{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,7]],"date-time":"2026-10-07T19:20:51Z","timestamp":1791400851363,"version":"4.3.3"},"reference-count":51,"publisher":"JMIR Publications Inc.","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JMIR Mhealth Uhealth"],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>HIV self-testing (HIVST) allows people to test for HIV outside traditional health facilities, but this presents challenges around pre- and posttest counseling, 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 standardized system for regulating or approving these interventions. The World Health Organization Prequalification Program (WHOPQ) is an international regulatory body that approves vaccines, medications, and in vitro diagnostics (IVDs) for low- and middle-income countries that do not have the capacity to do their own approvals. This paper explores whether WHOPQ could be used to prequalify digital interventions for HIVST. Over half the World Health Organization (WHO) member states have national regulatory bodies for medical devices, but low- and middle-income countries, 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 artificial intelligence (AI)\u2013enabled 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 funders and half of all prequalified medicines and IVDs are for treatment and diagnosis of HIV; however, only 2% are manufactured in Africa. If digital interventions for HIVST become prequalified, this could improve interoperability and ensure quality, accelerating their adoption at scale. However, care must be taken to remove barriers for African developers and ensure that prequalification does not delay access to people testing for HIV.<\/jats:p>","DOI":"10.2196\/60276","type":"journal-article","created":{"date-parts":[[2025,8,22]],"date-time":"2025-08-22T20:41:34Z","timestamp":1755895294000},"page":"e60276-e60276","source":"Crossref","is-referenced-by-count":2,"title":["Should Digital Interventions for HIV Self-Testing Be Regulated with World Health Organization Prequalification?"],"prefix":"10.2196","volume":"13","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6882-7245","authenticated-orcid":false,"given":"Alex Emilio","family":"Fischer","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3597-1643","authenticated-orcid":false,"given":"Samanta Tresha","family":"Lalla-Edward","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3952-4760","authenticated-orcid":false,"given":"Vinodh","family":"Edward","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2420-6954","authenticated-orcid":false,"given":"Musaed","family":"Abrahams","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9231-9155","authenticated-orcid":false,"given":"Luke","family":"Shankland","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5895-7935","authenticated-orcid":false,"given":"John","family":"de Wit","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1010","published-online":{"date-parts":[[2025,8,22]]},"reference":[{"key":"R1","unstructured":"Guidelines on HIV Self-Testing and Partner Notification: Supplement to Consolidated Guidelines on HIV Testing Services. World Health Organization; 2016."},{"key":"R2","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.e4636","article-title":"FDA approves \u201cinstant\u201d HIV home test","volume":"345","author":"Roehr","journal-title":"BMJ"},{"issue":"1","key":"R3","doi-asserted-by":"publisher","DOI":"10.7448\/IAS.20.1.21594","article-title":"Examining the effects of HIV self-testing compared to standard HIV testing services: a systematic review and meta-analysis","volume":"20","author":"Johnson","journal-title":"J Int AIDS Soc"},{"key":"R4","unstructured":"WHO Prequalification. 2023. URL: https:\/\/extranet.who.int\/pqweb\/ [Accessed 07-01-2023]"},{"key":"R5","unstructured":"Number of countries adopting HIV self-testing policies rises sharply. Unitaid. Jul 25, 2017. URL: https:\/\/unitaid.org\/news-blog\/number-countries-adopting-hiv-self-testing-policies-rises-sharply\/ [Accessed 11-08-2025]"},{"key":"R6","unstructured":"WHO list of prequalified in vitro diagnostic products. World Health Organization. 