Globally, many countries are transitioning from paper-based to digital health systems to achieve universal health coverage [1]. However, this process has not been without challenges. Digital ecosystems, in low- and middle-income countries, continue to be flooded with a multiplicity of digital tools [2]. It is also often difficult to ascertain the design process of these tools [3] and whether the underlying content is developed in accordance with the evolving clinical evidence base, protocols, and guidelines. This is largely due to the existing process of translating narrative guidelines into digital systems, which is often laborious, prone to error, and lacks accompanying technical documentation appropriate for digital use [4]. This results in disjointed digital health ecosystems with inadequate standards that hinder the quality of care, exchange of data, and reporting and hamper continuity of care [5]. To deliver sustainable digital health solutions for country impact, digital system development needs to be based on principles of transparency, accessibility, scalability, and interoperability [6]; be adherent to clinical guidelines [7] and data use and sharing standards; and be guided by national digital strategies.

To ensure an accurate reflection of guidance within digital systems, the World Health Organization (WHO) developed the SMART (Standards-based, Machine-readable, Adaptive, Requirements-based, and Testable) guideline approach, which includes Digital Adaptation Kits (DAKs) [6]. DAKs translate narrative guidelines into a format that informs the design of digital systems. They have been developed for health service areas such as antenatal care (ANC) [8], HIV [9], and family planning (FP) [10], with more health domains in the pipeline. DAKs are packaged as an operational guidance document (PDF) with four web annexes (Excel files): (1) core data elements/data dictionary, (2) decision support tables, (3) program indicator definitions, and (4) functional and nonfunctional requirements. They are structured into components, such as personas, workflows, data dictionaries, and decision-support logic [5], that are intended to be customized and adapted across diverse country digital and program landscapes and contexts. These include settings that already have established digital systems, as well as those that are preparing to transition from paper to digital systems.

Considering that SMART guidelines and DAKs are new concepts, it is important to establish defined processes to introduce, adapt, and integrate DAK content within countries’ existing digital ecosystems and programmatic landscapes. Drawing on experiences from 5 African countries (Ethiopia, Ghana, Malawi, Zambia, and Zimbabwe), we aim to develop and refine a replicable process for the country adaptation and implementation of DAKs. This will contribute to the creation of a framework that can be adapted by other countries, ensuring a consistent approach to digitalizing primary health care services. This article details the processes and lessons learned in developing a framework for the systematic implementation of DAKs within different country contexts.

The paper highlights the processes and lessons learned toward the development of a framework for the systematic implementation of DAKs within a country. The structured approach used to contextualize DAKs to national settings was conducted across 5 diverse programs and digital landscapes: Ethiopia, Ghana, Malawi, Zambia, and Zimbabwe.

The selected countries were part of a broader United Nations interagency initiative [11] to strengthen sexual and reproductive health and rights (SRHR) (Malawi, Zambia, and Zimbabwe), while Ethiopia and Ghana were positioned for implementation research leveraging this established process. Selected countries had prior significant digital investments, and the DAK country adaptation was conducted with the aim to enhance the following national digital systems: Bahmni (Ethiopia), eTracker (Ghana), Malawi Health Information System (Malawi), SmartCare (Zambia), and Impilo (Zimbabwe) in the respective countries.

For Malawi, Zambia, and Zimbabwe, this was part of WHO technical support, and there was no engagement with human subjects; therefore, ethics review was not required. Ghana and Ethiopia were part of an implementation research study that was approved by the WHO/Human Reproduction Program Research Project Review Panel, the WHO Ethical Review Committee (A66031), and the National Ethics Committee of the 2 countries (University of Gondar, Ethiopia Institutional Review Board [VP/RTT/05/752/2024] and Ghana Health Service Ethics Review Committee [GHS-ERC: 025/07/22]).

