Apple VP of Health says FDA was 'very critical' in Apple Watch clearance, relationship with agency is 'good'

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.