<p>Digital health technologies (DHTs) are often promoted as solutions to healthcare access challenges in low-income countries (LICs), where a lack of infrastructure, healthcare professionals, and regulatory capacity makes them especially appealing. In such contexts, DHTs can provide services that would otherwise remain out of reach. Yet their implementation raises significant ethical and regulatory concerns. These concerns are heightened in LICs, where technologies designed in high-income countries may perform less reliably, accountability is weak, and corporate interests often dominate development and governance. This paper compares DHTs with Early Access Programmes (EAPs) for investigational therapies, both of which involve offering imperfect interventions under conditions of uncertainty. While EAPs are tightly regulated, DHTs are often introduced with limited oversight and marketed as final solutions. Unlike pharmaceuticals, which carry immediate risks such as severe side effects, the risks associated with DHTs are typically indirect or delayed, manifesting through misdiagnoses, breaches of privacy and confidentiality, digital inequalities, and the erosion of trust in healthcare systems. Using examples from Uganda and Malawi, the analysis highlights how permissive adoption risks promoting a ‘better than nothing’ standard of care, while rigid regulation may deny immediate benefits. We argue for a tiered approach: conditional, context-sensitive oversight that expands access without normalising lower standards of care, embedding privacy, confidentiality, equity, and accountability as central design criteria.</p>