Sentinel Initiative: National Strategy for Monitoring Medical Product Safety

摘要

As we move into the 21st century, we have already begun modernizing our approach to managing health-related information. The U.S. Department of Health and Human Services, under the counsel of the Office of the National Coordinator for Health Information Technology (ONC), has launched a series of initiatives with input from the American Health Information Community. (1) These initiatives involve applying information technologies to the way we collect, manage, and share health-related information. (2) Technologies such as electronic health records (EHRs), e-prescribing, and electronic decision support tools will make our risk management systems more efficient, improve our ability to protect the public, and, potentially, reduce healthcare costs. The Food and Drug Administration is playing a key role in this effort. During the past several decades, FDA has taken the lead in developing and implementing standards and terminologies to help manage the regulated product data received as part of the product approval and postmarket surveillance processes. Since the formation of the Healthcare Information Technology Standards Panel, the FDA has coordinated its efforts closely with the standards harmonization process.