1.1. Background

Digital health, or the use of digital technologies for health, has become a salient field of practice for employing routine and innovative forms of information and communications technology (ICT) to address health needs. The term digital health is rooted in eHealth, which is defined as “the use of information and communications technology in support of health and health-related fields” (1). Mobile health (mHealth) is a subset of eHealth and is defined as “the use of mobile wireless technologies for public health” (2,3). More recently, the term digital health was introduced as “…a term encompassing eHealth (which includes mHealth), as well as emerging areas, such as the use of advanced computing sciences in ‘big data’, genomics and artificial intelligence” (3,4).

Digital health has attracted substantial interest from the medical and public health community, most notably in low- and middle-income countries, where mobile communication has opened a new channel for overcoming geographical inaccessibility of health care. Over a thousand digital health deployments have been recorded since 2008 (5), representing a fraction of the uses of digital health that may exist but are not formally documented. Governments, donors and multilateral institutions have also recognized the potentially transformative role of digital technologies for health system strengthening. In a joint document published in 2015, the World Bank Group, the United States Agency for International Development (USAID) and the World Health Organization (WHO) advocated the “use of the digital revolution to scale up health interventions and engage civil society” (6).

The World Health Assembly Resolution on Digital Health unanimously approved by Member States in May 2018 demonstrated a collective recognition of the value of digital technologies to contribute to advancing universal health coverage (UHC) and other health aims of the Sustainable Development Goals (SDGs) (4). This resolution urged ministries of health

to assess their use of digital technologies for health […] and to prioritize, as appropriate, the development, evaluation, implementation, scale-up and greater use of digital technologies, as a means of promoting equitable, affordable and universal access to health for all, including the special needs of groups that are vulnerable in the context of digital health (4).

Furthermore, it tasked WHO with providing normative guidance in digital health, including “through the promotion of evidence-based digital health interventions” (4).

Amid all the heightened interest, digital health has also been characterized, however, by implementations being widely rolled out in the absence of careful examination of the evidence base on benefits and harms (7). The enthusiasm for digital health has also driven a proliferation of short-lived implementations and an overwhelming diversity of digital tools, with a limited understanding of their impact on health systems and people’s well-being. This concern was highlighted most notably in the consensus statement of the WHO Bellagio eHealth Evaluation Group, which opened by stating: “To improve health and reduce health inequalities, rigorous evaluation of eHealth is necessary to generate evidence and promote the appropriate integration and use of technologies” (8). While recognizing the innovative role that digital technologies can play in strengthening the health system, there is an equally important need to evaluate their contributing effect to ensure that such investments do not inappropriately divert resources from alternative, non-digital approaches.

1.2. Role of digital health in health system strengthening and universal health coverage

UHC aims to ensure the quality, accessibility and affordability of health services. However, shortfalls remain in ensuring access to all who need health services and in ensuring that they are delivered with the intended quality without causing financial hardship to the people accessing them (9). The Tanahashi framework published by WHO in 1978 provides a time-tested model of understanding health system performance gaps and how they prevent the intended coverage, quality and affordability of health services to individuals (10). This cascading model illustrates how health systems lose performance because of challenges at successive levels, each dependent on the previous level. Health system challenges – such as geographical inaccessibility, low demand for services, delayed provision of care, low adherence to clinical protocols and costs to individuals/patients – contribute to incremental losses in health system performance that cumulatively impact on the health of individuals. These shortfalls limit the ability to close the gaps in coverage, quality and affordability, and undermine the potential to achieve UHC (Figure 1.1).

Figure 1.1

Layers of UHC achievement affected by health system performance. This adapted Tanahashi (10) model illustrates that each health system performance layer builds on the components below it but also falls short (dotted lines) of the optimal, desired level. (more...)

To deliver effective and affordable coverage of health services to all, this guideline extends the conceptual foundation of the Tanahashi framework, as follows (11).

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Accountability – Accountability coverage represents the proportion of people in the target population (registered a subset of the total population) in the health system (for example, through civil registration and vital statistics mechanisms, population censuses, the issuance of national or health identifiers), which importantly establishes the different population denominators of health care provision.

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Supply comprises the availability of commodities and equipment, of human resources and of health facilities, and facilitates access to appropriate services with qualified health workers in geographically accessible health facilities, where and when patients need them. Even where health services are available, there may be barriers to accessing them for target populations.

