HL7 publishes requirements for EHR clinical research

Health Level Seven (HL7) has published an American National Standards Institute (ANSI)-approved document that specifies the functional requirements for regulated clinical research in an EHR.

The EHR Clinical Research Functional Profile defines high-level requirements 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.

The HL7 EHR Clinical Research Functional Profile for EHR systems is based on the HL7 EHR work group’s EHR System Functional Model Release 1. The requirements were the result of a collaboration among industry stakeholders in the U.S. and the European Union for two years, according to the Ann Arbor, Mich.-based organization.

The EHR Clinical Research Functional 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.

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