Guiding Opinions of Promoting and Regulating the Application and Development of Big Data in Health and Medical Care

 2018-08-05  50



  • Document NumberNo. 47 [2016] of the General Office of the State Council
  • Area of Law Health and Sanitation Big Data Post and Telecommunications
  • Level of Authority Regulatory Documents of the State Council
  • Date issued06-21-2016
  • Effective Date06-21-2016
  • Issuing Authority General Office of the State Council
  • Status Effective



Guiding Opinions of the General Office of the State Council on Promoting and Regulating the Application and Development of Big Data in Health and Medical Care
(No. 47 [2016] of the General Office of the State Council)
The people's governments of all provinces, autonomous regions, and municipalities directly under the Central Government; all ministries and commissions of the State Council; and all institutions directly under the State Council:
Big data in health and medical care is the important, fundamental and strategic resource of the state. The application and development of big data in health and medical care is to bring profound changes to the health and medical care mode, is helpful to trigger and deepen the motivation and vigor for the reform of the medicine and health system, improve the efficiency and quality of health and medical care service, expand resource supply, and constantly satisfy the multiple-layer, diversified need of the people for health, and is helpful to foster new business types and economic growth points. For the purpose of implementing the requirement of the Notice of the State Council on Issuing the Action Plan for Promoting the Development of Big Data (No. 50 [2015], State Council), following the development trend of emerging information technology, and regulating and promoting the integration, sharing and open application of big data in health and medical care, with the approval of the State Council, the following opinions are hereby offered.
I. Guidelines, basic principles and development goals
(1) Guiding thought. The spirit of the 18th National Congress of the Communist Party of China (CPC) and the Third, Fourth, and Fifth Plenary Sessions of the 18th CPC Central Committee shall be implemented in depth, the concept of innovative, coordinated, green, open and sharing development shall be firmly developed and practically implemented, according to the decisions and arrangements of the CPC Central Committee and the State Council, the decisive role of market in resource allocation shall be made full use of, the role of the government shall be made better use of, beginning with the guarantee of the whole people's heath, top design shall be strengthened, grassroots foundation shall be consolidated, the policy system shall be improved, innovation in the working mechanism shall be conducted, the interconnection, integration, open and sharing of government health and medical care information system and the public health and medical care data shall be vigorously promoted, information isolated islands shall be eliminated, a development environment to promote the safety, regulation and innovative application of big data in health and medical care shall be vigorously created, through the "Internet plus health and medical care," new service modes shall be researched and new business types shall be fostered, and the medical care and health undertaking satisfying the people shall be vigorously developed, so as to provide powerful support to the building of a healthy China, comprehensively finishing building a moderately prosperous society, and the realization of the Chinese Dream of the great rejuvenation of the Chinese nation.
(2) Basic principles.
The people-oriented value shall be adhered to and innovation shall be adhered to as a driving force. The application and development of big data in health and medical care shall be incorporated into the state strategic arrangement of big data, the joint and collaborative innovation of politics, industry, academics, research and application shall be advanced, the basic research and essential technology development shall be strengthened, key fields and key parts of health and medical care shall be highlighted, and big data shall be used to expand service channels, extend and enrich service content, and better satisfy the need of the people for health and medical care.
Regulation, order, safety and controllability shall be adhered to. Rules and systems for the open and protection of big data in health and medical care shall be established and improved, the development of standards and safety system shall be enhanced, the security management responsibility shall be strengthened, the relationship between application and development, and security guarantee shall be properly handled, and the ability in technical safety support shall be improved, so as to effectively protect personal privacy and information safety.
Open, integration, joint development and sharing shall be adhered to. The cooperation between government and the social resources shall be encouraged, overall planning, combination of the short and long-term targets, and demonstration and pioneering shall be adhered to, priority shall be given to the revitalization and integration of existing resources, and the formation of a good situation featuring all parties' support, open in accordance with the law, convenience and benefits for the people, and thriving development shall be advanced, so as to fully unleash the data dividends, and trigger the vigor for entrepreneurship and innovation among all the people.
