醫療事故預防及爭議處理法（以下簡稱醫預法）業於2023年6月經總統公布制定，於2024年1月1日實施。衛生福利部（以下簡稱衛福部）積極與各界專家共同研商子法規與相關配套措施之準備，以建立完善「非訟化」之醫療爭議處理機制，並進而從中進行事故分析學習、改善及預防再發生。因應醫預法之強制性通報作業，除參考過去臺灣病人安全通報系統之統計分析紀錄，並借鏡英、美、澳等先進國家對重大醫療事故之定義及通報制度，以制訂本國之相關作業辦法。本文將進行重大醫療事故之通報定義及相關作業流程做說明，機構除主動進行通報外，內部應進行根本原因分析、檢討與改善，落實系統性除錯，以維護病人安全。

The Medical Accident Prevention and Dispute Resolution Act was promulgated by the President of Taiwan and implemented on January 1, 2024. The Ministry of Health and Welfare has proactively discussed sub-regulations together with experts from various fields and formulated relevant supporting measures to establish a comprehensive non-contentious medical dispute resolution mechanism. Based on the mechanism, accident analyses have been conducted to learn from past accidents, make improvements, and prevent other accidents from happening in the future. In response to the mandatory report operation in the aforementioned act, statistical analysis records on the patient safety report system in Taiwan as well as definitions and reporting systems of major medical accidents in developed countries, such as Great Britain, the United States, and Australia, have been referenced to device relevant operations and regulations in Taiwan. This study explained definitions regarding the reporting of major medical accidents and related operating procedures. In addition to the voluntary reporting of accidents, medical care institutions shall analyze the fundamental causes of these events, conduct internal cause analysis, and conduct reviews and improvements to achieve systematic error removal and maintain patient safety.