapping LLM-specific cybersecurity and privacy risks to Software as a Medical Device (SaMD) regulatory frameworks. We aimed to characterize deployment patterns, identify multi-layered risks, and evaluate alignment of repor
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