Ann Arbor, Mich.-based HL7 says it has published the healthcare industry’s first ANSI (American National Standards Institute)-approved standard that specifies the functional requirements for regulated clinical research in an electronic health record system.
The organization says the EHR Clinical Research Functional Profile defines high-level requirements critical for using electronic health record 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.
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.