We’re talking about people with disabilities, and depending on what you’re doing with AI, it can get organized under being a medically assistive device, which suddenly becomes an FDA issue.
Ask the people who run Open Source projects aimed at opening up things like Glucose monitors or CPAP machines. They are harangued by the FDA. The FDA claims the projects are dangerous and that only professionals and doctors should have any ability to modify them.
October 2023: FDA finalizes guidance mandating that all medical devices running software must create and maintain a software bill of materials (SBOM), including for open-source software.
Still, the point being is that to develop Open Source medical software, you’re going to be dealing with potential regulations that you must pass to be able to legally release the software in places like the USA (you can always host the files in some country that doesn’t give a shit). Achieving meeting the regulation can often drastically increase the cost of development. Open Source projects can’t just magic up more money for development like giant corporations can.
Look in 2024 we’re barely cracking 5% of people in the world using Linux as a desktop. The FDA doesn’t have to ban it to make “normal” people scared of using Open Source solutions. It’s a harder hill to climb than just getting people to change their desktop OS.
There are more ways to help people than making medical software. Rather than saying they could focus on doing simpler things, you automatically jumping to all projects running afoul of FDA regulations is pretty telling. All while still having not provided a single project halted by FDA order.
Open source AI is huge, and I don’t think you need FDA approval to distribute a model. Where are you even getting that from?
We’re talking about people with disabilities, and depending on what you’re doing with AI, it can get organized under being a medically assistive device, which suddenly becomes an FDA issue.
Ask the people who run Open Source projects aimed at opening up things like Glucose monitors or CPAP machines. They are harangued by the FDA. The FDA claims the projects are dangerous and that only professionals and doctors should have any ability to modify them.
Which projects have been shut down by FDA order?
You realize there’s regulation other than just banning things, right?
https://www.hhs.gov/sites/default/files/open-source-software-risks-in-the-health-sector-tlpclear.pdf
Still, the point being is that to develop Open Source medical software, you’re going to be dealing with potential regulations that you must pass to be able to legally release the software in places like the USA (you can always host the files in some country that doesn’t give a shit). Achieving meeting the regulation can often drastically increase the cost of development. Open Source projects can’t just magic up more money for development like giant corporations can.
Look in 2024 we’re barely cracking 5% of people in the world using Linux as a desktop. The FDA doesn’t have to ban it to make “normal” people scared of using Open Source solutions. It’s a harder hill to climb than just getting people to change their desktop OS.
There are more ways to help people than making medical software. Rather than saying they could focus on doing simpler things, you automatically jumping to all projects running afoul of FDA regulations is pretty telling. All while still having not provided a single project halted by FDA order.
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I accept regulations are real, but not all ways to help people require you dealing with regulations. I’m still waiting on that proof by the way.