JMIR Publications

ABSTRACT

The proliferation of AI mental health chatbots, such as those on platforms like OpenAI’s GPT Store and Character.AI, raises issues of safety, effectiveness, and ethical use; they also raise an opportunity for patients and consumers to ensure AI tools clearly communicate how they meet their needs. While many of these tools claim to offer therapeutic advice, their unregulated status and lack of systematic evaluation create risks for users, particularly vulnerable individuals. This viewpoint article highlights the urgent need for a standardized framework to assess and demonstrate the safety, ethics, and evidence basis of AI chatbots used in mental health contexts. Drawing on clinical expertise, research, co-design experience, and WHO guidance, the authors propose key evaluation criteria: adherence to ethical principles, evidence-based responses, conversational skills, safety protocols, and accessibility. Implementation challenges, including setting output criteria without one ‘right answer’, evaluating multi-turn conversations, and involving experts for oversight at scale, are explored. The authors advocate for greater consumer engagement in chatbot evaluation to ensure these tools address user needs effectively and responsibly, emphasizing the ethical obligation of developers to prioritize safety and a strong base in empirical evidence.