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Health apps are the most widely used digital health products globally [,]. Harnessing the potential of health apps creates a huge opportunity in providing support for health care delivery, including patient communication, patient education, and decision support for self-management [-]. Health apps can be an effective tool to strengthen health systems worldwide, especially in low- and middle-income countries including those in sub-Saharan Africa [,,]. As a result, the attainment of universal health coverage (UHC) and sustainable development goal (SDG) 3, good health and well-being, can be accelerated [,].
Many health apps fall below the expected quality threshold []. Several studies have found that widely used health apps are often technically unreliable and clinically unsafe [-] and do not comply with ethical standards and the principles of confidentiality of information and data privacy [,]. In addition, many commercially available health apps were not developed using interoperability standards that are widely accepted in sub-Saharan Africa (eg, Fast Healthcare Interoperability Resources [FHIR]) [-]. Consequently, it becomes difficult to integrate these apps into a clinical workflow.
Hence, regulation through robust mechanisms is crucial to enhance the development, implementation, and adoption of health apps. Regulatory standards and guidance are essential for the safety of patients as they ensure quality assurance of any new technology in health care and contribute to building mutual trust while promoting the optimal use of the technology [-]. Therefore, to ensure that health apps that are used to support the self-management of patients are technically reliable and clinically safe, interoperable across systems, and compliant with the principles of confidentiality of information and data privacy, there is a need for effective regulatory standards. Furthermore, effective regulation can help ensure that health apps for self-management are culturally functional and competent and are accessible to those who need them regardless of gender, ethnicity, geographical location, or financial status [-].
Since 2005, there have been ongoing efforts to strengthen digital health governance at both the national and international levels [,]. In 2018, the World Health Organization (WHO) member states renewed their commitment to using digital health technologies (DHTs) to advance UHC and SDG 3 []. However, to date, the extent to which the use of health apps for self-management is regulated across countries within the WHO African Region (also known as sub-Saharan Africa) remains unclear. Therefore, this review was conducted to identify available regulatory standards and guidance and assess the extent to which they regulate health apps for self-management in sub-Saharan Africa. The review also mapped out the key stakeholders and their roles in regulating health apps for self-management across sub-Saharan Africa.
Review QuestionsThe review attempted to answer the following questions: (1) What regulatory standards and guidance are available for regulating health apps for self-management across sub-Saharan Africa? (2) To what extent do regulatory standards and guidance regulate health apps for self-management in terms of what aspects are regulated; why, how, and for whom; and what aspects are not regulated? (3) Who are the key stakeholders and what are their roles in regulating health apps for self-management?
The process of this scoping review followed the methodological framework for conducting a scoping study originally described by Arksey and O’Malley [] and the updated methodological guidance for conducting a Joanna Briggs Institute scoping review [-]. The reporting of the review was guided by the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) checklist []. A completed PRISMA-ScR checklist is provided in . The protocol of this scoping review was published in BMJ Open [].
Identifying Relevant DocumentsTwo reviewers (BAB and SI) developed the search strategy with the assistance of a librarian and in consultation with other research team members (KPF, BIH, NU, NM, AM, and JC). The following key terms were included: policy, legislation, strategy, regulation, standard, criterion, framework, guidance, guideline, digital health, eHealth, app, WHO African Region, and sub-Saharan Africa, and the names of all sub-Saharan African countries.
Owing to the absence of regulatory standards and guidance in scientific databases, the search focus was narrowed down to gray literature sources and institutional websites, including OpenGrey, WHO Regional Office for Africa (AFRO) Library, repositories for digital health policies (ICTworks, WHO’s Directory of eHealth Policies, and Health Information System Strengthening Resource Center), as well as the websites of WHO, International Telecommunication Union (ITU), and Ministries of Health (MOHs). The only scientific databases searched were PubMed, Scopus, and WHO AIM. PubMed was not included in the protocol. We also conducted a systematic search on Google. We used truncation to increase the yield of the results. The search strategy was then applied across PubMed, Scopus, and WHO AIM databases using Boolean terms (mainly OR and AND) to combine search results. Gray literature sources and institutional websites were searched using phrases containing ≥2 keywords such as “eHealth regulation,” “digital health regulatory standard,” “eHealth regulatory standard,” “digital health regulation,” “digital health policy,” “eHealth policy,” “digital health strategy,” and “eHealth strategy.” For Google search, we added the names of the country to the phrases (eg, “digital health regulation Nigeria”). The reference lists of the included documents were also searched, and key individuals at the MOHs, WHO Country Offices, and the WHO AFRO were contacted for related documents. When our search was conducted, the WHO Directory of eHealth policies website was unavailable, and the WHO AFRO Library was undergoing reconstruction. The search strategies for PubMed, Scopus, and WHO AIM are provided in . The search was conducted between 2005 and January 2024.
