摘要： 跨境遠(yuǎn)程醫(yī)療、藥品和疫苗臨床試驗的國際合作、跨境學(xué)術(shù)研討與臨床研究等業(yè)務(wù)的發(fā)展使健康醫(yī)療數(shù)據(jù)跨境流動已成為不可逆趨勢。健康數(shù)據(jù)跨境流動規(guī)則需要在維護(hù)國家衛(wèi)生安全、保護(hù)公民隱私以及促進(jìn)健康產(chǎn)業(yè)發(fā)展等目標(biāo)和政策之間尋求平衡。本文運(yùn)用文獻(xiàn)研究、比較分析等方法，對澳大利亞健康醫(yī)療數(shù)據(jù)跨境的立法規(guī)制與監(jiān)管機(jī)制進(jìn)行研究。研究結(jié)果顯示，澳大利亞高度重視健康醫(yī)療數(shù)據(jù)的保護(hù)，通過設(shè)立專門機(jī)構(gòu)和系統(tǒng)的立法，對可識別個人的健康數(shù)據(jù)的跨境流動進(jìn)行嚴(yán)格監(jiān)管。我國應(yīng)構(gòu)建科學(xué)、完整、嚴(yán)密的健康數(shù)據(jù)保護(hù)、跨境流動的法律與政策體系，將法律法規(guī)與政策指南有機(jī)結(jié)合、配套實施；完善健康醫(yī)療數(shù)據(jù)出境標(biāo)準(zhǔn)合同條款，發(fā)揮標(biāo)準(zhǔn)合同監(jiān)管功能；積極利用現(xiàn)有健康數(shù)據(jù)的分級分類，構(gòu)建靈活多樣的健康數(shù)據(jù)出境規(guī)制模式；加強(qiáng)與"一帶一路"沿線國家，尤其是東盟成員國在健康數(shù)據(jù)跨境流動領(lǐng)域的交流和合作。

關(guān)鍵詞: 數(shù)據(jù)管理, 健康醫(yī)療數(shù)據(jù), 跨境流動, 分級分類, 數(shù)據(jù)安全, 風(fēng)險控制

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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