Apple sees mobile technology platforms, "as an opportunity for people to learn more about themselves," according to discussions held with Food and Drug Administration (FDA) officials. Highlights from the meeting were obtained by a Freedom of Information Act request filed by AppleToolBox, and show that Apple used the meeting to talk about medtech sensors, including a glucometer, regulations for such sensors, and the FDA's stance on apps dedicated to medical monitoring.
AppleToolBox gets huge props for obtaining the information about the meeting using a Freedom of Information Act request, but the thing that stood out for me was the titular point I started this article with.
It seems like every company on the planet views mobile as a way to learn more about us so they can sell that information to marketers. Apple, on the other hand, sees such technology as a way for us to learn more about ourselves. If ever there was an encapsulating statement demonstrating the difference between Apple and the rest of the industry, this is it.
It, along with the rest of the meeting highlights, gives us even more information about how Apple intends to leverage HealthKit and what we can expect to see with iWatch. In particular, Apple will be working closely with the FDA in developing unspecified products; those products will have sensors on them; but, the FDA is less concerned with the mere presence of sensors and more concerned about the software that uses the data from those sensors.
If the device and that software is being marketed as educational in nature—as in devices that a user could use to educate themselves about themselves—the FDA isn't interested in regulating it as a medical device. On the other hand, if a device with a glucometer was marketed as a tool for diabetics, it would be scrutinized as a medical device. Medical devices have substantially more regulations on them than many other devices.
The FDA only governs the U.S. in these areas, but Apple told officials it was happy with recent guidance issued by the FDA, and that it was interested in working within the framework intended by the FDA in order to avoid unexpected regulatory surprises later.
We know that Apple has had an interest in the medtech market for some time. The company has hired several experts in sensors, as well as more recent hires from chief medical officers from across the medtech industry. Last week, the company announced HealthKit, a system-wide service in iOS 8 that acts as a repository for health and fitness-related data for disparate apps.
It's very clear that all of this will involve the so-called "iWatch," and Apple's efforts to be in sync with regulators suggests that it's coming soon. The most recent rumors claim that Apple will announce the iWatch in an October media event.