China Officially Integrates Healthcare Big Data into National Strategy: Full Text of State Council General Office's Guiding Opinions Released
Guiding Opinions of the General Office of the State Council on Promoting and Regulating the Application and Development of Health and Medical Big Data
Guobanfa [2016] No. 47
To the People's Governments of all provinces, autonomous regions, and municipalities directly under the Central Government, and to all ministries and commissions of the State Council and its directly affiliated institutions:
Health and medical big data constitute a critical foundational strategic resource for the nation. The application and development of health and medical big data will bring about profound changes in healthcare delivery models, help stimulate momentum and vitality for deepening reforms of the pharmaceutical and healthcare systems, improve the efficiency and quality of health and medical services, expand resource supply, continuously meet the multi-level and diversified health needs of the public, and foster new business formats and economic growth drivers. To implement the requirements set forth in the Notice of the State Council on Issuing the Outline for Promoting the Development of Big Data (Guo Fa [2015] No. 50), adapt to the development trends of emerging information technologies, and standardize and promote the integration, sharing, open access, and application of health and medical big data, the following opinions are hereby proposed with the approval of the State Council.
(I) Guiding Principles
We must thoroughly implement the spirit of the 18th National Congress of the Communist Party of China and the Third, Fourth, and Fifth Plenary Sessions of its 18th Central Committee. We should firmly establish and effectively apply the development concepts of innovation, coordination, green development, openness, and shared benefits. In accordance with the decisions and arrangements of the CPC Central Committee and the State Council, we will allow the market to play a decisive role in resource allocation while better leveraging the role of the government. With the goal of safeguarding the health of all people, we will strengthen top-level design, solidify grassroots foundations, improve policies and institutions, and innovate working mechanisms. We will vigorously promote the interconnection, integration, openness, and sharing of government health and medical information systems and public health and medical data, eliminate information silos, and actively foster a development environment that ensures the security, standardization, and innovative application of big data in health and healthcare. By exploring new service models and cultivating new forms of development through “Internet + Health and Healthcare,” we will strive to build a healthcare system that satisfies the people, providing strong support for building a Healthy China, achieving the comprehensive construction of a moderately prosperous society, and realizing the Chinese Dream of the great rejuvenation of the Chinese nation.
(II) Basic Principles
Adhere to a people-oriented, innovation-driven approach. Integrate the development and application of health and medical big data into the national big data strategic layout, promote collaborative innovation among government, industry, academia, research, and users, strengthen basic research and breakthroughs in core technologies, highlight key areas and critical links in health and medical care, leverage big data to expand service channels, extend and enrich service content, and better meet the public’s health and medical needs.
Adhere to standardized, orderly, safe, and controllable practices. Establish and improve laws, regulations, and systems for the opening and protection of health and medical big data; strengthen the construction of standards and security systems; reinforce responsibilities for security management; properly balance the relationship between application development and security assurance; enhance technical support capabilities for security; and effectively protect personal privacy and information security.
Uphold openness, integration, co-construction, and sharing. Encourage collaboration between the government and social forces, adhere to integrated planning, combine immediate and long-term objectives, and leverage demonstration effects. Focus on revitalizing and integrating existing resources to foster a favorable environment characterized by broad support, lawful openness, convenience for the public, and robust development. Fully unleash the dividends of data and stimulate the vitality of mass entrepreneurship and innovation.
(III) Development Goals
By the end of 2017, achieve interconnectivity between the national and provincial population health information platforms and the national drug centralized bidding and procurement business application platform, basically forming a pattern of cross-departmental sharing and common use of health and medical data resources. By 2020, establish a national hierarchical open application platform for medical and health information, realize cross-departmental and cross-regional sharing with basic data resources such as population, legal entities, and spatial geography, and achieve significant results in the integrated application of data across related fields including medical care, pharmaceuticals, medical insurance, and health. Coordinate regional layout, rely on existing resources to build 100 regional clinical medical data demonstration centers, and basically ensure that urban and rural residents have standardized electronic health records and fully functional health cards. Continuously improve policies, regulations, security protection, and application standard systems related to health and medical big data; basically establish an application and development model for health and medical big data suited to national conditions; initially form a health and medical big data industrial system with vigorous development of new business formats; and deliver greater benefits to the people.