Study SelectionThe search results obtained from PubMed, Scopus, and WHO AIM were imported into Mendeley (Elsevier) [] to remove duplicates. The search conducted on OpenGrey did not yield any results, whereas relevant records obtained from institutional websites, repositories, and Google were downloaded as PDF copies and uploaded to Mendeley. After removing duplicates, the remaining results were imported into Covidence (Veritas Health Innovation) [] for screening. Two reviewers (BAB and SI) applied the predefined eligibility criteria () to screen the documents in 2 stages (title and abstract or executive summary). All discrepancies were discussed until the reviewers reached agreement.
Textbox 1. Inclusion and exclusion criteria.Inclusion criteria
Type of document: Regulatory standards, guidance, policies, strategies, and committee or government reports that address regulatory issues related to the use of health apps for self-managementLocation: Documents developed and implemented in countries within sub-Saharan AfricaDate of publication: Documents developed since 2005; the global efforts toward promoting standards to minimize variability and potential harms that could arise from poorly regulated use of digital health began in 2005 []Language: Documents written in English language and other official languages of sub-Saharan African countries (Portuguese and French)Exclusion criteria
Type of document: Standards, guidance, policies, strategies, and reports not related to regulation of health appsLocation: Documents from countries outside sub-Saharan AfricaDate of publication: Documents developed before 2005Language: NoneData Charting (Extraction)Two reviewers (BAB and SI), in consultation with the other members of the research team, developed the data extraction forms using an iterative process that included piloting data extraction and refinement until a consensus was reached.
We proposed in the study protocol [] that data extraction would be conducted by the 2 reviewers independently. However, owing to the approach adopted for data extraction (deductive qualitative content analysis), 1 reviewer, rather than 2, initially extracted data from the included documents, and any concerns were discussed with a second reviewer []. Unresolved issues were then discussed and resolved with a third reviewer in a steering group meeting.
Collating, Summarizing, and Reporting ResultsTo address the research questions (particularly question 2), we adopted a deductive descriptive qualitative content analysis method to analyze and report the key findings. The policy analysis framework by Walt and Gilson [] was adapted and applied to ensure that there was a consistent way of organizing the key findings: (1) Content (which aspects are regulated and which aspects are not?)—these are the components that directly or indirectly address regulatory issues related to the use of health apps for self-management, including areas that have not been addressed. (2) Context (why are those aspects regulated?)—this characterizes the rationale indicated for addressing regulatory issues related to the use of health apps for self-management. (3) Process (how are the regulatory standards developed and implemented?)—this describes the methods or approaches used to develop and implement regulatory standards. (4) Actors (who are the regulatory standards targeted toward?)—these are the key actors targeted by the standards.
Using a deductive descriptive qualitative content analysis approach, we examined each included document to systematically identify texts for concepts, patterns, and other relevant information. We then categorized them under content, context, process, or actors in relation to regulating health apps for self-management. The findings under content and context were further organized based on 4 predefined regulatory categories or themes as documented in the literature, namely (1) technical and clinical safety [-], (2) data protection and security [,], (3) standards and interoperability [,], and (4) inclusion and equitable access [-].
To address the third research question, the Reporting Items for Stakeholder Analysis (RISA) tool [] was used as a guide to group key stakeholders based on role categorization as recognized globally by the WHO, the ITU, and UNESCO [,,].
Ethical ConsiderationsPrimary data were not collected in this study. Therefore, no ethics approval was required.
A total of 2900 records were obtained after removing duplicates. Although the literature search was conducted in English, the search also yielded documents written in French and Portuguese from the ICTworks repository []. Following the initial screening of the title and abstract (or executive summaries), 73 documents were retrieved for full-text assessment. After applying the inclusion criteria for the full-text assessment, 49 documents were found eligible for inclusion in the review.
The PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) flow diagram [] showing the study selection process is presented in .
