Does Apple's HealthKit Prove FDA Guidance Is Working?

Skepticism remains over the Food & Drug Administration’s regulation of mobile health. The approach will just slow innovation, as Scott Gottlieb, MD, an American Enterprise Institute analyst and former FDA deputy commissioner, argued recently in the Wall Street Journal.  If Apple’s optimistic plans for the Health Kit mobile suite are any indication, though, the FDA is doing well so far in its risk- and discretion-based regulatory framework, subjecting mobile apps to the same standard as medical devices.

True, from a regulatory or product development standpoint, it may not be as easy for a tech startup to launch a mobile healthcare app as it is to build an app for finding the nearest food truck. But the FDA’s guidance on what it will and will not examine through device classification and premarket clearance processes is looking like it will be able to accommodate Apple’s much-hyped healthcare product, along with many more basic and advanced diagnostic, monitoring and engagement tools to come.  Since releasing the final framework last fall and meeting with Apple executives this past winter, the FDA has been occasionally updating its guidance and adding new examples of app functionality that won’t have to go through premarket approval, which of course can be a lengthy and protracted.

Among a few of the examples added to the list this year are apps that show drug-drug interactions and safety information, and one that should be relevant to Apple’s HealthKit: “Mobile apps that allows a user to collect, log, track and trend data such as blood glucose, blood pressure, heart rate, weight or other data from a device to eventually share with a healthcare provider, or upload it to an online (cloud) database, personal or electronic health record.”...