A quartet of heart doctors are trying to resuscitate health-monitoring tech outfit AliveCor’s antitrust lawsuit regarding the Apple Watch, by arguing changes made to the iMaker’s gadget “resulted in a loss of access to a potentially life-saving product.”
The physicians argue in their amicus brief [PDF] filed this week with the United States Ninth Circuit Court of Appeals that when Apple’s watchOS 5 replaced its Heart Rate Path Optimizer (HRPO) algorithm with a Heart Rate Neural Network (HRNN) and Irregular Rhythm Notifications (IRN), it made the wearables worse for monitoring heart health.
To catch you up with this twisty-turning saga: AliveCor, which makes electrocardiography (ECG) hardware and software, tried to sue Apple in 2021 on antitrust grounds, accusing the iGiant of unfairly trying to monopolize the personal heart-rate monitoring market.
AliveCor argued the changes introduced in watchOS 5 – dumping HRPO for the HRNN and IRN – meant its Apple smartwatch app SmartRhythm could not access a wearer’s full heart-rate data, reducing its abilities and had to be pulled, hence the antitrust complaint. Prior to watchOS 5, SmartRhythm would use the full data feed to continuously study the Watch wearer’s heart rate and prompt them to record a full ECG using other equipment if the readings suggested something was amiss. AliveCor offered separate FDA-approved ECG gear, such as a special Watch strap, for doing just that.
Thus, the introduction of HRNN cut third-party apps off from useful raw, continuous heart data – which was previously available via HRPO – and that also meant Apple’s OS performed only sporadic heart-rate measurements instead of constant monitoring, the doctors said in their amicus brief supporting AliveCor’s ongoing antitrust battle.
The specialists said those sporadic readings may cause software to miss signs of a forthcoming stroke, which would be bad, and continuous monitoring is preferred yet no longer possible.
That 2021 antitrust case was dismissed on grounds that HRNN was seen by the judge at the time as an improvement for wearers and therefore no competition law was broken. The cardiologists, who are trying to help AliveCor appeal against that dismissal with their amicus brief, argue that Apple’s changes with watchOS 5 deliver worse healthcare and were anticompetitive.
“From a medical point of view, IRN is inferior when it comes to medical monitoring,” wrote the doctors. “IRN only sporadically measures a user’s heart rhythm; and critically, unlike the AliveCor product, Apple’s feature is not FDA cleared for users with Afib [atrial fibrillation].”
“Indeed, Apple itself advises Afib patients not to use its replacement product for heart rhythm monitoring,” the doctors added. “Summary judgment in favor of Apple undermines the ability of patients to access the information they need to continuously monitor their heart rhythm.”
They continued: “Moreover, antitrust precedent is clear that the purported benefits of Apple’s product change still must be evaluated against its clear anticompetitive effects.”
QED, the lower court decision should be tossed.
It’s worth noting two of the four cardiac specialists who authored the brief are directly affiliated with AliveCor – one on its clinical advisory board, and another sits on the board of directors.
The director, Dr Toby Cosgrove, says he was not on the board when it began legal proceedings against Apple, and both maintain they wrote to the courts in an “individual capacity based upon [their] own medical experience.”
AliveCor declined to comment, while neither Apple nor representatives for the brief’s authors responded to questions.
Wait – which Apple Watch suit is this again?
We’ll forgive you for not being sure which Apple Watch lawsuit this is. There are several out there in various states of litigation right now, and this isn’t even the only one involving AliveCor.
Along with the aforementioned antitrust case, AliveCor also took Apple before the US International Trade Commission in 2022 to argue Cupertino had infringed several patents for its now-defunct FDA-cleared KardiaBand, which added ECG capabilities to older models of Apple Watch. The ITC decided in AliveCor’s favor in that case, finding that Apple infringed KardiaBand patents when it introduced heart-monitoring hardware in the Apple Watch Series 4.
Things haven’t gone entirely in AliveCor’s favor since then, though. The US Patent and Trademark Office (USPTO) concluded some of AliveCor’s patents contended in the case were invalid, throwing the ITC’s decision into question. AliveCor is appealing that USPTO decision.
Apple is also still appealing a case that found it liable in late 2023 of ripping off blood oxygen measuring patents held by health technology firm Masimo.
Despite the ongoing litigation, Apple still had to remove blood oxygen tracking from Watches in the US – which it did in January 2024, to comply with the Masimo ruling.
Apple Watches are still available on US shelves – without capabilities to measure blood oxygen – at least for now. ®