Hainan Provincial Health Commission

Notice on Issuing the Implementation Measures of Hainan Province for the Administration of Internet-based Diagnosis and Treatment

Health commissions of cities, counties and autonomous counties, Hainan Boao Lecheng International Medical Tourism Pilot Zone Administration, and all relevant medical institutions,

In order to further regulate Internet-based diagnosis and treatment in Hainan Province, enhance the regulatory system for these services, and promote their sustainable and healthy development, the Hainan Provincial Health Commission has developed the Implementation Measures of Hainan Province for the Administration of Internet-based Diagnosis and Treatment (“Measures”). These Measures are hereby issued for your compliance.

Hainan Provincial Health Commission

May 1, 2024  

Implementation Measures of Hainan Province for the Administration of Internet-based Diagnosis and Treatment

Chapter I General Provisions

Article 1 In order to further regulate Internet-based diagnosis and treatment (“IBDT”) in Hainan Province, enhance the regulatory system for these services, and promote their sustainable and healthy development, these implementation measures (“Measures”) are developed based on the relevant laws, regulations, and rules, such as the Law of the People’s Republic of China on Basic Medical and Health Care and the Promotion of Health, Regulations on Administration of Medical Institutions, Detailed Rules for the Implementation of the Medical Institute Management Regulations, Measures for the Administration of Internet-based Diagnosis and Treatment (Trial), Measures for the Administration of Internet Hospitals (Trial), Detailed Rules for the Regulation of Internet-based Diagnosis and Treatment (Trial), and Measures for the Administration of Verification of Medical Institutions (Trial), considering the actual situation in Hainan Province.

Article 2 These Measures are applicable to the administration of IBDT conducted by medical institutions in accordance with the relevant rules such as the Detailed Rules for the Regulation of Internet-based Diagnosis and Treatment (Trial).

Article 3 For the purposes of these Measures, “Internet hospitals” include those serving as the secondary name of physical medical institutions, as well as those independently established by relying on physical medical institutions.

Article 4 The Hainan Provincial Health Commission has established a special working group responsible for guiding the regulation of IBDT across Hainan Province. Health authorities at all levels (including competent authorities for traditional Chinese medicine [“TCM”], the same below) are responsible for local regulation.

Chapter II Qualification Admission to IBDT

Article 5 Medical institutions newly applying to establish an Internet hospital to conduct IBDT shall indicate such intention in their applications. At the same time, the Internet-based diagnostic and treatment activities they intend to conduct shall be detailed in their establishment feasibility reports. If they partner with third-party institutions to build an Internet-based diagnostic and treatment service information system, they shall submit the cooperation agreement.

Article 6 If physical medical institutions conduct IBDT only through their registered physicians, they shall apply to the incorporation registration authority to add “Internet-based diagnosis and treatment” to their services. They may also apply to designate the Internet hospital as their secondary name.

If physical medical institutions conduct IBDT through the physicians registering with both them and other institutions or if they partner with a third-party institution to establish an Internet hospital, they shall apply to the incorporation registration authority to add “Internet-based diagnosis and treatment” to their services. They shall also apply to designate the Internet hospital as their secondary name.

It is feasible to apply to establish an independent Internet hospital by relying on a physical medical institution that has obtained the Practicing License for a Medical Institution.

Independent Internet hospitals, which are established by relying on remote medical centers and primarily offer Internet-based diagnostic and treatment services, are encouraged to be established in designated key industrial parks within the province. These parks shall introduce appropriate supporting service measures.

Article 7 To establish an Internet hospital, the applicant shall apply to the practice registration authority of the physical medical institution on which the Internet hospital relies and submit the following materials:

i. An application for the establishment;

ii. A feasibility study report on the establishment, which may be appropriately simplified as needed;

iii. The address of the physical medical institution on which the Internet hospital relies;

iv. The cooperation agreement executed by the applicant and the physical medical institution to establish the Internet hospital.

Article 8 After accepting the application for the establishment, the practice registration authority shall review it in accordance with the Regulations on Administration of Medical Institutions and Detailed Rules for the Implementation of the Medical Institute Management Regulations. Then, it shall reply in writing, either approving or disapproving the application, within a specified period of time. If the practice registration authority approves the establishment and the use of the Internet hospital as the secondary name, it shall indicate such approval in the Approval for Medical Institution Establishment. If the authority approves a third-party institution’s application to establish an Internet hospital, an Approval for Medical Institution Establishment shall be issued. If the application fails the review, the applicant shall be notified in writing.

