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`UNITED STATES INTERNATIONAL TRADE COMMISSION
`WASHINGTON, D.C.
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`In the Matter of
`CERTAIN LIGHT-BASED PHYSIOLOGICAL
`MEASUREMENT DEVICES AND
`COMPONENTS THEREOF
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`Inv. No. 337-TA-1276
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`RESPONDENT APPLE INC.’S PUBLIC INTEREST STATEMENT
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`Respondent Apple Inc. respectfully submits the following comments regarding the public
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`interest pursuant to 19 C.F.R. § 210.50(a)(4).
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`I.
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`INTRODUCTION
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`Excluding the subject Apple Watch Series 6, 7, 8, and Ultra from the U.S. would broadly
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`harm the public interest. These smartwatches are an important part of many consumers’ daily
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`lives, including millions who rely on them to stay connected and receive the benefits of multiple
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`other functions including monitoring their individual health and wellness. In addition to the
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`Blood Oxygen feature at the heart of this investigation, Apple Watch also contains a suite of
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`important features that is unmatched in other wearables, including health, wellness, productivity,
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`payment, navigation, safety, and accessibility functionality, to name a few. An exclusion order
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`would take those features out of the hands of American consumers.
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`The proposed exclusion order would also be a setback for medical research, where Apple
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`Watch plays a critical role. Past and present studies have used Apple Watch to monitor and
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`accurately record various physiological parameters for research into stroke-prevention1 and
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`detection of heart arrhythmias.2 Unlike physiological measurement devices designed for the
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`clinical setting, Apple Watch is a widely available and popular consumer wearable device that
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`can collect data from study participants remotely without the need for them to wear a separate
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`device that is provided by the research organization. As such, Apple Watch is particularly well
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`positioned to allow researchers to conduct decentralized, minimally invasive studies, which the
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`1 K. Samuelson, Can Apple Watch Reduce Patients’ Reliance on Blood Thinners?, available at:
`https://news.northwestern.edu/stories/2022/08/30m-grant-to-study-wearables-stroke-prevention-in-
`patients-with-atrial-fibrillation/.
`2 D. Seshadri et al, Accuracy of Apple Watch for Detection of Atrial Fibrillation, available at:
`https://www.ahajournals.org/doi/full/10.1161/CIRCULATIONAHA.119.044126.
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`FDA has concluded help to ensure broader and more diverse representation among study
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`participants.3
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`Beyond the adverse impact on public health and welfare, the proposed exclusion order
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`would also have significant impacts on consumers and the economy at large. Without a delay in
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`the effective date of an exclusion order, an immediate and potentially multi-year shortage likely
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`could not be averted given alternative suppliers’ existing production capacities and a lack of
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`readily available components for use in alternative devices. The exclusion order will cause a
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`reduction in consumer choice and competition for new purchasers of wearable devices.
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`Moreover, without a warranty exception, the exclusion order’s impact will be exacerbated by the
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`threat to millions of existing Apple Watch owners with a need for service or repair.
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`For these and the other reasons set forth below, the Commission should exercise its
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`discretion not to issue an exclusion order.
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`II.
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`AN EXCLUSION ORDER WOULD HARM THE PUBLIC HEALTH AND
`WELFARE, WITH PARTICULAR IMPACT ON FUTURE MEDICAL STUDIES.
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`The subject Apple Watch devices contain a suite of convenience, connectivity, and health
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`and wellness features unmatched in the consumer wearable marketplace. In addition to
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`numerous consumer convenience functions, including cellular capability, messaging, email,
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`access to the Internet, and navigation, essential features that consumers require, these Apple
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`Watch models also offer IRN and ECG Apps, which provide notification of a potentially fatal
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`3 FDA Draft Guidance, Digital Health Technologies for Remote Data Acquisition in Clinical
`Investigations at 3-4 (Dec. 2021), https://www.fda.gov/media/155022/download. See also Kaveeta P.
`Vasisht, Bridget M. Nugent & Janet Woodcock, Progress and Opportunities for Women in Clinical Trials:
`A Look at Recent Data and Initiatives from the U.S. FDA, Med 2, 456–459 (2021),
`https://www.cell.com/action/showPdf?pii=S2666-6340%2821%2900159-8 (“Trials that incorporate
`components of decentralization, digital health, electronic platforms, and other technologies may ease the
`burden of participating in a clinical trial and potentially improve recruitment and retention of diverse
`patients.”).
