FDA Safety Communication on Cybersecurity Vulnerabilities

Today, the U.S. Food and Drug Administration (FDA) issued a safety communication to alert health care providers and patients about cybersecurity vulnerabilities identified in a wireless telemetry technology used for communication between Medtronic’s implantable cardiac devices, clinic programmers, and home monitors. The wireless telemetry protocol has cybersecurity vulnerabilities because it does not use encryption, authentication, or authorization. The FDA has confirmed that these vulnerabilities, if exploited, could allow an unauthorized individual (for example, someone other than the patient’s physician) to access and potentially manipulate an implantable device, home monitor, or clinic programmer. Medtronic is working on security updates. The full safety communication is at: https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm633960.htm

FDA and 62304 Training – Boston – June 4-6, 2019

3-day course is designed to gain an understanding of how 62304 and other standards can be implemented efficiently and effectively while meeting FDA expectations as well.  John F. Murray, Jr., will be among the faculty!
The discounted April registration expires on April 30, 2019, or when all discounted seats are sold.

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