A woman used a raspberry pi and created FOSS software for it that basically serves the function of an artificial pancreas.
I wonder what are the liability risks in developing and making openly available such a system/platform. Given how litigious medical practice is, I wonder if someone could sue if a bug in this synthetic pancreas causes serious harm or death. I would expect to be able to do it if I was using a commercial product and I would expect that a free and open source replica would be covered under the same FDA guidelines for medical devices safety.
Said in other words, does offering a free and open source medical device exclude you from medical liability?
They aren’t selling a medical device. People are choosing to connect their insulin pump to a glucometer with a pi and using this woman’s software to facilitate how those two things communicate. In order to do this you have to have an understanding of the technology involved. The only person liable is yourself who choose to use a DIY solution. At least until laws are made to address questions of the place DIY medical devices have.
To be honest though, the risk of uncontrolled diabetes far outweighs whatever risk there is using these devices and no matter what diabetics have to have a backup way to check their blood sugar and keep insulin and glucose on hand for emergencies. I have a diabetic alert dog that helps me to manage my diabetes, but its still incredibly hard to keep blood sugar in a very narrow range.
DIY medical devices help make things more affordable and accessible to the disabled who often don’t have thousands of dollars to spend giving money to a company. Then to top everything off, you can’t see what the company’s medical device is made from or what the software looks like. I would much prefer to see the software in a pace maker or insulin pump than use something with hidden source code that I can’t change to match my own circumstances or that might have security issues which will never be updated and fixed. Like seriously, how often do you think the software in a pace maker is updated?