Figure 1. PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) flow diagram showing the study selection process. The descriptive qualitative content analysis included only 3 of the 49 (6%) documents used for stakeholder mapping. WHO: World Health Organization. Types of DocumentsOn the basis of the inclusion criteria, 3 categories of documents were considered for this review, namely “stand-alone regulatory standards and guidance that potentially regulate health apps for self-management,” “national policies and strategies on digital health,” and “other national documents that relate to the regulation of health apps for self-management.” presents the types of documents obtained for each country within sub-Saharan Africa.
Table 1. Types of documents obtained for each sub-Saharan African country.CountryType of documentWe identified and included 6 stand-alone regulatory standards [,,-] from 3 countries (Ethiopia, Kenya, and Nigeria). All 6 documents were written in English. The years of development ranged between 2013 and 2021, as indicated in . The years of implementation were not specifically stated.
Although none of the included regulatory standards were exclusively developed to regulate health apps for self-management, 3 of them (Kenya Standards and Guidelines for mHealth Systems [], Kenya Standards and Guidelines for E-Health Systems Interoperability [], and Health Sector Information and Communications Technology Standards and Guidelines []) provided concept and information relevant to the regulation of health apps and were included in the qualitative content analysis. The Kenya Standards and Guidelines for mHealth Systems [] provides standards and guidelines on the design, development, and implementation of mobile health (mHealth) solutions to ensure they are interoperable, scalable, and sustainable. The Kenya Standards and Guidelines for E-Health Systems Interoperability [] outlines the principles, requirements, and standards for eHealth systems interoperability in Kenya. The Health Sector Information and Communications Technology Standards and Guidelines [] provide guidance and a consistent approach across the health sector in Kenya for establishing, acquiring, and maintaining current and future information systems and information and communications technology (ICT) infrastructure that foster interoperability across systems. These 3 documents are a good combination of regulatory standards and guidance that provide content and context relevant to the regulation of health apps in sub-Saharan Africa.
The remaining 3 standards (standard for electronic health record [EHR] system in Ethiopia [], standards and guidelines for electronic medical record systems in Kenya [], and the health information exchange standard operating procedure and guideline []) were exclusively developed for EHRs or electronic medical records. However, they contain information relevant for mapping stakeholders with potential roles in regulating health apps for supporting self-management.
National Policies and Strategies on Digital HealthThis review includes 35 national policies and strategies that are related to digital health (potentially covering health apps) [-] from 31 countries written in English, French, and Portuguese (Benin, Botswana, Burkina Faso, Burundi, Cameroon, Comoros, Côte d’Ivoire [Ivory Coast], Democratic Republic of the Congo, Eswatini, Ethiopia, Gabon, Ghana, Kenya, Liberia, Madagascar, Malawi, Mali, Mauritius, Mozambique, Namibia, Niger, Nigeria, Rwanda, Senegal, Sierra Leone, South Africa, Tanzania, Togo, Uganda, Zambia, and Zimbabwe). Although the literature search was conducted in English, it also yielded documents written in French and Portuguese from the ICTworks repository. The years of development and implementation range between 2005 and 2030. Policies and strategies written in French and Portuguese were translated into English using Google Translate. Documents labeled as national development plans, strategic plans, and strategic development plans were considered as national strategies.
National policies and strategies do not offer specific standards or guidance, but rather outline the country’s vision, policy directions, and strategies for using digital technologies in health care. They provide useful information for identifying digital health stakeholders who can play a role in regulating health apps for self-management. For example, Nigeria has a separate National Digital Health Policy [] and a National Digital Health Strategy []. Both documents were developed by building on the lessons learned from the end-term evaluation of the previous National Health ICT Strategic Framework []. They describe Nigeria’s renewed vision, mission, goals, objectives, and strategies for the development and implementation of digital health with the aim to improve the quality, efficiency, and effectiveness of health service delivery and health outcomes.
It is worth noting that for countries with >1 policy or strategy, we included only the most recent versions. For instance, as mentioned earlier, Nigeria now has both a national digital health policy and a national digital health strategy. These 2 documents supersede and thus replace the old National Health ICT Strategic Framework []. Details of included documents are presented in .
Other Related National DocumentsWe included 8 other documents [,,-] from 6 countries (Ethiopia, Kenya, Liberia, Nigeria, South Africa, and Tanzania) that did not fall under either stand-alone regulatory standards and guidance or national policies and strategies. These were mostly frameworks, road maps, and reports that potentially provide information relevant to the use of health apps. The years of development and implementation range from 2016 to 2025. These documents do not provide standards or guidance, but they contain information that can help map the digital health stakeholders that potentially play a role in regulating health apps for self-management. When multiple versions of a document exist, only the latest version was taken into consideration. provides details of the included documents.
