This consent form (“Consent”) reviews the benefits, risks and limitations of you, as the person who has created an Account (referred to as “you” or “your”), utilizing the Services provided by HealthConfirm (referred to as “HealthConfirm”, “we”, “us” or “our”). It also explains how your information and sample(s) will be used after performance of the Services. Your sample(s) will not be processed unless you confirm that you have read and understood the contents of this form.
By clicking on the box, you indicate that this Consent is a binding agreement and that you have read and understood the following terms. Capitalized terms used but not defined in this Consent have the meaning given to them in our other policies.
By clicking your acceptance, you have chosen to use our Services and have given your informed consent to have your biological sample(s) tested for biomarkers and/or genes. Biological samples shall consist solely of human fluids and/or tissue samples, depending on the test purchased, that are intended to be analyzed for the individual’s sole use, and not for any other purpose, including but not limited to research, publications, commercial uses, or any other purpose other than to inform the purchaser’s health and/or wellness.
Our Services are offered and available to users who are residents of the United States. Your use of HealthConfirm’s 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 a genetic counselor or your healthcare provider for further guidance about our Services.
Procedures and Protocol for HealthConfirm Tests
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. In order 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.
All 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 and order the applicable test(s). We will refund the applicable fees for such canceled tests.
You will collect the biological sample(s) (i.e., blood, saliva, or urine) 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 a number of biomarkers (including but not limited to vitamins, minerals, metabolites and hormones) and, if selected and purchased by you, genes that may inform your health and wellness choices.
The results of your test(s) will be made available to you through our Site. 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 the User Agreement, 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.
Utilizing our Services to discover what your genes and 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. A summary of the potential benefits of our tests is included below.
|Product Name||Potential Benefits Include Learning More Information About:|
|Cholesterol & Lipids||Your current cholesterol and lipid levels, which are associated with cardiac and other health conditions.|
|Heart Health||Your current cholesterol and lipids levels, plus HbA1c and hs-CRP.|
|Food Sensitivity||Your body’s IgG levels for many foods common in Western diets. These biomarkers are related to your body’s sensitivities to certain foods. These are not allergy tests.|
|Food Sensitivity Expansion||Your body’s IgG levels for 88 foods common in Western diets. These biomarkers are related to your body’s sensitivities to certain foods. These are not allergy tests.|
|HbA1c||Your body’s ability to control glucose levels.|
|Heavy Metals||The current levels of a variety of heavy metals in your body.|
|Men’s Health Test||A broad set of hormones and other biomarkers associated with male health, including testosterone.|
|Metabolism||Biomarkers that reflect your body’s metabolism (ability to efficiently translate food into energy).|
|STD Test – Male & STD Test – Female *||Whether you test positive for a range of common sexually transmitted diseases, including HIV/AIDS|
|Chlamydia and Gonorrhea *||Part of our single marker STD suite, this test evaluates only Chlamydia and Gonorrhea infections.|
|Hepatitis C *||Part of our single marker STD suite, this test evaluates Hepatitis C exposure.|
|Trichomoniasis *||Part of our single marker STD suite, this test evaluates Trichomonas infection.|
|HIV *||Part of our single marker STD suite, this test evaluates HIV exposure.|
|HPV Test – Female *||This test detects the presence of 14 high risk HPV genotypes.|
|Sleep and Stress Test||Hormones and other biomarkers associated with sleep quality and stress.|
|Testosterone Test||Your current level of testosterone, which is commonly known as the male sex hormone.|
|Thyroid Test||The current function of your thyroid, which is related to a number of health conditions.|
|Vitamin D||Your body’s current level of Vitamin D. Low levels of Vitamin D are associated with a range of health conditions.|
|Vitamin D & Inflammation||Your Vitamin D and CRP levels.|
|Women’s Health||Hormones associated with reproductive potential and women’s health.|
|Women’s Fertility||Hormones that influence normal ovarian function.|
|Ovarian Reserve||A hormone (FSH) associated with the number and quality of a woman’s eggs.|
|Perimenopause||Current levels of hormones that change before menopause.|
|Post-menopause||Current levels of ovarian hormones after menopause.|
|Folic Acid||Your body’s current level of Vitamin B9.|
|B Vitamins||Your body’s current level of vitamins B6, B9, and B12.|
|Lyme Disease *||This test detects the presence of antibodies associated with exposure to three common bacteria that cause Lyme Disease.|
|Indoor & Outdoor Allergy Test||Your IgE reactivity to indoor and outdoor allergens.|
|COVID-19 Test Home Collection Kit *||The presence or absence of RNA from SARS-CoV-2 virus.|
|Fecal Immunochemical Test (FIT)||The presence of blood in your stool to help detect colon cancer early so it may be treated.|
*Diagnostic test panels. If your results for these test panels identify a marker as detected or positive, a consult from a Health Consultant licensed in your state of residence will be offered to you at no additional cost. When appropriate and permitted by law, the Health Consultant may prescribe treatment for positive results.
