The National Health Commission publicly solicits opinions on the Internet diagnosis and treatment regulations (draft for comments)

On October 26, the National Health Commission issued the "Announcement on Public Consultation on Internet Diagnosis and Treatment Regulations (Draft for Comment)
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" The draft opinion proposes that medical institutions should have specialized departments to manage the medical quality, medical safety, pharmaceutical services, information technology, etc.
of Internet diagnosis and treatment, and establish corresponding management systems, including but not limited to the self-examination system of medical institutions practicing in accordance with the law, and medical treatment related to Internet diagnosis and treatment.
quality and safety management systems, patient safety, adverse event reporting system, medical staff training and examination system, the patient informed consent system, prescription management system, electronic medical records management system, information management system using the system
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Where medical institutions carry out drug distribution on their own or entrust a third party, relevant agreements and prescription circulation information should be traceable, and the data interface should be opened to the provincial-level supervision platform
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Medical institutions shall establish systems for network security, personal information protection, data use management, etc.
, and sign agreements with relevant partners to clarify the rights and responsibilities of each party
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Internet diagnosis and treatment adopt a real-name system, and patients are obliged to provide real identity certificates and basic information to medical institutions, and they must not fake others for treatment
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The original text is as follows: Announcement on Public Comment on Regulations for Internet Diagnosis and Treatment (Draft for 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 safety, the National Health Commission organized the drafting of the "Internet Diagnosis and Treatment Supervision Rules" (Draft for Solicitation of Comments)" (attached)
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We are now soliciting opinions from the public, and the public can give feedback in the following ways: 1.
E-mail: yzygjzyc@nhc.
gov.
cn 2.
Letter: Medical Political Doctor, National Health Commission, No.
38, Beilishi Road, Xicheng District, Beijing Management Bureau, Zip Code: 100044
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Please indicate on the envelope the words "Internet diagnosis and treatment supervision rules for comments"
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3.
Fax: 010-68792195 The deadline for feedback is November 26, 2021
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National Health Commission Medical Administration and Hospital Administration October 26, 2021 (Information Disclosure Form: Active Disclosure) Regulations on Internet Diagnosis and Treatment Supervision (Draft for Solicitation of Comments) Chapter 1 General Provisions Article 1 is to regulate Internet diagnosis and treatment activities and strengthen the Internet diagnosis and treatment supervision system Construction in accordance with the Basic Medical Hygiene and Health Promotion Law, Physician Law, Infectious Disease Prevention and Control Law, Medical Institution Management Regulations, Nurses Regulations, Internet Diagnosis and Treatment Management Measures (Trial), Internet Hospital Management Measures (Trial) And other laws, regulations and regulations, formulate these rules
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Article 2 The Internet diagnosis and treatment mentioned in these rules refers to the Internet diagnosis and treatment activities carried out by medical institutions in accordance with the "Internet Diagnosis and Treatment Management Measures (Trial)" and "Internet Hospital Management Measures (Trial)"
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Article 3 The national health authority and the Chinese medicine authority shall be responsible for guiding the supervision of internet diagnosis and treatment across the country
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Local health authorities at all levels (including TCM authorities, the same below) implement localized supervision responsibilities
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Chapter II Medical Institution Supervision Article 4 Provincial-level health and health authorities shall establish a provincial-level Internet medical service supervision platform (hereinafter referred to as the “provincial supervision platform”) to provide medical institutions that carry out Internet diagnosis and treatment activities within their jurisdiction (hereinafter referred to as “medical Institutions”) to achieve real-time supervision
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Article 5 Medical institutions that carry out Internet diagnosis and treatment activities shall actively connect with the local provincial-level supervision platform, upload and update relevant practice information such as the "Medical Institution Practicing License" in a timely manner, and actively accept supervision
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Article 6 Medical institutions shall have specialized departments to manage the medical quality, medical safety, pharmaceutical services, information technology, etc.
of Internet diagnosis and treatment, and establish corresponding management systems, including but not limited to the self-examination system of medical institutions practicing in accordance with the law, and the medical quality related to Internet diagnosis and treatment.
And safety management system, patient safety adverse event reporting system, medical staff training and assessment system, patient informed consent system, prescription management system, electronic medical record management system, information system use management system, etc..
