澳大利亚健康医疗数据跨境流动法律规制研究及其对中国的启示
摘要： 跨境远程医疗、药品和疫苗临床试验的国际合作、跨境学术研讨与临床研究等业务的发展使健康医疗数据跨境流动已成为不可逆趋势。健康数据跨境流动规则需要在维护国家卫生安全、保护公民隐私以及促进健康产业发展等目标和政策之间寻求平衡。本文运用文献研究、比较分析等方法，对澳大利亚健康医疗数据跨境的立法规制与监管机制进行研究。研究结果显示，澳大利亚高度重视健康医疗数据的保护，通过设立专门机构和系统的立法，对可识别个人的健康数据的跨境流动进行严格监管。我国应构建科学、完整、严密的健康数据保护、跨境流动的法律与政策体系，将法律法规与政策指南有机结合、配套实施；完善健康医疗数据出境标准合同条款，发挥标准合同监管功能；积极利用现有健康数据的分级分类，构建灵活多样的健康数据出境规制模式；加强与"一带一路"沿线国家，尤其是东盟成员国在健康数据跨境流动领域的交流和合作。
关键词: 数据管理, 健康医疗数据, 跨境流动, 分级分类, 数据安全, 风险控制
Abstract:
With the development of cross-border telemedicine, international cooperation in clinical trials of drugs and vaccines, cross-border academic discussions and clinical research, cross-border flow of health and medical data has become an irreversible trend. Rules for cross-border flow of health data require doing a balance among the objectives and policies of maintaining national health security, protecting citizens' privacy, and promoting the development of health industry. This paper uses literature research, comparative analysis and other methods to study the legislative regulation and regulatory mechanism of cross-border health data in Australia. The study's findings reveal that Australia prioritizes health data security, enforcing stringent oversight on the cross-border movement of personally identifiable health data through dedicated agencies and comprehensive legislation. China should build a scientific, complete and strict legal and policy system for health data protection and cross-border flow, and organically combine and implement laws and regulations with policy guidelines; improve the terms of standard contract for health data exit and play the function of the standard contract for regulation; actively use the existing hierarchical classification of health data to build a flexible and diverse health data exit regulation model; and strengthen exchanges and cooperation with countries along the "Belt and Road", especially ASEAN member countries, in the field of cross-border health data flow.
Key words: Data management, Health data, Cross-border flow, Hierarchical classification, Data security, Risk control
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