Shulou(Shulou.com)11/24 Report--

CTOnews.com, August 21, according to the Beijing Daily, the Beijing Municipal Health Commission recently led the formulation of the Beijing Municipal measures for the Supervision of Internet diagnosis and treatment (trial), and openly solicited opinions from the public. The public can give feedback to the Municipal Health Commission before September 16.

Picture source Pixabay according to measures: medical institutions to carry out Internet diagnosis and treatment activities to strengthen drug management, the use of artificial intelligence and other automatic generation of prescriptions, it is strictly forbidden to provide drugs to patients before prescriptions are issued.

The full text of the draft for soliciting comments is attached to CTOnews.com:

Measures of Beijing Municipality on the Supervision of Internet diagnosis and treatment (for trial implementation)

Chapter 1   General   Article 1   in order to further standardize Internet diagnosis and treatment activities and strengthen Internet diagnosis and treatment supervision, according to laws, regulations and regulations such as basic Medical Health and Health Promotion Law, traditional Chinese Medicine Law, Medical Institution Administration regulations, Internet diagnosis and treatment Administration measures (trial), Internet Hospital Administration measures (trial), Internet diagnosis and treatment Supervision rules (trial), etc. These measures are formulated in the light of the actual conditions of Beijing.

Article 2 these measures of   shall apply to the supervision of medical institutions in Beijing to carry out Internet diagnosis and treatment activities in accordance with the measures for the Administration of Internet diagnosis and treatment (trial) and the measures for Internet Hospital Administration (trial).

Article 3 the Beijing Municipal Health Commission and the Beijing Municipal Administration of traditional Chinese Medicine shall be responsible for the supervision of Internet diagnosis and treatment throughout the city. The health and health administrative departments of each district shall implement the responsibility of localized supervision and be responsible for the supervision and management of Internet diagnosis and treatment activities within their jurisdiction.

Chapter II Supervision of   Medical institutions Article 4   Beijing Municipal Health Commission establishes a Beijing Internet diagnosis and treatment supervision platform (hereinafter referred to as "Beijing Supervision platform") to supervise medical institutions that carry out Internet diagnosis and treatment activities.

Article 5   medical institutions shall take the initiative to dock with the Beijing regulatory platform, upload and update relevant practice information such as the practice license of Medical institutions in time, and take the initiative to accept supervision.

Article 6  , as the second name of the Internet hospital of the entity medical institution, shall be checked at the same time as the entity medical institution; the Internet hospital that relies on the entity medical institution to obtain the practice license of the medical institution shall be checked once a year. The docking and data submission between medical institutions and Beijing regulatory platform shall be included in the verification content.

Article 7   medical institutions shall set up special departments to be responsible for the management of medical quality, medical safety, pharmaceutical care and information technology of Internet diagnosis and treatment, and establish corresponding management systems. Including but not limited to the legal practice self-examination system of medical institutions, the medical quality and safety management system related to Internet diagnosis and treatment, the medical quality (safety) adverse event reporting system, the training and assessment system of medical personnel, the informed consent system of patients, prescription management system, electronic medical record management system, information system use management system and so on.

Article 8   medical institutions shall publish information such as electronic certificates of medical personnel providing Internet diagnosis and treatment services in a prominent position on the Internet diagnosis and treatment platform, so as to facilitate patients' inquiry.

Article 9   medical institutions shall fully inform patients of the rules, requirements and risks related to Internet diagnosis and treatment, and obtain the informed consent of patients before they can carry out Internet diagnosis and treatment activities.

Article 10 the administrative department of health in the urban area of   shall promptly publish to the public the names, service entrances, supervision telephones or other supervision methods of medical institutions and Internet hospitals that have approved the development of Internet diagnosis and treatment according to their limits of authority, and promptly accept and deal with violations of laws and regulations.

Article 11 the   urban health administrative department shall, in accordance with the detailed rules for the Supervision of Internet diagnosis and treatment (for trial implementation), 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 Supervision of   personnel Article 12   medical institutions shall carry out real-name authentication of medical personnel who carry out Internet diagnosis and treatment activities to ensure that medical personnel have legal qualifications.

