可穿戴技术发展迅速，在医疗领域的研究与应用日益增长。健康医疗可穿戴设备已成为新型智慧医疗智慧健康的重要组成部分，能够帮助人们更好地进行健康管理和临床治疗。其采集了大规模与用户健康直接相关的生理、行为等数据，这些数据背后隐藏了巨大的商业价值和社会价值。但由于可穿戴设备自身技术缺陷、数据流通环节管控缺失等诸多方面的问题，导致数据泄露、数据滥用等事件频发，对用户个人安全、患者生命安全和国家社会安全带来巨大威胁，引起各国政府和行业的高度重视。因此，本研究着重开展健康医疗可穿戴设备数据安全与隐私保护问题研究，希望能够对该领域问题的解决提供一些有益建议。

研究主要包括：

（1）系统梳理国内外法律政策制定及文献研究情况，发现相关研究主要从隐私保护意识、法律政策呼吁和数据保护技术等方面开展，但隐私安全问题分析的全面和深入性不足，且未将数据及其流动环节作为分析对象、缺少对安全和隐私相关角色主体责任的探讨以及存在缺少针对性法律政策等问题；

（2）界定健康医疗可穿戴设备数据安全与隐私保护概念，将健康医疗可穿戴设备与传统医疗模式的数据、数据安全与隐私特点进行比较分析，进而总结出其具有数据流动环节复杂、涉及角色主体多、传输介质与数据格式多样性和缺乏统一标准等特点；

（3）分析健康医疗可穿戴设备数据安全与隐私保护现存问题。剖析健康医疗可穿戴设备数据内容和数据流通路径，对采集、上传、集成交互、信息反馈各阶段中导致数据及隐私泄露的途径进行分析。开展健康医疗可穿戴设备数据安全与隐私保护意识与伦理问卷调查，分析用户隐私保护与他人隐私尊重中存在的问题，尝试从多方面总结健康医疗可穿戴设备数据安全与隐私保护现存问题；

（4）针对现存问题和结合我国国情，提出健康医疗可穿戴设备数据安全与隐私保护对策，包括四方面：①法律层面，应出台个人数据保护、数据安全管理和商业应用监管等法律法规；②管理层面，建立对政府权力滥用监督、出台国家和行业标准规范、完善数据使用追责机制和培养高级隐私保护专业人才等；③技术层面，要建立分级数据管控模式、应用多重数据加密和用户身份认证技术、优化设备场景识别和远程控制能力等；④伦理层面，应保障用户知情同意权利、在数据利用前开展风险评估工作、并通过隐私保护宣传和设备信息提示多途径帮助从业人员及用户提升健康医疗可穿戴设备数据安全与隐私保护意识，并结合专家咨询建议优化对策。

综上，本研究分析了健康医疗可穿戴设备数据及数据安全与隐私特点，基于数据内容和流动环节、用户伦理意识等多维度全面分析、总结健康医疗可穿戴设备数据安全与隐私保护的现存问题，从四个层面提出建立数据分级保护方案、完善数据使用追责机制等建议，为后续相关研究与工作实施提供理论参考。

Wearable technology is growing rapidly and its research and application in the medical field is growing. Health and medical wearable devices have become an important part of the new intelligent medicine and health, which can help people do better health management and clinical treatment. Health and medical wearable devices collects large numbers of data, such as physiology and behavior that are directly related to the health of the user, and hides the enormous commercial value and social value behind these data. However, due to the technical defects of the wearable devices and lack of control of data flow and other aspects of the problems, resulting in data leakage, data abuse and other events frequently, the user's personal safety, patient safety and national social security poses a huge threat, causing countries government and industry attach great importance. Therefore, this research mainly focuses on the research on data security and privacy protection of health and wearable devices, hoping to provide some useful suggestions for solving the problem in this field.

This research includes following aspects:

(1) Systematically combing domestic and foreign legal policy formulation and literature research, and we found that the relevant research carried out mainly from the privacy protection awareness, legal policy appeal and data protection technology and other aspects. But the analysis of security and privacy issues lacked comprehensiveness and depth, and didn’t analyzed the data and its flow as the object of analysis, had shortage of discussion of the responsibilities of security and privacy related to the main role and lacked of existence of targeted legal policy and other issues;

(2) This paper defined the concept of health and medical wearable devices data security and privacy protection, and compared it’s characteristics with traditional medical pattern from data, data security and privacy two aspects, and then summed up the characteristic of health and medical wearable data that has complexity of data flow, involving many main participants, transmission medium and data format diversity, and lack of uniform standards and so on.

 (3) This research analyzed the health and medical wearable devices data security and privacy existing problems, and the ways of data and privacy leakage from data flow including collection, upload, integration and interaction, and information feedback. And this research carried out questionnaire about the awareness and ethical issues of health and medical wearable devices data security and privacy protection of health and medical wearable devices, then analyzed existing problems on user’s privacy awareness and ethic respect for others’ privacy. In order to conclude the problems of health and medical wearable devices data security and privacy in multiple ways;

(4) Targeting existing problems and combining our country status, this research put forward the health and medical wearable devices data security and privacy countermeasure, including four aspects: ① At the legal level, our country should introduce personal data protection, data security management and business application regulations and so on; ② At management level, it is necessary to establish the supervision of the abuse of government rights, introduce national and industry standards and regulations, improve the accountability mechanism for the use of data and train more advanced privacy protection professionals, and so on.③Technically, we should establish a health and wearable devices data grading management mode, use multiple data encryption and user authentication technology, and optimize the health and medical wearable devices scene recognition and remote control capabilities, and so on.④ Ethically, we need to protect the right of informed consent of users, carry out risk assessment before using data, and help related practitioners and users to enhance health and medical wearable device data security and privacy awareness through privacy data protection propaganda and device interface information tips. At last, combined the expert consultation advices to optimize the health and medical wearable devices data security and privacy protection strategy.

In summary, this research analyzed the data and data security and privacy characteristics of health and medical wearable devices, and analyzed the existing problems of data security and privacy protection of health and medical wearable devices based on the comprehensive analysis of data content, data flow and users' ethical awareness. The research put forward some suggestions on the establishment of data grading protection solution, perfecting the use mechanism of data and so on, and hope to provide theoretical reference for the follow-up research and work implementation.