Apple Heart Study 1.2 FAQs

The Apple Heart Study 1.2 is a research study conducted to better understand the experience of users of the Apple Watch heart rhythm features. Apple is conducting this research study in collaboration with Stanford Medicine to understand people’s experience with using the Apple Watch Irregular Rhythm Notification feature and Apple Watch ECG app. Early detection of irregular heart rhythms may prevent more serious health issues.

The Apple Heart Study 1.2 will connect you to a Study Telehealth Provider from American Well, and you will 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. We will also ask you to complete questionnaires to understand your experience with using the Apple Watch features.

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 us understand the significance of using Apple Watch features to identify irregular rhythms suggestive of 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 12.1.1 or later
• Has an Apple Watch Series 1-4 with watch OS version 5.1.2 or later, has received an Irregular Rhythm Notification, or has received an ECG app classification of atrial fibrillation or inconclusive

Requires Apple Watch Series 1-4 with watchOS 5.1.2 and later. The Apple Heart Study 1.2 does not support earlier Apple Watches.

You will download the Apple Heart Study 1.2 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. You will wear an ePatch for up to 7 days. If you have the ECG app, we ask that you take an ECG twice daily while wearing the ePatch. After you wear the patch, you will have a video or voice visit with a study telehealth provider to discuss your patch results. You will also be asked to complete up to three short monthly surveys via the app and website during the study period (approximately 60 days).

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 and the ePatch 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 9 months, from December 6, 2018 to August 31, 2019. Your participation in the study will last approximately 60 days.

The study data that will be collected during your participation in the study includes data collected by the Apple Heart Study 1.2 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 researchers.

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 received by the Study Sponsor may be used for the purposes described in this consent document, including determining if sensor data can be used to identify irregular heart rhythms and for the development and improvement of said detection mechanisms evaluating heart rate variability across populations and at various activity levels, and for health-related product development and improvement activities as they relate to cardiovascular health and outcomes.

Study Data sent from Stanford to the Study Sponsor that is Protected Health Information will be deidentified (per HIPAA standards) before the Study Sponsor uses it for health related product development and improvement activities or potentially other research.

Apple Inc., Stanford University, American Well and it’s clinical partner, Online Care Group (Study Telehealth Provider), BioTelemetry (ePatch provider), and its subsidiaries/affiliates, 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 1.2 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 as they relate to cardiovascular health and outcomes. Study Data sent from Stanford to the Study Sponsor that is Protected Health Information will be deidentified (per HIPAA standards) before the Study Sponsor uses it for health related product development and improvement activities or potentially other research.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.

No, sharing Apple Watches or iCloud accounts is not allowed for this study.

As long as enrollment has not exceeded allowed limits, you can sign up for this study at your convenience anytime before August 31, 2019.

If you are unable to connect with the doctor, please contact support at 1-800-358-2286.

You can call 1-800-358-2286.

If you delete the app without withdrawing from the study, data will no longer be collected from you; however, you will still be officially enrolled in the study.

You can delete the app at anytime.

To withdraw, you must call 1-800-358-2286 or use the “Withdraw from Apple Heart Study 1.2” 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, and you have completed an iCloud or encrypted iTunes backup.

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 1-800-358-2286. You will also be able to withdraw from the study using the Apple Heart Study 1.2 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 1-800-358-2286 or use the “Withdraw from Apple Heart Study 1.2” 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 Stanford IRB, Stanford University, 3000 El Camino Real, Five Palo Alto Square, 4th Floor, Palo Alto, CA 94306., or call toll-free toll free at 1-866-680-2906 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 1-800-358-2286.

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.