A quartet of heart doctors is trying to revive health monitoring company AliveCor’s antitrust lawsuit involving the Apple Watch, claiming that changes to the iMaker gadget “resulted in the loss of access to a potentially life-saving product.”
The doctors argue in their amicus curiae brief [PDF] filed this week with the Ninth Circuit Court of Appeals in the United States 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 affected the wearables worsened for monitoring heart health.
To catch you up on this complicated story, AliveCor, a manufacturer of electrocardiography (ECG) hardware and software, tried to sue Apple under antitrust law in 2021. The company accused iGiant of unfairly trying to monopolize the personal heart rate monitor market.
AliveCor argued that the changes introduced in watchOS 5 – dumping HRPO for the HRNN and IRN – meant that the Apple smartwatch app SmartRhythm could not access a wearer’s full heart rate data, reducing its capabilities and had to be withdrawn, hence the antitrust complaint. Before watchOS 5, SmartRhythm used the entire data feed to continuously study the Watch wearer’s heart rate and prompt them to record a full ECG with other equipment if the readings indicated something was wrong. AliveCor offered separate, FDA-approved ECG equipment for this purpose, such as a special watch strap.
The introduction of HRNN has meant that third-party apps no longer have access to usable, raw, continuous heart data that was previously available through HRPO. It also means that Apple’s operating system now only measures heart rate sporadically, rather than monitoring it continuously, the doctors said in their amicus curiae brief supporting AliveCor in its ongoing fight against antitrust.
According to the specialists, these sporadic measurements can cause the software to miss signals of an impending stroke, which would be bad. Continuous monitoring is therefore preferable, but is no longer possible.
That 2021 antitrust case was dismissed on the grounds that HRNN was seen by the judge at the time as an improvement for carriers and that therefore there was no violation of competition law. The cardiologists, who are trying to help AliveCor appeal that denial with their amicus brief, argue that Apple’s changes with watchOS 5 result in poorer health care and were anti-competitive.
“From a medical perspective, IRN is inferior when it comes to medical monitoring,” the doctors wrote. “IRN only sporadically measures a user’s heart rhythm; and critically, unlike the AliveCor product, Apple’s feature is not FDA-approved for users with Afib [atrial fibrillation].”
“Indeed, Apple itself advises Afib patients not to use the replacement product for heart rhythm monitoring,” the doctors added. “A summary judgment in favor of Apple undermines patients’ ability to access the information they need to continuously monitor their heart rhythm.”
They continued: “Moreover, antimonopoly case law has clearly established that the alleged benefits of Apple’s product modification must still be weighed against its clear anticompetitive effects.”
QED, the lower court’s decision should be rejected.
It’s worth noting that two of the four heart specialists who wrote the letter are directly affiliated with AliveCor – one on the clinical advisory board and another on the board of directors.
The director, Dr. Toby Cosgrove, says he was not on the board of directors when the lawsuit against Apple began, and both claim they wrote to the courts in an “individual capacity based on [their] own medical experience.”
AliveCor declined to comment, while neither Apple nor representatives of the letter’s authors responded to queries.
Wait a minute – what Apple Watch suit is this again?
We forgive you for not being sure which Apple Watch lawsuit this is. There are several currently involved in various lawsuits, and this isn’t even the only one involving AliveCor.
In addition to the aforementioned antitrust case, AliveCor also sued Apple before the U.S. International Trade Commission in 2022, alleging that Cupertino infringed on several patents covering its now-defunct FDA-approved KardiaBand, which added ECG capabilities to older models of the Apple Watch. The ITC ruled in AliveCor’s favor in that case, finding that Apple infringed on KardiaBand patents when it introduced heart monitoring hardware in the Apple Watch Series 4.
Since then, however, things haven’t entirely gone in AliveCor’s favor. The U.S. Patent and Trademark Office (USPTO) found several of AliveCor’s patents in the case to be invalid, calling the ITC’s decision into question. AliveCor is appealing the USPTO’s decision.
Apple is also continuing to appeal a case in which it was found liable in late 2023 for ripping off blood oxygen measurement patents held by health technology company Masimo.
Despite the ongoing litigation, Apple was still required 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 U.S. shelves — without the ability to measure blood oxygen — at least for now. ®