2022. URL: https:\/\/extranet.who.int\/prequal\/vitro-diagnostics\/prequalified\/in-vitro-diagnostics [Accessed 31-07-2025]"},{"key":"R7","unstructured":"New US$1 price for HIV self-tests. World Health Organization. Jul 27, 2022. URL: https:\/\/www.who.int\/news\/item\/27-07-2022-new-1-dollar-price-for-hiv-self-tests [Accessed 08-11-2022]"},{"issue":"2","key":"R8","doi-asserted-by":"publisher","first-page":"497","DOI":"10.1007\/s10461-017-1707-8","article-title":"A global review of HIV self-testing: themes and implications","volume":"22","author":"Stevens","journal-title":"AIDS Behav"},{"issue":"1","key":"R9","doi-asserted-by":"publisher","DOI":"10.4102\/sajhivmed.v18i1.775","article-title":"South African HIV self-testing policy and guidance considerations","volume":"18","author":"Venter","journal-title":"South Afr J HIV Med"},{"key":"R10","doi-asserted-by":"publisher","DOI":"10.3389\/frph.2023.1121478","article-title":"The evolution of HIV self-testing and the introduction of digital interventions to improve HIV self-testing","volume":"5","author":"Fischer","journal-title":"Front Reprod Health"},{"issue":"1","key":"R11","doi-asserted-by":"publisher","DOI":"10.4102\/sajhivmed.v21i1.1088","article-title":"Evaluation of a mobile application to support HIV self-testing in Johannesburg, South Africa","volume":"21","author":"Gous","journal-title":"South Afr J HIV Med"},{"issue":"1","key":"R12","doi-asserted-by":"publisher","DOI":"10.4102\/sajhivmed.v22i1.1197","article-title":"Uptake of the Ithaka mobile application in Johannesburg, South Africa, for human immunodeficiency virus self-testing result reporting","volume":"22","author":"Fischer","journal-title":"South Afr J HIV Med"},{"key":"R13","doi-asserted-by":"publisher","DOI":"10.1016\/j.eclinm.2021.101059","article-title":"HIV self-testing with digital supports as the new paradigm: a systematic review of global evidence","volume":"39","author":"McGuire","journal-title":"EClinicalMedicine"},{"key":"R14","unstructured":"(WHO) Global Strategy on Digital Health 2020-2025. World Health Organization; 2021."},{"issue":"5","key":"R15","doi-asserted-by":"publisher","DOI":"10.2196\/25273","article-title":"Changes in perceptions and use of mobile technology and health communication in South Africa during the COVID-19 lockdown: cross-sectional survey study","volume":"5","author":"Fischer","journal-title":"JMIR Form Res"},{"issue":"1","key":"R16","doi-asserted-by":"publisher","first-page":"11","DOI":"10.1089\/pop.2021.0031","article-title":"Digital Health: unlocking value in a post-pandemic world","volume":"25","author":"D\u2019Anza","journal-title":"Popul Health Manag"},{"key":"R17","unstructured":"Virtual Interventions in Response to HIV, Sexually Transmitted Infections and Viral Hepatitis. World Health Organization; 2022."},{"issue":"1","key":"R18","doi-asserted-by":"publisher","first-page":"136","DOI":"10.9745\/GHSP-D-20-00578","article-title":"The evolving landscape of medical device regulation in East, Central, and Southern Africa","volume":"9","author":"Hubner","journal-title":"Glob Health Sci Pract"},{"key":"R19","unstructured":"Software as a Medical Device (SaMD). International Medical Device Regulators Forum. 2023. URL: https:\/\/www.imdrf.org\/working-groups\/software-medical-device-samd [Accessed 10-03-2023]"},{"key":"R20","unstructured":"South African Health Products Regulatory Authority, Classification of Medical Devices and IVDs. South African Health Products Regulatory Authority; 2019."},{"issue":"2","key":"R21","doi-asserted-by":"publisher","first-page":"79","DOI":"10.1093\/inthealth\/ihy095","article-title":"The World Health Organization Prequalification Programme-playing an essential role in assuring quality medical products","volume":"11","author":"Coyne","journal-title":"Int Health"},{"key":"R22","unstructured":"Department of Regulation of Medicines and Other Health Technologies. Impact Assessment of WHO Prequalification and Systems Supporting Activities. World Health Organization; 2019."