It’s fair to say that Apple isn’t just dipping its toe into healthcare anymore. This past year the company announced its first two FDA clearances including a De Novo clearance for a built-in Apple Watch ECG feature that went live in December. It also announced numerous hospital partners for Apple’s Health Records initiative, including, most recently, the Department of Veterans Affairs. And in interviews, CEO Tim Cook hasn’t downplayed Apple’s health efforts. On the contrary, in January he told Mad Money’s Jim Cramer “I do think, looking back, in the future, [you’ll say] Apple’s most-important contribution to mankind has been in health.”

MobiHealthNews had the opportunity this week to sit down with one of the top Cupertino executives involved in making this big move into healthcare happen: Dr. Sumbul Desai, Apple’s VP of Health (and an actively practicing physician) who joined the company back in 2017. While Desai wouldn’t tell us about Apple’s future plans, she did talk a lot about how the different pieces of the tech giant’s healthcare strategy fit together, who they build their health products for, and the company’s much-speculated-on relationship with the FDA.

This interview has been edited for length and clarity. 

MobiHealthNews: I think the [Apple Watch] ECG is the big thing people are talking about and excited about. When it was first announced, there was some pushback from doctors thinking ‘Are we going to get all of these people off the street who think they have a-fib and they don’t?’ or ‘Is everyone having an ECG on their wrist going to be a good thing or a bad thing?’ And I feel like it’s been long enough that we can start to see, has that happened? Or on the other hand, have we caught a lot of a-fib that we otherwise wouldn’t have caught?

Desai: I would preface by saying that it’s anecdotal.

Listen, as a doc I’m cynical too. It’s part of the DNA of being a physician — we [tend to worry] about a lot of things. … We were very concerned about ‘What is the impact this is going to have on the medical community?’ Because we don’t want to add to the burden. I mean, many of us are physicians and we still see patients. So this isn’t a group of doctors who don’t actually practice anymore. So we were very thoughtful about that.

The feedback has been pretty decent so far. I’ve heard some cardiologists say ‘Yep, I started getting ECGs mailed to me right away.’ And their biggest frustration isn’t around so much getting the ECG, because they’ve found that helpful, but it’s that the health systems are still figuring out the right way to handle that type of incoming.

But the customer stories have actually been really amazing. We’ve gotten a number of letters to Tim where we have customers saying ‘I took an ECG. I found this issue of atrial fibrillation. I went into the emergency room. They confirmed my ECG was indeed atrial fibrillation and I had X, Y, Z happen and my physician told me that had I not come in at that time I actually could have had a worse outcome or it could have been serious.’

MobiHealthNews: So that idea of doctors saying maybe their health system doesn’t know exactly what to do with the data, … that’s a nice segue into the other thing I wanted to ask about, which is Health Records. I think on the consumer side, the ECG is the thing everyone’s excited about but when I talk to doctors, Health Records is where they see the real change that Apple is inspiring happening. So how do those two pieces fit together?

Desai: How the two fit together is we think that empowering a customer and really democratizing the information for a customer to use and a patient to use so that they can engage in their health more effectively is really what we’re trying to do. So both of those features do that. By putting the ECG in someone’s hand and having the PDF [file] that’s designed for the physician so it’s not a whole different way of looking at things, [it] is really a way for you to engage with your physician in a different way.

Similarly with Health Records — and we’re really proud of what the team has done with the VA recently as well — Health Records now allows you to have all of your records, if you go to different systems in particular, in one place.

And I will tell you, as a physician I’ll see patients in the ER … and a lot of times the questions we ask are ‘What kind of medications are you on?’ … So now to have an area where I can look at all of that is very helpful. We’re very early in that journey … but there’s a lot of potential there and we’re really excited about what we can do. And we’re really excited that the medical community is excited about it.

MobiHealthNews: There’s a bidirectional aspect to it, right? If people are recording personal health data in HealthKit, can they put that into their record?

