KYB CHINA(2002年2月20日国务院第55次常务会议通过 2002年4月4日中华人民共和国国务院令第351号公布 自2002年9月1日起施行)
(Adopted at the 55th Executive Meeting of the State Council on February 20, 2002, promulgated by Decree No. 351 of the State Council of the People's Republic of China on April 4, 2002, and effective as of September 1, 2002)
总则
General Provisions
为了正确处理医疗事故，保护患者和医疗机构及其医务人员的合法权益，维护医疗秩序，保障医疗安全，促进医学科学的发展，制定本条例。
These Regulations are formulated for the purpose of properly handling medical accidents, protecting the legitimate rights and interests of patients and medical institutions and their medical personnel, maintaining medical order, ensuring medical safety, and promoting the development of medical science.
本条例所称医疗事故，是指医疗机构及其医务人员在医疗活动中，违反医疗卫生管理法律、行政法规、部门规章和诊疗护理规范、常规，过失造成患者人身损害的事故。
For the purposes of these Regulations, a medical accident refers to an accident in which a medical institution and its medical personnel, in the course of medical activities, violate health management laws, administrative regulations, departmental rules, and diagnostic and therapeutic nursing standards and routines, and negligently cause personal injury to a patient.
处理医疗事故，应当遵循公开、公平、公正、及时、便民的原则，坚持实事求是的科学态度，做到事实清楚、定性准确、责任明确、处理恰当。
The handling of medical accidents shall follow the principles of openness, fairness, impartiality, timeliness, and convenience, adhere to a scientific attitude of seeking truth from facts, and achieve clear facts, accurate characterization, clear responsibility, and appropriate handling.
根据对患者人身造成的损害程度，医疗事故分为四级：
According to the degree of personal injury caused to the patient, medical accidents are divided into four levels:
一级医疗事故：造成患者死亡、重度残疾的；
Level 1 medical accident: causing death or severe disability to the patient;
二级医疗事故：造成患者中度残疾、器官组织损伤导致严重功能障碍的；
Level 2 medical accident: causing moderate disability or organ tissue damage resulting in severe dysfunction to the patient;
三级医疗事故：造成患者轻度残疾、器官组织损伤导致一般功能障碍的；
Level 3 medical accident: causing mild disability or organ tissue damage resulting in general dysfunction to the patient;
四级医疗事故：造成患者明显人身损害的其他后果的。
Level 4 medical accident: causing other consequences of obvious personal injury to the patient.
具体分级标准由国务院卫生行政部门制定。
The specific classification standards shall be formulated by the health administrative department of the State Council.
医疗事故的预防与处置
Prevention and Handling of Medical Accidents
医疗机构及其医务人员在医疗活动中，必须严格遵守医疗卫生管理法律、行政法规、部门规章和诊疗护理规范、常规，恪守医疗服务职业道德。
Medical institutions and their medical personnel must strictly abide by medical and health management laws, administrative regulations, departmental rules, and diagnosis and treatment nursing standards and routines in medical activities, and adhere to medical service professional ethics.
医疗机构应当对其医务人员进行医疗卫生管理法律、行政法规、部门规章和诊疗护理规范、常规的培训和医疗服务职业道德教育。
Medical institutions shall provide training on medical and health management laws, administrative regulations, departmental rules, and diagnosis and treatment nursing standards and routines, as well as education on medical service professional ethics, to their medical personnel.
医疗机构应当设置医疗服务质量监控部门或者配备专(兼)职人员，具体负责监督本医疗机构的医务人员的医疗服务工作，检查医务人员执业情况，接受患者对医疗服务的投诉，向其提供咨询服务。
Medical institutions shall establish a medical service quality supervision department or assign full-time (or part-time) personnel specifically responsible for supervising the medical service work of their medical personnel, inspecting the practice status of medical personnel, accepting patient complaints about medical services, and providing consulting services to them.
医疗机构应当按照国务院卫生行政部门规定的要求，书写并妥善保管病历资料。
Medical institutions shall write and properly keep medical record materials in accordance with the requirements prescribed by the health administrative department of the State Council.
因抢救急危患者，未能及时书写病历的，有关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。
If a medical record cannot be written in time due to emergency rescue of a critically ill patient, the relevant medical personnel shall make a factual supplementary record within 6 hours after the rescue and annotate it.
严禁涂改、伪造、隐匿、销毁或者抢夺病历资料。
It is strictly prohibited to alter, forge, conceal, destroy, or seize medical record materials.
患者有权复印或者复制其门诊病历、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、手术及麻醉记录单、病理资料、护理记录以及国务院卫生行政部门规定的其他病历资料。
Patients have the right to copy or reproduce their outpatient medical records, inpatient records, temperature charts,Doctor's order sheet (medical order sheets), laboratory test sheets (test reports), medical imaging examination materials, special examination consent forms, surgical consent forms, surgical and anesthesia records, pathological materials, nursing records, and other medical record materials prescribed by the health administrative department of the State Council.
患者依照前款规定要求复印或者复制病历资料的，医疗机构应当提供复印或者复制服务并在复印或者复制的病历资料上加盖证明印记。复印或者复制病历资料时，应当有患者在场。
If a patient requests to copy or reproduce medical record materials in accordance with the preceding paragraph, the medical institution shall provide copying or reproduction services and affix a certification mark on the copied or reproduced medical record materials. When copying or reproducing medical record materials, the patient shall be present.
医疗机构应患者的要求，为其复印或者复制病历资料，可以按照规定收取工本费。具体收费标准由省、自治区、直辖市人民政府价格主管部门会同同级卫生行政部门规定。
Medical institutions, upon a patient's request to copy or reproduce medical records, may charge a fee for the cost of materials. The specific fee standard shall be stipulated by the price department of the people's government of the province, autonomous region, or municipality directly under the Central Government jointly with the health administrative department at the same level.
在医疗活动中，医疗机构及其医务人员应当将患者的病情、医疗措施、医疗风险等如实告知患者，及时解答其咨询；但是，应当避免对患者产生不利后果。
In medical activities, medical institutions and their medical personnel shall truthfully inform patients of their condition, medical measures, medical risks, etc., and promptly answer their inquiries; however, they shall avoid causing adverse consequences to the patient.
医疗机构应当制定防范、处理医疗事故的预案，预防医疗事故的发生，减轻医疗事故的损害。
Medical institutions shall formulate plans to prevent and handle medical accidents, prevent the occurrence of medical accidents, and mitigate the harm caused by medical accidents.
