Consent form

For questions or concerns, contact us.

Effective date: October 17, 2023. Version 2.0.

Molecular You Corporation (“MYCO” or “we” or “our”) requires that each participant in MYCO’s molecular profiling service acknowledges, agrees and consent to the terms in this consent form (“MYCO Consent Form”) before his or her samples will be processed.  If the participant is under 19 years of age or otherwise incapable of providing informed consent, this Consent Form must be agreed and consented to by both the participant and his/her parent or legal guardian or other personal representative with the legal authority to provide such consent. 

You should discuss your questions about MYCO services with your Third-Party Practitioner (as defined below).  Questions about the collection, use or disclosure of your information as set out in this Consent Form may be directed to MYCO’s privacy officer at #307-788 Beatty Street, Vancouver, British Columbia, Canada V6B 2M1 (the “Privacy Officer”) (Privacyofficer@molecularyou.com

This Consent Form incorporates by reference and includes the terms of the MYCO Assessment Terms and Conditions (https://www.molecularyou.com/assessment-terms-conditions), the MYCO Privacy Policy and all other applicable MYCO legal documents found at https://www.molecularyou.com/legal.

You acknowledge, agree and consent as follows: 

Definitions “Biomarkers” or “Biomarker Information” means (a) the Health Data and any other information regarding your personal biomarker-related data profile (including genes, metabolites, proteins, metals, minerals, nutrients, toxins, microbes, pharmacogenetics) generated or supplied by MYCO or by its contractors, whether through processing of your saliva, blood, urine and fecal matter or any other means of analyzing your samples, as well as (b) any other test results and related information that we generate from testing or analyzing your samples in any way in the course of providing Services to you; 

“De-Identified Information” means information that has had personally identifiable information (personal identifiers such as a person's name, email address, or social security number), removed in accordance with the standards set forth in the Privacy Regulations  at 45 CFR Section 164.514. For purposes of the MY Services deidentified Information shall include de-identified versions of your Biomarker Information and Self-Reported Information with your identity removed, versions of any other data generated from your samples with your identity removed and versions of any information that MYCO is provided about you (other than your Identifying Information) with your identity removed; for avoidance of any doubt, information about you is de-identified (i.e. your identity is removed) when personal identifiers about you are removed from the applicable information, excluding genetics and other Biomarkers which will remain as part of the de-identified information;

“Health Data” means biomarkers, measurements, and other health-related data that we generate from analyzing your samples and retain in an anonymized format with an encrypted unique identifier.  

“HIPAA” means the Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act (“HITECH”) and other legislation, and the regulations promulgated thereunder relating to the privacy and security of protected health information, as such statute and regulations may be amended from time to time. 

“Individual” shall have the same meaning as the term “individual” in the HIPAA regulations at 45 CFR § 160.103 and shall include a person who qualifies as a personal representative in accordance with the HIPAA Privacy Regulations at  45 CFR § 164.502(g). 

“Identifying Information” means your name, your contact information and your registration information that you provide when registering for the Services; 

“Individually identifiable health information” is information, including Personal Information (defined below), demographic data, that relates to: an individual’s past, present or future physical or mental health or condition; the provision of health care to the individual, or the past, present, or future payment for the provision of health care to the individual, and that identifies the individual or for which there is a reasonable basis to believe it can be used to identify the individual.  Individually identifiable health information may be referred to as Protected Health Information or “PHI.”

“MYCO Terms and Conditions” or “Terms and Conditions” means the Terms and Conditions available on our MYCO website (“MYCO Site”);

“Personal Information” means the personal information that is about you as an identifiable individual. MYCO collects and stores the following types of Personal Information: (i) Individually identifiable health information you provide and which may be collected, generated or developed by MYCO as part of MYCO Services; (ii) Registration Information” is the registration information you provide when registering for and/or purchasing our Services (e.g. name, email, address, user ID and password, and payment information); (iii) Biomarker Information as defined above;  and (iv) “Self-Reported Information” is all information about yourself that you enter into surveys, forms, or features while signed in to your MYCO account (including via the “About Me:” section or another section of the MYCO MY Health Intelligence Platform), including what you reported concerning your disease conditions, other health-related information, personal traits, ethnicity, family history, date of birth and other information that you enter into surveys, forms, or features while signed in to your MYCO account, and any other information about yourself (other than Registration Information) that you supply to us in one form or another, as well as any third-party generated results or information about yourself that you supply to us, that you have a third-party provide us or that you approve MYCO requesting and obtaining from a third-Party that you identify for us;

“Physician” means a third-party physician of your choice;   

“Privacy Rule” means the standards for Privacy of Individually Identifiable Health Information at 45 CFR part 160 and part 164, subparts A and E. 

