Emails between Apple and FDA hint at future plans

Mobi Health News:

Since its well-publicized meeting with the FDA in 2013, Apple has continued to meet with the agency regularly as well as to correspond by phone and email, according to emails obtained by MobiHealthNews via a Freedom of Information Act request to the FDA.

These emails show that Apple and the FDA have discussed the App Store review process, the 510(k) process, ResearchKit apps, diagnostic apps, working with the FDA in an “unregulated” way and more. The FDA even invited Apple to participate in regular briefings designed to help guide an international effort to harmonize medical software regulation. Though much of the sensitive information is redacted, the emails also point to three regulated medical devices that Apple is seriously pursuing: an app for diagnosing Parkinson’s disease and two separate but related cardiac devices.

It’s common knowledge that Apple has been very interested in developing hardware and software (likely associated with the Apple Watch) for various aspects of the healthcare industry. The problem is, as Cook said a year ago, Apple isn’t crazy about having to put the Apple Watch through the FDA process.