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If you have a safety-critical decision maker running on Android doesn't that raise the criticality of the OS (provided there is no other fall-back)? For the re
by DoingIsLearning 3y ago
If you have a safety-critical decision maker running on Android doesn't that raise the criticality of the OS (provided there is no other fall-back)?
For the regulatory people out there, how does this align in terms of risk management in the world of IEC 62304?
- iancmceachern 3y agoMany other similar devices use all types of OSS. You just need to make sure it fails safe. If the OS or any software hangs or crashes just make sure the thing turns off and doesn't dump all the insulin or anything.
- birdman3131 3y agoI would want a beep or something to let me know it had disconnected. (Also a low battery alarm as well.) On the device not on the phone. And the phone should have the same thing if the device does not respond to a heartbeat signal.
- deleted 3y ago[deleted]
- DoingIsLearning 3y agoBut this is the mitigations I am asking in terms of risk management. Perhaps people using the app can comment if any of this is already implemented?
- nshepperd 3y agoI have an AndroidAPS. This is how it works. If the phone loses contact for any reason the device just falls back to delivering insulin at a fixed rate as normal.