"Security Rule" means the standards for Security of Individually Identifiable Health Information at 45 CFR part 160 and part 164, subparts A and C.

“Service” or “Services” means MYCO’s products, software, services, mobile applications, features, tools, reports, and websites (including but not limited to text, graphics, images, and other material and information) for the collection and analysis of Biomarkers. The Services include access to a MYCO website or applications and certain personal Biomarker-related services.  

“Third-Party Practitioner” means a healthcare provider or personal health consultant that you consult with at your own choosing.  This may be your family physician, nutritionist, dietician, or other healthcare provider or personal health consultant that you choose to consult with in connection with the Biomarker Information about you generated by the Services and provided to you; 

Your Personal Information
MYCO will collect, use, maintain and disclose your Personal Information only for the purposes of providing the Services and for the other purposes described in this Consent Form.  We will protect your information, including all Identifying Information, from unauthorized access, use and disclosure, and we will not disclose it to any person without your consent except as described in this Consent Form or as required by law (ie. court order, subpoena) or legislation.  You acknowledge and recognize that while commercially reasonable measures appropriate for the sensitive nature of the data are employed by MYCO, we cannot guarantee absolute security.
MYCO may collect, store, and use your Personal Information for the purposes set out in the MYCO Privacy Policy, for the purposes set out in this Consent Form and for the purposes set out in the MYCO Terms and Conditions.

When you engage our Services, you will need to provide us with the following: your samples (e.g. urine, blood, stool, saliva) for molecular profiling analysis, and Registration Information about you (including your Identifying Information and credit card information as applicable).  On receipt of this material and applicable payment, MYCO will conduct molecular profiling analysis using your samples and other information provided by you or (if applicable) your Physician.  MYCO will then generate personalized Health Data set about you that will be shared with you.  MYCO will, using commercially reasonable security measures, retain your Health Data and other Biomarker Information in a coded, identifiable form so that it can provide further Services to you in the future. If or when your Health Data and other Biomarker Information no longer need to be retained in an identifiable format, we will de-identify such information in accordance with the standards of the Privacy Regulations  so that the data is De-Identified Information.

If you instruct us in writing (including by way of electronic communications from the email address that you provide as part of your registration information or otherwise) to share your Personal Information with your Third-Party Practitioner, you agree and consent that MYCO may share your Personal Information with your Third-Party Practitioner for the purposes of providing the Services and for the other purposes set out in or covered by this Consent Form.  Sharing such information with your Third-Party Practitioner takes time and resources.  You acknowledge and agree that consistent with the HIPAA rules, MYCO may charge a service fee if you request that we share your Personal Information with your Third-Party Practitioner.  You are of course free to share your Health Data and other Personal Information with your Third-Party Practitioner directly as you see fit.

MYCO undertakes to comply with our obligations under HIPAA, the Privacy and Security Rules and other laws applicable data protection and to the extent that they cover our processing of your Personal Information. Personal information will be kept, used and disclosed by us in accordance with our Privacy Policy. For further information about MYCO’s information management practices please contact the Privacy Officer.  Our Privacy Policy is available on our website at https://molecularyou.com/legal.