医务人员在医疗活动中发生或者发现医疗事故、可能引起医疗事故的医疗过失行为或者发生医疗事故争议的，应当立即向所在科室负责人报告，科室负责人应当及时向本医疗机构负责医疗服务质量监控的部门或者专(兼)职人员报告；负责医疗服务质量监控的部门或者专(兼)职人员接到报告后，应当立即进行调查、核实，将有关情况如实向本医疗机构的负责人报告，并向患者通报、解释。
When medical personnel, during medical activities, discover or become aware of a medical accident, medical negligence that may cause a medical accident, or a medical accident dispute, they shall immediately report to the head of their department; the department head shall promptly report to the department or person(s) responsible for medical service quality monitoring in the medical institution; after receiving the report, the department or person(s) responsible for medical service quality monitoring shall immediately investigate and verify, truthfully report the relevant situation to the head of the medical institution, and notify and explain to the patient.
发生医疗事故的，医疗机构应当按照规定向所在地卫生行政部门报告。
When a medical accident occurs, the medical institution shall report to the local health administrative department in accordance with regulations.
发生下列重大医疗过失行为的，医疗机构应当在12小时内向所在地卫生行政部门报告：
When the following major medical negligence occurs, the medical institution shall report to the local health administrative department within 12 hours:
(一)导致患者死亡或者可能为二级以上的医疗事故；
(1) Resulting in the death of a patient or possibly being a medical accident of level two or above;
(二)导致3人以上人身损害后果；
(2) Resulting in personal injury to three or more persons;
(三)国务院卫生行政部门和省、自治区、直辖市人民政府卫生行政部门规定的其他情形。
(3) Other circumstances stipulated by the health administrative department of the State Council and the health administrative departments of the people's governments of provinces, autonomous regions, or municipalities directly under the Central Government.
发生或者发现医疗过失行为，医疗机构及其医务人员应当立即采取有效措施，避免或者减轻对患者身体健康的损害，防止损害扩大。
When medical negligence occurs or is discovered, the medical institution and its medical personnel shall immediately take effective measures to avoid or mitigate harm to the patient's health and prevent the harm from expanding.
发生医疗事故争议时，死亡病例讨论记录、疑难病例讨论记录、上级医师查房记录、会诊意见、病程记录应当在医患双方在场的情况下封存和启封。封存的病历资料可以是复印件，由医疗机构保管。
When a medical accident dispute arises, records of death case discussions, difficult case discussions, senior physician ward rounds, consultation opinions, and course of illness records shall be sealed and unsealed in the presence of both the medical institution and the patient. The sealed medical records may be copies and shall be kept by the medical institution.
疑似输液、输血、注射、药物等引起不良后果的，医患双方应当共同对现场实物进行封存和启封，封存的现场实物由医疗机构保管；需要检验的，应当由双方共同指定的、依法具有检验资格的检验机构进行检验；双方无法共同指定时，由卫生行政部门指定。
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 physical evidence at the scene. The sealed physical evidence shall be kept by the medical institution; if testing is required, it shall be conducted by a testing institution jointly designated by both parties and legally qualified for testing. If the parties cannot jointly designate, the health administrative department shall designate.
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采供血机构派员到场。
If adverse consequences are suspected to be caused by blood transfusion and the blood needs to be sealed and preserved, the medical institution shall notify the blood collection and supply institution that provided the blood to send personnel to the scene.
患者死亡，医患双方当事人不能确定死因或者对死因有异议的，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。
If a patient dies and the medical institution and the patient's family cannot determine the cause of death or dispute the cause of death, an autopsy shall be performed within 48 hours after the patient's death; if conditions for body freezing exist, the period may be extended to 7 days. The autopsy shall be consented to and signed by the patient's close relatives.
尸检应当由按照国家有关规定取得相应资格的机构和病理解剖专业技术人员进行。承担尸检任务的机构和病理解剖专业技术人员有进行尸检的义务。
The autopsy shall be performed by an institution and pathological anatomy professionals who have obtained corresponding qualifications in accordance with relevant state regulations. The institution undertaking the autopsy and the pathological anatomy professionals have the obligation to perform the autopsy.
医疗事故争议双方当事人可以请法医病理学人员参加尸检，也可以委派代表观察尸检过程。拒绝或者拖延尸检，超过规定时间，影响对死因判定的，由拒绝或者拖延的一方承担责任。
Both parties to a medical accident dispute may invite forensic pathologists to participate in the autopsy, or may appoint representatives to observe the autopsy process. If a party refuses or delays the autopsy beyond the prescribed time, affecting the determination of the cause of death, that party shall bear the responsibility.
患者在医疗机构内死亡的，尸体应当立即移放太平间。死者尸体存放时间一般不得超过2周。逾期不处理的尸体，经医疗机构所在地卫生行政部门批准，并报经同级公安部门备案后，由医疗机构按照规定进行处理。
If a patient dies in a medical institution, the body shall be immediately moved to the mortuary. The storage period for the deceased's body shall generally not exceed 2 weeks. If the body is not disposed of within the time limit, after approval by the health administrative department where the medical institution is located and filing with the public security department at the same level, the medical institution shall dispose of it in accordance with regulations.
医疗事故的技术鉴定
Technical Appraisal of Medical Accidents
卫生行政部门接到医疗机构关于重大医疗过失行为的报告或者医疗事故争议当事人要求处理医疗事故争议的申请后，对需要进行医疗事故技术鉴定的，应当交由负责医疗事故技术鉴定工作的医学会组织鉴定；医患双方协商解决医疗事故争议，需要进行医疗事故技术鉴定的，由双方当事人共同委托负责医疗事故技术鉴定工作的医学会组织鉴定。
After receiving a report from a medical institution regarding a major medical negligence act or an application from a party to a medical accident dispute requesting handling of the dispute, if technical appraisal is needed, the health administrative department shall refer the matter to the medical association responsible for medical accident technical appraisal for organization of the appraisal. If the medical institution and the patient resolve the medical accident dispute through consultation and need technical appraisal, both parties shall jointly entrust the medical association responsible for medical accident technical appraisal to organize the appraisal.
设区的市级地方医学会和省、自治区、直辖市直接管辖的县(市)地方医学会负责组织首次医疗事故技术鉴定工作。省、自治区、直辖市地方医学会负责组织再次鉴定工作。
The local medical association at the level of a city divided into districts and the local medical association of a county (city) directly under the jurisdiction of a province, autonomous region, or municipality directly under the Central Government shall be responsible for organizing the initial medical accident technical appraisal. The local medical association at the level of a province, autonomous region, or municipality directly under the Central Government shall be responsible for organizing the reappraisal.
