Your privacy is important to LivNao and thus, we have developed a Consent Form that covers how we handle your information in connection with the LivNao Study 3.0 ("Study"). Please take a moment to familiarize yourself with our practices. Should you have any questions, please get in touch with our research team immediately using the information in the "Contact Us" section below.

The LivNao Study 3.0

The purpose of the LivNao Study 3.0 (the "Study") is not for medical treatment. The Study and the App are for research to determine whether the App and similar tools (such as the Apple iPhone, Apple Watch, Android device, and Android-compatible wearables) can accurately identify changes in mental health. The App analyzes responses collected by you throughout three sets of surveys. These include an onboard survey completed upon Sign Up, a set of daily questions administered after 12pm, and an off-board survey completed upon 30-days of participating in our Study. The passively collected information includes, but is not limited to; social & geo-location environment data captured by the smartphone’s Bluetooth, Location Services and motion sensors. Additionally, beat-to-beat calculation data captured by the Apple and Android-compatible wearables’ Photoplethysmography (PPG) sensor and additional data sources available via Apple Health or Google Fit are captured, anonymized and de-identified. If the App algorithm identifies a sustained mental health behaviour abnormality you may receive a notification on your smartphone. LivNao and its affiliates will receive information collected from or about you through the App or as part of this Study. Throughout this policy we may use the term "Study Team'' to refer to all the entities listed above that may have access to data collected from or about you through the App or as part of the Study. This Privacy Policy covers the information we collect or receive in connection with your use of the App and participation in the Study. This Privacy Policy does not cover information that we collect or receive about you in other contexts, such as when you use another LivNao product, browse LivNao websites, use other LivNao mobile apps. For our privacy practices generally, please see our general privacy policy.

Informed Consent

To participate in the Study, you must first review and sign the informed consent and authorization form ("Informed Consent") for the Study. By using the App, you consent to the collection, use, and sharing of your information as described in this Privacy Policy and as outlined in the Informed Consent. To the extent that anything in this Privacy Policy conflicts with the Informed Consent, the terms of the Informed Consent will control.

Collection and Use of Information

Personal information is data that can be used to identify or contact a single person. Certain personal information and non-personal information, as described below, may be collected from or about you through this App or as part of the Study. LivNao, its affiliates, and the other Study Team members may share the information we collect through the App with each other and use it consistent with this Privacy Policy. If you decide to participate in the Study, below are examples of the types of information that we collect and how we use it.

What information we collect

When you download the App and enroll in the Study, the following categories of information (which may include some personal information) may be collected from or about you through the App ("Study Data”):

  • Contact information such as your name, email address, state of residence, and phone number.

  • Demographic information, such as your age, gender, and race.

  • Self-reported medical history and information, such as your height/weight, prior medical diagnosis and testing (i.e., diagnosis of depression), current and previous use of certain medications (i.e., anti-depressant medications), certain family history (i.e., anxiety) and health habits (i.e., exercising). This information may be collected through in-app or other health surveys that you may be asked to complete.

  • Sensor information, such as Bluetooth, location services, accelerometer, heart rate and beat to beat calculations.

  • Technical data, which in many cases is non-personal information, i.e., data in a form that does not, on its own, permit direct association with any specific individual. Technical data includes, for example, information about your app usage (i.e., when the App was first launched), app version and installation ID, and technical data about your device, such as operating system and model. This App does not respond to browser "Do-Not-Track" signals.

  • Adverse event information, such as a concern, adverse event, or other reportable matter arising in the study.

Your Contact information and any other information that could directly identify you will be separated from the rest of the data collected from you through the App and as part of this Study and replaced with a random code ("Coded Study Data"). LivNao will only have access to Coded Study Data and will not have access to any Study Data that could directly identify you

How we use your information

Your personal information, such as your contact information, may be used for purposes such as:

  • To enroll you in the Study, including determining your eligibility for participation in the Study

  • To conduct and support the Study

  • To contact you with surveys or other messages related to the Study through in-app notifications, email, or otherwise

Your Coded Study Data may be used for purposes such as:

  • To conduct and support the Study

  • To evaluate heart rate variability across populations and at various activity levels To develop health-related products and improvement activities

  • For other research studies

  • To issue research findings and related reports, which will not identify you

Study Benefit Participation

Study Rules

Accounts, memberships in the Study, and promotions, benefits, awards, and rewards provided thereunder (and "Study Benefits") are offered at the discretion of LivNao and its affiliates, and LivNao has the right to terminate your Account, the Study, and any Study Benefits, and to change any terms, conditions of participation, rules, and procedures that LivNao adopts to govern the Study or Study Benefits (any "Study Rules"), in whole or in part, at any time, without notice, even though such changes may affect the value of Study Benefits or points obtained through use of the Services (or "Study Points") already accumulated. LivNao may, among other things, withdraw, limit, modify, or cancel any Study Benefits, increase the Study Points required for any Study Benefits, and modify or regulate the transferability of any Study Benefits in whole or in part, at any time, without notice. In accumulating Study Points, you may not rely upon the continued availability of a Study Benefit and you may not be able to obtain all offered Study Benefits.

