Recently, the National Health Commission and the State Administration of traditional Chinese medicine jointly issued the detailed rules for the supervision of Internet diagnosis and treatment (Trial). The detailed rules point out that when medical institutions carry out Internet diagnosis and treatment activities, prescriptions should be issued by the receiving doctor himself. It is strictly prohibited to use artificial intelligence and other automatic prescriptions. It is strictly prohibited to provide drugs to patients before prescribing**
It is strictly prohibited to unify the party for commercial purposes. The Internet hospital, as the second name of the entity medical institution, shall be verified at the same time with the entity medical institution; Internet hospitals that rely on physical medical institutions to obtain the practice license of medical institutions will be verified once a year
The detailed rules emphasize that doctors need to carry out real name authentication before receiving treatment to ensure that they provide diagnosis and treatment services. Other personnel and artificial intelligence software shall not falsely use or substitute doctors to provide diagnosis and treatment services. The competent health departments at all levels shall be responsible for supervising the personnel who carry out Internet diagnosis and treatment in the medical institution. If a medical staff carries out Internet diagnosis and treatment activities in an Internet hospital other than the main practice institution, they shall carry out practice registration or filing according to the practice related requirements of multiple institutions where the Internet hospital is located. The detailed rules specify that patients should provide medical records with clear diagnosis, such as outpatient medical records, inpatient medical records, discharge summary, diagnosis certificate, etc. when they go to see a doctor, the receiving doctor should keep relevant data and judge whether they meet the conditions for further consultation. Medical institutions shall specify the termination conditions for Internet diagnosis and treatment.
According to the detailed rules, the medical records of Internet diagnosis and treatment shall be managed in accordance with the relevant provisions of outpatient electronic medical records, and the retention time shall not be less than 15 years. The retention time of process records such as graphic dialogue, audio and video data during diagnosis and treatment shall not be less than 3 years. The electronic medical record information generated by medical institutions in the process of Internet diagnosis and treatment shall be consistent with the electronic medical record format of the entity medical institutions they rely on and shared by the system. The entity medical institutions they rely on shall carry out online and offline integrated quality control. Medical institutions shall establish systems for network security, data security, personal information protection, privacy protection, etc., and sign agreements with relevant partners to clarify the rights and responsibilities of each party.
According to the detailed rules, provinces with conditions are encouraged to set up rules for judging the rationality of Internet diagnosis and treatment in provincial regulatory platforms, and use emerging technologies such as artificial intelligence and big data for analysis and supervision. The provincial health authorities shall collect relevant data of medical institutions in accordance with the "least available principle", focusing on the qualifications of medical institutions, medical personnel, diagnosis and treatment subjects, etc., analyze the overall situation of Internet diagnosis and treatment, and specify the rectification period.
Original text
Detailed rules for the supervision of Internet diagnosis and treatment (for Trial Implementation)
Chapter I General Provisions
*Article 1 * in order to further standardize Internet diagnosis and treatment activities and strengthen the supervision of Internet diagnosis and treatment, these rules are formulated in accordance with laws, regulations and provisions such as the law on basic medical health and health promotion, the law on physicians, the law on traditional Chinese medicine, the regulations on the Administration of medical institutions, the administrative measures for Internet diagnosis and treatment (Trial), the administrative measures for Internet hospitals (Trial), and so on.
*Article 2 * these rules are applicable to the supervision of medical institutions' Internet diagnosis and treatment activities in accordance with the administrative measures for Internet diagnosis and treatment (Trial) and the administrative measures for Internet hospitals (Trial).
*Article 3 * the competent department of health and the competent department of traditional Chinese medicine under the State Council shall be responsible for guiding the supervision of Internet diagnosis and treatment throughout the country. The local health authorities at all levels (including the authorities in charge of traditional Chinese medicine, the same below) implement the localized supervision responsibility.
Chapter II Supervision of medical institutions
*Article 4 * the provincial health authorities shall establish a provincial internet medical service supervision platform (hereinafter referred to as the "provincial supervision platform") to supervise the medical institutions that carry out Internet diagnosis and treatment activities (hereinafter referred to as the "medical institutions").
*Article 5 * a medical institution shall take the initiative to connect with the local provincial regulatory platform, upload and update the practice license of medical institution and other relevant practice information in a timely manner, and actively accept supervision.
*Article 6 * a medical institution shall have a special department to manage the medical quality, medical safety, pharmaceutical care, information technology, etc. of Internet diagnosis and treatment, and establish corresponding management systems, including but not limited to the medical institution's legal practice self-examination system, medical quality and safety management system related to Internet diagnosis and treatment, medical quality (safety) adverse event reporting system, medical personnel training and assessment system, patient informed consent system Prescription management system, electronic medical record management system, information system use management system, etc.
