Procedures of Shanghai Municipality on Prevention and Mediation of Medical Malpractice Disputes

(Promulgated by Decree No. 12 of Shanghai Municipal People's Government on January 11, 2014; amended in accordance with Decree No. 13 of Shanghai Municipal People's Government on April 2, 2024)

Chapter I General Provisions

Article 1 (Purposes and Basis)

With a view to protecting the legitimate rights and interests of both patients and medical staffs, maintaining the normal order in medical institutions, and preventing and handling medical malpractice disputes in a timely manner, these Procedures are formulated in accordance with the provisions of People's Mediation Law of the People's Republic of China, Law on Doctors of the People’s Republic of China, Regulations on the Prevention and Handling of Medical Disputes,  and other relevant laws and rules, and in the light of the actual circumstances of this Municipality.

Article 2 (Definition)

The term "medical malpractice dispute" in these Procedures refers to disputes arising between patients on the one side and medical institutions and medical staffs thereof on the other over medical treatment and care.

Article 3 (Application Scope)

These Procedures apply to the prevention and people's medication of medical malpractice disputes within the administrative area of this Municipality.

Article 4 (Duties of Departments)

The justice department shall be responsible for guiding people's mediation of medical malpractice disputes and promoting the standardization of such mediation.

The public security department shall be responsible for maintaining the normal business order of the medical institutions, and for timely handling illegal acts that disrupt order in the said institutions or on the site of people's mediation of medical malpractice disputes.

The department of health shall be responsible for establishing a mechanism to prevent medical malpractice disputes and for guiding medical institutions toward resolution of such disputes by means of people's mediation.

Article 5 (People’s Mediation Committee for Medical Malpractice Disputes)

The district people's mediation committee for medical malpractice disputes (hereinafter referred to as the "Medical Malpractice Mediation Committee", or the "MMMC") is a non-government organization specializing in mediating medical malpractice disputes in the relevant jurisdiction, subject to the guidance of the district justice department.

The MMMC shall charge no fees for mediating medical malpractice disputes.

The MMMC shall mediate medical malpractice disputes according to law, free from any interference from any organization or individual.

Article 6 (People's Mediators)

Depending on the number and scale of the medical institutions within their respective jurisdictions and the number of people seeking treatment from these institutions, the MMMC shall engage an appropriate number of full-time and part-time people's mediators.

The people's mediators of the MMMC shall be impartial, upright, and enthusiastic about the work of people's mediation. They shall have special expertise in medical science, public health administration, or law.

Article 7 (Expert Pool)

The municipal department for health shall, jointly with the municipal justice department, set up a pool of experts for people's mediation of medical malpractice disputes (hereinafter referred to as the "expert pool").

The municipal administrative department of justice shall, jointly with the municipal department of health, formulate procedures and rules of expert consultation for people's mediation over medical malpractice disputes.

Article 8 (Funding)

The municipal and district people's governments shall provide necessary office work facilities and funds for people's mediation of medical malpractice disputes.

The municipal and district financial departments shall, according to relevant provisions, provide the necessary operating funds and subsidies for people's mediation of medical malpractice disputes, as well as allowances for mediators and fees for consultants.

The rates of mediators' allowances and consultants' fees shall be determined or adjusted by the municipal administrative department of justice jointly with the municipal finance department in the light of the actual circumstances of this Municipality and the demands of the work.

Article 9 (Medical Liability Insurance)

The department of health shall offer guidance and persuade medical institutions to buy medical liability insurance, and encourage them to negotiate and cooperate with medical liability insurers (hereinafter referred to as the "insurers"), so that medical liability insurance will have a part to play in risk sharing in people's mediation of medical malpractice disputes.

The government-funded medical institutions in this Municipality shall buy medical liability insurance, and the medical risk fund set aside according to relevant provisions shall be used to buy such insurance.

Article 10 (Insurers)

The insurers shall formulate the terms of insurance contracts reasonably and determine the premium rates in a scientific way in accordance with relevant provisions of the State and by adhering to the business principles of "fairness, impartiality and compliance". They shall improve medical liability insurance management and risk control, and play an active role in preventing medical liability and reducing or avoiding risks of malpractice liabilities on the part of medical institutions.

Chapter II Dispute Prevention

Article 11 (Supervision and Management)

The department of health shall strengthen its supervision over and management of the practice of medical institutions and their staffs, and urge them to raise their level of medicare skills and the quality of their services.

The department of health shall analyze and classify on a regular basis information regarding the medical institutions' medicare quality and hazards as reflected in the medical malpractice disputes, make statistical evaluations and comments, and issue guiding opinions to the medical institutions.

Article 12 (Requirements for Medical Practice)

Medical institutions and their medical staffs shall practice medicine according to the provisions of laws, rules and regulations and the norms of diagnosis, treatment and nursing.

