Apple has been secretly meeting with the FDA for years
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 health 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.
What they talked about:In the sometimes redacted emails seen by Mobi Health News, Apple officials discuss several unreleased products including:
- Two "possible (and related) products in the cardiac space"
- A diagnostic app for Parkinson's disease. Fast Company previously reported Apple is working on a Parkinson's monitoring app.
The "cardiac space" products are interesting, although the emails seen by Mobi Health News doesn't have more details. The reporters speculate that it might have to do with an EKG attachment for Apple Watch. AliveCor, a startup, makes a similar product called Kardia Band.
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 it a first for Apple.
Since then, Apple has been in regular contact with FDA officials, including FDA Commissioner Robert Califf, Jeffrey Shuren, director for the agency's Center for Devices and Radiological Health, and Bakul Patel, the FDA associate center director for digital health, Mobi Health News reported.
Both Califf and Shuren have public calendars because they are public officials, but their Apple meetings are not listed. Some meetings appear to have been renamed because of public calendar concerns.
Apple officials involved in the talks include director of federal government affairs Tim Powderly, Bud Tribble, a VP of Software Technology, Mike O'Reilly, Apple's VP of Medical Technology, and Divya Nag, who lists her title on LinkedIn as Special Projects.
Most of the talks centered around regulatory issues, such as how Apple's ResearchKit should be classified, how Apple approves health-focused apps in its App Store, and what working groups Apple scientists would join, according to the emails seen by Mobi Health News.
Apple health ambitions
"We believe that health is something that is a huge problem in the world, and we think it is ripe for simplicity and a new view, and we'd like to contribute to that," Cook said.
Apple has been building a large health team inside its Special Projects division that is working on a whole slew of projects, including new Apple Watch sensors, better fitness algorithms, medical record tracking and sharing, and now, apparently, cardiac devices.But if Apple were to truly attack the health space, in a way few other Silicon Valley tech giants have in the past, it would be very different from releasing new iPhones. Most medical technology is heavily regulated, and timelines for new devices can take years, which is much slower than Apple's typical pace.
Regardless, Apple wants to be a player in digital health, and in order to get there, it has to go through and work with the FDA.