Content: Aspects That Are Regulated and Aspects That Are NotTechnical and Clinical SafetyTechnical and clinical safety standards are required to prevent or minimize the harm that may arise from the use of the health ICT systems (including mHealth systems) as well as to improve the health outcomes and user satisfaction. As shown in , two subthemes were generated from included standards [,,] as content under technical and clinical safety: v(1) guidance on system quality and (2) guidance on software or app development, acquisition, support, and maintenance.
Figure 2. Summary of themes and subthemes covering content, context, process, and actors of the regulatory standards. The process is divided into development and implementation process. The subthemes relating to content and context are further categorized under technical and clinical safety, data protection and security, standards and interoperability, and inclusion and equitable access to services. ICT: information and communications technology. Notably, 2 of the included standards [,] provide guidance on system quality to ensure the quality, security, reliability, performance, and maintenance of eHealth and mHealth systems. The Kenya Standards and Guidelines for E-Health Systems Interoperability [] recommend the implementation of a data quality protocol to ensure that the data collection, collation, analysis, interpretation, dissemination, and use are managed in accordance with the quality standards. Similarly, the Kenya Standards and Guidelines for mHealth Systems [] recommends the inclusion of the following requirements in the technical manual: (1) minimum hardware requirements that should incorporate the preferred hardware architecture, (2) minimum software requirements that should include the minimum version of the underlying operating system as well as acceptable versions of related software, and (3) a detailed list of software dependencies (external libraries) necessary for the system to function properly.
The included standards [,] cover guidance on software or app development, acquisition, support, and maintenance, which aim to ensure the efficiency and effectiveness of eHealth and mHealth systems. The Kenya Standards and Guidelines for mHealth Systems [] recommends a technical manual to provide a detailed description of the system’s installation and maintenance processes for system administrators and implementers; a developer’s guide for software developers and programmers to provide them with an overview of the system, description of the software design methodologies, description of the system architecture, and technical design diagrams; and a user manual to aid users in understanding how the system works and how each feature operates; in addition, the technical manual contains instructions for operating the software; entering and updating data; and generating, saving, and printing reports.
Although the contents generated here provide guidance that is relevant to health apps, they are not specific to health apps. Moreover, there are no clear measures to enable individuals or organizations that use health apps to manage clinical risk appropriately.
Data Protection and SecurityData protection and security are crucial aspects of managing patient information, thus ensuring the confidentiality, integrity, and availability of data as well as the rights and interests of the patient. Two subthemes related to data protection and security are (1) security measures for adequate protection of patients’ digital records and (2) guidance on data exchange.
The included standards [,] provide security measures for eHealth or mHealth systems to ensure the adequate protection of digitally accessible patient records. These measures include authentication, accountability, identification, authorization, integrity, confidentiality, availability, security, administration, and audit. This will help to achieve confidentiality, integrity, availability, and nonrepudiation of patient data or health records. Additional levels of security such as data encryption are required when there is a need to store sensitive information on removable devices or media or outside the MOH premises.
The Kenya Standards and Guidelines for mHealth Systems [] provide the following guidance on data exchange to ensure privacy: (1) anonymize client data as much as possible before they can be shared; (2) where possible, use pseudonyms for the client data before they can be shared; (3) aggregate client data before they can be shared to reduce possibilities of tracing the data back to the client; and (4) minimize data so that access is available only to the data set required for that particular use. With regard to privacy rules, the Kenya Standards and Guidelines for E-Health Systems Interoperability [] propose that a notice of privacy practices should be given to patients describing how their information may be used or shared while also specifying their legal rights.
Standards and InteroperabilityStandards and interoperability are essential concepts in the field of IT, especially for systems that need to communicate and exchange data, as seen in the use of health apps for self-management. Two subthemes related to standards and interoperability are (1) interoperability as a basic requirement and (2) minimum standards to enable integration.
All the regulatory standards [,,] highlight the importance of having interoperability as a basic requirement when selecting software products or services for use within the health system. This facilitates interaction across systems. For instance, to facilitate seamless interaction between mHealth systems and primary information systems for data capture, reporting, and decision support in various domains of the health system, the Kenya Standards and Guidelines for mHealth Systems [] recommends the incorporation of at least 3 types of interoperability, namely, technical interoperability, semantic interoperability, and process interoperability.
