Expanding HL7 FHIR to Support Chronic Disease Registries
This project develops a regulatory-compliant implementation of the Fast Health Interoperability Resources (FHIR) standard, enabling incorporation of clinical research data from a wide variety of sources, including patient-reported outcomes (PROs).
What are our goals for a regulatory-compliant implementation of FHIR?
Under the auspices of a collaborative project grant from the U.S. Food and Drug Administration (Expanding HL7 FHIR to support post-marketing research and surveillance within multi-source, chronic disease registries), the Registries + Informatics R&D Group at Boston Children's Hospital has developed and implemented a new FHIR Implementation Guide that focuses on:
- Incorporating data from various clinical research sources, including patient-reported outcomes (PRO) data, into 21 CFR Part 11 compliant workflows using FHIR
- Implementing a standardized approach within FHIR to query and validate auditable, reproducible data warehousing and interchange to support 21 CFR Part 11 compliant analyses for all phases of clinical research