Measures of Shanghai Municipality for the Administration of Internet Hospitals

Chapter I General Provisions

Article 1 (Purposes and Basis)

With a view to promoting the sound development of Internet hospitals in Shanghai Municipality and regulating Internet diagnosis and treatment, the Measures of Shanghai Municipality for the Administration of Internet Hospitals are formulated in accordance with the provisions of the Basic Healthcare and Health Promotion Law of the People's Republic of China，the Law on Doctors of the People's Republic of China, the Law of the People's Republic of China on Traditional Chinese Medicine, the Regulation on the Administration of Medical Institutions, and other relevant laws and rules, as well as the Opinions of the State Council on Promoting the Development of "Internet plus Health Care", the National Health Commission's Measures for the Administration of Internet Hospitals (for Trial Implementation), Measures for the Administration of Internet Diagnosis and Treatment (for Trial Implementation), and Detailed Rules on the Supervision of Internet Diagnosis and Treatment (for Trial Implementation).

Article 2 (Definition)

The term "Internet hospitals" as mentioned in these Measures includes both Internet hospitals as the second name of physical medical institutions and Internet hospitals independently established with support from physical medical institutions.

Article 3 (Scope of Application)

These Measures shall apply to the establishment and practicing licensing of Internet hospitals within the administrative region of this Municipality, as well as to the supervision and administration of Internet diagnosis and treatment carried out by medical institutions in accordance with the Measures for the Administration of Internet Hospitals (for Trial Implementation) and the Measures for the Administration of Internet Diagnosis and Treatment (for Trial Implementation).

Article 4 (Access Management)

The municipal and district health administrative departments (including the competent departments in charge of traditional Chinese medicine, the same below) shall be responsible for the administration of the access of Internet hospitals in accordance with the relevant provisions of the Regulations on the Administration of Medical Institutions, the Detailed Rules for the Implementation of the Regulations on the Administration of Medical Institutions, the Measures for the Administration of Internet Hospitals (for Trial Implementation), and the Measures of Shanghai Municipality for the Administration of Medical Institutions.

Internet hospitals shall not provide Internet diagnosis and treatment before they have obtained the Medical Institution Practice License. Where physical medical institutions have obtained the Medical Institution Practice License, establish an information platform on their own or in cooperation with a third-party institution, and they employ medical practitioners registered with themselves or with other medical institutions to carry out Internet diagnosis and treatment, these physical medical institutions shall apply to use Internet hospital as their second name and to add "Internet diagnosis and treatment" to their service modes. Where physical medical institutions employ only medical practitioners registered with themselves to carry out Internet diagnosis and treatment, they shall apply to add "Internet diagnosis and treatment" to their service modes and may apply to use Internet hospital as their second name.

No entity or individual may carry out Internet diagnosis and treatment without the approval of the health administrative departments.

Article 5 (Scope of Diagnosis and Treatment)

The diagnosis and treatment services provided by Internet hospitals shall conform to the functional orientation of their physical medical institutions or other supporting physical medical institutions, and shall fall within the practice scope registered in the Medical Institution Practice License, which primarily includes a follow-up or a regular follow-up visit by patients with common or chronic diseases, and family doctor contract services.

Article 6 (Department Responsibility)

The municipal health administrative department shall be responsible for the supervision and administration of the Internet hospitals within this Municipality, and shall establish Shanghai Internet Diagnosis and Treatment Supervision and Administration Platform (hereinafter referred to as the "Supervision and Administration Platform"). The district health administrative departments shall be responsible for the supervision and administration of the Internet hospitals within their respective jurisdictions.

Internet hospitals that have obtained the Medical Institution Practice License as independent and legally responsible institutions, shall engage in Internet diagnosis and treatment in accordance with laws, rules and other relevant provisions so as to ensure medical safety, adherence to ethical standards, self-discipline, and accountability to society and the public, and shall be subject to public supervision and fulfill their social responsibilities. When third-party institutions set up Internet hospitals by relying on physical medical institutions, both parties shall specify their respective responsibilities, rights and interests in medical services, network security, data security, personal information protection, privacy protection, medical risks, allocation of responsibilities, etc. through agreements, contracts, or other means. When a physical medical institution takes Internet hospital as its second name, that medical institution shall be the legally responsible one.

