Breaking: National Health Commission Issues Groundbreaking Regulations on Internet-Based Diagnosis, Telemedicine, and Internet Hospitals

Recently, VCBeat (WeChat ID: vcbeat) learned that the National Health Commission and the State Administration of Traditional Chinese Medicine jointly issued the “Notice on Printing and Distributing Three Documents, Including the ‘Administrative Measures for Internet Diagnosis and Treatment (Trial)’.”

The objective is to further implement the relevant requirements of the "Opinions of the General Office of the State Council on Promoting the Development of 'Internet + Healthcare'."Standardize Internet-based diagnosis and treatment practices, leverage the positive role of telemedicine services, improve healthcare service efficiency, and ensure medical quality and safety.

The document primarily includes the “Measures for the Administration of Internet Hospitals (Trial),” the “Measures for the Administration of Internet Diagnosis and Treatment (Trial),” and the “Specifications for the Management of Telemedicine Services (Trial).”The specific detailed rules are as follows:

Article 1 To implement the Opinions of the General Office of the State Council on Promoting the Development of “Internet + Medical Health,” regulate internet-based diagnosis and treatment activities, promote the healthy and rapid development of internet medical services, and ensure medical quality and safety, these Measures are formulated in accordance with the Law on Licensed Physicians, the Regulations on the Administration of Medical Institutions, and other relevant laws and regulations.

Article 2 The term “Internet-based diagnosis and treatment” as used in these Measures refers to medical institutions leveraging physicians registered with their institution to conduct follow-up consultations for certain common and chronic diseases, and to provide “Internet +” family doctor contract services, through information technologies such as the Internet.

Article 3 The State implements access management for internet-based diagnosis and treatment activities.

Article 4 The health administrative department and the traditional Chinese medicine administration under the State Council shall be responsible for the supervision and administration of internet-based diagnosis and treatment activities nationwide. Local health administrative departments at all levels (including traditional Chinese medicine administrations, hereinafter referred to as the same) shall be responsible for the supervision and administration of internet-based diagnosis and treatment activities within their respective jurisdictions.

Chapter 2 Access to Internet-based Diagnosis and Treatment Activities

Article 5 Internet diagnosis and treatment activities shall be provided by medical institutions that have obtained the "Medical Institution Practice License".

Article 6. Medical institutions newly applying for establishment that intend to carry out internet-based diagnosis and treatment activities,The application form shall specify, and the feasibility study report shall detail, the circumstances regarding the conduct of internet-based diagnosis and treatment activities. If an information system for internet-based diagnosis and treatment services is established in cooperation with a third-party institution, the cooperation agreement shall be submitted.

Article 7After accepting the application, the health administrative department shall conduct a review in accordance with the relevant provisions of the Regulations on the Administration of Medical Institutions and the Detailed Rules for the Implementation of the Regulations on the Administration of Medical Institutions, and issue a written response indicating approval or disapproval within the prescribed time limit. Where the establishment is approved and the applicant is permitted to carry out internet-based diagnosis and treatment activities, such permission shall be specified in the Approval Certificate for the Establishment of Medical Institutions. The medical institution shall apply for practice registration in accordance with relevant laws, regulations, and rules.

Article 8 Medical institutions that have already obtained the "Medical Institution Practicing License" and intend to carry out internet diagnosis and treatment activities shall submit an application for practice registration to carry out such activities to the issuing authority of their "Medical Institution Practicing License," and submit the following materials:

(1) An application signed and approved by the legal representative or principal person in charge of the medical institution, stating the reasons and justification for applying to conduct internet-based diagnosis and treatment activities;

(2) If an internet-based diagnosis and treatment service information system is established in cooperation with a third-party institution, the cooperation agreement shall be submitted;

(3) Other materials required by the registration authority.

Article 9 The registration authority shall review the application materials for the registration of medical institutions in accordance with relevant laws, regulations, and rules. If the review is passed, the registration shall be granted, and “internet-based diagnosis and treatment” shall be added to the “service methods” section in the duplicate copy of the Medical Institution Practicing License. If the review fails, the applicant shall be notified of the review results in writing.

Article 10 The cooperation agreement between medical institutions and third-party organizations shall clearly define the responsibilities, rights, and interests of all parties with regard to medical services, information security, privacy protection, and other related matters.

Article 11 Medical institutions conducting internet-based diagnosis and treatment activities shall ensure that such activities are consistent with their approved scopes of practice.Medical institutions shall not conduct corresponding internet-based diagnosis and treatment activities for diagnostic and therapeutic subjects that have not been approved by the health administrative department.

