KYB CHINA(2018年6月20日国务院第13次常务会议通过 2018年7月31日中华人民共和国国务院令第701号公布 自2018年10月1日起施行)
(Adopted at the 13th Executive Meeting of the State Council on June 20, 2018, promulgated by Order No. 701 of the State Council of the People's Republic of China on July 31, 2018, and effective as of October 1, 2018)
总则
General Provisions
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。
These Regulations are formulated to prevent and properly handle medical disputes, protect the legitimate rights and interests of both medical parties, maintain medical order, and ensure medical safety.
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。
For the purposes of these Regulations, 'medical dispute' refers to a dispute arising between the medical parties due to diagnosis and treatment activities.
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。
The State shall establish a medical quality and safety management system, deepen the reform of the medical and health system, standardize diagnosis and treatment activities, improve medical services, enhance medical quality, and prevent and reduce medical disputes.
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。
In diagnosis and treatment activities, both medical parties shall respect each other and shall comply with relevant laws and regulations when safeguarding their own rights and interests.
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。
The handling of medical disputes shall follow the principles of fairness, impartiality, and timeliness, be based on facts, and be handled in accordance with the law.
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。
People's governments at or above the county level shall strengthen leadership and coordination for the prevention and handling of medical disputes, incorporate it into the comprehensive social management system, establish a departmental division of labor and coordination mechanism, and urge departments to perform their duties in accordance with the law.
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。
The health administrative department shall be responsible for guiding and supervising medical institutions in the prevention and handling of medical disputes, and guiding both medical parties to resolve medical disputes in accordance with the law.
司法行政部门负责指导医疗纠纷人民调解工作。
The judicial administrative department shall be responsible for guiding the people's mediation of medical disputes.
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 security organs shall maintain the public security order of medical institutions according to law, investigate and crack down on illegal and criminal acts that infringe upon the legitimate rights and interests of patients and medical personnel, or disrupt medical order.
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。
The finance, civil affairs, insurance supervision and other departments and institutions shall, in accordance with their respective duties, do a good job in the prevention and handling of medical disputes.
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。
The state establishes and improves the medical risk sharing mechanism, gives play to the role of insurance mechanism in third-party compensation and socialized sharing of medical risks in the handling of medical disputes, encourages medical institutions to participate in medical liability insurance, and encourages patients to participate in medical accident insurance.
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。
News media shall strengthen the publicity of medical and health laws, regulations and medical and health common sense, guide the public to treat medical risks rationally; when reporting medical disputes, they shall abide by the provisions of relevant laws and regulations, abide by professional ethics, and be truthful, objective and fair.
医疗纠纷预防
Prevention of Medical Disputes
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。
Medical institutions and their medical personnel shall, in the course of diagnosis and treatment activities, take patients as the center, strengthen humanistic care, strictly abide by medical and health laws, regulations, rules, and diagnosis and treatment related norms and routines, and abide by 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。
Medical institutions shall provide training on medical and health laws, regulations, rules, and diagnosis and treatment related norms and routines to their medical personnel, and strengthen professional ethics education.
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。
Medical institutions shall formulate and implement medical quality and safety management systems, set up medical service quality monitoring departments or be equipped with full-time (or part-time) personnel, strengthen standardized management of diagnosis, treatment, nursing, pharmacy, examination and other work, optimize service processes, and improve service levels.
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。
Medical institutions shall strengthen medical risk management, improve the identification, assessment and prevention and control measures of medical risks, regularly check the implementation of measures, and promptly eliminate hidden dangers.
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。
Medical institutions shall, in accordance with the medical technology clinical application management regulations formulated by the health administrative department of the State Council, carry out medical technology services commensurate with their technical capabilities, ensure the safety of clinical application, and reduce medical risks; when adopting new medical technologies, they shall conduct technical evaluation and ethical review to ensure safety, effectiveness and compliance with ethics.
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。
Medical institutions shall, in accordance with relevant laws and regulations, strictly implement systems for the inspection upon purchase and storage of drugs, medical devices, disinfectants, blood, etc. The use of drugs, medical devices, disinfectants, blood, etc. that lack certificates of conformity or are expired or otherwise unqualified is prohibited.
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。
Medical personnel shall, during diagnosis and treatment activities, explain the patient's condition and medical measures to the patient. Where surgery or clinical trials, or other special examinations or treatments that involve certain risks and may produce adverse consequences, are required, medical personnel shall promptly explain the medical risks, alternative treatment plans, etc. to the patient and obtain the patient's written consent; where the patient is in a coma or other state where he or she cannot make decisions independently, or where the condition is not suitable to be explained to the patient, the explanation shall be given to the patient's close relatives and their written consent shall be obtained.