Quality control centers, and industry institutes and associations shall formulate technical specifications and practicing instructions for Internet diagnosis and treatment for the purpose of strengthening industry self-regulation, guiding and standardizing Internet hospitals in their provision of Internet diagnosis and treatment in accordance with law, and protecting the legitimate rights and interests of patients.

Chapter II Access of Internet Hospitals

Article 7 (Access Application)

For Internet hospitals to be independently established with support from physical medical institutions, applications for establishment shall be filed with the competent authorities responsible for issuing the Medical Institution Practicing License to such physical medical institutions. After obtaining the Written Approval for the Establishment of a Medical Institution, an application shall be filed for the practicing registration in accordance with relevant provisions.

Where a physical medical institution has obtained the Medical Institution Practicing License and intends to form an Internet hospital and use Internet hospital as its second name, it shall file an application for practicing registration with the competent authorities that have issued to it the Medical Institution Practicing License.

Before conducting Internet diagnosis and treatment, Internet hospitals shall undergo procedures to obtain administrative permits (or recordation) related to telecommunications management, market regulation, cybersecurity, drug administration, and other aspects in accordance with law.

Article 8 (Conditions for Establishment)

To apply for the establishment of an Internet hospital, the following conditions shall be met:

1. compliance with the basic standards for Internet hospitals as prescribed by the State; 

2. and availability of an appropriate premise.

Entities that cannot independently assume civil liability and other responsible entities that are included in the national or municipal list of entities with serious dishonest acts are not eligible to apply to establish Internet hospitals.

Individuals who are serving a sentence, or do not have the full capacity for civil conduct, medical personnel who are involved in a Grade-2 or higher medical malpractice within the past five years or whose practicing certificates have been revoked, or former legal representatives or primary persons in charge of medical institutions whose Medical Institution Practicing License or Traditional Chinese Medicine Clinic Recordation Certificates have been revoked within the past five years, shall not act as legal representatives or primary persons in charge of Internet hospitals.

Article 9 (Submissions for Establishment)

When a third-party institution supported by a physical medical institution applies for the establishment of an Internet hospital, it shall submit the following materials:

1. a written application for the establishment of a medical institution;

2. a feasibility study report; 

3. and an agreement or contract jointly signed by the applicant and the physical medical institution for the establishment of an Internet hospital.

Where a physical medical institution applying for establishment intends to concurrently use Internet hospital as its second name, it shall indicate this intention in the application for the establishment of the medical institution in accordance with law, and also specify the relevant information of the Internet hospital in the feasibility study report on its establishment. In the case of cooperation with a third-party institution to establish an Internet hospital information platform, a cooperation agreement shall be submitted.

Article 10 (Public Disclosure)

The establishment of an Internet hospital shall be subject to a public disclosure system. The health administrative department shall issue a public announcement for a period of five working days regarding the intended establishment of the Internet hospital, which includes, inter alia, the name, type, address, and medical specialties of the Internet hospital to be established, as well as the names of the applicant and the supporting medical institution.

During the public disclosure period, the health administrative department shall make a prompt investigation into the issue when it receives non-anonymous reporting or objections. In case that the proposed Internet hospital does not stand the public disclosure, the health administrative department shall not approve its establishment.

Article 11 (Approval of Name)

The name of an Internet hospital shall comply with the provisions of the Regulations on the Administration of Medical Institutions, the Detailed Rules for the Implementation of the Regulations on the Administration of Medical Institutions, and the Measures of Shanghai Municipality for the Administration of Medical Institutions, as well as other relevant national and municipal provisions concerning the naming of medical institutions, and shall also satisfy the following requirements:

1. The name of a physical medical institution independently applying for an Internet hospital as the second name shall include the "name of the institution itself + Internet hospital";

2. The name of a physical medical institution that cooperates with a third-party institution to apply for Internet hospital as the second name shall include the "name of the institution itself + the identifiable name of its cooperator + Internet hospital"; 

3. And the name of an Internet hospital that is independently established shall include "Shanghai + the identifiable name of the applicant for its establishment + Internet Hospital".

The name of an Internet hospital shall be subject to the examination and approval by the municipal health administrative department in accordance with relevant provisions.

Article 12 (Establishment Approval)

After receiving an application for establishment, the health administrative department shall conduct examination in accordance with the relevant provisions of the Regulations on the Administration of Medical Institutions, the Detailed Rules for the Implementation of the Regulations on the Administration of Medical Institutions, and the Measures of Shanghai Municipality for the Administration of Medical Institutions, and shall issue a Written Approval for the Establishment of a Medical Institution with a one-year validity if the requirements are satisfied.

