Xia Linhua, Cao Zhen, Zhao Yue
School of Economics, Shenzhen Polytechnic University, Shenzhen, Guangdong, People's Republic of China.
School of Law, Hainan University, Haikou, Hainan, People's Republic of China.
Risk Manag Healthc Policy. 2024 Dec 21;17:3291-3304. doi: 10.2147/RMHP.S450082. eCollection 2024.
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.
全球医疗保健数据交流日益频繁，这就需要更具凝聚力和有效性的监管框架，以确保公平获取并保护患者隐私。然而，各国针对医疗保健数据的跨境监管规则存在差异，例如欧盟强调个人数据权利，并通过《通用数据保护条例》（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；而中国则在国家数据安全层面强调医疗保健数据的跨境监管规则。这种不一致的政策常常阻碍国际医学研究合作，削弱远程医疗的有效性，并给医疗服务提供者共享患者信息造成障碍。包含国家人权法、全球数字健康倡议和全球数字契约的文件倡导医疗保健数据利益相关者进行合作和行为共同监管，以实现将人置于医疗保健中心的战略目标，为解决这一问题提供了新思路。基于对这些挑战的探索，本文提出了一种基于人权的统一方法，进而弥合监管差距，并确保所有国家的数据安全、隐私和可及性。
