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应该通过世界卫生组织的预资格来监管HIV自检的数字干预措施吗?

Alex Emilio Fischer^1,2, Samanta Tresha Lalla-Edward³, Vinodh Edward^1,4

¹Department of Interdisciplinary Social Science, Public Health, Utrecht University, Heidelberglaan 1 3584 CS, Utrecht, The Netherlands, 31 302538252.

JMIR mHealth and uHealth

|August 22, 2025

概括

世界卫生组织预资格计划可以预资格数字艾滋病毒自我检测 (HIVST) 干预措施. 这可以提高质量和获取,特别是在资源较少的环境中,但需要当地开发商仔细考虑.

科学领域:

公共卫生
卫生技术法规
数字健康

背景情况:

艾滋病毒自我检测 (HIVST) 提供分散的检测,但在咨询,报告和护理联系方面面临挑战.
数字干预,如软件作为医疗设备 (SaMD),可以解决HIVST的挑战.
特别是在缺乏医疗器械监管能力的低收入和中等收入国家, SaMD存在监管缺口.

研究的目的:

探索世界卫生组织预资格计划 (WHOPQ) 预资格数字HIVST干预的可行性.
评估WHOPQ在规范HIVST的SaMD中的潜在作用,并与其在疫苗和IVD规范中的历史作用进行比较.

主要方法:

对世卫组织成员国医疗器械和安全药物现有监管环境的分析.
检查WHOPQ的任务,历史和药物和体外诊断 (IVD) 的现有预资格程序.
考虑HIVST和SaMD发展的具体背景,包括非洲开发商面临的挑战.

主要成果:

低收入和中等收入国家,特别是非洲国家,缺乏对医疗器械和SaMD的监管能力.
WHOPQ具有与艾滋病毒相关产品的重要历史,表明HIVST干预的潜力.
数字HIVST干预代表了一个潜在的低风险入口点,使WHOPQ获得SaMD预资格.

结论:

数字HIVST干预的WHOPQ预资格可以提高质量,互操作性和可扩展性.
解决监管能力缺口对于公平获得数字卫生工具至关重要.
必须小心避免延迟接入,并支持非洲本地开发商在预资格过程中.

关键词:

非洲艾滋病毒自我查艾滋病毒检测在LMIC 软件作为医疗设备世界卫生组织世界卫生组织可访问性数字健康低收入和中等收入国家接种疫苗疫苗法规

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