The district health administrative departments shall file the recordation with the municipal health administrative department within 15 days of issuing the Written Approval for the Establishment of a Medical Institution. The municipal health administrative department is authorized to correct or revoke the establishment approval issued by the district health administrative departments within 30 days of receiving the recordation report.

The Written Approval for the Establishment of a Medical Institution shall primarily register the following items:

1. the applicant;

2. the name;

3. the address;

4. the supporting physical medical institution;

5. the type;

6. service objects and modes;

7. the form of ownership, nature of business, and total investment; 

8. and the medical specialties.

In case that a physical medical institution applying for establishment intends to use Internet hospital as its second name, if its establishment application is approved by the health administrative department and Internet hospital is also approved to be used as its second name, this shall be indicated in the Written Approval for the Establishment of a Medical Institution.

Article 13 (Reapplication for Establishment)

Before the practicing registration of an Internet hospital, where there are any changes to its approved type, address, supporting physical medical institution, or applicant for establishment, a reapplication shall be submitted to undergo the establishment approval formalities.

Article 14 (Application for Practicing Registration)

Before engaging in Internet diagnosis and treatment, an Internet hospital shall apply to the health administrative department that initially approved its establishment to undergo the practicing registration formalities in order to obtain the Medical Institution Practicing License.

Article 15 (Conditions for Practicing Registration)

An Internet hospital that applies for the practicing registration shall meet the following conditions:

1. It has obtained the Written Approval for the Establishment of a Medical Institution;

2. It conforms to the basic standards for Internet hospitals as prescribed by the State;

3. It has health-related technical personnel, facilities and equipment in relation to the business to be carried out and also in compliance with the applicable provisions;

4. In accordance with the functional and technical specifications of relevant hospital information platforms as required by the National Health Commission and the provisions of the municipal medical service investigation system, it has established a corresponding information management platform, which is connected to the supervision and administration platform in accordance with the data interface requirements as specified by the municipal health administrative department;

5. It has the corresponding rules and bylaws;

6. And it is in a position to independently assume its civil liability.

Article 16 (Submissions for Practicing Registration)

An Internet hospital applying for practicing registration shall submit the following materials:

1. the registration certificate of the medical institution's application for practice;

2. the resumes, resident identity cards (or any other valid proof of identity), qualification certificates, and practicing certificates, of the legal representative and the primary person in charge of the Internet hospital;

3. a list of the health-related technical personnel with the Internet hospital;

4. a description of the establishment of an information management platform that conforms to the requirements and standards, and that is also connected with the supervision and administration platform;

5. a letter of commitment of the Internet hospital applying for practicing registration (including a commitment to the authenticity of the application materials and to the obtaining of relevant administrative approval and permits before practicing);

6. rules and bylaws of the Internet hospital;

7. information on the equipment and facilities for providing Internet diagnosis and treatment;

8. and materials that conform to the provisions and requirements for establishing a physical medical institution in case that the Internet hospital intends to set up a diagnosis and treatment site at the registered location of practicing.

Where a physical medical institution that has obtained a Medical Institution Practicing License intends to establish an Internet hospital and use Internet hospital as its second name, it shall file an application to add Internet hospital as its second name with the competent authorities issuing the Medical Institution Practicing License and submit the following materials:

1. an application for modification in the practicing registration as a medical institution;

2. an application signed by the legal representative or the primary person in charge of the medical institution, stating the cause(s) and reason(s) for applying to add Internet hospital as its second name;

3. information on the equipment and facilities for providing Internet diagnosis and treatment, as well as the status of the connection with the supervision and administration platform;

4. a cooperation agreement in the case of cooperation with a third-party institution to establish an Internet hospital; 

5. and rules and bylaws of the Internet hospital.

Article 17 (Practicing Registration Approval)

The health administrative departments shall review and verify the received materials submitted by the applicants for practicing registration as a medical institution and shall, if necessary, conduct an on-site inspection. Qualified applicants shall be registered, to whom a Medical Institution Practicing License shall be issued. Disqualified applicants shall be notified of the result in writing.

