The App will obtain information from you in two ways:
We receive and store some information you manually enter into the App. We do not collect Personal Information that directly identifies you, such as your name and birth date. Your name is only shown inside the app, and we only collect your birth year, conforming to the HIPAA Privacy Rule1. Instead, when you first use the app, a random number is created which will be used by us to know that the different information sent to us belongs to the same person.
In addition to directly identifiable Personal Information, we ask you to enter information including gender, weight and height. Information collected when you answer questionnaires may contain information about your medications, your insurance, how you feel and perform at your workplace and your wellness and activity. In the future we may collect additional health-related information as the App and the surveys presented to you are further developed. You can choose not to provide us with certain information by not providing this information in the “You” section inside the App, or simply by skipping questions that you are uncomfortable answering.
In addition to the Personal Information that you manually enter, the App also collects certain Personal Information about you automatically through your smartphone and/or any other wearable device which you use during the Study. For example, the App will interface with your smartphone or wearable device’s sensors (accelerometers, gyroscope, barometer, etc.) to collect the following information:
This data will be automatically uploaded when you complete a survey.
The App may also collect information about your location, including real-time location, through your smartphone or wearable device’s applicable geolocation, GPS, wi-fi or similar capabilities (“Location Information”). We will use the Location Information only when you sign up for the study to determine the state you live in. The App will not store your Location Information.
The App may also automatically receive technical information relating to your usage of the App such as your operating system, device, features used, content viewed and downloaded, the dates and times of your interactions with the App and other information. We may use this information to understand, customize and improve user experience with the App and the Study. For example, we may engage analytics services to analyze this information in order to help us understand how users engage with and navigate the App, how and when features within the App are used and by how many users. This information cannot be linked to you nor to the data you provide as part of the research study.
All information collected through the App is encrypted on your device. This makes it virtually impossible for anyone except the study organizers to read your information. Encrypted data is then sent to a server run by Boston Children’s Hospital and hosted by Amazon, then forwarded to a secure database hosted at Boston Children’s Hospital.
Because your data only contains your random number, researchers using the data will not be able to identify individuals participating in the study.
Access to the App on your smartphone is protected by Touch ID or the passcode you selected after you downloaded the app. One of these needs to be entered every time you access the App the first time after a few minutes. You should take steps to prevent unauthorized access to your account and personal information by selecting and protecting your Touch ID and passcode appropriately and limiting access to your smartphone.
We endeavor to protect the privacy of the Personal Information we hold in our records, but we cannot guarantee complete security. Unauthorized entry or use, hardware or software failure, and other factors, may compromise the security of your Personal Information at any time.
All information collected by the App will be processed in the United States. During the study, only Boston Children’s Hospital and contractors engaged by Boston Children’s Hospital will be able to compile data you generate or provide through or with the App. You should only transmit data for the Study if you are in the United States at the time you transmit such data. You should be aware that the laws in the United States may not protect your privacy to the same extent as the laws in the country from which you have transmitted data to the App.
The study uses C3-PRO, a technology framework that enforces data encryption from the mobile device to the final destination. In this case the Boston Children's Hospital computational infrastructure, a highly secured environment where no external access is allowed, and where only authorized researchers will be granted access.
If you have granted us permission to do so in the informed consent form for the Study, we may share your coded study data (data not containing your name nor date of birth) with researchers outside of Boston Children’s Hospital under criteria established by Boston Children’s Hospital.
The information collected by the App will not be shared with or sold for advertising purposes.
If required by law, your study information may be disclosed to United States Department of Health and Human Services agencies, the Office for Human Research Protection, and other agencies as required by law. Also, the Institutional Review Board at Boston Children’s Hospital, which monitors the safety and conduct of human research, can look at the study information.
One risk is a loss of privacy, which means that someone else would be able to see the information you report using the app, or learns that you have hepatitis C because you have the app on your iPhone.
For security, C Tracker requires that your iPhone be protected either by a passcode or the Apple Touch ID fingerprint sensor. This helps to prevent others from entering and using the app. Whenever app data is transferred from your iPhone back to the C3-PRO researchers, it will be encrypted so that it would be very difficult for anyone else to see your data.
If required by law, your anonymous study information may be disclosed to United States Department of Health and Human Services agencies, the Office for Human Research Protection, and other agencies as required by law. Also, the Institutional Review Board at Boston Children’s Hospital, which monitors the safety and conduct of human research, can look at the study information, but will not know who you are.
Yes, the results of this research may be published, including in research journals, and presented at research conferences so that others can learn about the results of this study. The results of the study will not be recorded in a way that identifies individual users.
Yes. If you start the research study but later do not wish to participate, you can use the “Leave Study” link in the Profile section of the app. You may choose to leave the study at any time, but this action cannot be undone.
The study investigators may also withdraw you from the study without your consent at any time for any reason, including if the study is cancelled.