Product EHR CR FP

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Product Brief - HL7 EHR Clinical Research Functional Profile (EHR CR FP)

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Product Name

Electronic Health Record Systems - Clinical Research Functional Profile(EHR CR FP)

Standard Category

Application Functional Specifications

Type

Normative, ANSI Standard

Releases

  • ANSI/HL7 EHR CRFP, R1-2009

Summary

The EHR/CR Functional Profile is intended to provide high-level requirements necessary for using electronic health record data for regulated clinical research, and to further provide a roadmap towards an evolutionary process of integrating the environment that provides both patient care and data for clinical research. This functional profile is aimed at encouraging EHR vendors to incorporate functions into their products that are necessary to utilize the Electronic Health Records 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.

Description

See http://xreg2.nist.gov:8080/ehrsRegistry/faces/view/detailFunctionalProfile.jsp?id=urn:uuid:03566bec-e0d5-448e-b373-9c1dea409f79

Business Case (Intended Use, Customers)

  • Clinical research institutions and system vendors seeking certification under CCHIT and EUROREC for certifying EHR systems.

Benefits

The EHR Clinical Research profile will identify EHR functions such that:

  • 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.

Implementations/ Case Studies (Actual Users)

Co-sponsors:

  • eClinical Forum
  • Pharmaceutical Research and Manufacturers of America (PhRMA)
  • Electronic Data Capture (EDC)/eSource Task Force

Resources

  • For more information on the EHR-S FM and the HL7 Electronic Health Records Work Group, please visit: www.HL7.org/ehr.

Work Groups

Education

Presentations

From HIMSS 2009

Relationship to/Dependencies on, other standards

EHR-S FM

Links to projects in development

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