The 14th Five-Year Plan for Standardization of Health Care

The 14th Five-Year Plan for Standardization of health care

Standards provide technical support for economic activities and social development, and are a basic system for modernizing a country's system and capacity for governance. Health standards are the technical guarantee for implementing health laws and regulations, implementing health policies and plans, and safeguarding people's health and life safety. The plan is formulated in accordance with the Standardization Law, the 14th Five-Year Plan for National Economic and Social Development and the Outline of the 2035 Vision Goals, the Outline of the Healthy China 2030 Plan and the National Outline of Standardization Development, in order to use standardization to help implement the Healthy China Strategy and actively respond to the National Strategy of aging population.

1. Planning background

During the 13th Five-Year Plan period, Chinese health standardization has developed rapidly, the standard system has formed, the standard management system has been gradually improved, the standard quality has been continuously improved, and the field of standardization has been expanding. In 2019, the NHC established the eighth National Committee on Health Standards. It has 21 standard specialties, including health information, medical and health construction equipment, infectious diseases, parasitic diseases, endemic diseases, nutrition, environmental health, school health, health pest control, medical institution management, medical services, hospital infection control, nursing, clinical examination, blood, grass-roots health, disinfection, geriatric health, maternal and child health, occupational health, radiation health and so on The committee. It has successively issued the Constitution of the National Health Standards Commission, the Measures for the Management of Health Standards and other standard management systems. During the 13th Five-Year Plan period (2016-2020), the NHC issued 597 health standards, which have been widely used in supervision and law enforcement, business guidance, technical services, and safety assurance. At the same time, the NHC launched the evaluation of the implementation of mandatory standards and important recommended standards.

Local standards in the field of health have been steadily developed, and 14 provincial-level administrative regions and three prefecture-level administrative regions have set up local technical committees for health standardization. Group standards are on the rise and have been formally incorporated into law. Nearly 100 social organizations in the health sector have launched group standardization work and released more than 1,000 group standards, which have proved effective in leading technological innovation and promoting high-quality development.

Various health standards have played an important technical supporting role in the prevention and control of the COVID-19 epidemic, the prevention of major diseases, the patriotic health campaign, the improvement of the quality of medical services, the improvement of people's health, and the promotion of health information connectivity.

In the period of the 14th Five-Year Plan, based on the new development stage, implementing the new development concept, building a new development pattern and promoting high-quality development, new demands are put forward for the standardization of health care. To comprehensively promote the building of a healthy China, implement the national strategy of actively responding to an aging population, and coordinate regular epidemic prevention and control as well as economic and social development, we need to give full play to the role of standards in guiding, regulating, supporting, guaranteeing and connecting the epidemic, uphold the bottom line of safety with strict standards, improve quality with high standards, and provide all-round, full-cycle health services to the people.

2. General requirements

(1) Guiding ideology.

 We will improve the system of health and health standards, improve the whole-cycle management of standards, increase the supply of quality standards, vigorously promote the implementation of standards, and constantly increase the voice of standards in the world, thus providing standardization support for the building of a healthy China.

(2) Basic principles.

Adhere to demand guidance. In order to comprehensively promote the building of a healthy China, we will closely combine the major strategies and arrangements for health work, take business work and the actual needs of the community as the guide, scientifically plan the layout of the health standards system, reasonably determine key areas of standards, increase the effective supply of standards, and constantly adapt to changes in standards demand.

Insist on quality first. Focusing on improving quality, we will continue to improve the management system, promote the transformation of standards from quantity and scale to quality and efficiency, optimize the structure of standards, raise the efficiency of standard setting, and achieve the unity of the quantity, quality, structure and efficiency of standards.

Adhere to the use of the first. We will attach equal importance to the formulation and implementation of standards, take multiple measures to promote the implementation and evaluation of standards, encourage institutions at all levels and of all types to widely implement the concept of standardization, and foster a sense of awareness and code of conduct in managing and acting in accordance with standards.

Be inclusive and open. We will mobilize the enthusiasm and initiative of all sectors of society to participate in the standardization of health care, and promote the coordinated development of various standards. We will continue to open up to standards and institutions, promote international exchanges and cooperation on standards, coordinate efforts to bring them in and go global, and use health standards to help build a community of health for all.

(3) Development goals.

By 2025, a system of health standards with Chinese characteristics that strongly supports the building of a healthy China will be basically in place. The foundation of health standardization has been strengthened, institutions and mechanisms have become more sound, the standard system has been further improved, and the situation of multi-channel supply and coordinated development of standards has basically taken shape. The application and implementation of standards has become more extensive, and the standardization of health services has been continuously improved, and the international influence of health standards has been significantly enhanced.