Article 9 To apply for practice registration to conduct IBDT, the applicant shall submit a practice registration application to the authority that issued the Practicing License for a Medical Institution or the authority that issued the Approval for Medical Institution Establishment, as well as the following materials:

i. An application signed for approval by the legal representative or principal person in charge of the medical institution, which shall state the reasons and grounds for conducting IBDT, as well as the reasons and grounds for using the Internet hospital as the secondary name if the applicant made such an application;

ii. Status of the connection to the provincial regulatory platform for Internet-based medical services (“provincial regulatory platform”);

iii. The cooperation agreement, provided that the applicant partners with a third-party institution to establish the Internet hospital;

iv. Other materials required by the registration authority.

Article 10 The practice registration authority shall review the registration application materials for the Internet hospital in accordance with the relevant laws, regulations, and rules, and conduct an on-site inspection at the physical medical institution on which the Internet hospital relies. If the materials pass the review, registration shall be conducted. If they fail the review, the applicant shall be notified in writing of the review results.

Article 11 Internet hospitals shall be named in compliance with the relevant rules, as well as the following requirements:

i. If a physical medical institution independently applies to use the Internet hospital as its secondary name, the name shall include “institution name + Internet hospital”;

ii. If a physical medical institution collaborates with a third-party institution to apply to use the Internet hospital as the secondary name, the name shall include “institution name + partner’s identifying name + Internet hospital”;

iii. The name of an independently established Internet hospital shall include “the identifying name of the applicant for the establishment + Internet hospital”.

Article 12 Applicants that apply to establish an Internet hospital or to use the Internet hospital as their secondary name shall comply with the Basic Standards for Internet Hospitals (Trial).

Article 13 In the case of cooperative Internet hospitals, if the partner changes or if there are other circumstances that invalidate the cooperation agreement, a new application to establish the Internet hospital shall be filed.

Chapter III Regulation of Medical Institutions

Article 14 The provincial health authorities shall establish a provincial regulatory platform to implement Level-3 and higher-level information security protection and regulate medical institutions conducting IBDT. These institutions shall proactively align themselves with the provincial regulatory platform, promptly upload and update information such as the Practicing License for a Medical Institution, the application entry point of the Internet-based diagnostic and treatment service system, and willingly accept supervision. Internet hospitals shall strengthen internal management in strict accordance with national laws and regulations.

Article 15 Medical institutions conducting IBDT through cooperation shall specify in the agreement or contract the responsibilities, rights, and obligations of each party involved regarding medical services, information security, privacy protection, medical risks, and liability distribution.

Article 16 Level-3 information security protection shall be implemented in accordance with the relevant national laws, regulations, and rules for Internet hospital information systems. The results of the classified protection assessment shall be uploaded to the provincial regulatory platform on an annual basis.

Article 17 Medical institutions shall establish dedicated departments to manage the quality and safety of IBDT, pharmaceutical services, medical records, information technology, and complaint settlement. They shall also establish appropriate management systems, including but not limited to the medical institution self-inspection system for lawful practice, the medical quality and safety management system for IBDT, the reporting system for adverse events arising from medical quality (safety), the medical staff training and appraisal system, and the informed consent system for patients, the prescription management system, the electronic medical record management system, the information system use management system, and the medical device use and quality management system.

Article 18 When providing Internet-based diagnostic and treatment services, medical institutions shall display the name approved by the incorporation registration authority in a prominent position on their IBDT platform. At the same time, they shall disclose the electronic credentials of the medical staff providing these services. This ensures that the physicians have professional qualifications and can be inquired about and supervised by patients. After the service is completed, the service window shall display the complaint and report entry point of the Internet-based medical service regulators of Hainan Province, as well as the consultation and complaint hotline for medical services.

Article 19 Health and administrative approval authorities at all levels shall disclose to the public the list of medical institutions approved to conduct IBDT within their respective jurisdiction, along with the supervision hotline or other supervision methods. They shall also establish complaint acceptance channels to promptly accept and address reports of illegal and non-compliant Internet-based diagnostic and treatment services.

Chapter IV Staff Regulation

Article 20 Physicians providing Internet-based diagnostic and treatment services shall have legally obtained the necessary practice qualifications, possess at least three years of experience in independent clinical work, and have obtained consent from the medical institutions where they have registered for practice. If the medical staff provide Internet-based diagnostic and treatment services at other Internet hospitals besides their primary practice institution, they shall register or file for practice as per the relevant requirements for multi-institution practice.

Article 21 Medical institutions shall conduct real-name authentication on medical staff providing Internet-based diagnostic and treatment services to ensure they have legal qualifications. Additionally, the staff’s necessary information, including the ID number, photo, qualifications, practice location(s), practice institution(s), scope of practice, and years of clinical experience, shall be uploaded to the provincial regulatory platform. This platform shall be connected to the electronic registration system for physicians and nurses. Pharmacists’ information shall also be uploaded to this platform and be accessible. Medical institutions, where possible, are encouraged to employ biometric authentication such as facial recognition to enhance the management of medical staff.