The original copy of the Medical Institution Practicing License shall primarily register the following matters:

1. the name and practicing address;

2. the legal representative and primary person in charge;

3. the medical specialties;

4. the nature of business; 

5. and the registration number, validity period, date of issuance, and issuing authorities, of the practicing license.

The duplicate copy of the Medical Institution Practicing License shall primarily register the following matters:

1. the name and practicing address;

2. the legal representative and primary person in charge;

3. the form of ownership, type, nature of business, objects of service, and registered capital;

4. the medical specialties;

5. the registration number, validity period, date of issuance, and issuing authorities, of the Practicing License;

6. the name of the supporting physical medical institution;

7. the name of the third-party cooperation institution;

8. the service items and service modes that are required to be registered in accordance with the provisions; 

9. and the records of verification, and the records of modification in the registration.

For Internet hospitals established by qualified physical medical institutions, the approved second name, service modes, and medical specialties shall be registered on the Medical Institution Practicing License issued to the physical medical institutions.

Article 18 (Type)

The medical institution type registered for the Internet hospital shall be consistent with what is registered on the Medical Institution Practicing License of the supporting physical medical institution.

Article 19 (Registration of Medical Specialties)

An Internet hospital shall determine the medical specialties based on the business to be carried out, and their registration shall meet the following requirements:

1. The medical specialties shall conform to the provisions of the List of Medical Specialties of Medical Institutions and the relevant specialty standards and regulations, and shall also be consistent with the practice scope and service items of the physical medical institution or the supporting physical medical institution, and with the type, scale, functions and responsibilities of medical institutions.

2. For an Internet hospital to provide relevant medical specialties, its supporting physical medical institution shall have at least one medical practitioner with a senior title in this specialty and one medical practitioner with an associate senior title registered in this institution (whose recordation in multiple institutions is allowed).

Article 20 (Post-Registration Supervision)

The health administrative department shall conduct supervisory inspections of the practicing of an Internet hospital within three months after its obtaining of the Medical Institution Practicing License. The focus of these inspections shall be to verify whether the Internet hospital's name, address, legal representative, primary person in charge, nature of business, medical specialties, practitioners, and actual connections of the hospital information system with the supervision and administration platform are consistent with what is registered in the Medical Institution Practicing License and with its written commitment in its application for practicing registration.

The health administration departments shall handle any issues that are discovered during the inspections in accordance with law. If it is confirmed that an Internet hospital has obtained the Medical Institution Practicing License through fraudulent or other illegal means, the health administrative department shall, in accordance with law, revoke the decision on the practicing registration and report the issue to the municipal public credit information service platform.

If an Internet hospital engages in practicing activities without obtaining the required administrative permits (or recordation) from the competent authorities of telecommunications administration, market regulation, network security, drug administration, etc., the health administrative departments shall transfer the case to the relevant departments for handling.

Article 21 (Other Requirements)

An Internet hospital that operates as the second name of a physical medical institution shall be verified at the same time as the physical medical institution. An Internet hospital that independently obtains the Medical Institution Practicing License with support from a physical medical institution shall undergo the verification procedure once a year. The connection of the Internet hospital with the supervision and administration platform and its data reporting shall be included in the verification procedure.

Modification, suspension (closure) of business, extension (replacement), re-issuance, cancellation, and other matters related to the Medical Institution Practicing License of an Internet hospital shall be handled in accordance with the relevant provisions of the Regulations on the Administration of Medical Institutions. The health administrative departments shall establish an evaluation and exit mechanism for Internet diagnosis and treatment in accordance with the Regulations on the Administration of Medical Institutions and the detailed implementation rules thereof.

In the event of a change in the partnership or other circumstances, under which the partnership agreement is invalidated, an Internet hospital established under a partnership shall be deregistered. In the event that a change in the partnership occurs but there is still a need to establish an Internet hospital, a new application for its establishment is required.

Chapter III Administration of Practicing

Article 22 (Principles for Practicing)

Internet hospitals providing Internet diagnosis and treatment must comply with relevant laws, rules and regulations concerning, inter alia, medical quality, medical safety, cybersecurity, epidemic prevention and control, as well as with technical standards on diagnosis and treatment, information management standards and professional ethics standards, and shall also adhere to the relevant provisions on hierarchical diagnosis and treatment so as to be compatible with the functional orientation of their supporting physical medical institutions. Physical medical institutions are encouraged, through Internet hospitals, to share data resources and collaborate with primary-level medical institutions, and medical institutions independently established by a third party, so as to accelerate the integration of medical resources across all levels, improve service convenience and efficiency, and promote the establishment of an orderly hierarchical diagnosis and treatment system.

