Regulations on Prevention and Handling of Health Care Disputes
Regulations on Prevention and Handling of Health Care Disputes
Regulations on Prevention and Handling of Health Care Disputes
Order of the State Council of the People's Republic of China No.701
July 31, 2018
The Regulations on Prevention and Handling of Health Care Disputes, which was adopted at the 13th executive meeting of the State Council on June 20, 2018, are hereby promulgated, and shall be implemented as of October 1, 2018.
Premier Li Keqiang
Regulations on Prevention and Handling of Health Care Disputes
Chapter I General Provisions
Article 1 These Regulations on Prevention and Handling of Health Care Disputes (the "Regulations") are hereby formulated in a bid to prevent and properly handle health care disputes, protect legitimate rights and interests of doctors and patients, maintain health care order and guarantee health care security.
Article 2 For the purpose of these Regulations, health care disputes refer to disputes arising from diagnosis and treatment activities between doctors and patients.
Article 3 The State shall establish a medical quality security management system, deepen medical and health system reform, regulate diagnosis and treatment activities, improve medical services, enhance medical quality, and prevent and minimize health care disputes.
During diagnosis and treatment activities, doctors and patients shall respect each other, and protect their own rights and interests in accordance with relevant laws and regulations.
Article 4 A health care dispute shall be handled in a fair, just and timely way and according to facts and laws.
Article 5 A people's government at or above the county level shall strengthen the leadership for and coordination in the prevention and handling of health care disputes, include the prevention and handling of health care disputes in the comprehensive governance system for social security, establish a departmental work division collaboration mechanism, and urge relevant departments to fulfill duties in accordance with the law.
Article 6 A competent department for hygiene shall guide and supervise medical institutions to effectively prevent and handle health care disputes, and guide doctors and patients to solve the disputes according to law.
An administrative department for justice shall guide the people's mediation for the health care disputes.
A public security authority shall maintain the public security order of medical institutions, and investigate and attack illegal and criminal behaviors such as the infringement upon legitimate rights and interests of patients and medical personnel and the disturbance of health care order.
Departments and institutions of finance, civil administration, insurance supervision and administration and so on shall do the work relating to the prevention and handling of health care disputes as per duties thereof.
Article 7 China shall institute and improve the health care risk sharing mechanism, under which the role of insurance mechanism in offering third-party indemnity and bearing health care risks in a socialized fashion is played, and medical institutions are inspired to take out the health care liability insurance while patients are encouraged to buy the medical negligence insurance.
Article 8 News media shall intensify the publicity of medical and health laws, regulations and general knowledge, guide the public to rationally treat health care risks, and cover health care disputes in accordance with relevant laws and regulations, in line with professional ethics and in a true, objective and just way.
Chapter II Prevention of Health Care Disputes
Article 9 A medical institution and medical personnel thereof shall, during diagnosis and treatment activities, center on patients, strengthen humanistic care, strictly observe medical and health laws, regulations and rules as well as regulations and conventions on diagnosis and treatment, and observe professional ethics.
A medical institution shall provide the medical personnel thereof with trainings on medical and health laws, regulations and rules as well as regulations and conventions on diagnosis and treatment, and consolidate the education on professional ethics for them.
Article 10 A medical institution shall formulate and implement a medical quality security management system, set a medical service quality monitoring department or allocate full-time (part-time) personnel to strengthen the standard management over diagnosis, treatment, nursing, pharmaceutical affairs, examination and other work, optimize service processes, and enhance service level.
A medical institution shall intensify health care risk management, improve the identification, evaluation, prevention and control measures for health care risks, and regularly check the implementation situations of such measures in order to eliminate hidden troubles.
Article 11 A medical institution shall provide medical technique services in line with its technical capacity, guarantee clinical application security and minimize health care risks pursuant to the administrative regulations on the clinical application of medical techniques formulated by the competent department for hygiene under the State Council; and, if any new medical technique is to be adopted, it shall make technical evaluations and ethical review to guarantee that the technique is safe, effective and in line with ethics.
