HITSP Begins Harmonization Process for Use of Electronic Health Records in Clinical...

HITSP Begins Harmonization Process for Use of Electronic Health Records in
Clinical Research

Thirty-five leading organizations from the clinical research community have
pledged support for new initiative

WASHINGTON, June 15 /PRNewswire-USNewswire/ -- 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:
-- Abbott
-- Accenture
-- 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
-- Genzyme
-- GlaxoSmithKline
-- Greenway Medical Technologies
-- HP
-- JSS Medical Research Inc.
-- McDougall Scientific Ltd.
-- Medidata Solutions Worldwide
-- MedXview
-- Nextrials, Inc.
-- Numoda Corporation
-- Oracle
-- Outcome
-- Partners HealthCare
-- Perceptive Informatics, a subsidiary of PAREXEL International
-- PharmaNet Development Group, Inc.
-- Pfizer
-- Quintiles
-- 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."

About HITSP

Operating under contract to the U.S. Department of Health and Human Services
(HHS), HITSP is administered by ANSI in cooperation with strategic partners
including the Healthcare Information and Management Systems Society (HIMSS),
the Advanced Technology Institute (ATI) and Booz Allen Hamilton.

About ANSI

ANSI is a private non-profit organization whose mission is to enhance U.S.
global competitiveness and the American quality of life by promoting,
facilitating, and safeguarding the integrity of the voluntary standardization
and conformity assessment system. Its membership is comprised of businesses,
professional societies and trade associations, standards developers,
government agencies, and consumer and labor organizations. The Institute
represents the diverse interests of more than 125,000 companies and
organizations and 3.5 million professionals worldwide.

The Institute is the official U.S. representative to the International
Organization for Standardization (ISO) and, via the U.S. National Committee,
the International Electrotechnical Commission (IEC), and is a U.S.
representative to the International Accreditation Forum (IAF). ANSI currently
has offices in New York City and Washington, DC.

SOURCE American National Standards Institute

Elizabeth Neiman of the American National Standards Institute,
+1-212-642-4911, eneiman@ansi.org