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Historically, some longstanding challenges have hindered efforts to integrate patient data from EMRs (Electronic Medical Record systems) with EDC (Electronic Data Capture) systems.
Historically, some longstanding challenges have hindered efforts to integrate patient data from EMRs (Electronic Medical Record systems) with EDC (Electronic Data Capture) systems. A few of these challenges include the low adoption rates of EMRs in physician practices, a dearth of interoperability tools and standards to extract data from EMRs to EDC systems, All subjects of clinical studies not being part of the same health system and therefore same EMR, and the inability to map and translate the EMR data into CRFs (case report forms) of the EDC systems.
These real-world hurdles have a tendency to hamper earnest attempts to drive significant progress towards a system that will help streamline clinical trials and empower clinicians, subjects and everyone else involved to engage in a better way. However, recently an evolution has taken place that is allowing this integration to be implemented today.
EMR adoption rates in physician practices saw a slow but steady rise in the early 2000s. Although EMR had clear advantages, the high startup and software costs, unavoidable upheaval in their practices, and the costly conversion of historic paper records, conspired to keep EMR adoption low. Then came President Obama’s HITECH, which paid physicians to achieve “meaningful use” of EMR, causing an explosive growth in the market. This made vendors rush to improve their systems and hospitals to upgrade to newer versions of their systems. In the past few years both physician practices and hospitals have been rapidly adding or upgrading their EMR systems to be compliant with HITECH rules. In fact, according to Health Information Technology in The United States report conducted by Mathematica Policy Research and the Harvard School of Public Health, EMR adoption rates have soared from single digits to more than 60 percent.
One certification requirement of “meaningful use” is interoperability, which requires both the physician practice and hospital EMRs to be able to export and import patient medical records using a common, standardized format. The EMR industry first converged on using the Continuity of Care Document (CCD), which provided a “snapshot-in-time summary” of a patient’s health record. However, the C-CDA (Consolidated Clinical Document Architecture) emerged as a bigger container. This led the way for all EMRs to be able to import and export patient records in a standard format.
Following this, statewide Health Information Exchanges (HIEs) were created, as well as interstate exchanges with protocols, for the Nationwide Health Information Network (NHIN), which enabled seamless, secure data transport across state boarders. Then the Direct Project evolved as a subset of HIE functionality and facilitated point-to-point delivery of medical records over the existing standard internet using the equivalent of secure email technology for transport.
Laboratories use the Direct Project to send diagnostic results into an ordering physician’s EMR. Many vendors have come to offer solutions for Direct, including the certification process for registering the physicians, the physician directories of registered users and the secure messaging software tools. It is an inexpensive solution and enables physicians to collect their meaningful use incentive payments; Direct’s adoption rates are beginning to climb rapidly.
Despite the lack of government incentives that the EMR vendors had, the EDC industry has been gravitating towards more standards and interoperability. For example, data dictionaries are now being used to ensure fields inputted in CRFs are uniform and reusable. This enables mapping and translation of data being imported to and exported from the CRFs. Additionally, the use of standards has increased with new formats for Clinical Research Data Capture (CRD) using both CCD standards as well as CDASH (Clinical Data Acquisition standards Harmonization). EDC systems that support CDASH and reusable CRF libraries are well-positioned to accept or exchange patient data with EMRs.
Because of evolved technologies and new policies, it is now possible (and increasingly likely) that all U.S. clinical trial sites will reside in states with robust HIEs. As such, many of the physician practices and hospitals will have their EMRs integrated to the HIE and will be able to exchange data in standardized formats. Connecting additional systems to the HIE is straightforward. For those practices not participating in the HIE, their certified EMRs can deliver data via Direct Project protocols to other physicians and systems. This means it is likely that most, if not all, of the patients enrolled can have their existing and future medical records be part of the study.
With today’s modern EDC systems, data being captured in EMRs can easily be pulled into a clinical study, speeding the process of data capture and reducing errors. Electronic transaction logs make it simple to audit the source data, and data received into the CRFs is already coded (medications, immunizations, allergies, problems, procedures, diagnostic results, etc.) in standard formats so that it can be understood by the systems and actionable.
The challenges and hurdles of integrating EMR with EDC are falling by the wayside. New standards are emerging, costs are coming down and technologies are evolving, all of which will help ensure streamlined, accurate and more successful clinical trials.