Yesterday, Apple dropped a bombshell on the digital health world, as it is prone to do in its highly-produced launch events. While the announcement included fall detection on the Apple Watch and some improvements to heart rate monitoring, the headline was definitely the announcement that the Apple Watch Series 4 would contain an FDA-cleared ECG sensor.

While much of the reaction has been positive, longtime watchers of Apple’s health initiatives noticed a few things that didn’t add up: Apple CTO Jeff William’s questionable claim that the ECG is the first of its kind, and the uncanny timing of the announcement and clearance that suggests a new level of industry-government collaboration.

An (un)predictable announcement

There’s a few reasons to be surprised by this news, and quite a few reasons not to. MobiHealthNews considered this exact possibility in 2016 when we reported on a series of emails between the FDA and Apple, obtained via a FOIA request. The emails described plans for “FDA clearances for two separate but related cardiac products.” There was even a patent filing around at that time.

Yesterday’s announcement also concerned two separate but related cardiac products. In addition to the ECG built into the Apple Watch, there was an FDA clearance for an algorithm that can predict atrial fibrillation from heart rate data. Both were De Novo clearances. MobiHealthNews predicted the second clearance back in February, when we spotted language in the Apple Heart Study's informed consent document that pointed to an FDA clearance in the works.

But there’s a key reason we didn’t predict an FDA-cleared Apple Watch: Tim Cook said in 2015 the company wasn’t likely to build one.

“We don’t want to put the Watch through the Food and Drug Administration (FDA) process,” he said at the time. “I wouldn’t mind putting something adjacent to the watch through it, but not the watch, because it would hold us back from innovating too much, the cycles are too long. But you can begin to envision other things that might be adjacent to it — maybe an app, maybe something else.”

What changed? Well, the FDA for one. It’s a much more flexible agency and more willing to work with companies than it was in 2015. Scott Gottlieb said in a tweet that the agency was specifically not clearing the Apple Watch, writ large, as a medical device.

“#FDA’s approval of 2 medical apps for Apple’s iWatch is a significant step forward in FDA policy because we decoupled review of the app from review of the watch itself,” he wrote. “The watch isn’t a medical device, just the apps that help consumers detect serious medical conditions.”

A (not) unprecedented product

One aspect of the announcement that has caused a stir is Apple CTO Jeff William’s assertion on stage that “this is the first ECG product offered over the counter, directly to consumers.”

It’s hard to parse that in a way that actually makes it true. Most people in the industry immediately pointed to AliveCor, the original iPhone ECG company that got over-the-counter (OTC) clearance from the agency in 2014. Even before that an AliveCor competitor called Cardiac Designs got OTC clearance in 2013.

And the question is bigger than just whether Williams misspoke. If the products aren’t new or innovative, than why use the De Novo process rather than a regular Class 2 filing citing AliveCor as a predicate device?

The FDA did respond to MobiHealthNews’s request for clarification, and it seems to lean on the same distinction Gottlieb made above.

“The ECG App is the first software-only ECG device that creates, analyzes, and displays ECG data for [OTC] use,” an agency spokesperson wrote. “This app is intended to be used with the Series 4 Apple Watch. Other ECG apps, like AliveCor, are both an app and custom electronics (i.e. finger pad or wrist sensor) intended for use with compatible smart phones. Unlike AliveCor's products, there is not an additional device intended for use with the ECG App or the Irregular Rhythm Notification apps. These apps are intended to be used solely with the existing Apple Watch product.”

It’s questionable whether it’s accurate to call the product a software-only device, since it relies on electrodes specially built into the Watch for that purpose. But the language of the De Novo clearance does refer specifically, and exclusively, to software. Either way, the real novelty seems to be in the fact that this ECG is built into an existing, popular multifunction consumer device.

Gottlieb’s comments on Twitter are also a bit baffling, since it's hard to see the difference between clearing a Watch app as distinct from a Watch and clearing a phone app as distinct from a phone, which the FDA has been doing for years.

It seems clear that the FDA chose to play the role it did in Apple’s launch in order to send a message to the industry. Gottlieb issued his own press release shortly after the launch highlighting the potential of digital health and the FDA’s commitment to enabling it.

