Using Fast Healthcare Interoperability Resources (FHIR®) for Clinical Research
Wayne R. Kubick, MBA
Chief Technology Officer
HL7 International, United States
While healthcare is rapidly adapting to the digital era, the basic systems and processes for conducting clinical studies to assess new medical treatments are still based on the legacy of a separate, paper-based, parallel process. EDC helped, but still was based on collecting data in a separate, siloed process disconnected from general healthcare practices. Given the priorities of the FDA to incorporate real-world evidence from EHRs as eSource, coupled with industry pressure to reduce cost and time to market while reducing the burden on sites, the emergence and adoption of HL7 FHIR as a universal standard API that can make healthcare data readily available in a standard format for research purposes provides a provocative lever for reimagining research.
This session will examine the current state, readiness, and opportunities for applying FHIR to dramatically transform the research process.
Learning Objective : Describe a novel interoperability standard “Fast Healthcare Interoperability Resources” (FHIR) in the area of electronic data capture at source, real world evidence, personalized care treatment and digital clinical trials. Discuss challenges and benefits of adopting such a standard in the life sciences industry.
Fast Health Care Interoperability Resources: An Evolving Data Standard for Interoperability in the Life Sciences Industry
Kunal Dubey, MBA
Citius Tech Healthcare Technology Pvt. Ltd., India
eSource and FHIR: The TransCelerate Experience
Jesper Kjaer, MS
Novo Nordisk A/S, Denmark