Apple officials have been in regular contact with the Food and Drug Administration over the past few years, discussing diagnostic apps and other unreleased health products.

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.

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 that Apple was working on an app to monitor Parkinson’s.

The “cardiac space” products are interesting, though the emails seen by Mobi Health News don’t have more details. The reporters speculate that it might have to do with an EKG attachment for the Apple Watch. AliveCor, a startup, makes a similar product called Kardia Band.

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Foto: sourceAliveCor

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.

Since 2013

Foto: Divya Nag, the head of Apple’s health projects and a member of Business Insider’s Silicon Valley 100.sourceApple

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.

Both Califf and Shuren have public calendars because they are public officials, but meetings with Apple are not listed for either of them. Some meetings appear to have been renamed because of public-calendar concerns.

Apple officials involved in the talks include the company’s director of federal government affairs, Tim Powderly, its vice president of software technology, Bud Tribble, its vice president of medical technology, Mike O’Reilly, and Divya Nag, who lists her title on LinkedIn as Special Projects.

Most of the talks centered on 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.

‘We’d like to contribute to that’

Foto: sourceAP / Alex Brandon

Cook has laid out Apple’s obvious medical ambitions in public a few times, notably in May, during a public talk.

“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 to get there it has to go through and work with the FDA.

All of Mobi Health News‘ coverage is worth a read if you’re interested in the future of digital health.

Apple declined to comment.