More information about the specific benefits of our tests and Services are available on our Site.
In order to utilize our Services, you must collect the appropriate biological sample(s) for the test(s). Some of our tests require a urine sample or a saliva sample; there are no risks associated with collecting urine or saliva samples using the containers provided in our test kits. Some of our tests require the collection of a blood sample. Although the risks and discomforts associated with a blood draw are very low, you might be at risk for excessive bleeding, fainting, 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 healthinformation that has no or limited meaning today, that information could have greater meaning in the future as new discoveries are made.
HealthConfirm, 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.
OUR SERVICES DO NOT PROVIDE MEDICAL ADVICE. The information and content provided, including but not limited to text, graphics, images, videos, and other material contained on our Site and in the Services, are for informational purposes only and are not intended as a substitute for professional medical advice, help, diagnosis or treatment. Always seek the advice of your physician or other qualified health care provider with any questions you have regarding your medical care, and never disregard professional medical advice or delay seeking it because of something you have read on or via our Site. Nothing contained in the Services is intended to constitute a medical diagnosis or treatment. Reliance on any information appearing in the Services, including but not limited to information provided by HealthConfirm or by other users of the Services, is solely at your own risk. By clicking your acceptance, you understand and agree that your results are not a substitute for professional medical advice. You understand that HealthConfirm does not provide medical services, diagnosis, treatment, or advice. You acknowledge that the Health Consultants are not employees of HealthConfirm and are not providing services on behalf of HealthConfirm, but instead are independent professionals solely responsible for the services each provides to you.
HealthConfirm does not warrant the accuracy, completeness, timeliness or usefulness of the opinions, content, services or other information provided through the Services or on the Internet generally. HealthConfirm and its affiliates, licensors, and suppliers have no control over and accept no responsibility for your compliance with the laws applicable to your state of residence.
HealthConfirm implements several safeguards to avoid technical errors, but as with all medical tests, there is a chance of a false positive or a false negative result. A false positive result means a biomarker was detected, which is not in fact present. A false negative result means the test failed to identify biomarker that is in fact present. Other sources of error include sample mix-up, poor sample quality or contamination, inherent DNA sequence properties, and technical errors in the laboratory. Some biological factors, such as a history of bone marrow transplants or recent blood transfusions may limit the accuracy of the results or prevent the Services from being completed.
Results interpretation is based on currently available information in the medical literature and scientific databases. The field of genetics is constantly changing and our understanding of biomarkers is evolving. New information may replace or add to the information that we used to interpret your results. We are not obligated to notify you if there is a new understanding of biomarkers that might result in a change to the interpretation of your results. We reserve the right to contact you, at our option, in the future.
Retention and Use of Your Information
We are subject to multiple laws on the retention of data. Accordingly, 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.
You will send your biological sample(s) directly to the Lab that will conduct the test. HealthConfirm has no obligations or liability regarding the 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.
