Notice: 7Drops’ testing services are presently available to ship to all U.S. States except New York. The testing services are not payable or reimbursable through a health plan, private insurance, or another payor like Medicare or Medicaid or any other governmental healthcare program. The person purchasing testing services is the party responsible to pay for the services and understands and acknowledges that he/she should not submit the cost of the testing services for payment to any health plan, private insurance, or any governmental healthcare program payor, such as Medicare or Medicaid.
Introduction
This consent form (“Consent”) reviews the benefits, risks and limitations pertaining to your use of the testing services (“Services”) provided by 7Drops Diagnostics Inc. (referred to as “7Drops Diagnostics”, “7Drops”, “we”, “us” or “our”) as the person (referred to as “you” or “your”) who has created an account (“Account”) to access our Services. It also explains how your information and sample(s) will be used and maintained. Your sample(s) will not be processed unless you confirm that you have read and understood the contents of this Consent.
Our Services are offered through our website www.7drops.com (referred to as “Site”) and available to users who are residents of the United States (excluding New York). Your use of 7Drops Diagnostics’ Services is voluntary. It is your choice whether to utilize our Services or not. Prior to signing this Consent, you may wish to speak with your healthcare provider for further guidance about our Services.
By completing this Consent and clicking on the acceptance below, you accept the terms of this Consent as a binding agreement on you and agree that you have read and understood the following terms. By clicking on the acceptance box, you also acknowledge that you have read and understand our Privacy Policy and Terms of Service.
Manifesting your acceptance to this Consent shows you have chosen to use our Services and have given your informed consent to have the biological sample(s) you submit tested for biomarkers. Biological samples shall consist solely of human fluids, that are intended to be analyzed solely for your personal use of the test results, and not for any other purpose, including but not limited to research, publications, commercial uses, or any other purpose other than to inform your health and/or wellness.
1. Testing Process
When you create your Account, we will collect some information from you. We cannot perform the Services without collecting information from you, but we will only collect information that will assist us in providing the Services that you have requested. For the Services to be provided as intended, you must provide accurate and correct information. Failure to provide required information or to execute required documents may result in your sample(s) not being tested.
To the extent legally required, requests for tests will be reviewed by a licensed physician (“Health Consultant”) affiliated with a company that we have partnered with to provide review and authorization of testing, review of lab results, prescriptions, and counseling where applicable. Services will not be provided to you if a Health Consultant does not authorize your request to order the applicable test(s). We will refund the applicable fees for such cancellations. Please see our Terms of Service regarding payment details.
You will collect the biological sample(s) (i.e., blood) that will be provided to and tested by one of our designated testing laboratory partners (“Lab”). You will send the sample(s) directly to the Lab where your sample(s) will be tested for several biomarkers (including Immunoglobulin E and G).
Once received and interpreted by a Health Consultant, the results of your test(s) will be made available to you through your Account. In the event we determine that a biological sample is not suitable for testing due to the content of the sample or because we believe the sample to have been submitted in violation of this Consent or our Terms of Service, we reserve the right to withhold the results and to not provide a refund. We will determine and establish normal ranges for all tests in conjunction with the Labs based on their validation and proficiency testing procedures. If your results are clinically significant or have a critical value that falls outside of our established normal ranges by at least a certain amount, a Health Consultant will make reasonable efforts to contact you to discuss test result and/or treatment options.
Utilizing our Services to discover what your biomarkers say about you can help you gain a better perspective on your health and how your body functions. You may use this information to make more informed health care decisions and choices pertaining specifically to potential allergies and food intolerance. A summary of the potential benefits of our tests is included below.
| Product Name | Potential Benefits Include Learning More Information About: |
| ALL (allergy test) | Your body’s IgE levels against 295 allergens from 165 different allergen sources including but not limited to grasses, trees, animals, insects and many others. These biomarkers are indicators of your body’s sensitizationSensitization is the first step towards developing a type I allergy. Allergic reactions do not occur upon first contact with an allergen. Before that can happen, your immune system must be able to recognize an allergen. When you get stung by a bee, your immune system will remember the structure of the allergen (= a protein in the insect venom) to be able to produce IgE antibodies against it in the future. This process is called sensitization. which in combination with other clinical findings can support your physician in establishing a diagnosis for allergy. |
| FIT (food intolerance test) | Your body’s IgG levels for 286 food antigens from 13 food groups common in Western diets. These biomarkers are related to your body’s sensitivities to certain foods. These are not allergy tests. |
More information about the specific benefits of our tests and Services are available on our Site.
2. Warnings, Limitations and Potential Risks
In-order-to utilize our Services, you must collect the appropriate capillary blood sample(s) for the test(s). Although the risks and discomforts associated with a blood draw are very low, you might be at risk for excessive bleeding, fainting (vasovagal syncope), feeling light-headed, bruising, hematoma (blood accumulating under the skin), or infection (a slight risk any time the skin is broken). If you have a history of excessive bleeding or fainting while having blood work done, we advise avoiding our tests that require self-collection of a blood sample.
Disclosing certain information may make you uncomfortable. Our Services include biomarker tests that may reveal sensitive information about your health. This information may be distressing.