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。
In an emergency, where the consent of the patient or his or her close relatives cannot be obtained, the corresponding medical measures may be implemented immediately with the approval of the person in charge of the medical institution or an authorized person.
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。
Where medical institutions carry out diagnosis and treatment activities with relatively high medical risks, such as surgery, special examinations, and special treatments, they shall prepare response plans in advance and proactively prevent sudden risks.
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。
Medical institutions and their medical personnel shall, in accordance with the provisions of the competent health department of the State Council, fill in and properly keep medical records.
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。
Where medical records cannot be filled in time due to emergency rescue, medical personnel shall truthfully supplement the records within 6 hours after the rescue and annotate them.
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。
No unit or individual may alter, forge, conceal, destroy, or seize medical records.
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。
Patients have the right to access and copy their outpatient medical records, inpatient records, temperature charts,Doctor's order sheet (medical order sheets), laboratory test reports, medical imaging examination data, special examination consent forms, surgical consent forms, surgical and anesthesia records, pathological data, nursing records, medical expenses, and all other medical records as specified by the competent health department of the State Council.
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 requests to copy medical records, the medical institution shall provide copying services and affix a certification mark on the copied medical records. When copying medical records, the patient or his or her close relatives shall be present. The medical institution may charge a cost fee for copying medical records at the patient's request, and the fee standard shall be made public.
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。
Where a patient dies, his or her close relatives may access and copy medical records in accordance with these Regulations.
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。
Medical institutions shall establish and improve a doctor-patient communication mechanism. They shall patiently explain and respond to inquiries, opinions, and suggestions raised by patients during the diagnosis and treatment process, and handle them in accordance with regulations. For questions raised by patients regarding diagnosis and treatment actions, they shall promptly verify and conduct self-inspections, and designate relevant personnel to communicate with the patient or their close relatives, truthfully explaining the situation.
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。
Medical institutions shall establish and improve a complaint reception system, set up a unified complaint management department or assign full-time (or part-time) personnel, and prominently display the pathways, procedures, and contact information for medical dispute resolution in the medical institution to facilitate patient complaints or inquiries.
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。
The health administrative department shall supervise medical institutions in implementing medical quality and safety management systems, organize medical quality and safety assessments, analyze medical quality and safety information, and formulate preventive measures for identified risks.
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。
Patients shall comply with medical order and the regulations of medical institutions regarding visits, treatment, and examinations, truthfully provide information related to their condition, and cooperate with medical personnel in carrying out diagnosis and treatment activities.
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。
People's governments at all levels shall strengthen health promotion and education efforts, popularize health science knowledge, and enhance the public's understanding of medical science knowledge such as disease treatment.
医疗纠纷处理
Handling of Medical Disputes
发生医疗纠纷，医患双方可以通过下列途径解决：
In the event of a medical dispute, both the medical institution and the patient may resolve it through the following pathways:
(一)双方自愿协商；
(1) Voluntary negotiation between both parties;
(二)申请人民调解；
(2) Applying for people's mediation;
(三)申请行政调解；
(3) Applying for administrative mediation;
(四)向人民法院提起诉讼；
(4) File a lawsuit with the People's Court;
(五)法律、法规规定的其他途径。
(5) Other channels provided by laws and regulations.
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：
In the event of a medical dispute, the medical institution shall inform the patient or their close relatives of the following matters:
(一)解决医疗纠纷的合法途径；
(1) Legal channels for resolving medical disputes;
(二)有关病历资料、现场实物封存和启封的规定；
(2) Provisions on sealing and unsealing of relevant medical records and on-site physical evidence;
(三)有关病历资料查阅、复制的规定。
(3) Provisions on accessing and copying relevant medical records.
患者死亡的，还应当告知其近亲属有关尸检的规定。
If the patient dies, the medical institution shall also inform their close relatives of the provisions on autopsy.
发生医疗纠纷需要封存、启封病历资料的，应当在医患双方在场的情况下进行。封存的病历资料可以是原件，也可以是复制件，由医疗机构保管。病历尚未完成需要封存的，对已完成病历先行封存；病历按照规定完成后，再对后续完成部分进行封存。医疗机构应当对封存的病历开列封存清单，由医患双方签字或者盖章，各执一份。
When sealing or unsealing medical records is necessary due to a medical dispute, it shall be done in the presence of both the medical institution and the patient. The sealed medical records may be originals or copies, and shall be kept by the medical institution. If medical records need to be sealed before completion, the completed parts shall be sealed first; after the records are completed according to regulations, the subsequent parts shall be sealed. The medical institution shall prepare a sealing inventory for the sealed medical records, which shall be signed or sealed by both parties, with each party retaining a copy.
病历资料封存后医疗纠纷已经解决，或者患者在病历资料封存满3年未再提出解决医疗纠纷要求的，医疗机构可以自行启封。
After the medical dispute is resolved, or if the patient has not raised a request to resolve the medical dispute within three years from the date of sealing, the medical institution may unseal the records on its own.
