Section 1b: EHR - Electronic Health Records
HL7 EHR Clinical Research Functional Profile (CRFP), Release 1
The EHR Clinical Research Functional Profile (EHR CR FP) provides high-level functional requirements necessary for using electronic health record (EHR) data for regulated clinical research. It also provides a roadmap towards an evolutionary process of integrating the environment that provides both patient care and data for clinical research. This functional profile encourages EHR vendors to incorporate functions into their products that are necessary to utilize the EHRs as a direct data source for clinical studies. It is intended to provide one overall view of the regulatory needs of clinical research with respect to electronic patient records.
HL7 EHR Clinical Research Functional Profile (CRFP), Release 1 may also go by the following names or acronyms:
- National Institute of Standards and Technology (NIST) along with its accredited certification bodies (ACB) use EHR functional profiles such as the CR FP as a basis for certifying EHR systems
- Clinical research institutions and system vendors seeking certification under ACBs and the European Institute for Health Records (EUROREC) for certifying EHR systems
- Electronic healthcare systems, when used to collect source data for clinical research, can supply regulatory authorities with proof that data used to support claims made regarding the safety and efficacy of new medicines can be traced back to a 'reliable' data source
- Clinical research through the use of EHRs is optimized for clinics and hospitals, allowing new therapies to be available to patients in the shortest time at the lowest cost
- eClinical Forum
- Pharmaceutical Research and Manufacturers of America (PhRMA)
- Electronic Data Capture (EDC)/eSource Task Force
The HL7 International EHR System Functional Model (EHR-S FM) outlines important features and functions that should be contained in an EHR system. The function list is described from a user perspective with the intent to enable consistent expression of system functionality. This EHRS Functional Model, through the creation of Functional Profiles for care settings and realms, enables a standardized description and common understanding of functions sought or available in a given setting (e.g., intensive care, cardiology, office practice in one country and primary care in another country.
The Clinical Research Functional Profile is just one of several functional profiles created by HL7 International and can be downloaded from the HL7 website (www.HL7.org).
- Regulated Studies
RESPONSIBLE WORK GROUP
- Functional Profile