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BACKGROUND Health apps are increasingly seen as key to supporting healthcare delivery in its various aspects from communication, patient education, and decision support to self-management. For all countries and especially low- and middle-income ones including those in sub-Saharan Africa (SSA), health apps could play a vital role. However, most health apps published in App stores are of unknown or poor quality with a high risk of compromising patient safety. Regulatory standards ensure quality assurance and guidance for the overall beneficial use of a (new) technology in healthcare thus promoting patient safety. OBJECTIVE This scoping review aimed to assess regulatory standards and guidance in SSA for health apps that would support evidence-based best practices, particularly for self-management. METHODS The study adopted the scoping review methodological framework developed by Arksey and O’Malley. Databases and repositories were searched including Scopus, OPENGREY, WHO Regional Office for Africa Library, African Index Medicus, WHO Directory of eHealth Policies Survey, the HIS Strengthening Resource Centre, and ICTWorks. Institutional websites (WHO, ITU and Ministries of Health) and Google were also searched. The findings were analysed using deductive descriptive qualitative content analysis. The policy analysis framework (content, context, process and actors) was adapted and used to organise the findings. The RISA (Reporting Items for Stakeholder Analysis) tool guided the identification and mapping of key stakeholders based on their potential roles in regulating the use of health apps for patient self-management. RESULTS A total of 48 documents (five standalone regulatory standards, 35 national policies/strategies, and eight other related documents), from 31 SSA countries were included. All 48 documents provided relevant information for stakeholder identification and mapping; however, only three included regulatory standards and guidance provided concepts and information relevant to the standardisation and regulation of health apps. Guided by four predefined themes (technical and clinical safety, data protection and security, standards and interoperability, and inclusion and equitable access) identified from literature, deductive subthemes were generated from the three included regulatory standards and guidance, and organised the findings based on adapted ‘content’ and ‘context’ of the policy analysis framework. Additionally, deductive themes and sub-themes were generated and organised under ‘process’ and ‘actors’. For stakeholder identification and mapping, eleven stakeholder categories were identified and mapped based on their roles using the RISA tool as a guide. CONCLUSIONS There are currently no specific national regulatory standards and guidance for health apps. While related standards and guidance may address regulations around technical and clinical safety, data protection and security, and standards and interoperability, they do not sufficiently address inclusion and equitable access to health apps for self-management. CLINICALTRIAL CRD42017071106 INTERNATIONAL REGISTERED REPORT RR2-http://dx.doi.org/10.1136/bmjopen-2018-025714 |