Furthermore, 2 regulatory standards [,] proposed minimum interoperability standards to enable the integration of services and data exchange between various systems in health care. For instance, the Kenya Standards and Guidelines for mHealth Systems [] suggests standards (for interoperability) for mHealth systems that are consistent with the recommendations in internationally accepted standards. They include the following: (1) clinical messaging—ensuring mHealth systems conform to Health Level 7 (HL7) version 3 standards and corresponding implementation guideline; (2) clinical terminology—ensuring terminologies and classifications for clinical concepts (eg, International Classification of Diseases, tenth revision—for diseases; Systemized Nomenclature of Medicine—for clinical data coding; Logical Observation Identifiers Names and Codes—for laboratories; and RxNorm—for Pharmacies); (3) the mHealth system must use the latest versions of international standards, such as HL7 Clinical Document Architecture for electronic sharing of clinical documents; (4) concepts—mHealth systems will use the idea of “concepts” so that information can be transmitted between systems without losing meaning or context, and HL7 Reference Implementation Model or other appropriate standards are recommended for implementing concepts; (5) architecture—to develop mHealth systems, developers should define the system architecture that should include data elements and business logic. Furthermore, to define how mHealth systems interact with other systems, developers of mHealth solutions must provide application programming interfaces. FHIR is the preferred application programming interface interoperability standard.
Inclusion and Equitable AccessInclusion and equitable access are essential principles to ensure that health apps are culturally appropriate and relevant and accessible to everyone, regardless of gender, ethnicity, location, or economic status.
All the included regulatory standards [,,] indicate that they were developed based on a combination of participatory and consultative approaches involving multiple actors or stakeholders, thus promoting inclusion. However, there are no specific measures or guidance to ensure adequate engagement and representation of all the relevant stakeholders and to sustain that engagement.
The Kenya Standards and Guidelines for mHealth Systems [] proposes the following systems attributes to ensure equitable access to mHealth services at all times and from anywhere: (1) allocation of adequate storage and bandwidth capacity; (2) fast response time; (3) fast recovery capabilities; (4) performance monitoring; (5) business continuity processes, for example, backups; and (6) redundant sites and links. Furthermore, the Kenya Standards and Guidelines for mHealth Systems [] prescribes the following metrics for measuring system availability: (1) downtime per year, (2) mean time between failure, (3) mean time to repair, and (4) failure in time.
Although the abovementioned systems attributes and metrics for measuring system availability are important, the included standards do not offer any concrete guidance or model for achieving a sustainable funding mechanism for health apps to ensure that they are readily available and accessible to those who need them.
Context: Reasons Why Those Aspects Are RegulatedTechnical and Clinical SafetyThe 3 standards [,,] were developed to address unsafe, isolated, and inconsistent implementation. The Health Sector ICT Standards and Guidelines [] suggest that although there has been a lot of ICT investment in the health sector leading to improvement in service delivery and information exchange, there remains the challenge of inconsistency in ICT implementation and harmonization of the health sector system requirements. Hence, there is a need to adopt global best practices for software development, acquisition, support, and maintenance by the MOH. In addition, the Kenya Standards and Guidelines for mHealth Systems [] indicates that standards and guidelines are necessary to ensure a consistent approach to the development of ICT systems. Similarly, the Kenya Standards and Guidelines for E-Health Systems Interoperability [] recognize the need to ensure that the processes of collecting, collating, analyzing, interpreting, disseminating, and using data are consistent with data quality standards.
Data Protection and SecurityTo build mutual trust and maximize the benefits of eHealth information exchange, the Kenya Standards and Guidelines for E-Health Systems Interoperability [] reiterate that as health data are constantly being exchanged across health information systems, robust security standards are required to maintain their integrity and confidentiality. This will build the trust of service users and consequently help to maximize the benefits of eHealth information exchange such as in self-management.
Standards and InteroperabilityTwo of the included regulatory standards [,] indicate that the context for standards and interoperability was (1) to address poor coordination, duplication of efforts, and inefficient use of resources and (2) to promote the integration of ICT systems.
The Kenya Standards and Guidelines for E-Health Systems Interoperability [] acknowledge that the absence of interoperability standards over the years has led to the duplication of efforts and the inefficient use of ICT resources in health care. Now that ICT has become increasingly relevant in improving efficiency in health service delivery, the Kenya MOH recognizes the need to adopt a standardized approach, hence the development of interoperability standards for eHealth systems. In addition, the Health Sector ICT Standards and Guidelines [] emphasize the relevance of interoperability as a requirement for addressing the inconsistency in implementing ICT in the health sector.
