Paradigm Transformation of Global Health Data Regulation: Challenges in Governance and Human Rights Protection of Cross-Border Data Flows.

IF 2.7 4区 医学 Q2 HEALTH CARE SCIENCES & SERVICES Risk Management and Healthcare Policy Pub Date : 2024-12-21 eCollection Date: 2024-01-01 DOI:10.2147/RMHP.S450082
Linhua Xia, Zhen Cao, Yue Zhao
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Abstract

The growing global exchange of healthcare data requires more cohesive and effective regulatory frameworks to ensure fair access and protect patient privacy. However, cross-border regulatory rules for healthcare data diverge across countries, such as the EU, which highlights personal data rights and restricts cross-border flow of healthcare data through the GDPR, the United States, which emphasizes the free flow of healthcare data trade or services, and China, which emphasizes cross-border regulatory rules for healthcare data at the level of national data security. Such inconsistent policies often impede international medical research collaborations, undermine the effectiveness of telemedicine, and create barriers for healthcare providers to share patient information. Documents containing national human rights laws, the Global Initiative on Digital Health and the Global Digital Compact, which advocate for cooperation and behavioral co-regulation of healthcare data stakeholders to achieve the strategic goal of putting people at the center of healthcare, provide new ideas for solving the problem. Based on an exploration of these challenges, this paper proposes a harmonized, human rights-based approach that in turn bridges regulatory gaps and ensures data security, privacy, and accessibility in all countries.

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全球卫生数据监管的范式转变:跨境数据流治理和人权保护方面的挑战。
日益增长的全球医疗保健数据交换需要更具凝聚力和有效性的监管框架,以确保公平访问和保护患者隐私。然而,医疗保健数据的跨境监管规则在各国之间存在差异,例如欧盟强调个人数据权利,并通过GDPR限制医疗保健数据的跨境流动,美国强调医疗保健数据贸易或服务的自由流动,而中国则强调医疗保健数据在国家数据安全层面的跨境监管规则。这种不一致的政策往往阻碍国际医学研究合作,破坏远程医疗的有效性,并为卫生保健提供者共享患者信息制造障碍。载有国家人权法、《数字健康全球倡议》和《全球数字契约》的文件为解决这一问题提供了新思路,这些文件倡导医疗保健数据利益攸关方进行合作和行为协同监管,以实现将人置于医疗保健中心的战略目标。在对这些挑战进行探讨的基础上,本文提出了一种统一的、基于人权的方法,从而弥合监管差距,确保所有国家的数据安全、隐私和可访问性。
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来源期刊
Risk Management and Healthcare Policy
Risk Management and Healthcare Policy Medicine-Public Health, Environmental and Occupational Health
CiteScore
6.20
自引率
2.90%
发文量
242
审稿时长
16 weeks
期刊介绍: Risk Management and Healthcare Policy is an international, peer-reviewed, open access journal focusing on all aspects of public health, policy and preventative measures to promote good health and improve morbidity and mortality in the population. Specific topics covered in the journal include: Public and community health Policy and law Preventative and predictive healthcare Risk and hazard management Epidemiology, detection and screening Lifestyle and diet modification Vaccination and disease transmission/modification programs Health and safety and occupational health Healthcare services provision Health literacy and education Advertising and promotion of health issues Health economic evaluations and resource management Risk Management and Healthcare Policy focuses on human interventional and observational research. The journal welcomes submitted papers covering original research, clinical and epidemiological studies, reviews and evaluations, guidelines, expert opinion and commentary, and extended reports. Case reports will only be considered if they make a valuable and original contribution to the literature. The journal does not accept study protocols, animal-based or cell line-based studies.
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