疑似输液、输血、注射、用药等引起不良后果的，医患双方应当共同对现场实物进行封存、启封，封存的现场实物由医疗机构保管。需要检验的，应当由双方共同委托依法具有检验资格的检验机构进行检验；双方无法共同委托的，由医疗机构所在地县级人民政府卫生主管部门指定。
If adverse consequences are suspected to be caused by infusion, blood transfusion, injection, medication, etc., both the medical institution and the patient shall jointly seal and unseal the on-site physical evidence. The sealed physical evidence shall be kept by the medical institution. If testing is required, both parties shall jointly entrust a testing institution with legal testing qualifications to conduct the test; if the parties cannot jointly entrust, the health authority of the county-level people's government where the medical institution is located shall designate one.
疑似输血引起不良后果，需要对血液进行封存保留的，医疗机构应当通知提供该血液的血站派员到场。
If adverse consequences are suspected to have been caused by blood transfusion and the blood needs to be sealed and preserved, the medical institution shall notify the blood station that provided the blood to send personnel to the scene.
现场实物封存后医疗纠纷已经解决，或者患者在现场实物封存满3年未再提出解决医疗纠纷要求的，医疗机构可以自行启封。
After the on-site physical evidence has been sealed and the medical dispute has been resolved, or if the patient has not raised a request to resolve the medical dispute within three years from the date of sealing the on-site physical evidence, the medical institution may unseal it on its own.
患者死亡，医患双方对死因有异议的，应当在患者死亡后48小时内进行尸检；具备尸体冻存条件的，可以延长至7日。尸检应当经死者近亲属同意并签字，拒绝签字的，视为死者近亲属不同意进行尸检。不同意或者拖延尸检，超过规定时间，影响对死因判定的，由不同意或者拖延的一方承担责任。
If a patient dies and the medical parties dispute the cause of death, an autopsy shall be performed within 48 hours after the patient's death; if conditions for corpse freezing exist, the period may be extended to 7 days. The autopsy shall be consented to and signed by the patient's close relatives; if they refuse to sign, it shall be deemed that the close relatives do not consent to the autopsy. If the refusal or delay in performing the autopsy exceeds the prescribed time and affects the determination of the cause of death, the party that refused or delayed shall bear the responsibility.
尸检应当由按照国家有关规定取得相应资格的机构和专业技术人员进行。
Autopsy shall be performed by institutions and professional personnel who have obtained corresponding qualifications in accordance with relevant state regulations.
医患双方可以委派代表观察尸检过程。
Both medical parties may appoint representatives to observe the autopsy process.
患者在医疗机构内死亡的，尸体应当立即移放太平间或者指定的场所，死者尸体存放时间一般不得超过14日。逾期不处理的尸体，由医疗机构在向所在地县级人民政府卫生主管部门和公安机关报告后，按照规定处理。
If a patient dies within a medical institution, the corpse shall be immediately moved to a mortuary or a designated place. The storage period for the corpse shall generally not exceed 14 days. If the corpse is not disposed of within the time limit, the medical institution shall report to the local healthcompetent authority of the people's government at the county level and the public security organ, and then dispose of it in accordance with regulations.
发生重大医疗纠纷的，医疗机构应当按照规定向所在地县级以上地方人民政府卫生主管部门报告。卫生主管部门接到报告后，应当及时了解掌握情况，引导医患双方通过合法途径解决纠纷。
If a major medical dispute occurs, the medical institution shall report to the local healthcompetent authority of the people's government at or above the county level in accordance with regulations. Upon receiving the report, the healthcompetent authority shall promptly understand and grasp the situation, and guide both medical parties to resolve the dispute through legal channels.
医患双方应当依法维护医疗秩序。任何单位和个人不得实施危害患者和医务人员人身安全、扰乱医疗秩序的行为。
Both medical parties shall maintain medical order in accordance with the law. No unit or individual may engage in acts that endanger the personal safety of patients and medical personnel or disrupt medical order.
医疗纠纷中发生涉嫌违反治安管理行为或者犯罪行为的，医疗机构应当立即向所在地公安机关报案。公安机关应当及时采取措施，依法处置，维护医疗秩序。
If a medical dispute involves acts suspected of violating public security management or criminal acts, the medical institution shall immediately report to the local public security organ. The public security organ shall promptly take measures, handle the matter according to law, and maintain medical order.
医患双方选择协商解决医疗纠纷的，应当在专门场所协商，不得影响正常医疗秩序。医患双方人数较多的，应当推举代表进行协商，每方代表人数不超过5人。
If both medical parties choose to resolve a medical dispute through negotiation, they shall negotiate in a dedicated venue and shall not affect normal medical order. If there are many participants from both parties, they shall elect representatives for negotiation, with no more than five representatives per party.
