Following Apple employees’ meeting with the FDA to discuss “mobile medical applications” earlier this year, AppleToolbox has published a response from the FDA to a Freedom of Information Act Request asking for more information about what was discussed.
A response to the request took three months to complete, and arrived just after Apple introduced its new HealthKit platform and Health app for iOS 8 last week. While much the FDA’s answer sounds like Apple was discussing HealthKit, the response also gives some interesting clues that Apple is working on health products that go beyond the sensors currently in the iPhone and iPad:
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… 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.
So we can assume Apple was likely meeting with the FDA for HealthKit, which takes advantage of the iPhone’s sensors and data collected by third-party apps through already available accessories, but it was also discussing implications of possibly tapping into additional sensors and doing more in the way of measuring health data. It won’t be any surprise to those that have followed our reports on iWatch as far back as last year, and we’ve continued following as Apple builds a team of medical, fitness, and sensor experts to work on the project.
The latest reports claim Apple could introduce its new wearable product as soon as October.
The full response from the FDA to the Freedom of Information Act Request is below:
FDA’s Response (Freedom of Information Act Request)
MEMORANDUM OF MEETING
December 12, 2013 1:00 – 2:00 pm
Subject: Meeting with Apple Executives
FDA: Margaret Hamburg, Sally Howard, Jeff Shuren, Bakul Patel, Jeff Shiffman
Apple: Jeff Williams, Senior Vice President of Operations Bud Tribble, MD-PhD, Vice President of Software Technology Cathy Novelli, Vice President of Worldwide Government Affairs Michael O’Reilly, MD MS, Vice President of Medical Technologies Tim Powderly, Director of Federal Government Affairs
Purpose: This was an external meeting between FDA and executives of Apple to discuss mobile health.
- Apple thanked FDA for the Mobile Medical Apps guidance. From their perspective, they said it was fair and they were pleased with the balance. Apple has received inquiries from Congress regarding whether the guidance is too heavy-handed, but Apple has responded praising FDA and the guidance document.
- Apple noted that while the 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.
- 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.
- 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 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 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. 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 will work closely with FDA as they develop future products. The earlier FDA is involved and advising, the less likely that Apple would be caught by surprise later when they wish to release a new product, if that product must be regulated.