La Apple Watch import ban in the United States The patent dispute with medical technology company Masimo has entered a new phase following recent court and U.S. International Trade Commission (ITC) decisions. The legal battle is not over, but Apple has secured access to the U.S. market for its redesigned smartwatches, with only the original version of one of its flagship health features remaining banned.
While the United States decides which models can cross the border and with what active features, in In Europe and Spain, the Apple Watch continues to sell normally.without specific restrictions in this case. Even so, the litigation sets a relevant precedent for understanding how the advanced health features in electronic devices that are marketed on both sides of the Atlantic.
How the Apple Watch import ban began
The origin of the conflict dates back more than six years, when Masimo accused Apple of poaching key employees and take advantage of their pulse oximetry technologyused to measure blood oxygen levels. This capability became one of the most striking health features of the Apple Watch in certain generations of the watch.
After investigating the complaints, the The U.S. International Trade Commission concluded in 2023 that some Apple Watch models infringed on Masimo's patents related to this measurement technique. The result was a limited exclusion order that led to a ban on importing recent models like the Apple Watch Series 9 and the Apple Watch Ultra 2 into the US market.
The decision had a direct impact on the company's business strategy in its main market. To avoid a complete shutdown, Apple initially opted for Remove the blood oxygen reading function of the units destined for the United States, allowing the watches to continue being sold but without one of their most recognizable health features.
This move was seen as a temporary and unsustainable solution. Apple, which has spent years positioning the Apple Watch as a health and wellness device, was not willing to simply abandon one of its flagship features. Therefore, it launched a technical redesign of the blood oxygen characteristic with the intention of respecting the ITC order without completely giving up the user experience.
The redesign of the blood oxygen function and the role of Customs
The key element to unlocking, at least partially, the Apple Watch import ban It was the creation of a modified version of the blood oxygen measurement function. In this new architecture, the watch continues to use its sensors to collect data, but the processing and presentation of the information are significantly different from the original version.
In the initial implementation, the Apple Watch itself It displayed the saturation levels directly on its screen. of blood oxygen. With the redesign, Apple moved much of the processing and display experience to associated devices like the iPhone, so that the information is mainly managed outside the watch, seeking to move away from the way described in Masimo's patents.
This solution had to be reviewed by U.S. Customs and Border Protection, which was responsible for determining whether the redesigned models still fell within the scope of the exclusion order issued by the ITC. Following their analysis, Customs gave the green light to the import of modified Apple Watches, interpreting that the adjusted version did not violate the restrictions imposed on the original technology.
Thanks to that decision, Apple was able to resume sales of their latest watches in the US market with the redesigned blood oxygen function already in place. In practical terms, the ban was limited to the original version of the feature, while the new variant was authorized to enter the United States and reach stores.
Masimo, however, did not share this interpretation and reacted by submitting new petitions for it to be will review the status of the updated modelsThe company argued that, despite the changes, Apple's design remained essentially within the scope of the exclusion order and that, therefore, imports should continue to be halted.
The latest ITC decisions: which models are still affected
Masimo's persistence led to a new review phase within the ITC. At that stage, Administrative Law Judge Monica Bhattacharyya analyzed the operation of the amended function in detail. In her initial determination, the judge concluded that The redesigned Apple Watches did not infringe on patents. involved in the original case, which clearly opened the door to closing the execution procedure.
In parallel, the Court of Appeals for the Federal CircuitThe Washington-based court reviewed the preliminary injunction related to the initial version of the feature. The court decided to uphold the ban on the original implementation of blood oxygen measurement, confirming that this specific variant remains prohibited in the United States.
It remained to be seen whether the full International Trade Commission would reopen its review of Bhattacharyya's decision. After considering the requests from Apple and Massimo, the ITC decided not reviewing the administrative determinationIn other words, it accepted the conclusion that the redesigned products do not infringe Masimo's patents and, consequently, should not be excluded from the market under the terms of the limited exclusion order.
With this decision, the ITC has terminated the enforcement proceedings stemming from the original order. Masimo, who intended reinstate a total ban Regarding the Apple Watch with the new blood oxygen function, this specific avenue is thus closed, although the company maintains other legal options open in higher instances.
In practice, the current scenario in the United States can be summarized as follows: The original version of the blood oxygen function remains prohibited.While models with the redesigned implementation can continue to be imported and sold without the restrictions that were applied in 2023 to the Apple Watch Series 9 and Ultra 2.
