June 15, 2009 HITSP Begins Harmonization Process for Use of Electronic Health Records in Clinical Research

The Healthcare Information Technology Standards Panel (HITSP), a cooperative partnership between the public and private sectors that works to ensure the interoperability of electronic health records (EHRs) in the United States, has begun work to identify global standards to support "core research data element exchange", specifically, a common set of information that can readily be exchanged between EHRs and clinical research systems.

As administrator of HITSP, the American National Standards Institute (ANSI) appreciatively acknowledges thirty-five organizations that have contributed their financial support to make this work effort possible, including:

BioClinica, formerly Phoenix Data Systems
Biogen Idec
Boehringer Ingelheim Pharmaceuticals, Inc.
Cleveland Clinical and Translational Science Collaborative at Case Western Reserve University
Case Western Reserve University
Cleveland Clinic
MetroHealth System
University Hospitals
Critical Path Institute
Deloitte Consulting LLP
Digital Infuzion
Duke University
Duke Comprehensive Cancer Center
Duke Clinical Research Institute
Eli Lilly and Company
Genentech, Inc.
Genetic Alliance
Greenway Medical Technologies
JSS Medical Research Inc.
McDougall Scientific Ltd.
Medidata Solutions Worldwide
Nextrials, Inc.
Numoda Corporation
Partners HealthCare
Perceptive Informatics, a subsidiary of PAREXEL International
PharmaNet Development Group, Inc.
Schering-Plough Research Institute
Target Health Inc.
"On behalf of ANSI, I thank these organizations for their generosity and forward thinking,"said Frances Schrotter, ANSI senior vice president and chief operating officer. "These contributions have made it possible for HITSP to begin working toward a sustainable, interoperable infrastructure through which healthcare advances clinical research and in turn informs clinical care."

In addition to the contributions from the clinical research community, six U.S. federal agencies have demonstrated their support, including the Eunice Kennedy Shriver National Institute of Child Health and Human Development, the National Cancer Institute, the National Center for Research Resources, the Office of the National Coordinator for Health Information Technology, the Department of Veterans Affairs, and the Assistant Secretary of Planning and Evaluation, Department of Health and Human Services.

The initiative began late last year when the U.S. Department of Health and Human Services (HHS) requested that ANSI convene a workgroup of experts to prioritize a value/use case for standards harmonization in this area. Co-chairs Dr. Rebecca Kush, president and CEO of the Clinical Data Interchange Standards Consortium (CDISC), and Dr. Gregory Downing, director of the Initiative on Personalized Health Care at the U.S. Department of Health and Human Services, are leading the workgroup effort. At an initial meeting in Washington, DC on November 10, 2008, the workgroup identified the need for a common set of information that can readily be exchanged between EHRs and clinical research systems to support research activities on a global scale.

With the initial priority "core research data element exchange" value case identified, HITSP convened a workgroup of technical experts and stakeholders in the clinical research space on June 9-11, 2009, in Arlington, Virginia. The final goal is to produce a streamlined electronic standards implementation guide that outlines the standards, how they support clinical research, and how they fit with existing HITSP guidelines –†termed "Interoperability Specifications" that are already in use within the clinical care environment.

"We are deeply appreciative of the many organizations who have committed their support and active participation to this initiative," said Dr. Kush. "Our work will help to streamline and enhance clinical research within the healthcare setting, providing the means to better assess such areas as efficacy, effectiveness and safety for the benefit of patients, investigators, clinicians, technology and service providers, and researchers alike."


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