“The FDA worked closely with the company as they developed and tested these software products, which may help millions of users identify health concerns more quickly,” he wrote. “Health care products on ubiquitous devices, like smart watches, may help users seek treatment earlier and will truly empower them with more information about their health.”

A (not so) quick clearance

Some in the industry have also pointed to the speed and timing of the clearances as surprising, and even as evidence of favoritism by the FDA.

“The clearance letters — posted the FDA's website — are dated September 11. What's remarkable about them is that Apple apparently filed its ECG clearance application on August 14, 2018, and the Irregular Rhythm Notification Feature application on August 9, 2018,” Bradley Merrill Thompson, a lawyer with Epstein Becker Green who specializes in FDA law, told MobiHealthNews in an email. “For those who may not have background in a De Novo request, these requests are for the first-of-a-kind device and therefore typically take longer to clear than a follow-on device cleared through the 510(k) process. … FDA's goal with regard to reviewing De Novo submissions is for FDA to ‘issue a decision within 150 FDA days of receipt of the submission for ... 50 percent of De Novo requests received in FY 2018.’ To be clear, that means it's expected that the other 50 percent will take longer than 150 days. FDA cleared not one but two Apple De Novo reviews in fewer than 30 days. That's remarkable.”

And Apple was able to arrange the timing of the publication of the De Novo clearances on FDA’s website such that the onstage announcement at its September 12th event was a surprise.

“I've never heard of an FDA approval timing with or for a major media event,” Scripps Research Executive Eric Topol, a cardiologist who is influential in the digital health space, told MobiHealthNews. “Perhaps it is a pure coincidence.”

“[Some] have asked me whether this is typical for FDA to accelerate a clearance review and issue a decision so as to coincide with a company preselected launch date for a new product,” Thompson said. “I've been doing this work for over 30 years, and I've never heard of that.”

Others saw the timeline as a positive sign, a harbinger of things to come with a new, more responsive FDA.

"We are entering a renaissance of sorts as technology companies and our government partner together," Linda Pissott-Reig, co-chair of Buchanan, Ingersoll, & Rooney's FDA Section, told MobiHealthNews in an email. "Consumers will benefit from new methods for monitoring their health. Beginning with the 21st Century Cures Act and its mandate that FDA revisit how it defines 'devices,' we are now seeing the Agency demonstrate its nimbleness and receptivity to new medical technologies to advance medical awareness and care. The regulatory framework is morphing to embrace new technologies. This is evidenced by the swift action of FDA — it took less than a month from Apple's application to approval. This event will undoubtedly encourage even greater innovation and financial investments that will transform how we define medical monitoring and care. Very exciting news!"

The FDA declined to comment on the specific arrangements with Apple but did offer some general comments.

“While we cannot comment on specific interactions with a company, the FDA's premarket decision is made after the submitter has demonstrated reasonable assurance of the safety and effectiveness of a device,” the spokesperson wrote. “That is independent from a company's decision to announce a product's marketing authorization or availability. We always encourage manufacturers/developers to communicate and work with the FDA beginning very early in their development process and on a continuing basis using the presubmission process and other interactions. Depending on several factors, such as the level of risk associated with a product, a company's amount of experience in working with FDA, or how novel a product is, different applicants may interact with the FDA for varying amounts of time.”

The key here is that Apple was working on these products with FDA much longer than 30 days. If we are right that these are the two cardiac product referenced in the emails, it’s been more like four years. And those emails demonstrated a very, perhaps problematically, cozy relationship between Apple and the FDA, to the point where the agency invited Apple to secretly participate in a working group that would help set policy on digital health regulation.

If the agency is demonstrating to the industry how much it's willing to work with innovators, that's a great sign for the digital health world. But if it's playing favorites with an old friend, that could be worrying for companies hoping to find the regulatory process a level playing field.

"I think FDA needs to comment publicly on what they've done, to allow the entire industry to know what the rules are," Thompson said. "It's important that the regulatory process be transparent, and if there are ways to accomplish what Apple accomplished in terms of timing going forward, everyone needs to know of those opportunities."