Article 22 A physician shall complete real-name authentication before receiving the patient. This ensures that the physician is personally attending to the consultation. No other persons or AI software are allowed to impersonate or substitute the physician. Medical institutions shall grant access to their authentication service interfaces to the provincial regulatory platform and submit authentication information to the platform for recordation. Health authorities at all levels shall supervise the staff providing Internet-based diagnostic and treatment services in those institutions.

Article 23 Medical institutions shall conduct periodic training for staff providing Internet-based diagnostic and treatment services and related management services. The training shall cover health-related laws and regulations, medical management policies, duties, procedures of IBDT, platform use, and emergency response. Assessments that focus on lawful practice, medical quality and safety, medical ethics and practices, and patient satisfaction shall be carried out, and mechanisms for admission and exit shall be established.

Chapter V Business Regulation

Article 24 Medical institutions shall conduct IBDT in compliance with the relevant rules on hierarchical diagnosis and treatment and their functional positioning. Tertiary hospitals shall prioritize developing Internet-based medical services in cooperation with secondary hospitals and primary healthcare institutions, providing technical support for primary healthcare institutions to conduct IBDT. They are encouraged to refer patients to inferior medical institutions within the integrated healthcare system using the Internet-based diagnostic and treatment information system.

Article 25 When a patient visits a physical medical institution, the receiving physician can invite other physicians for a consultation through the Internet-based diagnostic and treatment information system. The consultant can issue diagnostic opinions and prescribe medications. However, if patients directly seek consultations over the Internet, the receiving physician can only provide follow-up services for those with certain common or chronic diseases and shall not provide Internet-based diagnostic and treatment services for patients seeking initial consultations.

Medical institutions that provide contracted family doctor services through IBDT shall inform patients of the fee standards, services, procedures, responsibilities and rights of both parties, and potential risks in the contract and sign an informed consent.

Article 26 Medical institutions conducting IBDT shall fully inform patients of the IBDT rules, requirements, and risks and obtain their informed consent before proceeding.

Article 27 A real-name system shall be implemented for IBDT. Patients shall provide medical institutions with their genuine identification and basic information. They shall not impersonate others for consultations. A patient shall provide medical records with clear diagnoses at the time of consultation, such as outpatient records, inpatient records, discharge summaries, and diagnostic certificates. The medical institution shall keep these records and grant access to its data interfaces to the provincial regulatory platform. The receiving physician shall then determine whether the patient qualifies for a follow-up consultation.

Medical institutions shall define the termination conditions for IBDT. If a patient’s condition changes, the consultation is deemed an initial diagnosis, or other conditions unsuitable for IBDT arise, the receiving physician shall immediately terminate the Internet-based diagnosis and direct the patient to a physical medical institution.

Article 28 Medical institutions conducting IBDT shall establish electronic medical records for patients in accordance with the Regulation on Medical Records Management in Medical Institutions and the Basic Standards for Electronic Medical Records (Trial), and manage these medical records as per the relevant rules for outpatient electronic medical records. Internet hospitals shall share the same format with the physical medical institutions they rely on regarding electronic medical records. They shall also share system information. The physical medical institutions shall carry out integrated online and offline quality control. Patients can access their examination and test results, diagnostic and treatment plans, prescriptions, and medical orders online.

Medical records established during IBDT shall be managed in accordance with the relevant rules for outpatient electronic medical records, with a minimum retention period of 15 years. Text conversations, audio, and video throughout the consultation shall be recorded and retained for at least three years. If an Internet hospital changes its name, the medical records and other data shall remain under the care of the renamed hospital. If an Internet hospital is closed, the medical records and other data shall be kept by the physical medical institution the hospital previously relied on. If the physical medical institution is closed, the provincial health authorities or the institution designated by the authorities shall properly keep the records and data in accordance with the relevant rules.

Article 29 Medical institutions conducting IBDT shall strictly comply with rules such as the Measures for the Administration of Prescriptions and strengthen drug management. In IBDT, all prescriptions shall be issued by the receiving physician in person, bearing the physician’s electronic signature. Using artificial intelligence (“AI”) to automatically generate prescriptions is strictly prohibited. Prescriptions for narcotics, psychotropic drugs, and other high-risk medications with special management requirements shall not be issued over the Internet. When prescribing young children (under six years old) medication over the Internet, the presence of a guardian and a relevant professional physician shall be ensured.