Chapter III Practice Rules

Article 12 Medical institutions conducting internet-based diagnosis and treatment activities shall comply with medical administration requirements and establish rules and regulations for medical quality and medical safety.

Article 13 Medical institutions conducting internet-based diagnosis and treatment activities shall possess equipment, facilities, information systems, technical personnel, and information security systems that meet the technical requirements for internet operations, and shall implement Level 3 classified protection for information security.

Article 14Physicians and nurses engaged in internet-based diagnosis and treatment activities shall be queryable in the National Electronic Registration System for Physicians and Nurses.Medical institutions shall implement electronic real-name authentication for medical personnel engaged in internet-based diagnosis and treatment activities, and are encouraged to strengthen the management of medical personnel through biometric identification technologies such as facial recognition where conditions permit.

Article 15 Primary healthcare institutions implementing “Internet+” family doctor contract services shall inform patients of the service content, procedures, responsibilities and rights of both parties, and potential risks in the agreement, and obtain signed informed consent.

Article 16 When medical institutions conduct online follow-up consultations for certain common and chronic diseases, physicians shall review the patient’s medical records. A follow-up consultation may be provided for the same diagnosis only after it has been confirmed that the patient has received a clear diagnosis of one or more specific common or chronic diseases at a physical medical institution. If the patient’s condition changes and requires an in-person examination by medical personnel, the medical institution and its staff shall immediately terminate the internet-based diagnosis and treatment activities and guide the patient to seek care at a physical medical institution.

Internet diagnosis and treatment activities shall not be conducted for first-visit patients.

Article 17 Medical institutions conducting internet-based diagnosis and treatment activities shall establish electronic medical records for patients and manage them in accordance with relevant regulations, including the Provisions on the Management of Medical Records in Medical Institutions and the Basic Standards for Electronic Medical Records (Trial).

Article 18 Medical institutions conducting internet-based diagnosis and treatment activities shall strictly comply with prescription management regulations, including the Measures for the Administration of Prescriptions. After reviewing patients’ medical records, physicians may issue online prescriptions for certain common and chronic diseases. Online prescriptions must bear the physician’s electronic signature. Upon verification by a pharmacist, medical institutions and pharmaceutical distributors may entrust qualified third-party agencies to handle delivery.

Article 19 When conducting internet-based diagnosis and treatment activities, medical institutions shall not issue prescriptions for specially controlled drugs, such as narcotic drugs and psychotropic substances. When issuing online medication prescriptions for young children (under 6 years of age), it shall be confirmed that the pediatric patient is accompanied by a guardian and a qualified physician in the relevant specialty.

Article 20 Medical institutions shall strictly enforce relevant laws and regulations concerning information security and the confidentiality of medical data, properly safeguard patient information, and shall not illegally trade in or disclose such information. In the event of a leak of patient information or medical data, medical institutions shall promptly report to the competent health administrative department and immediately implement effective response measures.

Article 21 Medical institutions conducting internet-based diagnosis and treatment activities shall comply with the relevant provisions on tiered diagnosis and treatment and be consistent with their functional positioning.

Article 22 Encourage the use of internet technology within medical consortia to accelerate the vertical integration of medical resources, enhance the capacity and efficiency of primary healthcare services, and promote the establishment of an orderly tiered diagnosis and treatment system. Tertiary hospitals are encouraged to refer patients downward within medical consortia through internet-based diagnosis and treatment information systems.

Article 23 Tertiary hospitals shall prioritize the development of internet-based medical services with secondary hospitals and primary healthcare institutions, and provide technical support for internet-based diagnosis and treatment activities conducted by primary healthcare institutions.

Article 24 Medical institutions shall strengthen the management of internet-based diagnosis and treatment activities, establish and improve relevant management systems and service processes, ensure that the entire process of internet-based diagnosis and treatment activities is fully documented and traceable, and open data interfaces to regulatory authorities.

Article 25 Physicians engaging in internet-based diagnosis and treatment activities shall obtain the corresponding professional qualifications in accordance with the law, have at least three years of independent clinical work experience, and obtain approval from the medical institution where they are registered to practice.

Article 26 Medical institutions conducting internet-based diagnosis and treatment activities shall be subject to supervision and administration by the local health administrative departments at or above the county level, in accordance with the principle of territorial management.

