Article 1 These Regulations are formulated for the purpose of preventing and properly handling medical disputes, protecting the legitimate rights and interests of both doctors and patients, maintaining medical order and ensuring medical safety.
Article 2 Medical disputes as mentioned in these Regulations refer to disputes caused by medical activities between doctors and patients.
Article 3 The State establishes a medical quality and safety management system, deepens the reform of the medical and health system, standardizes diagnosis and treatment activities, improves medical services, improves medical quality, and prevents and reduces medical disputes.
In the diagnosis and treatment activities, both doctors and patients should respect each other, and safeguard their own rights and interests should abide by the provisions of relevant laws and regulations.
Article 4 Medical disputes shall be handled in accordance with the principles of fairness, impartiality and timeliness, seeking truth from facts and handling according to law.
Article 5 The people's governments at or above the county level shall strengthen the leadership and coordination of the prevention and handling of medical disputes, bring them into the comprehensive management system of social security, establish a division of labor and cooperation mechanism among departments, and urge departments to perform their duties according to law.
Article 6 The competent health department is responsible for guiding and supervising medical institutions to prevent and handle medical disputes, and guiding both doctors and patients to solve medical disputes according to law.
The judicial administrative department is responsible for guiding the people's mediation of medical disputes.
Public security organs maintain public order in medical institutions according to law, and investigate and deal with illegal and criminal acts that infringe on the legitimate rights and interests of patients and medical personnel and disrupt medical order according to law.
Financial, civil affairs, insurance supervision and management departments and institutions shall, in accordance with their respective responsibilities, do a good job in the prevention and handling of medical disputes.
Article 7 The State shall establish and improve the medical risk sharing mechanism, give full play to the role of insurance mechanism in third-party compensation and socialized sharing of medical risks in handling medical disputes, encourage medical institutions to participate in medical liability insurance, and encourage patients to participate in medical accident insurance.
Eighth news media should strengthen the publicity of medical and health laws and regulations and medical and health common sense, and guide the public to treat medical risks rationally; Reporting medical disputes should abide by the provisions of relevant laws and regulations, abide by professional ethics, be true, objective and fair.
Chapter II Prevention of Medical Disputes
Article 9 Medical institutions and their medical staff should take patients as the center in their diagnosis and treatment activities, strengthen humanistic care, strictly abide by medical and health laws, regulations, rules, relevant norms and operating procedures for diagnosis and treatment, and abide by professional ethics.
Medical institutions should train their medical staff in medical and health laws, regulations, rules, relevant diagnosis and treatment norms and routines, and strengthen professional ethics education.
Article 10 A medical institution shall formulate and implement a medical quality and safety management system, set up a medical service quality monitoring department or equip full-time (part-time) staff, strengthen standardized management of diagnosis and treatment, nursing, pharmacy and inspection, optimize service processes and improve service level.
Medical institutions should strengthen the management of medical risks, improve the identification, evaluation and prevention and control measures of medical risks, regularly check the implementation of measures, and eliminate hidden dangers in time.
Eleventh medical institutions shall, in accordance with the regulations on the management of clinical application of medical technology formulated by the competent department of health of the State Council, carry out medical technical services commensurate with their technical capabilities, ensure the safety of clinical application and reduce medical risks; The adoption of new medical technology shall be subject to technical evaluation and ethical review to ensure safety, effectiveness and ethics.
Twelfth medical institutions shall, in accordance with the provisions of relevant laws and regulations, strictly implement the acceptance and storage system of drugs, medical devices, disinfectants, blood, etc. Prohibit the use of substandard drugs, medical devices, disinfectants, blood, etc. No certificate or expired certificate.
Thirteenth medical personnel in the diagnosis and treatment activities should explain the condition and medical measures to patients. Need to perform surgery, or carry out clinical trials and other special examinations and special treatments that are dangerous and may have adverse consequences, medical personnel shall promptly explain the medical risks and alternative medical programs to patients and obtain their written consent; If the patient is in a coma and unable to make a decision on his own, or if the condition is not suitable for the patient, he should explain it to his close relatives and obtain his written consent.
If the opinions of patients or their close relatives cannot be obtained in an emergency, corresponding medical measures can be implemented immediately with the approval of the person in charge of the medical institution or the authorized person in charge.
Fourteenth to carry out medical activities with high medical risks such as surgery, special examination and special treatment, medical institutions should prepare a response plan in advance to take the initiative to prevent sudden risks.
Fifteenth medical institutions and their medical personnel shall fill in and properly keep the medical records in accordance with the provisions of the competent department of health in the State Council.
If the medical records cannot be filled out in time due to emergency rescue, the medical staff shall make up the records according to the facts within 6 hours after the rescue, and make records.
No unit or individual may tamper with, forge, conceal, destroy or rob medical records.