You understand that by providing any sample, having your sample processed, accessing your results, or providing information to us, you acquire no rights in any research or commercial products that may be developed by HealthConfirm or its collaborating partners. You specifically understand that you will not receive compensation for any research or commercial products that include or result from your sample or information.
Your information and test results may be stored in a repository and used for validation, educational, and/or research purposes. By clicking your acceptance of this Consent, you acknowledge and agree that HealthConfirm may de-identify the information that is obtained from our Services and that we may aggregate this information with de-identified information from other users. De-identification means that the personally identifiable information associated with your information will be removed. You understand that we will not disclose, sell and otherwise commercialize personally identifiable information but that we may disclose, sell and otherwise commercialize de-identified information and User Content without restriction.
We may incorporate different or additional technologies to test or analyze data in the future. We may, at our sole discretion, choose to test or analyze your data using such technologies. We are not obligated to notify you if we chose to conduct different or additional testing or analysis on your data. Your purchase of our Services does not automatically include any such different or additional technologies. You may have to pay additional fees in order to receive Services using any future or additional technologies or features.
Withdrawal of Consent
Your use of HealthConfirm’s Services is voluntary. You may choose to withdraw your Consent or to stop using HealthConfirm’s Services at any time. Such requests to should be sent to us by email at firstname.lastname@example.org or in writing at HealthConfirm., 10123 Carroll Canyon Rd., San Diego, CA 92131.
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.
In the event of any dispute, claim, question, or disagreement arising from or relating to this Consent or the purchase, registration, or use of any HealthConfirm product or Services, we and you (collectively, the “Parties”) shall use their best efforts to settle the dispute, claim, question, or disagreement. To this effect, the Parties shall consult and negotiate with each other in good faith and, recognizing their mutual interests, attempt to reach a just and equitable solution satisfactory to both Parties. If the Parties do not reach such solution within a period of thirty (30) days, then all disputes shall be resolved by binding arbitration in Austin, Texas, in accordance with the Commercial Arbitration Rules of the American Arbitration Association (the “AAA”), subject to the limitations of this section. This agreement to arbitrate will be specifically enforceable in any court having jurisdiction. Notice of a demand for arbitration shall be filed in writing with the other party hereto and with the AAA. The demand for arbitration shall be made within a reasonable time after the dispute has arisen, and in no event shall any such demand be made after the date when institution of legal or equitable proceedings based on such dispute would be barred by the applicable statute of limitations. The Parties agree that one (1) arbitrator shall arbitrate the dispute. The arbitrator shall be selected by the joint agreement of the Parties, but if they do not so agree within twenty (20) days after the date of the notice of a demand for arbitration referred to above, the selection shall be made pursuant to the Commercial Arbitration Rules of the AAA from the panels of business arbitrators maintained by the AAA. The Parties agree that the arbitrator shall have sole authority to decide whether claims brought by either party (excluding claims brought under immediately following paragraph regarding “Preliminary Equitable Relief and Intellectual Property Claims)) are subject to this dispute resolution agreement. The decision of the arbitrator shall be made in writing, shall be final, judgment may be entered upon it in any court having jurisdiction thereof, and the decision shall not be subject to vacation, modification or appeal, except to the extent permitted by sections 10 and 11 of the Federal Arbitration Act, the terms of which sections the Parties agree shall apply. The fees charged by the AAA and arbitrator shall be shared equally by the parties.
Preliminary Equitable Relief and Intellectual Property Claims
Either party may bring a claim related to intellectual property rights, or seek temporary or preliminary specific performance or temporary or preliminary injunctive relief, in any court of competent jurisdiction, without the posting of bond or other security.
All disputes arising out of or relating to this Consent or the purchase, registration, or use of any HealthConfirm product or Services shall be governed by Texas law regardless of where you access the Site or the Services, and notwithstanding of any conflicts of law principles.
