The South African Health Products Regulatory Authority (Sahpra) has launched a ground-breaking programme to develop safety standards for artificial intelligence mental-health tools, responding to rising concerns about unregulated therapy chatbots and diagnostic applications.
The initiative, named Comprehensive AI Regulation and Evaluation for Mental Health (Care MH), aims to establish evidence-based guidelines that will determine how AI technologies must undergo safety, inclusivity and effectiveness assessments before gaining market authorisation.
Sahpra developed the programme in collaboration with Path, a global non-profit dedicated to health equity. The initiative received financial support from Wellcome, a global charitable foundation focused on health research.
The regulatory body announced Care MH during the G20 Social Summit in Johannesburg. The programme addresses AI’s growing presence in mental health care, spanning therapy applications to diagnostic technology.
International experts from multiple institutions support the initiative, including Audere Africa, African Health Research Institute, UK regulatory agencies, University of Birmingham, University of Washington and Wits Health Consortium.
“You wouldn’t give your child or loved one a vaccine or drug that hadn’t been tested or evaluated for safety,” said Bilal Mateen, Chief AI Officer at Path.
“We’re working to bring that same standard of rigorous evaluation to AI tools in mental health, because trust must be earned, not assumed.”
South Africa will develop and test the framework initially, before expanding implementation throughout Africa and eventually to global partners.
“Sahpra is proud to lead the development of Africa’s first regulatory framework for AI in mental health linked directly to market authorisation,” said Christelna Reynecke, Chief Operations Officer of Sahpra.
The regulator aims to create comprehensive AI healthcare oversight that balances technological advancement with scientific validation, ethical considerations and public responsibility.
Prof Miranda Wolpert, Director of Mental Health at Wellcome, said mental health is projected to become the world’s biggest health burden by 2030.
“Care MH is a vital step towards ensuring that AI technologies in this space are safe, effective, and equitable.”
The collaborative partners aim to establish groundwork for responsible, evidence-driven AI implementation in mental health care.
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