What is Healthcare Link?
The opportunity to streamline research by leveraging standards and eSource (i.e., entering data electronically at the site/source) has been a CDISC goal since CDISC was initiated in 1997. The Healthcare Link Initiative began more ‘officially’ in ~2004 with a change in the CDISC Mission Statement to include a reference to healthcare and the development of the BRIDG Model, a domain analysis model for clinical research developed collaboratively with CDISC, NCI, HL7 and FDA to harmonize CDISC standards and form a ‘bridge’ to healthcare standards.
Since that time, progress has been made through the development of synergistic standards (CDISC, IHE, HL7, ISO) and integration profiles (workflow enablers) to make it possible to use electronic health records (EHRs) more efficiently and effectively for a number of use cases, including population of registries, safety surveillance, public health and clinical research. The U.S. FDA Commissioner is encouraging Evidence Generation and bringing the parallel universes together and the Japan Agency for Medical Research and Development is funding projects to accelerate progress in this area. The commitment to link research with healthcare remains one of the three CDISC Strategic Goals. (Read more here and see below for information on Current Healthcare Link projects).
Healthcare Link Goals
The overarching goals for CDISC Healthcare Link are to:
• Make it easier for physicians to conduct clinical research
• Collect data only once in an industry standard format for multiple downstream uses
• Improve data quality and patient safety
Healthcare Link Standards and Products
Healthcare Link products to date 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 documents that have either emanated from the CDISC Healthcare Link initiative and/or were published by EMA and FDA encouraging the use of EHRs or eSource for research in more recent years are the following:
• EMA Reflection Guide
• EHRA Endorsement Letter
• FDA eSource Guidance
• Press Release about FDA FR Notice
• Pending – FDA EHR Guidance (once FDA reviews comments on this draft)
• FDA Commissioner Blogs on Evidence Generation
See also 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 becoming the European Institute For Innovation through Health Data (I~HD) and the Learning Health Community (LHC: www.learninghealth.org).
Current Healthcare Link Projects
Use of EHRs for Regulated Research
CDISC is working with interested parties to demonstrate the value of eSource and provide concrete examples of how it can be implemented.
Unlocking the value of registries using RFD and FHIR: CDISC is partnering with the American College of Cardiology and with Duke University to investigate and plan a new design using RFD and FHIR, which will allow for an open-sourced solution to improve site workflow and maintain quality of data for registries.
Hospital Corporation of America (HCA) and CDISC are partnering to demonstrate and eSource project as part of FDA’s request for demonstration projects to use eSource in a regulated setting.
Biopharma: CDISC is partnering with several biopharma companies to demonstrate eSource solutions in a regulated environment. These specific projects will be listed as they reach the appropriate level of maturity.
eSource Stakeholders Group
CDISC has initiated the eSource Stakeholders Group (http://www.cdisc.org/CDISC-eSource-Stakeholders-Convene), an open, inclusive forum that focuses on and coordinates the increasing community of stakeholders interested in realizing the benefits of leveraging eSource in clinical trials and meeting regulatory requirements for eSource data to bring healthcare and clinical research together.
• 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 Head of Digital Healthcare