FAQs

The Apple Heart Study is a research study conducted to learn if the Apple Heart Study app can use data from Apple Watch to identify irregular heart rhythms, including those from potentially serious heart conditions such as atrial fibrillation. Apple is conducting this research study in collaboration with Stanford Medicine to improve the technology used to analyze irregular heart rhythms. Early detection of irregular heart rhythms may prevent more serious health issues.

The Apple Heart Study app uses data from Apple Watch to identify irregular heart rhythms, including those from potentially serious heart conditions such as atrial fibrillation. The Apple Heart Study app will notify you if the app identifies a possible irregular heart rhythm. As part of the study, you will be able to connect to a Study Telehealth Provider from American Well, and may be sent a small, discreet sensor device called an ePatch to wear for up to seven days. The ePatch adheres to your chest and is commonly used to monitor a person’s heart rhythm. After you return your ePatch, you will receive instructions to contact the Study Telehealth Provider who will review your ePatch results with you and may recommend that you seek further medical care from your own health care provider. The ePatch and the Study Telehealth Provider calls will be provided at no cost to you. However, any further medical care you seek from your own health care provider will be at your own cost.

One out of four individuals will have atrial fibrillation during their lifetime¹ a condition that significantly increases the risk of stroke and heart failure but often goes undiagnosed. You can help determine if the Apple Heart Study app together with Apple Watch can identify irregular heart rhythms, including those from potentially serious heart conditions such as atrial fibrillation.

Anyone who meets all of the following criteria may participate in the study:

• 22 years or older
• Resident of the United States
• Comfortable with written and spoken English
• Has an iPhone 5s or later with iOS version 11.0 or later
• Has an Apple Watch Series 1 or later with watchOS version 4.0 or later
• Has never been diagnosed with atrial fibrillation, atrial flutter, and is currently not taking any anticoagulant medication

Requires Apple Watch Series 1 (Fall 2016 model) or later with watchOS 4.0 and later. The Apple Heart Study does not support the original Apple Watch. 

You will download the Apple Heart Study app and install on your iPhone and Apple Watch. You will need to wear Apple Watch during the study period for the app to analyze your heart rhythm. If the app identifies any heart rhythm abnormality, you will be able to talk with the Study Telehealth Provider from American Well, who may suggest you wear an ePatch for 7 days (provided at no cost). You will also be asked to complete up to three short surveys via the app and website during the study period.

The heart rate is a measure of how fast or how slow your heart is beating. Learn more about the heart rate sensor on Apple Watch here: https://support.apple.com/en-us/HT204666

Yes, you may still enroll if you have not been diagnosed with atrial fibrillation by a health care provider.                                       

Apple is sponsoring this study. The study-related procedures, including study-related calls with the Study Telehealth Provider (if required) and the ePatch (if required) will be provided at no charge to you or your insurance company. There may be an indirect cost to participate in this study because the data collected for this study and transmitted to the study team will count against your phone’s data plan. A 10-minute study video visit will use approximately 20MB of your phone data when conducted via 3G/4G (rather than Wi-Fi).

If you are found to have an irregular heart rhythm, you are financially responsible for any follow-up treatment you seek from your own health care provider.

Medical care and services you decide to use because of study findings that are not part of this study (for example, Emergency Department visits or any subsequent treatment, whether recommended by the Study Telehealth Provider or not), may require co-payments if your insurance requires co-payment or may require you to bear the expenses if you do not have insurance. The sponsor will not be responsible for any costs beyond those described here.

Approximately 15 months, from November 29, 2017 to January 31, 2019.

The study data that will be collected during your participation in the study includes data collected by the Apple Heart Study app (using Apple Watch and iPhone), the ePatch (only if you receive an ePatch), survey responses, and data collected by the Study Telehealth Provider (if applicable). For the purposes of data analyses, only coded study data (explained below) will be used.

The study data gathered will go to a secure database where your name and other identifying information will be removed and replaced with a random code to protect your privacy. Your coded data will then go to a secure database to be combined with the study data from other participants to be analyzed by the sponsor and Stanford.

Your data will be kept confidential except if disclosure is required by law or as described in the informed consent and authorization document, which you will review and sign before any data about you is collected. The study team will do its best to ensure that the study data is kept private and secure. Your data will be stored and transmitted using secure systems. If the results of this study are published or presented at meetings, your name and other directly identifying information will not be used and you will not be identified. Your coded study data may be used by the sponsor for FDA submission to seek approval of the investigational device and also for the development of health-related product development and improvement activities. 

