There is great focus on how EHRs will change the face of medicine, but what about clinical research? It’s important to understand how EHRs may be used in research, and how this interoperability will stand to meet clinical research requirements and regulations. Health Level Seven (HL7), the global authority for interoperability and standards in healthcare IT, has published the first American National Standards Institute (ANSI) approved profile that specifies the functional requirements for regulated clinical research in an electronic health record system.

Pharmaceutical, biotechnology, clinical research technology vendor, healthcare technology vendor, and federal regulatory stakeholders from the United States and the European Union collaborated for two years to identify and address a broad list of data protection, regulatory and ethical research requirements. They developed the first EHR system functional requirements standard for clinical research to help safely and securely integrate electronic health information to support both patient care and clinical research processes.

 The profile will be complemented by the EHR-Clinical Research interoperability specification being developed by the U.S. Health Information Technology Standards Panel. The standards also provide a resource for the Certification Commission for Healthcare Information Technology as it defines new clinical research certification criteria for EHRs.

Interoperability is a major issue in health IT. Clinical research could greatly benefit from aggregation of EHR data, but the EHR system must first be able to extract pertinent clinical research data; second, compile it into a useful manner for clinical research; and third, maintain the standards of ethics, privacy and security set forth by clinical research regulations.