The American National Standards Institute (ANSI) just formed a new public and private-sector group called the “EHR Clinical Research Value Case Workgroup” to promote the convergence of global clinical research and healthcare.
The goal will be to pioneer a new “value case” approach that will assign priorities based on the potential for delivering value to stakeholders. The priorities identified by the work group will than go to the Healthcare Information Technology Standards Panel (HITSP) for harmonization and development of HITSP Interoperability Specifications.
ANSI has named Dr. Rebecca Kush, President and CEO of the Clinical Data Interchange Standards Consortium, and Dr. Gregory Downing, Director of the Initiative on Personalized health Care at HHS as co-Chairs.
The work group’s members include a cross section of experts representing healthcare 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.
At an initial meeting in Washington D.C. in November, the work group 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. Eventually patient recruitment, clinical research findings for patients and practitioners, and the improved use of EHR based clinical data for research purposes will be included.
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 as this financial support is needed before standards harmonization can begin.