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Demand – driving demand and increasing access can ensure that gaps in contact coverage (i.e. the gap between the total availability of services and the actual contact that individuals have with facilities, health workers and services) do not further undermine health system performance. Individuals often need multiple interactions and follow-up with the health system for health interventions to be effective, and continuous coverage defines the extent to which the full course of the interventions is achieved.

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Quality is related to effective coverage and can be undermined by gaps that that result when health interventions are delivered suboptimally, such as when health workers do not abide by treatment protocols.

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Affordability – direct and indirect costs to the patient can have catastrophic financial effects. Efforts made to ensure individuals are protected from impoverishment due to health interventions are reflected in the affordability layer as improved financial coverage.

Digital technologies introduce novel opportunities to address health system challenges, and thereby offer the potential to enhance the coverage and quality of health practices and services (Figure 1.2) (11,12). Digital health interventions may be used, for example, to facilitate targeted communications to individuals through reminders and health promotion messaging in order to stimulate demand for services and broaden access to health information. Digital health interventions may also be targeted to health workers to give them more immediate access to clinical protocols through, for example, decision-support mechanisms or telemedicine consultations with other health workers.

Figure 1.2

Digital health interventions to overcome health system challenges.

A digital health intervention is defined here as a discrete functionality of digital technology that is applied to achieve health objectives (13). The range of digital health interventions is broad, and the software and technologies – digital applications – that make it possible to deliver these digital interventions continue to evolve within the inherently dynamic nature of the field. A starting point for categorizing the different digital health interventions being used to overcome defined health system challenges is provided by WHO’s Classification of digital health interventions v1.0 (13), summarized in Figure 1.3.

Figure 1.3

Examples of how digital health interventions may address health system challenges, implemented through ICT systems. As an example, digital applications and ICT systems (such as logistics management information systems) are implemented and apply digital (more...)

Lastly, digital health interventions are applied within a country context and a health system, and their implementation is made possible by a number of factors (Figure 1.4). These include: (i) the health domain area and associated content; (ii) the digital intervention itself (i.e. the functionality provided); (iii) the hardware, software and communication channels for delivering the digital health intervention; and mediated within (iv) a foundational layer of the ICT and enabling environment, characterized by the country infrastructure, leadership and governance, strategy and investment, legislation and policy compliance, workforce, standards and interoperability, and common services and other applications.

Figure 1.4

Components of digital health implementations.

1.3. Objectives of this guideline

This guideline responds to the 2018 World Health Assembly Resolution on Digital Health, requesting WHO to provide Member States with normative guidance to inform the adoption of evidence-based digital health interventions. Within the Resolution, Member States specifically request:

… that WHO builds on its strengths, by developing guidance for digital health, including, but not limited to, health data protection and usage, on the basis of its existing guidelines and successful examples from global, regional and national programmes, including through the identification and promotion of best practices, such as evidence-based digital health interventions and standards (4).

The key aim of this guideline is to present recommendations based on a critical evaluation of the evidence on emerging digital health interventions that are contributing to health system improvements, including an assessment of the benefits, harms, acceptability, feasibility, resource use and equity considerations. For the purposes of the guideline, the recommendations examine the extent to which digital health interventions available via mobile devices are able to address health system challenges at different layers of coverage along the pathway to UHC. By reviewing the evidence of different digital interventions, as well as assessing the risks against comparative options, this guideline aims to equip health policy-makers and other stakeholders with recommendations and implementation considerations for making informed investments into digital health interventions.

This guideline urges readers to recognize that digital health interventions are not a substitute for functioning health systems, and that there are significant limitations to what digital health is able to address. Digital health interventions should complement and enhance health system functions through mechanisms such as accelerating exchange of information. However, digital health will not replace the fundamental components needed by health systems such as the health workforce, financing, leadership and governance, and access to essential medicines (14). An understanding of what health system challenges can realistically be addressed by digital technologies, along with an assessment of the ecosystem’s ability to absorb such digital interventions, is needed to inform investments in digital health.

This guideline reviewed the following interventions:

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birth notification via mobile devices

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death notification via mobile devices

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stock notification and commodity management via mobile devices across all health conditions

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client¹-to-provider telemedicine across all health conditions

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provider-to-provider telemedicine across all health conditions

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targeted client communication (TCC) via mobile devices (spread across five population groups for sexual, reproductive, maternal, newborn, child and adolescent health [SRMNCAH])

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health worker decision support via mobile devices across all health conditions

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digital tracking of patients’/clients’ health status and services via mobile devices across all health conditions

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provision of training to health workers via mobile devices (mLearning) across all health conditions.