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`cardiac condition (atrial fibrillation) and allow users to monitor their heart rhythm and share the
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`data with their doctors. These features are each supported by extensive clinical trials4 and
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`granted marketing authorization by the FDA. Further, Apple Watch includes a proprietary Blood
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`Oxygen feature that a person can use to monitor their physiology under different conditions, such
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`as at altitude, before and after exercise, and while sleeping. Excluding imports of Apple Watch
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`would take these important features out of the hands of consumers.
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`Apart from the direct impact on consumers’ health and wellness, an exclusion order
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`would also negatively affect major medical studies in other areas that plan to utilize Apple
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`Watches to collect data. At least three such studies are being planned:
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` A seven-year NIH-funded study related to stroke prevention sponsored by
`researchers at Northwestern University, Stanford, and UCSF5 (spring 2023);
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` A study by Yale (which began in December 2021 but is still currently in the
`recruiting phase) in collaboration with the Mayo Clinic and Duke University to
`study the effects of treatment on symptoms of atrial fibrillation6;
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` The Mayo Clinic is currently enrolling patients into a study to evaluate use of
`Apple Watch with ECG to assess cardiovascular health and detect unknown and
`asymptomatic diseases. The study remains in the recruiting phase with a target
`enrollment of one million patients.7
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`The proposed exclusion order would impede these and similar studies from obtaining the devices
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`specified in their research protocols and/or identifying users who own them, and consequently
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`impede their research goals. Outside the context of any specific study, the wide availability of
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`4 See, e.g., Saghir, N. et al., A Comparison of Manual Electrocardiographic Interval and Waveform
`Analysis in Lead 1 of 12-Lead ECG and Apple Watch ECG: A Validation Study, Card. Digital Health J.,
`Vol. 1, July/Aug. 2020, 30-36.
`5 NIH Funds Study to See If Apple Watch Can Prevent Strokes, Limit Blood Thinners, available at:
`https://www.insiderintelligence.com/content/nih-funds-study-see-apple-watch-prevent-strokes-limit-
`blood-thinners.
`6 See https://clinicaltrials.gov/ct2/show/NCT04468321.
`7 https://clinicaltrials.gov/ct2/show/NCT05324566.
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`Apple Watch enables researchers to conduct more decentralized studies, which promote greater
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`enrollment among more diverse populations.8 Future, unannounced medical studies (particularly
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`decentralized studies), which often require years of planning to execute, will be harmed by the
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`unavailability of Apple Watch.
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`Another area of research in which Apple Watch could potentially be impactful relates to
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`racial disparities in healthcare and the role that pulse oximetry plays in those disparities. For
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`example, a recent study published in the Journal of the American Medical Association (JAMA)
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`found that “racial and ethnic biases in pulse oximetry accuracy were associated with greater
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`occult hypoxemia in Asian, Black, and non-Black Hispanic patients with COVID-19, which was
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`associated with significantly delayed or unrecognized eligibility for COVID-19 therapies among
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`Black and Hispanic patients.”9 The FDA has directed resources to investigating this issue in
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`recent years.
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`During the development of the Blood Oxygen feature, Apple dedicated significant
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`resources to ensuring that Apple Watch worked well for people of all skin tones. Apple’s own
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`research, including a desaturation study published in 2022 conducted on fifty healthy adult
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`subjects, showed no “skin-tone dependence” for blood oxygen measurements taken by Apple
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`Watch when compared with contemporaneous blood tests.10 Apple Watch could therefore be an
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`important research tool and reference point for those seeking to study and correct this disparity.
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`An exclusion order would take this tool out of the hands of researchers.
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`8 See note 2, supra.
`9 Fawzy A., Wu TD, Wang K., et al. Racial and Ethnic Discrepancy in Pulse Oximetry and
`Delayed Identification of Treatment Eligibility Among Patients With COVID-19. JAMA Intern
`Med. 2022;182(7):730-738.
`10 Blood Oxygen App on Apple Watch, Oct. 2022, available at:
`https://www.apple.com/healthcare/docs/site/Blood_Oxygen_app_on_Apple_Watch_October_2022.pdf at
`3.
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`III. THERE IS NO EVIDENCE THAT OTHER SUPPLIERS COULD FILL THE
`SUPPLY GAP CAUSED BY AN EXCLUSION ORDER IN A COMMERCIALLY
`REASONABLE TIME.
