"Our objective is to create a sustainable, interoperable infrastructure through which healthcare advances clinical research and in turn informs clinical care." -- Frances Schrotter, ANSI senior vice president and COO.

The American National Standards Institute (ANSI), coordinator of the U.S. standards and conformity assessment system, is working to facilitate the use of electronic health information to support global clinical research activities. The Institute seeks the active engagement and financial support of the clinical research community to ensure that divergent and disparate standards do not inhibit the use of electronic health records (EHR) for future research and clinical decision support.

"We are faced with an important opportunity to ensure that clinical research needs are addressed in the work that is done to harmonize EHR standards," said Frances Schrotter, ANSI senior vice president and chief operating officer. "Our immediate goal is to raise sufficient private-sector funds to cover the organizational costs needed to address this activity. In the long term, our objective is to create a sustainable, interoperable infrastructure through which healthcare advances clinical research and in turn informs clinical care."

ANSI said that 27 organizations have already stepped forward with contributions in support of the effort.

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.


View Full Story