Apple's response and the options still available to Massimo
From Apple's perspective, the conclusion of this phase has been met with relief. In a statement, the company He thanked the ITC for its decision He emphasized that the ruling guarantees that it can continue to offer this health feature to users through the redesigned version of blood oxygen measurement in the United States.
Apple also took the opportunity to emphasize that, in its opinion, Masimo has maintained a constant legal campaign for more than six years against the Cupertino firm, and that a large portion of the claims have been rejected in various courts. The company insists it will continue to defend its innovations and focus on developing high-quality products and services for its user base.
In addition to legal defense, Apple has focused on the work of its research and development teams to continue expanding the health, wellness, and safety features on the Apple Watch and across the rest of its device ecosystem. The company reiterates its commitment to privacy and the responsible handling of sensitive data such as vital signs and physical activity.
For Masimo, the closure of the proceedings at the ITC does not mean the end of the conflict. The company may appeal the decision to the Federal Circuit Court of Appeals Based in Washington, so there is still room for the case to escalate again in the US judicial system.
Meanwhile, Masimo has other lawsuits pending against Apple, suggesting that the legal battle will continue. The import dispute is just one branch of a broader conflict surrounding the use of pulse oximetry technology in mass-market devices like the Apple Watch.
Parallel demands and the economic dimension of the conflict
The clash between Apple and Masimo isn't limited to the ITC front. A significant battle continues in US federal courts over patent infringement and theft of trade secrets related to the same blood oxygen measurement technology.
In one of these cases, a jury in California awarded Masimo a $634 million compensation in a patent trial held in November. The figure, which is pending appeal, illustrates the economic value that both companies attribute to the innovations at stake and to the connected health device market.
Apple has already indicated its intention to appeal the verdict, so the final amount and outcome of the proceedings remain uncertain. The dispute, therefore, still has potential both financially and legally, and could lead to further decisions with a direct impact on the wearables business.
Masimo has also filed a separate lawsuit against the company itself. Customs and Border Protection from the US, questioning the approval of the redesigned Apple Watch. With this move, the company intends to have Apple's changes reviewed to determine if they are sufficient to fall outside the scope of the original exclusion order issued by the ITC.
This entire legal framework highlights that the conflict is not a simple technical discussion, but rather lies at the intersection between Intellectual property, competition in the wearables market and the growing importance of health features in consumer devices. For Apple, the Apple Watch is a key component of its ecosystem and a gateway to health and fitness services; for Masimo, the disputed patents represent a core strategic asset of its medical technology business.
What does the Apple Watch ban mean for users in Spain and Europe?
Although the focus of the case is in the United States, the issue is being closely followed in the European Union and, in particular, in Spain. For the moment, There is no equivalent prohibition at the community levelNeither the European Commission nor other bodies have imposed restrictions on the sale of the Apple Watch for reasons related to these patents.
For European consumers, this means that models sold through official channels and authorized distributors They maintain the active oxygen function in the blood. Normally. The user experience in Spain and the rest of the EU countries currently conforms to Apple's original design without the specific limitations that have been applied in the US market.
However, the conflict serves as a warning. It's possible that, faced with litigation of this magnitude, manufacturers will opt for to more clearly differentiate the versions of their products according to the markets, adjusting health functions or advanced features to legal requirements and the risks of lawsuits in each territory.
From a European regulatory perspective, this case also underscores the importance of finding a balance between the protection of industrial property and promotion of innovation in healthcare technologies. Although the EU has not intervened directly in this dispute, such a high-profile clash between a major consumer technology company and a company specializing in medical devices does not go unnoticed by regulators and legislators.
In practical terms, those who buy an Apple Watch in Spain today should not notice any immediate changes resulting from this import ban limited to the US marketHowever, the evolution of the case could influence how Apple designs the next generations of the watch, which features it prioritizes, and to what extent it adapts its health solutions to comply in advance with various international regulations.
The scenario that has been consolidated leaves the limited Apple Watch import ban The original version of its blood oxygen function is still in the United States, while models with the redesigned feature are cleared to enter the country following recent rulings by the ITC and Customs. Meanwhile, the legal battle between Apple and Masimo continues in other courts, suggesting that this clash between Big Tech and the medical industry will continue to shape the debate on how health features are integrated into connected devices, both within and outside of Europe.