3. Main tasks

(4) Optimize the standard system.

Based on general health and general health, we will establish a system of "general standards" centered on people's health, and coordinate the coordinated development of national, industrial, local and corporate standards in accordance with the requirements of reasonable structure, systematic coordination, connectivity and comprehensive coverage. In accordance with the Standardization Law and the relevant provisions of The State Council on compulsory standards, we have accurately understood the positioning and scope of the bottom line and safety of compulsory health standards. We will appropriately control the number of government-recommended standards, focus on basic, universal and non-profit standards, clear up overlapping standards, and appropriately integrate and improve the coverage of individual standards. During the 14th Five-Year Plan period, no less than 100 national and industrial health standards were revised. Local governments give priority to formulating local standards that reflect local characteristics and meet local needs. Encourage and guide the development of group standards, enhance the vitality of standards, meet the market and innovative development of standards demand. We will establish a system of standards for coordinated development of health care, in which mandatory standards are safe, recommended standards are basic, local standards show distinctive features, and collective standards take the lead, to ensure that the system is systematic, integrated, and coordinated.

(5) Improve standard full-cycle management.

Improve the work procedures, strengthen the health standards of the whole process management. We will strengthen the foundation for preliminary research on standards. The establishment of major standards needs to be supported by basic research data, and priority will be given to translating research results into standards. Strict standard project, ensure the annual plan and long-term planning and standard system coordination, select the best standard undertakers. We will intensify training of standard drafters. We strengthened supervision over standard projects and properly controlled the period for setting standards, shortening the period by an average of six months from that of the 13th Five-Year Plan period. We will make the solicitation of opinions more extensive and representative. We will strengthen review of standards to ensure that technical content is scientific, rational and operable. We will implement standards review requirements, promptly revise or repeal outdated standards, and make them more timely, targeted, and effective. To ensure the implementation of health standards, especially mandatory standards, evaluate the implementation of no less than 50 important standards, establish relevant databases, and provide important basis for the review and revision of standards. All the data from the project establishment to the implementation of the standards will be incorporated into the health standard management information system to realize the whole-cycle information management of the standards.

6) Promoting local standardization.

We will revise relevant systems, clarify the responsibilities and tasks of local health institutions at all levels and of all types in their standardization work, and focus on strengthening the implementation of national and industrial standards at the local level. Local governments are encouraged to set up technical committees for health standardization, assist local health administrative departments to publicize and implement national and industrial standards, undertake the revision of local standards, and actively participate in the soliciting of opinions, feedback of information, and evaluation of implementation of national and industrial standards. During the 14th Five-Year Plan period, China set up a health standardization working mechanism and a team of experts at all provincial-level levels. We will encourage the Beijing-Tianjin-Hebei region, the Yangtze River Delta and other regions to jointly formulate and publish local health standards with regional characteristics, and promote the standardization and homogenization of health work in their own regions. We will promptly transform local standards that are applicable throughout the country and have popularizing value into national or industrial standards.

(7) Encourage the development of group standards.

Social organizations in the field of health care, such as societies and associations, are encouraged to meet the needs of practice and innovation, focus on new technologies, new business forms and new models, and play a leading role in innovation and industry self-discipline through the formulation of group standards. We will encourage the formulation and implementation of group standards that are higher than national and industrial standards to promote high-quality development of medical and health services. We will support social organizations in participating in the drafting of international standards, and develop international standards that are at the leading level. We will encourage multiple social organizations to jointly publish corporate standards and reduce cross-duplication of corporate standards. Social organizations shall formulate organizational standards in accordance with laws and regulations and relevant state policies. The health administrative departments at all levels shall guide and supervise the group standards issued by social organizations within their jurisdiction, and promptly accept, evaluate and correct the group standards reported by the public that violate laws, regulations and industrial policies. To organize the evaluation of group standards in the field of health, implement the training plan of group standards, promote the application demonstration of group standards, and select innovative, advanced and international group standards for key promotion. To create a good policy environment for the development of group standards, support the health administration departments to use appropriate group standards in the work of policy formulation, guidance and supervision, review and evaluation, bidding and procurement, etc.

(8) Improve the internationalization of standards.

