Cardiovascular Data Science (CarDS) Lab

PRECARDIA

Terms of Service

Welcome to the Precardia Study (Europe), a collaborative research initiative operated by the Cardiovascular Data Science (CarDS) Lab at Yale University in the United States and the Center for Translational Cardiology and Pragmatic Randomized Trials (CTCPR), Denmark (referred to collectively as “we,” “us,” or “our”).

Your enrollment in the Precardia Study and use of the CarDSPlus (EU) iOS 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 CarDSPlus (EU) app is a digital tool created exclusively for non-commercial, academic research under an Institutional Review Board (IRB)-approved protocol. It enables enrolled participants to share Apple Watch 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 you can use the Service, you must provide informed consent via the app. This includes:

A clear explanation of what data is collected (e.g., steps, heart rate, ECG, sleep).
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 from within the app.

4. Data Collection and Use

Your health and personal data will be collected and stored securely in accordance with:

The study’s consent form.
The Privacy Policy embedded in the app.
Applicable laws and IRB regulations.

We may use de-identified or anonymized data for research publications or academic presentations.

5. Participant Responsibilities

By using the app, you agree to:

Use the Service only for its intended research purpose.
Not misuse, replicate, or reverse engineer the app for any commercial or illegal activity.
Maintain the confidentiality of your login credentials.

6. Intellectual Property

All content, code, and materials in the 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 the purpose of participating in the study.

7. Termination of Participation

Your access to the app may be revoked if:

You withdraw from the study.
You breach any terms listed here.
The IRB suspends or ends the study.

Upon termination, your app access will be removed 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 use of your 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 from time to time to reflect changes in the study or legal requirements. You will be notified in-app of any material changes, and all modifications are subject to IRB review. Continued use of the app signifies your agreement to the updated Terms.

10. Governing Law

These Terms are governed by the laws of the State of Connecticut, United States, and applicable research ethics regulations. Any disputes shall be subject to the oversight of the IRB and relevant data protection authorities.

11. Contact Information

For any questions, concerns, or requests 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 (EU) app, you acknowledge that you voluntarily participate in the Precardia Study and agree to all the above Terms.

Cardiovascular Data Science (CarDS) Lab

PRECARDIA

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 by Cardiovascular Data Science (CarDS) Lab at Yale School of Medicine. By participating in the study and using the CarDSPlus (EU) iOS application (the “Service”), you agree to the practices described below and in your informed consent form.

1. What Data We Collect

When you use the Service, we collect personal and health-related information, including but not limited to:

Data from Apple Health and Apple Watch (e.g., step count, heart rate, ECG, sleep, and activity data)
Basic demographic details (e.g., name, sex, date of birth)
Metadata such as usage logs for quality control

All data collection is done under the oversight of an Institutional Review Board (IRB) and based on your explicit informed consent.

2. How We Use Your Data

Your data is used solely for research purposes related to the Precardia Study. This includes:

Analyzing health trends
Developing research insights
Improving the Service’s quality and functionality

We do not use your data for commercial purposes or for any purpose not explicitly described in the consent form.

3. Data Storage & Protection

All data is securely stored in encrypted servers compliant with HIPAA and Yale University’s security protocols. Access is strictly limited to IRB-approved researchers. Additional safeguards include:

Role-based access controls
Encrypted transfers and storage
Audit logs for all data interactions

4. Data Sharing

We may share de-identified or coded data with approved research collaborators, as permitted by the IRB and described in the study consent form. We do not share identifiable data with third parties for commercial or unrelated purposes.

5. Data Retention

Your data will be retained:

For as long as necessary to fulfill the goals of the research study
Or as required by Yale’s policies or applicable laws and regulations

6. Your Rights

As a participant, you have the right to:

Withdraw from the study at any time
Request deletion of the collected data
Request a copy of your data through the app

After withdrawal, your data will be handled in accordance with the study’s IRB-approved protocol.