Article 16 Patients have the right to consult and copy their outpatient medical records, inpatient medical records, temperature sheets, doctor's orders, laboratory sheets (inspection reports), medical imaging examination data, special inspection consent, operation consent, operation and anesthesia records, pathological data, nursing records, medical expenses and all other materials belonging to medical records as stipulated by the competent health department of the State Council.
If the patient requests to copy the medical records, the medical institution shall provide the copying service and affix the certification mark on the copied medical records. When copying medical records, patients or their close relatives should be present. Medical institutions may charge fees for copying medical records at the request of patients, and the charging standards shall be made public.
If the patient dies, his close relatives may consult and copy the medical records in accordance with the provisions of these regulations.
Seventeenth medical institutions should establish and improve the communication mechanism between doctors and patients, and patiently explain and explain the advice, opinions and suggestions put forward by patients in the process of diagnosis and treatment, and deal with them in accordance with the regulations; Questions about diagnosis and treatment raised by patients should be verified and checked in time, and relevant personnel should be designated to communicate with patients or their close relatives and truthfully explain the situation.
Article 18 Medical institutions shall establish and improve the complaint reception system, set up a unified complaint management department or be equipped with full-time (part-time) staff, and publish the methods, procedures and contact information of medical dispute settlement in a prominent position in medical institutions to facilitate patients' complaints or consultations.
Nineteenth health authorities should urge medical institutions to implement the medical quality and safety management system, organize medical quality and safety assessment, analyze medical quality and safety information, and formulate preventive measures for the risks found.
Twentieth patients should abide by the medical order and the provisions of medical institutions on medical treatment, treatment and examination, truthfully provide information related to their illness, and cooperate with medical personnel to carry out medical activities.
Twenty-first people's governments at all levels should strengthen health promotion and education, popularize health science knowledge, and improve the public's cognitive level of medical science knowledge such as disease treatment.
Chapter III Handling of Medical Disputes
Twenty-second medical disputes, doctors and patients can be resolved through the following channels:
(1) Both parties negotiate voluntarily;
(2) apply for people's mediation;
(3) Applying for administrative mediation;
(four) to bring a lawsuit to the people's court;
(five) other ways as prescribed by laws and regulations.
Article 23 When a medical dispute occurs, the medical institution shall inform the patient or his close relatives of the following matters:
(a) the legal way to solve medical disputes;
(2) Provisions on medical records, on-site physical storage and unsealing;
(3) Provisions on consulting and copying medical records.
If the patient dies, his close relatives shall also be informed of the provisions on autopsy.
Twenty-fourth medical disputes need to be sealed and unsealed, which should be carried out in the presence of both doctors and patients. Sealed medical records can be originals or copies, which are kept by medical institutions. If the unfinished medical records need to be sealed, the completed medical records should be sealed first; After the medical record is filled in according to the regulations, the subsequent filling part shall be sealed. Medical institutions shall make a list of sealed medical records, which shall be signed or sealed by both doctors and patients, and each party shall hold one copy.
After the medical record is sealed, the medical dispute has been resolved, or after the medical record has been sealed for three years, the patient has not put forward the request to solve the medical dispute, and the medical institution can unseal it by itself.
Twenty-fifth suspected infusion, blood transfusion, injection, medication and other adverse consequences, both doctors and patients should * * * seal and unseal the on-site physical objects, and the sealed on-site physical objects shall be kept by medical institutions. If inspection is required, both parties shall entrust an inspection agency with inspection qualification according to law for inspection; If the two parties are unable to entrust, it shall be designated by the competent health department of the people's government at the county level where the medical institution is located.
If it is suspected that blood transfusion will cause adverse consequences and it is necessary to seal up the blood, the medical institution shall notify the blood station that provided the blood to send personnel to be present.
If the medical dispute has been resolved after the on-site physical storage, or if the patient has not made a request to resolve the medical dispute after the on-site physical storage for 3 years, the medical institution can unseal it by itself.
Twenty-sixth patients died, and both doctors and patients have objections to the cause of death, an autopsy should be conducted within 48 hours after the death of the patient; It can be extended to 7 days if it meets the requirements for cryopreservation of corpses. Autopsy shall be approved and signed by the close relatives of the deceased. If the deceased refuses to sign, it shall be deemed that the close relatives of the deceased do not agree with the autopsy. If the autopsy is not agreed or delayed beyond the prescribed time, which affects the determination of the cause of death, the party who disagrees or delays shall bear the responsibility.
Autopsy shall be carried out by institutions and professional and technical personnel who have obtained corresponding qualifications in accordance with relevant state regulations.
Both doctors and patients can appoint representatives to observe the autopsy process.
