As a heart patient myself, I’m intrigued by the cyber-security aspects of these implantable devices. I think we’re going to see a lot in this area in the short-term.
Many medical devices—including Abbott’s ICD and CRT-D devices—contain configurable embedded computer systems that can be vulnerable to cybersecurity intrusions and exploits. As medical devices become increasingly interconnected via the Internet, hospital networks, other medical devices, and smartphones, there is an increased risk of exploitation of cybersecurity vulnerabilities, some of which could affect how a medical device operates.”
Source: Safety Communications > Battery Performance Alert and Cybersecurity Firmware Updates for Certain Abbott (formerly St. Jude Medical) Implantable Cardiac Devices: FDA Safety Communication
Alexa is always listening…..
Source: Alexa, Fitbit and Apple Watch are your digital snitches – CNET
In today’s digital world, Big Brother may be on your wrist, in your room — or inside your heart.
New warning letters out! These are largely GMP-specific. Like no other agency, FDA is reknowned for updating regulations via warning letter (rather than the onerous process of getting an actual new or updated regulation approved)….so it is good to always keep an eye on these to be clear on “FDA’s current thinking”. YMMV. In any case, check out the full information at the link below!
Source: Week of Mar 25th 2018 | FDA Sent These Warning Letters to Pharma Companies | FDAZILLA BLOG
FDA posted 8 warning letters this week, including:
I found this Ted Talk Statistics Ted Talk to be very entertaining….Enjoy