The Health Sector ICT Standards and Guidelines [] consider “integration of ICT systems” as one of its key guiding principles, acknowledging the lack of information systems integration as a challenge experienced by ICT services across Kenya.
Inclusion and Equitable AccessThe contexts for inclusion and equitable access as generated from included standards [,,] were (1) to promote inclusion and (2) to promote equitable access to services.
To promote inclusion, the standards [,,] highlight the importance of involving and engaging multiple actors and stakeholders during the development process. However, no emphasis was placed on the need to sustain stakeholder engagement during the implementation process.
Pertaining to equitable access, the Kenya Standards and Guidelines for mHealth Systems [] acknowledges that the public health care system is largely unavailable to most of the population in many developing countries because of geographical location, resource constraints, inefficiencies, and lack of awareness. Hence, it recognizes the importance of ensuring that mHealth services are always accessible by users and from anywhere as well as the need to put in place mechanisms to make this happen.
Process: How the Regulations Are Developed and ImplementedTwo themes were generated from the included standards: development and implementation processes [,,].
Development ProcessAll the included standards [,,] indicate that they were developed through a participatory process and in consultation with a range of subject experts and interest groups. In addition, the standards [,,] adopted a multisectoral approach to engage health-related stakeholders from government ministries or agencies and development partners and a range of subject experts and interest groups. It has also been reported that these standards [,,] were developed based on international best practices and with reference to international standards. However, there is no indication that a stakeholder engagement strategy was adopted to sustain the engagement of stakeholders through the entire development and implementation process.
Implementation ProcessThe 3 regulatory standards [,,] identify the key requirements to ensure effective implementation of IT services in the health sector. These are (1) legal authority, (2) coordination, (3) building capacity, and (4) monitoring and evaluation.
The included standards [,,] were established based on the legal provisions enshrined in the health and other related acts and laws of Kenya as well as the relevant policies and strategies. Hence, it is expected that their implementation will comply with and be backed by those legal provisions. For example, the Health Sector ICT Standards and Guidelines [] indicate that its implementation will be supported by the authority from the Kenya Communications Act 2009, E-Government Strategy, and National ICT Policy. Similarly, the Kenya Standards and Guidelines for mHealth Systems [] asserts that it will be implemented by complying with existing and relevant national policies, legal frameworks, strategies, and standards, including the Health Information Policy, ICT Standards, and System Interoperability Principles.
The included standards [,,] report that the implementation of regulations will require robust coordination mechanisms. For instance, the Health Sector ICT Standards and Guidelines [] indicate that, as the Ministry’s ICT resource manager, the principal secretary (also the head of ICT), in collaboration with the ICT Governance Committee, is responsible for coordinating the implementation of the standard. The ICT Governance Committee comprises representatives from the heads of departments and ICT development partners in the health sector. The committee’s responsibilities include overseeing, enforcing, and reviewing standards as well as initiating ICT projects.
The Health Sector ICT Standards and Guidelines [] highlight the need for capacity building or training of the MOH staff and stakeholders who are the primary users of the Ministry’s ICT services. This will enhance their capacity to implement the guidelines provided in the document in line with the ministry’s human resource development policies, regulations, and rules. However, it is acknowledged that building capacity for health ICT is a challenge given that there is low adoption of ICT among health providers, and ICT is not routinely included in the course content of most training programs. The Kenya Standards and Guidelines for mHealth Systems [] listed the “number of mHealth practitioners trained on the standards and guidelines” as one of the indicators for monitoring and evaluating mHealth interventions.
The Health Sector ICT Standards and Guidelines [] assert that monitoring and evaluation is an essential role of the MOH to ensure efficiency, accountability, and transparency throughout the implementation period. It further stresses that all those who use the Ministry’s ICT services are required to adhere to the provisions in the standard as the MOH will carry out quarterly monitoring exercises on the use of the standard to ensure compliance based on clear indicators. Furthermore, the ICT Governance Committee will periodically review and amend the standard to keep it relevant and effective. Similarly, the Kenya Standards and Guidelines for mHealth Systems [] establishes the following key indicators for effectively monitoring and evaluating the implementation of the standards and guidelines: (1) the number of counties in which the MOH has disseminated the standards and guidelines, (2) the number of counties successfully implementing the standards and guidelines, (3) the number of mHealth practitioners trained on the standards and guidelines, (4) the number of mHealth practitioners accessing the standards and guidelines, (5) the number of mHealth practitioners who correctly understand the standards and guidelines, (6) the number of stakeholders who adhere to the standards and guidelines, (7) the number of mHealth systems that follow the required development steps, and (8) the number of mHealth practitioners who have implemented their systems by using the standards and guidelines. In addition, the Kenya Standards and Guidelines for mHealth Systems [] indicates that the outlined standards will be reviewed every 3 years to ensure they are up to date with new changes including the changes in policies and systems upgrades.
