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?
Comment on AI could be a game changer for people with disabilities
SnotFlickerman@lemmy.blahaj.zone 3 weeks agoThey’re great, but if the last 20-30 years of Open Source are any indication, most average people do not use Open Source, and beyond that, most don’t even know what it is.
The use of Open Source projects is mainly in corporations, while individuals using Open Source projects make up a small minority of the use cases.
I would love to see growth in that arena, but if the past is any indication, it will struggle to grow.
Further, as these may be considered “medically assistive devices” you run into the issue of possibly needing FDA approval to even distribute it.
Even_Adder@lemmy.dbzer0.com 3 weeks ago
SnotFlickerman@lemmy.blahaj.zone 3 weeks ago
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.
Even_Adder@lemmy.dbzer0.com 3 weeks ago
Which projects have been shut down by FDA order?
SnotFlickerman@lemmy.blahaj.zone 3 weeks ago
You realize there’s regulation other than just banning things, right?
hhs.gov/…/open-source-software-risks-in-the-healt…
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 release the software. 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.
lemmeBe@sh.itjust.works 3 weeks ago
Exactly this. I’m a developer currently. Before that I had only a vague idea of what open source was, basically that it’s visible to everyone. Didn’t know about github, or any other application of open source outside of pc software and I was kinda advanced tech user with flashing custom roms, trying out Linux etc. Laymen have no idea what’s going on, exceptions aside.