Towards achieving semantic interoperability of clinical study data with FHIR

Area of Science:

• Health Informatics
• Clinical Research Data Management
• Interoperability Standards

Background:

• Observational clinical studies are crucial for medical advancement and patient care.
• Sharing and comparing study results is vital for evidence-based medicine but hindered by current data management limitations.
• Effective sharing of clinical research data is essential to reduce costs and advance healthcare.

Purpose of the Study:

• To propose a clinical study architecture for enhanced communication and contextual understanding of clinical data.
• To address limitations in current clinical research data sharing approaches.
• To facilitate unambiguous interpretation of clinical study data.

Main Methods:

• Mapping clinical data from Clinical Data Interchange Standards Consortium Operational Data Model (ODM) to Fast Healthcare Interoperable Resources (FHIR).
• Proposing two FHIR-based models for capturing clinical study metadata and data.
• Evaluating the strengths and weaknesses of the ODM to FHIR mapping approach.

Main Results:

• Proposed FHIR resources effectively enrich ODM data semantically.
• FHIR models preserve data organization while capturing essential context.
• FHIR can natively manage clinical data, improving data traversal and querying through multi-level links.

Conclusions:

• The proposed FHIR-based approach enhances semantic interoperability of clinical study data.
• Improved data exchange efficiency allows clinicians to focus more on decision-making and evidence-based practices.
• This architecture facilitates more effective data exchange, supporting the advancement of evidence-based medicine.