Is Apple "Pushing the Boundaries" of FDA Regulation?

June 17, 2014
Although Apple garnered some criticism from the media, you can't blame the tech company for what appears to be its desire to remain unregulated by the FDA.

Apple recently made a strong entry into the mHealth market when it introduced the Apple HealthKit at its World Wide Developers Conference in early June. Healthkit is a centralized, cloud-based health-information platform. The platform will accept and organize data collected by a variety of third-party health devices and apps, and give health care providers access to patient information stored in HealthKit. Essentially, a one-stop shop for all your health data conveniently located right on your iPhone or iPad.

A few months back, word got out that there had been a meeting between Apple executives and FDA officials last December. The blogger world was abuzz with speculation about the long-awaited Apple smartwatch, which is expected to include some health monitoring functions.

Apple Toolbox, a well-known troubleshooting resource site for Apple products, took it a step beyond speculation and submitted a Freedom of Information Act request to the FDA to find out what was discussed during the December Apple/FDA meeting.

The FDA's response to the FOIA request indicated a discussion between high-profile attendees on both sides about mobile health and the FDA’s final guidance on mobile medical applications issued last September.

According to the bullet point summary of the conversation provided by the FDA, Apple reportedly noted to the FDA, “while the mobile health guidance is a step in the right direction, industry is always going to be pushing the boundaries. Apple sees mobile technology platforms as an opportunity for people to learn more about themselves. With the potential for more sensors on mobile devices, Apple believes there is the opportunity to do more with devices, and that there may be a moral obligation to do more.”

Clearly, Apple has plans to "do more" and wants the FDA kept in the loop regarding these plans. To that end, it appears as though Apple intends to keep the FDA informed regarding Apple mHealth projects to avoid inadvertently developing a medical device that would require regulation. Meeting notes indicate that the FDA discussed the fine line between medical devices and "apps that are purely educational or informational."

Although Apple garnered some criticism from the media, you can't blame the tech company for what appears to be its desire to remain unregulated by the FDA.

So far, Apple may have gotten its wish to stay on the unregulated side of the fence. As reported by mobihealth news, the FDA made it pretty clear that it won't be regulating Apple's HealthKit in a rare move last Wednesday, when the agency added a new description for a type of mobile medical app that it would not regulate as a medical device to its mobile medical apps regulations. The description sounds very much like a description of Apple’s new HealthKit.

The positive takeaway from all of this is the hope for a good working relationship between the FDA and Big Tech – a relationship that allows patients to play a greater role in their own health without compromising their safety.

About the Author

Karen Langhauser | Digital Content Manager