One of the challenges in using data from EHRs is that no standards exist for describing the quality and completeness of electronic health data. Understanding the characteristics of a data source is critical for investigators in their determination about whether the data are fit for a specific use. Effective use of the growing number of data sources and distributed networks will require adoption of a uniform approach to describing the quality characteristics of electronic health data, as well as the data capture characteristics at the institutional, provider, and health plan level and data domain level. FDA is supporting a project to develop, test, and implement a standards-based approach to describing data and presenting data quality metrics.
Jeffrey Brown, PhD; Chayim Herzig-Marx, PhD; Jessica Malenfant, MPH; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA
Jamila Mwidau, RN, BSN, MPH; Office of Surveillance and Epidemiology, Center for Drug and Evaluation Research, US Food and Drug Administration, Silver Spring, MD
Kimberly Barret, MPH; Bridget Nolan; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA
General Dynamics Health Information Technology, Fairfax, VA