Integrating EHR with EDC: When Two Worlds Collide

Is the initiative to combine EHR and EDC the Holy Grail for clinical research or a tilt at windmills?
Mar 02, 2006

Photography: Comstock, Digital Stock, Jim Shive Illustration: Paul A. Belci
As acceptance of both electronic health records (EHR) and electronic data capture (EDC) becomes widespread, forward thinking clinicians and researchers have begun to consider the possibility of a single system to simultaneously collect both patient care and clinical research data. Data could be entered once at the bedside onto a single computer screen, where it would be available for both patient care and clinical research databases. This would improve workflow and efficiency at clinical research sites, eliminate errors from data transcription, eliminate the costly and time-consuming process of source data verification, and speed up the overall process of clinical trials.

Since the data and the methods of collection are similar or identical in the two processes, many assume that integration would be straightforward. However, few are familiar with the intricacies of both worlds, leading to simplified assumptions as well as schemas and timelines for integration that are very ambitious or unrealistic.

This paper will discuss some of the key obstacles in bringing EHR and EDC together, and will evaluate some of the proposed architectures for implementing an integration of the two.

Electronic health records

Table 1. Functions of EHR systems
It is challenging to draw conclusions about EHR systems as a whole because of the very wide range of functionality in different systems and the very diverse needs of different users (see Table 1). Although some systems have many of these functions, a single system may be targeted specifically to a particular area of functionality or even a specific function. Organizationally, solo practices, small group practices, large group practices, community hospitals, major hospitals, large hospital systems, and large health maintenance organizations have very different needs for EHR systems.

The EHR is much more common in European and other non-U.S. countries. In fact, physicians in countries such as Sweden and the Netherlands use the EHR for more than 80% of patient encounters.1 The lagging implementation of EHR in the United States is not because of a lack of available technology. The United States is hampered by a fragmented private health care system, where no central authority can dictate a single solution.

Furthermore, there are a plethora of potential solutions and vendors from which each autonomous practice or health care network can choose. A large institution may implement several different EHR systems, each for a different component of their need. Countries with governmentally managed health care systems, however, can require the use of particular EHR systems and can even dictate the common data dictionary and database structure to be used—allowing for a much more organized sharing of data within the system.

EHR vendors

Of the hundreds of vendors of EHR systems, dozens have significant sales in various segments of the EHR market (hospitals, large group practices, health maintenance organizations, and small practices). In large hospital systems, a handful of dominant vendors have emerged. Recently, consolidation is beginning to create vendors whose solutions operate in several different practice settings.

Although some of the systems are relatively modern, it is very common for commercial EHR systems to be built on older, specialized software languages for systems originating in the era of mainframe computers and minicomputers. These EHR systems may not incorporate modern information technology, including Web interfaces, the use of XML, or concepts such as Web services. Unfortunately, much of the interoperability between EHR systems and the potential for EHR/EDC integration would require the use of such tools.