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| Guiding Opinions of the General Office of the State Council on Promoting and Regulating the Application and Development of Health and Medical Big Data | | 国务院办公厅关于促进和规范健康医疗大数据应用发展的指导意见 |
| (No. 47 [2016] of the General Office of the State Council) | | （国办发〔2016〕47号） |
| The people's governments of provinces, autonomous regions, and municipalities directly under the Central Government; the ministries and commissions of the State Council; and the institutions directly under the State Council: | | 各省、自治区、直辖市人民政府，国务院各部委、各直属机构： |
| Health and medical big data is an important, fundamental, and strategic resource of the state. The application and development of health and medical big data will bring profound changes to the modes of health and medical care, is instrumental in unleashing the momentum and vigor for deepening the reform of the healthcare system, improving the efficiency and quality of health and medical services, expanding resource supply, and constantly satisfying the multilevel and diversified health needs of the people, and is instrumental in fostering new formats of business and economic growth points. For the purposes of implementing the requirements of the Notice by the State Council on Issuing the Action Plan for Promoting the Development of Big Data (No. 50 [2015], State Council), following the trend of development of emerging information technology, and regulating and promoting the integration, sharing, and open application of health and medical big data, with the consent of the State Council, the following opinions are hereby offered. | | 健康医疗大数据是国家重要的基础性战略资源。健康医疗大数据应用发展将带来健康医疗模式的深刻变化，有利于激发深化医药卫生体制改革的动力和活力，提升健康医疗服务效率和质量，扩大资源供给，不断满足人民群众多层次、多样化的健康需求，有利于培育新的业态和经济增长点。为贯彻落实《国务院关于印发促进大数据发展行动纲要的通知》（国发〔2015〕50号）要求，顺应新兴信息技术发展趋势，规范和推动健康医疗大数据融合共享、开放应用，经国务院同意，现提出如下意见。 |
| I. Guiding thoughts, basic principles, and development goals | | 一、指导思想、基本原则和发展目标 |
| 1. Guiding thoughts. 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, and 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 market shall play a decisive role in resource allocation, and the government shall play a better role. With guaranteeing the health of all people as the starting point, top design shall be strengthened, foundation shall be consolidated at the primary level, policies and systems shall be improved, innovation in working mechanisms shall be achieved, the interconnection, integration, open, and sharing of government health and medical information systems and public health and medical data shall be vigorously promoted, information islands shall be eliminated, and a development environment that promotes the security, regulation, and innovative application of health and medical big data shall be vigorously created. Through "Internet plus health and medical care," new service modes shall be explored, and new formats of business shall be fostered. Great efforts shall be made to develop a cause of healthcare to the satisfaction of the people and provide a powerful support for the building of a healthy China, comprehensive accomplishment of building a moderately prosperous society, and realization of the Chinese Dream of the great rejuvenation of the Chinese nation. | | （一）指导思想。深入贯彻落实党的十八大和十八届三中、四中、五中全会精神，牢固树立并切实贯彻创新、协调、绿色、开放、共享的发展理念，按照党中央、国务院决策部署，发挥市场在资源配置中的决定性作用，更好发挥政府作用，以保障全体人民健康为出发点，强化顶层设计，夯实基层基础，完善政策制度，创新工作机制，大力推动政府健康医疗信息系统和公众健康医疗数据互联融合、开放共享，消除信息孤岛，积极营造促进健康医疗大数据安全规范、创新应用的发展环境，通过“互联网＋健康医疗”探索服务新模式、培育发展新业态，努力建设人民满意的医疗卫生事业，为打造健康中国、全面建成小康社会和实现中华民族伟大复兴的中国梦提供有力支撑。 |
| 2. Basic principles. | | （二）基本原则。 |
| Adherence to the people-oriented approach and development driven by innovation: The application and development of health and medical big data shall be incorporated into the layout of the state's big data strategy, the joint and collaborative innovation by the government, industries, colleges, research institutes, and users shall be advanced, the basic research and the development of core technology shall be strengthened, major fields and key stages 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 health and medical needs of the people. | | 坚持以人为本、创新驱动。将健康医疗大数据应用发展纳入国家大数据战略布局，推进政产学研用联合协同创新，强化基础研究和核心技术攻关，突出健康医疗重点领域和关键环节，利用大数据拓展服务渠道，延伸和丰富服务内容，更好满足人民健康医疗需求。 |
| Adherence to regulation, order, security, and controllability: Legislation on the openness and protection of health and medical big data shall be enacted and improved, the development of the standard and security systems 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 technical support capability for security shall be improved, to effectively protect individual privacy and information security. | | 坚持规范有序、安全可控。建立健全健康医疗大数据开放、保护等法规制度，强化标准和安全体系建设，强化安全管理责任，妥善处理应用发展与保障安全的关系，增强安全技术支撑能力，有效保护个人隐私和信息安全。 |
| Adherence to openness, integration, joint development, and sharing: Public-private cooperation is encouraged, overall planning, combination of the short and long-term targets, and leading by example shall be adhered to, the revitalization and integration of existing resources shall be underscored, and the formation of a favorable situation of support from all quarters, lawful openness, convenience for and benefiting the people, and thriving development shall be advanced, to fully unleash data dividends and stimulate entrepreneurship and innovation among all the people. | | 坚持开放融合、共建共享。鼓励政府和社会力量合作，坚持统筹规划、远近结合、示范引领，注重盘活、整合现有资源，推动形成各方支持、依法开放、便民利民、蓬勃发展的良好局面，充分释放数据红利，激发大众创业、万众创新活力。 |
