中国药物警戒 ›› 2015, Vol. 12 ›› Issue (6): 363-365.

• 药械安全性研究 • 上一篇    下一篇

智能医疗器械信息安全问题研究与对策

张晨光1,刘岩1,许伟1*   

  1. 1国家食品药品监督管理总局医疗器械技术审评中心，北京100044;
    2内蒙古医科大学第三附属医院骨科，内蒙古 包头014010
  • 收稿日期:2015-03-24 出版日期:2015-06-08 发布日期:2015-07-27
  • 通讯作者: 许伟，女，硕士，研究员，医疗器械审评。
  • 作者简介:张晨光，男，硕士，工程师，医疗器械审评信息化。

Research and Countermeasure for Information Safety of Intelligent Medical Devices

ZHANG Chen-guang1,LIU Yan2,XU Wei1*   

  1. 1Center for Medical Evaluation, CFDA, Beijing 100044, China;
    2Department of orthopedics, Baogang hospital, Inner Mongolia Baotou 014010, China
  • Received:2015-03-24 Online:2015-06-08 Published:2015-07-27

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摘要： 目的 分析互联网时代智能医疗器械面临的信息安全挑战，通过研究医疗器械智能化发展趋势和信息安全案例，提出应对智能医疗器械信息安全问题的对策和建议。方法 研究远程医疗系统、可穿戴类、植入类和智能假肢类医疗器械的应用进展和特点，分析美国FDA通报的医疗器械信息安全不良事件和安全公司的模拟测试。结果 网络攻击、木马病毒、软件质量问题和信息安全监管缺失是造成智能医疗器械信息安全问题的主要原因。结论 应对智能医疗器械信息安全问题，应完善政府监管方式和手段，充分利用社会力量对智能医疗器械生产使用的全过程进行安全管理。

关键词: 关键字：医疗器械, 智能, 信息泄露, 信息安全

Abstract: Objective To study the challenges of information safety problems on intelligent medical devices, analyze industry development tendency and two information safety cases, so as to put forward countermeasure and suggestion on how to improve information safety of intelligent medical devices. Methods Terminal medical systems, wearable medical devices, implantable medical devices, intelligent artificial limbs were deeply studied.An adverse event reporting from FDA and a simulation from the safety service company Cardinal were also analyzed. Results Network attacks, computer viruses, software defects and government regulation defects were the root causes of the safety problems. Conclusion Government regulation should be strengthened and improved, the 3rd party safety company should be fully involved in the R&D and application processes of intelligent medical device life cycle.

Key words: medical devices, intelligence, information leak, information safety

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