Internet diagnosis and treatment supervision rules for comments: artificial intelligence software must not replace doctors to receive treatment

Source: National Health Commission website

The website of the National Health Commission published an announcement on the detailed rules for the supervision of Internet diagnosis and treatment (draft for solicitation of comments) for public comment.

In order to further standardize Internet diagnosis and treatment, promote the healthy development of Internet diagnosis and treatment services, and ensure medical quality and medical safety, the National Health Commission has drafted the Detailed Rules for the Supervision of Internet Diagnosis and Treatment (Draft for Comment) (attached). It is hereby open to the public for comments, and the public can give feedback through the following means:

1. E-mail: [email protected]

2. Letter: Medical Administration Bureau of the National Health Commission, No. 38 Beilishi Road, Xicheng District, Beijing, Zip Code: 100044. Please indicate on the envelope the words "Internet Diagnosis and Treatment Supervision Rules for Solicitation of Comments".

3. Fax: [phone] The deadline for feedback is November 26, 2021.

National Health Commission Medical Administration Bureau

October 26, 2021

Detailed Rules for the Supervision of Internet Diagnosis and Treatment (Draft for Solicitation of Comments)

Chapter I General Provisions

Article 1: These Detailed Rules are formulated on the basis of the Basic Medical Care and Health Promotion Law, the Physicians Law, the Law on the Prevention and Control of Infectious Diseases, the Regulations on the Administration of Medical Institutions, the Regulations on nurses, the Measures for the Administration of Internet Diagnosis and Treatment (for Trial Implementation), the Measures for the Administration of Internet Hospitals (for Trial Implementation), and the Measures for the Administration of Internet Hospitals (for Trial Implementation) so as to regulate Internet diagnosis and treatment activities and strengthen the construction of the Internet diagnosis and treatment supervision system.

Article 2: "Internet diagnosis and treatment" as used in these Detailed Rules refers to Internet diagnosis and treatment activities carried out by medical institutions in accordance with the Measures for the Administration of Internet Diagnosis and Treatment (Trial) and the Measures for the Administration of Internet Hospitals (Trial).

Article 3: The competent departments of national health and traditional Chinese medicine are responsible for guiding the nationwide efforts to supervise internet diagnosis and treatment. Local health authorities at all levels (including the competent departments of traditional Chinese medicine, the same below) implement the responsibility of localization supervision.

Chapter II: Supervision of Medical Institutions

Article 4: Provincial-level competent departments for health and health shall establish a provincial-level Internet medical service supervision platform (hereinafter referred to as the "provincial-level supervision platform"), to bring about real-time supervision of medical establishments within their jurisdiction that carry out Internet diagnosis and treatment activities (hereinafter referred to as "medical institutions").

Article 5: Medical establishments carrying out Internet diagnosis and treatment activities shall proactively dock with the local provincial-level supervision platform, promptly upload and update relevant practice information such as the "Medical Establishment Practice Permit", and actively accept supervision.

Article 6: Medical establishments shall have special departments to manage the medical quality, medical safety, pharmacy services, information technology, and so forth of Internet diagnosis and treatment, and establish corresponding management systems, including but not limited to the medical establishment's self-examination system for practicing in accordance with law, the medical quality and safety management system related to Internet diagnosis and treatment, the patient safety adverse event reporting system, the medical personnel training and assessment system, the patient informed consent system, the prescription management system, the electronic medical record management system, the information system use management system, and so forth.

Article 7: Internet hospitals that are the second name of entity medical institutions shall be verified at the same time as the entity medical institutions, and Internet hospitals that rely on entity medical institutions to separately obtain the "Medical Institution Practice License" shall be verified once a year.

Article 8: Practice information such as the electronic licenses of medical establishments and physicians providing Internet diagnosis and treatment services shall be published in a conspicuous position on the Internet diagnosis and treatment platform, facilitating patient inquiries.

Article 9: Medical establishments shall fully inform patients of the rules, requirements, and risks related to Internet diagnosis and treatment, and only after obtaining the patient's informed consent can they carry out Internet diagnosis and treatment activities.

Article 10: Local competent departments for health at all levels shall, on the provincial-level supervision platform, publish to the public the list of medical establishments within their jurisdiction that have approved the development of Internet diagnosis and treatment, supervision telephone numbers, and other supervision methods, set up channels for accepting complaints, and promptly handle violations of laws and regulations.