必要时，中华医学会可以组织疑难、复杂并在全国有重大影响的医疗事故争议的技术鉴定工作。
When necessary, the Chinese Medical Association may organize technical appraisal work for difficult, complex medical accident disputes that have significant national impact.
当事人对首次医疗事故技术鉴定结论不服的，可以自收到首次鉴定结论之日起15日内向医疗机构所在地卫生行政部门提出再次鉴定的申请。
If a party is dissatisfied with the conclusion of the first medical accident technical appraisal, they may apply for a reappraisal to the health administrative department of the place where the medical institution is located within 15 days from the date of receiving the first appraisal conclusion.
负责组织医疗事故技术鉴定工作的医学会应当建立专家库。
The medical association responsible for organizing medical accident technical appraisal shall establish an expert database.
专家库由具备下列条件的医疗卫生专业技术人员组成：
The expert database shall be composed of medical and health professionals who meet the following conditions:
(一)有良好的业务素质和执业品德；
(1) Possess good professional competence and practice ethics;
(二)受聘于医疗卫生机构或者医学教学、科研机构并担任相应专业高级技术职务3年以上。
(2) Be employed by a medical and health institution or a medical teaching or research institution and have held a corresponding senior technical position for more than 3 years.
符合前款第(一)项规定条件并具备高级技术任职资格的法医可以受聘进入专家库。
Forensic doctors who meet the conditions specified in item (1) of the preceding paragraph and possess senior technical qualifications may be employed to enter the expert database.
负责组织医疗事故技术鉴定工作的医学会依照本条例规定聘请医疗卫生专业技术人员和法医进入专家库，可以不受行政区域的限制。
The medical association responsible for organizing medical accident technical appraisal may employ medical and health professionals and forensic doctors into the expert database in accordance with these regulations, without being restricted by administrative regions.
医疗事故技术鉴定，由负责组织医疗事故技术鉴定工作的医学会组织专家鉴定组进行。
Medical accident technical appraisal shall be conducted by an expert appraisal group organized by the medical association responsible for organizing medical accident technical appraisal.
参加医疗事故技术鉴定的相关专业的专家，由医患双方在医学会主持下从专家库中随机抽取。在特殊情况下，医学会根据医疗事故技术鉴定工作的需要，可以组织医患双方在其他医学会建立的专家库中随机抽取相关专业的专家参加鉴定或者函件咨询。
Experts in relevant specialties participating in the medical accident technical appraisal shall be randomly selected from the expert database by both the medical and patient parties under the auspices of the medical association. Under special circumstances, the medical association may, based on the needs of the medical accident technical appraisal work, organize both parties to randomly select experts in relevant specialties from the expert databases established by other medical associations to participate in the appraisal or provide correspondence consultation.
符合本条例第二十三条规定条件的医疗卫生专业技术人员和法医有义务受聘进入专家库，并承担医疗事故技术鉴定工作。
Medical and health professional technicians and forensic doctors who meet the conditions specified in Article 23 of these Regulations are obligated to be recruited into the expert database and undertake the work of technical appraisal of medical accidents.
专家鉴定组进行医疗事故技术鉴定，实行合议制。专家鉴定组人数为单数，涉及的主要学科的专家一般不得少于鉴定组成员的二分之一；涉及死因、伤残等级鉴定的，并应当从专家库中随机抽取法医参加专家鉴定组。
The expert appraisal panel shall conduct technical appraisal of medical accidents under a collegial system. The number of members of the expert appraisal panel shall be an odd number, and the experts in the main disciplines involved shall generally not be less than one-half of the members of the appraisal panel; where the appraisal involves the cause of death or the grade of disability, forensic doctors shall be randomly selected from the expert database to participate in the expert appraisal panel.
专家鉴定组成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的方式申请其回避：
An expertmembers of the appraisal panel shall withdraw under any of the following circumstances, and the parties may also apply for their withdrawal orally or in writing:
(一)是医疗事故争议当事人或者当事人的近亲属的；
(1) They are a party to the medical accident dispute or a close relative of a party;
(二)与医疗事故争议有利害关系的；
(2) They have an interest in the medical accident dispute;
(三)与医疗事故争议当事人有其他关系，可能影响公正鉴定的。
(3) They have another relationship with a party to the medical accident dispute that may affect impartial appraisal.
专家鉴定组依照医疗卫生管理法律、行政法规、部门规章和诊疗护理规范、常规，运用医学科学原理和专业知识，独立进行医疗事故技术鉴定，对医疗事故进行鉴别和判定，为处理医疗事故争议提供医学依据。
The expert appraisal panel shall, in accordance with medical and health management laws, administrative regulations, departmental rules, and diagnostic and therapeutic nursing standards and routines, apply medical scientific principles and professional knowledge to independently conduct technical appraisal of medical accidents, identify and determine medical accidents, and provide medical evidence for handling medical accident disputes.
任何单位或者个人不得干扰医疗事故技术鉴定工作，不得威胁、利诱、辱骂、殴打专家鉴定组成员。
No unit or individual may interfere with the work of technical appraisal of medical accidents, nor threaten, induce, insult, or assault members of the expert appraisal panel.
专家鉴定组成员不得接受双方当事人的财物或者其他利益。
Members of the expert appraisal panel shall not accept property or other benefits from either party.
负责组织医疗事故技术鉴定工作的医学会应当自受理医疗事故技术鉴定之日起5日内通知医疗事故争议双方当事人提交进行医疗事故技术鉴定所需的材料。
The medical association responsible for organizing the technical appraisal of medical accidents shall, within 5 days from the date of accepting the technical appraisal of a medical accident, notify the parties to the medical accident dispute to submit the materials required for the technical appraisal of the medical accident.