(1) Strengthen the Foundation for the Application of Health and Medical Big Data
1. Accelerate the development of a unified, authoritative, and interconnected population health information platform. Implement the National Health Security Informatization Project, adhering to the principles of security first and privacy protection. Fully leverage the National E-Government Extranet and the Unified Data Sharing and Exchange Platform to expand and enhance existing infrastructure and resources. Comprehensively establish a four-tier population health information platform at the national, provincial, municipal, and county levels that enables interoperability and data sharing. Strengthen data collection, integration, sharing, and business coordination across application information systems for public health, family planning, medical services, healthcare security, drug supply, and comprehensive management. Innovate management models to promote online processing of birth registration. Eliminate data silos, facilitate data sharing channels among departments, regions, and industries, explore mechanisms for socialized interchange of health and medical data, and promote the aggregation of health and medical data on the platform, the handling of administrative matters through the platform, and government decision-making supported by the platform.
2. Promote the sharing and open access of health and medical big data resources. Encourage various medical and health institutions to advance the collection and storage of health and medical big data, strengthen application support and operational maintenance technical safeguards, and clear channels for data resource sharing. Accelerate the construction and improvement of foundational databases centered on residents’ electronic health records, electronic medical records, and electronic prescriptions. Establish a cross-departmental mechanism for close coordination and unified management of health and medical data sharing, involving departments responsible for health and family planning, traditional Chinese medicine, education, science and technology, industry and information technology, public security, civil affairs, human resources and social security, environmental protection, agriculture, commerce, work safety, inspection and quarantine, food and drug regulation, sports, statistics, tourism, meteorology, insurance regulation, and the China Disabled Persons’ Federation. Explore and promote the standardized integration of data resources generated by wearable devices, smart health electronic products, and mobile health and medical applications into population health information platforms. Establish a national catalog system for health and medical data resources, formulate policies and standards for the classified, graded, and domain-specific open application of health and medical big data, and steadily promote the opening up of health and medical big data.
(II) Comprehensively Deepen the Application of Health and Medical Big Data
3. Promote the application of big data in health and medical industry governance. Strengthen monitoring and evaluation of deepening healthcare system reforms, enhance precise statistical analysis and predictive assessment of key data such as residents' health status, and provide robust support for planning and decision-making in the Healthy China initiative. Comprehensively leverage health and medical big data resources and information technology to improve hospital evaluation systems, drive deeper reforms of public hospitals, refine modern hospital management systems, and optimize the allocation of healthcare resources. Strengthen oversight of healthcare institutions, establish sound mechanisms for monitoring the composition and trends of revenue from medical services, pharmaceuticals, and consumables, and integrate operational data on medical service pricing, health insurance payments, drug procurement and bidding, and drug utilization to facilitate coordinated reforms across healthcare delivery, health insurance, and pharmaceutical sectors.
4. Promote the application of big data in clinical healthcare and medical research. Relying on existing resources, establish a number of clinical medical data demonstration centers for cardiovascular and cerebrovascular diseases, oncology, geriatrics, and pediatrics; integrate national medical big data resources such as genomics and proteomics; and build clinical decision support systems. Advance the application of gene chip and sequencing technologies in the diagnosis of genetic disorders, early detection of cancer, and disease prevention and screening; strengthen the security management of population genomic information; and promote the development of precision medicine. In response to needs such as the development of clinical medications for major diseases and key generic technologies for pharmaceutical industrialization, establish mechanisms for predicting drug side effects and for the integration and sharing of data in innovative drug research and development. Fully leverage advantageous resources, optimize the layout of biomedical big data, rely on National Clinical Medical Research Centers and collaborative research networks, systematically strengthen the integration and sharing of clinical and scientific research data resources, enhance the efficiency of medical research and applications, and drive the development of smart healthcare.
5. Promote the application of big data in public health. Strengthen the development of information systems for public health services, improve the functionality of information systems such as the National Immunization Program, direct online reporting, networked emergency medical services, occupational disease prevention and control, and port public health risk warning and decision-making, as well as mobile emergency service platforms. Advance information sharing and operational coordination among medical institutions, public health agencies, and port inspection and quarantine authorities to comprehensively enhance capabilities in public health monitoring, assessment, and decision-making management. Integrate public information resources from social networks, refine early-warning mechanisms for sensitive disease-related information, and promptly capture and dynamically analyze trends in disease incidence across the entire population and international public health risks such as global infectious disease outbreaks, thereby improving early warning and emergency response capabilities for public health emergencies. Integrate multi-source monitoring data on environmental hygiene, drinking water, health hazard factors, port medical vector organisms, and nuclear, biological, and chemical threats to effectively evaluate social determinants of health. Conduct surveillance of key infectious diseases, occupational diseases, imported infectious diseases at ports, and medical vector organisms; integrate multi-source surveillance data for infectious and occupational diseases; establish a rapid identification network for laboratory pathogen test results; and effectively prevent and control major diseases. Promote intelligent applications for monitoring and assessing disease risk factors, as well as for maternal and child healthcare, elderly healthcare, and international travel health care, to popularize healthy lifestyles.