协商解决医疗纠纷应当坚持自愿、合法、平等的原则，尊重当事人的权利，尊重客观事实。医患双方应当文明、理性表达意见和要求，不得有违法行为。
Negotiation to resolve medical disputes shall adhere to the principles of voluntariness, legality, and equality, respect the rights of the parties, and respect objective facts. Both medical and patient parties shall express their opinions and demands in a civilized and rational manner and shall not engage in illegal acts.
协商确定赔付金额应当以事实为依据，防止畸高或者畸低。对分歧较大或者索赔数额较高的医疗纠纷，鼓励医患双方通过人民调解的途径解决。
The amount of compensation determined through negotiation shall be based on facts to prevent excessively high or low amounts. For medical disputes with significant disagreements or high claims, the medical and patient parties are encouraged to resolve them through people's mediation.
医患双方经协商达成一致的，应当签署书面和解协议书。
If the medical and patient parties reach an agreement through negotiation, they shall sign a written settlement agreement.
申请医疗纠纷人民调解的，由医患双方共同向医疗纠纷人民调解委员会提出申请；一方申请调解的，医疗纠纷人民调解委员会在征得另一方同意后进行调解。
To apply for people's mediation of a medical dispute, the medical and patient parties shall jointly submit an application to the Medical Dispute People's Mediation Committee; if one party applies for mediation, the Medical Dispute People's Mediation Committee shall conduct mediation after obtaining the consent of the other party.
申请人可以以书面或者口头形式申请调解。书面申请的，申请书应当载明申请人的基本情况、申请调解的争议事项和理由等；口头申请的，医疗纠纷人民调解员应当当场记录申请人的基本情况、申请调解的争议事项和理由等，并经申请人签字确认。
An applicant may apply for mediation in written or oral form. For a written application, the application shall state the basic information of the applicant, the disputed matters and reasons for applying for mediation, etc.; for an oral application, the medical dispute mediator shall record on the spot the basic information of the applicant, the disputed matters and reasons for applying for mediation, etc., and have the applicant sign for confirmation.
医疗纠纷人民调解委员会获悉医疗机构内发生重大医疗纠纷，可以主动开展工作，引导医患双方申请调解。
If the Medical Dispute People's Mediation Committee learns that a major medical dispute has occurred in a medical institution, it may proactively carry out work to guide the medical and patient parties to apply for mediation.
当事人已经向人民法院提起诉讼并且已被受理，或者已经申请卫生主管部门调解并且已被受理的，医疗纠纷人民调解委员会不予受理；已经受理的，终止调解。
If a party has already filed a lawsuit with a people's court and it has been accepted, or has already applied for mediation by the health administrative department and it has been accepted, the Medical Dispute People's Mediation Committee shall not accept the case; if it has already accepted, it shall terminate the mediation.
设立医疗纠纷人民调解委员会，应当遵守《中华人民共和国人民调解法》的规定，并符合本地区实际需要。医疗纠纷人民调解委员会应当自设立之日起30个工作日内向所在地县级以上地方人民政府司法行政部门备案。
The establishment of a Medical Dispute People's Mediation Committee shall comply with the provisions of the People's Mediation Law of the People's Republic of China and meet the actual needs of the local area. The Medical Dispute People's Mediation Committee shall, within 30 working days from the date of establishment, file a record with the local judicial administrative department of the people's government at or above the county level.
医疗纠纷人民调解委员会应当根据具体情况，聘任一定数量的具有医学、法学等专业知识且热心调解工作的人员担任专(兼)职医疗纠纷人民调解员。
The Medical Dispute People's Mediation Committee shall, based on specific circumstances, appoint a certain number of persons with professional knowledge in medicine, law, etc., and who are enthusiastic about mediation work, to serve as full-time or part-time medical dispute mediators.
医疗纠纷人民调解委员会调解医疗纠纷，不得收取费用。医疗纠纷人民调解工作所需经费按照国务院财政、司法行政部门的有关规定执行。
The Medical Dispute People's Mediation Committee shall not charge fees for mediating medical disputes. The funds required for medical dispute mediation work shall be handled in accordance with the relevant provisions of the financial and judicial administrative departments of the State Council.
医疗纠纷人民调解委员会调解医疗纠纷时，可以根据需要咨询专家，并可以从本条例第三十五条规定的专家库中选取专家。
When mediating a medical dispute, the People's Mediation Committee for Medical Disputes may consult experts as needed and may select experts from the expert database specified in Article 35 of these Regulations.
