背景:健康应用程序越来越被认为是增强医疗保健服务的重要工具。许多国家,特别是撒哈拉以南非洲地区,可以从使用健康应用程序支持自我管理中受益匪浅,从而有助于实现全民健康覆盖和第三个可持续发展目标。然而,在应用商店中发布的大多数健康应用都是未知或质量差的,这对患者安全构成了风险。监管标准和指南可以帮助解决这种风险并促进患者安全。
目的:本综述旨在评估支持撒哈拉以南非洲循证最佳实践的健康应用的监管标准和指南,重点是自我管理。
方法:应用了范围审查的方法学框架。在以下数据库中构建并应用了搜索策略,灰色文献来源,和机构网站:PubMed,Scopus,世界卫生组织(世卫组织)非洲指数,OpenGrey,世卫组织非洲图书馆区域办事处,ICTworks,世卫组织电子卫生政策目录,他的加强资源中心,国际电信联盟,卫生部网站,和Google。搜索范围为2005年1月至2024年1月。使用演绎性描述性内容分析对发现进行了分析。对政策分析框架进行了调整,并用于组织调查结果。用于利益相关者分析的报告项目工具根据关键利益相关者在管理自我管理的健康应用程序中的角色,指导识别和映射关键利益相关者。
结果:该研究包括来自31个撒哈拉以南非洲国家的49份文件。虽然所有文件都与利益相关者识别和映射相关,只有3个监管标准和指南包含有关健康应用程序监管的相关信息。这些标准和指南主要旨在建立相互信任;促进融合,inclusion,和公平获得服务;并解决执行问题和协调不力。他们提供了有关系统质量的指导,软件获取和维护,安全措施,数据交换,互操作性和集成,相关利益相关者的参与,和公平获得服务。加强落实,这些标准突出了法律权威,协调活动,能力建设,需要监测和评估。一些利益相关者,包括政府,监管机构,资助者,政府间和非政府组织,学术界,和医疗保健界,被确定为在管理健康应用程序方面发挥关键作用。
结论:健康应用程序在支持撒哈拉以南非洲的自我管理方面具有巨大潜力,但是缺乏监管标准和指导是一个主要障碍。因此,为了将这些应用程序安全有效地集成到医疗保健中,应该更加重视监管。向具有有效法规的国家学习可以帮助撒哈拉以南非洲建立更强大和反应更灵敏的法规体系,确保整个地区健康应用的安全和有益使用。
■RR2-10.1136/bmjopen-2018-025714。
BACKGROUND: Health apps are increasingly recognized as crucial tools for enhancing health care delivery. Many countries, particularly those in sub-Saharan Africa, can substantially benefit from using health apps to support self-management and thus help to achieve universal health coverage and the third sustainable development goal. However, most health apps published in app stores are of unknown or poor quality, which poses a risk to patient safety. Regulatory standards and guidance can help address this risk and promote patient safety.
OBJECTIVE: This review aims to assess the regulatory standards and guidance for health apps supporting evidence-based best practices in sub-Saharan Africa with a focus on self-management.
METHODS: A methodological framework for scoping reviews was applied. A search strategy was built and applied across the following databases, gray literature sources, and institutional websites: PubMed, Scopus, World Health Organization (WHO) African Index Medicus, OpenGrey, WHO Regional Office for Africa Library, ICTworks, WHO Directory of eHealth policies, HIS Strengthening Resource Center, International Telecommunication Union, Ministry of Health websites, and Google. The search covered the period between January 2005 and January 2024. The findings were analyzed using a deductive descriptive content analysis. The policy analysis framework was adapted and used to organize the findings. The Reporting Items for Stakeholder Analysis tool guided the identification and mapping of key stakeholders based on their roles in regulating health apps for self-management.
RESULTS: The study included 49 documents from 31 sub-Saharan African countries. While all the documents were relevant for stakeholder identification and mapping, only 3 regulatory standards and guidance contained relevant information on regulation of health apps. These standards and guidance primarily aimed to build mutual trust; promote integration, inclusion, and equitable access to services; and address implementation issues and poor coordination. They provided guidance on systems quality, software acquisition and maintenance, security measures, data exchange, interoperability and integration, involvement of relevant stakeholders, and equitable access to services. To enhance implementation, the standards highlight that legal authority, coordination of activities, building capacity, and monitoring and evaluation are required. A number of stakeholders, including governments, regulatory bodies, funders, intergovernmental and nongovernmental organizations, academia, and the health care community, were identified to play key roles in regulating health apps.
CONCLUSIONS: Health apps have huge potential to support self-management in sub-Saharan Africa, but the lack of regulatory standards and guidance constitutes a major barrier. Hence, for these apps to be safely and effectively integrated into health care, more attention should be given to regulation. Learning from countries with effective regulations can help sub-Saharan Africa build a more robust and responsive regulatory system, ensuring the safe and beneficial use of health apps across the region.
UNASSIGNED: RR2-10.1136/bmjopen-2018-025714.