随着小数据时代逐步发展至如今的大数据时代，为回应时代发展、民生关切，自2021年11月起我国正式颁行《个人信息保护法》，作为新时代保护个人信息的立法前沿，采取了以知情同意规则为基础辅以例外合理使用的特定情形，但是在实践中由于科技和社会的发展，知情同意规则的适用面临了挑战甚至有流于形式的风险，故本文立足于大数据时代的背景，研究个人信息保护中的知情同意规则，探明实践中的困境和理论上的困境，结合域外经验，为优化知情同意规则提供建议。本文共分为四个部分：

第一部分为知情同意规则的概念和法律属性。论文以现行法和学理为出发点，结合《民法典》和《个人信息保护法》有关法律条文，梳理我国知情同意规则的法律规定并进行学理阐述，探析知情同意规则各个环节的法律属性，明确其作为法律行为的效力以及在信息主体和信息处理者之间以合同的方式形成法律关系。

第二部分为知情同意规则的适用困境。通过将知情同意规则在实践中遇到的问题归纳分类，总结出现实困境与理论困境，一方面研究其由于信息主体和信息处理者之间地位悬殊而导致的信息主体同意效力出现瑕疵，对于行业和信息处理者的监管落实不到位，以及信息主体发现侵权行为后难以获得救济等问题，另一方面，结合其法律属性，分析因理性人假设和信息自决权而导致的理论困境。

第三部分为知情同意规则的域外考察。该部分主要分析欧盟及美国现行法律体系下，有关个人信息保护中涉及知情同意规则的内容，分析欧盟以GDPR为核心构建的严格保护个人信息安全的体系以及美国以行业自律和单行法规构建的强调经济效益的信息保护体系，归纳出欧盟及美国各自模式的优势所在，分析其不足，为我国的知情同意规则改进提供借鉴。

第四部分为知情同意规则的优化。在探明知情同意规则实践、理论中的困境以及域外经验考察的基础上，为知情同意规则各环节分别提供改进建议。在告知环节信息处理者需要改进告知的形式、内容以及有差异化的管理，在同意环节信息主体对不同敏感度信息可以采用不同的同意形式来衡平地位悬殊，扭转默示同意滥用现象，同时明确知情同意规则的适用范围，切实改进知情同意规则的实效。

With the gradual development of the small data era to the current big data era, in response to the development of the times and people's concerns, China has successfully executed the Personal Information Protection Law since November 2021. As the forefront of legislation for protecting personal information in the new era, it adopts specific situations based on informed consent rules and supplemented by exceptional and reasonable use. However, in practice, due to the development of technology and society, the application of informed consent rules faces challenges and even risks of being superficial. Therefore, this article is based on the background of the big data era, studying the informed consent rules in personal information protection, analyzing the difficulties and extraterritorial experiences that arise in practice, and providing suggestions for optimizing informed consent rules. This article is categorized as having no more than four divisions：

The conceptual and legal essence of the rule of the consent regime is set out in Part I.Starting from current laws and academic principles, this paper combines relevant legal Pursuant to the Civil Code and the Act on the Conservation of Privacy of Personal Documents to sort out the legal provisions of China's informed consent rules and provide theoretical explanations. It analyzes the necessity of applying the informed consent rules and explores the legal attributes of each link of the informed consent rules, clarifying their effectiveness as legal acts and forming legal relationships between information subjects and information processors through contracts.

The second component is the predicament of the application of the rule of prior knowledge as it applies to informed choice. By categorizing the problems encountered by the informed consent rule in practice and summarizing the practical and theoretical dilemmas, on the one hand, this study investigates the flaws in the effectiveness of information subject consent caused by the disparity in status between information subjects and information processors, the inadequate supervision and implementation of industry data subjects and digital filers, as well as the fact that it is difficult for media subjects to obtain remedies after discovering infringement. On the other hand, based on its legal attributes, this study analyzes the theoretical dilemmas caused by the assumption of rational persons and the right to information self-determination.

Part III provides an extraterritorial look at the informed consent rule. This part primarily addresses the specificity of the institutional rules on individual informants' consent for the protection of their person under the current EU legal system and the United States, analyzes the strict protection of personal information security system constructed by the European Union with GDPR as the core, and the information protection system constructed by the United States with industry self-discipline and single line regulations to emphasize economic benefits. It summarizes the advantages of the respective models of the European Union and the United States, analyzes their shortcomings, compares regimes in China, and provides experience reference.

The fourth part is the optimization of the informed consent rule. On the basis of studying the difficulties of informed consent rules in practice and examining external experiences, improvement suggestions are provided for each stage of Predictable consensuses for informed assents. Handlers of data at the point of transmittal need to improve the quality of the transmittal, its volume, and its customized management. In the consent stage, information subjects can use different forms of consent for different sensitivity information to balance the status gap, address the erosion of the misuses of  silent assent, and specify the framework for the implementation of the relevant guiding principles of qualified approval, effectively improving the effectiveness of the informant's assent code.