A comprehensive approach to patient safety requires the ability to anticipate and protect against circumstances that might lead to adverse events and implement corrective actions. Both adverse events and near misses require standard collection/reporting processes, datasets, definitions, and analytic approaches that can be achieved only by integrating patient safety reporting systems into the context of health information systems in both large institutions and office practices. These systems employ multiple detection methods and multiple reporting channels and involve a broad array of data elements. Establishing a national health information infrastructure is necessary to provide the backbone for such systems.