(3) Development goals. By the end of 2017, the interconnection between the state and provincial-level population health information platforms and the national medicine biding and procurement business application platform shall be realized to basically form the pattern of sharing and jointly using cross-departmental health and medical care data resources. By 2020, a state medical care and health information rating and open application platform shall be developed to realize cross-departmental and cross-regional sharing of population, legal persons, space, geography, and other basic data resources, and significant achievement in the integration and application of data in all the relevant fields of medical care, medicine, medical insurance and health shall be made; and the regional distribution shall be overall arranged, existing resources shall be depended on to establish 100 regional clinical medicine data demonstration centers, it shall be basically realized that urban and rural residents have standard electronic health archives and health cards with complete functions, policies, regulations, safety and protection, and application standard systems with regard to big data in health and medical care shall be constantly improved, the mode of the application and development of big data in health and medical care suitable for the state actuality shall be basically developed, the system of the industry of big data in health and medical care shall be initially formed, new business types shall thrive, and the people shall obtain more material benefits.
II. Key tasks and significant projects
(1) Consolidating the foundation of the application of big data in health and medical care.
i. Accelerating the development of uniform, authoritative population health information platform featuring interconnection. The whole people health security information project shall be implemented, according to the principle of safety first and privacy protection, fully depending on the National E-Government Network and uniform data sharing and exchange platform, existing facility resources shall be extended and improved, the state, provincial, municipal and county-level population health information platforms featuring interconnection and sharing shall be comprehensively developed, and data collection, integrated sharing and business coordination of such application information systems as public health, family planning, medical care services, medical care security, supply of medicine and comprehensive management shall be strengthened. The innovation in administration mode shall be conducted and the online handling of birth registration shall be advanced. Data barrier shall be eliminated to keep unimpeded the data sharing channel between departments, regions, and sectors, a interconnection mechanism of social health and medical care data and information shall be researched, and the realization of the cluster of health and medical care data on platforms, handling of business matters through platforms, and the dependence of government policies on the support of platforms shall be advanced.
ii. Advancing the sharing and open of big data in health and medical care. All types of medical care and health institutions shall be encouraged to advance the collection and storage of big data in health and medical care, strengthen application support and technical guarantee for operation and maintenance, and open up the charing channel of data resources. The development and improvement of basic database with residents' electronic health archives, electronic medical history, electronic prescription, etc. as its core shall be accelerated. A centralized health and medical care data sharing mechanism featuring the close cross-departmental cooperation among health and family planning, Chinese medicine and education, technology, industry and information, public security, civil affairs, human resources and social security, environmental protection, agriculture, commerce, safety supervision, inspection and quarantine, food and drug administration, sports, statistics, tourism, climate, insurance regulatory, disabled persons' federation, etc. shall be established. The regulated entry of data resource standards developed for the wearable devices, smart and health electronic products, mobile health and medical care applications, etc. into the population health information platforms shall be researched and advanced. A national health and medical care data resource catalog system shall be established, policies and standards on the open application of big data in health and medical care by category, by rating, by region shall be developed, and the open of big data in health and medical care shall be steadily promoted.
(2) Comprehensively deepening the application of big data in health and medical care.
iii. Advancing the application of big data in the governance of health and medical care sector. The assessment and monitoring of the reform of the medicine and health system shall be strengthened and deepened, and the precise statistics and predicting evaluation of important data on residents' health conditions, etc. shall be strengthened so as to powerfully support the planning and decision making on the development of healthy China. The big data resources in health and medical care and information technical means shall be comprehensively used to improve the hospital evaluation system, promote and deepen the reform of public hospitals, improve modern hospital administration system, and optimize the distribution of medical care and health resources. The regulation of medical institutions shall be strengthened, the mechanism to monitor the constitution and change trend of revenue from medical care, medicine, consumable items, etc. shall be improved, and business information on medical service prices, medical security disbursement, medicine biding and procurement, medicine use, etc. shall be coordinated, so as to help advance the joint reform of medical care, medical security and medicine.