Article 30 Where medical institutions conduct drug delivery on their own or by entrusting third parties, the relevant agreements and prescription circulation records shall be traceable, and data interface access shall be granted to the provincial regulatory platform.

Article 31 Medical institutions shall proactively strengthen their professional ethics and strictly follow the Nine Guidelines for the Integrity of Medical Staff and other relevant rules. The personal income of medical staff shall not be linked to drug revenue. Medical staff shall not, for personal gains, refer patients or specify locations for purchasing drugs and medical supplies.

Article 32 The fee-based items and fee standards of Internet-based diagnostic and treatment services shall be disclosed on the IBDT platform for the convenience of patients’ inquiries.

Article 33 Telemedicine services between medical institutions shall be administered as per the Specifications for the Administration of Telemedicine Services (Trial) and other relevant documents.

Article 34 Medical institutions shall ensure that the Internet-based diagnostic and treatment services they provide are fully traceable and grant access to their data interfaces to the provincial regulatory platform. The information platform for the “joint reform of medical services, medical insurance, and the pharmaceutical sector” shall be used to manage data throughout the process. Provincial health authorities shall collect the relevant data from medical institutions based on the “minimum necessary principle”. The collection shall focus on information such as the qualifications of these medical institutions and their medical staff, the specialties and diseases of the diagnosis and treatment, electronic medical records, electronic prescriptions, medication usage, satisfaction, patient complaints, and adverse events arising from medical quality (safety). Additionally, the authorities shall analyze the overall status of the IBDT, feed back issues to each medical institution and their registration authorities, and specify a remediation period. Upon receiving feedback from the provincial health authorities, medical institutions shall promptly remedy the issues and upload the remediation results to the provincial regulatory platform. They shall also report the remediation results to the registration authorities.

Article 35 In accordance with the requirements of the Opinions on Strengthening the Development of the National Health Information Standardization System, Internet hospitals are encouraged to use AI as per relevant regulations to assist physicians in diagnosis and treatment. As per the Management Measures for Investigator-Initiated Clinical Research Conducted by Medical and Health Institutions (Trial), Internet hospitals are encouraged to increase investment in the research and development of “AI doctors”.

Article 36 Internet hospitals are encouraged to use digital therapeutics (“DTx”) for diagnosis and treatment in accordance with the relevant rules.

Chapter VI Quality and Safety Regulation

Article 37 Medical institutions shall follow the relevant laws, regulations, and rules on medical quality, medical safety, network security, medical data, and personal privacy protection when conducting IBDT.

Article 38 Medical institutions shall establish adverse event prevention and handling procedures and a reporting system for adverse events arising from medical quality (safety). They shall also designate departments to collect, analyze, and summarize reports on adverse events arising from medical quality (safety) and encourage medical staff to proactively report such events. Adverse events in medical services and adverse reactions/events in drugs and medical devices shall be reported as per the relevant national regulations when they occur.

Article 39 Medical institutions shall establish systems for network security, data security, personal data protection, and privacy protection, and execute agreements with relevant partners to define their respective responsibilities and rights. Patient data shall be properly safeguarded and shall not be illegally traded or disclosed. In the event of a leakage of patient information or medical data, medical institutions shall promptly report it to the competent health authorities and take effective countermeasures.

Article 40 Physical medical institutions or third parties that have applied to establish an Internet hospital in cooperation with these physical medical institutions shall take out medical malpractice insurance for their physicians.

Article 41 Health authorities at all levels shall guide medical institutions to strengthen the management of medical quality and safety, incorporate IBDT into the local medical quality assurance system, and carry out integrated online and offline supervision to ensure medical quality and safety. Relevant services shall be included in the performance appraisal and medical institution review by administrative authorities for physical medical institutions.

Chapter VII Regulatory Responsibilities

Article 42 Internet hospitals that have obtained the Practicing License for a Medical Institution and are independently established act as independent legal entities. For Internet hospitals serving as the secondary names of physical medical institutions, these physical medical institutions shall be legal entities. All parties to an Internet hospital shall assume their respective legal responsibilities in accordance with the cooperation agreement and the relevant laws and regulations.

Article 43 If medical institutions or their medical staff conduct IBDT in violation of laws and regulations such as the Law on Doctors of the People’s Republic of China, Law of the People’s Republic of China on Prevention and Treatment of Infectious Diseases, Law of the People’s Republic of China on Traditional Chinese Medicine, Regulations on Administration of Medical Institutions, Regulations on Handling Medical Accidents, and Regulations on Nurses, they shall be handled in accordance with the relevant laws, regulations, and rules.

