Specifications and details here: https://openaps.readthedocs.io/en/latest/
The code is hosted on GitHub, and is against Microsoft's Terms and Conditions, for obvious reasons. Still, nothing is done about it.
It's not uncommon for these engineers to have a 'if I am incapacitated, do not hook me up to these devices' card in their wallet like you'd normally see for alllergies for products they've worked on.
Also, these projects were designed on purpose to circumvent or in some cases break the law, which is the wrong approach to medical device design. It's dangerous and designs kill, as you know.
See this stipulation (and control/command + f = "commercial" in paper):
27) ‘making available on the market’ means any supply of a device, other than an investigational device, for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge;
Also:
46) ‘investigational device’ means a device that is assessed in a clinical investigation
Also:
1) ‘medical device’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:
— diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,
Also:
(19) It is necessary to clarify that software in its own right, when specifically intended by the manufacturer to be used for one or more of the medical purposes set out in the definition of a medical device, qualifies as a medical device, while software for general purposes, even when used in a healthcare setting, or software intended for life-style and well-being purposes is not a medical device. The qualification of software, either as a device or an accessory, is independent of the software's location or the type of interconnection between the software and a device.
IMO, yeah, community approaches might not be the ideal solution, but when it comes to my health it's the better of the two options I have (community that I can actually look at the implementation of vs. proprietary that I know has systemic regulatory issues and is a crap shoot on if it is actively killing people and the engineers who worked on it don't ever want it used on them). If it comes down to it I'm going to choose my health over legality every time.
This could be done to keep the professionals on their toes without resorting to relying on random unvetted software.
They could even take pull requests, as long as the company takes responsibility for them.
Thanks, I am aware of this. It's called a block diagram, and is standard safety design. See page 3: https://pdfserv.maximintegrated.com/en/an/AN4675.pdf
I don't mean to single out you specifically, I keep noticing it now.
I was going to say (did type) that I can't think of another word that's used in the same sort of declaratory way - but actually, as I wrote, it occurred to me that 'funny' is too.
'Funny, I just never noticed it with 'sad' until a few years ago.'
Of course, those insulin pumps are running insecure firmware allowing for adjustments to be made remotely by an sbc (Raspberry Pi) where the OpenAPS software lives and takes measurements from a GCM. Without the insecure remote interface on those insulin pumps, OpenAPS might not exist.
I'm not sure it's moral to attack such a project built and maintained by diabetics who simply want to provide for themselves a better quality of life.
This is the issue here, with a cyber to physical attack, which is bound to happen at some point, with some medical device, and this project is a huge target for something like that. This project was specifically mentioned in the book "Click Here to Kill Everybody" by renowned cybersecurity expert Bruce Schriener, too.
OpenAPS was also designed to circumvent government laws, and is not-as-legal as the creators portray it to be. For example, one of the main "advocates" calls OpenAPS an "off-label qualification" for use (in the USA), when in order for that to apply, the specific device intended to be used must be FDA approved. As you know, OpenAPS cannot be FDA approved at this point of time. This individual also illegally markets unapproved medical devices across the United States, Europe, Australia, and New Zealand, plus online, with various gatherings for it. If you look at the specific laws of those lands, it is pretty clear cut what is going on is illegal. Plus, the new EU Medical Devices Regulation applies now.
Yes, it is illegal. I am astonished that this individual has not gotten in trouble with the FDA yet.
The key to safety is that hardware itself a) shows the real state of things and b) has safety mechanisms in place such that even the most malignant control software would be no worse than poorly timed manual dosing.
What are the obvious reasons?