Article 13 in carrying out Internet diagnosis and treatment activities,   doctors shall obtain corresponding professional qualifications in accordance with the law, have more than 3 years of independent clinical work experience, and shall be approved by the medical institutions in which they practice and register.

If medical personnel carry out Internet diagnosis and treatment activities in Internet hospitals other than the main practice institution, they shall carry out multi-agency record or practice registration in accordance with the relevant requirements of the state and this city.

Article 14 doctors shall carry out real-name authentication before receiving medical treatment to ensure that diagnosis and treatment services are provided by themselves. Other personnel and artificial intelligence software shall not falsely use or replace the doctor himself to provide diagnosis and treatment services. The administrative department of health at the district level shall be responsible for supervising the personnel of medical institutions within their jurisdiction who carry out Internet diagnosis and treatment.

Article 15   medical institutions shall upload the information of medical personnel carrying out Internet diagnosis and treatment activities to the Beijing Municipal Supervision platform, including ID card numbers, photos, relevant qualifications, place of practice, practice institutions, scope of practice, clinical work years and other necessary information. The supervision platform of Beijing should be connected with the electronic registration system of doctors and nurses, and the information of pharmacists should be uploaded to the supervision platform and can be queried.

Article 16 Medical institutions shall establish an assessment mechanism for medical personnel who carry out Internet diagnosis and treatment activities, assess according to the contents of legal practice, medical quality, medical safety, medical ethics and satisfaction, and establish access and exit mechanisms.

Article 17   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 procedures, use of the platform and emergency handling, etc.

Chapter IV   Business Supervision Article 18   Internet diagnosis and treatment shall implement the real-name system, and medical institutions shall inform patients that they have the obligation to provide real identity certificates and basic information to medical institutions, and shall not impersonate others to see a doctor.

Article 19 when seeking medical treatment, patients with   shall provide medical records with clear diagnosis, such as outpatient medical records, in-patient medical records, discharge summary, diagnosis certificate, etc., and the receiving physician shall retain the relevant data and judge whether they meet the conditions for revisit.

Medical institutions shall clearly define the conditions for the termination of Internet diagnosis and treatment. When the patient's condition changes, this visit is judged by the doctor as the first visit, or there are other situations 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 a physical medical institution.

Article 20 in carrying out Internet diagnosis and treatment activities,   medical institutions shall establish electronic medical records for patients in accordance with the requirements of relevant documents such as the regulations on the Management of Medical Records in Medical institutions and the Standards for the Application and Management of Electronic Medical Records (trial). The resulting electronic medical record information should be consistent with the format of the electronic medical record of the relying entity medical institutions and be systematically shared, and the relying entity medical institutions shall carry out online and offline integrated quality control.

Internet diagnosis and treatment medical records shall be managed in accordance with the relevant provisions of outpatient electronic medical records, and shall be kept for no less than 15 years. The recording time of picture-text dialogue, audio and video materials in diagnosis and treatment shall not be less than 3 years.

Article 21 when a   Internet hospital changes its name, the medical records and other data and information kept shall be kept by the changed Internet hospital.

After the cancellation of the Internet hospital, the medical records and other data and information kept by the relying entity medical institutions will continue to be kept. After the cancellation of the physical medical institution it relies on, it may be properly kept by the Beijing Municipal Health Commission or the institution designated by the Beijing Municipal Health Commission in accordance with the relevant provisions.

Article 22 when conducting Internet diagnosis and treatment activities, medical institutions shall strictly abide by the regulations such as the measures for the Administration of prescriptions, and strengthen the administration of drugs. The prescription shall be written by the receiving physician himself and will only take effect after being examined and approved by the pharmacist. it is strictly forbidden to use artificial intelligence to generate the prescription automatically. Prescription drugs shall be sold, dispensed and used on the basis of a doctor's prescription. It is strictly forbidden to provide drugs to patients before the prescription is issued. It is strictly forbidden to govern the party for commercial purposes.

Article 23 where a   medical institution carries out drug distribution by itself or entrusts a third party, the relevant agreements and prescription circulation information shall be traceable, and the data interface shall be opened to the Beijing Municipal Supervision platform.

Article 24 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' inquiry.

