Apple's conversation with the U.S. Food and Drug Administration shows how medicine, technology, and regulation could work together to help users and doctors monitor patient health in a world of connected sensors. As healthcare becomes more connected with apps and wearable devices gain ground, Apple Toolbox's Freedom of Information Act inquiry yielded some interesting talking points on what Apple and the FDA have been talking about when the two sides met on December 13th.
According to information made available by the Freedom of Information Act, Apple and the FDA are both exploring the market right now and both are pleased with the relationship that they share in approaching the wearables market. Apple says that it has a "moral obligation" to enter the market.
Essentially, what we learned is that apps and devices meant for learning about and tracking health won't be subjected to increased scrutiny from the FDA while those that are marketed to target specific conditions or illnesses--like glucose monitoring for diabetics--will be treated as medical devices and will face tougher approval processes.