| 關 鍵 詞： |
醫療過失；醫療常規；執業慣例；醫療水準；善良管理人；善良管理醫師；注意義務；醫事鑑定 |
| 中文摘要： |
醫糾審判常以醫療常規作為醫療過失之判斷基準，導致逐漸偏離過失理論，實務與學說對此已有認知並圖提出不同之判斷基準，而為甫修訂之醫療法所採。然而不同基準或理論概念各應做何理解？彼此間應如何整合？遂成問題。本文擬釐清對醫療常規一詞理解上之誤會，其次觀察到不論是美國習慣法從執業慣例演變至理性醫師說之嬗遞，或是日本法上捨醫療慣行至漸趨穩健之相對醫療水準說，均實質地影響著我國理論與實踐走向，而此等發展趨勢，實則與我國民法上「善良管理人注意程度」之基本理論若合符節。據此，本文認為應回歸過失基本理論，以善良管理醫師之注意程度作為醫療過失判斷基準，將紛亂之判準與過失基本理論整合，並分別就醫療政策面過失與執行面過失之判斷提出意見。
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| 英文關鍵詞： |
Medical Negligence；Medical Regulation；Professional Custom；Contemporary Medical Competency；The Due Care of a Good Administrator；The Due Care of a Good Physician；Duty of Care, Expert Testimony |
| 英文摘要： |
Due to the disciplinary gap between medicine and law, the judgement of negligence in the medical malpractice litigation often lies beyond the capacity of the judges, who after all have to resort to medical testimony. However, currently the opinions made by medical testimony are heavily dependent on whether the accused physician violates the “medical regulations” or not, and consequently the judgement of medical negligence bears the risk of straying from contemporary fault theory, therefore induces widespread criticism.
By way of multidisciplinary approach, this article makes efforts to help reaching a consensus on the term “medical regulations” and to investigate its feasibility in judging medical negligence. Hereafter this article attempts to explore and integrate the existing authoritative opinions regarding the criteria of judging medical negligence, many of which have already been stipulated into the newly amended Medical Care Act. Comparative law aspects on judgement criteria of medical negligence and their influences on us are thoroughly reviewed. It might be concluded that either the involution from “professional custom standard” to “reasonable physician standard” in case law or the transition from “medical customs” to “relative contemporary medical competency” in Japanese law reveals the return to fault theory that concurs with the concepts of “exercising the due care of a good administrator” in our civil code.
This article holds that the application of medical regulations in the judgement of medical negligence still might be of significant value in certain circumstances, and that the medical negligence could be divided into the fault in decision making process and the fault in practice and skill, and these two should be attentively discriminated. It is hoped that this article might help in better understanding and establishment of the judgment criteria of medical negligence.
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| 目 次： |
壹、問題意識
貳、醫療專業性過失之判定難題
一、一般侵害事件之過失理論基礎
二、醫療傷害事件之過失理論基礎
參、醫、法實務界對醫療過失之理解
一、對疏失與過失二分之辯正
二、以醫療常規做過失判準之辯正
（一）醫療常規之定義
（二）醫療常規與過失判定之關係
（三）審判實務對醫療常規判準之挑戰
三、以藥品仿單、儀器使用手冊內容做過失判準之辯正
四、以併發症發生率做過失判準之辯正
五、對援引外國法則做過失判準之辯正
六、小結
肆、學界對醫療過失之理解
一、對醫療常規作為判準提出批判
二、「理性醫師」注意程度說
（一）「理性醫師即是「善良管理醫師」
（二）「理性醫師」之形塑
三、醫療水準說
（一）基準之確立－最完善之注意義務
（二）基準之補充－醫療水準說之發明
四、外國法則之援引
（一）漢德公式（Hand formula）
（二）事實說明自己（res ipsa loquitur）
五、小結
伍、本文對醫療過失判定之補充建議
一、回歸新過失理論之判斷基準
二、訴訟實務上善良管理醫師之形塑
三、醫療決策面過失之判定
（一）以醫療常規作為判準有其理性基礎與前提
（二）醫療常規之違反與心證之形成
四、醫療執行面過失之判定
（一）病歷不會記載執行面疏失
（二）難藉由目前鑑定方式檢出執行面過失
（三）當前因應之道
陸、結論
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