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