iv. Advancing the application of big data in clinical medical care and scientific research. Existing resources shall be depended on to establish a group of demonstration centers of clinical medicine data on heart and cerebral vessels, cancer, geriatrics, pediatrics, etc., and state medical big data resources in genomics, proteomics, etc. shall be integrated to develop clinical decision making support system. The application of gene chip and sequencing technology in the aspects of the diagnosis of genetic diseases, early diagnosis of cancer and disease prevention and test shall be advanced, the population gene information safety management shall be strengthened, and the development of precision medical care technology shall be advanced. Centered on the need for the research of clinical medication for significant diseases, common key technologies in medicine industrialization, etc. a mechanism to integrate and share data on the prediction of the side effect of medicine, and research and development of innovative medicine shall be established. Superior resources shall be made full use of to optimize the distribution of big data in biomedicine, and, depending on the state clinical medicine research centers and coordinated research network, the integration and sharing of clinical and scientific research data resource shall be systematically strengthened, so as to improve the effectiveness of medical scientific research and application, and promote the development of smart medical care.
iv. Advancing the application of big data in public health. The development of public health business information system shall be strengthened, the national immunization program, direct network report, network-oriented first aid, occupational disease prevention and control, port public health risk early warning and decision making, and other information systems, as well as the functions of the mobile emergency response business platform applications, shall be improved, the information sharing and business coordination of medical institutions, public health institutions and port inspection and quarantine institutions shall be advanced, and the monitoring, assessment, and decision management ability shall be comprehensively improved. The public information resources of social network shall be integrated, the sensitive disease information early warning system shall be improved, and the whole-people disease prevalence trend as well as global epidemic information and other international public health risks shall be mastered in a timely manner and analyzed dynamically, so as to improve the early warning of public health events and emergency response ability. The multiple-aspect monitoring data on environmental health, drinking water, health hazardous factors, port medical vector, nuclear, biochemistry, etc. shall be integrated, to effectively evaluate social factors affecting health. Key infectious diseases, occupational diseases, port imported infectious diseases and medical vector shall be monitored, multiple-source monitoring data on infectious diseases and occupational diseases shall be integrated, and a quick recognition network and system of laboratory pathogenic test result shall be established, so as to effectively prevent and control significant diseases. The monitoring and assessment of disease risk factors and the smart application of maternal and child health care, aged health care, international travel health care, etc. shall be advanced, and healthy lifestyles shall be popularized.
vi. Fostering new business types in the application of big data in health and medical care. The research of key technologies such as health and medical care quantitative data storage and cleaning, analysis and mining, safety, and privacy protection shall be strengthened. Social resources shall be vigorously encouraged to innovate on and develop health and medical care business, the in-depth integration between health and medical care business and big data technology shall be promoted, the development of the industrial chain of big data in health and medical care shall be accelerated, and the coordinated development of health and medical care, health maintenance, old-age support, home services and other service sectors shall be constantly advanced. The information service in household health shall developed, online drugstores, delivery of medicine by third-party logistics, and other services shall be regulated, the development of health maintenance with traditional Chinese medicine, health and old-age support, heath management, health consultation, health culture, sports and fitting, health and medical care tourism, health environment, healthy diet, and other industries shall be propelled.
vii. Researching, developing and promoting digitalized smart health and medical care devices. Support shall be given to the research of artificial intelligence technology relating to health and medical care, three-dimensional (3D) bioprinting technology, medical robots, large medical equipment, health and rehabilitation assistance instrument, wearable devices and relevant micro sensors. The conversion of the results of research and development shall be accelerated, and the manufacturing level of digital medical devices, devices of the Internet of Things, smart health products, function status test and health maintenance devices of traditional Chinese medicine shall be raised, so as to promote the upgrade of the smart health and medical care equipment industry.
(3) Regulating and promoting the "Internet plus health and medical care" services.
viii. Developing smart health and medical care services convenient to and benefiting the people. The pioneering role of high-quality medical resources shall be underscored, social resources shall be encouraged to participate, online and offline resources shall be integrated, the management of the medical Internet of Things and the health and medical care applications shall be regulated, the application of health consultation via the Internet, online reservation and outpatient arrangement, mobile payment and check and test result inquiry, follow-up interview, etc. shall be vigorously advanced, and a standard, sharing diagnosis and treatment procedure with mutual trust shall be developed and optimized. An Internet health and medical care service mode shall be researched. Based on the concluded contracts of family doctor service, the integration of the application of residents' health cards and social security cards shall be advanced, the application of residents' electronic health archives shall be triggered, and the integrated electronic health service in the prevention, treatment, rehabilitation and health management covering the whole life cycle shall be promoted.
