Background:
Artificial Intelligence (AI) is reshaping healthcare through predictive diagnostics, patient monitoring, and efficient resource allocation. However, the absence of robust regulatory frameworks in many African countries raises ethical, legal, and governance concerns. Kenya’s Digital Health Act (2023) provides a pioneering attempt to regulate digital health through provisions on data protection, patient rights, and governance structures. Although the Act does not explicitly regulate AI, it offers a policy foundation for contextualizing AI oversight in healthcare. This study examines Kenya’s approach in comparison with South Africa, Nigeria, and Rwanda, identifying gaps, ethical considerations, and lessons for developing inclusive AI regulatory frameworks across Africa.