Health before hype: a V-Model blueprint for African digital health and AI regulatory sandboxes.

Journal: International health
Published Date:

Abstract

African governments must regulate fast-growing digital health and artificial intelligence technologies while building the continent's planned digital single market. Regulatory sandboxes are increasingly promoted as a solution, but most sandbox experience comes from finance, where the primary concern is market risk, not clinical safety or public health harm. Healthtech is not fintech, and failure carries very different consequences. We argue that the Global System for Mobile Communications (GSM) standards model offers a more appropriate template. Drawing on the V-Model framework, we propose that regional bodies verify technical interoperability while national regulators validate clinical and ethical suitability. Simulation-based exercises can test governance before technologies go live, building a cautious, collectively owned approach to digital health innovation on African terms.

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