},{"issue":"1","key":"R23","doi-asserted-by":"publisher","first-page":"52","DOI":"10.1016\/j.vaccine.2013.11.066","article-title":"Twenty-five years of the WHO vaccines prequalification programme (1987-2012): lessons learned and future perspectives","volume":"33","author":"Dellepiane","journal-title":"Vaccine (Auckl)"},{"issue":"2","key":"R24","doi-asserted-by":"publisher","first-page":"137","DOI":"10.1057\/jphp.2013.53","article-title":"A quiet revolution in global public health: The World Health Organization\u2019s Prequalification of Medicines Programme","volume":"35","author":"\u2019t Hoen","journal-title":"J Public Health Policy"},{"issue":"1","key":"R25","doi-asserted-by":"publisher","first-page":"68","DOI":"10.1002\/cpt.1680","article-title":"The World Health Organization prequalification program and clinical pharmacology in 2030","volume":"107","author":"Blaschke","journal-title":"Clin Pharmacol Ther"},{"issue":"1","key":"R26","doi-asserted-by":"publisher","DOI":"10.26717\/BJSTR.2020.28.004607","article-title":"Procedure and Outcome of Prequalification of Medicines Program by World Health Organization (WHO)","volume":"28","author":"Dey","journal-title":"Biomed J Sci Tech Res"},{"key":"R27","unstructured":"Prequalification fees: WHO prequalification of in vitro diagnostics. World Health Organization. 2018. URL: https:\/\/iris.who.int\/bitstream\/handle\/10665\/259171\/WHO-EMP-RHT-PQT-2017.04-eng.pdf?sequence=1&ua=1 [Accessed 31-07-2025]"},{"issue":"1","key":"R28","doi-asserted-by":"publisher","first-page":"2","DOI":"10.1038\/s41591-019-0717-7","article-title":"WHO wants to bring order to health data","volume":"26","author":"Shaffer","journal-title":"Nat Med"},{"key":"R29","unstructured":"Digital health trends 2021: innovation, evidence, regulation, and adoption. IQVIA Institute for Human Data Science; 2021."},{"key":"R30","unstructured":"Odaibo S . Risk management of AI\/ML Software as a Medical Device (SaMD): on ISO 14971 and related standards and guidances. arXiv. Preprint posted online on Sep 11, 2021. [doi: 10.48550\/arXiv.2109.07905]"},{"key":"R31","unstructured":"ISO\/TS 82304-2:2021 health software \u2014 part 2: health and wellness apps \u2014 quality and reliability. International Organization for Standardization. 2021. URL: https:\/\/www.iso.org\/standard\/78182.html [Accessed 10-03-2023]"},{"key":"R32","unstructured":"Welcome to FHIR. FHIR. 2023. URL: https:\/\/build.fhir.org\/index.html [Accessed 09-03-2023]"},{"key":"R33","unstructured":"Data Protection Act 2018. Legislation.gov.uk. 2018. URL: https:\/\/www.legislation.gov.uk\/ukpga\/2018\/12\/part\/2 [Accessed 24-10-2022]"},{"key":"R34","doi-asserted-by":"crossref","unstructured":"Hermon R Williams PP Mccauley PV . Software as a Medical Device (SaMD): useful or useless term? Presented at: Hawaii International Conference on System Sciences; Jan 5-8, 2021; Kauai, Hawaii, USA. [doi: 10.24251\/HICSS.2021.451]","DOI":"10.24251\/HICSS.2021.451"},{"issue":"1","key":"R35","doi-asserted-by":"publisher","DOI":"10.1038\/s41746-022-00573-1","article-title":"Health app policy: international comparison of nine countries\u2019 approaches","volume":"5","author":"Ess\u00e9n","journal-title":"NPJ Digit Med"},{"key":"R36","unstructured":"WHO recommends HIV self-testing as an approach to HIV testing services. World Health Organization. 2019. URL: https:\/\/www.who.int\/publications\/i\/item\/WHO-CDS-HIV-19.36 [Accessed 11-08-2025]"},{"key":"R37","unstructured":"Recognising the Value of Digital Health Apps: An Assessment of Five European Healthcare Systems. MedTech Europe; 2021."