What Can a Healthcare Delivery Organization Now Expect From These Changes in the Law?

The new law only applies to internet-connected medical devices. That doesn't mean that even if your device is not connected to the internet and you're going to submit a device that's say just connected to the local network of a hospital or at the USB ports, you don't have to follow the guidance anymore. In the past, they kind of enforced their will was to just ask questions, delay you during the submission because you didn't prove those risks were acceptable.