7. Changes to This Policy

We may update this Privacy Policy from time to time. Any changes will be:

Consistent with IRB and legal requirements
Communicated to participants in advance (minimum 30 days' notice if possible)
Approved by the IRB before taking effect

PRECARDIA

Terms of Service

Your enrollment in the Precardia Study and use of the CarDSPlus (EU) iOS 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

3. Consent Process

Before you can use the Service, you must provide informed consent via the app. This includes:

A clear explanation of what data is collected (e.g., steps, heart rate, ECG, sleep).

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 from within the app.

4. Data Collection and Use

Your health and personal data will be collected and stored securely in accordance with:

The study’s consent form.

The Privacy Policy embedded in the app.

Applicable laws and IRB regulations.

We may use de-identified or anonymized data for research publications or academic presentations.

5. Participant Responsibilities

By using the app, you agree to:

Use the Service only for its intended research purpose.

Not misuse, replicate, or reverse engineer the app for any commercial or illegal activity.

Maintain the confidentiality of your login credentials.

6. Intellectual Property

All content, code, and materials in the 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 the purpose of participating in the study.

7. Termination of Participation

Your access to the app may be revoked if:

You withdraw from the study.

You breach any terms listed here.

The IRB suspends or ends the study.

Upon termination, your app access will be removed 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 use of your 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 from time to time to reflect changes in the study or legal requirements. You will be notified in-app of any material changes, and all modifications are subject to IRB review. Continued use of the app signifies your agreement to the updated Terms.

10. Governing Law

These Terms are governed by the laws of the State of Connecticut, United States, and applicable research ethics regulations. Any disputes shall be subject to the oversight of the IRB and relevant data protection authorities.

11. Contact Information

For any questions, concerns, or requests 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 (EU) app, you acknowledge that you voluntarily participate in the Precardia Study and agree to all the above Terms.

PRECARDIA

Privacy Policy

Precardia Study Privacy Policy for Research Participants

Effective Date: 04/21/2025Last Updated: 04/21/2025

1. What Data We Collect

When you use the Service, we collect personal and health-related information, including but not limited to:

Data from Apple Health and Apple Watch (e.g., step count, heart rate, ECG, sleep, and activity data)

Basic demographic details (e.g., name, sex, date of birth)

Metadata such as usage logs for quality control

All data collection is done under the oversight of an Institutional Review Board (IRB) and based on your explicit informed consent.

2. How We Use Your Data

Your data is used solely for research purposes related to the Precardia Study. This includes:

Analyzing health trends

Developing research insights

Improving the Service’s quality and functionality

We do not use your data for commercial purposes or for any purpose not explicitly described in the consent form.

3. Data Storage & Protection

All data is securely stored in encrypted servers compliant with HIPAA and Yale University’s security protocols. Access is strictly limited to IRB-approved researchers. Additional safeguards include:

Role-based access controls

Encrypted transfers and storage

Audit logs for all data interactions

4. Data Sharing

We may share de-identified or coded data with approved research collaborators, as permitted by the IRB and described in the study consent form. We do not share identifiable data with third parties for commercial or unrelated purposes.

5. Data Retention

Your data will be retained:

For as long as necessary to fulfill the goals of the research study

Or as required by Yale’s policies or applicable laws and regulations

6. Your Rights

As a participant, you have the right to:

Withdraw from the study at any time

Request deletion of the collected data

Request a copy of your data through the app

After withdrawal, your data will be handled in accordance with the study’s IRB-approved protocol.

7. Changes to This Policy

Principal Investigator (USA):
Dr. Rohan Khera
Email: rohan.khera@yale.edu

IRB Contact (USA):
Yale University HRPP
Email: HRPP@yale.edu

Effective Date: 04/21/2025
Last Updated: 04/21/2025

Principal Investigator
Dr. Rohan Khera
📧 rohan.khera@yale.edu

Yale Institutional Review Board (IRB)
📧 HRPP@yale.edu