Study Participation

Participation in the Study is subject to any Study Rules that LivNao may, at its sole discretion, adopt, alter, or terminate from time to time. LivNao has the sole right to interpret and apply the Study Rules. Any failure to follow Study Rules, abuse of the Study, or misrepresentation of any information furnished to LivNao or LivNao Affiliates by you or anyone acting on your behalf may result in the termination of your Account and the cancellation of accrued Study Points, Study Benefits, or both.

Study Points and Study Benefits

The Study is generally structured to permit you to exchange Study Points for Study Benefits. The accumulation of Study Points and the redemption of such Study Points are subject to the specific Study Rules developed by LivNao. Following Account creation, Participants are eligible to accrue Study Points through methods of accrual set forth in the Study Rules. Participants may not accrue Study Points for the utilization of the Services by any other person, animal, object, or entity.

If LivNao improperly denies you an accrual of Study Points or a Study Benefit, LivNao’s sole liability will be limited to the equivalent of those Study Points or that Study Benefit.

LivNao reserves the right to make Study Benefits and promotional offers selectively available to certain Participants, at any time, based upon geographic locations, Program participation, or other factors determined at LivNao’s sole discretion. You are responsible for ensuring that your Study Points are properly credited. Study Points accrued in your Account will be maintained until such Study Points are redeemed, your Account is terminated, or such Study Points expire pursuant to the Study Rules, whichever occurs first. The accumulation of Study Points does not entitle you to any vested rights with respect to Study Benefits or the Study.

Study Benefit Redemption

The Study Benefits available and the amount of Study Points necessary to redeem each Study Benefit will be set by LivNao and be made available to you on the App. If any Study Benefits are subject to tariffs, taxes, or other required fees, you will be responsible. The number of Study Points required to redeem any award may be increased, a Study Benefit may be withdrawn, and restrictions may be placed on any Program Benefit or its redemption by LivNao at any time.

Audit Rights

LivNao reserves the right to audit any and all Accounts at any time and without notice for compliance with the Study Rules. In the event such an audit reveals discrepancies or possible violations, the processing of Study Benefit redemption requests may be delayed pending completion of the audit.

Disclosure to Third Parties

Service Providers

LivNao and the other Study Team members may share your information with companies who provide services for or on behalf of the Study in order to protect your rights as a research participant, or third parties that have been hired to perform Study-related services, such as receiving and processing Study-related complaints & other information, on our behalf. These companies are obligated to protect your information.

Others

Your personal information and Coded Study Data may also be disclosed to the following third parties:

  • Government and Regulatory authorities, such as Health Canada, the U.S. Department of Health and Human Services, the Food and Drug Administration, and other federal or provincial/state government agencies.

  • Law enforcement or other third parties pursuant to valid legal processes such as a subpoena, litigation or court order. We may also disclose information about you if we determine that for purposes of national security, or other issues of public importance, disclosure is necessary or appropriate.

  • Others, if we determine that disclosure is reasonably necessary to enforce our terms and conditions or protect our operations or users. Additionally, in the event of a reorganization, merger, or sale we may transfer all personal information we collect to the relevant third party.

Protection of Your Information

LivNao takes the security of your personal information very seriously. LivNao has implemented reasonable measures to keep the Study Data it maintains safe, and to protect the confidentiality of your information, including storing it in systems with limited access housed in facilities using physical security measures. Despite our security measures, total confidentiality cannot be guaranteed.

Retention of Personal Information

Your participation in the Study is voluntary. You may decide not to participate or you may leave the Study at any time. If you decide to withdraw, we will not delete the information that we have already collected and we may continue to use it, but we will stop receiving any new Study Data about you and will stop contacting you about the Study except in the case of serious, actionable medical need. Your coded study data collected during this study may be stored and used for future research. If so, any personal identifiers will be removed so that the information cannot be linked back to you. As a result, we will no longer be able to identify and destroy this information. Investigators, including investigators from collaborating institutions and other affiliates, can request this data for new research. Data may also be shared with outside non-profit academic investigators as well as with for-profit pharmaceutical investigators or commercial entities, with whom we collaborate. You will not be asked to provide additional informed consent for the use of your de-identified information in future research. Future research studies may include additional processing of information to build other algorithms.

Children

Participants in this Study are required to be 18 years or older. This App is not intended for children under the age of 18. If we learn that we have collected the personal information of a child under 18, we will take steps to delete the information as soon as possible.

Privacy Questions

If you have any questions or concerns about this privacy policy please contact us. If you have questions about the Study please contact our team at study@livnao.com. To withdraw from the Study, please contact our team at study@livnao.com. Please note that deleting the App will not withdraw you from the Study; to withdraw through the App, you must send a request to our team. LivNao may update this Privacy Policy from time to time and is subject to change without notice.

Contact Us

To address your individual concerns or if you have any Study-related questions or comments related to these Policies, please send an email to study@livnao.com.

LivNao Technologies Inc.

440 N Wolfe Road

Sunnyvale, CA,

USA, 94085

California Privacy Rights: Under California Civil Code sections 1798.83-1798.84, California residents are entitled to ask us for a notice identifying the categories of personal customer information which we share with our affiliates and/or third parties for marketing purposes, and providing contact information for such affiliates and/or third parties. If you are a California resident and would like a copy of this notice, please submit a written request to the address above.

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