Respectfully, it sounds like the FDA is trying to implement requirements for manufacturers to do what they should've been doing all along. The shitty flipside to my point is that market forces pushed manufacturers to cut costs and externalize the infosec risk onto the patients. The secure products aren't interesting to medical healthcare providers.
I'm, admittedly, a bit salty because I recently looked at a healthcare device that I was prescribed and found evidence that my data is likely being trivially exposed by anyone who wants to look. I can't verify this because it's very likely illegal, and I don't feel comfortable reporting it to the device vendor for fear of being accused of hacking. If there's a way to report it to the FDA, I'd be thrilled -- but I don't know what that looks like.
I'm, admittedly, a bit salty because I recently looked at a healthcare device that I was prescribed and found evidence that my data is likely being trivially exposed by anyone who wants to look. I can't verify this because it's very likely illegal, and I don't feel comfortable reporting it to the device vendor for fear of being accused of hacking. If there's a way to report it to the FDA, I'd be thrilled -- but I don't know what that looks like.