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TREND 9: EHR-EDC Integration

There was a lot of buzz in 2011 on the promise of using data from electronic health records (EHR) to populate clinical trial databases, especially through integration with electronic data capture (EDC) systems. Adoption of EHR systems is on the rise, particularly in the US where the 2009 HITECH Act, part of the American Recovery and Investment Act 2009, requires the “meaningful use” of this technology with associated Medicare and Medicaid financial incentives.

In some ways, clinical trial data collection duplicates information already captured in the patient medical record. Finding a way to extract that data from the EHR to populate the clinical trial database would help sponsors get a jumpstart on data collection.

Unfortunately, although EHR data has great potential for the clinical trials industry, data model standardization is still evolving. Standards such as the Integrating the Health Enterprise (IHE) Retrieve Form for Data Capture (RFD) exist to enable simplified data transfer between EHR and EDC, as successfully demonstrated at the 2011 DIA Interoperability Showcase by Medidata with a variety of EHR vendors. Moving from demonstration to implementation, however, is a challenge requiring deeper coordination of the EHR and EDC system and navigation of security and privacy issues at the clinical sites.

The EHR system landscape also complicates matters. There are many EHR system vendors serving different types of users from large hospital systems down to the individual physician’s office. Although there are EHR vendors with large customer bases, clinical studies conducted across multiple sites are likely to include a wide variety of systems from different vendors.

2012 could be the year in which simple file upload solutions for loading of EHR data to EDC emerge. Data formats like the ASTM Continuity of Care Record (CCR) and HL7′s Continuity of Care Document (CCD) are supported by many EHR systems—and are part of RFD, which as mentioned above, has been successfully demonstrated to facilitate integration—and upload of these files to EDC systems would be relatively easy to achieve. Patient privacy and the import of identifying information would have to be carefully managed. This kind of approach falls far short of the promise of existing EHR/EDC coordination standards but would be a small step in unlocking the value of EHR data for clinical studies.

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