1.4. Target audience

The primary target audience for this guideline is decision-makers in ministries of health and public health practitioners, to aid them to develop a better understanding of which digital health interventions have an evidence base to address health system needs. This guideline may also prove beneficial to organizations that invest resources into digital health systems as implementation and development partners. This document aims to strengthen evidence-based decision-making on digital approaches by governments and partner institutions, encouraging the mainstreaming and institutionalization of effective digital interventions within supportive digital systems.

1.5. Linkages with other WHO resources

WHO has published several resources on digital health, yet to date has not released normative guidelines detailing recommendations about which digital health interventions are supported by demonstrable evidence for addressing specific health system challenges.

Several WHO clinical and public health guidelines have been developed that include recommendations for digital technologies alongside other interventions, such as medication adherence and supporting community health workers. These include:

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2016 Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection (15)

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2017 update of Guidelines for treatment of drug-susceptible tuberculosis and patient care (16)

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2018 WHO guideline on health policy and system support to optimize community health worker programmes (17).

Within these examples, digital health interventions are embedded as part of a package of recommended options. This guideline, by contrast, will make explicit recommendations on the added value of specific digital interventions while also including the recommendations of those previous WHO guidelines, where relevant.

Other WHO resources on digital health, detailed below, include the National eHealth Strategy Toolkit published jointly with the International Telecommunication Union (ITU), reports from the Global Observatory for eHealth, the Classification of digital health interventions v1.0, the Digital Health Atlas and the Be He@lthy, Be Mobile initiative.

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The WHO/ITU National eHealth Strategy Toolkit is a foundational resource to guide policy-makers at ministries of health in establishing national eHealth/digital health strategies, which are necessary for national governance and a supportive ecosystem for digital health (18).

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The WHO Global Observatory for eHealth reports are based on periodic surveys conducted among Member States on their use of eHealth. The most recent eHealth report was in 2016 and featured survey responses from 125 countries (1). A similar report focused on mHealth was conducted in 2011 (2).

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The WHO Classification of digital health interventions v1.0 provides a shared language to describe the uses of digital technology for health, specifying discrete digital capabilities applicable to clients, health workers, health system managers, and data services (13).

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The WHO Digital Health Atlas is a website-based technology registry for systematically tracking national and subnational digital health activities, in order to equip governments, technologists, implementers and donors to better coordinate implementations, monitor their functionality and geographical growth, and establish gaps against which to collaboratively target investments (19).

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The Be He@lthy, Be Mobile initiative represents a collaboration between WHO and ITU to harness mobile technologies for communication on noncommunicable disease (NCD) risk factors (20).

1.6. Context and the enabling environment

The maturity of the ecosystem, comprising the enabling and ICT environments, has a critical influence on the relevance and impact of the recommended digital health interventions. The enabling environment is defined as the attitudes, actions, policies and practices that support the effective and efficient functioning of organizations and programmes. For digital health, this includes factors such as the leadership, governance mechanisms, regulatory and policy frameworks, strategy and financial investment, workforce capacity, standards and interoperability, and sociocultural considerations – as articulated within the pillars of the WHO/ITU eHealth Strategy Toolkit (18). The ICT environment consists of the infrastructure and the mechanisms for executing the digital health intervention, such as the hardware and digital applications.

There is considerable value in assessing the ecosystem in a given context or country, reviewing health system needs and tempering expectations and plans for adoption of different interventions based on the ICT and enabling environments available within a setting. In the absence of a robust enabling environment, there is the risk of a proliferation of unconnected systems and a severe impact on the effectiveness and sustainability of digital tools. To help assess ecosystem readiness and the maturity of the ecosystem, several resources exist, including the WHO Score assessment tool (21), MEASURE Evaluation’s Health Information Systems Interoperability Maturity Toolkit (22), the Partnership for Maternal, Newborn and Child Health’s ICT planning workbook (23) and the Global Digital Health Index (24).

As with any introduction of innovations and new approaches, digital health interventions require changes in behaviour and transitions to new practices. One example is moving away from entrenched paper-based systems to digital approaches. Implementations will succeed only if the digital health intervention is taken up by users, adds value, and facilitates the desired change or action. As such, implementers must be aware of the motivations, barriers and resistance to the disruption of the status quo that may affect the fidelity of deployment and understand that this will temper the possible benefit of digital health interventions.