医疗纠纷人民调解委员会调解医疗纠纷，需要进行医疗损害鉴定以明确责任的，由医患双方共同委托医学会或者司法鉴定机构进行鉴定，也可以经医患双方同意，由医疗纠纷人民调解委员会委托鉴定。
When mediating a medical dispute, if a medical damage appraisal is needed to clarify responsibility, it shall be conducted by a medical association or a judicial appraisal institution jointly commissioned by both the medical and patient parties, or may be commissioned by the People's Mediation Committee for Medical Disputes with the consent of both parties.
医学会或者司法鉴定机构接受委托从事医疗损害鉴定，应当由鉴定事项所涉专业的临床医学、法医学等专业人员进行鉴定；医学会或者司法鉴定机构没有相关专业人员的，应当从本条例第三十五条规定的专家库中抽取相关专业专家进行鉴定。
When a medical association or judicial appraisal institution accepts a commission to conduct a medical damage appraisal, it shall be performed by professionals in clinical medicine, forensic medicine, or other relevant specialties involved in the appraisal matter; if the medical association or judicial appraisal institution lacks relevant professionals, it shall select relevant experts from the expert database specified in Article 35 of these Regulations.
医学会或者司法鉴定机构开展医疗损害鉴定，应当执行规定的标准和程序，尊重科学，恪守职业道德，对出具的医疗损害鉴定意见负责，不得出具虚假鉴定意见。医疗损害鉴定的具体管理办法由国务院卫生、司法行政部门共同制定。
When conducting a medical damage appraisal, the medical association or judicial appraisal institution shall follow prescribed standards and procedures, respect science, uphold professional ethics, and be responsible for the medical damage appraisal opinions issued; it shall not issue false appraisal opinions. The specific management measures for medical damage appraisal shall be jointly formulated by the health and judicial administrative departments of the State Council.
鉴定费预先向医患双方收取，最终按照责任比例承担。
Appraisal fees shall be collected in advance from both the medical and patient parties and ultimately borne in proportion to liability.
医疗损害鉴定专家库由设区的市级以上人民政府卫生、司法行政部门共同设立。专家库应当包含医学、法学、法医学等领域的专家。聘请专家进入专家库，不受行政区域的限制。
The expert database for medical damage appraisal shall be jointly established by the health and judicial administrative departments of the people's governments at or above the city level with districts. The expert database shall include experts in fields such as medicine, law, and forensic medicine. The appointment of experts into the database shall not be restricted by administrative regions.
医学会、司法鉴定机构作出的医疗损害鉴定意见应当载明并详细论述下列内容：
Medical damage appraisal opinions issued by medical associations or judicial appraisal institutions shall include and discuss in detail the following contents:
(一)是否存在医疗损害以及损害程度；
(1) Whether there is medical damage and the extent of the damage;
(二)是否存在医疗过错；
(2) Whether there is medical fault;
(三)医疗过错与医疗损害是否存在因果关系；
(3) Whether there is a causal relationship between the medical fault and the medical damage;
(四)医疗过错在医疗损害中的责任程度。
(4) The degree of responsibility of medical fault in medical damage.
咨询专家、鉴定人员有下列情形之一的，应当回避，当事人也可以以口头或者书面形式申请其回避：
Consulting experts and appraisal personnel shall withdraw under any of the following circumstances, and the parties may also apply for their withdrawal orally or in writing:
(一)是医疗纠纷当事人或者当事人的近亲属；
(1) Being a party to the medical dispute or a close relative of a party;
(二)与医疗纠纷有利害关系；
(2) Having an interest in the medical dispute;
(三)与医疗纠纷当事人有其他关系，可能影响医疗纠纷公正处理。
(3) Having other relationships with a party to the medical dispute that may affect the fair handling of the medical dispute.
医疗纠纷人民调解委员会应当自受理之日起30个工作日内完成调解。需要鉴定的，鉴定时间不计入调解期限。因特殊情况需要延长调解期限的，医疗纠纷人民调解委员会和医患双方可以约定延长调解期限。超过调解期限未达成调解协议的，视为调解不成。
The Medical Dispute People's Mediation Committee shall complete mediation within 30 working days from the date of acceptance. If appraisal is required, the appraisal time shall not be counted in the mediation period. If an extension of the mediation period is necessary due to special circumstances, the Medical Dispute People's Mediation Committee and both the medical and patient parties may agree to extend the mediation period. If no mediation agreement is reached beyond the mediation period, it shall be deemed that mediation has failed.
医患双方经人民调解达成一致的，医疗纠纷人民调解委员会应当制作调解协议书。调解协议书经医患双方签字或者盖章，人民调解员签字并加盖医疗纠纷人民调解委员会印章后生效。
If both the medical and patient parties reach an agreement through people's mediation, the Medical Dispute People's Mediation Committee shall prepare a mediation agreement. The mediation agreement shall take effect after being signed or sealed by both parties, signed by the people's mediator, and affixed with the seal of the Medical Dispute People's Mediation Committee.