Article 13 (Popularizing Legal and Medical Knowledge)

Medical institutions shall disclose information on medical service as required, and shall publicize laws and rules on medicine and health care among patients and the general public, and disseminate relevant knowledge thereof by multiple means.

Article 14 (Active Prevention)

Medical institutions shall formulate plans for preventing and handling medical malpractice disputes, analyze on a regular basis the causes of such disputes, prevent the occurrence thereof, and resolve such disputes properly.

Medical institutions shall establish a working mechanism for resolving medical malpractice disputes, accept complaints about their medical services from patients or their close relatives, and provide consultation service thereto.

Article 15 (Security Precautions)

Medical institutions shall have in place a set of security rules, and shall implement such rules by taking into consideration relevant provisions, the number of patients seeking medical care therefrom, the size of their premises, and the grade of the hospital.

Article 16 (Obligation to Inform)

When a medical institution considers it necessary to give a patient a surgical operation or a special examination or treatment, its staff shall inform the patient or his/her close relative of the medical risks involved and alternative plans of treatment, and shall obtain written consent therefrom.

Article 17 (Keeping, Duplicating and Sealing of Medical Records)

Medical institutions shall properly keep patients' medical records during hospitalization, as well as outpatients' records of clinical visits or emergencies which shall be kept by the medical institutions.

Where a patient or his/her close relative seeks copies or duplicates of his/her medical records, the medical institution shall provide them according to relevant provisions on medical records management, together with a list of such copies or duplicates, all stamped with its official seal.

Where a patient or a close relative thereof requires sealing up his/her medical records or the physical objects on the site, the parties (the patient or his/her close relative on the one side and the medical institution on the other) shall accomplish the sealing up together. When sealing up the said materials or objects, the medical institution shall make a list of the items sealed up. The list shall have two counterparts, both properly signed or sealed by the parties, and each party shall have one of the counterparts.

Article 18 (Corpse Disposal)

When a patient dies in a medical institution, the institution shall move the corpse into the morgue immediately, and dispose of it according to relevant provisions. The patient's family shall cooperate.

Article 19 (Notification of Relevant Matters)

Where a medical malpractice dispute occurs, the medical institution shall designate specific personnel to answer the patient's or his/her close relative's questions, and shall notify the latter of the following:

1. the methods of resolving medical malpractice disputes, such as people's mediation;

2. the provisions regarding the sealing up and unsealing of medical records and on-site physical objects; 

3. and the provisions regarding copying or duplicating medical records.

If, in the event of a patient's death, the parties are not sure of the cause of the death, or if a party has doubts about the cause, the medical institution shall inform the other party of the provisions and procedures regarding autopsy.

Article 20 (Reporting)

If a grave medical malpractice dispute occurs, the medical institution shall report to the department of health promptly.

Article 21 (Prohibitions)

Both parties shall maintain the orderliness of the medical institution in accordance with the law.

No unit or individual shall do the following:

1. burn joss paper (ghost money), set up a mourning hall, put wreaths, hang banners without approval, lay corpses against rules, gather a crowd to provoke a quarrel or fight, or block the gates or important entrances or exits to hamper the free passage of people;

2. stir up trouble or provoke a quarrel or fight in medical institutions;

3. charge into or occupy offices of medical institutions or places of medical services;

4. illegally bring inflammables, explosives or other dangerous substances and controlled articles into a medical institution;

5. insult, threaten, menace or intentionally harm medical staff or limit their personal freedom, or otherwise threaten other persons' personal security;

6. intentionally damage or destroy, or steal or rob public or private property in medical institutions;

7. obstruct the moving of a corpse into the morgue or funeral parlor; 

8. or otherwise disrupt the normal order of medical institutions.

Article 22 (On-site Handling)

Upon receiving a report of a major medical malpractice dispute, the department of health shall urge the medical institution to take necessary steps to treat the patient and handle the case. When necessary, the said department shall send personnel to direct and coordinate such efforts, and guide both parties toward resolving the dispute by using people's mediation or other legal means. The public security department shall promptly take the following measures in handling acts that disrupt the normal order of a medical institution:

1. try to stop extreme behavior by education and persuasion;

2. deal with on-site illegal or criminal acts in accordance with the law; 

3. and take the suspects away from the site for investigation.

The medical institution shall cooperate with the public security department in maintaining the order of the site.

Chapter III Dispute Mediation

Article 23 (Application for Mediation)

If a medical malpractice dispute occurs, both parties may apply for mediation to the MMMC whose jurisdiction embraces the medical institution.

The parties may apply for mediation to the MMMC jointly or separately. If the party representing the patient applies for mediation alone, the medical institution shall cooperate if it is a government-funded one.