Article 12 A medical institution shall, as per relevant laws and regulations, strictly implement the systems for the restocking inspection, custody, and so on, of drugs, medical devices, disinfectants, blood, etc. It is forbidden to use any unqualified drugs, medical devices, disinfectants, blood and so on without a certificate of qualification or exceeding the period of validity.
Article 13 The medical personnel shall explain the state of an illness and medical measures to a patient during diagnosis and treatment activities. Where it is necessary to perform an operation or conduct a dangerous clinical trial or any other special examination or treatment which may lead to any adverse consequence, the medical personnel shall responsively explain health care risks, an alternative medical solution and so on to the patient concerned, and obtain the written consent thereof; where a patient is in a coma or in any other state with no ability to make a decision, or it is unsuitable for the patient to learn about the state of an illness and so on, they shall explain relevant situations to a near relative of the patient, and obtain the written consent thereof.
Where it is unable to obtain opinions of a patient or a near relative thereof in an emergency, corresponding medical measures may be taken immediately upon approval by the principal or authorized principal of the medical institution concerned.
Article 14 In conducting a diagnosis and treatment activity with high medical risks such as an operation, special examination or special treatment, a medical institution shall prepare a solution in advance and actively prevent unexpected risks.
Article 15 A medical institution and medical personnel thereof shall fill in and properly keep medical records as per provisions of the competent department for hygiene under the State Council.
Where any medical records are not filled in responsively due to an emergency rescue, the medical personnel shall supplement the records according to actual conditions within six hours after the rescue, and make explanations about the delay.
No entity or individual shall alter, forge, conceal, destroy or grab medical records.
Article 16 A patient shall have the right to consult and copy his outpatient medical records, hospitalization records, temperature chart, medical order sheet, laboratory test reports (examination reports), medical image examination data, written consent for special examination, written consent for operation, operation and anesthesia records, pathological data, nursing records, medical expenses as well as all of other medical records stipulated by the competent department for hygiene under the State Council.
Where a patient requires copying his medical records, the medical institution shall provide copying services, and affix its seal for proof on the copied medical records.
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Order of the State Council of the People's Republic of China No.701
July 31, 2018
The Regulations on Prevention and Handling of Health Care Disputes, which was adopted at the 13th executive meeting of the State Council on June 20, 2018, are hereby promulgated, and shall be implemented as of October 1, 2018.
Premier Li Keqiang
Regulations on Prevention and Handling of Health Care Disputes
Chapter I General Provisions
Article 1 These Regulations on Prevention and Handling of Health Care Disputes (the "Regulations") are hereby formulated in a bid to prevent and properly handle health care disputes, protect legitimate rights and interests of doctors and patients, maintain health care order and guarantee health care security.
Article 2 For the purpose of these Regulations, health care disputes refer to disputes arising from diagnosis and treatment activities between doctors and patients.
Article 3 The State shall establish a medical quality security management system, deepen medical and health system reform, regulate diagnosis and treatment activities, improve medical services, enhance medical quality, and prevent and minimize health care disputes.
During diagnosis and treatment activities, doctors and patients shall respect each other, and protect their own rights and interests in accordance with relevant laws and regulations.
Article 4 A health care dispute shall be handled in a fair, just and timely way and according to facts and laws.
Article 5 A people's government at or above the county level shall strengthen the leadership for and coordination in the prevention and handling of health care disputes, include the prevention and handling of health care disputes in the comprehensive governance system for social security, establish a departmental work division collaboration mechanism, and urge relevant departments to fulfill duties in accordance with the law.
Article 6 A competent department for hygiene shall guide and supervise medical institutions to effectively prevent and handle health care disputes, and guide doctors and patients to solve the disputes according to law.
An administrative department for justice shall guide the people's mediation for the health care disputes.
A public security authority shall maintain the public security order of medical institutions, and investigate and attack illegal and criminal behaviors such as the infringement upon legitimate rights and interests of patients and medical personnel and the disturbance of health care order.
