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  • 期刊

從風險管理論醫療糾紛:以告知義務為中心

Medical Disputes from the Perspective of Risk Management: Centering on the Obligation of Notification

摘要


醫療本身就是一件複雜的工作,在醫療過程中存在著太多不確定的因素,若因醫病間溝通出現問題,而事後發生病人身體上的傷害或是更嚴重的後果,那麼醫療糾紛就會應孕而生了,本文期藉由風險管理理論來控制醫療糾紛的發生,由法院醫療糾紛訴訟案件之內容分析,以釐清醫療過程中醫療糾紛的風險因子,其中以告知義務及手術同意書最受爭議,本文將法院判決予以類型化其樣態,並分析其造成訴訟的原因,最後提出建議,期盼在風險控制下,能夠減少手術同意書的醫療糾紛,改善醫病雙方關係。

並列摘要


Medical treatment is a complicated task. There are too many uncertain factors in the medical process. If there is a problem in communication between the doctor and the patient and then results in the patient's injury or more serious consequences, the medical dispute will occur. This article uses risk management theory to analyze the occurrence of medical disputes. The content of the court medical dispute litigation cases is analyzed to obtain the risk factors of medical disputes during the medical process, including the obligation to inform and the surgical consent form which are the most frequently disputed. In this article, we will categorize court judgments, analyzes the reasons for litigation, and give some suggestions. It is hoped that under risk control, medical disputes on surgical consent can be reduced and the relationship between doctors and patients can be improved.

參考文獻


International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use: Guideline for good clinical practice E6(R2), 2002;Sec.3.1.2&4.4.1.
Food and Drug Administration: Recruiting Study Subjects- FDA Guidance for IRB and Clinical Investigators, 1998. www.fda.gov/regulatory- information/search-fda-guidance-documents/recruiting-study-subjects Accessed October 22, 2021.
Medicines and Healthcare Products Regulatory Agency: The Medicines for Human Use (Clinical Trials) Regulations, 2004;51.
衛生福利部:藥品臨床試驗申請須知,2019;8。
衛生署:2010.10.11衛署醫字第0990264204號函稱:「試驗機構須嚴審招募廣告,並不定期查核計畫主持人是否擅自變更招募內容,違反者依醫療法第105條第4項重罰試驗機構。」

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