3 ms·

I'm sure you know this, but giving someone a large and unexpected bolus of insulin is a good way to kill them, particularly if they are asleep. If I were desig

I'm sure you know this, but giving someone a large and unexpected bolus of insulin is a good way to kill them, particularly if they are asleep. If I were designing an artificial electronic pancreas like that, I would be super, super paranoid. It's probably one of the few medical devices that I really think should be a strong user of asymmetric cryptography with a challenge-response-challenge-response protocol and multiple independent sanity-checking validation steps at every opportunity. If it can't deliver the bolus it thinks you need, it should alarm loudly and tell you to manually check. If it has a bit flip in the night and slowly drives 255 units of insulin into your bloodstream at 3 am, you won't wake up.

gmueckl 5y ago
I would expect that any modern insulin pump is required to be protected very thoroughly against random malfunctions. Some certification authorities seem to require IEC 61508 (functional safety) as a prerequisite for IEC 60601 (safety of medical equipment). IEC 61508 kind of requires self-monitoring against malfunctions in a reliable way. This includes mechanisms for detecting random bit flips if these can cause potential harm.
omh 5y ago
You're right that an artificial pancreas needs to be super careful. The diabetes community got started on this before the official manufacturers did. Probably in part because the manufacturers were concerned about being 100% bulletproof whereas (some) people living with diabetes were willing to take a bit more risk. And there's a balance around alarms. Some glucose monitoring tech can be frustrating and lead to "alarm fatigue". Most of the artificial pancreases I'm aware of mitigate some of the risk by rarely sending large boluses at all. They tend to adjust the background basal rate and only send a bolus when you explicitly tell them you've eaten.

gmueckl 5y ago

I would expect that any modern insulin pump is required to be protected very thoroughly against random malfunctions. Some certification authorities seem to require IEC 61508 (functional safety) as a prerequisite for IEC 60601 (safety of medical equipment). IEC 61508 kind of requires self-monitoring against malfunctions in a reliable way. This includes mechanisms for detecting random bit flips if these can cause potential harm.

omh 5y ago

You're right that an artificial pancreas needs to be super careful. The diabetes community got started on this before the official manufacturers did. Probably in part because the manufacturers were concerned about being 100% bulletproof whereas (some) people living with diabetes were willing to take a bit more risk. And there's a balance around alarms. Some glucose monitoring tech can be frustrating and lead to "alarm fatigue". Most of the artificial pancreases I'm aware of mitigate some of the risk by rarely sending large boluses at all. They tend to adjust the background basal rate and only send a bolus when you explicitly tell them you've eaten.