The ability to share data across the world improves medical care. If a local physician can't quite read a scan, the scan can be shared to instantly which improves the overall care the patient receives. That's why you want this stuff on a network.
I work in the medical device industry and none of this is all that new. It's clear that the FDA wants companies it regulates to THINK ABOUT RISK and then show that you've mitigated the relevant risks and can prove that's true. It's not rocket science, and doesn't have to be that expensive. When you build a network, you figure this stuff out anyway; all the FDA wants you to do is WRITE DOWN what you did.
It can be a pain, but it doesn't have to be any more painful that good basic application control and change management.