U.S. Legal System for Medical Safety and Quality-Focusing on Reporting Systems, Administrative Sanctions, and Performance Evaluation

Abstract

Much attention has been paid to the medical safety and quality around the world for the last several years. This article analyzes the U.S. legal and institutional system for medical safety and quality as reference for designing Japanese legal and institutional system for medical safety and quality. Overall structure of government organizations at federal and state level, hospital organizations, quality improvement organizations, consumer organizations for medical safety and quality is analyzed, and lessons are drawn for the designing Japanese system. Concretely, accident and incident reporting system and protection from discovery, administrative licensing and sanctions mechanism for medical doctors, clinical performance evaluation and information disclosure are the focus of the analysis.