> after I saw him speak in San Francisco about the dangers of digital rectal thermometers, that was the moment when I realized that this is just a crank.
While that's a funny example, it is hard to draw a sharp distinction between various categories of medical devices that range from CPAP machines to pacemakers to continuous glucose monitors, all the way up to MRIs and external beam therapy devices.
Ultimately, if you own a device -- and it is hard to argue that you don't own something that is attached to, or implanted in, your body -- a whole set of rights should apply to your ability to inspect and control the associated data, hardware, and software. Any rule that excludes the manufacturer of a digital rectal thermometer from requirements to honor those rights becomes a huge loophole that will be exploited ruthlessly.
Since there is no rule that says a device manufacturer has to disclose the code to anyone (not even to the FDA) in the first place, there is no need for a loophole. Device manufacturers largely keep their code secret (and yes, in a few cases where such code has had to be disclosed anyway because of a lawsuit or the like, it has been shown to be pretty crappy).
So, I'm saying that if code disclosure and the like (ala Right to Repair, etc.) was required, but some subset of devices was exempt, manufacturers would do their best to cram their devices into the exempt category.
While that's a funny example, it is hard to draw a sharp distinction between various categories of medical devices that range from CPAP machines to pacemakers to continuous glucose monitors, all the way up to MRIs and external beam therapy devices.
Ultimately, if you own a device -- and it is hard to argue that you don't own something that is attached to, or implanted in, your body -- a whole set of rights should apply to your ability to inspect and control the associated data, hardware, and software. Any rule that excludes the manufacturer of a digital rectal thermometer from requirements to honor those rights becomes a huge loophole that will be exploited ruthlessly.