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`There has been no evidence that any other manufacturer or group of manufacturers has
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`sufficient excess capacity to fill, in a commercially reasonable time, the supply gap that an
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`exclusion order would immediately create in the United States. Multiple factors are expected to
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`contribute to the expected multi-year duration and scope of the shortage. For one, the
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`extraordinary popularity of Apple Watch translates to a very large supply gap, as many millions
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`of the devices are sold in the U.S. each year. Additionally, the components needed to
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`manufacture wearable electronic devices are typically custom designed. Therefore, components
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`produced for use in excluded Apple products, such as application-specific integrated circuits
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`(ASICs), cannot simply be redirected to other products.11
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`IV.
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`PUBLIC HARM WILL BE MAGNIFIED ABSENT A WARRANTY EXCEPTION.
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`Finally, should the Commission accept the ALJ’s recommended determination not to
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`grant an exception to allow Apple to import devices to service and/or replace Apple Watches
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`purchased before the entry of the exclusion order, those who relied on and depend on Apple’s
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`warranty program, including the public at large and medical researchers, would be harmed
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`because Apple would be unable to service or replace their devices.
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`11 Examples of components that are custom-designed for Apple Watch include the ECG and IRN sensors,
`accelerometers, gyroscopes, compass, water pressure sensor, and display driver.
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`Dated: February 23, 2023
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`Respectfully Submitted,
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`/s/ Sarah R. Frazier
`Mark D. Selwyn
`WILMER CUTLER PICKERING
` HALE AND DORR LLP
`2600 El Camino Real
`Suite 400
`Palo Alto, CA 94306
`Telephone: (650) 858-6031
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`Joseph J. Mueller
`Richard Goldenberg
`Sarah R. Frazier
`WILMER CUTLER PICKERING
` HALE AND DORR LLP
`60 State Street
`Boston, MA 02109
`Telephone: (617) 526-6000
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`Michael D. Esch
`David Cavanaugh
`WILMER CUTLER PICKERING
` HALE AND DORR LLP
`2100 Pennsylvania Ave., NW
`Washington, DC 20037
`Telephone: (202) 663-6000
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`Counsel for Respondent Apple Inc.
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`CERTAIN LIGHT-BASED PHYSIOLOGICAL MEASUREMENT
`DEVICES AND COMPONENTS THEREOF
`
`Inv. No. 337-TA-1276
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`CERTIFICATE OF SERVICE
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`I, Lanta M. Chase, hereby certify that true and correct copies of the foregoing,
`RESPONDENT APPLE INC.’S PUBLIC INTEREST STATEMENT, have been filed and
`served on this 23rd day of February 2023, on the following in the manner indicated:
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` Via Electronic Filing
`(cid:31) Via Hand Delivery (2 Copies)
`(cid:31) Via Overnight Delivery
`
`
`(cid:31) Via Hand Delivery (2 Copies)
`(cid:31) Via Overnight Delivery
`(cid:31) Via Facsimile
` Via Electronic Mail
`edward.jou@usitc.gov
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` Via Hand Delivery (2 Copies)
` Via Overnight Delivery
` Via Facsimile
` Via Electronic Mail
`masimo.appleitc@knobbe.com
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`
`
`The Honorable Lisa R. Barton
`Secretary
`U.S. International Trade Commission
`500 E Street, S.W.
`Washington, DC 20436
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`The Honorable Monica Bhattacharyya
`Administrative Law Judge
`U.S. International Trade Commission
`500 E Street, S.W., Room 317
`Washington, DC 20436
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`Stephen C. Jensen
`Joseph R. Re
`Sheila N. Swaroop
`Ted. M. Cannon
`Alan G. Laquer
`Kendall M. Loebbaka
`KNOBBE, MARTENS, OLSON & BEAR, LLP
`2040 Main Street
`Fourteenth Floor
`Irvine, CA 92614
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`William R. Zimmerman
`Jonathan E. Bachand
`KNOBBE, MARTENS, OLSON & BEAR, LLP
`1717 Pennsylvania Avenue N.W., Suite 900
`Washington, DC 20006
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`Brian C. Horne
`KNOBBE, MARTENS, OLSON & BEAR, LLP
`1925 Century Park East
`Suite 600
`Los Angeles, CA 90067
`Karl W. Kowalis
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`Matthew S. Friedrichs
`KNOBBE, MARTENS, OLSON & BEAR, LLP
`1155 Avenue of the Americas
`24th Floor
`New York, NY 10036
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`Counsel for Complainants
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`/s/ Lanta M. Chase
`Lanta M. Chase
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