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Monday, June 25 • 11:00am - 12:15pm
#110: Using Fast Healthcare Interoperability Resources (FHIR®) for Clinical Research

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Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-523-L04-P; CME 1.25; IACET 1.25; RN 1.25

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 Objectives

Discuss the basics of FHIR APIs, how they support goals of 21st Century Cures, and what FHIR can do for a variety of research-related use cases; Describe how experienced implementers worked with FHIR, and how the FHIR community is working to achieve interoperability among providers, investigators, researchers and patients.


Wayne R. Kubick, MBA


Fast Healthcare Interoperability Resources: An Evolving Data Standard for Interoperability in the Life Sciences Industry
Kunal Dubey, MBA

eSource and FHIR: The TransCelerate Experience
Jesper Kjaer, MS

avatar for Kunal Dubey

Kunal Dubey

Healthcare Consultant, Citius Tech Healthcare Technology
Kunal has worked in Healthcare IT sector for over 7 years. Over the course, he has advised leading pharmaceutical and clinical trial companies on data integration, analysis and interoperability. Kunal has worked with leading IT companies as a consultant helping their clients map technologies... Read More →

Jesper Kjaer

Director, DM Process and Innovation, Novo Nordisk A/S
Director for Data Management Process and Innovation at Novo Nordisk A/S. MSc in bioinformatics and computer science. Driving new ways of working agile in data management. Implementation of automation, eSource and robotics. Co-lead for TransCelerate Biopharma Inc eSource workstream... Read More →
avatar for Wayne Kubick

Wayne Kubick

Chief Technology Officer, HL7 International
Mr. Kubick is CTO for Health Level Seven International, intent on improving clinical research through technology and data standards. He was formerly CTO and a Board member for CDISC, and has 2+ decades in a variety of leadership roles in clinical R&D with BBN, Parexel International... Read More →

Monday June 25, 2018 11:00am - 12:15pm EDT
Room 208 Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  03: Data-Data Standards, Session