4 ms·
This looks good as an overarching framework but will likely fall into the same bucket as a lot of regulation in cutting edge fields (if this ever becomes mandat
by smitec 3y ago
This looks good as an overarching framework but will likely fall into the same bucket as a lot of regulation in cutting edge fields (if this ever becomes mandatory). These are only as good as the quality of the people doing the assessment.
I've worked with a lot of people in the medical world while developing SaMD (software as a medical device) in the past that had little to no idea about software. They can apply the principles in the abstract but will likely not dig deep enough to catch some very major issues.
In the medical world, things like post market surveillance and notification of adverse events help to at least create a public feedback loop here. I think we will need something similar in this space if we really want to see more than a surface level, checklist ticking exercise.
- ftxbro 3y ago> software as a medical device I had a question about this earlier, if a doctor uses Google to look up something, then is Google being used in some legal or regulatory sense as a medical device?
- neandrake 3y agoNo because google is not marketing their service for medical use. The doctor is responsible for the diagnosis/prescription, which they’re allowed to use any tool they deem necessary. Medical devices are marketed for specific medical use, which doctors rely upon to do what’s medically expected. These devices will have an “expected use” and “indications for use” that largely cover how they are design/expected/tested for use. They need 510k clearance to be classified by the FDA as a medical device.
- ftxbro 3y agoThanks! So if a doctor uses one of the GPTs like GPT-4 in a similar way to how they use Google today, it also wouldn't be a medical device I guess. But if someone wanted to make a MedGPT for doctors then that one would probably be subject to the FDA regulations because it will have an 'expected use' for doctors.
- neandrake 3y agoEssentially yes, assuming MedGPT is marketed to clinicians as being a tool they can use for diagnosis/treatment. The process is pretty involved, but to add some clarification - the "indications for use" or "expected use" are things the manufacturer are required to include with their device when submitting for 510k clearance from FDA, so that it can then be marketed for medical use. They can only market it as a medical device once it has 510k from FDA.
- user3939382 3y agoI’m not very hopeful of the effect given a high profile example of their failure: they issue high quality password strength guidelines, and they can’t even get most Federal agencies to adopt them. CSF has a fair amount of traction I guess. I’d be happy for my pessimism to be proven wrong.