达成调解协议的，医疗纠纷人民调解委员会应当告知医患双方可以依法向人民法院申请司法确认。
Upon reaching a mediation agreement, the Medical Dispute People's Mediation Committee shall inform both parties that they may apply to the people's court for judicial confirmation in accordance with the law.
医患双方申请医疗纠纷行政调解的，应当参照本条例第三十一条第一款、第二款的规定向医疗纠纷发生地县级人民政府卫生主管部门提出申请。
If both the medical and patient parties apply for administrative mediation of a medical dispute, they shall submit an application to the healthcompetent authority of the people's government at the county level where the medical dispute occurred, in accordance with the provisions of Article 31, paragraphs 1 and 2 of these Regulations.
卫生主管部门应当自收到申请之日起5个工作日内作出是否受理的决定。当事人已经向人民法院提起诉讼并且已被受理，或者已经申请医疗纠纷人民调解委员会调解并且已被受理的，卫生主管部门不予受理；已经受理的，终止调解。
The healthcompetent authority shall decide whether to accept the application within 5 working days from the date of receipt. If the parties have already filed a lawsuit with the people's court and it has been accepted, or have already applied for mediation by the Medical Dispute People's Mediation Committee and it has been accepted, the healthcompetent authority shall not accept the application; if already accepted, the mediation shall be terminated.
卫生主管部门应当自受理之日起30个工作日内完成调解。需要鉴定的，鉴定时间不计入调解期限。超过调解期限未达成调解协议的，视为调解不成。
The health authority shall complete mediation within 30 working days from the date of acceptance. If appraisal is needed, the appraisal period shall not be counted in the mediation period. If no mediation agreement is reached beyond the mediation period, it shall be deemed as failed mediation.
卫生主管部门调解医疗纠纷需要进行专家咨询的，可以从本条例第三十五条规定的专家库中抽取专家；医患双方认为需要进行医疗损害鉴定以明确责任的，参照本条例第三十四条的规定进行鉴定。
Where the health authority needs expert consultation in mediating a medical dispute, it may select experts from the expert database specified in Article 35 of these Regulations; if both the medical and patient parties consider that medical damage appraisal is necessary to clarify liability, the appraisal shall be conducted in accordance with Article 34 of these Regulations.
医患双方经卫生主管部门调解达成一致的，应当签署调解协议书。
If the medical and patient parties reach an agreement through mediation by the health authority, they shall sign a mediation agreement.
医疗纠纷人民调解委员会及其人民调解员、卫生主管部门及其工作人员应当对医患双方的个人隐私等事项予以保密。
The People's Medical Dispute Mediation Committee and its mediators, as well as the health authority and its staff, shall keep confidential matters such as the personal privacy of both the medical and patient parties.
未经医患双方同意，医疗纠纷人民调解委员会、卫生主管部门不得公开进行调解，也不得公开调解协议的内容。
Without the consent of both the medical and patient parties, the People's Medical Dispute Mediation Committee and the health authority shall not conduct mediation publicly, nor shall they disclose the content of the mediation agreement.
发生医疗纠纷，当事人协商、调解不成的，可以依法向人民法院提起诉讼。当事人也可以直接向人民法院提起诉讼。
If a medical dispute occurs and the parties fail to resolve it through negotiation or mediation, they may file a lawsuit with the People's Court in accordance with the law. The parties may also directly file a lawsuit with the People's Court.
发生医疗纠纷，需要赔偿的，赔付金额依照法律的规定确定。
If a medical dispute occurs and compensation is required, the amount of compensation shall be determined in accordance with the provisions of the law.
法律责任
Legal Liability
医疗机构篡改、伪造、隐匿、毁灭病历资料的，对直接负责的主管人员和其他直接责任人员，由县级以上人民政府卫生主管部门给予或者责令给予降低岗位等级或者撤职的处分，对有关医务人员责令暂停6个月以上1年以下执业活动；造成严重后果的，对直接负责的主管人员和其他直接责任人员给予或者责令给予开除的处分，对有关医务人员由原发证部门吊销执业证书；构成犯罪的，依法追究刑事责任。
If a medical institution alters, forges, conceals, or destroys medical records, the directly responsible supervisor and other directly responsible personnel shall be given or ordered to be given a sanction of demotion or removal from their positions by the health authority of the people's government at or above the county level; the relevant medical personnel shall be ordered to suspend their practice for not less than 6 months but not more than 1 year; if serious consequences are caused, the directly responsible supervisor and other directly responsible personnel shall be given or ordered to be given a sanction of dismissal, and the relevant medical personnel shall have their practice certificate revoked by the original issuing authority; if a crime is constituted, criminal liability shall be pursued in accordance with the law.