Article 27 Local health administrative departments at or above the county level shall make public to society the list of medical institutions permitted to carry out internet diagnosis and treatment activities, publish supervisory telephone numbers or other means of supervision, and promptly accept and handle reports of illegal or non-compliant internet diagnosis and treatment services. Upon discovering any non-compliance with these Measures, they shall promptly notify the relevant competent authorities.

Article 28 Where a lower-level health administrative department fails to administer internet-based diagnosis and treatment activities in accordance with the Regulations on the Administration of Medical Institutions and these Measures, the higher-level health administrative department shall promptly correct such failure.

Article 29 Local health administrative departments at or above the county level shall give full play to the role of social organizations and strengthen industry supervision and self-discipline over internet-based diagnosis and treatment activities.

Chapter V Supplementary Provisions

Article 30 Medical institutions that have already engaged in internet diagnosis and treatment activities before the implementation of these Measures shall, within 30 days from the date of implementation of these Measures, re-submit an application for practice registration in accordance with the requirements of these Measures.

Article 31 Telemedicine services shall be administered in accordance with the "Administrative Specifications for Telemedicine Services (Trial)" and other relevant documents.

Internet hospitals are managed in accordance with the "Measures for the Administration of Internet Hospitals (Trial)."

Article 32 These Measures shall come into force on the date of promulgation.

Chapter I General Provisions

Article 1 To implement the "Opinions of the General Office of the State Council on Promoting the Development of 'Internet + Medical Health'," promote the sustained and healthy development of internet hospitals, standardize the management of internet hospitals, improve the efficiency of medical services, and ensure medical quality and safety, these Measures are formulated in accordance with the "Law on Licensed Physicians," the "Regulations on the Administration of Medical Institutions," and other relevant laws and regulations.

Article 2 The term "internet hospital" as used in these Measures refers to internet hospitals that operate under a secondary name of a physical medical institution, as well as independently established internet hospitals relying on a physical medical institution (see the Appendix for the Basic Standards for Internet Hospitals).
Article 3 The State shall implement access management for internet hospitals in accordance with the Regulations on the Administration of Medical Institutions and the Detailed Rules for the Implementation of the Regulations on the Administration of Medical Institutions.

Article 4 The health administrative department and the traditional Chinese medicine administrative department of the State Council shall be responsible for the supervision and administration of internet hospitals nationwide. Local health administrative departments at all levels (including traditional Chinese medicine administrative departments, hereinafter the same) shall be responsible for the supervision and administration of internet hospitals within their respective jurisdictions.

Chapter 2 Access to Internet Hospitals

Article 5 Where a physical medical institution independently or in cooperation with a third-party institution establishes an information platform and uses physicians registered at its own institution or other medical institutions to carry out internet-based diagnosis and treatment activities, it shall apply for the addition of “Internet Hospital” as its secondary name.

Physical medical institutions that exclusively use physicians registered at their own facilities to conduct internet-based diagnosis and treatment activities may apply to register an internet hospital as their secondary name.

Article 6 Prior to the implementation of internet hospital accreditation, the provincial-level health administrative department shall establish a provincial-level supervision platform for internet medical services, integrate it with the internet hospital information platform, and achieve real-time supervision.

Article 7 An application for the establishment of an Internet hospital shall be submitted to the registration authority of the physical medical institution on which it relies, along with the following materials:

(I) Application Form for Establishment;

(II) Prepare a feasibility study report, with the content appropriately simplified as circumstances warrant;

(3) The address of the affiliated physical medical institution;

(4) The cooperation agreement for the joint establishment of an internet hospital, signed by both the applicant and the physical medical institution.

Article 8 Where a newly applied-for physical medical institution intends to use an internet hospital as its secondary name, it shall indicate this in the application for establishment and provide details regarding the establishment of the internet hospital in the feasibility study report. If the internet hospital information platform is to be established in cooperation with a third-party institution, the cooperation agreement shall be submitted.

Article 9 Upon acceptance of an application for the establishment of a medical institution, the health administrative department shall conduct review in accordance with the relevant provisions of the Regulations on the Administration of Medical Institutions and the Detailed Rules for the Implementation of the Regulations on the Administration of Medical Institutions, and issue a written response indicating approval or disapproval within the prescribed time limit. Where the establishment is approved and the applicant is permitted to use “Internet Hospital” as its secondary name, such approval shall be indicated in the Approval Certificate for Establishment of Medical Institution. For third-party institutions applying to establish an Internet Hospital, the Approval Certificate for Establishment of Medical Institution shall be issued. The medical institution shall apply for practice registration in accordance with relevant laws, regulations, and rules.

