SMART Guidelines Starter Kit
2.1.0 - ci-build
SMART Guidelines Starter Kit
2.1.0 - ci-build
SMART Guidelines Starter Kit, published by WHO. This guide is not an authorized publication; it is the continuous build for version 2.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/WorldHealthOrganization/smart-ig-starter-kit/ and changes regularly. See the Directory of published versions
The current understanding is that in order for a digital health application/system to be considered L4 compliant, it should be L2 and L3 compliant. L4 compliance is designed to ensure that digital health applications align with WHO guidelines while balancing innovation and practicality. By complying with L2 and L3, L4 applications and software are able to integrate more seamlessly with evolving WHO standards and guidelines. WHO adopts a flexible compliance approach, providing standards for L2 and L3 while enabling self-attestation without formal prequalification or certification for software systems to be L4 compliant.
L3-compliant L4 applications can dynamically leverage and reuse existing L3 packages (e.g., ANC, Immunization), reducing development time and effort when WHO updates L1 normative guidelines.
L3 compliance enhances adherence to WHO guidelines by enabling the use of pre-developed, quality-assured code.
L3 compliance supports seamless integration across digital health systems, improving interoperability.
Many digital health systems are built on legacy software using traditional development approaches, where L2 serves as a Product Requirement Document (PRD) to guide system development, but such software may be unable to ingest L3 (any reference to FHIR?).
While these systems may lack the flexibility and extensibility of L3-compliant applications, they remain widely deployed and operational in various settings.
WHO provides L2 and L3 Standard Operating Procedures (SOPs) and requires the L4 community to self-attest their compliance with L2 and/or L3. However, WHO does not conduct prequalification or certification of software/digital health tools.
L3 compliance can be assessed through sandbox and test environments, with structured test plans currently under development.
SMART Guidelines — Standards-based, Machine-readable, Adaptive, Requirements-based, and Testable — are a comprehensive set of reusable digital health components. These include interoperability standards, code libraries, algorithms, and technical and operational specifications.
Definition: WHO guidelines are recommendations intended to inform decisions made by policy-makers, program managers, providers, recipients of health care, and other stakeholders. Recommendations may be for clinical interventions, public health activities, or government policies. These guidelines are rigorously developed through the WHO Guidelines Review Committee.
Key Outputs: Published narrative guidelines and recommendations.
How it is used by digital health tools: L1 serves as the foundational reference for public health practitioners and policymakers, informing the design and implementation of digital health tools. These digital health tools align with L1 to ensure evidence-based decision-making.
Definition: Human-readable, software-neutral documentation that systematically translates clinical and public health guidelines into structured requirements for digital health systems.
Key Output: Digital Adaptation Kit (DAK) – a structured business requirements document containing nine interlinked components described in the L2 SOP.
How it is used by digital health tools: L2 provides structured implementation guidance (Product Requirement Document) to software developers and system designers, enabling them to configure digital health applications leveraging WHO recommendations. It acts as a software-agnostic bridge between health policies and digital implementation/tools.
Definition: A structured, software-neutral representation of L2 content, including code, classifications, terminologies, and interoperability standards in a computable format.
Key Outputs: FHIR Implementation Guide (FHIR IG) – structured according to WHO’s SMART Guidelines machine-readable recommendations template.
How it is used by digital health tools: L3 provides computable logic and structured specifications that digital health systems use to automate processes. It defines system actors, transactions, computable data dictionaries, and indicators, enabling interoperability and seamless guideline updates within software applications.
Definition: Software applications capable of retrieving and executing algorithms based on interoperable digital components, implementing operational and functional requirements outlined in L2 (DAK) and/or L3 (Machine-readable recommendations).
Key Outputs: Software modules for clinical decision support, executable algorithms, and digital components.
How it is used by digital health tools: L4 enables data collection, processing, and exchange between different systems. It ensures interoperability with other SMART Guidelines-compliant tools, enhancing the ability to integrate and scale digital health solutions effectively.