Health Level Seven, which sets standards for healthcare information technology, has published a standard for clinical research in an electronic health record system.

The standard, which specifies the functional requirements for regulated clinical research in an EHR, has been approved by the American National Standards Institute (ANSI).

The HL7 EHR Clinical Research Functional Profile for EHR systems is based upon the HL7 EHR Work Group's EHR System Functional Model Release 1, which is also an ANSI-approved American national standard.

The new profile defines requirements for using EHR data for regulated clinical research and provides a guide for integrating the information environment to support both the patient care and the downstream clinical research processes.

"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, co-chairman of the HL7 EHR Work Group and member of the HL7 Board of Directors.

Pharmaceutical, biotechnology, clinical research technology and healthcare technology vendors worked with federal regulatory stakeholders from the United States and the European Union for two years to identify and address data protection, regulatory and ethical research requirements.

The profile is also a resource for the Certification Commission for Healthcare Information Technology (CCHIT) Clinical Research Work Group as it defines new clinical research certification criteria for EHR systems. It will be complemented by the EHR-clinical research interoperability specification now being developed by the Health Information Technology Standards Panel (HITSP).

The Clinical Data Interchange Standards Consortium "is pleased to be a collaborator and to contribute clinical research standards and eSource Data Interchange concepts towards these initiatives," said Rebecca Kush, president and CEO of the CDISC. "The ultimate goal is to accelerate the pace at which research informs healthcare for the benefit of patients and this functional profile contributes to the achievement of that goal."

HL7 is a nonprofit, ANSI-accredited standards development organization, with members in 57 countries.