Article 10 Where a physical medical institution that has already obtained the "Medical Institution Practice License" intends to establish an internet hospital and use the internet hospital as its secondary name, it shall apply to the issuing authority of the "Medical Institution Practice License" for the addition of the internet hospital as a secondary name, and submit the following materials:
(I) An application signed and approved by the legal representative or principal person in charge of the medical institution, stating the reasons and rationale for requesting the addition of “Internet Hospital” as a secondary name;
(2) Status of integration with the provincial internet medical service supervision platform;
(3) If an internet hospital is established in cooperation with a third-party institution, the cooperation agreement shall be submitted;
(4) Other materials required by the registration authority.

Article 11 The practicing registration authority shall review the application materials for internet hospital registration in accordance with relevant laws, regulations, and rules. Applications that pass the review shall be registered. For applications that fail the review, the applicant shall be notified of the review results in writing.

Article 12 The naming of internet hospitals shall comply with relevant regulations and meet the following requirements:
(1) Where a physical medical institution independently applies to establish an internet hospital as its secondary name, the name shall include “Name of the Institution + Internet Hospital”;
(2) When a physical medical institution applies to partner with a third-party organization to establish an internet hospital as its secondary name, the name shall follow the format: “Name of the Institution + Identifier of the Partner + Internet Hospital”;
(3) The name of an independently established internet hospital shall include the “applicant’s identifying name + Internet Hospital”.

Article 13 Where there is a change in the cooperating parties or other circumstances rendering the cooperation agreement invalid for an internet hospital established through cooperation, a new application for the establishment of the internet hospital shall be required.

Chapter 3 Practice Rules

Article 14 Internet hospitals shall implement the technical specifications for diagnosis and treatment and operational procedures formulated by national authorities or industry associations.

Article 15 The information system of an Internet hospital shall implement Level 3 classified protection for cybersecurity in accordance with relevant national laws, regulations, and provisions.

Article 16 Physicians and nurses providing medical services through internet hospitals shall be queryable in the National Electronic Registration System for Physicians and Nurses. Internet hospitals shall implement electronic real-name authentication for medical personnel. Internet hospitals with the necessary conditions are encouraged to strengthen the management of medical personnel by employing biometric identification technologies, such as facial recognition.

Article 17 Where a third-party institution jointly establishes an internet hospital with a physical medical institution, it shall provide the physical medical institution with professional services from physicians, pharmacists, and other personnel, as well as information technology support services. The rights, obligations, and liabilities of all parties concerning medical services, information security, and privacy protection shall be clearly defined through agreements, contracts, or other means.

Article 18 Internet hospitals must provide risk disclosures to patients and obtain their informed consent.

Article 19 When an internet hospital invites other physicians for consultation, the consulting physicians may provide diagnostic opinions and issue prescriptions. For patients who have not visited a physical medical institution, physicians may only provide follow-up services via the internet hospital for certain common and chronic diseases. Internet hospitals may offer family doctor contracting services.

When a patient's condition changes or other factors make online diagnosis and treatment inappropriate, physicians shall guide the patient to seek care at a physical medical institution.

Article 20 Internet hospitals shall strictly comply with the Measures for the Administration of Prescriptions and other regulations on prescription management. Before issuing an online prescription, physicians shall review the patient’s medical records. Upon confirming that the patient has received a clear diagnosis of one or more common or chronic diseases at a physical medical institution, the physician may issue an online prescription for conditions consistent with such diagnosis.

All online diagnoses and prescriptions must bear the electronic signature of a licensed physician. A prescription shall become valid only after it has been reviewed and approved by a pharmacist. Medical institutions and pharmaceutical distributors may entrust qualified third-party agencies to handle delivery. It is prohibited to issue online prescriptions for narcotic drugs, psychotropic substances, and other medications with high usage risks or subject to special regulatory requirements. When prescribing internet-based medication for young children (under 6 years of age), it must be confirmed that the child is accompanied by a guardian and a relevant specialist physician.

Article 21 Internet hospitals conducting online diagnosis and treatment activities shall establish electronic medical records for patients and manage them in accordance with relevant regulations, including the Provisions on the Management of Medical Records by Medical Institutions and the Basic Specifications for Electronic Medical Records (Trial). Patients may access their medical record information online, including examination and test results and data, diagnostic and treatment plans, prescriptions, and medical orders.

Article 22 Adverse medical service events and adverse drug events occurring in internet hospitals shall be reported in accordance with relevant national regulations.

