| Order of the State Council | | 国务院令 |
| (No. 701) | | （第701号） |
| The Regulation on the Prevention and Handling of Medical Disputes, as adopted at the 13th executive meeting of the State Council on June 20, 2018, is hereby issued, and shall come into force on October 1, 2018. | | 《医疗纠纷预防和处理条例》已经2018年6月20日国务院第13次常务会议通过，现予公布，自2018年10月1日起施行。 |
| Premier: Li Keqiang | | 总理 李克强 |
| July 31, 2018 | | 2018年7月31日 |
| Regulation on the Prevention and Handling of Medical Disputes | | 医疗纠纷预防和处理条例 |
| Chapter I General Provisions | | 第一章 总 则 |
| Article 1 This Regulation is developed for purposes of preventing and properly handling medical disputes, protecting the lawful rights and interests of both medical institutions and patients, maintaining the medical order, and guaranteeing medical safety. | | 第一条 为了预防和妥善处理医疗纠纷，保护医患双方的合法权益，维护医疗秩序，保障医疗安全，制定本条例。 |
| Article 2 For the purpose of this Regulation, “medical disputes” means the disputes arising from diagnosis and medical care activities between both medical institutions and patients. | | 第二条 本条例所称医疗纠纷，是指医患双方因诊疗活动引发的争议。 |
| Article 3 The state shall establish a medical quality safety management system, further the reform of the medical and health care system, regulate diagnosis and medical care activities, improve medical services, enhance medical quality, and prevent and reduce medical disputes. | | 第三条 国家建立医疗质量安全管理体系，深化医药卫生体制改革，规范诊疗活动，改善医疗服务，提高医疗质量，预防、减少医疗纠纷。 |
| In diagnosis and medical care activities, medical institutions and patients shall respect each other and protect their rights and interests in accordance with the provisions of relevant laws and regulations. | | 在诊疗活动中，医患双方应当互相尊重，维护自身权益应当遵守有关法律、法规的规定。 |
| Article 4 Medical disputes shall be handled under the principles of fairness, justness, and timeliness, be handled according to facts and in accordance with the law. | | 第四条 处理医疗纠纷，应当遵循公平、公正、及时的原则，实事求是，依法处理。 |
| Article 5 The people's government at or above the county level shall strengthen the leadership and coordination of the prevention and handling of medical disputes, include it in the comprehensive medical care system for public security, establish a departmental work division and coordination mechanism, and urge the relevant departments to perform their functions in accordance with the law. | | 第五条 县级以上人民政府应当加强对医疗纠纷预防和处理工作的领导、协调，将其纳入社会治安综合治理体系，建立部门分工协作机制，督促部门依法履行职责。 |
| Article 6 The health administrative department shall be responsible for guiding and supervising medical institutions in their prevention and handling of medical disputes, and directing both medical institutions and patients so that they resolve medical disputes in accordance with the law. | | 第六条 卫生主管部门负责指导、监督医疗机构做好医疗纠纷的预防和处理工作，引导医患双方依法解决医疗纠纷。 |
| Judicial administrative departments shall be responsible for guiding the people's mediation of medical disputes. | | 司法行政部门负责指导医疗纠纷人民调解工作。 |
| Public security authorities shall, in accordance with the law, maintain the public security order of medical institutions, investigate and deal with and crack down on the illegal and criminal acts which infringe upon the lawful rights and interests of patients and medical staff and disrupt the medical order, among others. | | 公安机关依法维护医疗机构治安秩序，查处、打击侵害患者和医务人员合法权益以及扰乱医疗秩序等违法犯罪行为。 |
| Public finance, civil affairs, insurance supervision and administration, and other departments and institutions shall, according to their respective functions, effectively conduct the work relating to the prevention and handling of medical disputes. | | 财政、民政、保险监督管理等部门和机构按照各自职责做好医疗纠纷预防和处理的有关工作。 |
| Article 7 The state shall establish and improve the medical risk allocation mechanism, bring into play the role of the insurance mechanism in the third-party compensation and socialized allocation of medical risks in the handling of medical disputes, encourage medical institutions to participate in medical liability insurance, and encourage patients to participate in medical accident insurance. | | 第七条 国家建立完善医疗风险分担机制，发挥保险机制在医疗纠纷处理中的第三方赔付和医疗风险社会化分担的作用，鼓励医疗机构参加医疗责任保险，鼓励患者参加医疗意外保险。 |
| Article 8 News media shall strengthen the publicity of laws and regulations on and general knowledge of medical and health care, direct the public so that they rationally treat medical risks; report medical disputes in accordance with the provisions of relevant laws and regulations, scrupulously abide by professional ethics, and be authentic, objective and impartial. | | 第八条 新闻媒体应当加强医疗卫生法律、法规和医疗卫生常识的宣传，引导公众理性对待医疗风险；报道医疗纠纷，应当遵守有关法律、法规的规定，恪守职业道德，做到真实、客观、公正。 |
| Chapter II Prevention of Medical Disputes | | 第二章 医疗纠纷预防 |