当事人应当自收到医学会的通知之日起10日内提交有关医疗事故技术鉴定的材料、书面陈述及答辩。医疗机构提交的有关医疗事故技术鉴定的材料应当包括下列内容：
The parties shall, within 10 days from the date of receiving the notice from the medical association, submit materials, written statements, and defenses related to the medical accident technical appraisal. The materials submitted by the medical institution for the medical accident technical appraisal shall include the following:
(一)住院患者的病程记录、死亡病例讨论记录、疑难病例讨论记录、会诊意见、上级医师查房记录等病历资料原件；
(1) Original medical records such as the course records of inpatients, death case discussion records, difficult case discussion records, consultation opinions, and ward round records of senior physicians;
(二)住院患者的住院志、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、手术及麻醉记录单、病理资料、护理记录等病历资料原件；
(2) Original medical records such as inpatient admission records, temperature charts,doctor's orders sheets, laboratory test sheets (test reports), medical imaging examination data, special examination consent forms, surgical consent forms, surgical and anesthesia records, pathological data, and nursing records;
(三)抢救急危患者，在规定时间内补记的病历资料原件；
(3) Original medical records supplemented within the prescribed time limit for emergency rescue of critically ill patients;
(四)封存保留的输液、注射用物品和血液、药物等实物，或者依法具有检验资格的检验机构对这些物品、实物作出的检验报告；
(4) Sealed and retained physical items such as infusion and injection supplies, blood, and drugs, or inspection reports on these items and physical objects issued by inspection institutions legally qualified for inspection;
(五)与医疗事故技术鉴定有关的其他材料。
(5) Other materials related to the medical accident technical appraisal.
在医疗机构建有病历档案的门诊、急诊患者，其病历资料由医疗机构提供；没有在医疗机构建立病历档案的，由患者提供。
For outpatients and emergency patients who have established medical record files in the medical institution, their medical records shall be provided by the medical institution; for those who have not established medical record files in the medical institution, they shall be provided by the patient.
医患双方应当依照本条例的规定提交相关材料。医疗机构无正当理由未依照本条例的规定如实提供相关材料，导致医疗事故技术鉴定不能进行的，应当承担责任。
Both the medical and patient parties shall submit relevant materials in accordance with the provisions of these Regulations. If the medical institution, without justifiable reasons, fails to truthfully provide relevant materials in accordance with these Regulations, resulting in the inability to conduct the medical accident technical appraisal, it shall bear responsibility.
负责组织医疗事故技术鉴定工作的医学会应当自接到当事人提交的有关医疗事故技术鉴定的材料、书面陈述及答辩之日起45日内组织鉴定并出具医疗事故技术鉴定书。
The medical association responsible for organizing the medical accident technical appraisal shall, within 45 days from the date of receiving the materials, written statements, and defenses submitted by the parties, organize the appraisal and issue the medical accident technical appraisal report.
负责组织医疗事故技术鉴定工作的医学会可以向双方当事人调查取证。
The medical association responsible for organizing the medical accident technical appraisal may investigate and collect evidence from both parties.
专家鉴定组应当认真审查双方当事人提交的材料，听取双方当事人的陈述及答辩并进行核实。
The expert appraisal panel shall carefully review the materials submitted by both parties, listen to their statements and defenses, and verify them.
双方当事人应当按照本条例的规定如实提交进行医疗事故技术鉴定所需要的材料，并积极配合调查。当事人任何一方不予配合，影响医疗事故技术鉴定的，由不予配合的一方承担责任。
Both parties shall truthfully submit the materials required for medical accident technical appraisal in accordance with these Regulations, and actively cooperate with the investigation. If either party fails to cooperate, affecting the medical accident technical appraisal, that party shall bear the responsibility.
专家鉴定组应当在事实清楚、证据确凿的基础上，综合分析患者的病情和个体差异，作出鉴定结论，并制作医疗事故技术鉴定书。鉴定结论以专家鉴定组成员的过半数通过。鉴定过程应当如实记载。
The expert appraisal panel shall, on the basis of clear facts and conclusive evidence, comprehensively analyze the patient's condition and individual differences, make an appraisal conclusion, and produce a medical accident technical appraisal report. The appraisal conclusion shall be adopted by a majority of the members of the expert appraisal panel. The appraisal process shall be truthfully recorded.
医疗事故技术鉴定书应当包括下列主要内容：
The medical accident technical appraisal report shall include the following main contents:
(一)双方当事人的基本情况及要求；
(1) Basic information and requests of both parties;
(二)当事人提交的材料和负责组织医疗事故技术鉴定工作的医学会的调查材料；
(2) Materials submitted by the parties and investigation materials from the medical association responsible for organizing the medical accident technical appraisal;
(三)对鉴定过程的说明；
(3) Explanation of the appraisal process;
(四)医疗行为是否违反医疗卫生管理法律、行政法规、部门规章和诊疗护理规范、常规；
(4) Whether the medical act violated medical and health management laws, administrative regulations, departmental rules, and diagnosis and treatment nursing standards and routines;
(五)医疗过失行为与人身损害后果之间是否存在因果关系；
(5) Whether there is a causal relationship between the medical fault act and the personal injury consequences;
(六)医疗过失行为在医疗事故损害后果中的责任程度；
(6) The degree of responsibility of the medical fault act in the damage consequences of the medical accident.
(七)医疗事故等级；
(7) Medical accident level;
(八)对医疗事故患者的医疗护理医学建议。
(8) Medical care and nursing recommendations for the patient of the medical accident.
医疗事故技术鉴定办法由国务院卫生行政部门制定。
The technical appraisal method for medical accidents shall be formulated by the health administrative department of the State Council.
有下列情形之一的，不属于医疗事故：
The following circumstances do not constitute a medical accident:
(一)在紧急情况下为抢救垂危患者生命而采取紧急医学措施造成不良后果的；
(1) Adverse consequences caused by emergency medical measures taken to save the life of a critically ill patient in an emergency;
(二)在医疗活动中由于患者病情异常或者患者体质特殊而发生医疗意外的；
(2) Medical accidents occurring due to abnormal patient condition or special patient constitution during medical activities;
(三)在现有医学科学技术条件下，发生无法预料或者不能防范的不良后果的；
(3) Adverse consequences that are unforeseeable or unavoidable under current medical science and technology conditions;
(四)无过错输血感染造成不良后果的；
(4) Adverse consequences caused by no-fault blood transfusion infection;
(五)因患方原因延误诊疗导致不良后果的；
(5) Adverse consequences caused by delayed diagnosis and treatment due to the patient's reasons;
(六)因不可抗力造成不良后果的。
(6) Adverse consequences caused by force majeure.
医疗事故技术鉴定，可以收取鉴定费用。经鉴定，属于医疗事故的，鉴定费用由医疗机构支付；不属于医疗事故的，鉴定费用由提出医疗事故处理申请的一方支付。鉴定费用标准由省、自治区、直辖市人民政府价格主管部门会同同级财政部门、卫生行政部门规定。
Medical accident technical appraisal may charge appraisal fees. If the appraisal determines that it is a medical accident, the appraisal fee shall be paid by the medical institution; if it is not a medical accident, the appraisal fee shall be paid by the party who applied for the medical accident handling. The appraisal fee standard shall be stipulated by the pricecompetent authority of the province, autonomous region, or municipality directly under the Central Government in conjunction with thesame level financial department and health administrative department.
