Challenge: Interoperability between Healthcare and Clinical Research
For years now, researchers have dreamed of accessing the data held within electronic health records (EHRs) and using it for research purposes. And site investigators, who provide the data, have dreamed of a solution that eliminates double data entry of research data.
The CDISC Healthcare Link project began in 2005 and focuses on the mission of interoperability between healthcare (the EHR) and clinical research. The roots of the Healthcare Link project come from the collaborative work of a preceding initiative-- the eSDI project, an FDA-CDISC project to encourage the use of eSource data (e.g. EHRs) in regulated clinical research, leveraging CDISC standards.
Solution: Integration Standards to connect disparate systems and data
The solution is here. CDISC and IHE (Integrating the Healthcare Enterprise) have created the inaugural working link between EHRs and clinical research systems. This groundbreaking approach uses the CDISC/IHE developed integration profile, Retrieve Form for Data-capture profile (RFD), along with CDISC standards to collect relevant data from the electronic health record for critical secondary uses such as Safety Reporting (and Biosurveillance), Clinical Research, and Disease Registries. Reaching through to the EHR in this way to pull key data of interest to clinical research that is already existing in the EHR creates system interoperability and improves data quality and most importantly timeliness of data sharing (key in safety reporting) while alleviating the Investigator site from supporting and entering data in to multiple redundant (from the investigator’s perspective) data collection tools for the purpose of the secondary uses.
This integration creates the first ‘sticky parts’ that connect healthcare and clinical research data workflow.
IHE Retrieve Form for Data Capture Profile
Case Studies
RFD has also been useful in debunking both the overly facile illusions of turnkey access to EHR data, and the overly pessimistic view that such access is twenty years off.
The case study work completed thus far by the Healthlink Initiative falls into two primary areas: interoperability demonstrations and production pilot implementations. We anticipate that the efforts made thus far by the Healthcare link Initiative will provide a foundation for the harmonization of standards between EHRs and clinical research-- and will support a new value case that was prioritized through an ANSI workgroup recently convened for this purpose.
Interoperability Demonstrations
RFD has been through a number of live Interoperability demos at HIMSS07, HIMSS08, CDISC International Interchange and most recently at the 2009 DIA Annual in San Diego.
HIMSS Flyer 2007
HIMSS Flyer 2008
DIA Flyer 2009
CDISC received a letter of endorsement from EHRA (the Electronic Health Record Association) in 2008 for the development work with IHE and the resulting RDF integration profile.
Futures
RFD will soon be augmented by additional IHE profiles to form an ever growing toolkit.
Contact
For information or inquiries, please contact CDISC Healthcare Link Program Manager, Landen Bain.
