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In the wake of an announcement on Apple’s HealthKit health data platform and news of a sensor-laden Apple health wearable coming this fall, many have wondered how the U.S. Food and Drug Administration will regulate the growing ecosystem of health-related apps and devices.
Apple has apparently wondered this, too. The FDA has just released the summary of a meeting on the matter that it had with Apple, in response to a Freedom of Information Act request that website Apple Toolbox submitted.
We’ll never know exactly what was said in that meeting, but the FDA’s summary portrays the delegation from Apple testing the regulatory waters for health devices and apps that use sensors to gather information like blood glucose levels.
At issue was the question of what sorts of health apps and devices would the FDA feel compelled to regulate. This is especially important to Apple, because the sensors that will line the band of Apple’s new wearable will be collecting information that’s far deeper than how many steps the wearer has taken.
Here’s the key exchange between Apple and the FDA during the December 2013 meeting:
- Apple to FDA: Sensors already exist on medical devices. For instance, Apple’s devices have cameras and accelerometers. There is still an opportunity to innovate, but Apple wants to make sure they are on the side of the FDA.
- FDA to Apple: Under the current regulatory scheme, FDA will review a device based on the manufacturer’s intended use for the device. With regards to sensors, the presence of a particular sensor will not necessarily lend the device to FDA regulation. Instead, FDA would be more likely to regulate the software that puts the sensor to use, if use of the software alters the device’s use to be a medical device.
The FDA goes on to set some boundaries for Apple around which health devices or apps it would regulate and which it would not.
- FDA to Apple: 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, a 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 regulate 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. 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.
Apple also told the FDA during the meeting that it approved of the agency’s handling of consumer-health apps and devices so far. The FDA acknowledged that Apple had told Congress that it did not believe the FDA had been too “heavy-handed.”
Interestingly, Apple told the FDA it has a “moral obligation” to do more with health apps and devices. Apple called the FDA’s guidance a “step in the right direction” and said that the industry will “always push the boundaries” with new health technologies.
Apple designs and markets consumer electronics, computer software, and personal computers. The company's best-known hardware products include the Macintosh line of computers, the iPod, the iPhone and the iPad. Apple software includes t... read more »
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