Overcoming personal information protection challenges involving real-world data to support public health efforts in China

Author:

Yao Yu,Yang Fei

Abstract

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.

Publisher

Frontiers Media SA

Subject

Public Health, Environmental and Occupational Health

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