Class Action Waiver
Any proceedings to resolve or litigate any dispute in any forum will be conducted solely on an individual basis. Neither you nor we will seek to have any dispute heard as a collective or class action or in any other proceeding in which either party acts or proposes to act in a representative capacity, and each party hereby waives any right to assert consolidated claims with respect to any disputes subject to arbitration under the User Agreement. No arbitration or proceeding will be combined with another without the prior written consent of all parties to all affected arbitrations or proceedings.
Limitation of Time to File Claims
Any action, claim or dispute you have against us must be filed within one year, unless prohibited by applicable law. To the extent permitted by law, any claim or dispute under this agreement must be filed within one year in an arbitration proceeding. The one-year period begins when the claim or notice of dispute first could be filed. If a claim or dispute is not filed within one year, it is permanently barred.
You agree that we may provide you with notices by email to the address you provided at the time of registration or as changed in your Member profile on the Site.
No Affiliation with HealthConfirm
You agree not to hold yourself out as in any way sponsored by, affiliated with, endorsed by, in partnership or venture with, nor as an employee or employer of HealthConfirm, any of our affiliates or service providers.
This Agreement, including the other documents referenced and referred to herein, 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. No failure to exercise, and no delay in exercising, on the part of either party, any right or any power hereunder shall operate as a waiver thereof, nor shall any single or partial exercise of any right or power hereunder preclude further exercise of that or any other right hereunder. In the event of a conflict between this Agreement and any applicable purchase or other terms, the terms of this Agreement shall govern. If any provision of this Agreement 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 Agreement will continue in full force and effect. The headings of sections and paragraphs in this Agreement are for convenience only and shall not affect its interpretation.
Special Notice for COVID-19 Testing In Connection with Employment for Work Safety Purposes
If COVID-19 testing is being provided by your employer for work safety testing purposes on either a voluntary or mandatory basis, then the following additional statements apply and supersede other provisions in this consent form. Your signature on this Consent means you have read, understood and agree to the following:
This COVID-19 testing is for public health and work safety purposes in connection with your employment, is not a health benefit and is not part of a health plan or wellness plan. You are an employee undergoing testing in connection with your employment.
Results from the COVID-19 testing, as well as information you provide during registration, will be shared by HealthConfirm and the Labs with your employer as well as the vendor(s) who provides services to your employer in support of the employer’s business related to these results, including your employer’s franchisor and/or affiliate company. Signing this Consent is required in order to receive the COVID-19 testing services provided by your employer.
Although this form mentions other tests provided by HealthConfirm, the specimen you provide will ONLY be tested to diagnose COVID-19.
This COVID-19 testing is an at-home self-collection kit which uses a nasal swab. Wording regarding blood, urine or saliva does not apply and should be disregarded.
This COVID-19 testing is provided at no cost to you. Wording about fees, insurance, refunds, and reimbursement do not apply and should be disregarded.
Any resulting research studies, publications or commercial uses conducted by or for HealthConfirm or the Labs will not identify you, your employer, your employer’s franchisor or your employer’s affiliate company.
You can opt out of receiving marketing communications from HealthConfirm through “unsubscribe” links available on all marketing communications.
This COVID-19 testing does not involve medication or treatment for COVID-19. Physician consultation provided as part of this COVID-19 testing are physician services necessary to perform the COVID-19 testing, such as education provided to you regarding the test result and a telehealth consult. These services do not involve medication or treatment. As with other types of lab testing, there may be false positives and false negatives. If you have a positive test result, you should follow up with your personal health care provider.
This COVID-19 test is a point in time snapshot about your current status at this time; a person could still contract COVID-19 or test positive for COVID 19 in the future even if he/she has a negative result now.
If you have questions or comments about our Services or this Consent, please contact us by email at email@example.com , by phone at 888-526-6347, or in writing at HealthConfirm, 10123 Carroll Canyon Rd., San Diego, CA 92131