Article 27 If a patient dies in a medical institution, the body shall be immediately moved to the mortuary or a designated place, and the storage time of the body shall generally not exceed 14 days. If the corpse is not disposed of within the time limit, the medical institution shall report to the competent health department of the local people's government at the county level and the public security organ and dispose of it according to the regulations.
Twenty-eighth major medical disputes, medical institutions shall report to the local health authorities at or above the county level in accordance with the provisions. After receiving the report, the competent health department shall timely understand the situation and guide both doctors and patients to resolve disputes through legal channels.
Twenty-ninth doctors and patients should maintain medical order according to law. No unit or individual may commit any act that endangers the personal safety of patients and medical personnel and disrupts medical order.
If a medical dispute is suspected of violating the administration of public security or committing a criminal act, the medical institution shall immediately report the case to the local public security organ. The public security organ shall take timely measures to deal with it according to law and maintain medical order.
Thirtieth doctors and patients choose to negotiate to solve medical disputes, they should negotiate in a special place, and shall not affect the normal medical order. If there are a large number of doctors and patients, representatives shall be elected for consultation, and the number of representatives of each party shall not exceed 5.
To resolve medical disputes through consultation, we should adhere to the principles of voluntariness, legality and equality, respect the rights of the parties and respect the objective facts. Both doctors and patients should express their opinions and demands in a civilized and rational way, and there must be no illegal acts.
The amount of compensation determined through consultation should be based on facts to prevent abnormally high or low. For medical disputes with big differences or high claims, both doctors and patients are encouraged to settle them through people's mediation.
If both doctors and patients reach an agreement through consultation, a written settlement agreement shall be signed.
Thirty-first to apply for people's mediation of medical disputes, both doctors and patients should apply to the people's mediation Committee of medical disputes; If one party applies for mediation, the People's Mediation Committee for Medical Disputes shall conduct mediation with the consent of the other party.
The applicant may apply for mediation in writing or orally. If the application is made in writing, the application shall specify the basic information of the applicant, the disputed matters and the reasons for applying for mediation. ; If an oral application is made, the people's mediator of medical disputes shall record the basic information of the applicant, the disputed matters and the reasons for applying for mediation on the spot, and the applicant shall sign it for confirmation.
When the People's Mediation Committee for Medical Disputes learns that a major medical dispute has occurred in a medical institution, it can take the initiative to guide both doctors and patients to apply for mediation.
The people's mediation committee for medical disputes will not accept the case if the parties have brought a lawsuit to the people's court and accepted it, or have applied to the competent department of health for mediation and accepted it; If it has been accepted, the mediation shall be terminated.
Article 32 The establishment of a people's mediation committee for medical disputes shall comply with the provisions of the Law of China on People's Opinion Survey and meet the actual needs of the region. The people's mediation committee for medical disputes shall, within 30 working days from the date of its establishment, file with the judicial administrative department of the local people's government at or above the county level.
The people's mediation committee of medical disputes shall, according to the specific circumstances, employ a certain number of people with medical, legal and other professional knowledge and enthusiastic mediation as full-time (part-time) people's mediators of medical disputes.
The people's mediation committee for medical disputes shall not charge fees for mediation of medical disputes. The funds needed for people's mediation of medical disputes shall be implemented in accordance with the relevant provisions of the financial and judicial administrative departments of the State Council.
Article 33 When mediating medical disputes, the People's Mediation Committee for Medical Disputes may consult experts as needed, or select experts from the expert database specified in Article 35 of these Regulations.
Article 34 If the People's Mediation Committee for Medical Disputes needs to identify medical damage to clarify the responsibility, it shall be entrusted by both doctors and patients to a medical association or a judicial authentication institution, or it may be entrusted by the People's Mediation Committee for Medical Disputes with the consent of both doctors and patients.
The medical association or judicial authentication institution entrusted to engage in medical damage identification shall be identified by professionals such as clinical medicine and forensic medicine who participate in the identification; If there are no relevant professionals in medical associations and judicial authentication institutions, relevant professional experts shall be drawn from the expert database as stipulated in Article 35 of these regulations for identification.
Medical associations or judicial authentication institutions shall implement the prescribed standards and procedures, respect science, abide by professional ethics, be responsible for the medical injury authentication opinions issued, and shall not issue false authentication opinions. The specific measures for the administration of medical damage identification shall be jointly formulated by the health and judicial administrative departments of the State Council.
The appraisal fee is charged to both doctors and patients in advance, and is finally borne according to the proportion of responsibility.
Thirty-fifth medical damage identification expert database is jointly established by the health and judicial administrative departments of the people's governments at or above the municipal level. The expert database shall include experts in the fields of medicine, law and forensic medicine. Hiring experts to enter the expert database is not restricted by administrative regions.
