Regulatory Standards and Guidance for the Use of Health Apps for Self-Management in Sub-Saharan Africa: Scoping Review.

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. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1136/bmjopen-2018-025714.

Regulatory standards and guidance for the use of health applications for self-management in Africa: scoping review protocol.

INTRODUCTION: Despite health applications becoming ubiquitous and with enormous potential to facilitate self-management, regulatory challenges such as poor application quality, breach of data privacy and limited interoperability have impeded their full adoption. While many countries now have digital health-related policies/strategies, there is also a need for regulatory standards and guidance that address key regulatory challenges associated with the use of health applications. Currently, it is unclear the status of countries in Africa regarding regulatory standards and guidance that address the use of health applications.This protocol describes the process of conducting a scoping review which aims to investigate the extent to which regulatory standards and guidance address the use of health applications for self-management within the WHO African Region countries. METHODS: The review will follow the methodological framework for conducting a scoping study by Arksey and O'Malley (2005), and the updated methodological guidance for conducting a Joanna Briggs Institute (JBI) scoping review. Given that regulatory standards and guidance are unlikely to be available in scientific databases, we will search Scopus, Google, OpenGrey, WHO Regional Office for Africa Library (AFROLIB), African Index Medicus (AIM), websites of WHO, ITU and Ministries of Health, repositories for digital health policies. We will also search the reference lists of included documents, and contact key stakeholders in the region. Results will be reported using descriptive qualitative content analysis based on the review objectives. The policy analysis framework by Walt and Gilson (1994) will be used to organise findings. A summary of the key findings will be presented using tables, charts and maps. ETHICS AND DISSEMINATION: The collection of primary data is not anticipated in this study and hence ethical approval will not be required. The review will be published in a peer-reviewed journal while key findings will be shared with relevant organisations and/or presented at conferences.