Article 23 Internet hospitals shall strictly enforce relevant laws and regulations concerning information security and the confidentiality of medical data, properly safeguard patient information, and are prohibited from illegally trading or disclosing such information. In the event of a leak of patient information or medical data, the medical institution shall promptly report to the competent health administrative department and immediately implement effective response measures.

Article 24 Physical medical institutions, or third parties applying jointly with physical medical institutions for an internet hospital, shall purchase medical liability insurance for physicians.

Article 25 Internet hospitals shall provide medical services in compliance with the relevant regulations on tiered diagnosis and treatment, and their functions shall be aligned with the functional positioning of the affiliated physical medical institutions.

Article 26 Encourage tertiary hospitals in urban areas to share data resources and collaborate operationally with medical institutions in remote areas, primary healthcare institutions, general practitioners, and specialists through internet hospitals, thereby promoting the decentralization of high-quality medical resources.

Chapter 4 Supervision and Administration

Article 27 Internet hospitals shall strictly strengthen internal management in accordance with national laws and regulations.

Article 28 Internet hospitals shall establish procedures for the prevention and handling of adverse events related to internet medical services, implement measures to protect personal privacy information, strengthen content review and management of internet hospital information platforms, and ensure that internet medical services are conducted in a safe, effective, and orderly manner.

Article 29 Physicians providing diagnosis and treatment services through internet hospitals shall obtain the corresponding practice qualifications in accordance with the law, be registered at the affiliated physical medical institution or other medical institutions, and have more than three years of independent clinical work experience. Physicians providing services through internet hospitals shall ensure the completion of diagnosis and treatment duties as prescribed by their primary practice institution.

Article 30 Provincial health administrative departments and the registration authorities for internet hospitals shall jointly supervise internet hospitals through the provincial internet medical service supervision platform, with a focus on overseeing personnel, prescriptions, diagnostic and treatment practices, patient privacy protection, and information security. Internet hospitals shall be incorporated into the local medical quality control system. Relevant services shall be included in the performance evaluations and accreditation reviews of physical medical institutions conducted by administrative departments, thereby implementing integrated online-offline supervision to ensure medical quality and safety.

Article 31 Local health administrative departments at or above the county level shall make public to the society the list of internet hospitals and supervision telephone numbers or other means of supervision. They shall promptly accept and handle reports of illegal and non-compliant internet medical services. Upon discovering any non-compliance with these Measures, they shall promptly inform the relevant competent authorities.

Article 32 Internet hospitals that have obtained the "Medical Institution Practice License" shall independently serve as the subject of legal liability. Where a physical medical institution uses an internet hospital as its secondary name, the physical medical institution shall be the subject of legal liability. All parties cooperating in the operation of the internet hospital shall bear corresponding legal liabilities in accordance with the cooperation agreement.

When a medical dispute arises between a patient and an internet hospital, the patient shall file an application for resolution with the registration authority of the internet hospital. Legal liability shall be pursued in accordance with relevant laws, regulations, and provisions.

Article 33 Where medical institutions and medical personnel violate the Law on Licensed Physicians, the Regulations on the Administration of Medical Institutions, the Regulations on the Handling of Medical Accidents, the Regulations on Nurses, and other laws and regulations in the course of providing internet-based medical services, they shall be dealt with in accordance with the provisions of relevant laws and regulations.

Article 34 Where a lower-level health administrative department fails to administer internet hospitals in accordance with the Regulations on the Administration of Medical Institutions and these Measures, the higher-level health administrative department shall promptly correct such failure.

Chapter V Supplementary Provisions

Article 35 Internet hospitals that have been approved for establishment or filed prior to the implementation of these Measures shall, within 30 days from the date of implementation of these Measures, re-submit applications for establishment and practice registration in accordance with the requirements of these Measures.

Article 36 These Measures shall come into force on the date of promulgation.

Entities applying to establish an internet hospital or to use “internet hospital” as their secondary name shall comply with this standard.

I. Scope of Diagnosis and Treatment

Internet hospitals shall determine their diagnostic and treatment specialties based on the scope of their business activities, and such specialties must not exceed those authorized for the affiliated physical medical institution.

II. Departmental Structure

Internet hospitals shall establish corresponding clinical departments in accordance with the scope of their business activities, ensuring alignment with the clinical departments of the affiliated physical medical institutions. They are required to establish a medical quality management department, an information technology service and management department, and a pharmaceutical care department.

III. Personnel

(1) For the clinical departments established by an internet hospital, the corresponding clinical departments of its affiliated physical medical institution shall have at least one licensed physician with a senior professional title and one with an associate senior professional title registered at that institution (multi-site practice is permitted).