Article 11: Local competent departments of health at all levels shall, in accordance with the "Regulations on the Administration of Medical Institutions" and their implementation rules, establish evaluation and withdrawal mechanisms for medical establishments.

Chapter III: Supervision of Personnel

Article 12: Medical establishments shall conduct real-name authentication of medical personnel carrying out Internet diagnosis and treatment activities, ensuring that medical personnel have lawful qualifications.

Article 13: Physicians are required to undergo real-name authentication before receiving treatment to ensure that they are admitted in person. Other personnel, artificial intelligence software, etc. must not fraudulently use or substitute for physicians to receive treatment. The competent departments for health at all levels shall be responsible for supervising and supervising the personnel carrying out Internet diagnosis and treatment in that medical establishment.

Article 14: Medical establishments shall share information on medical personnel carrying out Internet diagnosis and treatment activities with provincial-level regulatory platforms, including necessary information such as ID card numbers, photos, relevant qualification information, practice locations, and years of clinical work. The provincial supervision platform shall be connected with the electronic registration system for physicians and nurses, and the information of pharmacists shall be uploaded to the supervision platform and can be queried, and the health supervision information system shall be connected with the health supervision information system when conditions permit.

Medical establishments shall establish assessment mechanisms for medical personnel carrying out Internet diagnosis and treatment activities, conducting assessments on the basis of lawful practice, medical quality, medical safety, medical ethics, medical style, satisfaction, and other such content, and establishing mechanisms for access and withdrawal.

Article 15: Medical establishments shall carry out regular training for personnel carrying out Internet diagnosis and treatment activities and engaging in related management services, and the content of the training includes laws and regulations related to health and health, policies related to medical management, job responsibilities, Internet diagnosis and treatment processes, use of information platforms, and crisis response.

Article 16: If medical personnel carry out Internet diagnosis and treatment activities in an Internet hospital other than the main place of practice, they shall conduct practice registration or filing in accordance with the relevant requirements for multi-institutional practice in the location of the Internet hospital.

Chapter IV: Business Supervision

Article 17: The real-name system is implemented for Internet diagnosis and treatment, and patients have the obligation to provide medical establishments with real identification and basic information, and must not impersonate others for treatment.

Article 18: When patients seek medical treatment, they shall provide medical records with a clear diagnosis, such as outpatient medical records, inpatient medical records, discharge summaries, diagnostic certificates, etc., and the receiving physician shall judge whether they meet the conditions for follow-up consultation, and collect paper or electronic voucher information that proves that the patient has been diagnosed.

Medical establishments shall clarify the conditions for termination of Internet diagnosis and treatment. When the patient's condition changes, the current visit is judged by the physician to be the first consultation, or there are other circumstances that are not suitable for Internet diagnosis and treatment, the receiving physician shall immediately terminate the Internet diagnosis and treatment activities and guide the patient to the physical medical institution for treatment.

Article 19: Electronic medical record information generated by medical establishments in the course of carrying out Internet diagnosis and treatment shall be shared with the electronic medical record system of the entity medical institution on which they are relying, and the entity medical institutions relying on it shall carry out integrated online and offline quality control.

Internet diagnosis and treatment medical record records are managed in accordance with the relevant provisions of outpatient electronic medical records, and the graphic dialogue, audio and video materials, etc. in the process of diagnosis and treatment shall be traced and traceable throughout the process, and the data interface shall be open to the provincial supervision platform, and the storage time shall not be less than 15 years.

Article 20: Medical establishments' electronic prescriptions, prescription review records, and prescription review records shall be traceable, and data interfaces shall be opened to provincial-level regulatory platforms.

Article 21: Medical establishments carrying out Internet diagnosis and treatment activities shall strictly abide by the "Prescription Management Measures" and other prescription management provisions, strengthen drug management, and prohibit the occurrence of problems such as unified prescriptions and supplementary prescriptions. The personal income of medical and health personnel shall not be linked to the income of medicines and medical examinations.

Article 22: Where medical establishments carry out drug distribution on their own or by entrusting a third party, the relevant agreements and prescription circulation information shall be traceable, and the data interface shall be open to the provincial-level regulatory platform.

