The American National Standards Institute (ANSI), coordinator of the U.S. standards and conformity assessment system, has formed a new public and private-sector working group to promote convergence within the global clinical research and healthcare arenas. Patient health records have been an important source of information to support activities such as clinical trials, population-based studies, outcomes evaluations, and other studies involving human health.
The newly formed EHR Clinical Research Value Case Workgroup will identify priorities for the harmonization of the technical standards that are necessary to ensure the interoperability of electronic health records (EHRs) and clinical research applications. It will also be pioneering a new “value case” approach that will assign priorities based on the potential for delivering value to stakeholders. The process mirrors the approach that was used by the American Heath Information Community (AHIC) and that will subsequently be used by the AHIC successor.
Priorities identified by the workgroup will then be transmitted to the Healthcare Information Technology Standards Panel (HITSP) for harmonization and the development of HITSP Interoperability Specifications (IS). HITSP IS represent an unambiguous “cookbook” that identifies “named” standards and provide implementation guidance to all stakeholders exchanging the health care information specified in each value case.
ANSI has named 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, as co-chairs of this initiative. The workgroup’s members include a cross-section of experts representing health care systems and technology providers, as well as researchers, academicians, patients, and others to advise on the content areas and processes where standards harmonization with healthcare will bring the greatest value to clinical research.
Fran Schrotter, ANSI senior vice president and chief operating officer, noted that “this workgroup has an important opportunity to ensure that clinical research needs are addressed in the work that is done within HITSP to harmonize EHR standards.”
At an initial meeting in Washington DC on November 10, the workgroup identified the need for a clinical research core dataset as an initial priority. Members also agreed to develop a consensus vision statement for better use of EHRs and secure data exchange in support of clinical research, ultimately including patient recruitment, clinical research findings for patients and practitioners, and improved use of EHR-based clinical data for research purposes.
“The global clinical research community has been developing interchange standards for the past decade and is extremely pleased to have all stakeholders coming together to establish priority areas and endorse the launch of a coordinated harmonization process,” said co-chair Rebecca Kush. “The workgroup’s initial priority of identifying a common set of information that can readily be exchanged between EHRs and clinical research systems will provide a foundation for future value cases such as safety reporting, patient participation in research and personalized healthcare, with a vision of ultimately creating an infrastructure through which healthcare advances clinical research which in turn informs clinical care.”
The group was also addressed by Dr. John Halamka, CIO of Deaconess Beth Israel Hospital in Boston and Chair of HITSP, who emphasized the importance of the issue and the critical time point for harmonization of these two domains of information.
Dr. John Glaser, CIO of Harvard Partners Health Care and a board member of the AHIC successor organization, conveyed to the workgroup that they have an important opportunity to define a pathway to show how standards-based health information exchange can provide added value to our nation’s clinical research processes.
Unlike previous work within HITSP, the clinical research value case has not received funding from the federal government. An initiative is currently underway to solicit funding from stakeholders in both the private and public sectors; this financial support will be a prerequisite before standards harmonization can begin.
Members of the Workgroup include
Society for Clinical Data Management
Phoenix Data Systems
Duke Comprehensive Cancer Center
Kenneth Buetow, PhD
Center for Biomedical Informatics and Information Technology
National Cancer Institute
Michael Cantor, MD
Pfizer Global Research and Development Informatics
Christopher Chute, MD, DrPH
Perry Cohen, PhD
Parkinson Pipeline Project
Critical Path Institute
Elaine Collier, MD
National Center for Research Resources
National Institutes of Health
Kevin M. Coonan, MD
Timothy J. Cromwell, RN, PhD
VHA OI, Department of Veterans Affairs
Healthcare Information and Management Systems Society
Cancer Information & Support Network
*Gregory Downing, MD, PhD
Department of Health and Human Services
Paul Harris, MD
Steven Hirschfeld, MD
National Institute for Child Health and Human Development
Charles Jaffe, MD, PhD
Health Level 7
Michael Kahn, MD, PhD
Clinical Informatics, The Children’s Hospital, Denver
American Medical Information Association
eClinical Forum EHR/CR Initiative; PhRMAEDC Task Force
Eli Lilly and Company
Judith Kramer, MD, MS
Clinical Trials Transformation Institute
*Rebecca Kush, PhD
Clinical Data Interchange Standards Consortium
Armando Oliva, MD
Office of the Critical Path Programs
Food & Drug Administration
Rachel Richesson, PhD, MPH
University of Southern Florida
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.