When first presenting the concept of SMART guidelines and DAKs, they were initially perceived as abstract materials, and stakeholders in the countries often requested an understanding of what the “end product” would look like. Stakeholders often expected a tangible digital tool and required extensive communication on how SMART guidelines-DAKs work to inform their existing digital systems as software-neutral resources. Furthermore, a reference software app reflecting DAK content was often demonstrated during the orientation to provide clarity on how the DAKs would eventually appear in a digital interface. Demonstrating this linkage between the data elements and decision support logic in the DAK (in spreadsheet form) and how they would appear on a digital platform/system can also help distinguish the DAKs from the software app (Table 2).

In addition, this orientation and socialization of the DAKs identified additional scenarios to support countries’ digital health journeys, such as informing assessments of existing digital systems and enabling a common reference standard, particularly in settings where there may be several electronic medical records systems, like Malawi. The DAKs were found to be clearly structured, with some MOHs proposing to adopt the DAK approach to document business processes. For example, in Zambia, this approach has been adopted and is currently being leveraged for other health domains. Additionally, engaging the system users in the adaptation processes will be essential to ensuring the adoption of the system (Table 2).

The overall content adaptation and validation process provided an opportunity for countries to collectively review their business requirements processes for standardizing content within their digital system. This was a new process for stakeholders, especially as some health program managers were not familiar with digital system design or requirements gathering. The review and validation process, which included respective DAK domain service providers, provided an opportunity for both digital and health literacy capacity building. Clinicians not only saw themselves providing service to clients through the review processes but also actively participated in the process of developing a digital module that they themselves would be using.

In preparing for the digital system content update, DAKs were found to be clearly structured, with some MOHs proposing to adopt the DAK approach to document business processes for other health domains and include it as part of their broader strategy to digitalizing SRH services at the primary health care level. Examples include Malawi and Zambia [17] where the ANC and FP DAKs have been integrated into the respective health domain guidelines and strategies. Decision support functionalities were found to be a valuable addition due to their potential to guide or remind clinicians of key clinical recommendations during the provision of care. This is especially important since most digital systems they were accustomed to focused heavily on data collection rather than person-centered care.

These initial experiences of introducing and implementing DAKs across 5 countries provide a foundation for developing a replicable, software-neutral integration process. Additionally, the findings will be important for informing not only the development of global DAKs but also how WHO and implementing agencies can support countries with their integration. The country assessment was critical across all sites for initiating conversations around digital systems, as well as for bringing stakeholders such as program managers on board. Additionally, the set-up of multistakeholder teams including the program, digital health leads, clinical informatics specialists, and clinicians was critical for driving the adaptation process forward. The structured format of DAKs facilitated a transparent process for content review and validation. Moreover, the collaboration across sectors, with the program and health domain experts leading ensured that the process was centered around the user—a critical component for system adoption [18,19].

The DAKs were initially viewed as “abstract” by stakeholders, and as software rather than health content due to limited engagement in the design of digital systems. The stakeholder consultations also provided opportunities for users to review existing systems and also appreciate existing gaps and propose how these could be enhanced with DAK content. The adaptation process revealed several layers of adaptation, and that multiple iterations would be required, including considerations around linkages with other components such as health management information systems. Some challenges included the large volume of DAK elements, which was initially overwhelming and time-consuming at the beginning of the review and content adaptation process. However, we learned that conducting preparatory steps, including guideline extraction and premapping, can help to optimize time and resources by first highlighting expected adaptations for stakeholder review (Table 2). Last, it is important to consider the different stages of digital maturity of a system; and the current strategic direction and priorities of the government during the introduction of DAKs at the country level (Table 2).

To integrate the DAKs within a country’s national health system, it is vital to align them with the broader national health strategic priorities and frameworks [20]. The examples highlighted above from Zambia and Malawi represent a great starting point for harmonization and integration into broader health strategic documents and plans. This ensures that DAKs are embedded as critical elements of the national strategy rather than being viewed as isolated initiatives—which can negatively affect their adoption at different levels of the health system (Table 2). It is, therefore, imperative that government stakeholders, particularly MOH program managers and health domain and digital health experts, actively advocate for and ensure the inclusion of these guidelines into national policies, during annual and midterm policy and health strategic reviews and planning. This will require strong leadership and coordination across relevant sectors.

