The American National Standards Institute (ANSI), a standards-setting organization, has tapped health organizations for funding to ensure the use of electronic health records will support clinical research.
The Institute seeks the active engagement and financial support of the clinical research community, officials said, because divergent standards could inhibit the use of electronic health records 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.
Schrotter said ANSI's long-term objective is to create a sustainable, interoperable infrastructure through which healthcare advances clinical research and informs clinical care."
Twenty-seven organizations have joined the effort and pledged financial support:
They are:
- Abbott
- Biogen Idec
- Boehringer Ingelheim Pharmaceuticals, Inc.
- Cleveland Clinical and Translational Science Collaborative at Case Western Reserve University, which includes Case Western Reserve University, Cleveland Clinic, MetroHealth System, and University Hospitals
- Critical Path Institute
- Digital Infuzion
- Duke University, including Duke Comprehensive Cancer Center and Duke Clinical Research Institute
- Genetic Alliance
- GlaxoSmithKline
- Greenway Medical Technologies
- HP
- JSS Medical Research Inc.
- McDougall Scientific Ltd.
- Medidata Solutions Worldwide
- MedXview
- Nextrials, Inc.
- Numoda Corporation
- Outcome
- Partners HealthCare
- PharmaNet Development Group, Inc.
- Pfizer
- Phoenix Data Systems, a division of Bio-Imaging Technologies
- Quintiles
- Target Health Inc.
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 Rebecca Kush, president and CEO of the Clinical Data Interchange Standards Consortium (CDISC), and 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, D.C. on Nov.10, 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.
In addition to the contributions from the clinical research community, six U.S. federal agencies have demonstrated their support through contributions to development of the workgroup's value/use case document: 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 clinical research community must have a voice in the development of EHRs to ensure that globally accepted clinical research standards are recognized, leveraged, and included in the harmonization process," said Kush.
