Use of Patient Level Data for Biomedical Research—Path to Interoperability
International Organization for Standardization (ISO) standard. In fact, at the time of writing, the next version of the EHR-FM is undergoing balloting by the ISO. Perhaps more importantly, the HL7 Reference Information Model (RIM) has served as an invaluable framework for enhancing interoperability and reuse of healthcare data. This is no more evident than in the notable achievements of the Biomedical Research Integrated Domain Group (BRIDG). This joint initiative, launched by members of HL7, CDISC, and the National Cancer Institute of the National Institutes of Health (NCI) in Bethesda, MD, has provided a model for exchanging data between healthcare and biomedical research systems.
The increasing application of HL7 specifications has been aided by a very active Genomics Work Group, which has provided new exchange schema and incorporated a growing body of technical requirements and terminology standards. In addition, the collaboration between CDISC and HL7 has advanced the understanding of global regulatory bodies responsible for the approval of drugs and biologicals. Although the CDISC specifications have been recognized by these agencies for electronic data submission, the application of HL7 technologies, particularly CDA, has been critical in the use of EHRs for primary source documentation. Despite the reluctance of some regulators to permit the direct utilization of EHR-derived data for clinical research, important regulatory barriers are being overcome.
In addition, CDISC and other organizations have promoted the use of CDA for data exchange to support pharmacovigilance and biosurveillance. After systematic de-identification, personal health data can be applied and reused for a broad range of solutions, including for public health programs and the design and identification of populations for clinical trials. In fact, data collected for primary patient care has been translated into post-approval studies in the biopharma industry as well as departments of health worldwide.
A number of key initiatives are under way to promote interoperability at this level of knowledge management. These efforts have been embraced in the North American countries, in which primary care data has been collected in English, French and Spanish. It is challenging to consider that the next steps will be embraced by the European countries that participate in the epSOS project, in which data from a multitude of languages must be expressed in a standardized, machine-readable format. Collateral efforts in several European countries are promising. Certainly the European and North American initiative for knowledge representation, the two year-old ARGOS eHealth pilot project, initiated by the European Institute for Health Records (EuroRec), has the potential to leverage key experiences and technical successes.
At the heart of data interoperability and reuse lies the fundamental requirement for collaboration. The many successful programs of the last few years give promise to the ultimate goal of healthier populations. ■
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