As a guideline derivative product, DAKs can be used to accelerate guideline update processes by highlighting differences in global and national protocols (including reporting tools), particularly in settings where the narrative guidelines are not up-to-date (Table 2). The adaptation process can be useful for informing the updates for narrative guidelines and aligning to the latest WHO guidelines. However, the DAK itself cannot be a substitute for undergoing the formal process of updating national health program guidelines [12]. However, it will be important to also consider the current status of guideline uptake at the facility level. Conducting a site visit to a health facility, as part of the content review process, will not only enhance the DAK adaptation process by highlighting areas within the guideline content that require reinforcement but can also improve the uptake of the guidelines (Table 2).

When introducing DAKs within a country’s digital and program ecosystem, it is important to consider the modality for DAK implementation. This can be particularly challenging in settings where there have been prior digital investments that are disease-specific. Where the identified digital system might be used for certain health areas (eg, HIV), clinicians would already be used to these systems, leading to the underuse of other modules. Enhancing the “other” modules with the DAKs within such platforms would require adequate awareness and training to improve uptake and use. The localized DAK could act as the benchmark that all other digital systems adhere to if there are many digital systems with varying degrees of coverage and maturity. Moreover, showcasing the system during content adaptation sessions could be a helpful approach to increase understanding of the various digital modules within a point-of-care system. Additionally, implementation modalities should also consider engagement with private sector partners and subnational adaptations based on the program and digital landscape of the countries.

The strength of this paper is that it represents replicable processes that have been developed through firsthand learning from countries and offers a foundation that can undergo further refinement as new countries embark on the implementation of SMART guidelines, specifically DAKs. These learnings will be complemented through implementation research [21] and communities of practice, and culminate in the development of a living technical guidance to facilitate the effective uptake of DAKs. Some of the limitations and challenges, such as the intensive resources initially required, were due to the novelty of the approach and having limited prior reference in the implementation of SMART guidelines. Additionally, another limitation is the absence of detailed cost estimates for the DAK adaptation and implementation processes, as a systematic evaluation of costs was not included. Given the focus on methodological processes and the variability in country contexts, providing a comprehensive budget was not feasible at this stage. Furthermore, it is important to note that countries’ digital systems are dynamic and constantly changing. Despite DAKs being software agnostic, critical reflections are also needed on transitioning a package adapted for a legacy system to newer versions, while also introducing interoperability standards, such as Fast Healthcare Interoperability Resources (FHIR) [22].

Leveraging existing digital investments to reinforce evidence-based recommendations offers a sustainable pathway for institutionalizing WHO SMART guidelines-DAKs within health systems. However, to achieve this, a multifaceted approach will be necessary: strong digital health leadership and governance [23], along with coordination and strategic direction for digital investments, will be critical [21], particularly in countries where systems are still disease-specific [24]. Moreover, the collaboration between program leads, policy makers, and digital teams will also be vital, including engaging program managers and policy makers in system update training, continuous system monitoring and identification of “system champions” at the facility level. Further, plans for interoperability and data use standards will also need to be incorporated. These initial sets of country experiences offer insights into the requirements and opportunities to optimize the use of WHO SMART guidelines-DAKs as a tool for strengthening countries’ digital investments in a structured manner. This approach sets the foundation for a systematic approach to implementing DAKs and will be further refined through research to evaluate the resulting impact on service delivery outcomes and data flows [9]. Overall, standardizing a common approach to DAK implementation will be important to facilitate peer-to-peer exchange among countries, foster regional and global cooperation required for standards-based digital transformation, and ultimately optimize the impact of digital health systems for universal health coverage.