The conversations suggest that Apple has significant ambitions in health technology far beyond the nascent services it has publicly released so far — ambitions that may lead to new products that require government regulation as medical devices.
The meetings were not listed on FDA public calendars. They were discovered and reported by Mobi Health News, which obtained emails between Apple and FDA officials through a Freedom of Information Act request.
In the redacted emails discovered by Mobi Health News, Apple officials allegedly discussed several unreleased products including:
- Two "possible (and related) products in the cardiac space"
- A diagnostic app for Parkinson's disease. Fast Company previously reported that Apple was working on an app to monitor Parkinson's.
It's also possible that Apple is planning to integrate better heart-rate tracking into future versions of the Apple Watch.
Plus, there have been rumors from earlier this year that Apple is working on a health-focused hardware device. And Apple CEO Tim Cook has hinted that a regulated medical device is something the company would be interested in.
The Parkinson's app, if it were able to diagnose the disease, would most likely require federal regulation, which would make the product a first for Apple.
Apple notably met with the FDA in 2013, before the Apple Watch was released. Based on a document previously accessed through a FOIA request, the two sides met to discuss what seems to have later become ResearchKit and CareKit, software frameworks to make health apps on iPhones.
But at the time, some thought the meeting hinted at an Apple Watch that was decidedly health-focused.
Since then, Apple has been in regular contact with FDA officials including the agency's commissioner, Robert Califf, the director of its Center for Devices and Radiological Health, Jeffrey Shuren, and its associate center director for digital health, Bakul Patel, Mobi Health News reported.