Apple HealthKit, To Regulate or Not Regulated..That is the Question

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If you haven’t heard that Apple has been developing a health care platform, then you have been living under a rock. Last week Apple announced the release of IOS 8, which includes HealthKit, which organizes all kinds of personal health data in one platform. This announcement was followed quickly by speculation that the “iWatch” will be released this fall to coincide with the IOS 8 release.

Hype and excitement immediately ensued in the tech community. At WhiteCity we receive more hits on our Apple articles than any other post. The one question I am always asked is how will HealthKit be used? Is this just another FitBit like app, or will it provide realtime monitoring and diagnostics that can be used by healthcare professionals?

Other than Apple’s splash into the healthcare market last week, they have not released many details about HealthKit, how it will get its data or how it will be used.

But it was reported that Apple executives met with FDA officials and in a new development, a Freedom of Information Act request from Apple Toolbox produced highlights of a conversation the U.S. Food and Drug Administration had with Apple executives in December last year. The result is a summary of highlights from the hour-long meeting. Apple Toolbox published them on its website.

According to the FDA, intent of use will play a large role in regulation and they will be monitoring Apple’s marketing of HealthKit. And you can believe that Apple will be walking a fine line.

For instance, look at the picture at the top of this post, it is from the announcement of HealthKit. FDA claims that sensors are not likely to be regulated but software that puts the sensor to use may be regulated. Furthermore the screen displaying health information would not be subjected to regulation. And all of this is based on the intended use of the data. If the data is used for education and informational purposes, the FDA may not regulate the software, take FitBit for example. But in the picture above, a glucose meter is shown, as well as medication reminders.

The current mobile medical app guidance indicates that FDA does not view apps that are purely educational or informational as medical devices. Apps that actively measure something are considered diagnostic. For instance, the glucometer would be considered diagnostic because it measures blood sugar; it would not be considered merely information although it “informs” the user of the blood sugar level.

The display screen of the glucometer would not be regulated, as it only receives the data and shows it. The software that does the measuring is the part that is regulated. FDA will regulated based on the intended use of a device. Using the glucometer example, the glucometer may be unregulated if the intent is for a user to follow their blood sugar for the purposes of better nutrition. You can see in the picture, the comment bubble about meeting weekly nutrition goals is inline with the “inform and education”. Very tricky Apple, very tricky.

If the glucometer is marketed for diabetics, however, it would more likely be regulated as a medical device. FDA looks at how devices are actually used. If the manufacturer advertises the device for an unapproved use of FDA sees a lot of off-label use that is potentially dangerous, FDA may regulate after the fact.

That last sentence is probably exactly what Apple is trying to avoid. Apple is going to have to walk a very fine line, it will be interesting to see how this all works out.