In the case of a medical malpractice dispute in which the party representing the patient seeks a compensation of over 30,000 yuan, the medical institution shall notify that party that it may apply for mediation to the MMMC. Both the medical institution and the party representing the patient shall subject themselves to the mediation.

Article 24 (Methods of Mediation Application)

The parties may make a written or oral application for medication. When an applicant applies for application orally, the MMMC shall make a written record on site of the applicant's basic information, the issues in dispute and the reasons giving rise to the mediation application.

When the MMMC learns that a major medical dispute has arisen in a medical institution, it shall assign a people's mediator to do on-site persuasion. It may also accept a mediation application from the parties.

Article 25 (Other Participants)

The party representing the patient may entrust his/her close relative, a lawyer or grassroots-level legal service provider to represent him/her in the mediation of a medical malpractice dispute. The entrusted person shall present proof of kinship or the power-of-attorney, and his/her license if he/she is a lawyer or legal service provider.

Article 26 (Period of Mediation)

The MMMC shall conclude a mediation within 30 days from the date when either party files an application therefor. If the period of mediation needs to be extended due to special circumstances, the period may be extended by agreement among the MMMC and the two parties; if the parties fail to reach any mediation agreement within the period agreed upon, the mediation shall be deemed as having failed.

Article 27 (Cases Not Subject to Mediation)

The MMMC shall not mediate a medical malpractice dispute under any of the following circumstances:

1. A party has already applied for administrative ruling of a medical accident dispute to the department of health, and the latter has already filed the application or handed down its ruling;

2. A party has already brought the dispute to a people's court, and the latter has already filed the case or handed down its ruling;

3. Or other circumstances that render mediation by the MMMC inappropriate.

Article 28 (Designation of Mediators)

Upon filing an application for mediation of a medical malpractice dispute, the MMMC shall designate one or more people's mediators to preside over the mediation. It may also have the parties choose one or more people's mediators to preside over the mediation.

Article 29 (Mediator's Recusal)

A people's mediator who fits into any of the following descriptions shall recuse himself/herself from mediation, and the parties shall have the right to apply for recusal orally or in writing:

1. The prospective mediator is a party to the dispute or is a close relative of a party or its representative;

2. He/she is or was once an employee of the medical institution involved in the dispute;

3. He/she has an interest in the manufacturer or distributor of the medicine or medical appliance involved in the medical malpractice dispute; 

4. Or he/she is otherwise considered unsuitable by the parties due to circumstances that might affect impartiality of the mediation.

The MMMC shall promptly make a decision on the recusal application and notify both parties thereof.

Article 30 (Confidentiality)

The MMMC and its people's mediators shall keep confidential the parties' commercial secrets, personal privacy matters or personal information.

Without consent of both parties, the mediation shall not proceed in an open setting and information relating to it shall not be disclosed.

Unless otherwise provided for by laws, rules or these Procedures, the MMMC shall not use the relevant materials obtained in the process of mediating the medical malpractice dispute for purposes other than the mediation. Nor shall it provide such materials to any other organization or individual.

Article 31 (Expert Consultation)

If a medical malpractice dispute fits into any of the following description, the MMMC shall initiate the procedure of expert consultation:

1. The estimated compensation exceeds 100,000 yuan;

2. The patient is dead;

3. The parties differ significantly on the facts in dispute;

4. The estimated insurance claim exceeds 100,000 yuan and the insurer proposes expert consultation; 

5. Or other circumstances exist that call for expert consultation.

Experts for consultation in a particular case shall be chosen from the expert pool subject to the principle of recusal. When necessary, a consultation expert may be chosen from outside the expert pool in the light of the actual circumstances of mediation.

Article 32 (Expert Opinions)

The MMMC may solicit opinions from the experts on the following matters:

1. Whether the medical institution is at fault in following the usual practice of diagnosis or treatment, or in performing its obligation of notification;

2. Whether there is a causal relationship between the fault and the injury;

3. The extent of liability for the injury resulting from the fault; 

4. And other technical questions relating to the facts in dispute.

The experts shall, on the principle of independence, objectiveness and impartiality, give opinions on the matters presented by the MMMC for consultation, and properly sign or seal the opinion letter.

The experts' opinion letter is for reference by the MMMC in its mediation.

Article 33 (Impartiality)

People's mediators shall treat the parties equally, respect their right of expression, and pay full attention to the statements of the parties. They shall not repress or hinder the parties' expression of opinions, or favor one party over the other.

After gaining full knowledge of the different accounts of what happened and on the basis of investigation and verification, the people's mediator shall put forward to the parties in due course his/her proposals for solving the dispute.

Article 34 (Obligations of Parties)

The medical institution shall conduct a preliminary investigation of a medical malpractice dispute, and submit in a timely manner to the MMMC relevant evidentiary materials as well as its tentative proposal.