Internet hospitals shall establish dedicated departments to manage medical quality, medical safety, pharmaceutical services, and information technology of Internet diagnosis and treatment, with the establishment of corresponding management systems, which include but are not limited to: a self-inspection system for medical institutions’ practice in accordance with law, a medical quality and safety management system related to Internet diagnosis and treatment, a reporting system of adverse medical quality (safety) events, a medical personnel training and evaluation system, an informed consent system for patients, a prescriptions management system, an electronic medical records management system, and a management system with regard to the use of the information system.

Internet hospitals shall, in accordance with national and municipal requirements for medical management and information management, implement various relevant rules and regulations, as well as the responsibility systems for personnel of various posts at different levels, strengthen medical quality management, and carry out medical quality assurance programs. Internet hospitals shall organize monitoring, early warning, analysis, assessment, evaluation and feedback processes related to medical quality within the institution. Internet hospitals shall enhance quality management and control throughout the entire process of Internet diagnosis and treatment, so as to ensure medical quality and safety, and continuous improvement of services.

Article 23 (Construction of the Information System)

Internet hospitals shall establish an Internet diagnosis and treatment information system in accordance with the provisions of laws, rules and regulations such as the Cybersecurity Law of the People's Republic of China, the Regulations on the Network Security Rated Protection, the Measures for the Administration of Standards, Security and Services of National Health and Medical Care Big Data (for Trial Implementation), the Guiding Opinions on the Rated Protection of Information Security in the Health Industry, and the Basic Standards for Internet Hospitals, so as to ensure that the entire process of Internet diagnosis and treatment is being tracked and is trackable, is conducted by professional information technicians and conforms to relevant cybersecurity laws, rules and regulations.

The information system of an Internet hospital shall be rated, kept on file, and continuously evaluated in accordance with the Grade-3 or higher standards provided for in the Basic Requirements for Information Security Technology Network Security Rated Protection. Annual evaluations shall be conducted in accordance with law, and, upon the passing of the evaluation, an annual system evaluation report shall be submitted.

Internet hospitals shall voluntarily connect their information systems with the supervision and administration platform to achieve interconnectivity of business information, and they shall promptly upload and update relevant practicing information such as the Medical Institution Practicing License and information about the medical personnel involved in Internet diagnosis and treatment (including their ID numbers, photos, relevant qualifications, practicing locations, the institutions with which they practice, scope of practicing, years of clinical work experience), and shall report their business data, and voluntarily subject themselves to supervision.

The medical artificial intelligence products, mobile devices, applications and servers that are equipped and used by Internet hospitals are subject to supervision and administration by relevant departments.

Article 24 (Information Security Management)

An Internet hospital is the entity responsible for managing its information platform used for Internet diagnosis and treatment, with its primary person in charge being the primary responsible person.

Internet hospitals shall strictly implement the relevant laws, rules and regulations on cybersecurity and confidentiality of medical data, and appropriately keep their patients' information, which shall not be illegally traded or disclosed. When patients' information and medical data are leaked, the medical institution concerned shall report the issue to the health administrative department in a timely manner and immediately take effective countermeasures.

Internet diagnosis and treatment information shall not be stored on servers located abroad, and the information platform shall not be deployed on servers that are hosted or leased abroad.

Article 25 (Public Disclosure System)

Internet hospitals shall prominently disclose the following information on the Internet diagnosis and treatment platform in accordance with relevant provisions:

1. the practicing license issued, basic information on the lawful practicing registration of health-related technical personnel, and the identity markers (such as electronic ID) of health-related technical personnel when providing diagnostic and treatment;

2. the medical specialties approved by the health administrative departments;

3. information on the diagnosis and treatment provided, including service hours, items, content, methods (such as video, audio, text and images), process, and duration;

4. the charging items and standards of the diagnosis and treatment, prescribed medications and main medical consumables;

5. procedures for handling medical disputes, the mailbox for complaints about medical services, and the telephone number for making complaints and inquiries; 

6. and measures for providing convenience to people during medical services.

Article 26 (Rules on the Use of Name)

When providing Internet diagnosis and treatment, an Internet hospital shall clearly display the name as approved by the health administrative department in a prominent position.