6. Cultivate new business models for the application of big data in health and medical care. Strengthen breakthroughs in key technologies such as massive data storage and cleaning, analysis and mining, and security and privacy protection in the health and medical sector. Actively encourage social forces to innovate and develop health and medical services, promote the deep integration of health and medical services with big data technology, accelerate the construction of the health and medical big data industry chain, and continuously advance the coordinated development of health and medical care with service industries such as wellness, elderly care, and domestic services. Develop home-based health information services, standardize services such as online pharmacies and third-party pharmaceutical logistics distribution, and promote the development of industries including traditional Chinese medicine wellness, healthy aging, health management, health consultation, health culture, sports and fitness, health and medical tourism, healthy environments, and healthy diets.
7. Develop and promote digital smart health and medical devices. Support the research and development of artificial intelligence technologies, biological three-dimensional (3D) printing technologies, medical robots, large-scale medical equipment, health and rehabilitation assistive devices, wearable devices, and related micro-sensors relevant to healthcare. Accelerate the transformation of R&D achievements, enhance the manufacturing capabilities of digital medical equipment, Internet of Things (IoT) devices, smart health products, and traditional Chinese medicine (TCM) functional status detection and wellness instruments, thereby promoting the industrial upgrading of smart health and medical equipment.
(3) Standardize and promote “Internet + Health and Medical” services
8. Develop smart healthcare services that are convenient and beneficial to the public. Leverage the leading role of high-quality medical resources, encourage participation by social forces, integrate online and offline resources, standardize the management of the Medical Internet of Things (IoMT) and health and medical applications (apps), and vigorously promote applications such as online health consultations, online appointment scheduling and triage, mobile payments, query of examination and test results, and follow-up tracking, so as to optimize and establish standardized, shared, and mutually trusted diagnosis and treatment processes. Explore internet-based health and medical service models. Based on family doctor contract services, promote the integration of applications such as resident health cards and social security cards, activate the use of electronic health records (EHRs) for residents, and drive the development of integrated e-health services covering prevention, treatment, rehabilitation, and health management throughout the entire life cycle.
9. Comprehensively establish a telemedicine application system. Implement the Healthy China Cloud Service Plan, build an integrated platform for health and medical services, provide remote consultation, remote imaging, remote pathology, and remote electrocardiogram (ECG) diagnosis services, and improve the mechanism for mutual recognition and sharing of examination and test results. Promote data resource sharing and operational collaboration between large hospitals and primary healthcare institutions, as well as between general practitioners and specialists. Improve the tiered diagnosis and treatment information system based on internet and big data technologies, extend and amplify the service capabilities of healthcare institutions, and targetedly promote the “shifting of focus downward and sinking of resources.”
10. Promote the application of health and medical education and training. Support the establishment of a cloud-based platform for health and medical education and training, anchored by the National Open University of Health and Medicine and supported by the China MOOC Alliance for Health and Medical Education. Encourage the development of MOOC-based training materials for health and medicine, explore new internet-based teaching models and methods, and organize high-quality faculty to advance the open sharing and online interaction of medical educational resources, as well as applications such as remote training, remote surgical demonstrations, and learning outcome assessments. This will facilitate lifelong education for medical personnel and enhance the service capacity of primary healthcare institutions.
(4) Strengthening the Construction of Health and Medical Big Data Assurance Systems
11. Strengthen the development of regulatory and standard systems. Formulate and improve laws and regulations governing the application and development of health and medical big data, strengthen standardized management of resident health information services, clarify data access permissions, and effectively safeguard the legitimate rights and interests of all relevant parties. Improve the support service system for data openness and sharing, and establish a management framework based on "tiered authorization, categorized application, and consistency of rights and responsibilities." Standardize market entry requirements in the field of health and medical big data applications, establish integrity and exit mechanisms for big data applications, and strictly regulate behaviors related to big data development, mining, and application. Establish unified standards for disease diagnosis coding, clinical medical terminology, examination and testing specifications, drug application coding, information data interfaces, and transmission protocols, thereby promoting the standardization of health and medical big data products and service processes.
12. Advance the development of a trusted network system. Strengthen the management of digital identities in healthcare, establish a nationwide unified system for trusted medical digital identities, electronic real-name authentication, and data access control for healthcare professionals and institutions, actively promote the application of electronic signatures, and gradually build a new model of healthcare management characterized by traceable service management, secure operation of clinical data, and multi-party collaborative participation.