Although all the abovementioned indicators are relevant, the implementation process is not explicit on the approach for regulating health apps and ensuring compliance with regulatory standards and guidance.
Actors: Those the Regulations Are Targeted atThe included standards [,,] identified 2 main groups of actors for whom the regulations and guidance were targeted. They included (1) those who provide digital health services and (2) those who use the ICT infrastructure of the MOH.
Two of the standards [,] indicated that the regulations should be implemented by all individuals and organizations that provide ICT-related health care services to the public. Similarly, the Health Sector ICT Standards and Guidelines [] state that all those who access or use the MOH ICT infrastructure are expected to adhere to the guidelines outlined in the document.
Mapping of StakeholdersTo address the third research question, we conducted a stakeholder mapping guided by the RISA tool [].
A total of 11 categories of key stakeholders were identified from all 49 included documents (6 stand-alone regulatory standards and guidance, 35 national policies or strategies, and 8 other related documents). These categories are consistent with the digital health stakeholders recognized by the WHO, ITU, and UNESCO [,,]. presents the mapping of stakeholders according to their role categorization. A more detailed table with a potential role description with regard to regulating health apps for self-management is presented in .
Table 2. Mapping of stakeholders according to their potential role with regard to regulating health apps for self-management.Stakeholder categoryList of stakeholdersRole categorizationA1: Government (health sector)Ministry of HealthaWHO: World Health Organization.
This paper presents the findings of a scoping review of regulatory standards and guidance for the use of health apps for self-management in sub-Saharan Africa. To the best of our knowledge, this is the first study that attempted to identify and assess the extent to which regulatory standards and guidance regulate and guide the use of health apps for self-management in sub-Saharan Africa as well as map out the key stakeholders and their potential roles.
Our findings reveal that only 1 country (Kenya) in sub-Saharan Africa currently has national regulatory standards that could potentially regulate the use of health apps for self-management. The included standards failed to adequately address adequate attention to inclusion and equitable access. This is concerning given the growing need to promote the adoption of culturally appropriate and relevant health apps and to ensure that they are available to those who need them regardless of gender, ethnicity, geographical location, or financial status [-]. Consequently, this review provides insights into the regulation of health apps for self-management in sub-Saharan Africa, which needs to be given more attention if the potential of these apps is to be harnessed in the region.
Principal FindingsWe identified 49 documents from 31 countries in sub-Saharan Africa. Although none of the included standards provided a specific set of regulations on health apps for self-management, we identified 3 standards [,,] that provided relevant information regarding the regulation of health apps. The included national policies and strategies, in contrast, only outline the goals and commitments made by national governments to promote the adoption of digital technologies in the health sector and the plans and paths set forth to achieve these goals. However, the information they provided was relevant for identifying and mapping digital health stakeholders who potentially have vital roles in regulating the use of health apps for self-management.
The policy analysis framework (content, context, process, and actors) [] was adapted and applied to organize the key findings. The content covered the following areas: guidance on systems quality; guidance on software and app development, acquisition, support, and maintenance; security measures for adequate protection of patients’ digital records; guidance on data exchange; interoperability as a basic requirement; minimum standards to enable integration; involvement and engagement of relevant stakeholders; and system attributes for equitable access to services. Meanwhile, the context was to address unsafe, isolated, and inconsistent implementation; to build mutual trust and maximize the benefits of eHealth information exchange; to address poor coordination, duplication of efforts, and inefficient use of resources; to promote the integration of ICT systems; and to promote inclusion and equitable access to services. The process involved the development process (which covers participatory and consultative processes and multisectoral approach, with reference to international standards and best practices) and the implementation process (which covers legal authority, coordination, capacity building, and monitoring and evaluation). The targeted actors were those who provided digital health services and those who used the ICT infrastructure of the MOH.
