From the opinion: "As health-care providers computerize how they take care of us,
we're computerizing how we take care of ourselves—and how we connect back to
our doctors. There are apps for managing our prescriptions, tracking blood
sugar, and monitoring pacemakers or pregnancies. These tools are critical to
breaking the chokehold that paperwork, waiting rooms and endless process have
on medicine.
Like all apps that have revolutionized the way we interact with our physical
world, mobile health apps are the creatures of an innovation juggernaut. Now
this culture of innovation is threatened by government bureaucracy. Are mobile
apps for monitoring blood sugar and the like "medical devices," as
the FDA wants to classify them? Of course not. They're programs for managing
your own care, not for doctoring yourself.
A handful of mobile apps read data streams transmitted by medical devices implanted
in patients, but one that tracks your pacemaker or blood sugar isn't the same
as software embedded in medical devices that are cut into your body and then
generate data. In its regulatory grab, the FDA is pretending not to be able to
tell the difference." Read more