医疗事故的行政处理与监督
Administrative Handling and Supervision of Medical Accidents
卫生行政部门应当依照本条例和有关法律、行政法规、部门规章的规定，对发生医疗事故的医疗机构和医务人员作出行政处理。
The health administrative department shall, in accordance with these Regulations and relevant laws, administrative regulations, and departmental rules, impose administrative sanctions on medical institutions and medical personnel involved in medical accidents.
卫生行政部门接到医疗机构关于重大医疗过失行为的报告后，除责令医疗机构及时采取必要的医疗救治措施，防止损害后果扩大外，应当组织调查，判定是否属于医疗事故；对不能判定是否属于医疗事故的，应当依照本条例的有关规定交由负责医疗事故技术鉴定工作的医学会组织鉴定。
After receiving a report from a medical institution regarding a major medical negligence act, the health administrative department shall, in addition to ordering the medical institution to take necessary medical treatment measures in a timely manner to prevent the expansion of harm, organize an investigation to determine whether it constitutes a medical accident; if it cannot be determined whether it constitutes a medical accident, it shall, in accordance with the relevant provisions of these Regulations, refer the matter to the medical association responsible for medical accident technical appraisal for appraisal.
发生医疗事故争议，当事人申请卫生行政部门处理的，应当提出书面申请。申请书应当载明申请人的基本情况、有关事实、具体请求及理由等。
In the event of a medical accident dispute, if a party applies to the health administrative department for handling, a written application shall be submitted. The application shall state the basic information of the applicant, relevant facts, specific requests, and reasons.
当事人自知道或者应当知道其身体健康受到损害之日起1年内，可以向卫生行政部门提出医疗事故争议处理申请。
A party may submit an application for handling a medical accident dispute to the health administrative department within one year from the date when the party knows or should have known that their health has been harmed.
发生医疗事故争议，当事人申请卫生行政部门处理的，由医疗机构所在地的县级人民政府卫生行政部门受理。医疗机构所在地是直辖市的，由医疗机构所在地的区、县人民政府卫生行政部门受理。
In the event of a medical accident dispute, if a party applies to the health administrative department for handling, it shall be accepted by the health administrative department of the people's government at the county level where the medical institution is located. If the medical institution is located in a municipality directly under the Central Government, it shall be accepted by the health administrative department of the district or county people's government where the medical institution is located.
有下列情形之一的，县级人民政府卫生行政部门应当自接到医疗机构的报告或者当事人提出医疗事故争议处理申请之日起7日内移送上一级人民政府卫生行政部门处理：
Under any of the following circumstances, the health administrative department of the people's government at the county level shall, within seven days from receiving the report from the medical institution or the application for handling a medical accident dispute from the party, transfer the case to the health administrative department of the people's government at the next higher level for handling:
(一)患者死亡；
(1) The patient dies;
(二)可能为二级以上的医疗事故；
(2) It may be a medical accident of level two or above;
(三)国务院卫生行政部门和省、自治区、直辖市人民政府卫生行政部门规定的其他情形。
(3) Other circumstances prescribed by the health administrative department of the State Council and the health administrative departments of provinces, autonomous regions, and municipalities directly under the Central Government.
卫生行政部门应当自收到医疗事故争议处理申请之日起10日内进行审查，作出是否受理的决定。对符合本条例规定，予以受理，需要进行医疗事故技术鉴定的，应当自作出受理决定之日起5日内将有关材料交由负责医疗事故技术鉴定工作的医学会组织鉴定并书面通知申请人；对不符合本条例规定，不予受理的，应当书面通知申请人并说明理由。
The health administrative department shall, within 10 days from the date of receiving the application for handling a medical accident dispute, conduct a review and decide whether to accept it. If it meets the requirements of these Regulations and is accepted, and a medical accident technical appraisal is needed, it shall, within 5 days from the date of the acceptance decision, submit the relevant materials to the medical association responsible for organizing medical accident technical appraisals for appraisal and notify the applicant in writing; if it does not meet the requirements of these Regulations and is not accepted, it shall notify the applicant in writing and state the reasons.
当事人对首次医疗事故技术鉴定结论有异议，申请再次鉴定的，卫生行政部门应当自收到申请之日起7日内交由省、自治区、直辖市地方医学会组织再次鉴定。
If a party disagrees with the conclusion of the first medical accident technical appraisal and applies for a re-appraisal, the health administrative department shall, within 7 days from the date of receiving the application, submit it to the local medical association of the province, autonomous region, or municipality directly under the Central Government for a re-appraisal.
当事人既向卫生行政部门提出医疗事故争议处理申请，又向人民法院提起诉讼的，卫生行政部门不予受理；卫生行政部门已经受理的，应当终止处理。
If a party both submits an application for handling a medical accident dispute to the health administrative department and files a lawsuit with the people's court, the health administrative department shall not accept the application; if the health administrative department has already accepted it, it shall terminate the handling.
卫生行政部门收到负责组织医疗事故技术鉴定工作的医学会出具的医疗事故技术鉴定书后，应当对参加鉴定的人员资格和专业类别、鉴定程序进行审核；必要时，可以组织调查，听取医疗事故争议双方当事人的意见。
After receiving the medical accident technical appraisal report issued by the medical association responsible for organizing medical accident technical appraisals, the health administrative department shall review the qualifications and professional categories of the appraisers and the appraisal procedures; if necessary, it may organize an investigation and hear the opinions of both parties to the medical accident dispute.
卫生行政部门经审核，对符合本条例规定作出的医疗事故技术鉴定结论，应当作为对发生医疗事故的医疗机构和医务人员作出行政处理以及进行医疗事故赔偿调解的依据；经审核，发现医疗事故技术鉴定不符合本条例规定的，应当要求重新鉴定。
After review, if the health administrative department finds that the medical accident technical appraisal conclusion complies with these Regulations, it shall serve as the basis for administrative processing of the medical institution and medical personnel involved in the medical accident and for mediation of medical accident compensation; if it finds that the medical accident technical appraisal does not comply with these Regulations, it shall require a new appraisal.
医疗事故争议由双方当事人自行协商解决的，医疗机构应当自协商解决之日起7日内向所在地卫生行政部门作出书面报告，并附具协议书。
If a medical accident dispute is resolved through negotiation between the parties, the medical institution shall, within 7 days from the date of the negotiation, submit a written report to the local health administrative department, together with the agreement.
