School of Law, China Jiliang University, Hangzhou, China.
Front Public Health. 2023 Sep 22;11:1265050. doi: 10.3389/fpubh.2023.1265050. eCollection 2023.
In the information age, real-world data-based evidence can help extrapolate and supplement data from randomized controlled trials, which can benefit clinical trials and drug development and improve public health decision-making. However, the legitimate use of real-world data in China is limited due to concerns over patient confidentiality. The use of personal information is a core element of data governance in public health. In China's public health data governance, practical problems exist, such as balancing personal information protection and public value conflict. In 2021, China adopted the Personal Information Protection Law (PIPL) to provide a consistent legal framework for protecting personal information, including sensitive medical health data. Despite the PIPL offering critical legal safeguards for processing health data, further clarification is needed regarding specific issues, including the meaning of "separate consent," cross-border data transfer requirements, and exceptions for scientific research. A shift in the law and regulatory framework is necessary to advance public health research further and realize the potential benefits of combining real-world evidence and digital health while respecting privacy in the technological and demographic change era.
在信息时代，基于真实世界数据的证据可以帮助推断和补充随机对照试验的数据，从而使临床试验和药物研发受益，并改善公共卫生决策。然而，由于对患者隐私的担忧，真实世界数据在中国的合法使用受到限制。个人信息的使用是公共卫生数据治理的核心要素。在中国的公共卫生数据治理中，存在着平衡个人信息保护和公共价值冲突等实际问题。2021 年，中国通过了《个人信息保护法》（PIPL），为保护个人信息，包括敏感的医疗健康数据，提供了一致的法律框架。尽管《个人信息保护法》为处理健康数据提供了关键的法律保障，但仍需要进一步明确具体问题，包括“单独同意”的含义、跨境数据传输要求以及科学研究的例外情况。需要改变法律和监管框架，以推进公共卫生研究，并在技术和人口变化时代，在尊重隐私的前提下，实现将真实世界证据和数字健康相结合的潜在好处。
