EHR eSource: Sword of Change?


Applied Clinical Trials

Applied Clinical TrialsApplied Clinical Trials-06-01-2016
Volume 25
Issue 6

Recent FDA draft guidance pushes for the use of electronic health record data in clinical investigations-and synching EHRs with research systems.

Now that the era of digital health is upon us in the U.S. and other countries, it’s time for a fresh look at how we collect research data. What if we could make a great leap forward by completely changing our approach through electronic health record (EHR) eSource? Would we dare to try?

“Source” is the initial recording of data for a clinical study.  When the original recording is on digital media rather than paper, it’s “eSource.” Clinical trials have used eSource for years in ECG readings, lab results, and other measurements.  The FDA eSource Guidance describes different ways to transmit eSource data (from direct capture, devices, transcription, EHRs, or patient-reported outcome instruments) to an electronic case report form (eCRF) system, and several approaches have been proposed for trying to feed EHR data into our existing EDC-based processes. Last year the FDA even asked for demonstration projects to explore such approaches. 

But a more recent draft Guidance on Use of EHR Data in Clinical Investigations offers another take entirely with explicit goals to “facilitate the use of EHR data in clinical investigations” and to “promote the interoperability of EHRs” with clinical research systems.  The guidance recognizes that the ONC Health IT Certification Program can indicate the readiness of EHRs to support research. And ONC’s Advancing Care Information initiative relies heavily on leveraging application program interfaces (APIs) to make health data more timely and accessible to patients and caregivers.

This is where HL7’s FHIR platform standard comes in:

  • FHIR’s Data Access Framework will provide a universal API to EHR systems that can be used to populate much of a casebook in a clinical database. 

  • The Smart on FHIR specification demonstrates how patients can grant researchers access to their data through electronic informed consent, as well as input outcome data through smartphones and browsers-data that can be directed to an EHR or a trusted third-party cloud-based research repository simply by selecting the appropriate target FHIR server.

  • Since EHR data is eSource, FHIR can also provide authorized access to remote study monitors.

  • And since FHIR can update as well as read data, it can also support the processing of data clarification transactions, thus making it possible to synchronize EHR records with clinical databases, improving transparency and traceability for both monitors and regulatory inspectors.

  • FHIR makes it possible for regulatory reviewers to delve into the full EHR database to explore, for example, serious adverse events, in more depth than was ever possible before.

In the future, it may not be necessary to have an eCRF system in the middle of the process. That would enable using the EHR data directly to feed our analysis so that all health data could potentially be reused as research data. 


Wayne Kubick, is Chief Technology Officer, Health Level Seven International, and a member of Applied Clinical Trials’ Editorial Advisory Board 

Related Videos
Related Content
© 2024 MJH Life Sciences

All rights reserved.