Apple VP of Health says FDA was 'very critical' in Apple Watch clearance, relationship wit...
In an interview published Friday, Apple VP of Health Dr. Sumbul Desai discussed the company's newfound interest in health and medicine, suggesting products like Apple Watch Series 4 and the Health app are stepping stones to more advanced devices and services.
Apple VP of Health Dr. Sumbul Desai. | Source: MobiHealthNews
Speaking with MobiHealthNews, Desai said initial response to Apple's first foray into devices cleared by the U.S. Food Drug Administration -- Apple Watch Series 4 -- has been "pretty decent," with doctors already receiving actionable data from Watch's ECG feature.
"I've heard some cardiologists say, Yep, I started getting ECGs mailed to me right away,'" Desai said. "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."
Apple is attempting to solve medical data handling -- what Desai calls a democratization of data -- through apps and services like Health Records. Traditionally, patient health information is siloed in repositories maintained by health records firms, but Apple's goal is to make that data portable. The company has also built direct sharing capabilities into its software, including PDF exports for data generated by the ECG app for Apple Watch.
The latest Watch model is the first of Apple's devices to receive clearance from the FDA. COO Jeff Williams touted the achievement during a launch event last September, saying Watch is "the first EKG product offered over the counter directly to consumers."
Desai offered background on the certification process in the interview, noting Apple has developed a relationship with the FDA after having worked with the agency for years on various projects.
"So we have a good relationship with the FDA," Desai said. "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."
As Apple just recently dipped its toe into the waters of health technology, Desai said the FDA has helped the company navigate stringent regulatory processes.
She goes on to mention customer testimonials lauding Watch's ability to identify atrial fibrillation and other irregular heart rhythms. Some of those stories have made the news, including a recent case in which Watch's ECG data aided in the discovery of AFib in a Seattle man who was being monitored for the condition.
Desai touches on other Apple Watch-related topics including demographic targeting. Some viewed Watch's new ECG and fall detection features as being most beneficial for older users, but Desai refutes those claims. Falls, she said, are one of the most common causes of emergency room visits across all ages, while studies are currently assessing the prevalence of AFib in younger patients.
While she declined to comment on future products, Desai did say that Apple is in the "first inning" of its push into health technology. More products like Apple Watch appear to be in the pipeline, but it could be Apple's efforts in health data storage and distribution where the company leaves its mark on the industry.
"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," she said.
Desai joined Apple in 2017 after serving as Chief of the Stanford Center for Digital Health, Vice Chair of Strategy and Innovation at Stanford's Department of Medicine and Associate Chief Medical Officer of Digital Strategy and Innovation at Stanford Healthcare.
Apple VP of Health Dr. Sumbul Desai. | Source: MobiHealthNews
Speaking with MobiHealthNews, Desai said initial response to Apple's first foray into devices cleared by the U.S. Food Drug Administration -- Apple Watch Series 4 -- has been "pretty decent," with doctors already receiving actionable data from Watch's ECG feature.
"I've heard some cardiologists say, Yep, I started getting ECGs mailed to me right away,'" Desai said. "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."
Apple is attempting to solve medical data handling -- what Desai calls a democratization of data -- through apps and services like Health Records. Traditionally, patient health information is siloed in repositories maintained by health records firms, but Apple's goal is to make that data portable. The company has also built direct sharing capabilities into its software, including PDF exports for data generated by the ECG app for Apple Watch.
The latest Watch model is the first of Apple's devices to receive clearance from the FDA. COO Jeff Williams touted the achievement during a launch event last September, saying Watch is "the first EKG product offered over the counter directly to consumers."
Desai offered background on the certification process in the interview, noting Apple has developed a relationship with the FDA after having worked with the agency for years on various projects.
"So we have a good relationship with the FDA," Desai said. "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."
As Apple just recently dipped its toe into the waters of health technology, Desai said the FDA has helped the company navigate stringent regulatory processes.
She goes on to mention customer testimonials lauding Watch's ability to identify atrial fibrillation and other irregular heart rhythms. Some of those stories have made the news, including a recent case in which Watch's ECG data aided in the discovery of AFib in a Seattle man who was being monitored for the condition.