Apple Inc., Stanford University, Schulman Institutional Review Board (ethics committee), American Well and it’s clinical partner, Online Care Group (Study Telehealth Provider), Biotelemetry (ePatch provider), and its subsidiaries/affiliates, Data Safety Monitoring Board, Office for Human Research Protections in the U.S. Department of Health and Human Services, the FDA (Food and Drug Administration) and other international regulatory agencies may have access to your data.

You do not have to sign a consent authorization form, but if you do not sign, you will not be able to participate in the study. The informed consent and authorization document will be available for you to read and sign within the Apple Heart Study app. A copy of your signed informed consent will be made available to you.

No.

Study data may be used for health-related product development and improvement activities. The sponsor has no plans to offer you financial compensation or share any profits from the commercialization of any products, processes, or services developed from your information. You will not, however, lose any legal rights to which you are entitled by agreeing to participate in this study.

Yes, as long as it is paired with the iPhone onto which you have downloaded the Apple Heart Study app.

Yes.

You can sign up for this study at your convenience anytime before August 1, 2018 (unless study enrollment has been closed).

Notifications for participation will be sent on a rolling basis in order to accommodate the large volume of participants anticipated across the U.S. The waiting period may vary for participants. You will receive a notification on your iPhone and Apple Watch when the study is ready for you to participate. Please do not delete the app or turn off notifications during this waiting period. This notification will direct you to return to the Apple Heart Study app. Upon launching the app, you can expect to see a "Welcome Back" message, be instructed to enter your current state of residence, be presented with the informed consent and authorization, and answer some brief questionnaires in order to complete enrollment in the study. 

If you cannot connect with a Heart Study doctor through the app, please update the app. Go to the App Store, tap the Updates icon at the bottom of the screen, find Apple Heart Study, and tap the Update button. This will update the app to Version 1.0.1 (or higher). If you have already updated the app and are still unable to connect with the doctor, please contact support at (844) 606-1609.

You can call (844) 606-1609.

If you delete the app without withdrawing from the study, data will no longer be collected from you; however, you will still be enrolled in the study. If you accidentally delete the app, you can redownload the app from the App Store.

You can delete the app at anytime.

To withdraw, you must call (844) 606-1609 or use the “Withdraw from Apple Heart Study” button in the app. After you withdraw, no further data will be collected about you for study purposes.

You can reinstall the app to continue participation, as long as the iPhone and the iOS version meet the requirements of the study.

Exercise will not affect the results. You can wear the Apple Watch during exercise. 

You can shower normally while wearing the ePatch, but you cannot swim or take a bath.

Participation in this study is not a substitute for medical care or medical advice you get from your doctor or other health care provider. You should continue to see your regular doctor and keep any scheduled physical exams, cardiac screening procedures, and medical appointments. Always seek professional medical advice whenever you need it. 

After you decide to participate, you can withdraw your participation at any time. To stop participating in the study, please call (844) 606-1609. You will also be able to withdraw from the study using the Apple Heart Study app. We will not delete the information or data about you that we have already collected, but we will stop collecting any new information about you and will turn off further notifications. If you delete the app, you will not be withdrawn from the study. To withdraw, you must call (844) 606-1609 or use the “Withdraw from Apple Heart Study” button in the app. After you withdraw, no further data will be collected about you for study purposes.

The sponsor can stop your participation at any time without your consent for the following reasons:

• If you fail to follow directions for participating in the study;
• If it is discovered that you do not meet the study requirements;
• If the study is canceled;
• If you do not consent to continue your participation in the study after being told of new changes in the study that may affect you; or
• For administrative reasons, including reaching the target number of subjects who have entered the study.

An institutional review board (IRB) is an independent committee established to help protect the rights of research subjects. If you have any questions about your rights as a research subject, and/or concerns or complaints regarding this research study, you should write to Schulman IRB, 4445 Lake Forest Drive, Suite 300, Cincinnati, Ohio 45242, or call toll-free (888) 557-2472 during business hours Monday to Friday 8:00 a.m. to 6:00 p.m. ET and reference this study. The IRB will not be able to answer any study or app related questions; for all questions about the research study, including technical support, please call (844) 606-1609.

Disclaimer: These FAQs are meant to serve as guidance and may be updated if needed. Study participants with questions should call (844) 606-1609.

¹ Andrade J, Khairy P, Dobrev D, Nattel S. The clinical profile and pathophysiology of atrial fibrillation: relationships among clinical features, epidemiology, and mechanisms. Circ Res. 2014;114(9):1453-1468.