Article 27 (Personnel Management)

Physicians and nurses who provide medical services in Internet hospitals shall have obtained the corresponding practicing qualifications in accordance with law, which can be verified in the national electronic registration system for physicians and nurses. Non-health technical personnel or unregistered health technical personnel shall not be employed to provide Internet diagnosis and treatment.

Physicians shall be registered with the supporting physical medical institutions or other medical institutions, shall have no less than three years of independent clinical work experience, and shall ensure that they have completed the diagnosis and treatment required by their primary practicing institution, and provide Internet diagnosis and treatment within the practicing type and scope specified in the Physician Practicing Certificate. In case that they engage in Internet diagnosis and treatment at Internet hospitals other than their primary practicing institution, physicians shall register or file their practicing in accordance with the requirements on practicing in multi-institutions of the district where the Internet hospital is located.

Internet hospitals shall conduct electronic real-name authentication of medical personnel. When conditions permit, Internet hospitals should strengthen their management of medical personnel through facial recognition technologies and other biometric recognition technologies. Physicians must go through real-name authentication before receiving patients in order to ensure that they provide diagnosis and treatment in person, and no other individuals, or artificial intelligence software, shall be allowed to impersonate or substitute the physicians to provide diagnosis and treatment.

Internet hospitals shall provide regular training for medical personnel engaged in Internet diagnosis and treatment, as well as for those engaged in related management services, and the training should cover health-related laws, rules and regulations, related policies on medical services management, job-related responsibilities, Internet diagnosis and treatment processes, use of platforms, and emergency response. Internet hospitals shall establish an evaluation mechanism for medical personnel engaged in Internet diagnosis and treatment, of whom the evaluation shall be based on factors such as practicing in accordance with law, medical quality, medical safety, medical ethics and practices, and patient satisfaction, and also a mechanism of entry and exit shall be established.

A third-party institution supported by a physical medical institution to jointly form an Internet hospital shall provide the physical medical institution with services of physicians, pharmacists and other professionals, as well as information technology support services, whose respective responsibilities, rights and interests shall be stipulated through an agreement, a contract, or other methods.

Article 28 (Information Disclosure)

When providing Internet diagnosis and treatment, Internet hospitals should inform the patients about the relevant information regarding the Internet hospitals and the physicians, and fully inform them about the related rules, requirements and potential risks associated with Internet diagnosis and treatment. Internet diagnosis and treatment shall not be provided without the patients' informed consent.

Internet diagnosis and treatment are provided on a real-name basis. Patients should obey the medical order and comply with the relevant provisions of the medical institutions regarding patients' visits, diagnoses, treatment and examinations, and they should provide truthful information about their identity and medical conditions, and cooperate with the medical personnel engaged in the diagnostic and treatment services.

Article 29 (Diagnosis and Treatment)

When patients seek to receive medical treatment, physicians should have a full understanding of the patients' pre-existing illnesses, diagnoses, and prescription medications, before providing diagnosis and treatment through the Internet hospital within the prescribed scope of services in a smooth and real time doctor-patient communication environment.

Patients should provide medical records with clear diagnoses, such as outpatient records, inpatient records, discharge summaries, and diagnostic certificates, which may be retained by the receiving physician to assess whether the patients meet the conditions for follow-up visits.

When patients seek to receive medical treatment at a physical medical institution and the physicians receiving the patients invite other physicians to hold group consultation through Internet hospitals, the physicians attending the group consultation may issue a diagnosis opinion and make a prescription.

Internet hospitals shall specify the conditions for the termination of Internet diagnosis and treatment. When a patient's condition of illness(es) changes, or if the physician determines that this is the patient's first consultation on a disease or there are other circumstances under which Internet diagnosis and treatment are inappropriate, the receiving physician shall immediately terminate the Internet diagnosis and treatment and direct the patient to seek medical treatment at a physical medical institution. In the case of infectious diseases or suspected infectious diseases, they should be monitored and reported in accordance with the requirements on infectious diseases management.

Internet hospitals should promptly announce important information such as physicians' consultation hours and the calling off of their consultation hours, arrange for flexible consultation hours to meet the needs of various groups, including working adults and students, and continuously improve service efficiency and quality. Internet hospitals should regularly review and streamline their diagnosis and treatment processes to provide patients with convenient online services in terms of registration for treatment, examinations and tests, prescribing, drug delivery, and payment and refund procedures, thereby improving patients' online service experience. Internet hospitals shall not provide false medical information, publish advertisements in violation of rules or regulations, or engage in unlawful promotion of health products or any other activities prohibited by the health administration departments.

