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Published on: February 19, 2021
Fast healthcare interoperability resources (FHIR) implementation guide creation process: scoping review.
Vanessa Pereira Corrêa Rampinelli1, Ranieri Alves Dos Santos1, Ianka Cristina Celuppi1
1Bridge Laboratory, Federal University of Santa Catarina (UFSC), Florianópolis, Brazil.
International Journal of Medical Informatics
|June 20, 2026
Summary
Developing Fast Healthcare Interoperability Resources (FHIR) Implementation Guides (IGs) involves a seven-step cycle. Improving clinical validation and narrative documentation is crucial for broader adoption of these essential digital health tools.
Area of Science:
- Digital Health Standards
- Health Informatics
- Software Engineering in Healthcare
Background:
- Fast Healthcare Interoperability Resources (FHIR) is a global standard for digital health data exchange.
- Existing literature on creating FHIR Implementation Guides (IGs) lacks systematization.
Purpose of the Study:
- To synthesize the scientific literature on developing FHIR IGs for electronic health records.
- Identify methodological steps, toolchains, governance patterns, and gaps limiting clinical adoption.
Main Methods:
- Scoping review following JBI and PRISMA-ScR guidelines.
- Searched nine databases; analyzed eleven studies (2021-2025).
- Focused on development stages, team composition, authoring tools, and validation workflows.
Main Results:
- Synthesized a seven-step IG lifecycle: requirements, modeling, terminology, narrative documentation, technical validation, clinical validation, and publication.
- Observed a shift towards "Infrastructure as Code" using FHIR Shorthand (FSH) and CI/CD pipelines.
- Technical validation was common, but clinical validation and comprehensive narrative documentation were inconsistent, hindering clinical adoption.
Conclusions:
- FHIR IG creation is a complex discipline merging software engineering, clinical semantics, and governance.
- This review provides a systematic, replicable seven-step cycle for FHIR IG development.
- Addressing the gap between technical readiness and clinical applicability, particularly through enhanced clinical validation and documentation, is critical.
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