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Healthcare Link

What is Healthcare Link?

Healthcare Link is a CDISC initiative to collect relevant data from the electronic health record (EHR) or other health electronic systems for critical secondary uses, such as clinical research, safety reporting, bio-surveillance, and disease registries. 

To connect EHRs and research systems, technologies such as HL7 FHIR® resources coupled with CDISC Operational Data Model version 2.0 (ODM 2.0) specifications, an effort currently in prototype, or CDISC/IHE-developed integration profile Retrieve Form for Data Capture (RFD) and/or mobile RFD with CDISC data collection or organization standards are utilized.

Healthcare Link Goals

The goals of Healthcare Link include:
•    Making it easier for physicians to conduct clinical research
•    Collecting data only once in an industry standard format for multiple downstream uses
•    Improving data quality and patient safety

Healthcare Link Products

Healthcare Link products include an eSource Data Interchange (eSDI) Document citing 12 requirements for using eSource (including EHRs) for regulated research, a number of CDISC-IHE Healthcare Link integration profiles, a HITSP Interoperability Specification (#158), and a Healthcare Link User Guide

Relevant Documentation

Relevant documents that have come forth from the CDISC Healthcare Link initiative or were published by EMA and FDA encouraging the use of EHRs or eSource for research include the following:
•    EMA Reflection Guide
•    EHRA Endorsement Letter
•    FDA eSource Guidance
•    Press Release about FDA FR Notice
•    FDA EHR Guidance
•    FDA Commissioner Blogs on Evidence Generation

Please also see the HHS/ONC Interoperability Standards Advisory, which cites CDISC standards and CDISC-IHE Profiles.

CDISC has also worked with IMI on the EHR4CR Project, which is now the European Institute For Innovation through Health Data (I~HD) and the Learning Health Community.


•    eSDI Document
•    CDISC and IHE Linking Research Data Capture to Electronic Health Records
•    Connecting Clinical Research and Health Care — The Time Is Now!  by Joe Dustin and Landen Bain
•    EMA Reflection Paper on eSource
•    FDA eSource Guidance
•    HITSP IS # 158
•    Healthcare Link User Guide

For additional information or inquiries, please contact CDISC