Furthermore, key stakeholders with potential roles in regulating health apps for self-management were identified. They include the government, regulatory bodies, funders, intergovernmental and nongovernmental organizations, academia, and the health care community.
Implications of the Study Findings for PracticeOverviewRegulatory standards and guidance act as a bridge between technological innovation and its safe and effective use in health care. They ensure that while technology continues to advance, the safety and trust of patients are never compromised. Among the plethora of health apps on the market, the over-the-counter, nonregulated apps such as wellness and fitness apps are the most mainstream [-]. On the other side of the spectrum, there are regulated health apps that are classified under medical devices or software as medical device products [,]. Some of these are prescription-only apps, such as digital therapeutics (DTx) apps for managing substance dependence [,].
Although some high-income countries have made significant strides in ensuring the safety, effectiveness, and accessibility of health apps, the journey has indeed not been without challenges and hurdles. Sub-Saharan Africa, although dealing with its own unique set of challenges, has the opportunity to learn from the experiences of these high-income countries. This could potentially allow the region to bypass some of the hurdles encountered by high-income countries in their journeys.
Technical and Clinical SafetyTechnical and clinical safety are essential requirements that health apps must meet before they can be considered for use for self-management to minimize the risk of harm to patients. It is well documented that health apps that function poorly pose a serious threat to the safety of patients. An example illustrating how health apps used for self-management can threaten patient safety is evident in a study []. This study [] revealed that widely used health apps designed to calculate and estimate insulin doses could endanger patients by providing incorrect or inappropriate dose recommendations. Similarly, 2 successive studies that assessed the contents and tools of apps for asthma discovered that none of the apps in the first study offered comprehensive information or adequate tools for asthma self-management, whereas the follow-up study, which was conducted 2 years later, showed a 2-fold increase in the number of asthma apps, yet there was no improvement in the content and tools offered by the newer apps. In fact, many apps recommended self-management procedures that were not supported by evidence [,]. Accordingly, some health apps that support the self-management of long-term conditions do not adhere to evidence-based guidelines and are unresponsive to the evolving health needs of patients.
Although the context of included regulatory standards with regard to technical and clinical safety was to address unsafe, isolated, and inconsistent implementation, the guidance provided by these regulatory standards is not specific to health apps, and they do not provide appropriate guidance and standards for health organizations and other key stakeholders to establish a framework for managing the clinical risks associated with deploying and implementing self-management health apps. Considering the rapid advancements in digital health (including artificial intelligence [AI] or machine learning and big data), health apps will increasingly play a crucial role in supporting self-management through digitally enabled care pathways that will improve personalized care and health outcomes [,]. Therefore, it is imperative to ensure the technical reliability and clinical safety of health apps for self-management through robust regulatory standards and guidance. For instance, a guide on the criteria for health app assessment, developed by the UK government, includes technical stability and clinical safety as criteria for deciding whether health apps should be considered for use in the National Health Service (NHS) []. In addition, medical device apps are required to conform to the NHS clinical risk management standards as part of the clinical safety requirements [,]. In the event of any concerns regarding the safety of a medical device app, the Yellow Card reporting system can be used by a responsible clinical safety officer or any other individual to notify the Medicines and Healthcare products Regulatory Agency (MHRA) [,].
Data Protection and SecurityTo adequately manage patient information when health apps are used for self-management, data protection and security standards and guidance are required. They guarantee that data are kept and handled safely and responsibly within the provisions of the law and that patients’ rights and interests are respected.
There have been ongoing concerns about compliance with ethical standards, the principles of confidentiality of information, and data privacy. For example, an assessment of apps that had previously been endorsed by the former UK NHS Apps Library revealed substantial gaps in compliance with data protection principles regarding the collection, storage, and transmission of personal information. This has raised a fundamental concern about the credibility of developer disclosures and whether these disclosures can be trusted by certification programs []. A study assessed the privacy practices of the 36 most popular apps for depression and smoking cessation for Android and iOS in the United States and Australia []. The findings revealed that although only 69% (25/36) of the apps included a privacy policy, 92% (33/36) of the apps shared data with a third party, and only 92% (23/25 with privacy policy) of the apps disclosed sharing data with a third party in their policy. Although 81% (29/36) of the apps shared data with Google and Facebook for the purposes of advertising, marketing, or analytics, only 43% (12/28) of the apps that shared data with Google and 50% (6/12) of the apps that shared
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