The July 2018 FDA guidance titled Use of Electronic Health Record Data in Clinical Investigations (
https://www.fda.gov/media/97567/download) encourages the sponsors to use EHR data as a means of data collection during clinical trials as noted in the statement below.
"FDA encourages sponsors and clinical investigators to work with the entities that control the EHRs, such as health care organizations, to use EHRs and EDC systems that are interoperable. EHRs may be interoperable with EDC systems in a variety of ways depending on supportive technologies and standards. Interoperable technology may involve automated electronic transmission of relevant EHR data to the EDC system. For example, data elements originating in an EHR (e.g., demographics, vital signs, past medical history, past surgical history, social history, medications, adverse reactions) may automatically populate the eCRFs within an EDC system."
With this background there is a clear need to develop HL7 FHIR capabilities and an implementation guide for use of EHR data in this way.
An initial connectathon track in January 2021 explored collection of Concomitatant Medication data. Further tracks are planned to inform development of the IG.