医疗事故争议经人民法院调解或者判决解决的，医疗机构应当自收到生效的人民法院的调解书或者判决书之日起7日内向所在地卫生行政部门作出书面报告，并附具调解书或者判决书。
If a medical accident dispute is resolved through mediation or judgment by the people's court, the medical institution shall, within 7 days from the date of receiving the effective mediation document or judgment from the people's court, submit a written report to the local health administrative department, together with the mediation document or judgment.
县级以上地方人民政府卫生行政部门应当按照规定逐级将当地发生的医疗事故以及依法对发生医疗事故的医疗机构和医务人员作出行政处理的情况，上报国务院卫生行政部门。
The health administrative department of the local people's government at or above the county level shall, in accordance with regulations, report step by step to the health administrative department of the State Council the medical accidents occurring locally and the administrative processing of the medical institutions and medical personnel involved in the medical accidents according to law.
医疗事故的赔偿
Compensation for Medical Accidents
发生医疗事故的赔偿等民事责任争议，医患双方可以协商解决；不愿意协商或者协商不成的，当事人可以向卫生行政部门提出调解申请，也可以直接向人民法院提起民事诉讼。
For civil liability disputes such as compensation arising from a medical accident, the medical and patient parties may resolve through negotiation; if negotiation is not desired or fails, the parties may apply to the health administrative department for mediation, or directly file a civil lawsuit with the people's court.
双方当事人协商解决医疗事故的赔偿等民事责任争议的，应当制作协议书。协议书应当载明双方当事人的基本情况和医疗事故的原因、双方当事人共同认定的医疗事故等级以及协商确定的赔偿数额等，并由双方当事人在协议书上签名。
When the parties resolve civil liability disputes such as compensation for a medical accident through negotiation, a settlement agreement shall be prepared. The agreement shall include the basic information of both parties, the cause of the medical accident, the grade of the medical accident jointly recognized by both parties, and the amount of compensation determined through negotiation, and shall be signed by both parties.
已确定为医疗事故的，卫生行政部门应医疗事故争议双方当事人请求，可以进行医疗事故赔偿调解。调解时，应当遵循当事人双方自愿原则，并应当依据本条例的规定计算赔偿数额。
If a medical accident has been confirmed, the health administrative department may, upon request of both parties to the medical accident dispute, conduct mediation on compensation for the medical accident. Mediation shall follow the principle of voluntariness of both parties, and the amount of compensation shall be calculated in accordance with these Regulations.
经调解，双方当事人就赔偿数额达成协议的，制作调解书，双方当事人应当履行；调解不成或者经调解达成协议后一方反悔的，卫生行政部门不再调解。
If an agreement on the amount of compensation is reached through mediation, a mediation document shall be prepared, and both parties shall perform it; if mediation fails or one party reneges after reaching an agreement through mediation, the health administrative department shall no longer mediate.
医疗事故赔偿，应当考虑下列因素，确定具体赔偿数额：
The specific amount of compensation for a medical accident shall be determined by considering the following factors:
(一)医疗事故等级；
(1) The grade of the medical accident;
(二)医疗过失行为在医疗事故损害后果中的责任程度；
(2) The degree of responsibility of the medical negligent conduct in the harmful consequences of the medical accident;
(三)医疗事故损害后果与患者原有疾病状况之间的关系。
(3) The relationship between the harmful consequences of the medical accident and the patient's pre-existing disease condition.
不属于医疗事故的，医疗机构不承担赔偿责任。
If it does not constitute a medical accident, the medical institution shall not bear liability for compensation.
医疗事故赔偿，按照下列项目和标准计算：
Compensation for medical accidents shall be calculated according to the following items and standards:
(一)医疗费：按照医疗事故对患者造成的人身损害进行治疗所发生的医疗费用计算，凭据支付，但不包括原发病医疗费用。结案后确实需要继续治疗的，按照基本医疗费用支付。
Calculated based on the medical expenses incurred for treating the personal injury caused by the medical accident, paid upon presentation of receipts, but excluding expenses for the original disease. If continued treatment is necessary after case closure, payment shall be made according to basic medical expenses.
(二)误工费：患者有固定收入的，按照本人因误工减少的固定收入计算，对收入高于医疗事故发生地上一年度职工年平均工资3倍以上的，按照3倍计算；无固定收入的，按照医疗事故发生地上一年度职工年平均工资计算。
For patients with fixed income, calculated based on the fixed income lost due to the absence from work. If the income exceeds three times the average annual wage of employees in the location of the medical accident in the previous year, it shall be calculated at three times. For those without fixed income, it shall be calculated based on the average annual wage of employees in the location of the medical accident in the previous year.
(三)住院伙食补助费：按照医疗事故发生地国家机关一般工作人员的出差伙食补助标准计算。
Calculated according to the standard of meal subsidies for general staff of state organs on business trips in the location of the medical accident.
(四)陪护费：患者住院期间需要专人陪护的，按照医疗事故发生地上一年度职工年平均工资计算。
If a patient requires dedicated nursing during hospitalization, it shall be calculated based on the average annual wage of employees in the location of the medical accident in the previous year.
(五)残疾生活补助费：根据伤残等级，按照医疗事故发生地居民年平均生活费计算，自定残之月起最长赔偿30年；但是，60周岁以上的，不超过15年；70周岁以上的，不超过5年。
Based on the disability grade, calculated according to the average annual living expenses of residents in the location of the medical accident, with a maximum compensation of 30 years from the date of disability determination. However, for those aged 60 or above, it shall not exceed 15 years; for those aged 70 or above, it shall not exceed 5 years.
(六)残疾用具费：因残疾需要配置补偿功能器具的，凭医疗机构证明，按照普及型器具的费用计算。
If compensatory functional appliances are needed due to disability, the cost shall be calculated based on the cost of popular-type appliances, with a certificate from a medical institution.
(七)丧葬费：按照医疗事故发生地规定的丧葬费补助标准计算。
Calculated according to the funeral subsidy standard stipulated in the location of the medical accident.
(八)被扶养人生活费：以死者生前或者残疾者丧失劳动能力前实际扶养且没有劳动能力的人为限，按照其户籍所在地或者居所地居民最低生活保障标准计算。对不满16周岁的，扶养到16周岁。对年满16周岁但无劳动能力的，扶养20年；但是，60周岁以上的，不超过15年；70周岁以上的，不超过5年。
Limited to persons who were actually supported by the deceased or the disabled person before the loss of labor capacity and who have no labor capacity themselves. Calculated according to the minimum living standard for residents in their registered or habitual residence. For those under 16 years old, support until age 16. For those aged 16 or above but without labor capacity, support for 20 years; however, for those aged 60 or above, it shall not exceed 15 years; for those aged 70 or above, it shall not exceed 5 years.