Personal Information submitted to us, whether through a MYCO website, the Services, your samples or otherwise, may be used by us for the purposes specified in this Consent Form, any Study specific Personal Information and Consent Form, the MYCO Terms and Conditions, our Privacy Policy or as otherwise communicated to you in connection with your use of the Services. In addition, MYCO may use your Personal Information to: (i) carry out the Services; (ii) administer, operate and maintain MYCO websites, applications and the provision of Services; (iii) test and analyze samples that you provide; (iv) generate and maintain Health Data and other  Biomarker Information; (v) personalize the Services and aspects of MYCO websites and applications; (vi) process transactions related to your use of the Services; (vii) handle inquiries, complaints, submissions and feedback relating to the Services and/or MYCO websites and applications; (viii) contact you with your consent, including to promote, update, and announce new, improved or expanded Services or products, special offers, or other useful information pertaining to your needs; (ix) maintain copies or backups of your Personal Information for security and archival purposes where we consider it appropriate; (x) verify compliance with agreements between you and us; (xi) improve the Services and MYCO websites and applications; (xii) generate De-Identified Information for ongoing research and development and commercial use by MYCO and its affiliates to enhance and expand upon our Services, systems, software, databases, products and offerings; (xiii) conduct surveys or research about your opinion of current Services or of potential new Services that may be offered in the future; (xiv) track and monitor your activity through MYCO websites and applications and the Services; (xv) comply with legal and regulatory requirements; and (xvi) achieve other purposes as may, from time to time, be permitted by law.

We may engage other companies and individuals (“Third-Party Service Providers”) and other researchers, investigators, and organizations (“Research Partners”) to carry out some or all of the uses of the Personal Information and/or De-Identified Information referred to in the foregoing paragraphs, and/or to perform some or all of the Services on our behalf. Third-Party Service Providers and Research Partners may require or be provided with access to your Personal Information and/or De-Identified Information. Each Third Party Service Provider and Research Associate shall agree to comply with all applicable laws pertaining to the privacy and security of PHI and shall execute a business associate agreement or other applicable document with MYCO for that purpose.

Personal Information that we collect may be uploaded, moved, stored, processed in, backed up, transmitted and/or transferred between any of the countries in which we operate (including across international borders), in our discretion, in order to enable us to use the Personal Information in accordance with our Privacy Policy, and you consent to the same.

Your Samples
In order to receive the Services, a MYCO customer coordinator or an entity designated by MYCO (each a “Customer Coordinator”) will contact you and arrange for you to provide your samples to MYCO for analysis by MYCO and/or its contractors.  Your samples will be used for testing and molecular profiling.  We may retain samples until the samples are depleted. You may request the destruction of your samples before testing is complete by contacting the Privacy Officer at the above address.  If you do make such a request, we will be unable to provide you with the Services and any fees paid by you will be non-refundable and forfeited by you.  We encourage you to discuss the withdrawal of your samples with the Customer Coordinator before choosing to withdraw.

De-Identified Information
MYCO shall have the right to deidentify your Individually Identifiable Health Information and Personal Information and use the De-Identified Information, including with third parties, to carry out the activities described herein, as well as to: 
(a) conduct scientific and commercial research and development with the purpose of advancing personal care in human performance and health and improving and furthering the products and services we provide; 
(b) conduct surveys and/or research relating to the opinion of customers and potential customers with respect to our Services or of potential new Services that may be offered in the future;
(c) publish or have published observations, analyses, data and/or results in scientific journals or other publications;
(d) advance and implement our commercial business and engage in commercial activity to further our business, including through enhancement and expansion of our Services, systems, software, databases, products and offerings; 
(e) engage in research and development that result in the development of commercial products or services; and
(f) conduct data analysis in connection with any of the foregoing activities.

De-Identified Information may be used, stored, disclosed and otherwise made use of as MYCO considers commercially reasonable at its sole discretion.  Without limiting the generality of the foregoing, MYCO may or will use De-Identified Information to study a specific or general group or population, identify potential areas or targets for therapeutics development, conduct or support the development of drugs, diagnostics or devices to diagnose, predict or treat medical or other health conditions, work with public, private and/or non-profit entities on Biomarker-related research initiatives, or otherwise create, commercialize, and apply this knowledge to improving our understanding of the Biomarker-related field and human-related conditions and factors.  

You agree that in no event will you gain or be entitled to any personal financial advantage or compensation from MYCO’s use and commercialization of De-Identified Information.  

You agree that all ownership and other rights in all works, programs, knowhow, techniques, formulas, data, manuals, methods, inventions, ideas, designs, discoveries, processes and other works of authorship, intellectual property and improvements thereof developed, conceived or reduced to practice by MYCO, whether alone or with others, which results or arises from the Services, including processes and techniques for the generation of your Health Data, or the use or commercialization of De-Identified Information shall be the exclusive property of MYCO.