Article 36 The opinions on medical damage appraisal made by medical associations and judicial authentication institutions shall clearly and in detail discuss the following contents:
(a) whether there is medical damage and the degree of damage;
(two) whether there is a medical fault;
(three) whether there is a causal relationship between medical fault and medical damage;
(four) the degree of responsibility of medical fault in medical damage.
Thirty-seventh consulting experts and appraisers should withdraw in any of the following circumstances, and the parties may also apply for their withdrawal orally or in writing:
(1) Being a party to a medical dispute or a close relative of a party;
(two) interested in medical disputes;
(3) Having other relations with the parties to a medical dispute, which may affect the fair handling of the medical dispute.
Article 38 The people's mediation committee for medical disputes shall complete mediation within 30 working days from the date of acceptance. Need to identify, the identification time is not included in the mediation period. If it is necessary to extend the mediation period due to special circumstances, the mediation period may be extended with the consent of the people's mediation Committee for medical disputes and both doctors and patients. If no mediation agreement is reached within the mediation period, it shall be deemed that the mediation has failed.
Thirty-ninth people's mediation, the doctors and patients reached an agreement, the people's mediation committee of medical disputes shall make a mediation agreement. The mediation agreement shall come into effect after being signed or sealed by both doctors and patients, signed by the people's mediator and stamped with the seal of the people's mediation committee for medical disputes.
If a mediation agreement is reached, the people's mediation committee for medical disputes shall inform both doctors and patients that they can apply to the people's court for judicial confirmation according to law.
Article 40 Where both doctors and patients apply for administrative mediation of medical disputes, they shall refer to the provisions of the first and second paragraphs of Article 31 of these Regulations to apply to the competent health department of the people's government at the county level where the medical dispute occurred.
The competent health department shall make a decision on whether to accept the application within 5 working days from the date of receiving it. If the parties have brought a lawsuit to the people's court and accepted it, or have applied to the people's mediation Committee for mediation of medical disputes and accepted it, the competent health department will not accept it; If it has been accepted, the mediation shall be terminated.
The competent health department shall complete the mediation within 30 working days from the date of acceptance. Need to identify, the identification time is not included in the mediation period. If no mediation agreement is reached within the mediation period, it shall be deemed that the mediation has failed.
Forty-first health authorities need expert consultation to mediate medical disputes, and they can draw experts from the expert database specified in Article 35 of these regulations; If both doctors and patients think that it is necessary to carry out medical damage identification to clarify the responsibility, the identification shall be carried out with reference to the provisions of Article 34 of these regulations.
After mediation by the competent health department, if both doctors and patients reach an agreement, a mediation agreement shall be signed.
Forty-second people's mediation committee for medical disputes and its people's mediators, health authorities and their staff shall keep the personal privacy of both doctors and patients confidential.
Without the consent of both doctors and patients, the people's mediation committee of medical disputes and the competent department of health shall not publicly mediate or disclose the contents of the mediation agreement.
Article 43 In the event of a medical dispute, if the parties fail to negotiate or mediate, they may bring a lawsuit to the people's court according to law. The parties may also bring a lawsuit directly to the people's court.
Article 44 Where a medical dispute needs compensation, the amount of compensation shall be determined in accordance with the law.
Chapter IV Legal Liability
Article 45 If a medical institution falsifies, forges, conceals or destroys medical records, the directly responsible person in charge and other directly responsible personnel shall be given or ordered by the competent health department of the people's government at or above the county level to lower their post level or be dismissed, and the relevant medical personnel shall be ordered to suspend their practice for more than 6 months 1 year; If serious consequences are caused, the directly responsible person in charge and other directly responsible personnel shall be given or ordered to be dismissed, and the practice certificate of the relevant medical personnel shall be revoked by the original issuing department; If a crime is constituted, criminal responsibility shall be investigated according to law.
Article 46 If a medical institution applies a new medical technology that has not passed the technical evaluation and ethical review to the clinic, the health administrative department of the people's government at or above the county level shall confiscate the illegal income and impose a fine of not less than 50,000 yuan but not more than 654.38+10,000 yuan; Give or order the directly responsible person in charge and other directly responsible personnel to be demoted or dismissed, and order the relevant medical personnel to suspend their practice for more than 6 months but not more than 1 year; If the circumstances are serious, the directly responsible person in charge and other directly responsible personnel shall be given or ordered to be dismissed, and the practice certificate of the relevant medical personnel shall be revoked by the original issuing department; If a crime is constituted, criminal responsibility shall be investigated according to law.
Article 47 If a medical institution and its medical staff are under any of the following circumstances, the competent health department of the people's government at or above the county level shall order them to make corrections, give them a warning and impose a fine of more than 50,000 yuan 1 10,000 yuan; If the circumstances are serious, the directly responsible person in charge and other directly responsible personnel shall be given or investigated for responsibility.