Regulations on the Prevention and Handling of Medical Disputes
Order No. 701 of the State Council of the People’s Republic of China
Chapter I General Provisions
Article 1 These Regulations are formulated to prevent and properly handle medical disputes, protect the legitimate rights and interests of both medical institutions and patients, maintain medical order, and ensure medical safety.
Article 2 For the purposes of these Regulations, a medical dispute refers to a controversy between medical institutions and patients arising from diagnostic or therapeutic activities.
Article 3 The state establishes a medical quality and safety management system to deepen reforms in the healthcare sector, standardize diagnostic and therapeutic practices, improve medical services, and enhance medical quality to prevent and reduce medical disputes.
In diagnostic and therapeutic activities, both medical institutions and patients shall respect each other and comply with relevant laws and regulations in safeguarding their rights and interests.
Article 4 Medical disputes shall be handled in accordance with the principles of fairness, impartiality, and timeliness, based on facts and in compliance with the law.
Article 5 People’s governments at or above the county level shall strengthen leadership and coordination in the prevention and handling of medical disputes, incorporate them into the comprehensive management of social security, establish interdepartmental collaboration mechanisms, and supervise relevant departments to fulfill their duties.
Article 6 The health administrative department shall guide and supervise medical institutions in preventing and handling medical disputes, and guide the mediation of medical disputes by people’s mediation organizations.
The judicial administrative department shall guide the mediation of medical disputes by people’s mediation organizations.
Public security organs shall maintain public order in medical institutions, investigate and punish illegal acts that infringe upon the legitimate rights and interests of patients and medical personnel, or disrupt medical order.
Other departments, such as finance, civil affairs, and insurance supervision, shall perform their respective duties in preventing and handling medical disputes.
Article 7 The state establishes and improves a medical risk-sharing mechanism, leveraging insurance mechanisms to provide third-party compensation and socialized risk sharing in medical disputes. Medical institutions are encouraged to participate in medical liability insurance, and patients are encouraged to participate in medical accident insurance.
Article 8 News media shall strengthen publicity of laws, regulations, and common knowledge related to healthcare, guide the public to rationally approach medical risks, and report on medical disputes in a truthful, objective, and fair manner in accordance with the law.
Chapter II Prevention of Medical Disputes
Article 9 Medical institutions and their medical personnel shall prioritize patient-centered care, strengthen humanistic concern, strictly comply with laws, regulations, technical standards, and ethical norms in medical practice, and uphold professional ethics.
Medical institutions shall provide training on laws, regulations, technical standards, and ethical norms to their medical personnel and strengthen professional ethics education.
Article 10 Medical institutions shall establish and implement a medical quality and safety management system, set up dedicated departments or appoint full-time/part-time personnel to manage service quality, optimize service processes, and enhance service standards.
Medical institutions shall strengthen medical risk management, improve mechanisms for identifying, assessing, and controlling risks, and regularly inspect the implementation of risk prevention measures.
Article 11 Medical institutions shall conduct medical services in accordance with the regulations of the National Health Commission on the clinical application of medical technologies, ensuring safety and reducing risks. The use of new medical technologies shall be subject to technical evaluation and ethical review to ensure safety and compliance with ethics.
Article 12 Medical institutions must strictly follow laws and regulations regarding the procurement, storage, and use of drugs, medical devices, disinfectants, blood, and other supplies. The use of unqualified, expired, or uncertified products is prohibited.
Article 13 Medical personnel shall inform patients of their condition and proposed medical measures. For high-risk procedures such as surgery, clinical trials, or special examinations/treatments that may cause adverse effects, medical personnel shall explain risks, alternative options, and obtain written consent. In cases where patients are unconscious or unable to decide for themselves, consent shall be obtained from their close relatives.
In emergencies where consent cannot be obtained, approval from the head of the medical institution or authorized personnel is required to proceed with necessary measures.
Article 14 Medical institutions shall prepare contingency plans for high-risk diagnostic and therapeutic activities (e.g., surgery, special examinations) to proactively mitigate risks.
Article 15 Medical institutions and medical personnel must accurately and completely document and preserve medical records in accordance with national regulations. Any amendments or additions to records must be noted and signed.
Under no circumstances shall medical records be altered, forged, concealed, destroyed, or seized.
Article 16 Patients have the right to access and copy their complete medical records, including outpatient records, inpatient logs, test results, surgical records, anesthesia records, pathology reports, and billing details. Copies must be provided free of charge except for reasonable printing costs.
Article 17 Medical institutions shall establish communication mechanisms to address patient inquiries and concerns promptly and transparently.
Article 18 Medical institutions shall set up dedicated complaint management departments or personnel to publicly display dispute resolution channels, procedures, and contact information.
