Use of Patient Level Data for Biomedical Research—Path to Interoperability

As our global population ages, two of the greatest challenges for healthcare are the improvement in quality and the reduction of costs. Our success in achieving this is predicated, in part, upon the ability of health systems to freely exchange data. More important, however, is the ability to reuse the data that we are amassing but are unable to aggregate or analyze, for which there is a growing demand.

There remains a profound gap between the need and the solutions. This gap is most critically found in the application of primary bench research for patient care. Equally problematic is our inability to use patient level information to inform clinical and preclinical research.

Obstacles to this process include the lack of interoperability between health information systems. Transfer of information to foundational research databases is non-existent. Of course, some obstacles are related to the inconsistency of structured vocabulary and terminologies. The various efforts to leverage ontological models have lagged behind.

Progress has been made in one significant area: the harmonization of data exchange utilizing standards developed by Health Level Seven International (HL7) and the Clinical Data Interchange Standards Consortium (CDISC). In the world of global healthcare standards, HL7 has provided a lingua franca for data exchange and interoperability in nearly forty countries. Over the past two decades, this growth of standardization has increased to include most of the English-speaking world and many non-English speaking European countries. In fact, the epSOS (Smart Open Services for European Patients) project of the European Union has embraced the HL7 CDA (Clinical Document Architecture) specifications for the exchange of clinical summaries and electronic prescriptions between nearly thirty countries.

The adoption of HL7 interoperability standards has been accelerated by the organizational-level collaboration with other standards development organizations, including the International Health Terminology Standards Development Organisation (IHTSDO) based in Copenhagen and the Regenstrief Institute in Indianapolis, IN.