(II) The internet hospital shall have designated personnel responsible for managing medical quality, medical safety, and electronic medical records, as well as providing technical services such as maintenance of the internet hospital information system to ensure its stable operation.

(3) Dedicated pharmacists shall be responsible for online prescription review, ensuring that at least one pharmacist is on duty to review prescriptions during business hours. In the event of insufficient pharmacist staffing, prescription reviews may be conducted by qualified pharmacists from third-party institutions through collaborative arrangements.

(4) Relevant personnel must undergo training in healthcare laws and regulations, policies related to medical services, various institutional rules and regulations, job responsibilities, procedural standards, and emergency response plans, to ensure they master service workflows and clearly understand potential risks.

IV. Premises and Equipment/Facilities

(1) At least two sets of servers shall be deployed for the operation of the internet hospital, with database servers and application system servers physically or logically separated. The server room shall be equipped with dual-circuit power supply or emergency power generation facilities. Servers storing medical data shall not be located outside the territory of China.

(2) Possess at least two audio-video communication systems for conducting internet hospital services (including necessary software systems and hardware equipment).

(3) Possess high-speed, highly reliable network access. The network bandwidth used for services shall be no less than 10 Mbps, and services shall be provided by at least two broadband network providers. Internet hospitals with the necessary conditions are encouraged to connect via dedicated internet lines or Virtual Private Networks (VPNs) to ensure the quality of service for medical data transmission.

(4) Establish a data access control information system to ensure system stability and full-process traceability of services, and achieve data exchange and sharing with the HIS, PACS/RIS, and LIS systems of physical medical institutions.

(5) Capable of providing remote consultation, remote outpatient services, remote pathological diagnosis, remote medical imaging diagnosis, and remote electrocardiogram (ECG) diagnosis.

(6) The information system shall implement Level 3 classified protection for information security.

V. Rules and Regulations

Establish a management system for internet-based medical services, along with related administrative regulations, personnel job responsibilities, and service workflows. The rules and regulations shall include: the management system for internet-based medical services; the management system for the use of information systems in internet hospitals; the quality control and evaluation system for internet-based medical care; the online prescription management system; the patient informed consent and registration system; the management system for online medical documentation; the risk assessment and emergency prevention and response system for online follow-up patients; the personnel training and assessment system; and contingency plans for emergencies such as power outages, network disruptions, equipment failures, and cybersecurity incidents.

To implement the "Opinions of the General Office of the State Council on Promoting the Development of 'Internet + Medical Health'" (Guo Ban Fa [2018] No. 26), further promote the sustained and healthy development of telemedicine services, optimize the allocation of medical resources, facilitate the downward flow of high-quality medical resources, advance the integration and sharing of regional medical resources, and enhance the capacity and level of medical services, these Specifications are hereby formulated.

I. Scope of Management

Remote medical services as referred to in this Specification include the following scenarios:

(1) A medical institution (hereinafter referred to as the "Inviting Party") directly extends an invitation to other medical institutions (hereinafter referred to as the "Invited Party"). The Invited Party leverages information technologies, such as telecommunications, computer, and network technologies, to provide technical support for the diagnosis and treatment of patients of the Inviting Party. Both parties shall clearly define their respective responsibilities, rights, and interests through a formal agreement.

(II) Medical activities in which the inviting party or a third-party institution establishes a telemedicine service platform, the invited party registers on the platform as an institution, the inviting party publishes requests through the platform, and the platform matches these requests with the invited party or other medical institutions that proactively respond. These activities utilize information technologies such as telecommunications, computing, and networking to provide technical support for the diagnosis and treatment of patients of the inviting party. The inviting party, the platform builder/operator, and the invited party shall clearly define their respective responsibilities, rights, and interests through agreements.

Where the inviting party directly invites medical personnel to provide online medical services through an information platform, it must apply for the establishment of an internet hospital, which shall be approved and regulated in accordance with the Administrative Measures for Internet Hospitals (Trial) (hereinafter referred to as the “Measures”).

II. Basic Requirements for Providing Telemedicine Services

(I) Basic Requirements for Medical Institutions. The institution must have the corresponding clinical specialties for providing telemedicine services, as approved by the health administrative authorities (including traditional Chinese medicine authorities). It shall have professional technical personnel registered at the institution who meet the requirements for telemedicine services. Additionally, it must establish comprehensive management systems for telemedicine services, along with safeguards for medical quality, patient safety, and information technology.

