Jing Wei Yi [2023] No.104
District Health and Wellness Committees, Social Affairs Bureau of Beijing Economic and Technological Development Zone, and Municipal Health and Wellness Supervision Office:
The Interim Measures for the Record-keeping Management of Clinics in Beijing has been deliberated and adopted by the 15th Director’s Office Meeting of Beijing Municipal Health and Wellness Committee in 2023, and is hereby issued to you, please follow it.
Beijing Municipal Health and Wellness Committee
Beijing Municipal Administration of Traditional Chinese Medicine
November 14th, 2023
Interim Measures of Beijing Municipality on the Administration of Clinic Filing
Chapter I General Principles
Article 1 In order to do a good job in clinic filing management, these Measures are formulated in accordance with laws, regulations and provisions such as the Law of People’s Republic of China (PRC) on Basic Health Care and Health Promotion, the Law of People’s Republic of China (PRC) on Doctors, the Regulations on the Administration of Medical Institutions and the Interim Measures for the Administration of Clinic Filing.
Article 2 A clinic is a medical institution that provides outpatient diagnosis and treatment for patients. It mainly provides diagnosis and treatment services for common diseases and frequently-occurring diseases, and there is no inpatient bed (maternity bed). These Measures shall apply to clinics set up within the scope of this Municipality, excluding Chinese medicine clinics that are filed in accordance with the relevant provisions of the Interim Measures for the Administration of Filing of Chinese Medicine Clinics.
Article 3 The Beijing Municipal Health and Wellness Committee is responsible for guiding the filing management of general clinics, dental clinics and medical beauty clinics in all districts; The Municipal Bureau of Traditional Chinese Medicine is responsible for guiding the filing management of traditional Chinese medicine (comprehensive) clinics and integrated Chinese and Western medicine clinics in all districts; The health administrative departments of each district are responsible for the filing, supervision and management of general clinics, dental clinics, medical beauty clinics, traditional Chinese medicine (comprehensive) clinics and integrated Chinese and Western medicine clinics within their respective administrative areas.
Chapter II Case Preparation
Article 4 A unit or individual setting up a clinic shall report to the health administrative department of the district where the clinic is to be set up for the record, and can only carry out the practice activities after obtaining the record certificate of the clinic.
Article 5 The establishment of a clinic shall meet the following conditions:
(a) individuals who set up clinics must have been practicing in medical and health institutions for five years after registration; If the unit sets up a clinic, the main person in charge of the clinic shall meet the above requirements;
(two) in line with the basic standards of the clinic;
(3) The name of the clinic conforms to the Detailed Rules for the Implementation of the Regulations on the Administration of Medical Institutions and other relevant provisions;
(four) the clinic should be docked with the clinic information supervision platform where the filing organ is located, upload relevant information such as practice activities in time, and take the initiative to accept supervision;
(5) Being able to bear civil liability independently.
The Detailed Rules for the Implementation of the Regulations on the Administration of Medical Institutions stipulates that no unit or individual may apply for the establishment of a medical institution or set up a clinic.
Article 6 The filing of clinics in this Municipality shall be managed by electronic filing. If a clinic files a record, it shall submit the following materials through the electronic registration management platform:
(1) Basic information of clinic filing;
(two) the floor plan of the clinic house (referring to the scale of the house used by the clinic, indicating the functional distribution and area size);
(3) Property right certificate or lease contract of the clinic premises;
(four) the legal representative of the clinic, the main person in charge of the valid identity certificate and a copy of the relevant qualification certificate and practice certificate;
(5) Directory of other health technical personnel, valid identity certificates and copies of relevant qualification certificates and practice certificates (if the registration information of doctors and nurses submitted in the application materials is verified by the electronic registration system, it is not required to submit the relevant qualification certificates and practice certificates separately);
(6) rules and regulations of the clinic;
(7) List of clinic instruments and equipment;
(eight) the list of drugs attached to the pharmacy (cabinet);
(nine) the treatment plan of sewage, dirt and feces in the clinic, and the description of the surrounding environment of the clinic;
(10) Description of the information system of the clinic (including but not limited to the construction unit, project functions, hardware configuration, use process, etc., and whether it is connected to the supervision platform, etc.);
(eleven) the business license registration information of for-profit clinics (checked by the health administrative department through information sharing among government departments);
(12) Where a legal person or other organization sets up a clinic, it shall also provide the qualification certificate of the legal person or other organization, the identity certificate of the legal representative or the identity certificate of the representative of other organization.
