Health Level Seven (HL7), the non-profit standards development organization, has published the health care industry’s first American National Standards Institute (ANSI)-approved standard that specifies the functional requirements for regulated clinical research in an electronic health record system (EHR-S). The HL7 EHR Clinical Research Functional Profile for EHR systems is based on the HL7 Work Group’s EHR System Functional Model Release 1, which is also an ANSI-approved American National Standard.
The EHR Clinical Research Functional Profile defines high-level requirements critical for using EHR data for regulated clinical research, and provides a roadmap for integrating the information environment that must support both the patient care and the downstream clinical research processes, according to HL7.
“This profile is an excellent demonstration of how important functional requirements for secondary data use, such as clinical research, can be integrated into the patient care workflow and documented in EHR systems,” said Donald Mon, PhD, co-chair of the HL7 EHR Work Group and member of the HL7 board of directors. Pharmaceutical, biotechnology, clinical research technology vendors, health care technology vendors 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.
The EHR Clinical Research Functional Profile is also a resource for the Certification Commission for Healthcare Information Technology (CCHIT) Clinical Research Work Group as they define new clinical research certification criteria for EHR systems. This functional profile will be complemented by the EHR-Clinical Research Interoperability specification currently being developed by the Health Information Technology Standards Panel.
