移动医疗网络安全监管策略研究

摘要

The cyber-security of mobile medical device is a new issue in the regulation of the medical device industry. On the one hand, the safety and integrity of data constitute the basis of big data collection and analysis, which impact the effectiveness of mobile medical device. On the other hand, the cyber communication function of mobile medical device not only involves with patients' privacy, but also has risks on hacker attack and even on health hazard, which impacts the safety of mobile medical device. Currently, various countries are publishing regulation documents on the cyber safety of mobile medical device. This paper summarized the regulation status in China and other countries, and provided suggestion on the enhancement of cyber safety regulation in China.%移动医疗器械的网络安全是医疗器械监管面临的一个新问题.一方面,数据的安全和完整性构成了大数据采集和分析的基础,涉及到医疗器械的有效性.另一方面,移动医疗器械的网络通信功能不仅涉及患者隐私,也存在被黑客攻击的风险,甚至会带来人身安全的危害,涉及医疗器械的安全性.目前,世界各国纷纷针对移动医疗器械的网络安全提出指导文件.本文对国内外监管情况进行了介绍,对加强我国移动医疗器械的网络安全监管提出了建议.