Background

This is Vulcan Accelerator project.  

Real World Data can be considered data created in the “real world” of everyday experience, such as a routine patient visit to a healthcare provider, as opposed to data created under clearly defined protocols typical of controlled clinical trials.  The primary purpose for such data, collected for a purpose other than use in a clinical trial, is in support of clinical care of patients and knowledge for their healthcare providers.  However, large amounts of such information could potentially be used for the secondary purpose of supporting clinical research to analyze the data and generate supporting evidence for, as an example, a new indicated use for an already approved pharmaceutical drug or safety-related analyses. 

Many sources of RWD exist, but for the current phase of work, the scope of the track is firmly limited to the use of Electronic Health Record (EHR) systems as sources of RWD.  Additionally, broad use case is currently limited to the use of EHRs for retrospective analysis of data (to generate evidence for new indications, comparisons, and/or safely) and preparation of such data for submission to governmental regulatory bodies covering pharmaceutical approvals such as the United States Food and Drug Administration (FDA).  The use of EHRs as a mode of direct data collections for traditional prospective clinical trials (sometimes called “electronic source data” or “eSource” activities) is not currently in scope.  However, we consider it highly likely that types of solutions developed for eSource and for RWD will have significant overlap. 

Scope

This project aims to develop a FHIR Implementation Guide that defines FHIR profiles that can be used to retrieve relevant research data from Real World Data sources – specifically Electronic Health Record (EHR) systems - and ultimately transform that data into a format suitable for submission to pharmaceutical regulatory agencies. In addition this project also aims to demonstrate how HL7 FHIR can directly support clinical research and regulatory uses. Our intent is to be a Universal project and we will be looking at the International Patient Summary (IPS) project for a baseline dataset from which to build our profiles. The profiles built by this project will enhance the IPS profiles for the purposes of conveying data needed for clinical research.

PSS Link:   PSS-2008 - Getting issue details... STATUS

IG Build Site: http://build.fhir.org/ig/HL7/vulcan-rwd/index.html

Project Status

  • ACTIVE  (Status Date: 10/2022 )

Meetings

Tuesdays 11am Eastern

Zoom: https://hl7-org.zoom.us/j/95325319019?pwd=dHU0WG1tb0MzVTNpQWVzamVNUUtXdz09

FHIR Resources

Last Updated: 10/2022

This guide currently inherits from the International Patient Summary FHIR guide.  It reuses most of the profiles defined in that guide but does define new profiles for the following resources:

  • Condition
  • Encounter
  • MedicationAdministration
  • MedicationDispense
  • MedicationRequest
  • MedicationStatement
  • Observation (for Laboratory Results)
  • Procedure





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