13. Strengthen the security assurance of health and medical data. Accelerate the development of a health and medical data security system, establish a data security management accountability system, and formulate rules for identification coding, scientific classification, risk stratification, and security review. Develop a population health information security plan, strengthen national and regional engineering and technical capabilities in population health information, emphasize content and technological security, and ensure that national critical information infrastructure and core systems are independently controlled, stable, and secure. Conduct reliability, controllability, and security evaluations of big data platforms and service providers, as well as security evaluations and risk assessments of applications; establish software evaluation and security review systems covering security protection, system interconnectivity and sharing, and citizen privacy protection. Enhance big data security monitoring and early warning, establish mechanisms for security information notification and coordinated emergency response, develop sound operational mechanisms for the security of “Internet + Health and Medical” services, improve measures for identifying and addressing risks and hazards, strengthen the protection of important information involving national interests, public safety, patient privacy, and trade secrets, and enhance security precautions in medical schools, research institutions, and related entities.
14. Strengthen the development of a multidisciplinary workforce for health and medical informatics. Implement the National Plan for the Development of Health and Medical Informatics Talent, strengthen the construction of medical informatics as a discipline, and cultivate “digital physicians.” Focus on nurturing high-level, multidisciplinary R&D talent and research teams, and foster a cohort of specialized professionals, disciplinary leaders, and industry pioneers with international influence. Innovate continuing education models for specialized personnel, improve a multi-tiered and diverse talent training system, promote collaborative talent cultivation by governments, higher education institutions, research institutes, healthcare organizations, and enterprises, and advance the development of the health and medical big data workforce.
(I) Strengthen overall planning. Establish a working framework characterized by leadership of Party committees and governments, multi-party participation, resource sharing, and coordinated advancement. The National Health and Family Planning Commission shall exercise comprehensive coordination and strengthen implementation; relevant departments shall cooperate closely to form synergies and promote the implementation of key tasks. All regions shall attach importance to the application and development of health and medical big data, effectively carry out overall planning, infrastructure development, and security supervision, and ensure that all tasks and measures are implemented in practice. Promote the integrated civil-military development of health and medical big data, and facilitate standardized linkage, interoperability and sharing, and collaborative application of military and civilian health and medical data. Strengthen guidance on the application and development of health and medical big data, enhance overall coordination of technological research and development, cultivation of new business models, and promotion of applications, establish an expert committee, and organize the formulation of development strategies and related policies, regulations, and standards.
(2) Focus on key areas to achieve breakthroughs. Starting from fields with urgent public demand, prioritize the promotion of convenient and beneficial applications such as online appointment scheduling and triage, telemedicine, and the sharing and mutual recognition of examination and test results. Accelerate the nationwide networking of basic medical insurance and the settlement of cross-regional medical expenses. Support the development of intelligent medical devices and smart wearable equipment, and strengthen research in key areas such as difficult-to-treat diseases. Select a number of regions and sectors with sound foundational conditions, high work enthusiasm, and robust privacy and security safeguards to pilot the application of health and medical big data, summarize experiences, and promote implementation in a steady and orderly manner.
(3) Strengthen policy support. Formulate and refine government support policies to provide necessary assistance for the development and application of health and medical big data in areas such as fiscal taxation, investment, and innovation. Promote the Public-Private Partnership (PPP) model, encouraging and guiding social capital to participate in infrastructure construction, application development, and operational services related to health and medical big data. Encourage cooperation between the government and enterprises, public institutions, and social organizations, and explore methods such as government procurement and crowdsourcing to integrate government applications with social applications in the field of health and medical big data. Fully leverage the role of established investment funds, stimulate the enthusiasm of social and private capital, encourage innovative and diversified investment mechanisms, improve risk prevention and regulatory systems, and support the development and application of health and medical big data.
(4) Strengthen policy publicity and outreach. Enhance the interpretation of policies regarding the development and application of health and medical big data, vigorously promote the significant importance and promising prospects of such applications, actively respond to public concerns, and foster a favorable social atmosphere. Actively guide medical and health institutions and social forces to participate in diverse science popularization activities, disseminate knowledge on the application of health and medical big data, encourage the development of user-friendly digital medical tools, and continuously improve the public’s ability to utilize these applications as well as overall health literacy.
(5) Promoting International Exchange and Cooperation. Orderly advance talent and technical exchanges and cooperation in the application and development of health and medical big data. Encourage relevant enterprises and research institutions to introduce, absorb, and re-innovate advanced international technologies, promoting the synchronized global development of China’s independent technologies. Strengthen efforts to track, evaluate, and adapt international standards for the application of health and medical big data, actively participate in the formulation of international standards, and enhance influence in related rule-making. Adhering to the principles of maintaining domestic leadership, strengthening regulation, and ensuring security, steadily explore new models of international cooperation in the application and development of health and medical big data, continuously improving China’s level of health and medical big data application, core industrial competitiveness, and degree of internationalization.
General Office of the State Council
June 21, 2016
(This document is publicly released)