ix. Comprehensively establishing a long-distance medical application system. The healthy China cloud service plan shall be implemented, a health and medical care integration platform shall be developed to provide long-distance consultation, long-distance video, long-distance pathology, long-distance electrocardio diagnosis services, and the mutual admission and sharing mechanism of check and test results shall be improved. The data resource sharing and business coordination between large hospitals and grassroots medical and health institutions, between general medical practitioners and specialist physicians shall be advanced, the level-by-level diagnosis and treatment information system based on the Internet and big data technology shall be improved, the service ability of medical and health institutions shall be improved, and "priority and resources to lower levels" shall be promoted in a targeted way.
x. promoting the application of education and training on health and medical care. Support shall be given to the development of a health and medical care education and training platform based on the national open university of health and medical care, supported by the China health and medical care MOOC league, the development of text books for the MOOC training on health and medical care shall be encouraged, new type of Internet teaching mode and methods shall be researched, high-quality teaching resources shall be organized to advance the open and sharing of medical education resources online, online interaction, long-distance training, long-distance surgery demonstration teaching, study performance assessment, and other applications, the lifelong education for medical staff shall be facilitated, and the ability of grassroots medical and health services shall be improved.
(4) Strengthening the development of a guarantee system for big data in health and medical care.
xi. Strengthening the development of a law, regulation and standard system. Laws and regulations on the application and development of big data in health and medical care shall be developed and improved, the regulated administration of residents' health information service shall be enhanced, and the power to use information shall be defined, so as to practically protect the legitimate rights and interests of all parties. The supporting service system for data open and sharing shall be improved, and an administration system of "authorization by level, application by category, powers consistent with responsibilities" shall be established. The access standard in the field of the application of big data in health and medical care shall be regulated, a good faith and exit mechanism for the big data application shall be established, and the development, mining and application of big data shall be strictly regulated. Uniform disease diagnosis coding, clinical medical terminology, check and test regulations, medicine application cording, information data interface and transmission protocol, and other relevant standards shall be developed to promote the standardization of products and service process of big data in health and medical care.
xii. Advancing the development of Internet credibility system The administration of digital institution in health and medical care shall be strengthened, an information system of credible medical digital identification certificates of medical and health personnel and medical and health institutions with national uniform identifications, electronic real-name registration, and data access control shall be developed, and a new health and medical care administration mode featuring traceable and retroactive service administration, safe operation of diagnosis and treatment data, and the cooperation and participation of multiple parities shall be gradually established.
xiii. Strengthening safety control of health and medical care data. The development of the safety system of health and medical care shall be accelerated, a data safety administration responsibility system shall be established, and the rules for the assignment of identification codes, scientific category, risk rating, and safety examination shall be developed. The planning on the safety of population health information shall be made, the state and regional ability for population health information project technologies shall be enhanced, and content safety and technical safety shall be prioritized, so as to ensure the independence, controllability, stability and safety of key state information infrastructures and core systems. The assessment of reliability, controllability and safety of big data platforms and service suppliers, and the safety and risk assessment of applications shall be conducted, and an evaluation and safety review system of softwares in safety protection, system interconnection and sharing, protection of citizens' privacy, etc. shall be established. The monitoring and early warning of the safety of big data shall be strengthened, a joint system of safety information report and emergency disposition shall be established, a working mechanism for the safety of "Internet plus health and medical care" services shall be established and improved, the measures to resolve and respond to hidden risks shall be improved, the protection of important information on national interests, public security, patient privacy, business secrets, etc. shall be strengthened, and the safety prevention of medical schools, scientific research institutions, and other aspects shall be improved.
xiv. Strengthening the development of inter-disciplinary talents in the health and medical care information. The national health and medical care information talent development plan shall be implemented, the development of the discipline of medical informatics and the fostering of "digital doctors" shall be enhanced, the fostering of high-level, and interdisciplinary research and development talents and scientific research teams shall be prioritized, so as to foster a group of special talents, discipline leaders and sector leaders with international influence. The innovation on the continuing education for specialized talents shall be conducted, the multiple-layer, multiple-type talent fostering and training system shall be improved, governments, institutions of higher learning, scientific research institutions, and enterprises shall be promoted in jointly fostering talents, and the development of talent team of big data in health and medical care shall be promoted.
