When an EHR system is implemented, it is frequently customized for the users, meaning that even record systems developed by the same vendor could collect the same information in different ways for different institutions, according to lead author Rebecca D. Kush, PhD, from the Clinical Data Interchange Standards Consortium (CDISC) in Austin, Texas, and colleagues.
“Without the use of common vocabularies, it is impossible not only for a given hospital's computer system to understand a patient record from another hospital, but also for researchers to compare data across organizations or to collect sufficient data to make informed decisions,” the authors noted.
The researchers also pointed out that the “FDA houses the largest repository of clinical research information in the world, and cannot efficiently compare pharmaceutical products of the same class: many of the data exist only on paper or in numerous different electronic formats that cannot be readily integrated into a single database.”
The authors stressed the need for data standards in healthcare and medical research that can permit data to be integrated and analyzed into data sets, and are able to inform valid decision making, so that “healthcare benefits from adequate research information.”
Kush and colleagues mentioned the efforts of Health Level 7 (HL7), which devises standards for the exchange of healthcare information, and the Clinical Data Interchange Standards Consortium (CDISC), which develops standards for medical research data. In 2001, CDISC and HL7 began to harmonize their standards.
Together, the agencies have developed a structured way of describing and documenting the information requirements of medical research through the Biomedical Research Integrated Domain Group (BRIDG) model. The BRIDG model can be used to represent the domain of medical research in work being done on healthcare standards so that the systems supporting healthcare and those supporting research will ideally speak the same language, according to the authors.
CDISC has also been working with HL7, the FDA, and Integrating the Healthcare Enterprise (IHE). IHE is an initiative that would make it easier for physicians to conduct medical research while practicing medicine. It would make it possible for data to be entered only once and then be used for multiple downstream purposes such as reporting adverse events and conducting clinical research.
The authors suggest that the IHE initiative will help promote the global registration of clinical trials.
However hard these initiatives are working towards standardization, obstacles still exist. “One stumbling block is that many organizations developed proprietary formats before industry standards were available, and changing over from an existing system is never easy,” the authors noted.
However difficult the path to EHR adoption remains, the ultimate goal “is to facilitate the translation of innovations from research into the daily practice of medicine in ways that enhance the quality of care and the safety of patients,” the authors concluded.