Desai: So it depends on the health institution. Some health institutions do allow you to put data from HealthKit into your actual record. But what’s really cool about what’s going on right now is we’ve had a few — I’ve actually heard this from a few of my physician colleagues anecdotally. They’ll have a patient who will show them what was happening on their HealthKit in terms of their heart rate. And then they’ll look at the medication that they were on in Health Records, when it was started, and then figure out what trajectory they were on. And one physician, and this is again anecdotal, shared with me that he was able to get someone out of the hospital sooner because he had those pieces of information together.

MobiHealthNews: Interesting. So even if they’re not interoperating inside the box, just having them both when you’re in the office with the patient is a step forward, right? More data is better.

Desai: Right. Well, more data that’s actionable is better.

MobiHealthNews: One thing I’ve heard about both ECG and fall detection when I’ve spoken with others in this space is this idea that the demographic that most stands to benefit from this stuff — older folks, over 65, over 70 — is not necessarily the demographic that has Apple Watches. … How does that sit from Apple’s perspective?

Desai: There’s a few things I’ll say. One, we build our products for everyone. We don’t ever sit and say ‘Hmmm, what demographic are we building this for?’

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.

With atrial fibrillation, it is true that the highest prevalence you see is in the older population. However, … there’s also a lot of studies being done in the cardiology community of what really is the prevalence of a-fib [in younger populations], and that’s not known yet. So that’s what we’re doing with the Apple Heart Study, where we’re looking at an undiagnosed population.

And again, [we’re] very early in the journey. We’re in the first inning when we think about where we are with health. [But hopefully we] will understand potentially, or at least it will give us a clue potentially, of what is the occurrence of atrial fibrillation across all populations. And then the next question is ‘What do you do with it?’ And that’s where we work with the healthcare community. Once you understand that someone has atrial fibrillation, what is the right pathway for them? We know for older populations what the right pathway is, but the question is for those that are in the middle.

And we’re still partnering with the medical community to learn that, but the way we look at it is that we are driving the conversation around heart health for people that don’t know they have a condition. And atrial fibrillation is one of those conditions that affects everybody. There are a lot of people, even in the letters that we have, that are much younger, and it has been meaningful for them to understand that they have this condition.

MobiHealthNews: Because those are the people who aren’t likely to detect it any other way?

Desai: Yeah, and a-fib’s one of those conditions that doesn’t always have symptoms. So sometimes it’s useful to learn that you have a condition that you didn’t know you had.

MobiHealthNews: I want to talk about the FDA a little bit. I think a lot of people were surprised or excited that you were moving into the realm of FDA-cleared products, and I think there’s a question of ‘What’s next?’ Do you have an ongoing relationship with them, do you have more products in the pipeline and what do you want to do going forward?

Desai: [laughing] Good try on trying to figure out our future roadmap. I will not be giving you that answer, but I commend you for the attempt.

MobiHealthNews: Gotta try.

Desai: We obviously are very interested in the health space and so we’ll continue to do great work in that space. And we’re very committed to it.

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.

They have an incredibly hard job and I think we’re very respectful of the job they have and we have found them to be very thoughtful in their thinking about these technologies and what’s the right way to innovate, but also maintain the customer’s and patient’s safety.

So I commend what they do and we’ve had a really good experience in terms of learning from them. We’re early in the space so we’re very humble about what we know, and they have been very helpful about educating us as we go through the process.

MobiHealthNews: Do you think that Apple gets treated differently from anyone else at the FDA?

Desai: Absolutely not. Absolutely not. If anything, I think … we were asked a lot of really tough questions and we had the answers for them.

MobIHealthNews: I know Tim Cook has brought up health a lot recently, oftentimes when he wasn’t specifically asked about it, when talking about the big picture of the future of Apple. I think he said something recently like ‘In the future people will look back and say that’s the most important thing Apple did.’ So I was hoping you could talk a little bit about that. How do you see how important health is to the big picture of everything Apple does?

Desai: I think it’s exactly what Tim said. 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.

Three small changes in wording have been made to this piece post-publication to clarify the speaker’s intent. 

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