The F.D.A. will now regulate mobile medical devices. However, only devices that can cause potential risks to patients.
This is an important step as industry moves toward the creation of the Medical Tricorder. One concern I have is that “harm” could be misjudged here. Sure a mobile electrocardiogram device should be regulated, but what about the data that this device generates? Is that up for grabs by social-economic machine, i.e., Google, Facebook, Twitter? Should medical devices conform to HIPAA and other regulations?