智能医疗器械信息安全问题研究与对策
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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。
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.
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.
引文
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[12]张强,刘胜林,严毅,等.对2005-2006年美国FDA召回的医疗器械产品分析[J].中国医疗器械杂志,2011,35(4):280-283.
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[14]俞思聪,潘鹰,俞西萍,等.国内外医疗器械软件安全性评价方法比较研究[J].中国医疗器械杂志,2010,(5):360-364.
[15]王兰明.中国医疗器械注册管理工作的现状与思考[J].中国医疗器械信息,2012,(11):28-34.
[16]王璐野.论个人医疗信息的法律保护[D].西南政法大学,2012:21-22.
[2]李燕静.浅析我国医疗器械行业发展状况及其建议[J].中国外资月刊,2013,(7):124-125.
[3]李月恩,王红霞.浅析医疗器械行业中的工业设计[J].中国医疗器械信息,2006,12(1):5-6.
[4]洪华峰.家庭便携式远程医疗监护器的研究与设计[D].厦门:华侨大学,2007:15-21.
[5]陈荣佳.可穿戴设备瞄准医疗健康领域[J].软件和信息服务,2014,(9):16-16.
[6]来欣,王.心脏起搏器的临床应用进展[J].疑难病杂志,2014,(11):1197-1198.
[7]戴宇.用于人工假肢的分布式柔性电容触觉传感器的设计与制造[D].浙江大学,2014:34-39.
[8]Connolly C.Prosthetic hands from Touch Bionics[J].Industrial Robot:An International Journal,1973,35(4):290-293.
[9]金雷,谢立.网络安全综述[J].计算机工程与设计,2003,24(2):19-22.
[10]FDA.Cardinal Health Alaris Infusion Pump Module(formerly Medley Pump Module),Model 8100 Class 1 Recall[EB/OL].(2007-10-29)[2015-02-24].http://www.fda.gov/Medical Devices/Safety/Listof Recalls/ucm062366.htm.
[11]中国网.韩国爆出医疗器械因连接网络也有可能被黑客攻击[EB/OL].(2013-08-07)[2015-02-24].http://www.china.com.cn/news/world/2013-08/07/content_29648627.htm.
[12]张强,刘胜林,严毅,等.对2005-2006年美国FDA召回的医疗器械产品分析[J].中国医疗器械杂志,2011,35(4):280-283.
[13]Gardner B.Building an Information Security Awareness Program[M].Waltham:Elsevier,2014:15-24.
[14]俞思聪,潘鹰,俞西萍,等.国内外医疗器械软件安全性评价方法比较研究[J].中国医疗器械杂志,2010,(5):360-364.
[15]王兰明.中国医疗器械注册管理工作的现状与思考[J].中国医疗器械信息,2012,(11):28-34.
[16]王璐野.论个人医疗信息的法律保护[D].西南政法大学,2012:21-22.