医疗机构将未通过技术评估和伦理审查的医疗新技术应用于临床的，由县级以上人民政府卫生主管部门没收违法所得，并处5万元以上10万元以下罚款，对直接负责的主管人员和其他直接责任人员给予或者责令给予降低岗位等级或者撤职的处分，对有关医务人员责令暂停6个月以上1年以下执业活动；情节严重的，对直接负责的主管人员和其他直接责任人员给予或者责令给予开除的处分，对有关医务人员由原发证部门吊销执业证书；构成犯罪的，依法追究刑事责任。
If a medical institution applies new medical technology that has not passed technical evaluation and ethical review to clinical practice, the health authority of the people's government at or above the county level shall confiscate the illegal gains and impose a fine of not less than 50,000 yuan but not more than 100,000 yuan; the directly responsible supervisor and other directly responsible personnel shall be given or ordered to be given a sanction of demotion or removal from their positions; the relevant medical personnel shall be ordered to suspend their practice for not less than 6 months but not more than 1 year; if the circumstances are serious, the directly responsible supervisor and other directly responsible personnel shall be given or ordered to be given a sanction of dismissal, and the relevant medical personnel shall have their practice certificate revoked by the original issuing authority; if a crime is constituted, criminal liability shall be pursued in accordance with the law.
医疗机构及其医务人员有下列情形之一的，由县级以上人民政府卫生主管部门责令改正，给予警告，并处1万元以上5万元以下罚款；情节严重的，对直接负责的主管人员和其他直接责任人员给予或者责令给予降低岗位等级或者撤职的处分，对有关医务人员可以责令暂停1个月以上6个月以下执业活动；构成犯罪的，依法追究刑事责任：
Where a medical institution or its medical staff falls under any of the following circumstances, the health authority of the people's government at or above the county level shall order correction, give a warning, and impose a fine of not less than 10,000 yuan but not more than 50,000 yuan; if the circumstances are serious, the directly responsible person in charge and other directly responsible personnel shall be given or ordered to be given a sanction of demotion or removal from post, and the relevant medical staff may be ordered to suspend practice for not less than one month but not more than six months; if a crime is constituted, criminal liability shall be pursued according to law:
(一)未按规定制定和实施医疗质量安全管理制度；
(1) Failing to formulate and implement medical quality and safety management systems as required;
(二)未按规定告知患者病情、医疗措施、医疗风险、替代医疗方案等；
(2) Failing to inform patients of their condition, medical measures, medical risks, alternative treatment plans, etc. as required;
(三)开展具有较高医疗风险的诊疗活动，未提前预备应对方案防范突发风险；
(3) Carrying out diagnostic and treatment activities with relatively high medical risks without preparing contingency plans in advance to prevent sudden risks;
(四)未按规定填写、保管病历资料，或者未按规定补记抢救病历；
(4) Failing to fill in or keep medical records as required, or failing to supplement emergency records as required;
(五)拒绝为患者提供查阅、复制病历资料服务；
(5) Refusing to provide patients with services for consulting or copying medical records;
(六)未建立投诉接待制度、设置统一投诉管理部门或者配备专(兼)职人员；
(6) Failing to establish a complaint reception system, set up a unified complaint management department, or assign full-time or part-time personnel;
(七)未按规定封存、保管、启封病历资料和现场实物；
(7) Failing to seal, keep, or unseal medical records and on-site physical evidence as required;
(八)未按规定向卫生主管部门报告重大医疗纠纷；
(8) Failing to report major medical disputes to the health authority as required;
(九)其他未履行本条例规定义务的情形。
(9) Other failures to perform obligations stipulated in these Regulations.
医学会、司法鉴定机构出具虚假医疗损害鉴定意见的，由县级以上人民政府卫生、司法行政部门依据职责没收违法所得，并处5万元以上10万元以下罚款，对该医学会、司法鉴定机构和有关鉴定人员责令暂停3个月以上1年以下医疗损害鉴定业务，对直接负责的主管人员和其他直接责任人员给予或者责令给予降低岗位等级或者撤职的处分；情节严重的，该医学会、司法鉴定机构和有关鉴定人员5年内不得从事医疗损害鉴定业务或者撤销登记，对直接负责的主管人员和其他直接责任人员给予或者责令给予开除的处分；构成犯罪的，依法追究刑事责任。
If a medical association or forensic identification institution issues a false medical damage appraisal opinion, the health and judicial administrative departments of the people's government at or above the county level shall, according to their duties, confiscate the illegal gains, impose a fine of not less than 50,000 yuan but not more than 100,000 yuan, order the medical association, forensic identification institution, and relevant identification personnel to suspend medical damage appraisal business for not less than 3 months but not more than 1 year, and impose or order the imposition of demotion or removal from office on the directly responsible supervisors and other directly responsible personnel; if the circumstances are serious, the medical association, forensic identification institution, and relevant identification personnel shall be prohibited from engaging in medical damage appraisal business for 5 years or have their registration revoked, and the directly responsible supervisors and other directly responsible personnel shall be imposed or ordered to be imposed with expulsion; if a crime is constituted, criminal liability shall be pursued according to law.