Article 23: The items and charging standards for medical services for Internet diagnosis and treatment shall be publicized online to facilitate patient inquiries.

Article 24 Medical establishments or medical personnel shall not introduce patients in violation of regulations, purchase drug consumables at designated locations, and so forth.

Article 25: Provincial-level competent departments of health and health shall, in accordance with the "principle of least availability", collect relevant data from medical establishments, focusing on collecting information such as medical establishment qualifications, medical personnel qualifications, diagnosis and treatment subjects, types of diagnosis and treatment, electronic medical records, electronic prescriptions, medication situations, satisfaction evaluations, patient complaints, and adverse patient safety events, conducting an analysis of the overall situation of Internet diagnosis and treatment, periodically (at least once a month) to give feedback to each medical establishment and its registration organs, and clarifying the period for rectification, After receiving feedback from the provincial health authorities, medical institutions shall promptly rectify the problems, and upload the rectification situation to the provincial supervision platform, and report it to their registration authorities at the same time.

Provinces with the capacity to do so set rules for determining the rationality of Internet diagnosis and treatment in provincial-level regulatory platforms, and use emerging technologies such as artificial intelligence and big data to implement analysis and supervision.

Chapter V: Quality and Safety Supervision

Article 26: Medical establishments carrying out Internet diagnosis and treatment activities shall comply with relevant laws, regulations, and provisions on medical quality, patient safety, and network security.

Article 27: Medical establishments shall establish a reporting system for adverse events on patient safety, designate special departments to be responsible for the collection, analysis, and summarization of reports of adverse events for patient safety, and encourage medical staff to actively report adverse events.

Article 28: Medical establishments shall establish systems such as for network security, personal information protection, and data use management, and sign agreements with relevant partners to clarify the rights and responsibilities of all parties.

Article 29: Medical establishments shall strengthen content management of information published on the Internet, ensuring that information is lawful, compliant, true, and effective.

Article 30: Local competent departments for health at all levels shall guide medical establishments to strengthen medical quality and safety management efforts and achieve continuous improvement.

Article 31: Provincial-level regulatory platforms and medical establishments' use of Internet diagnosis and treatment platforms shall implement level 3 and above information security level protection.

Chapter VI: Regulatory Responsibilities

Article 32: Internet hospitals that have obtained the "Medical Institution Practice License" and are independently set up shall independently be the subject of legal liability; when an entity medical institution uses an Internet hospital as its second name, the entity medical institution shall be the subject of legal liability. The cooperating parties of the Internet hospital shall bear the corresponding legal responsibilities in accordance with the cooperation agreement in accordance with laws and regulations.

Article 33: Where medical establishments and medical personnel violate the "Physicians Law", the "Law on the Prevention and Control of Infectious Diseases", the "Regulations on the Management of Medical Institutions", the "Regulations on the Handling of Medical Accidents", the "Nurses Regulations" and other laws and regulations in the course of Internet diagnosis and treatment, they shall be dealt with in accordance with the relevant laws and regulations.

Article 34: When a network security incident such as a leak of patients' personal information or medical data occurs in a medical establishment, it shall promptly report to the relevant competent departments and employ effective response measures.

Article 35: Where medical establishments have medical accidents or cause medical disputes in the course of carrying out Internet diagnosis and treatment activities, they shall handle it in accordance with the "Regulations on the Handling of Medical Accidents", the "Regulations on the Prevention and Handling of Medical Disputes" and other relevant laws and regulations and provisions. The registration organs of medical institutions shall perform corresponding handling responsibilities in accordance with relevant laws and regulations.

Article 36: Medical establishments shall control the quality and safety of Internet diagnosis and treatment activities, and set up information feedback channels for patient complaint handling.

Article 37: Provincial-level competent departments for health shall incorporate Internet diagnosis and treatment into the local medical quality control system, carrying out integrated online and offline supervision to ensure medical quality and medical safety.

Chapter VII Supplementary Provisions

Article 38: The National Medical Service Data Center is to dock with each provincial-level regulatory platform to analyze data related to Internet diagnosis and treatment nationwide.

Article 39: The provincial-level competent departments for health and health shall formulate implementation measures for these Detailed Rules.

Article 40 The National Health Commission shall be responsible for the interpretation of these Detailed Rules.

Article 41 These Detailed Rules shall take effect as of January 2021.