(II) Basic Personnel Requirements. The inviting party and the invited party shall arrange for appropriate medical personnel to participate in telemedicine services based on the patient’s condition. The inviting party must have at least one licensed physician (who may practice at multiple locations) present; if the inviting party is a primary healthcare institution, a licensed assistant physician or a village doctor may serve as the accompanying professional. The invited party must provide telemedicine services through at least one licensed physician who possesses corresponding diagnostic and treatment capabilities and has independently engaged in clinical work for more than three years (such physician may also practice at multiple locations). Depending on the patient’s condition, remote multidisciplinary joint diagnosis and treatment services may be provided.

Dedicated personnel shall be responsible for the regular testing, registration, maintenance, modification, and upgrading of instruments, equipment, facilities, and information systems, in compliance with health information standards and information security regulations related to telemedicine, so as to ensure that the telemedicine service information system (hardware and software) operates normally and meets the needs of medical institutions in providing telemedicine services.

(3) Basic Conditions for Equipment and Facilities.

1. The telemedicine information system shall ensure the secure, real-time transmission of images, audio, text, and other medical data required for diagnosis and treatment, with clear image quality and accurate data, in compliance with the "Technical Guidelines for the Construction of Telemedicine Information Systems" to meet the requirements of clinical diagnosis and treatment.
2. Critical equipment and networks shall be equipped with uninterruptible power supplies (UPS).
3. The telemedicine service network shall be supported by at least two network service providers to ensure smooth transmission of telemedicine information; where conditions permit, a dedicated telemedicine network may be established.

III. Telemedicine Service Process and Related Requirements
(I) Execution of Cooperation Agreements. Medical institutions that provide telemedicine services directly or through third-party platforms shall enter into telemedicine cooperation agreements, specifying the purpose and conditions of cooperation, scope of collaborative activities, telemedicine workflows, rights and obligations of all parties, as well as risks of medical malpractice and allocation of liability. Such cooperation agreements may be executed in electronic form.
(II) Informed Consent. The inviting party shall organize telemedicine services based on the patient’s condition and preferences, fully disclose to the patient the details of the telemedicine services, including costs, obtain the patient’s written consent, and have the patient sign an informed consent form for telemedicine services. If it is inappropriate to disclose the medical condition to the patient, written consent shall be obtained from the patient’s guardian or close relatives.
(3) Remote Consultation. Medical institutions conduct consultations remotely, with the invited party providing diagnostic and treatment recommendations, and the inviting party finalizing the diagnostic and treatment plan.
1. Issue an invitation. Where the inviting party intends to conduct case-based discussions with the invited party through telemedicine services, it shall extend an invitation directly or via a third-party platform. The invitation shall at least include the reason and purpose of the invitation, schedule, a summary of the patient’s relevant medical records, and the professional background and technical title qualifications of the physicians to be invited. Within medical consortia, stable mechanisms for remote electrocardiogram (ECG) diagnosis, remote imaging diagnosis, and remote pathology diagnosis may be established through negotiation to strengthen technical support from tertiary hospitals to primary healthcare institutions.

2. Acceptance of Invitation. Upon receiving an invitation for remote medical services from the inviting party or a third-party platform, the invitee shall promptly decide whether to accept the invitation. If the invitation is accepted, the invitee must notify the inviting party and make necessary preparations; if declined, the invitee shall promptly inform the inviting party and provide reasons. Where a third-party platform is involved in matching, the invitee shall also notify the platform operator of its decision regarding the acceptance of the invitation.
3. Service Implementation. The invited party shall conscientiously arrange medical personnel with appropriate qualifications and technical capabilities to provide telemedicine services in accordance with relevant laws, regulations, and clinical practice guidelines. The invited party shall promptly communicate its diagnostic and treatment opinions to the inviting party and issue a diagnostic and treatment opinion report signed by the attending physician(s). Based on the patient’s clinical data and with reference to the invited party’s diagnostic and treatment opinions, the inviting party shall determine the final diagnosis and treatment plan.
(4) Remote Diagnosis. The inviting party and the invited party shall establish a counterpart support relationship or form a medical consortium, among other cooperative arrangements. The inviting party shall perform auxiliary examinations, such as medical imaging, pathology, electrocardiography (ECG), and ultrasound, while the invited higher-level medical institution shall conduct the diagnosis. The specific procedures shall be clearly defined in an agreement between the inviting and invited parties.
(5) Proper Preservation of Records. The inviting party and the invited party shall jointly complete medical record documentation in accordance with relevant regulations on medical record writing and custody, with the original copies archived and preserved separately by each party. Documents related to telemedicine services may be transmitted via fax, scanned files, or electronic files with electronic signatures. After providing consultation services to patients, medical personnel shall document the consultation information.
IV. Management Requirements
(I) Institutional Management. Medical institutions providing telemedicine services shall carry out their work in accordance with the following requirements:

