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.