| Article 9 A medical institution and its medical staff shall, in their diagnosis and medical care activities, center on patients, strengthen humanistic care, strictly abide by medical and health care laws, regulations, rules, diagnosis and medical care norms and routines, and scrupulously abide by professional ethics. | | 第九条 医疗机构及其医务人员在诊疗活动中应当以患者为中心，加强人文关怀，严格遵守医疗卫生法律、法规、规章和诊疗相关规范、常规，恪守职业道德。 |
| A medical institution shall provide its medical staff with training on medical and health care laws, regulations, rules, diagnosis and medical care norms and routines, and strengthen the education on professional ethics. | | 医疗机构应当对其医务人员进行医疗卫生法律、法规、规章和诊疗相关规范、常规的培训，并加强职业道德教育。 |
| Article 10 A medical institution shall formulate and implement medical quality safety management rules, set up a department for monitoring the quality of medical services, or assign full-time (or part-time) personnel, strengthen the standardized administration of diagnosis, medical care, nursing, pharmaceutical affairs, examination and other work, optimize the service process, and enhance the service level. | | 第十条 医疗机构应当制定并实施医疗质量安全管理制度，设置医疗服务质量监控部门或者配备专（兼）职人员，加强对诊断、治疗、护理、药事、检查等工作的规范化管理，优化服务流程，提高服务水平。 |
| A medical institution shall strengthen the management of medical risks, improve the measures for the identification, assessment, prevention and control of medical risks, inspect the implementation of such measures on a periodical basis, and eliminate hidden risks in a timely manner. | | 医疗机构应当加强医疗风险管理，完善医疗风险的识别、评估和防控措施，定期检查措施落实情况，及时消除隐患。 |
| Article 11 A medical institution shall, in accordance with the provisions on the administration of clinical application of medical technologies formulated by the health administrative department of the State Council, provide medical technical services matching its technical capacities, guarantee the safety of clinical application, and reduce medical risks. If the medical institution plans to adopt any new medical technologies, it shall conduct technology assessment and ethical review so as to ensure that the technologies are safe, effective and in line with ethics. | | 第十一条 医疗机构应当按照国务院卫生主管部门制定的医疗技术临床应用管理规定，开展与其技术能力相适应的医疗技术服务，保障临床应用安全，降低医疗风险；采用医疗新技术的，应当开展技术评估和伦理审查，确保安全有效、符合伦理。 |
| Article 12 A medical institution shall, in accordance with the provisions of relevant laws and regulations, strictly implement the rules for the purchase inspection and storage of drugs, medical devices, disinfectants, and blood, among others. It is prohibited to use any unqualified drugs, medical devices, disinfectants, and blood, which have no qualification certificates or are expired. | | 第十二条 医疗机构应当依照有关法律、法规的规定，严格执行药品、医疗器械、消毒药剂、血液等的进货查验、保管等制度。禁止使用无合格证明文件、过期等不合格的药品、医疗器械、消毒药剂、血液等。 |
| Article 13 Medical staff shall explain to a patient his or her state of illness and medical measures in diagnosis and medical care activities. If it is necessary to conduct operation or clinical experiment or any other special examination or special medical care that has certain risk and may cause any adverse effect, the medical staff shall explain the medical risks, alternative medical care plans and other information to the patient in a timely manner, and obtain his or her written consent. Under the circumstance where the patient is in a state of unconsciousness or otherwise unable to make a decision independently or it is inappropriate to explain the state of illness to the patient, the medical staff shall explain to the close relative of the patient and obtain his or her written consent. | | 第十三条 医务人员在诊疗活动中应当向患者说明病情和医疗措施。需要实施手术，或者开展临床试验等存在一定危险性、可能产生不良后果的特殊检查、特殊治疗的，医务人员应当及时向患者说明医疗风险、替代医疗方案等情况，并取得其书面同意；在患者处于昏迷等无法自主作出决定的状态或者病情不宜向患者说明等情形下，应当向患者的近亲属说明，并取得其书面同意。 |
| Where it is unable to obtain the opinions of a patient or his or her close relative in an emergency, corresponding medical measures may be taken immediately with the approval of the person in charge or authorized person in charge of the medical institution. | | 紧急情况下不能取得患者或者其近亲属意见的，经医疗机构负责人或者授权的负责人批准，可以立即实施相应的医疗措施。 |
| Article 14 For the diagnosis and medical care activities with relatively high medical risks, such as operation, special examination and special medical care, a medical institution shall prepare a solution in advance, and take the initiative to prevent unexpected risks. | | 第十四条 开展手术、特殊检查、特殊治疗等具有较高医疗风险的诊疗活动，医疗机构应当提前预备应对方案，主动防范突发风险。 |
| Article 15 A medical institution and its medical staff shall enter and properly keep medical records in accordance with the provisions of the health administrative department of the State Council. | | 第十五条 医疗机构及其医务人员应当按照国务院卫生主管部门的规定，填写并妥善保管病历资料。 |
| Where medical records are not entered in a timely manner due to emergency rescue, the medical staff shall enter the records according to actual conditions within six hours after the rescue, and make explanations on the delay. | | 因紧急抢救未能及时填写病历的，医务人员应当在抢救结束后6小时内据实补记，并加以注明。 |
