ABSTRACT:
Artificial Intelligence (AI)–enabled Point-of-Care Testing (POCT) systems are rapidly transforming healthcare delivery in Africa and other low- and middle-income countries (LMICs). By enabling diagnosis, triage, and monitoring “near the patient,” these technologies offer unprecedented potential to improve access, reduce delays, and support the United Nations’ Sustainable Development Goal of universal health coverage. Yet this technological promise unfolds within a policy vacuum in which innovation consistently outpaces regulation, producing conditions of ethical vulnerability. In regions marked by health system scarcity, low eHealth literacy, and limited regulatory capacity, the uptake of AI-enabled POCT is driven by necessity rather than informed consent, raising new questions around data sovereignty, algorithmic accountability, and distributive justice. Existing AI ethics frameworks largely developed in Europe and North America do not fully address the sociocultural, infrastructural, and geopolitical contexts shaping African health systems. This paper argues that Africa is not merely a late adopter of AI but is positioned at a critical normative moment in which it can articulate its own ethical paradigm for health AI. We propose a multi-layered governance ecosystem grounded in ethical sovereignty and Afrocentric relational values. Specifically, we integrate Readiness Assessments, Ethical Impact Assessments, Value Sensitive Design, and the Modified Delphi Method as synergistic tools to align AI-enabled POCT with societal values and population needs. The aim is not to reject global standards but to assert African co-authorship over them. This approach reframes Africa as a producer of ethical norms rather than a passive regulatory consumer. We conclude by outlining a phased roadmap for implementation and by calling for AI ethics scholarship to expand beyond generic “responsible AI” rhetoric toward regionally situated frameworks capable of governing health futures with dignity.