Article 7 Internet hospitals, which are the second-named physical medical institutions, shall be verified at the same time as the physical medical institutions; Internet hospitals that rely on physical medical institutions to obtain the "Medical Institution Practicing License" shall be verified once a year
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Article 8: Medical institutions and medical practitioners who provide Internet diagnosis and treatment services, such as electronic certificates and licenses, shall be published in a prominent place on the Internet diagnosis and treatment platform to facilitate patients' inquiries
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Article 9: Medical institutions shall fully inform patients of the rules, requirements, and risks related to Internet diagnosis and treatment, and obtain the patient’s informed consent before conducting Internet diagnosis and treatment activities
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Article 10: Local health authorities at all levels shall publish to the public the list of medical institutions approved to conduct Internet diagnosis and treatment in their jurisdiction, supervision telephone numbers and other supervision methods on the provincial supervision platform, set up complaint acceptance channels, and deal with violations of laws and regulations in a timely manner
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Article 11 The local health authorities at all levels shall establish an evaluation and withdrawal mechanism for medical institutions in accordance with the "Regulations on the Management of Medical Institutions" and its implementation rules
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Chapter III Personnel Supervision Article 12 Medical institutions shall conduct real-name authentication of medical personnel conducting Internet diagnosis and treatment activities to ensure that medical personnel have legal qualifications
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Article 13 A doctor must perform real-name authentication before receiving a consultation to ensure that it is received by himself
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Other personnel, artificial intelligence software, etc.
shall not fraudulently use or substitute for the doctor's own consultation
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The health authorities at all levels shall be responsible for supervising the personnel conducting Internet diagnosis and treatment in the medical institution
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Article 14 Medical institutions shall share the information of medical personnel who carry out Internet diagnosis and treatment activities with the provincial supervision platform, including necessary information such as ID card numbers, photos, relevant qualification information, practice locations, and clinical working years
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The provincial supervision platform should be connected to the electronic registration system for physicians and nurses, and the pharmacist information should be uploaded to the supervision platform and can be searched, and it should be connected to the health supervision information system when conditions permit. .
Medical institutions shall establish an assessment mechanism for medical personnel who carry out Internet diagnosis and treatment activities, conduct assessments based on legal practice, medical quality, medical safety, medical ethics, medical ethics, and satisfaction, and establish access and exit mechanisms
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Article 15 Medical institutions shall conduct regular training for personnel who carry out Internet diagnosis and treatment activities and related management services.
The training content includes health-related laws and regulations, medical management-related policies, job responsibilities, Internet diagnosis and treatment procedures, information platform use and crisis to deal with and so on
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Article 16 Medical personnel who carry out Internet diagnosis and treatment activities in other Internet hospitals other than the main practice location shall register or file in accordance with the relevant requirements of the practice of multiple institutions in the location of the Internet hospital
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Chapter IV Business Supervision Article 17 The real-name system is implemented for Internet diagnosis and treatment, and patients are obliged to provide true identity certificates and basic information to medical institutions, and must not fake others for medical treatment
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Article 18 The patient shall provide medical records with a clear diagnosis, such as outpatient medical records, inpatient medical records, discharge summary, diagnosis certificate, etc.
, when visiting a doctor.
The receiving physician shall determine whether the conditions for re-examination are met, and collect paper or documents proving that the patient has been diagnosed.
Electronic voucher information
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Medical institutions should clarify the termination conditions for Internet diagnosis and treatment
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When the patient's condition changes, the doctor judges that this visit is the first visit, or there are other conditions 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
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Article 19 The electronic medical record information generated by medical institutions during the process of Internet diagnosis and treatment shall be shared with the electronic medical record system of the entity medical institution that they rely on, and the entity medical institution that they rely on shall carry out integrated online and offline quality control
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Internet diagnosis and treatment medical records are managed in accordance with the relevant regulations of outpatient electronic medical records.
