Fast healthcare interoperability resources (FHIR) implementation guide creation process: scoping review

The Fast Healthcare Interoperability Resources (FHIR) standard is a global benchmark for digital health data exchange. Despite its widespread adoption, the scientific literature on the methodological processes for creating FHIR Implementation Guides (IGs) remains fragmented and lacks systematization.

This scoping review aims to synthesize the scientific literature on the process of developing FHIR IGs for electronic health records, identifying methodological steps, toolchains, governance patterns, and critical gaps that limit clinical adoption.

Following JBI and PRISMA-ScR guidelines, a comprehensive search was conducted across nine databases in August 2025. From an initial 5,552 records, eleven studies published between 2021 and 2025 were selected for analysis. Data extraction focused on development stages, team composition, authoring tools, and validation workflows.

The study identified a synthesized seven-step implementation lifecycle: requirements, modeling, terminology, narrative documentation, technical validation, clinical validation, and publication. A significant methodological shift toward "Infrastructure as Code" was observed, with frequent use of FHIR Shorthand (FSH) and Continuous Integration/Continuous Deployment (CI/CD) pipelines, particularly in European national initiatives. While technical validation was nearly universal (10 out of 11 studies), clinical validation was inconsistently addressed (7 out of 11 studies), often relegated to future work, resulting in IGs that are syntactically correct but insufficiently aligned with real-world clinical workflows. Narrative documentation, essential for non-technical stakeholders, was reported as comprehensive in only four studies, limiting broader clinical adoption. All studies reported multidisciplinary team involvement, confirming that IG development is fundamentally an exercise in clinical governance and consensus.

The creation of FHIR IGs has evolved into a complex discipline requiring a convergence of software engineering, clinical semantics, and institutional governance. This review advances beyond existing FHIR literature by providing the first systematic synthesis focused specifically on the IG creation process, presenting a replicable seven-step cycle that can guide implementers, researchers, and policy makers. Closing the gap between technical readiness and clinical applicability remains a critical challenge. Future research should prioritize ongoing clinical validation, the establishment of standardized reporting frameworks for IG development, and the integration of generative AI tools to enhance narrative documentation and terminology binding.