摘 要：
随着智能可穿戴设备向医疗健康领域深度渗透，其采集的生理参数、生物特征等敏感医疗数据呈爆发式增长，数据安全已成为制约行业高质量发展的核心瓶颈。本文基于数据全生命周期理论，结合《数据安全法》《个人信息保护法》等法规要求，先明确医疗数据保护与共享的辩证价值，再系统识别智能可穿戴设备在技术架构、管理机制与法律适配层面的多重风险，重点剖析医疗数据分级分类缺失、知情同意机制僵化等行业痛点，构建“技术防护-管理协同-法律保障”三维治理体系，提出动态防护、标准统一、授权优化等可落地路径，为平衡医疗数据保护与共享价值提供理论支撑与实践参考。
关键词：可穿戴设备；医疗数据；数据安全；数据保护；数据共享；风险识别；治理路径；数据治理
Abstract:
With the in-depth penetration of intelligent wearable devices into the medical and health field, the sensitive medical data collected such as physiological parameters and biometrics has experienced explosive growth, and data security has become a core bottleneck restricting the high-quality development of the industry. Based on the data lifecycle theory and in accordance with the requirements of laws such as the Data Security Law and the Personal Information Protection Law, this paper first clarifies the dialectical value of medical data protection and sharing, then systematically identifies multiple risks of intelligent wearable devices in terms of technical architecture, management mechanisms, and legal adaptation. It focuses on analyzing industry pain points such as the lack of medical data classification and grading, and the rigidity of the informed consent mechanism. Furthermore, a "three-dimensional governance system (technical protection - management coordination - legal guarantee)" is constructed, and practical paths such as dynamic protection, standard unification, and authorization optimization are proposed. This study provides theoretical support and practical references for balancing the value of medical data protection and sharing.
Keywords: Wearable devices; Medical data; Data security; Data protection; Data sharing; Risk identification; Governance paths; Data governance
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