The adoption of the recommendations in this guideline should not exclude or jeopardize the provision of quality health services in places where there is no access to the digital interventions, or because they are not acceptable or affordable for target communities. Additionally, in contexts where the ecosystem may not be mature enough to accommodate specific digital health interventions, there should be a focus on strengthening the health system and addressing gaps in the enabling environment to facilitate the implementation of these recommendations in the future.

1.7. Linkages to the broader digital health architecture

Digital health interventions are intended to integrate with and fit into an overall digital health architecture. The digital health architecture provides an overview or blueprint to describe how different digital applications (software and ICT systems) and related functionalities would interact with each other within a given context (25). While the unit of analysis for this guideline focuses on the value of specific digital interventions, there is an equally important need to support a cohesive approach to implementation, in which different digital interventions can operate together, rather than as duplicative and isolated implementations. Stakeholders will benefit from a thorough review of guidance found in the following complementary sources.

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The WHO/ITU National eHealth Strategy Toolkit (18) gives government agencies a framework and methods for developing a national eHealth vision, an action plan and a monitoring framework – critical elements for establishing an enabling environment.

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The ITU Digital Health Platform Handbook: Building a Digital Information Infrastructure (Infostructure) for Health (25) provides guidance for ensuring investments into digital health systems are systematically planned as part of an enterprise architecture that establishes core systems (such as health management information systems, logistics management information systems and electronic medical records) and common functionalities (such as registries, data exchange, terminology services) that are interoperable and reusable across different health programme areas.

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The Principles for Digital Development (26) are nine living concepts designed to help implementers integrate established best practices into digital programmes, facilitate the avoidance of common pitfalls and encourage the adoption of approaches that have demonstrated value over time. These include principles of designing with users, understanding the ecosystem, reuse of and improvement upon existing digital solutions, and addressing privacy and security concerns.

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The Principles of Donor Alignment for Digital Health (27) offer ministries of health the tools to hold signatory donors and technical partners accountable for making investments in digital health that align in a coordinated way with the national digital health strategies that support national health strategies. This document also calls for a heightened focus on architecture, standards, investment frameworks, privacy protection and detailed operational and monitoring plans.

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The forthcoming WHO Planning and Costing Guide for Digital Interventions for Health Programmes serves as an implementation guide for ministries of health to operationalize these recommendations into a costed plan for their health programmes. The Guide provides a systematic approach to assessing health system gaps and needs, a stepwise approach to identifying appropriate digital health interventions within the digital ecosystem, and the planning tools for costing implementation, which are appropriate within and across health programme areas within a ministry of health.

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Resources available from Integrating the Healthcare Enterprise (IHE) (28), including standards-based tools and services (resources) to improve the way digital systems in health care function and interoperate, to support patient and population care.

Communities of practice focused on strengthening capacity and digital health implementation through knowledge-sharing and coordination include (in alphabetical order):

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African Alliance of Digital Health Networks (African Alliance) (29)

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Asia eHealth Information Network (AeHIN) (30)

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Global Digital Health Network (31)

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Health Data Collaborative, Digital Health and Interoperability Working Group (32)

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Open Health Information Exchange (OpenHIE community of practice) (33).

1.8. Living guidelines approach

This guideline includes recommendations on a list of prioritized digital health interventions accessible via mobile devices, representing a subset of a much larger set of digital interventions. This guideline aims to incorporate a broader set of emerging digital health interventions gradually in subsequent versions. The WHO Classification of digital health interventions v1.0 (13), provides a starting point to tackle the evolving nature of digital health and to identify interventions for future inclusion in updated guidelines. This version applies WHO Guidelines Review Committee procedures (34) to a priority list of emerging digital innovations, while also acknowledging that future guideline versions will need to incorporate the evidence for additional digital health interventions. This approach to updating WHO guidelines is known as “living guidelines”.

The living guidelines approach also facilitates the updating of existing recommendations as new evidence becomes available and the inclusion of additional health domains that might not have been reflected in this initial release. For example, the evidence and recommendations for the digital health intervention of targeted client communication (TCC) was restricted to specific health areas and a subsequent version of the guideline will expand on this area to include the use of TCC for noncommunicable diseases. Chapter 6 (Disseminating and updating the guideline) also details the living guidelines approach for updating and broadening the set of digital health interventions falling under a WHO guideline development process.

Footnotes

1

Although WHO’s Classification of digital health interventions v1.0 uses the term “client” (13), the terms “individual” and “patient” may be used interchangeably, where appropriate.