Article 30 (Medical Record Management)

Internet hospitals that carry out Internet diagnosis and treatment shall, in accordance with the State's Provisions on the Administration of Medical Records in Medical Institutions, the Basic Norms for Writing Medical Records, the Management Standards for the Application of Electronic Medical Records (for Trial Implementation), and other relevant instruments, establish electronic medical records for patients, and ensure proper management of medical records according to the provisions, including their storage, lending and copying, sealing and unsealing, and preservation. Internet hospitals should manage all digital information generated during the provision of Internet diagnosis and treatment, including the texts, symbols, charts, graphics, data, audio and video, which, in accordance with the requirements for electronic medical records, shall be consistent with the format of electronic medical records of the supporting physical medical institution, be shared within the system, and be subject to integrated online and offline quality control by the supporting physical medical institution. Data transmission and storage shall be properly encrypted.

Internet diagnosis and treatment records shall be retained for no less than 15 years in accordance with the relevant provisions for outpatient electronic medical records. The retention period for the process records, such as the texts, images, and audio-video materials in diagnosis and treatment, shall be no less than three years.

When an Internet hospital changes its name, the medical records and other data that it retains should continue to be kept by the renamed Internet hospital. After an Internet hospital is deregistered, the medical records and other data it retains should continue to be kept by the supporting physical medical institution. If the supporting physical medical institution is also deregistered, the medical records and other data may be properly kept by an institution designated by the competent authorities issuing the Medical Institution Practicing License.

Patients may check online the results and documents of their examinations and tests, diagnosis and treatment plans, prescriptions, medical advice, and other medical records.

Article 31 (Prescription and Drug Administration)

Internet hospitals shall strictly adhere to the Measures for the Administration of Prescriptions, the Provisions on the Administration of Pharmaceutical Affairs of Medical Institutions and other relevant provisions in order to ensure proper management of prescription issuance, dispensing and storage. Before issuing a prescription online, the physician must review the patient's medical records, and only after being confirmed that the patient has been diagnosed at a physical medical institution with a common or several common disease(s) or chronic disease(s) may he/she issue a prescription online for the same disease(s). The issuance of long-term prescriptions shall be consistent with the Regulations on the Administration of Long-term Prescriptions. It is strictly prohibited to use artificial intelligence or other automated means to generate prescriptions, to provide medications to patients before the issuance of prescriptions, and to conduct drug utilization reviews (DUR) for commercial purposes.

All online diagnoses and prescriptions must bear the physicians' electronic signatures. A prescription shall not be valid until after being examined and verified by a pharmacist. Medical institutions and drug enterprises may entrust qualified third-party institutions for drug distribution. Relevant agreements and prescription circulation information must be traceable, and the data interfaces should be accessible to the supervision platform. No prescription for narcotic drugs, psychotropic drugs, or any other drugs with a relatively high risk of drug use or under other special control shall be issued online.

To issue a drug prescription online for a young child (under the age of six), it shall be confirmed that the child is accompanied by a guardian and a physician of the relevant specialty.

Article 32 (Price Management)

The pricing management of Internet diagnosis and treatment shall be implemented in accordance with the provisions of the municipal health and medical security departments.

Internet hospitals shall establish a system for price disclosure and prior notification, which requires a clear indication of the items of medical services, the content, the pricing unit, the price standard, and the explanations at a prominent location and in an effective pricing format, in order to ensure patients' right to be informed and right of choice. Patients should not be induced or forced to accept Internet diagnosis and treatment.

Article 33 (Medical Risk Control and Medical Dispute Resolution)

Internet hospitals shall control the quality and safety of Internet diagnosis and treatment and establish feedback channels for handling patients' complaints. A dedicated department should be designated to handle the collection, analysis and summarization of reports concerning adverse events related to medical quality (safety).

During the provision of Internet diagnosis and treatment, Internet hospitals shall inform patients about their conditions of illness(es) and the medical measures. In case that there are changes in the major professional technicians, key equipment or facilities, or other auxiliary conditions of Internet hospitals, which cannot meet the needs of Internet diagnosis and treatment, or in case that there are potential hazards concerning medical quality or safety, as well as serious adverse consequences such as adverse medical service events and adverse drug events, Internet hospitals shall immediately cease providing their services, and report to the competent authorities in accordance with relevant provisions.