Article 25   medical institutions shall consciously strengthen the construction of their work style and strictly implement the relevant provisions such as the Nine guidelines for honest practice of staff of Medical institutions. The personal income of medical personnel shall not be linked to drug income. It is strictly forbidden to refer patients or purchase drugs and consumables at designated places for the purpose of seeking personal interests.

Article 26 Medical institutions shall ensure that the whole process of Internet diagnosis and treatment activities is traceable and traceable, and open data interfaces to the Beijing Municipal Regulatory platform. The Beijing Municipal Health Committee collects the relevant data of medical institutions in strict accordance with the principle of minimum availability, focusing on the qualifications of medical institutions, medical personnel, subjects of diagnosis and treatment, types of diagnosis and treatment, electronic medical records, electronic prescriptions, drug use, satisfaction evaluation, patient complaints, medical quality (safety) adverse events and other information. set the rules for judging the rationality of Internet diagnosis and treatment in the Beijing regulatory platform Use artificial intelligence, big data and other emerging technologies to carry out analysis and supervision, and analyze the overall situation of Internet diagnosis and treatment, regularly feedback problems to various medical institutions and their registration authorities, and define the time limit for rectification and reform. Medical institutions shall promptly rectify the situation after receiving feedback from the Beijing Municipal Health Commission, and upload the rectification situation to the Beijing Municipal Supervision platform and report to its registration authority at the same time.

Chapter V   quality and Safety Supervision Article 27   medical institutions shall abide by medical quality, medical safety, network security and other relevant laws, regulations and regulations when conducting Internet diagnosis and treatment activities.

Article 28   medical institutions shall establish systems such as network security, data security, personal information protection and privacy protection, and sign agreements with relevant partners to clarify the rights and responsibilities of all parties.

Article 29 in case of network security incidents such as the leakage of patients' personal information and medical data,   medical institutions shall promptly report to the relevant competent departments and take effective measures.

Article 30   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 31   medical institutions shall designate special departments to be responsible for the collection, analysis and summary of reports on adverse events of medical quality (safety), and encourage medical personnel to actively report adverse events.

Article 32   medical institutions shall strengthen the content management of the release of diagnosis and treatment information on the Internet, so as to ensure that the information is legal, compliant, true and effective.

Article 33 the health administrative departments at the municipal and district levels of   shall guide the medical institutions within their jurisdiction to strengthen the management of medical quality and safety so as to achieve continuous improvement.

Article 34 the   Beijing regulatory platform and the Internet diagnosis and treatment platform used by medical institutions shall implement the third level and above information security level protection, and upload the evaluation results to the Beijing regulatory platform.

Chapter VI   Supervision responsibility Article 35 Internet hospitals that   has obtained the practice license of medical institutions and set up independently shall bear legal liability according to law; when the second name of an entity medical institution is an Internet hospital, the entity medical institution shall bear legal liability in accordance with the law. The cooperation parties of the Internet hospital shall bear the corresponding legal responsibilities in accordance with the law and regulations in accordance with the cooperation agreement.

Article 36 in the course of diagnosis and treatment on the Internet,   medical institutions and medical personnel who violate the Law on doctors, the Law on Prevention and treatment of Infectious Diseases, the Law on traditional Chinese Medicine, the regulations on the Administration of Medical institutions, the regulations on the Prevention and handling of Medical disputes, and the regulations on Nurses shall be dealt with in accordance with relevant laws and regulations.

Article 37 if medical accidents or medical disputes occur in   medical institutions in the course of carrying out Internet diagnosis and treatment activities, they shall be dealt with in accordance with the regulations on the Prevention and handling of Medical disputes and other relevant laws and regulations. The health administrative department at the district level where the medical institution is located shall perform the corresponding handling responsibilities in accordance with relevant laws and regulations.

Article 38 the health administrative departments at the municipal and district levels of   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 safety.

Chapter VII   with   rules

Article 39   medical institutions shall provide medical and health information services other than diagnosis and treatment activities to patients through the Internet diagnosis and treatment platform, such as medical navigation, registration appointment, report inquiry, live broadcast of public welfare, provision of documents, etc., which shall be carried out in accordance with the relevant provisions of the State and shall not fall within the scope of supervision of these measures.

Article 40 the interpretation of these measures of   shall be vested in the Beijing Municipal Health Commission.

Article 41 these measures of   shall enter into force as of the date of issuance.

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