Article 44 If an independently established Internet hospital closes, it shall deregister with the original registration authority or file with the original filing authority. Upon approval by the registration authority, its Practicing License for a Medical Institution shall be retrieved. Where a medical institution has been shut down for more than one year due to reasons other than reconstruction, expansion, or relocation, it shall be deemed closed.

Article 45 Where a medical accident or dispute occurs during IBDT, it shall be handled in accordance with the relevant laws, regulations, and rules, such as the Regulations on Handling Medical Accidents and Regulations on Preventing and Handling Medical Disputes. The health authorities at the county level or above in the place where the medical institution is located shall perform the corresponding responsibilities in accordance with the relevant laws and regulations.

Article 46 Internet hospitals serving as the secondary names of physical medical institutions shall be verified together with the physical medical institutions. Those obtaining a separate Practicing License for a Medical Institution relying on physical medical institutions shall be verified once a year. The verification shall be conducted in accordance with the Measures for the Administration of Verification of Medical Institutions (Trial).

Chapter VIII Supplementary Provisions

Article 47 For matters regarding IBDT not covered herein, the relevant regulations and rules of the National Health Commission, such as the Measures for the Administration of Internet-based Diagnosis and Treatment (Trial), Measures for the Administration of Internet Hospitals (Trial), and Basic Standards for Internet Hospitals shall be followed.

Attachment: Basic Standards for Internet Hospitals (Trial)

Attachment

Basic Standards for Internet Hospitals (Trial)

Physical medical institutions that apply to establish Internet hospitals or to use Internet hospitals as their secondary names shall comply with the Basic Standards for Internet Hospitals (Trial) (these “Standards”).

I. Diagnostic and Treatment Specialties

Internet hospitals shall determine their diagnostic and treatment specialties based on their services and shall not exceed the scope of specialties offered by the physical medical institutions they rely on.

II. Department Establishment

Internet hospitals shall establish appropriate clinical departments based on their services and ensure alignment with the clinical departments of the physical medical institution they rely on. Additionally, departments for medical quality management, information technology service and management, and pharmacy services shall be established.

III. Staff

i. For each clinical department established by an Internet hospital, the corresponding department at the physical medical institution it relies on shall have at least one chief and one associate practicing physician registering with the institution (multi-institution practice is allowed).

ii. Internet hospitals shall have dedicated staff to manage the medical quality, medical safety, and electronic medical records and provide technical services such as information system maintenance to ensure stable system operation.

iii. Internet hospitals shall have dedicated pharmacists to review online prescriptions. They shall also ensure that at least one pharmacist is on duty during business hours to review the prescriptions. In the event that Internet hospitals are short-handed for online prescription review, they may cooperate with pharmacists from qualified third-party institutions.

iv. Relevant staff shall complete training on medical and health laws and regulations, medical service-related policies, various rules and policies, duties, procedure specifications, and contingency plans. This ensures that they master the service procedures and understand the potential risks.

IV. Facilities

i. Internet hospitals shall be equipped with at least two sets of servers for operation, and the database server shall be separated from the application server. The server room shall have dual power supplies or emergency power facilities. Servers storing medical data shall not be stored outside the Chinese mainland.

ii. Internet hospitals shall have at least two sets of multimedia communication systems (including necessary software systems and hardware equipment) for providing Internet-based medical services.

iii. Internet hospitals shall have high-speed and high-reliability network access with a minimum bandwidth of 10 Mbps for business purposes, and shall use services from at least two broadband providers. Internet hospitals, where possible, are encouraged to use dedicated Internet access (“DIA”) or virtual private networks (“VPNs”) to ensure the quality of medical data transmission services.

iv. Internet hospitals shall establish a data access control information system to ensure system stability and full traceability of services and enable data exchange and sharing with the hospital information system (“HIS”), picture archiving and communication system (“PACS”)/radiology information system (“RIS”), and laboratory information system (“LIS”) of the physical medical institutions.

v. Internet hospitals shall be capable of providing services such as remote medical second opinions, remote outpatient services, remote pathological diagnosis, remote medical imaging diagnosis, and remote ECG diagnosis.

vi. Internet hospitals shall implement Level-3 information security protection for their information systems.

V. Rules and Regulations

Internet hospitals shall establish an Internet-based medical service management system and related management systems, and define the duties of their staff and their service procedures. Rules and regulations shall include the Internet-based medical service management system, the Internet hospital information system management system, the Internet-based medical quality control and evaluation system, the online prescription management system, the informed consent and registration system for patients, the online medical documentation management system, the patient risk assessment and emergency prevention and response system for online follow-up visits, and the staff training & appraisal system, as well as contingency plans for power outages, network interruptions, equipment failures, and network information security.