JMIR Publications

ABSTRACT

HIV self-testing(HIVST) allows people to test for HIV outside traditional health facilities, but this presents challenges around pre-and-post-test counselling, reporting results and linking to care. Digital interventions for HIVST, a type of software as a medical device(SaMD), have been shown to address these challenges, but there is currently no standardised system for regulating or approving these interventions. The WHO Prequalification Program(WHOPQ) is an international regulatory body that approves vaccines, medications, and in vitro diagnostics(IVDs), for low-and middle-income countries(LMICs) that do not have the capacity to do their own approvals. This article explores whether WHOPQ could be used to prequalify digital interventions for HIVST. Over half the WHO member states have national regulatory bodies for medical devices, but LMICs, especially in Africa, do not have the capacity to regulate medical devices, let alone SaMD. This gap parallels the gap in vaccine regulation that initially led to the development of WHOPQ, and while sophisticated AI/ML-enabled SaMD are being developed, digital interventions for HIVST could be used as a low-risk test case for prequalification of SaMD. The WHOPQ already has a strong history with HIV; over half the WHOPQ funding is from HIV-related donors and half of all prequalified medicines and IVDs are for treatment and diagnosis of HIV, however, only 2% are manufactured in Africa. If WHO opts to enable prequalification of digital interventions for HIVST, they must consider accessibility for digital health companies from Africa and ensure that prequalification does not delay access to people testing for HIV.