Article 19 The health administrative department shall supervise medical institutions’ implementation of quality and safety management systems, analyze risks, and develop preventive measures.
Article 20 Patients shall comply with medical institution rules, provide accurate health information, and cooperate with diagnostic and therapeutic activities.
Article 21 Governments shall strengthen public health education to improve awareness of disease prevention and treatment.
Chapter III Handling of Medical Disputes
Article 22 Medical disputes may be resolved through the following channels:
(1) Negotiation between the parties;
(2) Mediation by people’s mediation organizations;
(3) Administrative mediation by health authorities;
(4) Litigation in people’s courts;
(5) Other lawful methods.
Article 23 Upon a medical dispute, medical institutions shall inform patients or their close relatives of:
(1) Legal dispute resolution channels;
(2) Procedures for sealing/unsealing medical records and physical evidence;
(3) Rules for accessing/copying medical records.
If the patient dies, information about autopsy procedures must also be provided.
Article 24 Sealing/unsealing of medical records must be conducted jointly by both parties in the presence of witnesses. Sealed records may be original or copies, stored by the medical institution. After dispute resolution or if no further claims are filed within 3 years, the records may be unsealed.
Article 25 In cases involving suspected adverse reactions to treatments (e.g., transfusions, medications), both parties shall jointly seal physical evidence (e.g., remaining fluids, devices). Disagreements over testing shall be resolved through mutual agreement or designation by the local health authority.
Article 26 Autopsies must be conducted within 48 hours of death (or 7 days if refrigerated). Consent from close relatives is required; refusal will be deemed as disagreement. Autopsies shall be performed by qualified institutions and personnel, with representatives from both sides allowed to observe.
Article 27 Corpses must be moved to designated morgues or facilities within medical institutions and disposed of within 14 days. Unclaimed corpses may be handled by the institution after reporting to local authorities.
Article 28 Medical institutions must report major disputes to local health authorities, who shall guide resolution through legal channels.
Article 29 All parties must maintain order during disputes. Illegal acts disrupting medical order shall be reported to public security authorities for prompt intervention.
Article 30 Negotiations must occur in dedicated venues without disrupting medical services. Agreements reached shall be documented in writing and signed by both parties.
Article 31 Mediation by people’s mediation organizations requires joint application by both parties. Mediators shall be impartial and may consult experts or commission appraisals. Mediation agreements are binding upon signing.
Article 32 Mediation committees shall be established in accordance with the People’s Mediation Law and registered with local judicial administrative departments. Mediators shall possess medical, legal, or related expertise.
Article 33 Mediation committees may consult experts or commission appraisals to clarify liability. Appraisals shall be conducted by qualified medical associations, forensic institutions, or experts selected from a centralized pool.
Article 34 Appraisal reports must detail injury severity, causal relationships, and liability proportions. Fees shall be shared proportionally by the parties based on the outcome.
Article 35 Expert pools shall include professionals from medicine, law, and forensic science, selected without regional restrictions.
Article 36 Mediation agreements shall be confirmed by both parties and may be enforced through judicial procedures.
Article 37 Confidentiality of personal information and mediation content must be maintained. Unauthorized disclosure is prohibited.
Article 38 Unresolved disputes may be resolved through litigation.
Article 39 Compensation amounts shall be determined in accordance with applicable laws.
Chapter IV Legal Liabilities
Article 40 Medical institutions or personnel found guilty of altering, forging, concealing, or destroying medical records shall face disciplinary action, suspension, or revocation of licenses. Criminal offenses shall be prosecuted.
Article 41 Application of unapproved medical technologies shall result in fines, confiscation of illegal gains, and penalties for responsible personnel.
Article 42 Violations such as inadequate risk management, failure to obtain informed consent, or refusal to provide medical records shall incur warnings, fines, or suspension of operations.
Article 43 False appraisal reports by medical associations or forensic institutions shall lead to fines, suspension of operations, and criminal charges for severe cases.
Article 44 Mediators or staff involved in misconduct (e.g., bias, bribery) shall be disciplined or dismissed.
Article 45 Public security authorities shall penalize disruptive or violent behavior in medical disputes.
Article 46 Government officials failing to fulfill duties shall face administrative sanctions or criminal prosecution.
Article 47 Parties causing harm during disputes shall bear civil, administrative, or criminal liability.
Chapter V Supplementary Provisions
Article 48 These Regulations shall apply to military medical institutions as implemented by the Central Military Commission in coordination with the National Health Commission.
Article 49 Administrative investigations of medical accidents shall follow the Regulations on the Handling of Medical Accidents.
Article 50 These Regulations take effect on October 1, 2018.