To carry out research on the strategy and mechanism of internationalization of health standards, and grasp the standard demand in the new international situation. We will intensify the dynamic tracking and evaluation of international health standards, and speed up the adoption of international standards suitable for our national conditions. Actively participating in standardization activities of international organizations such as the International Organization for Standardization and the World Health Organization. We will take advantage of the Belt and Road Initiative to explore exchanges and cooperation on health standards with countries along the Belt and Road. We encourage health experts and institutions to promote China's health standards on such platforms as international academic forums. We will foster, develop and promote the transformation of Chinese standards that meet international application needs into international standards, and work with other countries to build an international health standards system and contribute to the building of a community of human health.

(9) Promoting standardization across the board.

Popularize the concept of standardization in the whole health industry, establish the awareness of standardization, improve the enthusiasm, initiative and creativity of the use of standards, and form a good atmosphere for the whole industry to learn standards, abide by standards, apply standards and implement standards. Make full use of the Internet remote platform to improve the efficiency of standard publicity and practice training and cover the population. New media means such as wechat public account, micro video, MOOCs and other means are adopted to improve the awareness rate and publicity effect of health standards. Carry out pilot projects of health standards, promote the promotion of standardization concept through typical experience, and take standards as the basis and means to improve management level, carry out technological innovation, improve service quality and ensure safe development. Carry out standardization publicity in an all-round and multi-channel way, tell standardization stories well, and cultivate and develop standardization culture in the whole industry.

4. Key areas

(10)Building a strong public health system through standardization.

We will give priority to prevention, and set standards for monitoring and early warning, testing and diagnosis, control and elimination, and effectiveness evaluation of infectious, parasitic, endemic and other major diseases that seriously affect people's health. Research has been carried out to standardize the prevention of chronic diseases, early screening and comprehensive intervention. We will improve the standard system for mental health and mental health services, and explore ways to establish a standard system for injury prevention. It has actively developed standards for the construction of CDC, laboratory equipment configuration and laboratory management of CDC.

We will study and establish an emergency response standard system to improve the ability and level of response to public health emergencies in a standardized way, and formulate technical standards for the prevention of infectious diseases and disasters and accidents, emergency preparedness, monitoring, response, handling and emergency drills. We will promote coordination between medical and preventive care, improve the construction standards of infectious disease prevention and treatment facilities in general hospitals, improve emergency medical treatment reserve capacity, and strengthen the standardization of fever clinics in medical institutions. Cooperate with relevant departments to study the standardization interface and standardization process of integrated renovation of large-scale public building facilities.

(11) Standardization leads the high-quality development of medical and health services.

Establish a standard system to promote the high-quality development of public hospitals. We will improve the standard system of medical and health services, promote the expansion, sinking and balanced distribution of high-quality medical resources through standardization, and strengthen the standardization of facilities and equipment in county-level hospitals. To improve the scientific, standardized and refined level of hospital management by standardization. We will continue to improve medical quality standards and make medical services more homogeneous in different regions and hospitals.

We will strengthen the standardization of community-level medical and health institutions, improve the standardization of community-level medical and health services, and improve community-level capacity for integrated prevention and treatment and health management.

We will develop standards for day service and multi-disciplinary joint diagnosis and treatment, and promote innovation in medical service models. We will strengthen the formulation of hospital information standards to help build telemedicine and smart hospitals. To unify clinical testing standards and promote mutual recognition of test results. Standardized means to facilitate the development of high quality nursing. We will strengthen the standardization of hospital infection control and blood safety to ensure medical safety. Promote the standardized mode of pre-hospital medical emergency, and improve the capacity of pre-hospital medical emergency services. Standardize drug supply and use management, and formulate pharmaceutical standards, drug application coding standards, drug use monitoring guidelines, drug clinical comprehensive evaluation guidelines and data set standards. We will formulate referral standards for common diseases and promote graded diagnosis and treatment. To explore and promote the formulation of technical standards for human biological samples in medical and health institutions.

(12) Promoting the patriotic health campaign through standardization.

To strengthen the standardization of public health and environmental infrastructure, with the goal of promoting urban and rural sanitation improvement, speed up the formulation of standards for environmental sites and environmental media, and improve environmental health investigation and monitoring standards and environmental health risk assessment standards. We will formulate technical standards for the prevention and control of health pests, strengthen vector prevention and control, and support vector risk assessment, green control and the construction of beautiful villages. To develop disinfection standards related to risk control of infectious disease transmission, so as to provide scientific basis for guiding relevant places to carry out accurate disinfection during infectious disease epidemics. Conduct research on standardization of health promotion, formulate technical standards for health promotion at appropriate times, strengthen health education, popularize health knowledge, and guide good behavior and lifestyle.

(13) Promoting the health of key groups through standardization.

