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FDA will refuse new medical devices for cybersecurity reasons on Oct. 1 (scmagazine.com)
10 points by transpute on April 18, 2023 | hide | past | favorite | 3 comments



Good idea, but the time between announcement and deadline is pretty short. Hopefully this doesn't delay anything for redesign, and kill anyone who needs the device sooner than they can update it.


Every impediment to getting a new product on the market means people live without that product. In the case of medical products, that can have real consequences.

Assuming you are not on the MIT campus, the odds of someone hacking your medical device is practically 0%.

I have heard that my wife's diabetic Freestyle Libre 2 Continuous Glucose Monitor (CGM) was not able to be used with my phone because of security concerns. That meant that this disabled woman could not use her phone to check her blood sugar with the new Libre 2. So she used the outdated Libre 14-day. (Yes, the 2 is newer than the 14-day.) That meant she did not get alerts when her blood sugar went too high or too low. That had real consequences for her. All because someone wanted the software to be 100% hack proof against unrealistic scenarios.

Why not use the laws on the books? Anyone who hacks a medical device needs to go to prison on felony charges.


Im a libre2 user myself, i have to use the dedicated hardware reader as i also cannot use the abbot app.

I was also recently informed that with future versions of the libre patch the hardware reader I depend on will stop working.

The solution given to me by everyone else as if it isnt an insane notion "why not just get a secondary phone"

This has 2 possible interpretations

1. I buy a budget smartphone to handle my sensitive private medical data which likely will not be treated well with security updates as time goes on.

2. I buy a used smartphone that might also have similar baggage on top of potential compromise from the previous owner.

I've been a type1 diabetic for about a year now and I am DISGUSTED with how user hostile these companies are who design these solutions.

I feel like the worlds going mad considering the fact Im faced with the dilemma that my life literally is somewhat dependant on google play services




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