Article 7 Filing persons shall truthfully provide relevant materials and reflect the real situation, and be responsible for the authenticity of the substantive contents of their filing materials. If the filer puts forward the need for on-site guidance of clinic practice before filing, the health administrative department may organize on-site guidance services of clinic practice according to the needs.
Eighth district health administrative departments after receiving the filing materials, the materials are complete and meet the filing requirements for the record, and the clinic filing vouchers are issued on the spot; If the materials are incomplete or do not meet the filing requirements, the filer shall be informed of all the materials that need to be supplemented at one time through the electronic registration system on the spot or within 5 days from the date of receiving the filing materials.
Article 9 A clinic shall publicize the clinic filing certificate and the practice registration information of health technicians in a prominent position in the clinic and accept social supervision.
Article 10 The name, address, legal representative or principal responsible person, ownership form, diagnosis and treatment subjects, service mode and other actual settings of the clinic shall be consistent with the items recorded in the clinic record voucher. If the above record information changes, it is necessary to apply to the original record-keeping organ for change through the electronic registration system.
After receiving the materials for filing changes, the health administrative departments of all districts shall make filing changes for those materials that are complete and meet the requirements for filing changes, and renew the changed clinic filing vouchers on the spot; If the materials are incomplete or do not meet the requirements for filing changes, the filer shall be informed of all the materials that need to be corrected at one time through the electronic registration system on the spot or within 5 days from the date of receiving the materials for filing changes.
Article 11 A clinic shall submit the following materials to the original filing organ through the electronic registration system when handling the change filing:
(1) Description of the matters to be changed for the record;
(two) to change the name of the clinic, the approval document or certificate issued by the competent unit of the clinic shall be submitted;
(three) to change the practice address, it shall submit the floor plan of the new address, the certificate of property rights and the lease contract;
(4) If the legal representative is changed, the identity certificate of the personnel shall be submitted; If the main person in charge is changed, the identity certificate, qualification certificate and practice certificate of the personnel shall be submitted;
(5) If the subject of diagnosis and treatment is changed, the floor plan of the clinic (indicating the location of the newly-added room for diagnosis and treatment), the list of health technical personnel who intend to practice in the subject of diagnosis and treatment, qualification certificates, practice certificates and valid identification certificates (if the registration information of doctors and nurses submitted in the application materials is verified by the electronic registration system, it is not required to submit the relevant qualification certificates and practice certificates separately), the equipment of the subject of diagnosis and treatment, and the list of relevant rules and regulations;
(6) If the number of dental chairs is changed, the design plan indicating the location of dental chairs, the list of health technical personnel to be practicing, qualification certificates, practice certificates and professional titles shall be submitted (if the registration information of doctors and nurses submitted in the application materials is verified by the electronic registration system, it is not required to submit the relevant qualification certificates and practice certificates separately), and the equipment;
(seven) the business license registration information of for-profit clinics (checked by the health administrative department through information sharing among government departments).
Twelfth clinics should carry out their practice activities in accordance with the requirements of the Regulations on the Administration of Medical Institutions and other relevant laws and regulations.
Thirteenth clinics closed, must be through the electronic registration system to the original filing authority for the record.
If the clinic is closed for more than one year due to reasons other than reconstruction, expansion or relocation, it shall be deemed as closed.
Fourteenth clinic filing vouchers shall not be forged, altered, sold, transferred or lent.
If the clinic filing certificate is lost, it shall be declared in time and apply to the original filing authority for a replacement.
Fifteenth clinics should carry out diagnosis and treatment activities according to the recorded diagnosis and treatment subjects, and strengthen the management of staff, diagnosis and treatment activities, medical quality and medical safety. The development of medical technical services shall comply with the relevant provisions of the Measures for the Administration of Clinical Application of Medical Technology.
The clinic shall not carry out medical activities without filing.
Sixteenth clinics should strictly abide by the "People’s Republic of China (PRC) Infectious Disease Prevention Law" and other laws and regulations on the prevention and control of infection in medical institutions.
Seventeenth clinics should establish an information system to record the diagnosis and treatment information, and submit and upload the diagnosis and treatment information to the local clinic information supervision platform in accordance with the provisions and standards of the urban health administrative department.
Chapter III Supervision and Administration
Eighteenth district health administrative departments should strengthen the supervision and management of clinic practice, medical quality, medical safety and so on. The health administrative department of each district shall, within 20 days from the date of issuing the clinic filing certificate, disclose the clinic filing information to the public through the official website of this district, so as to facilitate the inquiry and supervision of the society and the masses.
The health administrative departments of all districts shall promptly submit the filing information of clinics within their respective jurisdictions to the municipal health administrative department or the competent department of traditional Chinese medicine. If the municipal health administrative department or the competent department of traditional Chinese medicine finds that the filing matters do not conform to the provisions of the present measures, it shall order the district health administrative department to make corrections.