We will provide comprehensive life-cycle health services to the people based on health standards. With the focus on improving the quality of births, we will improve the full range of services for healthy and healthy births, strengthen pre-pregnancy and perinatal health services, and explore the development of premarital and pre-pregnancy health standards, as well as pregnancy and perinatal health standards. We will implement active maternity support measures, improve the standard system of infant care services, improve the formulation of standards for the quality, evaluation and supervision of childcare services, and strengthen the implementation and promotion of these standards. To ensure the health of minors, China has formulated health standards for children and students, focusing on the prevention and control of myopia in children and adolescents, obesity intervention, and nutrition standards for students. We will improve the occupational health standard system, study and formulate diagnostic criteria for diseases newly included in the Classification and Catalogue of Occupational Diseases, and establish standards for the prevention and control of occupational hazards in key industries. To accelerate the revision of the standards for occupational health limits and detection methods. Standardizing the prevention and control of occupational radiation diseases and the prevention and control of health hazards caused by ionizing radiation. We will improve the supply of health services for the elderly by means of standardization, improve the standards of old-age care, hospice care and other health services for the elderly, improve the standards of social support for the elderly and the combination of medical and nursing care for the elderly, and consolidate the basic standards of health care for the elderly. We will formulate and improve dietary guidelines for different populations and nutritional guidelines for the prevention and control of diet-related non-communicable chronic diseases.

(14)Supporting the innovation and development of health services through standardization.

Follow up the development of relevant standards for new technologies, new products and new services in the health field in a timely manner to meet the demand for standards for emerging business forms such as Internet health services, fitness and leisure, health management, smart health products and services, and health and medical tourism.

We will improve the standard system of health information, improve the formulation of six information standards, namely basic, data, application, technology, management, security and privacy, and focus on two key business standards, namely regional national health informatization with residents' electronic health records as the core and hospital informatization with electronic medical records as the core. We will promote the supply of convergence standards between the Internet, big data, artificial intelligence, blockchain, 5G, Internet of Things, IPv6 (Internet Protocol Version 6) and other emerging information technologies and the health industry. We will strengthen the evaluation of the effectiveness of the application of health information standards, and promote information sharing, mutual recognition and interconnection. The overall level of informatization construction of regional and medical institutions was evaluated based on the evaluation of the standardization maturity of national medical and health information connectivity.

(15) Ensure the safe development of health services through standardization.

To formulate laboratory biosafety standards and strengthen the management of pathogenic microorganism laboratory biosafety. In combination with the prevention and control situation of infectious diseases in recent years and the construction and development of pathogenic microbiology laboratory, the biosafety standard system of pathogenic microbiology laboratory is established to ensure the biosafety of the laboratory, aiming at the risk assessment, biosafety and security, experimental activities, facilities and equipment of pathogenic microbiology laboratory such as bacteria, viruses, fungi and parasites. To provide technical support and guarantee for prevention and control of infectious diseases. We will work well to formulate and implement major safety-related standards such as fire control, security check and radiological protection in medical and health institutions. We will strengthen the development of health cyber security standards.

5. Safeguard measures

(16)Strengthen organizational leadership.

 Designate departments to undertake standardization tasks. We will strengthen the construction of professional standards committees and adjust the setting of professional committees according to work needs. Each standard professional committee may formulate the professional development plan according to this plan to ensure the implementation of this plan.

(17)Strengthening institutional development.

We will strictly implement the Standardization Law and a series of national management systems on standards, and strengthen research on theories and management strategies of health standardization. In the aspects of project approval, drafting, examination and local standardization of health standards, timely revise and improve relevant systems according to practical experience and problems found in the work. In the areas of pilot health standardization, implementation of standards, review of standards, and management of group standards, effective practices will be formed and solidified in a timely manner, and the health standards system will continue to mature and finalize.

(18)Strengthening personnel development.

We will strengthen the management, development and application of health standards, as well as the construction of talents for international standardization, and raise the level of technical personnel for revising standards, reviewing standards and applying standards. The research and development of standards will be included in the policy of professional title evaluation and talent reward, and the enthusiasm of scientific researchers to participate in standardization work, especially international standardization work will be aroused. Establish and implement performance evaluation and reward and punishment mechanisms for members, and implement dynamic management for members. We have continuously enriched and improved the team of experts on health standards, and established a database of dynamic experts in various specialties to better serve the standardization of health.

(19)Increasing funding.

We will establish a sustainable and stable funding mechanism for health standards, with a focus on supporting the revision, publicity and implementation of the major standards identified in this Plan. We will strictly manage expenditures on health standards and improve their efficiency.