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Difference between revisions of "Product EHR CR FP"

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==Product Brief - HL7 EHR Clinical Research Functional Profile (EHR CR FP)==
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=Product Brief - HL7 EHR Clinical Research Functional Profile (EHR CR FP)=
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Electronic Health Record Systems - Clinical Research Functional Profile
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__TOC__
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back to [[Main_Page]]<br/>back to [[Product_List]]
 
back to [[Main_Page]]<br/>back to [[Product_List]]
 
===Product Name===
 
===Product Name===
 
Electronic Health Record Systems - Clinical Research Functional Profile(EHR CR FP)
 
Electronic Health Record Systems - Clinical Research Functional Profile(EHR CR FP)
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===Topics===
 
===Topics===
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===Standard Category===
 
===Standard Category===
 
Application Functional Specifications
 
Application Functional Specifications
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===Integration Paradigm===
 
===Integration Paradigm===
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===Type===
 
===Type===
 
Normative, ANSI Standard
 
Normative, ANSI Standard
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===Summary===
 
===Summary===
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The healthcare industry will reap tremendous benefits by adopting a common standard for electronic health record systems (EHR-S). The HL7 EHR-S Functional Model outlines important features and functions that should be contained in an EHR system. Through the creation of functional profiles, this model provides a standard description and common understanding of functions for healthcare settings. To date, HL7 has developed or is developing profiles for areas such as child health, emergency care, long term care, behavioral health and vital statistic reporting.
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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===
 
===Description===
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In February 2007, the HL7 Electronic Record Health System Functional Model (EHR-S FM) became the healthcare industry’s first ANSI-approved standard that specifies the functional requirements for an electronic health record
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See http://xreg2.nist.gov:8080/ehrsRegistry/faces/view/detailFunctionalProfile.jsp?id=urn:uuid:03566bec-e0d5-448e-b373-9c1dea409f79
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system (EHR-S). The standard has received broad industry input from more than a thousand clinicians, as well as from EHR vendors, payers, researchers, and others across the industry.
 
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The EHR-S FM outlines important features and functions that should be contained in an EHR system.
 
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The standard’s Functional Model contains approximately 1,000 conformance criteria across 130 functions, including medication history, problem lists, orders, clinical decision support, and those supporting privacy and security. The functions are described from a user perspective and enable consistent expression of EHR system functionality, while the conformance criteria serves as a reference for purchasers of EHR systems and vendors developing EHR software.
 
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To date, a number of profiles have been developed. 
 
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*The Electronic Health Record (EHR)/Clinical Research (CR) Profile provides high-level requirements necessary for using electronic health record data for regulated clinical research, as well as a roadmap for integrating the data collection for both patient care and clinical research (“collect once, re-purpose many times.”). This functional profile encourages EHR vendors to incorporate functions into their products so that electronic health records can be a direct data source for clinical studies as appropriate. This profile was approved as an ANSI standard in January 2009.
 
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For those thinking about creating a profile, the How to Guide for Creating Functional Profiles is available on the Work Group’s Functional Profile webpage (www.Hl7.org/ehr). In addition, the HL7 EHR Work Group is available to provide further guidance.
 
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Any functional profile that conforms to the EHR System Functional Model standard can be registered with HL7. This registration involves self-attestation of conformance by those submitting the functional profile for registration via a questionnaire that is completed at submission time. Registration can facilitate the adoption of the profile by making it publicly available for use. All registered profiles are available to the public through a searchable registry at: http://www.nist.gov/profileregistry.
 
  
 
===Business Case (Intended Use, Customers)===
 
===Business Case (Intended Use, Customers)===
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*
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*Clinical research institutions and system vendors seeking certification under CCHIT and EUROREC for certifying EHR systems.
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*
 
 
===Benefits===
 
===Benefits===
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*
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The EHR Clinical Research profile will identify EHR functions such that:
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*
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*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.
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*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.
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===Implementations/ Case Studies (Actual Users)===
 
===Implementations/ Case Studies (Actual Users)===
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*
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Co-sponsors:
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*
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*eClinical Forum
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*Pharmaceutical Research and Manufacturers of America (PhRMA)
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*Electronic Data Capture (EDC)/eSource Task Force
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===Resources===
 
===Resources===
 
*For more information on the EHR-S FM and the HL7 Electronic Health Records Work Group, please visit: www.HL7.org/ehr.
 
*For more information on the EHR-S FM and the HL7 Electronic Health Records Work Group, please visit: www.HL7.org/ehr.
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====Education====
 
====Education====
 
* See more at http://www.hl7.org/implement/training.cfm
 
* See more at http://www.hl7.org/implement/training.cfm
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<!--
 
=====Certification Available=====
 
=====Certification Available=====
 
*none
 
*none
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====Presentations====
 
====Presentations====
 
From HIMSS 2009 <br/>
 
From HIMSS 2009 <br/>
 
* [http://www.hl7.org/documentcenter/public/calendarofevents/himss/2009/presentations/HL7_EHR_2009_HIMSS_presentation1_Sunday.pdf EHR-S FM and Standard]
 
* [http://www.hl7.org/documentcenter/public/calendarofevents/himss/2009/presentations/HL7_EHR_2009_HIMSS_presentation1_Sunday.pdf EHR-S FM and Standard]
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===Relationship to/Dependencies on, other standards===
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EHR-S FM
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====Links to projects in development====
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none

Revision as of 17:05, 11 November 2009

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

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back to Product_List

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

none

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