民法典第1219条“知情同意”规则之解释论构造

Interpretation of the “Informed Consent” Rule in Article 1219 of the Civil Code

《民法典》第1219条将医疗伦理责任之“知情同意”规则进一步界分为一般告知义务及需要患者同意之具体告知义务。具体告知应采具体病人标准,就医方满足合理病人标准而未达具体病人标准之告知,应由患者承担举证责任。“知情同意”规则的例外情形可类型化为以欠缺知情同意能力基础之客观不能告知,以及服务于治疗目的之主观不宜告知情形,其中,客观不能情形应与医疗机构紧急情况下之特殊干预权相区辩。对于既侵害知情同意权又造成患者人身损害之侵权行为,自可追究其侵权责任;而对于未告知同意而为有益治疗之损害赔偿存在侵权损害赔偿数额认定之障碍,可通过追究医疗机构的违约责任,消弭医疗救助目的与患者知情及自决权之间的紧张与冲突。

Article 1219 of the Civil Code further divides the“informed consent”rule of medical ethical responsibility into general obligation of disclosure and specific obligation of disclosure requiring patient consent.Specific patient criteria should be adopted for specific notification,and the burden of proof should be borne by the patient for notification that the physician meets reasonable patient criteria but fails to meet specific patient criteria.Exceptions to the“informed consent”rule can be classified into the objective inability to inform and the subjective inability to inform for the purpose of treatment,among which the objective inability should be distinguished from the special intervention right in the emergency situation of the medical institution.For the tort acts that infringe upon the right of informed consent and cause personal injury to the patient,the tort liability can be investigated.If there is an obstacle to the determination of the amount of tort damage compensation for the beneficial treatment without giving consent,the tension and conflict between the purpose of medical assistance and the patient's right to know and self-determination can be resolved by investigating the medical institution's liability for breach of contract.