On November 1, 2024, the National Health Commission, the Ministry of Commerce, the National Administration of Traditional Chinese Medicine and the National Disease Control Bureau jointly announced the "Pilot Work Plan for Expanding Opening-up in the Field of Sole Proprietorship Hospitals." we are sharing the highlights of the plan as follows:
* Pilot Tasks
Foreign-funded sole proprietorship hospitals (excluding traditional Chinese medicine categories and not including the acquisition of public hospitals) are allowed to be established in Beijing, Tianjin, Shanghai, Nanjing, Suzhou, Fuzhou, Guangzhou, Shenzhen, and the entire Hainan Island.
* Requirements
(1) Investor.
Overseas investors applying for the establishment of foreign-funded sole proprietorship hospitals should be legal persons capable of bearing civil liability independently, with experience in investment and management in the field of medical and health, and meet the following conditions:
1. Able to provide internationally advanced hospital management concepts, models, and service models;
2. Able to provide medical technology and equipment at the international leading level;
3. Capable of complementing or improving local deficiencies in medical service capacity, medical technology, and medical facilities, and expanding a diversified service supply pattern.
(2) Establishment and Operation Requirements.
Foreign-funded sole proprietorship hospitals should be established and operated in accordance with the "Basic Medical and Health Promotion Law of the People's Republic of China," "Biological Safety Law of the People's Republic of China," "Data Security Law of the People's Republic of China," "Regulations on the Administration of Medical Institutions," "Regulations on the Administration of Human Genetic Resources of the People's Republic of China," and other laws and regulations, and meet the following conditions:
1. The hospital's operation nature can be for-profit or non-profit;
2. The hospital category is comprehensive hospitals, special hospitals, rehabilitation hospitals, with a hospital level of grade three, and it is not allowed to establish psychiatric hospitals, infectious disease hospitals, hematological hospitals, traditional Chinese medicine hospitals, integrated hospitals of traditional Chinese and Western medicine, and ethnic medicine hospitals;
3. The hospital's diagnostic subjects shall not register hematology;
4. The hospital shall not carry out medical and ethical high-risk diagnostic and treatment activities, mainly including: human organ transplantation technology, human assisted reproductive technology, prenatal screening and prenatal diagnosis technology, psychiatric inpatient treatment, tumor cell treatment new technology pilot treatment, etc.;
5. Foreign physicians, Hong Kong and Macao and Taiwan physicians, and other health professional technical personnel from Hong Kong and Macao are allowed to be employed according to regulations for short-term practice, and the proportion of Chinese (mainland) personnel in the hospital's management and health professional and technical personnel shall not be less than 50%;
6. The hospital's information management system should be connected to the local medical service supervision platform, and the information storage server for electronic medical records and medical equipment should be located within the territory of China;
7. Hospitals that meet the regulations of medical insurance can apply for inclusion in the designated medical insurance institutions according to procedures. At the same time, support hospitals to dock with domestic and foreign commercial health insurance.
* Management Measures
Local health and health administrative departments should legally fulfill the entry and post-event management responsibilities for foreign-funded sole proprietorship hospitals. Foreign-funded sole proprietorship hospitals should carry out diagnostic and treatment activities according to the law and strengthen self-management.
(1) Access Management.
The approval for the establishment and practice registration of foreign-funded sole proprietorship hospitals shall be preliminarily reviewed by the municipal health and health administrative department and reported to the provincial health and health administrative department for review. Those who meet the conditions will be issued a certificate of approval for the establishment of medical institutions and a medical institution practice license by the provincial health and health administrative department. The handling process, application materials, and processing period for the establishment approval and practice registration shall refer to the "Interim Measures for the Management of Sino-foreign Joint Venture and Cooperative Medical Institutions" and the "Notice of the Ministry of Health on Adjusting the Approval Authority of Sino-foreign Joint Venture and Cooperative Medical Institutions." The validity period of the medical institution practice license for foreign-funded sole proprietorship hospitals is 5 years, and it can apply for renewal according to regulations before the expiration of the validity period. Those who meet the conditions will be issued a new medical institution practice license.
(2) Practice Management.
Health and health administrative departments should include foreign-funded sole proprietorship hospitals in the scope of medical quality safety management and encourage them to participate in hospital evaluation. Foreign-funded sole proprietorship hospitals should manage and operate according to Chinese laws and regulations and carry out diagnostic and treatment activities in accordance with clinical diagnosis and treatment guidelines, clinical technical operation standards, industry standards, and medical ethics norms.