¹Universitätsmedizin Greifswald, Klinik für Anästhesie, Intensiv-, Notfall- und Schmerzmedizin, Greifswald, Germany
²2 Core Unit Digital Medicine and Interoperability, Berlin Institute of Health at Charité – Universitätsmedizin Berlin, Berlin, Germany
³Howto Health GmbH, Berlin, Germany
⁴Association of the Scientific Medical Societies' Institute for Medical Knowledge-Management at Philipps-University, Marburg, Germany
⁵Core Unit Digital Medicine and Interoperability, Berlin Institute of Health at Charité – Universitätsmedizin Berlin, Berlin, Germany

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Introduction: Clinical guidelines are essential tools for evidence-based healthcare. Traditionally, these guidelines are disseminated in text-based documents, limiting their integration into digital health systems and their use for automated clinical decision support and quality management. In Germany, the Association of the Scientific Medical Societies (AWMF) oversees guideline publication via its registry. To support digital transformation, the AWMF initiated the Dissolve-E project, aiming to enhance the FAIR principles of findability, accessibility, interoperability and reusability [1] in its guideline registry. Central to this effort is the development of structured guideline representations to support interoperability across clinical and research infrastructures.

State of the art: Internationally, efforts have been made to represent guidelines in machine-readable formats using standards like Fast Healthcare Interoperability Resources (FHIR®) [2], [3], [4]. Earlier approaches like GLIF and GEM pioneered structured guideline models but pre-date FHIR and lack native integration with current standards [5]. EBMonFHIR provides a framework for modeling guideline content, metadata, and evidence linkage. However, practical implementations remain rare. Challenges in operationalizing these standards include supporting varying levels of guideline representation, from semi-structured text to fully computable formats, and integration into registry workflows.

Concept: The Dissolve-E project, funded by the Federal Joint Committee (Gemeinsamer Bundesausschuss, G-BA; Grant 01VSF23021), seeks to transform the AWMF guideline registry into a digital, interoperable system aligned with international health information standards. This transformation encompasses several key objectives, forming the basis for the FHIR-based guideline model:

1. Digital Structuring and Interoperability: Defining a machine-readable format for clinical guidelines, enabling their integration with electronic health data, clinical decision support systems, and other digital platforms, supporting multiple levels of knowledge representation, from text-based to computable forms.
2. Governance and Infrastructure: Developing the technical foundation to support maintenance, authoring workflows, quality assurance, and version control.
3. Evaluation: Assessing usability, accessibility, and impact of the digital registry through a before-and-after comparison, based on initial requirements analysis, using surveys, focus groups, and selected use cases.

Implementation: Requirements for the digital guideline registry were gathered using stakeholder interviews, focus groups, and workshops to identify the needs of guideline developers, users, and registry operators. Based on these requirements, we developed a FHIR implementation guide with profiles and extensions tailored to the registry’s needs, building on EBMonFHIR and aligned with other initiatives. Collaboration with domain experts ensured that the FHIR profiles accurately reflect the methodology and structure of clinical guidelines. Existing registry entries are converted to FHIR instances, focusing on consistent semantic and syntactic representation. The implementation guide will be published on the AWMF website (https://fhir.awmf.org).

Lessons learned: Several insights emerged during implementation: Content standardization requires clear governance and close collaboration with guideline authors, as aligning with structured formats may require adjustments to established editorial workflows. Alignment with existing initiatives demands iterative refinement and active stakeholder engagement. While technical and syntactic interoperability was achieved, ensuring semantic interoperability requires ongoing collaboration between clinicians, informaticians, and standards organizations.

Dissolve-E demonstrates that transitioning to FHIR-based digital guidelines is technically feasible and beneficial for clinical knowledge dissemination. However, continuous engagement, training, evaluation and refinement are essential to fully realize their benefits.

The authors declare that they have no competing interests.

The authors declare that an ethics committee vote is not required.

Literatur

[1] Wilkinson MD, Dumontier M, Aalbersberg IJ, Appleton G, Axton M, Baak A, et al. The FAIR Guiding Principles for scientific data management and stewardship. Sci Data. 2016 Mar 15;3(1):160018.
[2] Alper B, Mayer M, Shahin K, Richardson J, Schilling L, Tristan M, et al. Achieving evidence interoperability in the computer age: setting evidence on FHIR. BMJ Evid-Based Med. 2019 Jul 1;24(Suppl 1):A15–A15.
[3] Lichtner G, Alper BS, Jurth C, Spies C, Boeker M, Meerpohl JJ, et al. Representation of evidence-based clinical practice guideline recommendations on FHIR. J Biomed Inform. 2023 Mar 1;139:104305.
[4] Mehl G, Tunçalp Ö, Ratanaprayul N, Tamrat T, Barreix M, Lowrance D, et al. WHO SMART guidelines: optimising country-level use of guideline recommendations in the digital age. Lancet Digit Health. 2021 Apr 1;3(4):e213–6.
[5] Peleg M, Haug P. Guidelines and workflow models. In: Greenes RA, Del Fiol G, editors. Clinical Decision Support and Beyond. Elsevier; 2023. p. 309–48.