Privacy Policy

Limbix Health, Inc. Spark Clinical Research Study Privacy Policy

This service is provided by Limbix Health, Inc.


THIS PRIVACY POLICY AND NOTICE DESCRIBES HOW INFORMATION ABOUT YOU MAY BE USED AND DISCLOSED AND HOW YOU CAN GET ACCESS TO THIS INFORMATION. PLEASE REVIEW IT CAREFULLY.

In this clinical research study, Limbix Health (“Limbix”, “we” or “us”) is testing the effectiveness of two participant-facing mobile applications designed to treat depression in adolescents. In addition to the primary intervention, these mobile applications (the “Apps”) include data collection, storage, analysis and reporting tools and functions. Collectively, these will be referred to in this Privacy Policy as the “Service.” We also operate a website (the “Website” or “Site”) for participants to submit additional study-related information at https://portal.limbix.com. This Privacy Policy covers how Limbix collects, receives, uses, retains, and discloses Personally Identifiable Information (“PII”) on the Apps and Website. PII includes information about you that is not publicly available, and that is personally identifying such as your name, email address, phone number, medical history, and medication list. PII may include other types of information depending on the legal definition that applies in your physical location. Only the legal definitions of PII that apply in your location will apply to you under this Privacy Policy.  

Research Administrators (“Administrators”) are individuals who are responsible for conducting or providing safety oversight for the Limbix Spark study. These individuals may include Limbix research staff, the Institutional Review Board, the Data Safety Monitoring Board, and study clinicians serving as safety monitors. Participants are adolescents who are participating in the study investigating the effectiveness of the Apps. As you use the Apps, Site, and the Service, the information you provide will be viewed by Administrators to ensure your safety and to facilitate the running of the study. The Apps are available only to Participants who have been given the necessary password or similar credential to access the Service. In order to receive access to and use the Service, Participants (and their legal guardian, where applicable) must have given their consent to Limbix regarding the use and disclosure of their information as described in this Privacy Policy. 


Agreement 

By using the App or the Service, and/or by providing PII to Limbix, you accept and hereby expressly consent to our collection, use, retention, and disclosure of your PII in accordance with the terms of this Privacy Policy. Requested PII will be identified as required or optional. If you choose not to provide required information, you will not be able to access the Service. 


Limbix’s Obligations 

Limbix is required to abide by the terms of this Privacy Policy and Notice currently in effect. However, this Privacy Policy may change from time to time. If we make changes to this privacy policy, we will notify you at the email address we have on file. Please also check back periodically to check the most recent modification date to ensure that you are aware of any changes in our processing of your PII. Your continued use of the App, Service, or Website after any changes signifies your express, explicit, voluntary, and unambiguous consent to any such changes. If you do not agree to such changes, you must notify us that you are withdrawing your consent and immediately stop using the App, the Service, and the Website. This Privacy Policy was last modified on June 5th, 2020.


Information Collection and Use; Choice and Consent 

Uses and Disclosures 

Participants must be registered on the Service and have an active account in order to use the Service. We receive PII about Participants directly from Participants or their legal guardians in order to establish an account and for you to be able to register for and use the Service and identify you as an authorized Participant. Limbix may collect PII when Participants are registered by Administrators and gain access to the App, Site, or Service. When registering, we collect your email address, phone number and password. We will also collect limited PII from your legal guardian (if applicable) to complete the consent process. When you use the App or Site, we may also collect information from you regarding your medical history, medication list, symptoms, and usage of the Service. It is always your choice whether or not to provide us with such information. Limbix uses PII and information you provide to us through the App, the Site, and the Service: 


a. To run the Limbix Spark study (for example, Limbix may use or disclose PII for the purpose of allowing research staff or study clinicians to ensure your safety or  to remind you to complete certain study-related tasks); 

b. To communicate with you or your legal guardian, for example to reset password or reminders; 

c. To communicate with regulatory bodies, such as the Institutional Review Board (IRB) or Food and Drug Administration (FDA), that are overseeing Limbix Spark research. 

d. To communicate with individuals that can help you if you should threaten to harm yourself or others. If keeping information obtained during the study private would immediately put you or others in danger, we will release that information.

d. For payment – we may use/disclose your information for the purpose of paying you for your participation in the study. 

e. To create user profiles; 

f. To create de-identified analytical information about the effectiveness of the Services; 

g. To reply to your request for information or comments. 


Analytics 

When you use the App or the Service, we collect information relating to your browser or device type, the time and date you use the Service, operating system, identification of Site or App page views, use of particular Service features, geographic location and other statistical information relating to your use of the App or the Service. This information is referred to in this Privacy Policy as “Analytics.” We use Analytics to develop, improve, extend and test the Service (and underlying technology platforms).. 


Authorization for Disclosures to Third Parties 

A separate authorization would be required for any use and disclosures of PII not described in this Privacy Policy and Notice. 


