The South African Health Products Regulatory Authority (Sahpra) has launched a pioneering initiative named Comprehensive AI Regulation and Evaluation for Mental Health (Care MH) to establish safety standards for artificial intelligence (AI) tools in mental health. This program responds to increasing concerns over unregulated therapy chatbots and diagnostic applications. Developed in partnership with Path and supported by Wellcome, Care MH aims to create evidence-based guidelines for assessing safety, inclusivity, and effectiveness of AI technologies before market authorization. The initiative, announced at the G20 Social Summit in Johannesburg, signifies a commitment to addressing AI’s role in mental health care, backed by international experts from renowned institutions. Sahpra seeks to ensure rigorous evaluation standards for AI tools, paralleling those for vaccines and drugs. This regulatory framework represents a significant step towards responsible AI implementation in mental health, ultimately aiming to expand its influence across Africa and globally, addressing the projected rise in mental health issues by 2030.
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