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.
Photography: Comstock, Digital Stock, Jim Shive Illustration: Paul A. Belci
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
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.
Table 1. Functions of 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.
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
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.