1. Formulate and implement management rules and regulations, enforce technical standards and operational procedures issued or recognized by the state, establish emergency response plans, and ensure medical quality and safety.
2. Establish a dedicated department for medical quality and safety management, or assign full-time personnel, to be responsible for the quality management and control of telemedicine services, and fulfill the following duties:
① Inspect the implementation of rules and regulations, technical specifications, and operating procedures; ② Conduct inspections on medical quality, as well as the management of instruments and equipment;
③ Monitor, analyze, and provide feedback on key processes and high-risk factors affecting medical quality and safety, and propose preventive and control measures;
① Provide guidance and conduct inspections on medical record documentation and data preservation.
3. Medical quality and safety management personnel shall possess relevant professional knowledge and work experience.
4. All parties involved in the operation of telemedicine shall strengthen information security and patient privacy protection, prevent unlawful transmission or modification of data, prevent data loss, establish data security management protocols, and ensure network security, operational security, data security, and privacy security.
5. For those collaborating with third-party institutions to develop telemedicine services, the rights, obligations, and legal liabilities of all parties shall be clearly defined through agreements, and various financial management systems shall be implemented.
(II) Personnel Management.
1. Medical institutions shall formulate and implement training programs for medical personnel involved in telemedicine services to ensure they possess the professional knowledge relevant to their duties. Institutions shall establish management systems and maintain records pertaining to the continuous updating of technical staff’s professional knowledge, as well as the maintenance and development of their professional skills. Relevant management systems and operational standards shall be strictly implemented.
2. Healthcare providers shall adhere to standard nursing practices and clinical guidelines when delivering telemedicine services to patients.
(III) Quality Management. Medical institutions providing telemedicine services shall carry out medical quality management work in accordance with the following requirements:
1. Establish and implement a medical quality management system in accordance with the requirements of diagnosis and treatment technical specifications and operational procedures issued or recognized by the state, comply with relevant technical regulations and standards, implement real-name patient management, and continuously improve medical quality.
2. Actively participate in medical quality management and control activities organized by provincial-level or higher telemedicine service quality control centers, and accept professional guidance and supervision from health administrative departments and quality control centers.
3. Medical quality and safety management personnel shall supervise the implementation of various rules and regulations and daily management tasks, and conduct regular inspections of the institution’s telemedicine service practices.
4. IT professionals shall perform routine maintenance of telemedicine equipment to ensure its proper operation.
5. Medical personnel from the invited party participating in telemedicine services shall possess emergency response capabilities.
6. Telemedicine service centers that provide medical examination and testing services shall be staffed with qualified health professionals and operate in accordance with applicable regulations.
7. Establish a sound doctor-patient communication mechanism to safeguard patients' right to informed consent and protect their legitimate rights and interests.
8. Strictly adhere to relevant regulations and requirements for the standardized use and management of medical equipment, medical consumables, disinfectants and sterilization devices, and other medical supplies.
V. Strengthening Supervision

(I) Local health administrative departments at all levels shall strengthen the supervision and administration of telemedicine services provided by medical institutions within their respective jurisdictions, incorporate telemedicine services into the local medical quality control system, and ensure the quality and safety of telemedicine services.

(2) In the event of a medical dispute arising during the provision of telemedicine services, the patient shall submit an application for handling to the health administrative department at the location of the inviting party. The inviting party shall bear the corresponding legal liability for remote consultations, while both the inviting party and the receiving party shall jointly bear the corresponding legal liability for remote diagnoses.

(3) In the event of disputes arising from telemedicine services conducted through collaboration between medical institutions and third-party organizations, the inviting party, the invited party, and the third-party organization shall handle such disputes in accordance with relevant laws, regulations, and agreements reached among all parties, and shall bear corresponding liabilities.

(4) Where medical institutions and medical personnel violate laws and regulations such as the Law on Licensed Physicians, the Regulations on the Administration of Medical Institutions, the Regulations on the Handling of Medical Accidents, and the Regulations on Nurses in the course of providing telemedicine services, the health administrative departments shall handle such cases in accordance with the relevant laws and regulations.