Health information that you choose to share with your physician or other healthcare providers may become part of your medical record and through that route may be accessible to other healthcare providers and/or insurance companies in the future. Information that you share with family, friends or employers may also be used against your interests. Even if you share health information that has no or limited meaning today, that information could have greater meaning in the future as new discoveries are made.
7Drops Diagnostics, or the Health Consultant who reviews your results, may advise you to have a follow-up visit with your doctor after reviewing the results of your test. As a result, you may learn about health conditions and problems or potential health risks that you were not aware of before you utilized our Services. You may experience stress, anxiety, or emotional or physical discomfort when you learn about health problems or potential health problems. There may also be additional risks of utilizing our Services that are currently unforeseeable.
The testing that is part of the Services may be subject to occasional false positive or false negative results, and is not a substitute for discussing your symptoms with your physician or other healthcare provider, who may recommend additional testing or follow-up for your individual circumstances.
The testing services are not covered by a health plan, private insurance, or another payor like Medicare or Medicaid or any other governmental healthcare program.
3. Specimen Retention and Use of Your Information
We retain any information collected about you for as long as we are required to maintain it for regulatory and compliance purposes or for a legal or business necessity. 7Drops does not store your biological sample(s). You will send your biological sample(s) directly to the Lab that will conduct the test. 7Drops Diagnostics has no obligations or liability regarding the viability, storage or retention of your sample(s). The Lab testing your sample(s) is subject to multiple laws regarding the retention of data and samples and will maintain your data and sample(s) for as long as required for regulatory and compliance purposes or for legal or business necessity.
4. Your Consent and Withdrawal of Consent
This Consent represents your giving permission for 7Drops Diagnostics, its representatives, affiliates, staff, agents, the Lab and designees to perform the requested Services on the sample(s) you provide and to disclose your information and results in accordance with our Privacy Policy and your HIPAA Authorization. You also represent to us that you are not an insurance company or an employer attempting to obtain information about an insured person or an employee. You may only submit biological samples to us using a testing kit for yourself, or for your child, solely if you are the child’s parent or legal guardian. When you register the test kit, you will indicate whose samples it contains and represent and warrant to us that you are the child’s parent or legal guardian if submitting samples for child. Otherwise, you may not submit samples for anyone other than yourself.
Your use of our Services is voluntary. You may choose to withdraw your acceptance of this Consent or to stop using our Services at any time. Requests to withdraw this Consent should be sent to us by email at [email protected] or in writing at 7Drops Diagnostics Inc., 5718 Westheimer Rd, Suite 1000 Houston, Texas 77057.
Please note that while any such requests you make will be reflected in our databases within a reasonable period-of-time, we may retain your information in the ordinary course of business, for the satisfaction of our legal obligations, or where we otherwise reasonably believe that we have a legitimate reason to do so. Information that has already been de-identified, anonymized, or aggregated may not be retrievable or traced back for destruction, deletion, or amendment.
5. Miscellaneous
This Consent, including the other documents referenced and referred to herein such as our Terms of Service and Privacy Policy, constitutes the entire agreement between you and us with respect to the Site and the Services and supersede all prior or contemporaneous understandings and agreements, whether written or oral, with respect thereto. In the event of a conflict between this Consent and any applicable purchase or other terms, the terms of this Consent shall govern. If any provision of this Consent is illegal or unenforceable under applicable law, the remainder of the provision will be amended to achieve as closely as possible the effect of the original term and all other provisions of this Consent will continue in full force and effect. The headings of sections and paragraphs in this Consent are for convenience only and shall not affect its interpretation.
6. Contact Us
If you have questions or comments about our Services or this Consent, please contact us by email at [email protected] or in writing at 7Drops Diagnostics Inc., 5718 Westheimer Rd, Suite 1000 Houston, Texas 77057.
CONSENT
By checking the box below, you indicate your acknowledgement and affirmation of the following:
- I have read, reviewed, and understand the processes associated with the 7Drops Services as well as the offered tests FIT (food intolerance test) and ALL (allergy test), including the nature and purpose of the test(s) and Services to be performed; the risk, benefits, and limitations of immunological testing; the reliability of positive or negative results and level of certainty a positive result serves as a predictor for a specific condition; and the meaning of the results.
- I understand that 7Drops or a third party retained by 7Drops will attempt to contact me with the results of the testing, that the testing 7Drops and the Lab will perform does not replace the interpretation of results and medical recommendations of a physician, and that it is solely my responsibility to discuss my results with my healthcare provider.
- The tests offered by 7Drops are not reimbursed under any private or public insurance. I acknowledge and understand that testing ordered through the Services is my financial responsibility and I will be required to pay for the testing out of pocket. I will not be able to, and should not, submit any invoice or claim for the Services to an insurer, health plan, or other payor such as Medicare or Medicaid.
- I am 18 years or older and have legal authority to consent to the test(s) on my own behalf or as a parent or legal guardian on behalf of my child.
I consent that I would like to proceed with the 7Drops Services as well as the FIT (food intolerant test) ALL and (allergy test) as indicated in my order form and understand that no other testing will be performed unless I consent.