Reminder from FDA: Cybersecurity for Networked Medical Devices is a Shared Responsibility
MedSun: Newsletter #43, December 2009

FDA Medical Device Safety website

FDA wants to remind you that cybersecurity for medical devices and their associated communication networks is a shared responsibility between medical device manufacturers and medical device user facilities. The proper maintenance of cybersecurity for medical devices and hospital networks is vitally important to public health because it ensures the integrity of the computer networks that support medical devices. FDA is aware of misinterpretation of the regulations for the cybersecurity of medical devices that are connected to computer networks. FDA’s interpretation of the regulations can be found in the 2005 guidance for industry and its accompanying information for healthcare organizations.

Additional Information:

FDA Medical Device Safety website. Reminder from FDA: Cybersecurity for Networked Medical Devices is a Shared Responsibility. November 4, 2009.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm189111.htm


MedSun Newsletters are available at www.fda.gov/cdrh/medsun