},{"issue":"12","key":"R38","doi-asserted-by":"publisher","first-page":"4209","DOI":"10.1007\/s10461-021-03296-8","article-title":"Changing knowledge and attitudes towards HIV Treatment-as-Prevention and \u201cUndetectable\u2009=\u2009Untransmittable\u201d: a systematic review","volume":"25","author":"Bor","journal-title":"AIDS Behav"},{"issue":"11","key":"R39","doi-asserted-by":"publisher","DOI":"10.1002\/jia2.25635","article-title":"Sexual behaviour change following HIV testing services: a systematic review and meta-analysis","volume":"23","author":"Tiwari","journal-title":"J Int AIDS Soc"},{"issue":"1","key":"R40","doi-asserted-by":"publisher","DOI":"10.1186\/s12936-018-2303-8","article-title":"A qualitative assessment of the challenges of WHO prequalification for anti-malarial drugs in China","volume":"17","author":"Huang","journal-title":"Malar J"},{"issue":"6","key":"R41","doi-asserted-by":"publisher","first-page":"102764","DOI":"10.1016\/j.jiph.2025.102764","article-title":"HIV, hepatitis, and syphilis self-testing among adolescents and young adults: a systematic review and meta-analysis","volume":"18","author":"Zhang","journal-title":"J Infect Public Health"},{"issue":"2","key":"R42","doi-asserted-by":"publisher","first-page":"94","DOI":"10.7861\/futurehosp.6-2-94","article-title":"The potential for artificial intelligence in healthcare","volume":"6","author":"Davenport","journal-title":"Future Healthc J"},{"issue":"9","key":"R43","doi-asserted-by":"publisher","first-page":"1380","DOI":"10.1038\/s41591-020-1045-7","article-title":"Insulin dose optimization using an automated artificial intelligence-based decision support system in youths with type 1 diabetes","volume":"26","author":"Nimri","journal-title":"Nat Med"},{"key":"R44","doi-asserted-by":"publisher","DOI":"10.3389\/fpubh.2024.1334881","article-title":"Measuring the performance of computer vision artificial intelligence to interpret images of HIV self-testing results","volume":"12","author":"Roche","journal-title":"Front Public Health"},{"issue":"6464","key":"R45","doi-asserted-by":"publisher","first-page":"447","DOI":"10.1126\/science.aax2342","article-title":"Dissecting racial bias in an algorithm used to manage the health of populations","volume":"366","author":"Obermeyer","journal-title":"Science"},{"issue":"3","key":"R46","doi-asserted-by":"publisher","first-page":"491","DOI":"10.1093\/jamia\/ocz192","article-title":"A governance model for the application of AI in health care","volume":"27","author":"Reddy","journal-title":"J Am Med Inform Assoc"},{"key":"R47","unstructured":"HIV\/AIDS. World Health Organization African Region. 2018. URL: https:\/\/www.afro.who.int\/health-topics\/hivaids [Accessed 12-03-2023]"},{"key":"R48","unstructured":"Estimated number of startups in selected African countries in 2022. Statista. 2023. URL: https:\/\/www.statista.com\/statistics\/1290679\/number-of-startups-in-africa-by-country\/#:~:text=The%20number%20of%20startups%20in,in%20the%20same%20year%2C%20respectively [Accessed 12-03-2023]"},{"key":"R49","unstructured":"Dushime A . These four countries are leading Africa\u2019s start-up scene \u2014 here\u2019s why. World Economic Forum. 2022. URL: https:\/\/www.weforum.org\/agenda\/2022\/08\/africa-start-up-nigeria-egypt-kenya-south-africa\/ [Accessed 12-03-2023]"},{"key":"R50","unstructured":"Jackson T . Fintech dominant for African startup funding but overall share fell in 2022. Disrupt Africa. URL: https:\/\/disrupt-africa.com\/2023\/02\/15\/fintech-dominant-for-african-startup-funding-but-overall-share-fell-in-2022\/ [Accessed 12-03-2023]"},{"key":"R51","unstructured":"A new digital health platform for Africa. Africa CDC. Nov 10, 2024. URL: https:\/\/africacdc.org\/news-item\/a-new-digital-health-platform-for-africa\/ [Accessed 23-04-2023]"}],"container-title":["JMIR mHealth and uHealth"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/mhealth.jmir.org\/2025\/1\/e60276","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,7,31]],"date-time":"2026-07-31T22:31:56Z","timestamp":1785537116000},"score":1,"resource":{"primary":{"URL":"https:\/\/mhealth.jmir.org\/2025\/1\/e60276"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,8,22]]},"references-count":51,"URL":"https:\/\/doi.org\/10.2196\/60276","relation":{},"ISSN":["2291-5222"],"issn-type":[{"value":"2291-5222","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,8,22]]},"article-number":"v13i1e60276"}}