| No entity or individual may falsify, forge, conceal, destroy or seize medical records. | | 任何单位和个人不得篡改、伪造、隐匿、毁灭或者抢夺病历资料。 |
| Article 16 A patient shall have the right to consult and duplicate his or her outpatient medical records, hospitalization records, temperature sheets, medical order sheets, laboratory test reports (examination reports), medical image examination data, special examination consent form, operation consent form, operation and anesthesia records, pathological data, nursing records, medical expenses, and all other materials falling under medical records as prescribed by the health administrative department of the State Council. | | 第十六条 患者有权查阅、复制其门诊病历、住院志、体温单、医嘱单、化验单（检验报告）、医学影像检查资料、特殊检查同意书、手术同意书、手术及麻醉记录、病理资料、护理记录、医疗费用以及国务院卫生主管部门规定的其他属于病历的全部资料。 |
| Where a patient requests the duplication of medical records, the medical institution shall provide duplication services and affix its seal for proof to the duplicated medical records. The patient or his or her close relative shall be present when his or her medical records are duplicated. The medical institution that duplicates medical records at the request of patients may charge the production cost, and the charging standards shall be disclosed. | | 患者要求复制病历资料的，医疗机构应当提供复制服务，并在复制的病历资料上加盖证明印记。复制病历资料时，应当有患者或者其近亲属在场。医疗机构应患者的要求为其复制病历资料，可以收取工本费，收费标准应当公开。 |
| Where a patient dies, his or her close relative may consult and duplicate his or her medical records in accordance with the provisions of this Regulation. | | 患者死亡的，其近亲属可以依照本条例的规定，查阅、复制病历资料。 |
| Article 17 A medical institution shall establish and improve the mechanism for communication between it and patients, patiently offer interpretation and explanation concerning the inquiries, opinions and suggestions put forward by patients in the process of diagnosis and medical care, and handle them in accordance with the relevant provisions. For any doubt raised by a patient on diagnosis and medical care, the medical institution shall conduct verification and self-inspection in a timely manner, and designate the relevant person to communicate with the patient or his or her close relative, and truthfully explain the situation. | | 第十七条 医疗机构应当建立健全医患沟通机制，对患者在诊疗过程中提出的咨询、意见和建议，应当耐心解释、说明，并按照规定进行处理；对患者就诊疗行为提出的疑问，应当及时予以核实、自查，并指定有关人员与患者或者其近亲属沟通，如实说明情况。 |
| Article 18 A medical institution shall establish and improve the complaint reception rules, set up a uniform complaint management department or assign full-time (or part-time) personnel, and publicize the means, procedures and contact information, among others, for the settlement of medical disputes in a conspicuous position of the medical institution so as to facilitate the complaint or inquiries of patients. | | 第十八条 医疗机构应当建立健全投诉接待制度，设置统一的投诉管理部门或者配备专（兼）职人员，在医疗机构显著位置公布医疗纠纷解决途径、程序和联系方式等，方便患者投诉或者咨询。 |
| Article 19 The health administrative department shall urge medical institutions to implement medical quality safety management rules, organize medical quality safety assessment, analyze medical quality safety information, and develop prevention measures for discovered risks. | | 第十九条 卫生主管部门应当督促医疗机构落实医疗质量安全管理制度，组织开展医疗质量安全评估，分析医疗质量安全信息，针对发现的风险制定防范措施。 |
| Article 20 A patient shall abide by the medical order and the provisions of the medical institution on seeing a doctor, medical care, and examination, truthfully provide information relating to the state of illness, and cooperate with the medical staff in conducting diagnosis and medical care activities. | | 第二十条 患者应当遵守医疗秩序和医疗机构有关就诊、治疗、检查的规定，如实提供与病情有关的信息，配合医务人员开展诊疗活动。 |
| Article 21 People's governments at all levels shall strengthen health promotion and education, popularize scientific knowledge on health, and enhance the public's cognition of medical science knowledge such as disease medical care. | | 第二十一条 各级人民政府应当加强健康促进与教育工作，普及健康科学知识，提高公众对疾病治疗等医学科学知识的认知水平。 |
| Chapter III Handling of Medical Disputes | | 第三章 医疗纠纷处理 |
| Article 22 Where any medical dispute occurs, both the medical institution and the patient may resolve the dispute by the following means: | | 第二十二条 发生医疗纠纷，医患双方可以通过下列途径解决： |
| (1) Voluntary consultation between both parties. | | （一）双方自愿协商； |
| (2) Applying for the people's mediation. | | （二）申请人民调解； |
| (3) Applying for administrative mediation. | | （三）申请行政调解； |
| (4) Filing a lawsuit with the people's court. | | （四）向人民法院提起诉讼； |
| (5) Other means prescribed by laws and regulations. | | （五）法律、法规规定的其他途径。 |
| Article 23 Where any medical dispute occurs, the medical institution shall inform the patient or his or her close relative of the following matters: | | 第二十三条 发生医疗纠纷，医疗机构应当告知患者或者其近亲属下列事项： |
| ．．．．．． | | ．．．．．． |
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