*Article 7 * as the second name of an entity medical institution, the Internet hospital shall be verified at the same time with the entity medical institution; Internet hospitals that rely on physical medical institutions to obtain the practice license of medical institutions will be verified once a year.
*Article 8 * a medical institution shall publish the electronic certificates and other information of its medical personnel providing Internet diagnosis and treatment services in a prominent position on the Internet diagnosis and treatment platform for the convenience of patients' query.
*Article 9 * medical institutions shall fully inform patients of the rules, requirements and risks related to Internet diagnosis and treatment, and carry out Internet diagnosis and treatment activities only after obtaining the informed consent of patients.
*Article 10 * local health authorities at all levels shall publish to the public the list of medical institutions approved to carry out Internet diagnosis and treatment within their jurisdiction, supervision telephone numbers and other supervision methods, set up complaint acceptance channels and deal with violations in a timely manner.
*Article 11 * local health authorities at all levels shall establish an evaluation and withdrawal mechanism for Internet diagnosis and treatment activities in accordance with the regulations on the administration of medical institutions and its implementation rules.
Chapter III personnel supervision
*Article 12 * medical institutions shall carry out real name authentication for medical personnel carrying out Internet diagnosis and treatment activities to ensure that medical personnel have legal qualifications.
*Article 13 * doctors shall be certified with their real names before receiving a doctor, so as to ensure that they can provide diagnosis and treatment services by themselves. Other personnel and artificial intelligence software shall not falsely use or substitute doctors to provide diagnosis and treatment services. The competent health departments at all levels shall be responsible for supervising the personnel who carry out Internet diagnosis and treatment in the medical institution.
*Article 14 * medical institutions shall upload the information of medical personnel who carry out Internet diagnosis and treatment activities to the provincial supervision platform, including the ID card number, photos, relevant qualifications, practice location, practice institution, practice scope, clinical work years and other necessary information. The provincial supervision platform shall be connected with the electronic registration system of doctors and nurses. The pharmacist information shall be uploaded to the supervision platform and can be queried. If possible, it shall be connected with the health supervision information system.
A medical institution shall establish an assessment mechanism for medical personnel who carry out Internet diagnosis and treatment activities, assess them according to the contents of legal practice, medical quality, medical safety, medical ethics and satisfaction, and establish an access and exit mechanism.
*Article 15 * medical institutions shall carry out regular training for personnel engaged in Internet diagnosis and treatment activities and related management services, including health-related laws and regulations, medical management related policies, job responsibilities, Internet diagnosis and treatment process, platform use and emergency disposal, etc.
*Article 16 * if a medical staff carries out Internet diagnosis and treatment activities in an Internet hospital other than the main practice institution, they shall carry out practice registration or filing according to the practice requirements of multiple institutions where the Internet hospital is located.
Chapter IV Business Supervision
*Article 17 * Internet diagnosis and treatment adopts the real name system. Patients have the obligation to provide real identity certificates and basic information to medical institutions. They are not allowed to fake others for medical treatment.
*Article 18 * patients shall provide medical records with clear diagnosis, such as outpatient medical records, inpatient medical records, discharge summary, diagnosis certificate, etc. when they go to see a doctor, the receiving doctor shall keep relevant materials and judge whether they meet the conditions for further consultation.
Medical institutions shall specify the termination conditions for Internet diagnosis and treatment. When the patient's condition changes, the first visit is judged by the doctor or there are other conditions unsuitable for Internet diagnosis and treatment, the receiving doctor shall immediately terminate the Internet diagnosis and treatment activities and guide the patient to the entity medical institution for treatment.
*Article 19 * the electronic medical record information generated by medical institutions in the process of Internet diagnosis and treatment shall be consistent with the electronic medical record format of the entity medical institutions they rely on and shared systematically. The entity medical institutions they rely on shall carry out online and offline integrated quality control.
Internet medical records of diagnosis and treatment shall be managed in accordance with the relevant provisions of outpatient electronic medical records, and the retention time shall not be less than 15 years. The retention time of process records such as graphic dialogue, audio and video data during diagnosis and treatment shall not be less than 3 years.
*Article 20 * when an Internet hospital changes its name, the medical records and other data information it keeps shall continue to be kept by the Internet hospital after the change.
After the cancellation of the Internet hospital, the medical records and other data information kept by it will continue to be kept by the entity medical institution it relies on. After the cancellation of the entity medical institution it relies on, it may be properly kept by the provincial health authority or the institution designated by the provincial health authority in accordance with the provisions.
*Article 21 * when conducting Internet-based diagnosis and treatment activities, medical institutions shall strictly abide by the prescription management measures and other provisions, and strengthen drug management. The prescription shall be issued by the receiving doctor himself. It is strictly prohibited to use artificial intelligence to automatically generate the prescription. Prescription drugs shall be sold, dispensed and used on the basis of doctors' prescriptions. It is strictly prohibited to provide drugs to patients before prescribing. It is strictly prohibited to unify the party for commercial purposes.