Nineteenth district health administrative departments shall conduct on-site verification (including the uploading of diagnosis and treatment data) within 30 days from the date of issuing the clinic filing certificate to the newly established clinics, and make rectification within 1-6 months if they do not meet the filing conditions. Refusing to make rectification within the time limit or failing to meet the requirements after rectification, the record shall be revoked and announced to the public in a timely manner.
Twentieth district health administrative departments should establish a clinic integrity file. The "Clinic Filing Voucher" obtained by the filer through filing is revoked due to violation of Article 19 of these measures, and will be recorded in the integrity file, which will be used as the basis for joint credit punishment of relevant departments.
Twenty-first district health administrative departments should make full use of information technology, big data and other means to improve the efficiency of supervision, and bring clinics into the medical quality management control system of their respective administrative areas to ensure the quality and safety of medical care.
Clinics should connect with the practice and service supervision platform of medical institutions in Beijing, upload relevant information such as practice activities in time, and take the initiative to accept supervision.
Article 22 The health administrative department of each district shall conduct on-site supervision and inspection on the clinics within its jurisdiction at least once a year, and conduct on-site inspection on the clinics whose practice address, diagnosis subjects, number of dental chairs and other items are changed within 30 days from the date of issuing or renewing the clinic filing vouchers, and conduct daily supervision and monthly practice analysis by using the information supervision platform, and form a supervision and analysis report on the practice activities of the clinics within its jurisdiction at least once every six months. District-level health administrative departments have the right to require clinics to provide materials needed for supervision, and clinics shall not refuse, conceal or conceal them.
Article 23 In the process of supervision and management, the urban health administrative department and the Municipal Bureau of Traditional Chinese Medicine find that there are illegal cases in the clinic, and they shall be punished and dealt with according to the People’s Republic of China (PRC) Physician Law, the Regulations on the Management of Medical Institutions, the Detailed Rules for the Implementation of the Regulations on the Management of Medical Institutions, and the relevant regulations on the management of bad practice points of medical institutions in Beijing.
Article 24 Under any of the following circumstances, the clinic shall report to the local health administrative department, or if the health administrative department and the competent department of traditional Chinese medicine find any of the following circumstances in the process of supervision and management, the original filing organ shall revoke its filing and make a timely announcement to the public:
(1) The clinic is closed;
(2) The clinic voluntarily terminates its practice activities;
(three) using false materials for the record;
(four) the occurrence of "Regulations on the Administration of Medical Institutions" and other laws and regulations should be ordered to stop practicing activities.
Article 25 Clinics should strengthen network security management and personal information protection in accordance with the Network Security Law of the People’s Republic of China, the Data Security Law of People’s Republic of China (PRC), the Personal Information Protection Law of People’s Republic of China (PRC), the Measures for the Administration of Network Security of Medical and Health Institutions and other relevant laws, regulations and provisions. When network security incidents such as personal information and medical data leakage of patients occur, they should promptly report to relevant departments and take effective countermeasures.
Twenty-sixth clinic practitioners should actively participate in professional and technical training, continuing education and other activities to improve the professional and technical level.
Twenty-seventh clinics should establish a sound management system for medical quality and medical safety, and strengthen the management of medical quality and medical safety.
Chapter IV Supplementary Provisions
Twenty-eighth district health administrative departments after the completion of the clinic record, should be through the electronic registration information system of medical institutions to print the "clinic record certificate", no longer issued the "practice license of medical institutions". Clinics that have previously obtained the Practice License of Medical Institutions shall be directly filed and renewed with the Certificate of Clinic Filing, with a transition period of one year. Newly filed clinics shall be filed in accordance with these measures and the latest version of the basic standards for clinics.
Clinics should comply with the relevant provisions of the electronic license work of medical institutions.
Twenty-ninth Sino foreign joint ventures, cooperative clinics, Hong Kong, Macao and Taiwan funded clinics management in accordance with the relevant provisions.
Thirtieth the time limit stipulated in these Measures shall be calculated in working days.
Thirty-first district clinics filing work should comply with the relevant provisions of the city’s "one industry and one license" and the relevant requirements of the list of prohibited and restricted new industries in Beijing.
Article 32 These Measures shall come into force as of December 31, 2023. "Notice of Beijing Municipal Health and Wellness Committee on Printing and Distributing the Administrative Measures of Beijing Clinics for Filing (Trial)" (Jing Wei Yi〔2021〕No.19) shall be abolished at the same time.