Informed Consent for Use of the QDX™ HealthID App
By clicking the “I agree and give my informed consent” button and signing I represent that I (i) am eighteen years of age or older, (ii) have the capacity to understand the terms in this document, (iii) have read this document carefully, and (iv) understand the risks and benefits of the QDX™ HealthID App and the HealthID that it generates. By clicking “I Agree and give my informed consent” I understand that I give my consent as set forth below regarding (i) what happens to my data in using the App and its Service and (ii) my permission to allow a health care provider or other third party designated for the testing process to administer a test to me.
QDX™ HealthID is an application-based platform for a mobile device that allows individuals to share their Health Status. “Health Status” comprises the recording of the outcome and data around specific events related to your health. “Service” means all the services provided to you through the App that result in and include your Health Status and HealthID. The Service does not diagnose sickness or disease. The Service does not provide any clinical services or support. It reports test result information and generates a “HealthID” that allows an end user (“you,” “your”) to verify and display your “Health Status” to third parties of your choosing. You access the Service through the QDX™ HealthID mobile application (“App”), which is available for your use only after you choose to accept the Terms and Conditions for the Service (which include and incorporate by reference the Privacy Notice and this Informed Consent). The App is owned and operated by QDX™ HealthID Incorporated (“QDXH”) and its parent company, Quantum Materials Corp (“QMC”) (also referred to collectively as “QDXH”).
Use of the Service involves (1) registering, by creating an account with a password and multi-factor authentication for security; (2) authenticating your identity, via a third party’s verification system used to validate your government-issued photo identification; (3) connecting this verified identity and photographic image to a test kit and the person administering the test, if any (some end users may be self-testing), and your test result using QDXH’s proprietary technology and processes; and (4) displaying your Health Status on your mobile device using color indicators (green, yellow, red) that together comprise a HealthID. If you take multiple diagnostic tests, your Health Status is updated accordingly.
Your identity is stored in the App’s underlying platform in a de-identified manner. The data comprising your test results and other health-related information that may be obtained at the time of your testing are stored in a separate secure, cloud-hosted database that includes the safeguards legally required for both the transmission and storage of personal and medical information. This hosted database with de-identified data about your Health Status may be accessible to researchers, policymakers, and healthcare authorities for data required to address public health emergencies and workforce planning. If your employer has purchased or otherwise obtained products or services from QDXH your de-identified data may be available to your employer.
The QDX™ Platform and the Service incorporate network and software security protocols to protect the confidentiality of patient identification connected to a test result and include measures to safeguard the data and ensure its integrity against intentional or unintentional corruption. However, an emergency or similar declaration at any level of government, domestically or internationally, regarding public health and safety may mandate uses of the Service’s data that cannot be reasonably foreseen at this time and would not require your consent for use for those purposes.
- Verification that you took a particular test using a test kit that has been authenticated as not counterfeit
- Verifiable and authoritative means to prove your test results belong to you such that your test results cannot be confused with or substituted with or for another person’s test results
- Authentication of the identity, credentials, and Health Status of the person administering a test to you
- Verifiable and authoritative means to produce your Health Status to anyone of your choosing
- Despite the safeguards in place, in very rare events, security protocols could fail, either within the Service or by virtue of the Service’s use of third-party providers, causing a breach of privacy or personal medical information.
- The person administering a test to you may commit independent acts of negligence, that is, make mistakes, in administering the test to you that cannot be attributed to QDXH, QMC, or the App.
Your agreeing to these terms means that you understand and agree with the following:
- I consent to receiving my test results via electronic communications. I understand that the receipt of my test results electronically means that I will have a digital (i.e., “electronic”) HealthID that allows me to display my Health Status on my mobile device to a third party. I understand that if and when I show my test results to a third party, in addition to or instead of displaying only the HealthID, I am consenting to the transmission of my test results to that person or entity.
- Each time I use the App to authenticate the health care provider, or other third person administering the test to me, I recognize that I am consenting to, and do hereby consent to, the test being administered to me.
- I understand it is my responsibility to understand and ask questions of a health care provider regarding the risks and procedures involved in taking a particular test.
- I understand that the App and its Service do not replace or change my right to access details about my test results through other means that may be available to me now or in the future, such as through a request for my health record from the health care provider.
- I understand that subsequent testing and changes in rules and regulations governing a Health Status may yield different results and the color-coded status indicators on my HealthID may change as a result.
- I understand that U.S. federal and state laws require protecting the privacy and the security of health information. I understand that although neither QDXH nor the QDX™ HealthID or any of the App’s Services perform a clinical service or diagnostic function, QDXH will take steps to make sure that my test results and my Health Status are not seen by anyone who should not see them.
- I understand that I have the right to withhold or withdraw my consent to the use of the Service before or after the testing process by deleting the App from my mobile device and deleting my account, which will delete all the data associated with my HealthID and that the Service does not store any data about my Health Status or HealthID that I may retrieve at a later time.
- I understand that I may expect the anticipated benefits from the use of the Service but that no results can be guaranteed or assured.
- I understand that my de-identified data may be accessible to third parties for research or to governmental entities or other persons or companies for workforce-related and policy-making decisions.
- I understand that a legal authority, whether a court of law or governmental entity, may require QDXH to release data that could involve data that identifies me and my test results without the security protocols that ordinarily protect my test results.
- I understand that my employer may have purchased or otherwise obtained products or services from QDXH that may allow my employer to see data that identifies me and my test results and that I must consult my employer for questions regarding workplace-related use of my data.
- In the event of an unexpected data breach that involves personal health information that identifies me, I understand that if QDXH is required to give notice, I will be notified according to the U.S. Department of Health and Human Services’ Office of Civil Rights guidance at 45 CFR § 164.404.