為求醫療刑事責任認定之合理化與明確化，醫療法第82條之修正，以「違反醫療上必要之注意義務且逾越合理臨床專業裁量」為刑事上過失責任有無的判斷基準，明確指示於判斷醫療行為是否有過失時，應考量臨床指引以及臨床醫療的複雜性及醫師之判斷空間。如此之立法方向亦與德國實務上認定醫事人員是否負有過失責任之判斷方式相符。各地方檢察署在修法通過施行後至撰文前之醫療案件終結數據亦顯示，在偵查實務中，對醫事人員責任有無的判斷亦趨嚴格。相信如此的偵查實務發展，對避免預防防衛性醫療、減缓外科及婦產科醫師人力流失、改善醫療體系之發展、醫療環境合理化等問題，有實質上之助益。

In order to clarify the standard to determine the criminal responsibility concerning medical practices, article 82 of Medical Care Act has been amended: only when the medical practices, which breach medical due care and go beyond the reasonable exercise of professional clinical discretion, can the medical personnel who made such practices be blamed. This amendment specifically indicates that professional clinical discretion, guidelines and clinical diagnosis are the basis of evaluation. Such evaluation standard corresponds to the standard to determine the criminal responsibility of medical personnel. Analyzing the statistics before and after this amendment, the number of cases, which the medical personnel been charged of offenses of negligently causing bodily harm or causing death due to negligence, has shown a tendency of decline. It indicates that the prosecutors have started to determine the criminal responsibility of the suspects in malpractice cases with a stricter standard. It is to believed that such development of criminal procedure can help avoiding defensive medicine and reducing the loss of personnel in the departments with threat of malpractices litigations, such as division of surgery, obstetrics and gynecology, etc. This amendment also has shown the positive meaning of rationalization the criminal responsibility of medical personnel.