穿戴裝置醫療認定之界限──COMGO案：醫療器材之認定標準與間接故意之判斷難題【學習式判解評析】 試閱
The Limit of Indentification of Wearable Devices as Medical Treatment: The Case COMGO—— The Identification Standards of Medical Devices and the Difficulty in Judging Dolus Indirectus
針對醫療器材之製造或輸入，藥事法具有相當嚴謹之 審核管制措施；然而科技發展的日新月異，讓許多智 慧手環、智慧手錶等智慧裝置也能同時兼具醫療監測 之功能。本案面臨兩大爭議。第一，針對智慧裝置具 備某些心血管監測功能後，是否即屬於受藥事法管制之醫療器材，認定上仍有疑義。第二，針對製造該智慧裝置之當事人，是否具備對此產品可能是醫療器材之情事具有認知，抑或有相當程度地預見可能性，則牽涉到刑法間接故意之舉證責任認定標準。
The Pharmaceutical Affairs Act has rigorous review and control measures for manufacturing or importing medical devices. However, with the rapid development of technology, many smart devices, such as smart bracelets and smartwatches, can also have medical monitoring functions. There are two major controversies in this case. First, there is still doubt whether a smart device equipped with certain cardiovascular monitoring functions is considered a medical device controlled by the Pharmaceutical Affairs Act. Second, whether the party who manufactured the smart device knew that the product might be a medical device or had reasonable foreseeability. This involves the burden of proof standard for dolus indirectus in criminal law.
038-057
