實驗性檢測方法違反醫師法案：非醫事機構檢測結果 vs.執行醫療業務的界線【學習式判解評析】 試閱
A Case in Violation of Physician Act: Examination Result from Private Laboratory without the Examination Slip Issued by a Physician
本案被告開設公司，以自行開發之「嗅癌犬檢測法」，除曾與某國立大學附設醫院簽訂臨床試驗計畫協議書，於一定期間內進行人體試驗外，又於該人體試驗計畫外向數名受測者以收費方式進行該檢測法之大腸癌「罹癌風險評估」，檢測後出具「檢驗報告」並由被告向受測者說明是否罹患癌症、後續是否應進一步進行檢測等內容，經法院認定已違反醫師法非法執行醫療業務罪（另涉犯未繳納股款罪部分未納入本文評析之範圍），於二審判決處以6個月有期徒刑，得易科罰金。本文擇非法執行醫療業務罪中，判斷專屬醫師執行之醫療核心業務，及實驗性檢測方法與醫學檢驗師法所指檢驗業務間之差異進行評析。
In this case review, the defendant, hereafter referred to as he, set up a company to operate the medical examination business, which was called “Canine detection of the human cancer VOC” (volatile organic compounds, VOC). The clinical trial was conducted in a collaborative manner with one national university hospital. Besides, he recruited a few healthy human subjects out of the trial and even charged them to estimate the risk of having cancer. He then delivered the documentations named “medical test report” to those individuals with the information about the probability of developing cancers and the needs for further medical intervention. The defendant was convicted of violation of article 28, Physician Act, and was sentenced to 6 months in prison, which could be commuted to a fine. This article analyzed part of the case about how to distinguish the differences between experimental examination methods, medical functions performed by medical technologists and the practicing of physicians.
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