*Article 22 * if a medical institution carries out drug distribution by itself or by entrusting a third party, the relevant agreements and prescription circulation information shall be traceable, and the data interface shall be opened to the provincial supervision platform.
*Article 23 * the charging items and standards of medical services for Internet diagnosis and treatment shall be publicized on the Internet diagnosis and treatment platform to facilitate patients' query.
*Article 24 * medical institutions shall consciously strengthen the construction of professional ethics, strictly implement the nine guidelines for the honest practice of medical institution staff and other relevant provisions, the personal income of medical personnel shall not be linked to the income of drugs, and it is strictly prohibited to refer patients for the purpose of seeking personal interests and purchase drugs and consumables at designated places.
*Article 25 * medical institutions shall ensure that Internet diagnosis and treatment activities are traceable throughout the process, and open data interfaces to provincial regulatory platforms. The provincial health authorities shall collect relevant data of medical institutions in accordance with the "least available principle", focusing on the qualification of medical institutions, qualification of medical personnel, diagnosis and treatment subjects, diagnosis and treatment diseases, electronic medical records, electronic prescriptions, drug use, satisfaction evaluation, patient complaints, medical quality (safety) adverse events and other information, and analyze the overall situation of Internet diagnosis and treatment, Regularly feed back problems to each medical institution and its registration authority, and specify the rectification period. After receiving the problem feedback from the provincial health authority, the medical institution shall rectify in time, upload the rectification to the provincial supervision platform, and report to its registration authority at the same time.
Provinces where conditions permit are encouraged to set up rules for judging the rationality of Internet diagnosis and treatment in provincial regulatory platforms, and use emerging technologies such as artificial intelligence and big data for analysis and supervision.
Chapter V quality and safety supervision
*Article 26 * medical institutions conducting Internet-based diagnosis and treatment activities shall comply with relevant laws, regulations and provisions on medical quality, medical safety, network security and so on.
*Article 27 * medical institutions shall establish network security, data security, personal information protection, privacy protection and other systems, and sign agreements with relevant partners to clarify the rights and responsibilities of each party.
*Article 28 * in case of network security incidents such as the disclosure of patients' personal information and medical data, the medical institution shall timely report to the relevant competent departments and take effective countermeasures.
*Article 29 * medical institutions shall control the quality and safety of Internet diagnosis and treatment activities, and set up information feedback channels for the handling of patients' complaints.
*Article 30 * a medical institution shall establish a medical quality (safety) adverse event reporting system, designate a special department to be responsible for the collection, analysis and summary of medical quality (safety) adverse event reports, and encourage medical personnel to actively report adverse events.
*Article 31 * medical institutions shall strengthen the content management of Internet diagnosis and treatment information release to ensure that the information is legal, compliant, true and effective.
*Article 32 * local health authorities at all levels shall guide medical institutions to strengthen the management of medical quality and safety and achieve continuous improvement.
*Article 33 * provincial regulatory platforms and medical institutions used for Internet diagnosis and treatment platforms shall implement level 3 or above information security protection, and upload the evaluation results of such protection to the provincial regulatory platform.
Chapter VI Supervision Responsibility
*Article 34 * Internet hospitals that have obtained the practice license of medical institutions and have been set up independently shall bear legal liabilities according to law; When an entity medical institution takes the Internet hospital as its second name, the entity medical institution shall bear legal liabilities according to law. All parties to the Internet hospital cooperation shall bear corresponding legal liabilities according to the cooperation agreement.
*Article 35 * in the process of Internet diagnosis and treatment, medical institutions and medical personnel who violate laws and regulations such as the doctor law, the law on the prevention and control of infectious diseases, the law on traditional Chinese medicine, the regulations on the administration of medical institutions, the regulations on the handling of medical accidents, and the nurses' regulations shall be dealt with in accordance with relevant laws, regulations and provisions.
*Article 36 * medical institutions that have medical accidents or medical disputes in the course of carrying out Internet diagnosis and treatment activities shall be handled 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, regulations and provisions. The competent health department at or above the county level in the place where the medical institution is located shall perform the corresponding handling responsibilities in accordance with relevant laws and regulations.
*Article 37 * the provincial health authorities shall incorporate Internet diagnosis and treatment into the local medical quality control system, carry out online and offline integrated supervision, and ensure medical quality and safety.
Chapter VII supplementary provisions
*Article 38 * the state monitors and analyzes the data related to Internet diagnosis and treatment throughout the country through the information system.
*Article 39 * the provincial health authorities shall formulate implementation measures in accordance with these rules and in combination with local actual conditions.
*Article 40 * the state health commission shall be responsible for the interpretation of these rules.
*Article 41 * these Rules shall come into force as of the date of printing and distributing.