Cardiovascular Data Science (CarDS) Lab
PRECARDIA (FitBit)
Terms of Service
Welcome to the Precardia Study (Europe), a collaborative research initiative operated by the Cardiovascular Data Science (CarDS) Lab at Yale University (USA) and the Center for Translational Cardiology and Pragmatic Randomized Trials (CTCPR) in Denmark (referred to collectively as “we,” “us,” or “our”).
Your enrollment in the Precardia Study and use of the CarDSPlus Fitbit Web Application (the “Service”) is subject to the following Terms and Conditions (“Terms”). Please read them carefully before participating.
1. Acceptance of Terms
By enrolling in the Precardia Study and using the Service, you acknowledge that you have read, understood, and agreed to these Terms, as well as the accompanying informed consent and Privacy Policy. If you do not agree to these Terms, you may not participate in the study.
2. Purpose of the Service
The Fitbit Web App is a digital platform created exclusively for non-commercial, academic research under an Institutional Review Board (IRB)-approved protocol. It enables enrolled participants to securely connect their Fitbit accounts to share health data for research purposes. This app is not a medical device and does not provide medical advice, diagnosis, or treatment.
3. Consent Process
Before using the Service, you must provide informed consent via the platform, which includes:
A clear explanation of what data will be collected from Fitbit (e.g., steps, heart rate, sleep, activity logs).
How your data will be used by the CarDS Lab and CTCPR.
Potential risks and benefits.
Your rights, including the ability to withdraw at any time, request a copy of your data, or request deletion of your data.
4. Data Collection and Use
Your Fitbit health and personal data will be collected through Fitbit’s secure OAuth authorization and stored securely in accordance with:
The study’s consent form.
The Privacy Policy embedded in the web app.
Applicable laws and IRB regulations.
We may use de-identified or anonymized data for research publications or academic presentations. Your Fitbit credentials are not stored; only access tokens are used for secure data retrieval.
5. Participant Responsibilities
By using the Service, you agree to:
Use the Service only for its intended research purpose.
Not misuse, replicate, or reverse engineer the app for commercial or illegal activities.
Maintain the confidentiality of any account credentials used to access the Service.
6. Intellectual Property
All content, code, and materials within the web app are the intellectual property of the CarDS Lab or its licensors. You are granted a non-exclusive, non-transferable, and revocable license to use the Service solely for study participation.
7. Termination of Participation
Your access to the web app may be revoked if:
You withdraw from the study.
You breach any of these Terms.
The IRB suspends or terminates the study.
Upon termination, your access will be disabled and no further data will be collected.
8. Limitation of Liability
To the extent permitted by law, the CarDS Lab, CTCPR, and their affiliates, employees, and collaborators shall not be liable for:
Indirect or incidental damages.
Loss of data, profit, or goodwill.
Unauthorized access to your Fitbit account or data.
The Service is provided “as-is” with no warranties beyond those explicitly stated.
9. Modifications to Terms
These Terms may be updated to reflect changes in the study or legal requirements. You will be notified via the platform of any material updates, all of which will be subject to IRB review. Continued use of the app signifies your acceptance of the updated Terms.
10. Governing Law
These Terms are governed by the laws of the State of Connecticut, United States, and relevant data protection and research ethics regulations. Any disputes will be overseen by the IRB and appropriate regulatory bodies.
11. Contact Information
For any questions or concerns related to your participation or data:
Principal Investigator (USA):
Dr. Rohan Khera
📧 Email: rohan.khera@yale.edu
IRB Contact (USA):
Yale University HRPP
📧 Email: HRPP@yale.edu
By using the CarDSPlus Fitbit Web App, you confirm your voluntary participation in the Precardia Study and accept all Terms outlined above.
Cardiovascular Data Science (CarDS) Lab
Title
Privacy Policy
Precardia Study Privacy Policy for Research Participants
Effective Date: 04/21/2025
Last Updated: 04/21/2025
This Privacy Policy outlines how your personal and health-related information is collected, used, stored, and shared through your participation in the Precardia Study, a research initiative led by the Cardiovascular Data Science (CarDS) Lab at Yale School of Medicine. By participating in the study and using the CarDSPlus Fitbit Web Application (the “Service”), you agree to the practices described below and in your informed consent form.
1. What Data We Collect
When you connect your Fitbit account and use the Service, we collect personal and health-related information, including but not limited to:
Fitbit health data (e.g., step count, heart rate, activity, sleep, calories)
Basic demographic details (e.g., name, sex, date of birth)
Metadata such as usage logs for quality control
All data collection occurs under the oversight of an Institutional Review Board (IRB) and is based on your explicit informed consent.
2. How We Use Your Data
Your data is used solely for research purposes within the scope of the Precardia Study. This includes:
Analyzing health and activity patterns
Developing scientific insights
Improving the performance and utility of the Service
We do not use your data for commercial purposes or any purposes beyond what is explicitly described in the study’s informed consent form.
3. Data Storage & Protection
All data is securely stored on encrypted servers that meet HIPAA and Yale University security standards. Access to the data is strictly limited to researchers approved under the IRB protocol. Our safeguards include:
Role-based access control
End-to-end encryption during data transfer and at rest
Comprehensive audit logs to track data access and activity
4. Data Sharing
We may share de-identified or coded data with approved research collaborators, as described in the study consent form and permitted by the IRB. We will never share identifiable data with third parties for commercial, marketing, or unrelated purposes.
5. Data Retention
Your data will be retained:
For as long as necessary to fulfill the study’s research objectives
Or as required by Yale’s data retention policies or applicable laws
6. Your Rights
As a participant, you have the right to:
Withdraw from the study at any time
Request deletion of your collected data
Request a copy of your data through the web app interface
If you choose to withdraw, your data will be handled in accordance with the study’s IRB-approved withdrawal protocol.
7. Changes to This Policy
We may revise this Privacy Policy from time to time. Any changes will be:
Reviewed and approved by the IRB
Communicated to participants in advance, with at least 30 days’ notice where feasible
Consistent with applicable research and privacy regulations