Once we generate De-Identified Information it will not be possible to delete it from MYCO’s databases or systems. Accordingly, if you do not wish to provide consent to the generation or use of De-Identified Information you must not use our Services and promptly notify us, before we have analyzed your samples and generated any Health Data, that you are withdrawing your samples and withdrawing from the use of our Services.  Once we have analyzed your samples and generated Health Data, the De-Identified Information generated by or on behalf of MYCO will become the exclusive property of MYCO.  

Withdrawal from MYCO Services
Should you decide you no longer want our Services and provide us with written notification (including to our Privacy Officer) requesting to have your MYCO account closed, MYCO will close your MYCO account, delink your Health Data from your Registration Information and permanently delete your Registration Information, thereby leaving only De-Identified Information with us, along with separately held records of our having provided you with Services as is customary when running a business but which will not be linked to your biomarker data. 

MYCO Does Not Provide Medical Advice
You acknowledge and agree that your Health Data and any other Biomarker Information that we provide to you does not constitute medical advice; that MYCO does not provide or purport to provide medical advice; and that you are not seeking medical advice in any way from MYCO.  You acknowledge and agree that if you wish to receive or need to receive medical advice relating to any Health Data or any other Biomarker Information or otherwise, you must consult with a qualified Physician. You acknowledge and agree that you are solely responsible for any associated costs involved in seeking or obtaining such medical advice. 

You are strongly advised to arrange a consultation with a Physician in the event that any observation in your Health Data or in any other Biomarker Information is of concern, and in such case such observation(s) should be validated through medical testing by an appropriate Physician before decisions are made by you regarding medical interventions of any kind. You are entirely responsible for seeking and obtaining such tests and clinical follow up with a Physician of any observations, including associated costs. 

Risks Blood collection: While bearing minimal risk, blood collection can be uncomfortable and distressing for individuals. There is a very small risk of bleeding (if taking blood thinning medications for preventative measures), bruising, and infection. Careful technique and collection from subjects in the proper setting will minimize these risks. If you have any concerns relating to the samples that you are to provide in order for MYCO to provide the Services, you should consult with a Physician. You are entirely responsible for seeking and obtaining medical advice and other advice from a Physician or any Third-Party, including associated costs.

Biomarkers that you share with others could be accessible to third parties and could be used against your interests.  MYCO has no ability to control the use of information you provide to third parties. As a result, you should be careful about sharing your Health Data with others. You may want to consult a lawyer to understand the extent of legal protection of your Health Data  before you share it with anybody.  

Receiving your Health Data may cause you to have anxiety or distress, have other adverse mental health implications or alter your decision to have a child or other lifestyle decisions for you or a family member.  There is also no guarantee that your Health Data will benefit you.

Disclaimer
MYCO is only generating Biomarker Information based on the samples that you provide.  MYCO does not provide or purport to provide services to interpret Biomarker Information or to diagnose, treat or mitigate any diseases or conditions.  You acknowledge and agree that it is entirely your responsibility to review with a Third-Party Practitioner of your choosing the Health Data and any other Biomarker Information that we generate for you based on your samples, and to seek medical advice from such Third-Party Practitioner.  You also acknowledge and agree that when you seek medical advice from a Third-Party Practitioner, it is that Third-Party Practitioner’s responsibility to receive, interpret and explain your Health Data and other Biomarker Information to you and to provide related medical advice.  By agreeing to this Consent Form you acknowledge that MYCO (including its officers, directors, employees and agents) shall not be liable to you whatsoever for the delivery of the Services or any Biomarker Information generated.  You also agree that MYCO (including its officers, directors, employees and agents) shall not be liable to you for any loss or damage whatsoever in relation to the Services or the provision of your Health Data or other Biomarker Information.

Governing Law; Arbitration 
This Consent Form shall be governed by and construed in accordance with the laws of the State of Washington and of the United States, or with the laws of the Province of British Columbia and Canada, as applicable, without regard to conflict of law principles or the United Nations Convention for the International Sale of Goods.  Any dispute or claim arising out of or relating to this Consent Form shall be resolved by final and binding arbitration under the rules and auspices of the American Arbitration Association and shall take place in Clark County, Washington, USA and the language of the arbitration will be English. The party that ultimately loses will be responsible for arbitration costs and reasonable documented legal costs of both parties.  Either party may obtain injunctive relief (preliminary or permanent) and orders to compel arbitration or enforce arbitral awards in any court of competent jurisdiction.

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