(九)交通费：按照患者实际必需的交通费用计算，凭据支付。
Calculated based on the transportation expenses actually necessary for the patient, paid upon presentation of receipts.
(十)住宿费：按照医疗事故发生地国家机关一般工作人员的出差住宿补助标准计算，凭据支付。
Calculated according to the standard of accommodation subsidies for general staff of state organs on business trips in the location of the medical accident, paid upon presentation of receipts.
(十一)精神损害抚慰金：按照医疗事故发生地居民年平均生活费计算。造成患者死亡的，赔偿年限最长不超过6年；造成患者残疾的，赔偿年限最长不超过3年。
(11) Mental distress damages: Calculated based on the average annual living expenses of residents in the place where the medical accident occurred. If the patient dies, the compensation period shall not exceed 6 years; if the patient is disabled, the compensation period shall not exceed 3 years.
参加医疗事故处理的患者近亲属所需交通费、误工费、住宿费，参照本条例第五十条的有关规定计算，计算费用的人数不超过2人。
The transportation, lost work, and accommodation expenses incurred by the patient's close relatives participating in the handling of the medical accident shall be calculated with reference to the relevant provisions of Article 50 of these Regulations, and the number of persons for which expenses are calculated shall not exceed 2.
医疗事故造成患者死亡的，参加丧葬活动的患者的配偶和直系亲属所需交通费、误工费、住宿费，参照本条例第五十条的有关规定计算，计算费用的人数不超过2人。
If a medical accident causes the death of a patient, the transportation, lost work, and accommodation expenses incurred by the patient's spouse and direct relatives participating in the funeral activities shall be calculated with reference to the relevant provisions of Article 50 of these Regulations, and the number of persons for which expenses are calculated shall not exceed 2.
医疗事故赔偿费用，实行一次性结算，由承担医疗事故责任的医疗机构支付。
Medical accident compensation expenses shall be settled in a lump sum and paid by the medical institution that bears responsibility for the medical accident.
罚则
Penalties
卫生行政部门的工作人员在处理医疗事故过程中违反本条例的规定，利用职务上的便利收受他人财物或者其他利益，滥用职权，玩忽职守，或者发现违法行为不予查处，造成严重后果的，依照刑法关于受贿罪、滥用职权罪、玩忽职守罪或者其他有关罪的规定，依法追究刑事责任；尚不够刑事处罚的，依法给予降级或者撤职的行政处分。
If a staff member of the health administrative department, in the process of handling a medical accident, violates the provisions of these Regulations by taking advantage of their position to accept property or other benefits from others, abusing their power, neglecting their duties, or failing to investigate illegal activities discovered, thereby causing serious consequences, criminal liability shall be pursued in accordance with the provisions of the Criminal Law on the crime of bribery, abuse of power, dereliction of duty, or other relevant crimes; if the conduct does not constitute a crime, an administrative sanction of demotion or removal from office shall be imposed in accordance with the law.
卫生行政部门违反本条例的规定，有下列情形之一的，由上级卫生行政部门给予警告并责令限期改正；情节严重的，对负有责任的主管人员和其他直接责任人员依法给予行政处分：
If a health administrative department violates the provisions of these Regulations in any of the following circumstances, the superior health administrative department shall issue a warning and order correction within a specified period; if the circumstances are serious, the responsible persons in charge and other directly responsible personnel shall be given administrative sanctions in accordance with the law:
(一)接到医疗机构关于重大医疗过失行为的报告后，未及时组织调查的；
(1) Failing to organize an investigation in a timely manner after receiving a report from a medical institution regarding a major medical negligent act;
(二)接到医疗事故争议处理申请后，未在规定时间内审查或者移送上一级人民政府卫生行政部门处理的；
(2) Failing to review or transfer a medical accident dispute application to the health administrative department of the people's government at the next higher level within the prescribed time limit after receiving it;
(三)未将应当进行医疗事故技术鉴定的重大医疗过失行为或者医疗事故争议移交医学会组织鉴定的；
(3) Failing to refer a major medical negligent act or medical accident dispute that should undergo medical accident technical appraisal to the medical association for appraisal;
(四)未按照规定逐级将当地发生的医疗事故以及依法对发生医疗事故的医疗机构和医务人员的行政处理情况上报的；
(4) failing to report local medical accidents and the administrative handling of medical institutions and medical personnel involved in medical accidents step by step as required;
(五)未依照本条例规定审核医疗事故技术鉴定书的。
(5) failing to review the medical accident technical appraisal certificate in accordance with these Regulations.
医疗机构发生医疗事故的，由卫生行政部门根据医疗事故等级和情节，给予警告；情节严重的，责令限期停业整顿直至由原发证部门吊销执业许可证，对负有责任的医务人员依照刑法关于医疗事故罪的规定，依法追究刑事责任；尚不够刑事处罚的，依法给予行政处分或者纪律处分。
If a medical accident occurs in a medical institution, the health administrative department shall, based on the level and circumstances of the medical accident, give a warning; if the circumstances are serious, order a suspension of operations for rectification within a time limit, or even revoke the practice license by the original issuing authority; for responsible medical personnel, criminal liability shall be pursued in accordance with the provisions of the Criminal Law on the crime of medical accident; if the circumstances are not serious enough for criminal punishment, administrative sanctions or disciplinary actions shall be imposed according to law.
对发生医疗事故的有关医务人员，除依照前款处罚外，卫生行政部门并可以责令暂停6个月以上1年以下执业活动；情节严重的，吊销其执业证书。
For relevant medical personnel involved in the medical accident, in addition to the punishment under the preceding paragraph, the health administrative department may also order a suspension of practice activities for not less than 6 months but not more than 1 year; if the circumstances are serious, their practice certificate shall be revoked.
