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Section 1c: FHIR®
Section 2: Clinical and Administrative Domains
Section 3: Implementation Guides

HL7 FHIR® Implementation Guide: Retrieval of Real World Data for Clinical Research, Release 1

DESCRIPTION

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.

 

See the specification at http://hl7.org/fhir/uv/vulcan-rwd/STU1

ALTERNATIVE NAMES

HL7 FHIR® Implementation Guide: Retrieval of Real World Data for Clinical Research, Release 1 may also go by the following names or acronyms:

"HL7 FHIR® IG: Retrieval of Real World Data for Clinical Research, R1",RWD

BENEFITS

  • Enables the clinical data collected for support of clinical care of patients and knowledge for their healthcare providers to be used for a secondary purpose of supporting clinical research to analyze the data and generating supporting evidence 
  • Demonstrates how HL7 FHIR can directly support clinical research and regulatory uses.

RELATED DOCUMENTS

HL7 FHIR® Implementation Guide: Retrieval of Real World Data for Clinical Research, Release 1

STU DOCUMENTS

HL7 FHIR® Implementation Guide: Retrieval of Real World Data for Clinical Research, Release 1 See the standard at http://hl7.org/fhir/uv/vulcan-rwd/STU1. (Submit Feedback on STU)

ADDITIONAL DETAILS

The primary purpose for EHR 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. This project intends to demonstrate how HL7 FHIR can directly support clinical research and regulatory uses.

TOPIC

  • Regulated Studies

BALLOT TYPE

  • STU

STATUS DATE

2022-05-26

RESPONSIBLE WORK GROUP

Biomedical Research and Regulation

PRODUCT TYPE

  • Implementation Guide

STAKEHOLDERS

  • EHR, PHR Vendors
  • Local and State Departments of Health
  • Regulatory Agency

FAMILY

  • FHIR

CURRENT STATE

  • Active

REALM

  • Universal