The parties shall provide relevant medical records and materials as required by the people's mediator.

Article 35 (Notification to Insurer)

In cases where the medical institution has purchased medical liability insurance, the MMMC may notify the insurer to be present in the mediation.

The insurer's failure to come to the mediation upon receiving the MMMC's notice shall not affect the process of mediation.

Article 36 (Mediation in the Presence of Insurer's Representative)

Upon notice from the MMMC, the insurer may send its representative to the mediation and provide professional service relating to medical malpractice liability insurance in accordance with the following:

1. If the estimated amount of insurance compensation is no more than 30,000 yuan, the insurer may decide by itself whether to send an employee to attend the mediation;

2. And if the estimated amount of insurance compensation is more than 30,000 yuan, the insurer shall send an employee to attend the mediation and give opinions on compensation.

The provisions above in this Article regarding the estimated amount of insurance compensation shall be adjusted from time to time after consultation between the municipal administrative department of justice, the insurance regulatory commission and the insurers.

Article 37 (Mediation Agreement)

The people's mediator shall help the parties to make a dispute resolution plan on the principles of impartiality, free-will and reasonableness, and according to the rules of mediation.

If the two parties reach an agreement after mediation, the MMMC shall prepare a written mediation agreement. The mediation agreement shall be signed or sealed by the two parties, and shall be effective upon being signed by the people’s mediator and stamped with the seal of the MMMC.

If the mediation agreement contains no provision for payment of money or other things of value and the two parties deem it unnecessary to make a written mediation agreement, the agreement may be in oral form, but the people's mediator shall record the contents of the agreement in writing. The record shall be signed or sealed by the parties and the people's mediator, and the MMMC shall affix its official seal to it.

Article 38 (Insurance Payment)

A mediation agreement reached under the auspices of the MMMC shall be the basis for insurer's payment of compensation for medical malpractice liability.

Article 39 (Judicial Confirmation)

Upon reaching a mediation agreement, the parties may duly apply to a people's court for judicial confirmation if they deem necessary.

If a mediation agreement cannot be performed promptly, the people's mediator shall advise the two parties to apply for judicial confirmation.

Article 40 (Performance of the Mediation Agreement)

The parties shall voluntarily perform the mediation agreement. In the event of a dispute over the performance or content of the agreement, they may bring the dispute to a people's court for adjudication.

Article 41 (Written Suggestions)

The MMMC may submit written proposals on preventing medical malpractice disputes to the department of health and the medical institutions in the light of its mediation of medical malpractice disputes.

Article 42 (Advice to Parties Who Do Not Seek Mediation or Fail to Reach Mediation Agreement)

If the parties refuse to subject themselves to mediation or fail to reach a mediation agreement, the MMMC shall notify them to the effect that they may duly seek to resolve their dispute by other legal means, such as applying to the department of health for resolution or filing a lawsuit with a people's court.

Chapter IV Legal Liability

Article 43 (Legal Liability for Illegal Acts)

If anyone has committed an act under Paragraph 2 of Article 21 hereof, the public security department shall impose punishment thereon according to the Law of the People's Republic of China on Public Security Administration and Imposition of Punishment; if such act constitutes a crime, the wrongdoer shall be prosecuted for criminal liability according to law.

Article 44 (Legal Liability of Medical Institutions and Their Staffs)

If a medical institution or any member of its staff does any of the following in violation of the provisions hereof, the department of health shall impose punishment according to relevant provisions of the Law on Doctors of the People's Republic of China and the Regulations on the Prevention and Handling of Medical Disputes:

1. violating health administration rules, regulations or standard technical procedures, causing serious consequences;

2. giving experimental clinical treatment without the consent of the patient or his/her close relative;

3. failing to advise the patient of his/her condition, the medical measures, the risks thereof and the alternative medical solutions;

4. tampering, forging, concealing, and destroying medical documents and related materials;

5. failing to seal, keep or unseal medical records or on-site physical objects in accordance with relevant provisions;

6. divulging patients' privacy matters, causing serious consequences;

7. or refusing to provide the patient or his/her close relative with service of copying or duplicating medical records and materials.

Article 45 (Legal Liabilities of People's Mediators)

If a people's mediator has done any of the following acts in the mediation work, the MMMC shall educate or criticize him/her, and order him/her to make corrections. If the case is serious, he/she shall be fired:

1. favoring one party over the other;

2. insulting a party;

3. seeking or accepting payments or gifts or other unjustifiable gains; 

4. or divulging a party's personal privacy matters or commercial secrets.

Chapter V Supplementary Provision

Article 46 (Effective Date)

These Procedures shall be effective as of March 1, 2014.