Should Digital Interventions for HIV Self-Testing Be Regulated with World Health Organization Prequalification?

Area of Science:

• Public Health
• Health Technology Regulation
• Digital Health

Background:

• HIV self-testing (HIVST) offers decentralized testing but faces challenges in counseling, reporting, and care linkage.
• Digital interventions, as Software as a Medical Device (SaMD), can address HIVST challenges.
• A regulatory gap exists for SaMD, particularly in low- and middle-income countries lacking medical device regulatory capacity.

Purpose of the Study:

• To explore the feasibility of the World Health Organization Prequalification Program (WHOPQ) prequalifying digital HIVST interventions.
• To assess WHOPQ's potential role in regulating SaMD for HIVST, drawing parallels with its historical role in vaccine and IVD regulation.

Main Methods:

• Analysis of the existing regulatory landscape for medical devices and SaMD in WHO member states.
• Examination of WHOPQ's mandate, history, and existing prequalification processes for medicines and in vitro diagnostics (IVDs).
• Consideration of the specific context of HIVST and SaMD development, including challenges for African developers.

Main Results:

• Low- and middle-income countries, especially in Africa, lack regulatory capacity for medical devices and SaMD.
• WHOPQ has a significant history with HIV-related products, indicating potential for HIVST interventions.
• Digital HIVST interventions represent a potential low-risk entry point for WHOPQ to prequalify SaMD.

Conclusions:

• WHOPQ prequalification of digital HIVST interventions could enhance quality, interoperability, and scalability.
• Addressing regulatory capacity gaps is crucial for equitable access to digital health tools.
• Care must be taken to avoid delaying access and to support local African developers in the prequalification process.