Wednesday, May 30, 2012

There's a Medical App for That—Or Not

Gottlieb, Scott and J.D. Kleinke"There's a Medical App for That—Or Not."The Wall Street Journal, May 29, 2012.

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