Departments and institutions of finance, civil administration, insurance supervision and administration and so on shall do the work relating to the prevention and handling of health care disputes as per duties thereof.
Article 7 China shall institute and improve the health care risk sharing mechanism, under which the role of insurance mechanism in offering third-party indemnity and bearing health care risks in a socialized fashion is played, and medical institutions are inspired to take out the health care liability insurance while patients are encouraged to buy the medical negligence insurance.
Article 8 News media shall intensify the publicity of medical and health laws, regulations and general knowledge, guide the public to rationally treat health care risks, and cover health care disputes in accordance with relevant laws and regulations, in line with professional ethics and in a true, objective and just way.
Chapter II Prevention of Health Care Disputes
Article 9 A medical institution and medical personnel thereof shall, during diagnosis and treatment activities, center on patients, strengthen humanistic care, strictly observe medical and health laws, regulations and rules as well as regulations and conventions on diagnosis and treatment, and observe professional ethics.
A medical institution shall provide the medical personnel thereof with trainings on medical and health laws, regulations and rules as well as regulations and conventions on diagnosis and treatment, and consolidate the education on professional ethics for them.
Article 10 A medical institution shall formulate and implement a medical quality security management system, set a medical service quality monitoring department or allocate full-time (part-time) personnel to strengthen the standard management over diagnosis, treatment, nursing, pharmaceutical affairs, examination and other work, optimize service processes, and enhance service level.
A medical institution shall intensify health care risk management, improve the identification, evaluation, prevention and control measures for health care risks, and regularly check the implementation situations of such measures in order to eliminate hidden troubles.
Article 11 A medical institution shall provide medical technique services in line with its technical capacity, guarantee clinical application security and minimize health care risks pursuant to the administrative regulations on the clinical application of medical techniques formulated by the competent department for hygiene under the State Council; and, if any new medical technique is to be adopted, it shall make technical evaluations and ethical review to guarantee that the technique is safe, effective and in line with ethics.
Article 12 A medical institution shall, as per relevant laws and regulations, strictly implement the systems for the restocking inspection, custody, and so on, of drugs, medical devices, disinfectants, blood, etc. It is forbidden to use any unqualified drugs, medical devices, disinfectants, blood and so on without a certificate of qualification or exceeding the period of validity.
Article 13 The medical personnel shall explain the state of an illness and medical measures to a patient during diagnosis and treatment activities. Where it is necessary to perform an operation or conduct a dangerous clinical trial or any other special examination or treatment which may lead to any adverse consequence, the medical personnel shall responsively explain health care risks, an alternative medical solution and so on to the patient concerned, and obtain the written consent thereof; where a patient is in a coma or in any other state with no ability to make a decision, or it is unsuitable for the patient to learn about the state of an illness and so on, they shall explain relevant situations to a near relative of the patient, and obtain the written consent thereof.
Where it is unable to obtain opinions of a patient or a near relative thereof in an emergency, corresponding medical measures may be taken immediately upon approval by the principal or authorized principal of the medical institution concerned.
Article 14 In conducting a diagnosis and treatment activity with high medical risks such as an operation, special examination or special treatment, a medical institution shall prepare a solution in advance and actively prevent unexpected risks.
Article 15 A medical institution and medical personnel thereof shall fill in and properly keep medical records as per provisions of the competent department for hygiene under the State Council.
Where any medical records are not filled in responsively due to an emergency rescue, the medical personnel shall supplement the records according to actual conditions within six hours after the rescue, and make explanations about the delay.
No entity or individual shall alter, forge, conceal, destroy or grab medical records.
Article 16 A patient shall have the right to consult and copy his outpatient medical records, hospitalization records, temperature chart, medical order sheet, laboratory test reports (examination reports), medical image examination data, written consent for special examination, written consent for operation, operation and anesthesia records, pathological data, nursing records, medical expenses as well as all of other medical records stipulated by the competent department for hygiene under the State Council.
Where a patient requires copying his medical records, the medical institution shall provide copying services, and affix its seal for proof on the copied medical records.
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