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Informed Consent - SLITPOPR
Informed Consent - SLITPOPR

Biscuit Health is committed to protecting your privacy and ensuring your data is only used to improve Quality of Care for all our patients

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Written by Biscuit Health
Updated over 4 months ago

DISCLAIMER: DO NOT USE THE PLATFORM OR PLATFORM SERVICES FOR MEDICAL EMERGENCIES. IF YOU HAVE A MEDICAL EMERGENCY, CALL 911 IMMEDIATELY OR ATTEND THE EMERGENCY ROOM OF THE NEAREST HOSPITAL OR HEALTH CENTRE.

Introduction:

As part of our mission to improve accessibility to allergy care for Canadians while offering the best possible patient experience, Biscuit Health is conducting a continuous research study (the "Study" or "SLITPOPR") on the interaction and outcomes of Sublingual Immunotherapy (SLIT) across our patient population to better understand how SLIT can be optimized according to a patient's lifestyle for maximum efficacy, with the goal of reducing treatment time.

Transparency around your privacy is important to us at Biscuit Health Inc ("Biscuit") and thus, we have developed an informed consent policy in connection with how we handle and use your data for research purposes.

Please take a moment to familiarize yourself with our practices and let us know by clicking here immediately should you have any questions.

Biscuit Health ā€” Sublingual Immunotherapy Population Review (SLITPOPR):

By clicking the button titled ā€œBegin Medical Intakeā€, ā€œGet Startedā€, or checking the related checkbox in the Biscuit Health App (the "Platform" or the "App"), you acknowledge that you have read and understood this informed consent document in full and are providing your informed consent to participate in our Sublingual Immunotherapy Population Study (the "Study" or "SLITPOPR").

The purpose of this continuous Study is to continually improve the way treatment is customized and delivered to Biscuit Health patients. Evidence gathered in the Study may be used in publications to support the efficacy, effectiveness and other observations made throughout the treatment we provide our patients.

Data We Collect:

In an effort to protect your privacy, data collected by your phone is anonymized when possible before it leaves your device, meaning physical access to your device would be required for you to be identified.

In the chart below, we outline the raw data ("Data") we collect from your device

What we collect:

How we use it:

Apple Health + Google Fit

Data from Apple Health such as your heart rate, heart rate variability, nutrition habits, physical activity, respiratory rate & other variables to help us understand how different populations react to our treatment.

As treatment is customized to both your allergy test and your lifestyle, we may make adjustments to your treatment based on your lifestyle.

For example, we may discover that those who are active respond better to our treatment when administered in the evening. This will help us adjust your treatment regimen for maximum efficacy.

CoreMotion (Accelerometer)

Data from your device's accelerometer (CoreMotion) allows us to understand how much time you spend exercising, sitting, and standing.

As treatment is customized to both your allergy test and your lifestyle, we may make adjustments to your treatment based on your lifestyle.

For example, we may discover that those who sit for an extended amount of time see better reactions to our treatment when taken in the morning. This will help us adjust your treatment regimen for maximum efficacy.

Location (GPS + WiFi)

De-identified fused-location data (GPS + WiFi) allows us to understand how exposure to various pollens across geographical regions affects our treatment.

As treatment is customized to both your allergy test and your lifestyle, we may make adjustments to your treatment based on your lifestyle.

For example, we may discover that those who live in urban environments react better to our treatment when taken in the afternoon when pollen counts are at their peak. This will help us adjust your treatment regimen for maximum efficacy.

Self-Reported Information (Contact, Demographics, Medical History, etc.)

Self-reported information such as your name, email, phone, address, age, gender, race, medical history, etc. is collected to create your patient profile.

Complete and accurate patient profiles are required for us to provide proper care to our high standards and may be required by law in certain regions we serve.

Technical Data (i.e. Diagnostics, Logs, etc.)

Technical data reported by your device helps us identify and address bugs (i.e. App versions, installation IDs, operating system and model).

NOTE: This app does not respond to browser "Do-Not-Track" signals.

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;

  • To conduct and support the Study;

  • To develop health-related products and improvement activities;

  • For other research studies;

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

Protection of Your Information:

Biscuit takes the security of your personal information and your privacy very seriously. We have implemented reasonable measures to keep your Data 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 Data about you and will stop contacting you except in the case of serious, actionable medical need.

NOTE: The services and treatment we provide you may be limited should you opt out of the Study. Opting out of the study may result in reduced efficacy of your treatment as we will no longer be able to customize or tailor our treatment to your lifestyle.

To opt out, please email opt-out.slitpopr@heybiscuit.ca with your Name and DOB along with the nature and details of your request to opt out. Deleting the app will not withdraw you from the Study.

Disclosure To Third Parties:

Biscuit may share your information with companies who provide services for or on behalf of the Study, such as an independent third-party Ethics Review Board (EBR) responsible for reviewing this Study and protecting 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, on our behalf.

Your personal information and Coded 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, the 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 any and all personal information we collect to the relevant third party.

Cross-Border Transfer of Your Information:

We may transfer your personal data to countries outside of your country of residence, which may have different personal data protection laws than the country in which you initially provided the information. In doing so, we comply with applicable legal requirements pertaining to the transfer of personal data to other countries and will protect that information as described in this Informed Consent.

Although you may access the Biscuit Health App or participate in the Study from a location outside of Canada or the United States, any personal data collected by us in connection with the Biscuit Health App or the Study may be transferred to, processed, and stored within Canada or the United States. Also, we may transfer your data from Canada or the United States to other countries or regions in connection with the storage and processing of data, fulfilling your requests, and operating the Biscuit Health App and the Study.

By using the Biscuit Health App or participating in the Study, you will be asked to consent to the transfer of your personal data to countries outside of your country of residence.ā€Ø

Our Privacy Commitment:

To the extent Privacy Commitment, the terms of this Informed Consent shall supersede our Privacy Commitment.

Minors:

You must be at least 16 years of age to participate in the Study. If you are between 16 and the age of majority in your jurisdiction of residence, you must have the permission of a parent or guardian and they must read and accept the Terms and Conditions on your behalf prior to creating a User Account. For access to Premium Health and Wellness Service, you must also have the permission of a parent or guardian to use their credit card for the payment of any related Fees. A Healthcare Practitioner or Wellness Practitioner reserves the right to assess whether a minor has the capacity to provide consent to his or her Health and Wellness Services treatment on a case-by-case basis. The Health and Wellness Services may also be available for use by children at the discretion of the Healthcare or Wellness Practitioner, but the user and User Account for all patients under the age of 16 must be the patientā€™s parent or legal guardian. If you register as the parent or legal guardian on behalf of a minor, you are fully responsible for complying with these Terms and Conditions. The Health Services are not intended to replace the services of a Pediatrician.

The Terms and Conditions set out under the ā€˜Consent to Treatmentā€™ and ā€˜Privacyā€™ sections apply to minors who receive Health Services and Wellness Services.

Questions?

Should you have any questions regarding this Informed Consent, the Study or our policies, you may contact our support team by clicking here.

Biscuit Health Inc. may update this Informed Consent from time to time. If we change the policy in a material way, a notice will be posted in the App along with the updated Informed Consent.

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