iWatch-Concept-future-05Following 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)

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MEMORANDUM OF MEETING

December 12, 2013 1:00 – 2:00 pm

Subject: Meeting with Apple Executives

Attendees:

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.

Discussion Highlights:

  • 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.

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19 Responses to “FDA details high-level meeting with Apple: “Moral obligation to do more” with health, innovative sensors”

  1. RP says:

    Anything that requires the FDA has a long and slow road to trudge. The tech industry is used to moving quickly, it will be interesting to see what happens when the go knee deep into the thick morass that is government bureaucracy.

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    • Reading the brief it sounds like the software will have to be FDA approved not the hardware. Maybe that is why the software was glossed over during WWDC.

      I don’t think even a heavily sensors laden iWatch will have to go through FDA hurdles.

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      • RP says:

        You may be right. Apple may have to be careful how they sell certain features, but how useful will sensors be without the FDA approved software, And another landmine could be the possibility of faulty sensors.sending inaccurate heath data in this litigation crazed society. The implications are far more serious than gyroscope or accelerometer malfunctions.

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      • I’m pretty sure healthkit will have to be FDA approved. I don’t see iWatch having to be unless Apple sells a higher end model that is sold as a medical monitoring device instead of a general health tracker.

        Healthkit would be held reliable for accurately getting, displaying and storing data from glucose monitors or other diagnostic medical devices.

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    • Sometimes taking time is good. This is public health we are talking after all.

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  2. irelandjnr says:

    Imagine regulation killed the iWatch .

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  3. Seems like Apple is trying to release the iWatch without FDA certification. Sounds like parts of health,it might have to be FDA approved, but the sensors or hardware will not have to be if it is intended as a health advisory device instead of a medical device.

    I hope Apple can release an iWatch with an glucometer and not have to get FDA approval.

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  4. I think this article spins some unwarranted conclusions out of a fairly typical and uninteresting meeting. I don’t see any new information, nor any new implications. Perhaps after having spent the time and effort to do the FOI request, the author felt obligated to write something, even if it has no content?

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  5. drtyrell969 says:

    Now that’s a cool design. Let’s pray this one is it.

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  6. Maybe it is just me, but isn’t this going to far? Demanding information on what Apple discussed with the FDA? Must Apple do everything in public? I have not seen people to go these lengths with other companies. No, seriously, if we really like Apple (and its products) and are concerned about its competitiveness going forward, my opinion is that we should really have a rethink about getting in Apple’s business. To be fair to Apple competitors, they are not going to any length to uncover Apple’s secrets; but don’t have to – they have the supposedly Apple fans doing that for them (in abundance).

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    • herb02135go says:

      Apple is not subject to FOI request but the FDA is.
      The public has a right to know what government agencies are doing and who they are meeting with. There are ways to protect trade secrets.

      If Apple/developers want this to be taken seriously they NEED FDA approval. Otherwise it will be as useless as a mood ring.

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    • Heck, I’d like to see this level of concern out of what the government does!! (any government from any party!)

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  7. Leo Chan says:

    I’m reading that device with its sensors will not be subject to regulatory review, but the software may be based on its intended use.

    For the Quantified Self/Fitness users, the software need not be regulated. But for true mHealth applications, where the data is medically actionable, then the software would be subject to regulation. The example states that if glucose reading app is used to determine insulin dosing then, it would be subject to regulation.

    Now if the diagnostics were performed in a secure health data repository (iHeathVault), rather than on the iPhone, and the Heath app would only need to be subjected to minimal regulation (Class I MDDS).

    I would like to see Apple host such a (HIPAA compliant) iHealthVault. Tim, do you read 9to5Mac?

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  8. BTW, I like this design also.

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  9. I am doing a medical innovation project and i am interested in using this as a product to use for my presentation. I am going to have to present it in front of thousands of students. this seems to be a great example i can use. can some please let me know more information about the Health-Kit .

    Like