医疗机构违反本条例的规定，有下列情形之一的，由卫生行政部门责令改正；情节严重的，对负有责任的主管人员和其他直接责任人员依法给予行政处分或者纪律处分：
If a medical institution violates the provisions of these Regulations in any of the following circumstances, the health administrative department shall order correction; if the circumstances are serious, the responsible person in charge and other directly responsible personnel shall be given administrative sanctions or disciplinary actions according to law:
(一)未如实告知患者病情、医疗措施和医疗风险的；
(1) failing to truthfully inform patients of their condition, medical measures, and medical risks;
(二)没有正当理由，拒绝为患者提供复印或者复制病历资料服务的；
(2) refusing, without justifiable reasons, to provide patients with services for copying or reproducing medical records;
(三)未按照国务院卫生行政部门规定的要求书写和妥善保管病历资料的；
(3) failing to write and properly keep medical records in accordance with the requirements prescribed by the health administrative department of the State Council;
(四)未在规定时间内补记抢救工作病历内容的；
(4) failing to supplement the content of rescue work medical records within the prescribed time;
(五)未按照本条例的规定封存、保管和启封病历资料和实物的；
(5) failing to seal, keep, and unseal medical records and physical evidence in accordance with the provisions of these Regulations;
(六)未设置医疗服务质量监控部门或者配备专(兼)职人员的；
(6) Failure to establish a medical service quality monitoring department or to assign full-time or part-time personnel;
(七)未制定有关医疗事故防范和处理预案的；
(7) Failure to formulate relevant plans for preventing and handling medical accidents;
(八)未在规定时间内向卫生行政部门报告重大医疗过失行为的；
(8) Failure to report major medical negligence to the health administrative department within the prescribed time limit;
(九)未按照本条例的规定向卫生行政部门报告医疗事故的；
(9) Failure to report medical accidents to the health administrative department in accordance with the provisions of these Regulations;
(十)未按照规定进行尸检和保存、处理尸体的。
(10) Failure to conduct autopsies and preserve and dispose of bodies in accordance with regulations.
参加医疗事故技术鉴定工作的人员违反本条例的规定，接受申请鉴定双方或者一方当事人的财物或者其他利益，出具虚假医疗事故技术鉴定书，造成严重后果的，依照刑法关于受贿罪的规定，依法追究刑事责任；尚不够刑事处罚的，由原发证部门吊销其执业证书或者资格证书。
If personnel participating in medical accident technical appraisal work violate the provisions of these Regulations by accepting property or other benefits from one or both parties applying for appraisal, and issue false medical accident technical appraisal certificates, causing serious consequences, criminal liability shall be pursued in accordance with the provisions of the Criminal Law on the crime of bribery; if the conduct is not serious enough for criminal punishment, the original issuing authority shall revoke their practice certificate or qualification certificate.
医疗机构或者其他有关机构违反本条例的规定，有下列情形之一的，由卫生行政部门责令改正，给予警告；对负有责任的主管人员和其他直接责任人员依法给予行政处分或者纪律处分；情节严重的，由原发证部门吊销其执业证书或者资格证书：
If a medical institution or other relevant organization violates the provisions of these Regulations in any of the following circumstances, the health administrative department shall order correction and give a warning; the responsible supervisors and other directly responsible personnel shall be given administrative sanctions or disciplinary actions according to law; if the circumstances are serious, the original issuing authority shall revoke their practice certificate or qualification certificate:
(一)承担尸检任务的机构没有正当理由，拒绝进行尸检的；
(1) The institution responsible for autopsy tasks refuses to perform an autopsy without justifiable reasons;
(二)涂改、伪造、隐匿、销毁病历资料的。
(2) Altering, forging, concealing, or destroying medical records.
以医疗事故为由，寻衅滋事、抢夺病历资料，扰乱医疗机构正常医疗秩序和医疗事故技术鉴定工作，依照刑法关于扰乱社会秩序罪的规定，依法追究刑事责任；尚不够刑事处罚的，依法给予治安管理处罚。
If anyone, on the pretext of a medical accident, engages in provocative activities, seizes medical records, disrupts the normal medical order of a medical institution or the work of medical accident technical appraisal, criminal liability shall be pursued in accordance with the provisions of the Criminal Law on the crime of disturbing social order; if the conduct is not serious enough for criminal punishment, public security penalties shall be imposed according to law.
附则
Supplementary Provisions
本条例所称医疗机构，是指依照《医疗机构管理条例》的规定取得《医疗机构执业许可证》的机构。
Medical institutions as mentioned in these Regulations refer to institutions that have obtained the "Medical Institution Practice License" in accordance with the provisions of the "Regulations on the Administration of Medical Institutions".
县级以上城市从事计划生育技术服务的机构依照《计划生育技术服务管理条例》的规定开展与计划生育有关的临床医疗服务，发生的计划生育技术服务事故，依照本条例的有关规定处理；但是，其中不属于医疗机构的县级以上城市从事计划生育技术服务的机构发生的计划生育技术服务事故，由计划生育行政部门行使依照本条例有关规定由卫生行政部门承担的受理、交由负责医疗事故技术鉴定工作的医学会组织鉴定和赔偿调解的职能；对发生计划生育技术服务事故的该机构及其有关责任人员，依法进行处理。
For institutions engaged in family planning technical services in cities at or above the county level that carry out clinical medical services related to family planning in accordance with the provisions of the "Regulations on the Administration of Family Planning Technical Services", any family planning technical service accidents that occur shall be handled in accordance with the relevant provisions of these Regulations. However, for family planning technical service accidents occurring in institutions that are not medical institutions but are engaged in family planning technical services in cities at or above the county level, the family planning administrative department shall exercise the functions of accepting, referring to the medical association responsible for medical accident technical appraisal for organization of appraisal, and compensation mediation, which are originally undertaken by the health administrative department according to the relevant provisions of these Regulations; the institution and its responsible personnel involved in the family planning technical service accident shall be dealt with according to law.
非法行医，造成患者人身损害，不属于医疗事故，触犯刑律的，依法追究刑事责任；有关赔偿，由受害人直接向人民法院提起诉讼。
If illegal medical practice causes personal injury to a patient, it does not constitute a medical accident. If it violates criminal law, criminal liability shall be pursued according to law; for related compensation, the victim may directly file a lawsuit with the people's court.
军队医疗机构的医疗事故处理办法，由中国人民解放军卫生主管部门会同国务院卫生行政部门依据本条例制定。
The measures for handling medical accidents in military medical institutions shall be formulated by the health department of the People's Liberation Army jointly with the health administrative department of the State Council in accordance with these Regulations.
本条例自2002年9月1日起施行。1987年6月29日国务院发布的《医疗事故处理办法》同时废止。本条例施行前已经处理结案的医疗事故争议，不再重新处理。
These Regulations shall come into effect as of September 1, 2002. The "Measures for the Handling of Medical Accidents" promulgated by the State Council on June 29, 1987 shall be repealed simultaneously. Medical accident disputes that have been settled before the implementation of these Regulations shall not be re-handled.