Desai touches on other Apple Watch-related topics including demographic targeting. Some viewed Watch's new ECG and fall detection features as being most beneficial for older users, but Desai refutes those claims. Falls, she said, are one of the most common causes of emergency room visits across all ages, while studies are currently assessing the prevalence of AFib in younger patients.
While she declined to comment on future products, Desai did say that Apple is in the "first inning" of its push into health technology. More products like Apple Watch appear to be in the pipeline, but it could be Apple's efforts in health data storage and distribution where the company leaves its mark on the industry.
"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," she said.
Desai joined Apple in 2017 after serving as Chief of the Stanford Center for Digital Health, Vice Chair of Strategy and Innovation at Stanford's Department of Medicine and Associate Chief Medical Officer of Digital Strategy and Innovation at Stanford Healthcare.
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"I've heard some cardiologists say, Yep, I started getting ECGs mailed to me right away,'" Desai said. "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."
Again, can those who said the Watch ECG was useless and doctors would laugh at it come out of hiding??
Samsung is just junk. There’s no way I would ever trust any Samsung consumer product to monitor my life functions.
what about keeping your milk refrigerated? apparently they're decent at that?
Got it. Thanks.
tl;dr FDA clearance really isn't that hard. Samsung could get that. https://www.wareable.com/health-and-wellbeing/apple-fitbit-samsung-fda-health-pilot-fast-track-3311
FDA approval on the other hand... that's a "whole nother" kettle-o-fish.
https://9to5mac.com/2019/02/20/apple-watch-blood-pressure-samsung-galaxy-active/
I'm starting to get old - half way through 74.
I've had a few falls, but some were just stumbles.
I take my heart & blood pressure fairly religiously.
The wife and daughter bought me an Watch for Christmas
Fall and Heart detections were the reason
Nuff said
The critical app for me is fall detection and that means I only take it of for recharging when I'm going.set in my chair foe a while. Never charging overnight.
But, happily, I can say I was wrong. Apple went some ways to enter into the medical side and gain credibility. And, at the same time, the FDA softened its aversion to consumer devices and gave Apple a fair hearing.
And, the winner is not so much Apple as it is us! Thank you Apple!
So his wife was holiday shopping on a Sunday in early December and he came over to my house to watch football. And as luck would have it, we started comparing those traces on our Apple Watches during halftime. His definitely didn't look like mine.
A little internet search, since neither of us knew what we were looking at, turned up the following site:
https://www.practicalclinicalskills.com/sinus-rhythm
https://www.practicalclinicalskills.com/ekg-reference-type/1/Normal-Sinus-Rhythm
So then we knew what a "normal" sinus rhythm trace should look like and mine did, repeatable for 30 seconds.
OTOH, his didn't.
Next entry I found on the site was this page:
https://www.practicalclinicalskills.com/ekg-reference-area?Position=Sinus-Origin
Top trace was a repeat of the "Normal Sinus Rhythm" trace.
But the next one down was a Sinoatrial Block trace:
https://www.practicalclinicalskills.com/ekg-reference-type/7/Sinoatrial-Block
And that long interval in the middle caught my attention immediately, it was on my neighbor's stored "Inconclusive" traces.
So then we looked up Sinoatrial Block on Wiki and my neighbor decided he'd 'bother' his family Doc after all. And that led to a cardiologist appointment which resulted in a couple periods of wearing a Holter Monitor (portable cardiac monitor) some medicine and more frequent heart monitoring with treadmill stress tests.
So I guess you could say that Apple Watch was responsible for ultimately persuading him to seek medical attention. If Apple is really sure their one-lead device is a worthy initial diagnostic tool, maybe they should do more to convince watch wearers to 'bother' their family practitioners. It was actually the traces from this website linked above that convinced my neighbor. Maybe Apple should do more to explain what the EKG trace is all about and post examples of abnormal traces. This website has some 40 examples which would probably be excessive for Apple but a common half-dozen or so might be helpful. In this case, it was the very first one we looked at and was instantly obvious.