HL7 finalizes standard for EHRs in clinical research

Health Level Seven has published the health IT industry's first ANSI-approved standard for using EHR information in clinical research. The standard--known as Electronic Health Record Clinical Research Functional Profile and based on the HL7 EHR System Functional Model Release 1--is a roadmap for integrating data to support both patient care and clinical research processes, the Ann Arbor, Mich.-based standards organization says.

The standard is the result of two years of work by representatives of the pharmaceutical, biotechnology, health IT, clinical research IT and regulatory community in the U.S. and Europe. "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 work flow and documented in EHR systems," says Donald Mon, vice president of practice leadership at the American Health Information Management Association and co-chair of the HL7 EHR Work Group.

HL7 says the standard is intended to complement the EHR-Clinical Research specification that the Health Information Technology Standards Panel is developing. It also will serve as a resource for the Clinical Research Work Group of the Certification Commission for Healthcare Information Technology, which is working to include clinical research criteria in CCHIT's EHR certification program.

To learn more:
- read this Health Data Management story
- see this HL7 press release (.pdf)