A physical medical institution, or a third party applying for the establishment of an Internet hospital jointly with a physical medical institution shall purchase medical liability insurance for their physicians.

In the event of medical disputes arising out of the provision of Internet diagnosis and treatment, Internet hospitals shall handle them in accordance with the Regulations on the Prevention and Handling of Medical Disputes and the Measures of Shanghai Municipality for Medical Dispute Prevention and Mediation.

Chapter IV Supervision and Administration

Article 34 (Internal Management)

Internet hospitals shall strengthen internal management in strict accordance with the laws, rules and regulations of the State.

Internet hospitals shall establish procedures for the prevention and handling of adverse events arising from Internet medical services, implement measures for the protection of personal privacy information, and strengthen the examination and management of the content on the Internet hospital information platform, to ensure safe, effective and orderly development of Internet medical services.

Internet hospitals should conscientiously strengthen the development of industry ethics and practices and strictly implement the relevant provisions, such as the Nine Guidelines for Integrity of Practitioners of Medical Institutions. The personal income of medical personnel shall not be linked to the income from medicinal products and medical devices, and it is strictly prohibited to refer patients or designate locations for purchasing drugs and consumables to seek personal gains.

Article 35 (Requirements on Management)

This Municipality's health administrative departments at all levels are responsible for the supervision and administration of Internet hospitals within their jurisdictions, and shall supervise, inspect, guide and assess the Internet hospitals' implementation of relevant laws, rules, regulations and standards, as well as their service quality. The roles of quality control organizations, industry institutes and associations, and other academic and industry social groups should be brought into full play in the supervision and administration.

The health administrative departments supervise and administer Internet hospitals through the supervision and administration platforms, which will collect relevant data with a focus on the qualifications of medical institutions and medical personnel, medical specialties, categories of diseases that are diagnosed and treated, electronic medical records, electronic prescriptions, administration of medication, satisfaction evaluations, patients' complaints, and adverse events related to medical quality (safety), and which will primarily supervise aspects of Internet hospitals such as personnel, prescriptions, diagnosis and treatment, protection of patients' privacy, and information security. Technologies such as artificial intelligence and big data will be utilized to regularly analyze the overall situation of Internet diagnosis and treatment, look into the legality and rationality of the services and management, provide feedback on issues to various medical institutions and registration authorities, and specify the rectification deadlines. Upon receiving the feedback on issues from the health administrative departments, Internet hospitals should promptly take corrective measures and upload the rectifications to the supervision and administration platform, and concurrently report to the registration authorities.

The health administrative departments shall include Internet hospitals in the medical service quality control system, and subject them to integrated online and offline supervision and administration in order to ensure medical service quality and medical safety. The volumes of diagnosis and treatment provided by Internet hospitals are included in the daily business statistics of medical institutions and medical personnel, and are to be taken into consideration during the performance evaluation and assessment of physical medical institutions.

Public medical institutions, as the main entities, shall fulfill relevant management responsibilities and guide their affiliated medical institutions to effectively manage Internet hospitals. If a non-local medical institution is found in violation of relevant provisions regarding the management of Internet diagnosis and treatment, the municipal health administrative department should promptly give a written notification to the health administrative departments with the jurisdiction.

Article 36 (Public Supervision)

This Municipality's health administrative departments at all levels shall disclose to the public the lists of registered Internet hospitals, and the supervision telephone numbers or other supervision methods, and promptly accept and handle the reporting on Internet diagnosis and treatment in violation of laws, rules or regulations. Where there are inconsistencies with the provisions of these Measures, the relevant competent departments shall be notified in a timely manner.

Chapter V Supplemental Provisions

Article 37 (Convenience-for-People Measures)

The municipal health administrative department shall formulate and publicly announce the service guidelines for the approval of Internet hospitals in accordance with laws, rules and regulations.

The district health administrative departments shall improve the corresponding service guidelines in accordance with the unified requirements of the municipal health administrative department.

When the materials required to be submitted by applicants under these Measures can be obtained through data mutual recognition and sharing, the applicants shall not be asked to provide them once again.

Article 38 (Effective Date)

These Measures shall be effective as of September 1, 2024, and remain valid until August 31, 2029.