Cardiovascular Data Science (CarDS) Lab - Center for Translational Cardiology and Pragmatic Randomized Trials (CTCPR)

Precardia

Terms of Service

Your enrollment for the Precardia Study (the "Service") operated by the Cardiovascular Data Science (CarDS) Lab at Yale University in USA and Center for Translational Cardiology and Pragmatic Randomized Trials (CTCPR) in Denmark ("we", "us", or "our") is subject to your acceptance of and compliance with the following Terms of Use for Research Study Participants ("Terms").

By enrolling for the study, you agree to be bound by these Terms. If you disagree with any component of these Terms, you may not enroll for the study.

Purpose

The Service is designed exclusively for research purposes within the constraints of the IRB-approved study being conducted by the CarDS Lab and CTCPR. It provides a web platform for research participants to enroll and share data from their Garmin Wearable devices. The Service is not intended for commercial purposes, nor for medical advice or diagnosis.

Consent Process

In order to access and use the Service, you must provide your informed consent in the web platform. This consent process includes information on the collection, use, and sharing of your personal and health-related data with the CarDS Lab and CTCPR, as well as any potential risks, benefits, and alternatives. You have the right to withdraw your consent at any time during the research study. You have the right to request a copy of the collected data and to request deletion of the collected data.

Data Collection and Use

We will collect and use your data in accordance with the research study's consent form, as well as our Privacy Policy, which is incorporated into these Terms by reference. Please review the consent form and Privacy Policy to understand our practices for data collection, usage, and sharing.

User Responsibilities

By accessing or using the Service, you agree to:
a. Use the Service for research purposes only, and not for commercial purposes or any purpose that is unlawful or prohibited by these Terms.
b. Comply with all applicable laws and regulations, as well as the terms and conditions of the IRB-approved research study.
c. Protect your account credentials and notify us immediately if you become aware of any unauthorized access to your account.

Intellectual Property

All intellectual property rights in the Service, including but not limited to copyrights, trademarks, and patents, are owned by or licensed to the CarDS Lab. You are granted a limited, non-exclusive, non-transferable, and revocable license to use the Service for research purposes only, in accordance with these Terms.

Termination

We may terminate or suspend your enrollment to the study immediately, without prior notice, if you breach these Terms, or if required by the IRB or any applicable laws and regulations. Upon termination, your right to use the Service will immediately cease.

Limitation of Liability

To the fullest extent permitted by law, in no event shall the CarDS Lab, its affiliates, employees, or licensors be liable for any indirect, incidental, special, consequential, or punitive damages, including but not limited to loss of profits, data, use, goodwill, or other intangible losses, resulting from (i) your access to or use of, or inability to access or use the Service; (ii) any conduct or content of any third party on the Service; (iii) any content obtained from the Service; and (iv) unauthorized access, use, or alteration of your transmissions or content, whether based on warranty, contract, tort (including negligence), or any other legal theory, whether or not we have been informed of the possibility of such damage, and even if a remedy set forth herein is found to have failed of its essential purpose.

Changes

We may revise or modify these Terms at any time, provided that the changes are consistent with the requirements of the IRB and applicable laws and regulations. If a revision is made, we will make reasonable efforts to provide at least 30 days’ notice prior to any new terms taking effect, subject to IRB approval. By continuing to access or use our Service after those revisions become effective, you agree to be bound by the revised terms. If you do not agree to the new terms, please stop using the Service.

Governing Law

These Terms are governed by and shall be construed in accordance with the laws of State of Connecticut, United States of America, without regard to its conflict of law provisions, and in accordance with the regulations and guidelines of the overseeing IRB.

Contact Information

For any questions regarding these Terms or concerns about the Service, please contact the Principal Investigator at rohan.khera@yale.edu or the IRB responsible for the research study at HRPP@yale.edu.

By accessing or using the Service, you acknowledge that you have read, understood, and agreed to be bound by these Terms, as well as your informed consent for research study.

Cardiovascular Data Science (CarDS) Lab - Center for Translational Cardiology and Pragmatic Randomized Trials (CTCPR)

Precardia

Privacy Policy

This Precardia Privacy Policy for Research Study Participants Document ("Privacy Policy") governs the collection, use, storage, and disclosure of your personal information and health-related data by the Cardiovascular Data Science (CarDS) Lab at Yale School of Medicine and Center for Translational Cardiology and Pragmatic Randomized Trials (CTCPR) in Denmark ("we") upon the use of the HealthTracker web application (the "Service"). This Privacy Policy is designed to be consistent with the requirements of the Institutional Review Board (IRB) as well as the applicable laws and regulations.

Data Collection

We collect personal and health-related data when you use the Service, including, but not limited to, information from Gramin devices. We collect this data as part of the IRB-approved research study you are participating in, in accordance with the consent form and the applicable laws and regulations.

Data Use

We use the collected data for research purposes within the context of the IRB-approved research study you are participating in. This may include data analysis, quality control, and improvement of the Service. We do not use your data for commercial purposes or any purpose that is not consistent with the research study's consent form.

Data Storage

Your data is stored on servers in EU that are compliant with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule and GDPR regulations. Only researchers approved by the IRB have access to these servers. These servers are encrypted and have built-in audit logs. We take appropriate measures to protect your data from unauthorized access, disclosure, alteration, or destruction.

Data Disclosure

We may share your data with other researchers, as described in the research study's consent form and approved by the IRB. We do not disclose your data to third parties for commercial purposes or any purpose that is not consistent with the research study's consent form.

Data Retention

We may retain the collected data as long as is necessary for the completion of the research study’s purposes, or as is required by applicable laws and regulations.

Withdrawal of Consent

You have the right to withdraw your consent to participate at any time during this research study. If you withdraw your consent, your data will be managed according to the procedures established by the IRB. Please contact the IRB or the Principal Investigator of the study to withdraw your consent.

Changes to the Privacy Policy

We reserve the right to modify or replace this Privacy Policy at any time, provided that any changes are consistent with the requirements of the IRB and applicable laws and regulations. If a revision is made, we will make reasonable efforts to provide at least 30 days’ notice prior to any new Privacy Policy taking effect, subject to approval from the IRB.

Contact Information

In case of any questions regarding this Privacy Policy, please contact the Principal Investigator at rohan.khera@yale.edu or the IRB responsible for the research study at HRPP@yale.edu.

By using the Service, you acknowledge that you have read, understood, and agreed to this Privacy Policy, as well as your informed consent form for the research study.