The graphic dialogues, audio and video materials in the diagnosis and treatment process should be traced and traceable, and the data interface should be opened to the provincial supervision platform, and the storage time should not be less than 15 year
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Article 20 The electronic prescriptions, prescription review records, and prescription review records of medical institutions shall be traceable, and the data interface shall be opened to the provincial supervision platform
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Article 21: Medical institutions shall strictly abide by the "Prescription Management Measures" and other prescription management regulations when carrying out Internet diagnosis and treatment activities, strengthen drug management, and prohibit problems such as unified prescriptions and supplements
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The personal income of medical and health personnel shall not be linked to the income of medicines and medical examinations
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Article 22: Where medical institutions conduct drug distribution on their own or entrust a third party, relevant agreements and prescription circulation information shall be traceable, and the data interface shall be opened to the provincial-level supervision platform
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Article 23 The medical service charging items and charging standards of Internet diagnosis and treatment shall be publicized on the Internet to facilitate patients' inquiries
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Article 24 The medical institution or medical worker is allowed illegal patient referral, the designated place to buy drugs and other supplies
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Article 25 Provincial-level health authorities shall collect relevant data of medical institutions in accordance with the "minimum availability principle", focusing on collecting medical institution qualifications, medical staff qualifications, diagnosis and treatment subjects, types of diagnosis and treatment, electronic medical records, electronic prescriptions, and medications.
, Satisfaction evaluation, patient complaints, patient safety adverse events, etc.
, analyze the overall situation of Internet diagnosis and treatment, regularly (at least once a month) feedback problems to medical institutions and their registration agencies, and specify the time limit for rectification.
After receiving the feedback from the provincial health authority, the rectification should be made in a timely manner, and the rectification should be uploaded to the provincial supervision platform and reported to its registration authority
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Encourage qualified provinces to set rules for determining the rationality of Internet diagnosis and treatment in the provincial supervision platform, and use artificial intelligence, big data and other emerging technologies to implement analysis and supervision
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Chapter V Quality and Safety Supervision Article 26 Medical institutions shall abide by relevant laws, regulations and regulations on medical quality, patient safety, and network safety when carrying out Internet diagnosis and treatment activities. .
Article 27: Medical institutions shall establish a patient safety adverse event reporting system, designate a special department to be responsible for the collection, analysis and summary of patient safety adverse event reports, and encourage medical staff to actively report adverse events
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Article 28: Medical institutions shall establish systems for network security, personal information protection, data use management, etc.
, and sign agreements with relevant partners to clarify the rights and responsibilities of each party
.
Article 29: Medical institutions shall strengthen the content management of information released on the Internet to ensure that the information is legal, compliant, true and effective
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Article 30 The local health and health authorities at all levels shall guide medical institutions to strengthen the management of medical quality and safety and achieve continuous improvement
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Article 31.
Provincial-level supervision platforms and medical institutions used by Internet diagnosis and treatment platforms shall implement third-level and higher level of information security protection
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Chapter VI Supervision Responsibilities Article 32 Internet hospitals that have obtained the "Medical Institution Practicing License" and independently set up are the subject of legal responsibility independently; when the entity medical institution uses the Internet hospital as the second name, the entity medical institution is the subject of legal responsibility
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All parties to the Internet hospitals shall bear corresponding legal responsibilities in accordance with the law and regulations in accordance with the cooperation agreement
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Article 33: Medical institutions and medical staff have violated the "Physician Law", "Infectious Disease Prevention Law", "Medical Institution Management Regulations", "Medical Accident Handling Regulations", "Nursing Regulations" and other laws and regulations during Internet diagnosis and treatment.
Dispose of in accordance with relevant laws and regulations
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Article 34: When a medical institution has a network security incident such as the leakage of patient personal information or medical data, it shall promptly report to the relevant competent authority and take effective response measures
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Article 35: Medical institutions that experience medical accidents or trigger medical disputes during Internet diagnosis and treatment activities shall be dealt with in accordance with the "Regulations on the Handling of Medical Accidents", "Regulations on the Prevention and Handling of Medical Disputes," and other relevant laws, regulations and regulations
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The medical institution registration agency shall perform corresponding handling responsibilities in accordance with relevant laws and regulations
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Article 36 Medical institutions shall control the quality and safety of Internet diagnosis and treatment activities, and set up information feedback channels for the handling of patient complaints
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Article 37 The provincial health and health authorities shall incorporate Internet diagnosis and treatment into the local medical quality control system, and carry out integrated online and offline supervision to ensure medical quality and medical safety
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Chapter VII Supplementary Provisions Article 38 The National Medical Service Data Center will interface with various provincial-level regulatory platforms to analyze data related to Internet diagnosis and treatment across the country
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Article 39 The provincial-level health authorities shall formulate implementation measures for these rules
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Article 40 The National Health Commission is responsible for the interpretation of these rules
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Article 41 These rules shall come into force on January, 2021
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