| 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 have been realized to basically form a pattern of sharing and joint use of cross-departmental health and medical data resources. By 2020, the building of a national healthcare information grading and open application platform shall have been completed to realize cross-departmental and cross-regional sharing of population, legal person, space, geography, and other basic data resources, and significant achievement in the integration and application of data in the relevant fields of medical care, medicine, medical insurance, and health shall have been made; and by the overall planning on regional distribution and relying on existing resources, the building of 100 exemplary regional clinical medicine data centers shall have been completed, it shall have been basically realized that urban and rural residents own standard electronic health files and health cards with extensive functions, the policies, legislation, and safety protection and application standard systems related to health and medical big data shall have been continuously improved, a mode of application and development of health and medical big data adapted to the national condition shall have been basically established, the system of the health and medical big data industry shall have been initially formed, new business formats shall have thrived, and the people shall have obtained more benefits. | | （三）发展目标。到2017年底，实现国家和省级人口健康信息平台以及全国药品招标采购业务应用平台互联互通，基本形成跨部门健康医疗数据资源共享共用格局。到2020年，建成国家医疗卫生信息分级开放应用平台，实现与人口、法人、空间地理等基础数据资源跨部门、跨区域共享，医疗、医药、医保和健康各相关领域数据融合应用取得明显成效；统筹区域布局，依托现有资源建成100个区域临床医学数据示范中心，基本实现城乡居民拥有规范化的电子健康档案和功能完备的健康卡，健康医疗大数据相关政策法规、安全防护、应用标准体系不断完善，适应国情的健康医疗大数据应用发展模式基本建立，健康医疗大数据产业体系初步形成、新业态蓬勃发展，人民群众得到更多实惠。 |
| II. Priority tasks and major projects | | 二、重点任务和重大工程 |
| 1. Consolidating the foundation of application of health and medical big data. | | （一）夯实健康医疗大数据应用基础。 |
| (1) Accelerating the development of a unified, authoritative, and interconnected population health information platform: The universal health security information project shall be implemented. According to the principle of safety first and privacy protection and by fully depending on the National E-Government Network and the unified data sharing and exchange platform, existing facility resources shall be extended and improved, the comprehensive building of the health information platforms at four levels (state, provincial, municipal, and county) featuring interconnection and sharing shall be completed, and the data collection, integration, sharing, and business coordination of application information systems of public health, family planning, medical services, medical security, supply of medicine, and comprehensive management, etc. shall be strengthened. Innovation on the administrative mode shall be achieved, and the online birth registration shall be promoted. Data barrier shall be eliminated to maintain clear data sharing channels between departments, regions, and sectors, a socialized information interconnection mechanism for health and medical data shall be explored, and the realization of concentration of health and medical data on platforms, transaction of business through platforms, and government policy-making relying on support from platforms shall be promoted. | | 1.加快建设统一权威、互联互通的人口健康信息平台。实施全民健康保障信息化工程，按照安全为先、保护隐私的原则，充分依托国家电子政务外网和统一数据共享交换平台，拓展完善现有设施资源，全面建成互通共享的国家、省、市、县四级人口健康信息平台，强化公共卫生、计划生育、医疗服务、医疗保障、药品供应、综合管理等应用信息系统数据采集、集成共享和业务协同。创新管理模式，推动生育登记网上办理。消除数据壁垒，畅通部门、区域、行业之间的数据共享通道，探索社会化健康医疗数据信息互通机制，推动实现健康医疗数据在平台集聚、业务事项在平台办理、政府决策依托平台支撑。 |
(2) Promoting the sharing and openness of health and medical big data resources: All kinds of health care institutions are encouraged to advance the collection and storage of health and medical big data, strengthen application support and technical guarantee for operations and maintenance, and open up the sharing channel of data resources. The development and improvement of basic databases with residents' electronic health files, electronic medical histories, electronic prescriptions, etc. at the center shall be accelerated. A health and medical data sharing mechanism featuring unified management and close cross-departmental cooperation between health, family planning, and Chinese medicine and education, technology, industry and information, public security, civil affairs, human resources and social security, environmental protection, agriculture, commerce, work safety regulation, inspection and quarantine, food and medicinal product regulation, sports, statistics, tourism, meteorology, insurance regulation, disabled persons' federation, etc. shall be established. The regulated entry of data resources generated from wearable devices, smart health electronic products, mobile health and medical applications, etc. into the population health information platforms shall be explored and advanced. A national health and medical data resource catalog system shall be established, policies and norms on the open application of health and medical big data by category, grade, and region shall be developed, and the openness of health and medical big data shall be steadily promoted.
．．．．．． | | 2.推动健康医疗大数据资源共享开放。鼓励各类医疗卫生机构推进健康医疗大数据采集、存储，加强应用支撑和运维技术保障，打通数据资源共享通道。加快建设和完善以居民电子健康档案、电子病历、电子处方等为核心的基础数据库。建立卫生计生、中医药与教育、科技、工业和信息化、公安、民政、人力资源社会保障、环保、农业、商务、安全监管、检验检疫、食品药品监管、体育、统计、旅游、气象、保险监管、残联等跨部门密切配合、统一归口的健康医疗数据共享机制。探索推进可穿戴设备、智能健康电子产品、健康医疗移动应用等产生的数据资源规范接入人口健康信息平台。建立全国健康医疗数据资源目录体系，制定分类、分级、分域健康医疗大数据开放应用政策规范，稳步推动健康医疗大数据开放。
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