SMART on FHIR brings RWE to clinical trials
Clinical Trial Technology

How SMART on FHIR unlocks the power of real-world data for clinical trials

To say I’m ecstatic about the impact of SMART on FHIR on the usefulness of real-world data in clinical research is quite the understatement.

To put my enthusiasm in perspective, think Charlie Bucket getting one of five golden tickets to Willy Wonka’s Chocolate Factory, the Boston Red Sox beating the New York Yankees in 2004 and ending the ‘Curse of the Bambino’ and, much more recently, the Boston Celtics winning an improbable game six against the Miami Heat with a buzzer-beating putback and a final score of 104 to 103.

In short, SMART on Fast Healthcare Interoperability (FHIR) unlocks the power of real-world data (RWD). It improves the clinical workflow, enables clinical trials to integrate RWD in a non-disruptive way, and ultimately reduces burnout among clinical trial researchers.

These are the points I will be making at the DIA 2023 Global Annual Meeting in Boston, MA, June 25-29.

SMART on FHIR: DIA 2023 Global Annual Meeting

As you probably know, DIA 2023 is the largest global multidisciplinary event for life sciences professionals. Conference organizers expect 5,000+ global attendees and the top 30 biopharmaceutical companies to travel to Boston. In the words of the organizers, ‘DIA 2023 will bring industry, regulators, academics, and patients together to illuminate solutions to global and local challenges in the life sciences community, highlighting expertise from around the globe and creating opportunities to work collaboratively toward solutions.’

As you might imagine, I’m nearly as ecstatic that I was chosen to speak at DIA 2023.

My session, SMART on FHIR: Integrating Electronic Health Records as Real-World Data, on June 27 at 4:00 pm Eastern, will cover the input and output potentials when working with electronic health records (EHRs) for RWD decision making and the applicability of standards. I will be joined by:

  • Elise Berliner, Global Senior Principal for Real World Evidence Strategy, Cerner Enviza, who will share perspective on patient registries in the era of electronic health record (EHR) big data,
  • Dave deBronkart, “e-Patient Dave,” who is a patient advocate, cancer survivor and founding member of the HL7 FHIR Patient Empowerment Workgroup, the BMJ patient advisory panel and the Society for Participatory Medicine, and
  • Nicholas Rattenni, Senior Advisory Consultant, NNIT.

During the session, I plan to discuss:

  • My role as a steering committee member of the Vulcan Program, Health Level Seven’s (HL7) newest FHIR Accelerator,
  • The state of structured versus unstructured data and how it is evolving,
  • The clinical workflow and how to integrate RWD in a non-disruptive way, and
  • How SMART on FHIR is being used in conventional trials.

SMART on FHIR: Automated Source Data Capture

As we wrote in the playbook, Fast-tracking clinical trials with automated source data capture, SMART on FHIR apps mean “validating integrations can happen ahead of time. This maturity means SMART on FHIR technologies can be implemented in days, not months.”

The SMART on FHIR standards drive two key processes:

  • Authorization via SMART App Launch
  • Authorizes a user-facing client application (“App”) to connect to a FHIR Server.
  • Allows for “launch context” such as currently selected patient to be shared with the app, based on a user’s session inside an EHR or other health data software.
  • Allows for delegation of a user’s permissions to the app itself.
  • Data sharing facilitated by FHIR Resources
  • FHIR® – Fast Healthcare Interoperability Resources (
  • FHIR combines the best features of HL7’s v2, HL7 v3 and CDA while leveraging the latest web standards and applying a tight focus on implementation.
  • FHIR solutions are built from a set of modular components called “Resources.”
  • CMS Interoperability and Patient Access final rule presented guidelines that require most public payer entities and healthcare organizations to adopt standards.

SMART on FHIR: Auto-Populate eCRFs on Study Day One

The OpenClinica Unite EHR integration is built on Part 11-compliant electronic data capture (EDC), has traceability to source (data originator, data element identifiers per FDA 2018 EHR guidance) and synchronizes data and builds reconciliation workflows per trial needs.

In other words, OpenClinica Unite automates source data acquisition from patient medical record systems (EHRs) to clinical trial research databases (EDCs) and case report forms (eCRFs) to view study data safely, accurately and efficiently. This secure bridge between healthcare and research eliminates manual data transcription and is especially suited for rigorous GCP and Part 11-compliant clinical trials.

That means you can auto-populate eCRFs on study day one with OpenClinica Unite.

Join me at DIA Global 2023 to learn how SMART on FHIR enables you to auto-populate eCRFs on study day one.

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