HL7 announced yesterday that is 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 (EHR-S). 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 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. Pharmaceutical, biotechnology, clinical research technology vendor, healthcare technology vendor, and federal regulatory stakeholders from the United States and the European Union collaborated for two years to identify and address a broad list of data protection, regulatory and ethical research requirements.
To see the full press release, please click here.
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