Withdrawing Consent 

You may withdraw from the Limbix Spark study at any time, which will terminate future collection of PII. Data already collected during the study will be maintained and used for research purposes in accordance with FDA regulations. If you wish to access, amend, or modify your information in any way, please discuss this change with an Administrator.


Protecting Your Information 

Limbix uses secure server software (SSL), firewalls, and end-to-end encryption to protect your PIIfrom unauthorized access, disclosure, alteration, or destruction. All PII is transmitted, stored, and processed in a secure environment. However, no method of transmission over the Internet, or method of electronic storage, is 100% secure. Therefore, we cannot guarantee its security. We will retain PII during the collection and processing of study results, but in no case later than six (6) years following the end of the study or withdrawal of your consent, unless otherwise required by regulatory bodies. We will retain and use PII as necessary to comply with our legal obligations, resolve disputes, and enforce our agreements. 


Information Sharing and Disclosure 

Your PII may be shared with individuals and organizations that conduct or watch over this research, including:


● The research sponsor

● People who work with the research sponsor

● Government agencies, such as the Food and Drug Administration

● The Institutional Review Board (IRB) that reviewed this research


We also disclose your PII and other data to third party vendors who help us operate the App, Site, and Service. These third parties are contractually obligated to maintain the confidentiality of your PIIconsistent with the terms of this Privacy Policy and to comply with the applicable data protection laws. We will disclose your information in response to valid legal process, for example, in response to a court order, a subpoena or other legal request for information, and/or to comply with applicable legal and regulatory reporting requirements. We also may disclose your information in response to a law enforcement agency’s request or other request for information from the U.S. or other government entities, or where we believe it is necessary to investigate, prevent, or take action regarding illegal activities, suspected fraud, situations involving potential threats to the physical safety of any person, or to verify or enforce compliance with the policies governing our products and/or services and with applicable laws, or as otherwise required or permitted by law or consistent with legal requirements. In addition, we may, upon notice to you, transfer your information to an entity or individual that acquires, buys, or merges with Limbix. We share anonymized, de-identified Analytics with third parties to market and promote Limbix and the Service. 


Links to Other Sites; Third Party Apps; Transactions with Third Parties 

The App and Site may contain links to other sites that are not owned or controlled by Limbix. Please be aware that we are not responsible for the privacy practices of these other sites. We encourage you to review the privacy policies and statements of other sites to understand their information practices. Our Privacy Policy applies only to information collected by our App, Site and Services. You may be able to obtain an App, access the Service and/or communicate with the Service from, and you may be able to link or communicate from the Service to, applications, devices, distribution platforms and websites owned and operated by Apple, Google or other third party distribution platform operators (“Channel Partners”). These other applications, devices, platforms and websites belong to third parties and are not operated or controlled by Limbix. Our Privacy Policy does not apply to any information collected, received, used, processed, transferred or disclosed by such third parties. Additional or different terms and conditions (including without limitation, privacy and security practices) apply when you access and use third party applications, devices, platforms and websites, which are not the responsibility of Limbix. Limbix is not responsible for and will not be a party to any transactions between you and a third party provider of products, information or services. Limbix does not monitor such transactions or ensure the confidentiality of your PII for any third party transaction. Any separate charges or obligations you incur in your dealings with these third parties linked to Limbix’s Site are solely your responsibility. 


Children under 13 years of age

Our Service is intended for individuals who are 13 years old or older. If you believe someone who is under age 13 has used the Service and entered personal information, please contact us using one of the options provided below. 


Your California Privacy Rights; California Do Not Track Disclosures 

If you are a California resident, California Civil Code Section 1798.83 permits you to request information regarding the disclosure of your personal information, as defined in California Civil Code Section 1798.83(e) (7), by Limbix or its subsidiaries to a third party for the third party’s direct marketing purposes. Because we do not make such disclosures, we are exempt from these reporting requirements. Your browser may offer you a “Do Not Track” option, which allows you to signal to operators of websites and web applications and services (including behavioral advertising services) that you do not wish such operators to track certain of your online activities, over time and across different websites. We do not honor “Do Not Track” signals. 


Accessing Your Information 

Administrators may access, review, change, or update your PII through the Site, and you should speak to an Administrator to make changes on your behalf. You may reset your password through the App by following the password reset instructions. 


Contact Us About Complaints, Questions or Notices Relating to this Privacy Policy 


Limbix commits to resolving complaints about your privacy and our collection or use of your PII. If you believe your privacy rights have been violated or you disagree with any action Limbix has taken with regard to your PII, you may file a complaint with Limbix by emailing us at spark_study@limbix.com. Limbix will not take any action against you for making a complaint. 


If you would like more information about your privacy rights or this Privacy Policy, or if you have related questions or suggestions, please email us at spark_study@limbix.com. You may also contact us at: 


Limbix Health, Inc. 

Attn: Security Official 

839 Emerson Street

Palo Alto, CA 94301

USA