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Apple's VP of Health Says Apple Has 'Good' Relationship With FDA, Will Continue to Do Great Work in the Health Space

Apple's VP of Health Dr. Sumbul Desai recently sat down for an interview with MobiHealthNews where she discussed Apple's health products, the company's relationship with the FDA, the success of the ECG feature on the Apple Watch, and more.

On the topic of Apple's relationship with the FDA, Desai said that while Apple has a "good" relationship with the FDA, the FDA asked "hard questions" about the ECG feature in the Apple Watch, which received De Novo clearance in the U.S. ahead of its release.


Apple gets no special treatment from the FDA and undergoes the same scrutiny any other company does.
With regards to the FDA, we have been working with them for years and we have developed a relationship. ... So we have a good relationship with the FDA. However, they held us to task. I mean, they asked us really hard questions and, given the size and impact we had, were very critical of our products and making sure that we're doing the right thing and thinking about the user first and the customer's safety first -- which they should do.
On the ECG feature, which was added in the Apple Watch Series 4 and is available in the U.S., Desai said that customer stories "have been amazing." Cook has gotten a "number of letters" from people who were able to detect atrial fibrillation and get help earlier than they might have otherwise been able to.

Response from doctors has also been "pretty decent," but cardiologists are still working on the best way to handle that kind of data coming from patients.

In response to a question about ECG and another new health feature, fall detection, being targeted to an older demographic that may not own the Apple Watch, but Desai says that these features can help everyone.
With regards to fall detection, I know that was the immediate place that people took it, but if you look at the stats, falls are one of the most common reasons for people to go into the emergency room across all age groups. So you can imagine, and this has happened to me, going up on your step stool to try to get some flour or sugar, no matter what age group you're in, and having a fall. And that happens. And so we really built fall detection for everyone.
Atrial fibrillation is also a condition that "affects everybody," and Apple has received positive responses from younger people diagnosed with the condition that were able to get help.

Desai says that Apple is "very interested in the health space" and will "continue to do great work" in health. She agreed with Tim Cook's recent statement suggesting health is the area where Apple may ultimately have the greatest impact on mankind. Apple has a lot to share in the future, says Desai, and is still "in the first inning."
We think health is an area where we can have incredible impact and meaningful impact. And how do you not work in a space, at the scale that we're at, and not have impact? So that is what drives us. What drives us is hearing from our customers that we've had an impact in terms of their health and we've really moved towards thinking about how do we democratize data, health and education, and really democratize being well for everyone.

We're excited about the work we do and there's a lot of exciting things ahead, but we take it day by day. I think Tim has also said that we're in the first inning, and I think we all recognize that as well.
Desai's full interview, which is worth reading for anyone interested in Apple's health initiatives, can be found over at the MobiHealthNews website.



Top Rated Comments

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4 weeks ago
If any other company had gotten FDA approval for a wristwatch that serves as a portable ECG, their stock would have gone through the roof and the media would not stop talking about it. Apple does it and everyone yawns and asks, “where’s the innovation?”

Edit: Should have said "clearance" instead of approval. Substance of the post still stands.
Rating: 20 Votes
4 weeks ago
I wonder why that same "good relationship" isn't there with the European Commission or any individual member state health regulatory authority?

Anyone expecting the S4 ECG-like feature to be made available outside of the US anytime soon, is an example of wishful thinking meets blatant misrepresentation.
Rating: 7 Votes
4 weeks ago
It's great that Apple is focusing on the health aspects of tech. But if today's news about apps sharing customer data with Facebook isn't a warning, it definitely should be. Especially since a couple of those apps were health related.
Rating: 7 Votes
4 weeks ago

If any other company had gotten FDA approval for a wristwatch that serves as a portable ECG, their stock would have gone through the roof and the media would not stop talking about it. Apple does it and everyone yawns and asks, “where’s the innovation?”


If Apple had obtained FDA approval its stock would indeed have gone through the rough. But it didn't, so there you go.
[doublepost=1550887851][/doublepost]

The approval Apple got is "informational only", it's not a medical device. But the information seemingly spurs people to go to doctors, as appropriate, and get a sound medical opinion. The watch isn't supposed to render a medical diagnosis. But people are claiming the "information" spurred them to go to a doctor.


The FDA did not approve anything. What Apple received was clearance to sell the device.
[doublepost=1550887955][/doublepost]

?

https://www.healthcareitnews.com/news/apple-unveils-watch-series-4-fda-approved-ecg


The article (if you actually read it rather than just the headline) states "the company has received FDA clearance for both an atrial fibrillation-detecting algorithm and an ECG that will be built into the new Apple Watch Series 4"

The headline is incorrect. The text of the article is correct. Approval and clearance are not the same thing.
[doublepost=1550888054][/doublepost]

I wonder why that same "good relationship" isn't there with the European Commission or any individual member state health regulatory authority?

Anyone expecting the S4 ECG-like feature to be made available outside of the US anytime soon, is an example of wishful thinking meets blatant misrepresentation.


Who said it isn't there? A good relationship doesn't mean Apple can ignore laws, or that a country will look the other way when a company does.
[doublepost=1550888178][/doublepost]

Apple’s stock is already through the roof but I definitely agree that if it were any other company it would be more highly touted than it has been but I think as the data starts to emerge about how many lives it saves it will receive the attention it deserves.


Apple's stock is down nearly 30% from its high and trading at barely 10 times earnings. That is most definitely not "through the roof." Toilet is more like it.
Rating: 6 Votes
4 weeks ago
I'm just hopeful that while they focus on health, that they keep in mind that it shouldn't be a premium and inaccessible to a growing number of people. Same with privacy, you get what you pay for... but only if you can afford it. Apple is ultimately a business like any other though I hope they can continue their focus on intersecting technology with humanities / liberal arts
Rating: 6 Votes
4 weeks ago

If any other company had gotten FDA approval for a wristwatch that serves as a portable ECG, their stock would have gone through the roof and the media would not stop talking about it. Apple does it and everyone yawns and asks, “where’s the innovation?”


To be fair, Apple has not received FDA approval for their ECG function.
Rating: 5 Votes
4 weeks ago
Buddy up with Health Canada and get the ECG functionality working on the Series 4 please.
Rating: 4 Votes
4 weeks ago

I heard that Apple doesn't have the usual approval that people think about when related to medical devices. The approval that Apple has is less meaningful

The approval Apple got is "informational only", it's not a medical device. But the information seemingly spurs people to go to doctors, as appropriate, and get a sound medical opinion. The watch isn't supposed to render a medical diagnosis. But people are claiming the "information" spurred them to go to a doctor.
Rating: 4 Votes
4 weeks ago

Fall detection goes off A LOT when I am playing soccer and I save a hard strike in goal. It's not easy to take your gloves off to prevent it from calling 999 mid match. Hope they can sort this.


You can turn it off.
https://support.apple.com/en-us/HT208944
Rating: 3 Votes
4 weeks ago

I don’t think doctors as a rule are unethical money hungry people but I can be sure that more than a few, not to mention the big diagnostic equipment companies, are looking at the Apple Watch and thinking, uh-oh, I hope we can make it to retirement.


If anything, doctors will be receiving more calls from self diagnosing internet patients saying "My watch tells me this", "My watch says that", etc. No different from the customer telling the genius at the Apple Store "My son is a computer engineer and he says you have to do X,Y,Z."
Rating: 3 Votes

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