尸检机构出具虚假尸检报告的，由县级以上人民政府卫生、司法行政部门依据职责没收违法所得，并处5万元以上10万元以下罚款，对该尸检机构和有关尸检专业技术人员责令暂停3个月以上1年以下尸检业务，对直接负责的主管人员和其他直接责任人员给予或者责令给予降低岗位等级或者撤职的处分；情节严重的，撤销该尸检机构和有关尸检专业技术人员的尸检资格，对直接负责的主管人员和其他直接责任人员给予或者责令给予开除的处分；构成犯罪的，依法追究刑事责任。
If an autopsy institution issues a false autopsy report, the health and judicial administrative departments of the people's government at or above the county level shall, according to their duties, confiscate the illegal gains, impose a fine of not less than 50,000 yuan but not more than 100,000 yuan, order the autopsy institution and relevant autopsy professional technicians to suspend autopsy business for not less than 3 months but not more than 1 year, and impose or order the imposition of demotion or removal from office on the directly responsible supervisors and other directly responsible personnel; if the circumstances are serious, the autopsy qualification of the autopsy institution and relevant autopsy professional technicians shall be revoked, and the directly responsible supervisors and other directly responsible personnel shall be imposed or ordered to be imposed with expulsion; if a crime is constituted, criminal liability shall be pursued according to law.
医疗纠纷人民调解员有下列行为之一的，由医疗纠纷人民调解委员会给予批评教育、责令改正；情节严重的，依法予以解聘：
If a medical dispute people's mediator commits any of the following acts, the medical dispute people's mediation committee shall give criticism education and order correction; if the circumstances are serious, the mediator shall be dismissed according to law:
(一)偏袒一方当事人；
(1) Favoring one party;
(二)侮辱当事人；
(2) Insulting the parties;
(三)索取、收受财物或者牟取其他不正当利益；
(3) Soliciting or accepting property or seeking other improper benefits;
(四)泄露医患双方个人隐私等事项。
(4) Disclosing personal privacy of the medical and patient parties.
新闻媒体编造、散布虚假医疗纠纷信息的，由有关主管部门依法给予处罚；给公民、法人或者其他组织的合法权益造成损害的，依法承担消除影响、恢复名誉、赔偿损失、赔礼道歉等民事责任。
If a news media fabricates or disseminates false medical dispute information, the relevant competent department shall impose penalties according to law; if it causes damage to the lawful rights and interests of citizens, legal persons, or other organizations, it shall bear civil liability such as eliminating the impact, restoring reputation, compensating for losses, and making apologies according to law.
县级以上人民政府卫生主管部门和其他有关部门及其工作人员在医疗纠纷预防和处理工作中，不履行职责或者滥用职权、玩忽职守、徇私舞弊的，由上级人民政府卫生等有关部门或者监察机关责令改正；依法对直接负责的主管人员和其他直接责任人员给予处分；构成犯罪的，依法追究刑事责任。
If the health competent department of the people's government at or above the county level and other relevant departments and their staff fail to perform their duties, abuse their power, neglect their duties, or engage in malpractice for personal gain in the prevention and handling of medical disputes, the health department of the higher-level people's government or the supervisory authority shall order correction; the directly responsible supervisors and other directly responsible personnel shall be given sanctions according to law; if a crime is constituted, criminal liability shall be pursued according to law.
医患双方在医疗纠纷处理中，造成人身、财产或者其他损害的，依法承担民事责任；构成违反治安管理行为的，由公安机关依法给予治安管理处罚；构成犯罪的，依法追究刑事责任。
If the medical and patient parties cause personal, property, or other damage in the handling of medical disputes, they shall bear civil liability according to law; if the act constitutes a violation of public security administration, the public security organ shall impose public security administration penalties according to law; if a crime is constituted, criminal liability shall be pursued according to law.
附则
Supplementary Provisions
军队医疗机构的医疗纠纷预防和处理办法，由中央军委机关有关部门会同国务院卫生主管部门依据本条例制定。
The measures for the prevention and handling of medical disputes in military medical institutions shall be formulated by the relevant departments of the Central Military Commission jointly with the health authorities of the State Council in accordance with these Regulations.
对诊疗活动中医疗事故的行政调查处理，依照《医疗事故处理条例》的相关规定执行。
The administrative investigation and handling of medical accidents in diagnosis and treatment activities shall be carried out in accordance with the relevant provisions of the Regulations on the Handling of Medical Accidents.
本条例自2018年10月1日起施行。
These Regulations shall come into force on October 1, 2018.