Postmarket Management of Cybersecurity in Medical Devices
Guidance for Industry and Food and Drug Administration Staff
Document issued on December 28, 2016.
The draft of this document was issued on January 22, 2016.
Over the past sixteen years with the approval of 802.11b virtually every mobile medical device (infusion pumps and patient monitors), among other devices have been “in a wireless fashion connected”. That does not include other devices such as C-arms or other fixed medical equipment that might be connected to a network port by ethernet.
The changes in the wireless enterprise from a security standpoint are evolving at a rapid rate and need to be taken into account during both the design and the entire product life cycle of the medical device. Security encompasses the entire ecosystem from wireless and wired medical devices, as well as during hardware and software updates. It is an on-going management and testing process.
Attachment One: Postmarket Management of Cybersecurity in Medical Devices
Guidance for Industry and Food and Drug Administration Staff
Document issued on December 28, 2016.
The draft of this document was issued on January 22, 2016.
Attachment Two: Is the Health Care Cyber Breach Report for 2016 December 2016 from
by TrapX Labs A Division of TrapX Security, Inc.
Attachment Three:
Learn Cybersecurity the Healthcare Way
http://www3.gehealthcare.com/en/education/clinical_education/cybersecurity_essentials_for_healthcare
Your cybersecurity challenges are unique to healthcare.
(c) 2016 General Electric Company JB37816xx
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