The American National Standards Institute (ANSI, Washington), 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.
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 records and clinical research applications, says the organization. It will also be pioneering a new “value case” approach that will assign priorities based on the potential for delivering value to stakeholders. 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).
At an initial meeting in Washington DC on Nov. 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.