Apple Today: Keeping Regulation Away

Apple’s strong entry into the mHealth market was slightly more subdued than you might expect

By Karen Langhauser, Digital Content Manager

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Apple_MHealthApple, the world’s most valuable company, tends to launch new products with much fanfare and bravado — complete with months of social media gushing facilitated by loyal tech bloggers and fanatical Apple enthusiasts.

While clearly not meant to be subtle, Apple’s strong entry into the mHealth market was slightly more subdued than you might expect from the pomaceous technology giant.

Apple made a significant leap into mHealth 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 organize data collected by third-party health devices and apps, and give health care providers access to this patient information. Essentially, a one-stop shop for all your health data conveniently located 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 smartwatch, which is expected to include 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. According to the bullet-point summary provided by the FDA in response to the FOIA request, 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 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” — and all signs point to Apple riding that line as closely as possible.

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.

As reported by mobihealth news, the FDA made it pretty clear that it won’t be regulating Apple’s HealthKit in a rare move on June 11, 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. Not surprisingly, the description sounded quite similar to a description of Apple’s new HealthKit.

I’m not a corporate strategy expert, but I’m assuming Apple didn’t become the world’s most valuable brand by being careless. Avoiding the paperwork, cash and hassle associated with selling a medical device when you are actually a tech company seems savvy. And the positive takeaway from all of this is the hope of 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.

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