III. Strengthening organization and implementation
(1) Strengthening overall arrangement and planning. A working pattern featuring the leadership of the CPC committees and governments, the participation of multiple parties, resource sharing, and coordinated advancement shall be developed. The National Health and Family Planning Commission shall make comprehensive and overall arrangement and strengthen the implementation, and all relevant departments shall closely cooperate to form joint forces and promote the implementation of key tasks. All regions shall attach importance to the application and development of big data in health and medical care, practically make overall planning and conduct infrastructure construction and safety supervision, and ensure the implementation of all tasks and measures. The military and civilian integration and development of big data in health and medical care shall be advanced, and the connection of standards, interconnection, sharing and coordinated application of military and civilian health and medical care data shall be promoted. The guidance for the application and development of health and medical care data shall be strengthened, the overall arrangement and coordination of technology research and development, development of new business types, and application and promotion shall be strengthened, the establishment of expert committees shall be researched, and the research and development of development strategies and relevant policies, regulations and standards shall be organized.
(2) Focusing on key points and making efforts to make efforts. Beginning from the fields where the people have urgent need, the online reservation and outpatient management, long-distance medical care, sharing and mutual admission of check and test results, and other applications convenient to and benefiting people shall be advanced in priority. The advancement of the nationwide network of basic medical insurance and settlement of hospitalization in different locations shall be accelerated. The development of smart medical devices and smart wearable devices shall be supported, and the research in difficult diseases and other key aspects shall be strengthened. A group of regions and fields with good basic conditions, enthusiasm in work, and guarantee of privacy, safety and prevention shall be selected for the pilot program of big data in health and medical care, and experience shall be summarized for solid and orderly advancement.
(3) Providing more policy support. Government support policies shall be researched and made, and necessary support shall be given to the application and development of big data in health and medical care from public finance, tax, investment, innovation, and other aspects. The public private partnership shall be promoted and used, and private sources shall be encouraged and guided in participating in infrastructure projects, application development and operation services of big data in health and medical care. Government shall be encouraged to cooperate with enterprises, public institutions and private institutions, and the integration of the application of big data in health and medical care by government and society shall be realized. The role of the relevant investment funds already established shall be made full use of, the enthusiasm of private capital and non-governmental capital shall be fully stimulated, the innovation on diversified investment mechanism shall be encouraged, and the risk prevention and supervision system shall be improved, so as to support the application and development of big data in health and medical care.
(4) Strengthening the publicity and popularization of policies. The interpretation of the policies on the application and development of big data in health and medical care shall be strengthened, the significance in the application and development as well the perspective of the application shall be vigorously publicized, positive response shall be given to social concern, and a good social atmosphere shall be created. The medical and health institutions and private resources shall be vigorously directed in participating in the conduct of various campaigns to popularize scientific knowledge, and publicize and popularize knowledge of the application of health and medical care, and the development of easy digital medical tools shall be encouraged, so as to constantly improve the people's ability to master relevant applications and the public health.
(5) Advancing international exchange and cooperation. The exchange and cooperation in the talents and technologies with regard to the application and development of big data in health and medical care shall be advanced orderly. Relevant enterprises and scientific research entities shall be encouraged to import, digest, absorb and re-innovate on advanced international technologies, and promote China's independent technologies in keeping pace with the rest of the world. The trace, evaluation and conversion of the standard for the application of big data in health and medical care shall be enhanced, the development of international standards shall be vigorously participated in, and more voice shall be given to the development of relevant rules. The principle of maintaining independence, strengthening supervision and ensuring safety shall be adhered to, a new mode of cooperation in the application and development of big data in international health and medical care shall be steadily researched, and the level of the application, industrial core competitiveness and internationalization of big data in health and medical care in China shall be constantly improved.
General Office of the State Council
June 21, 2016