Last Updated December 30, 2020
INFORMED CONSENT FOR ACCESS AND USE OF SAMPLE AND PERSONAL INFORMATION BY ELO HEALTH, INC. AND MICRODROP, LLC
IMPORTANT: PLEASE READ THIS AGREEMENT CAREFULLY BEFORE CHECKING THE BOX TO ACKNOWLEDGE YOUR CONSENT.
The testing services offered by Elo Health, Inc. (“Elo Health”) are provided through Microdrop, LLC (“Microdrop”), which offers imaware™ -- an online wellness platform that utilizes blood biomarker sample testing to provide insight into an individual’s risk for health-related conditions. This Informed Consent describes Microdrop’s imaware™ services and reviews the benefits, risks and limitations to you, as the person who created an Elo Health user account, along with an explanation of how your sample, the test results, and your personal information will be accessed and used by Microdrop in order to provide the imaware™ services to you.
Elo Health and Microdrop offer an online wellness-focused service that assists its subscribers by facilitating access to laboratory testing services, that are ordered by a licensed physician or other authorized person and performed by a CLIA-certified laboratory (“Test Laboratory”), enabling subscribers to receive personalized health data and associated reports containing wellness-oriented information. Elo Health and Microdrop are not clinical laboratories and does not collect blood or other specimens from subscribers. Elo Health and Microdrop are not a provider of medical or health services and does not provide any diagnosis, treatment or medical advice and are not a substitute for an in-person medical evaluation. We encourage you to share any reports or information delivered by Elo Health or Microdrop, including the imaware™ Report, with your primary care provider or other qualified healthcare provider (“Health Professional”).
There are certain conditions that, despite their severe impact on an individual’s quality of life, are currently underdiagnosed. Elo Health’s and Microdrop’s goals are to expand awareness of such conditions through convenient and simple blood sample testing and actionable reports that are easy to understand. Our affiliation with multiple Test Laboratories allows Elo Health and Microdrop to enhance their wellness offerings by incorporating insights from test results into their condition-specific reports.
imaware™ reviews the blood biomarkers identified in the laboratory test results to assess the likelihood that an individual may have the specified condition that they have chosen to have tested and provides a personalized report regarding the subscriber’s risk level associated with the tested sample, as well as general information regarding that condition (“imaware™ Report”). Elo Health’s and Microdrop’s insights are developed by identifying certain established biomarkers associated with particular conditions, based on scientific journals and other credible scientific resources.
In order to provide imaware™ services, you must hereby request and consent to the Test Laboratory’s performance of the blood biomarker, DNA or RNA testing on your specimen and hereby authorize the Test Laboratory to release your test results to Elo Health and Microdrop. The Test Laboratory will share with Elo Health and Microdrop only the data that is necessary to provide imaware™ services. Elo Health and Microdrop do not perform any diagnostic testing.
The health and wellness insights provided by Elo Health and Microdrop in the imaware™ Report will be based on blood biomarker data generated by the Test Laboratory and information then currently contained in scientific literature and other resources. Your imaware™ Report will include references to the studies that Elo Health and Microdrop used to prepare your health and wellness insights and an indication of the strength of the evidence supporting the influence of a particular biomarker or genotype on the risk of having a particular condition.
Once this Informed Consent has been signed, you will be able to request the appropriate test and your imaware™ collection kit will be mailed to the address listed in your user account. A test order from a licensed physician or other authorized person is required, and the collection kit will not be shipped until a valid test order from the licensed physician or other authorized person is confirmed as received by the Test Laboratory.
imaware™ allows for an at-home sample collection process. Once you receive the imaware™ collection kit, you will need to follow the enclosed instructions to collect a sample and mail back your sample to the designated Test Laboratory. IF YOU DO NOT COLLECT AND RETURN YOUR SAMPLE IN THE COLLECTION KIT WITHIN (60) DAYS OF RECEIPT, THE LABORATORY TEST MAY NOT BE PERFORMED AND YOU WILL NEED TO REORDER A COLLECTION KIT. Elo Health and/or Microdrop will send an email to the address provided in your user account letting you know when your imaware™ Report is available on the Elo Health or Microdrop website. The test results from the Test Laboratory and your imaware™ Report will only be accessible via your user account.
Elo Health and Microdrop do not provide any diagnosis, treatment or medical advice. imaware™ is not intended to diagnose a disease or condition or to predict whether you may develop a disease or condition in the future. Always seek the advice of your Health Professional with any questions or concerns you have regarding your health and need for medical treatment or care, and never disregard professional medical advice or delay seeking it because of something you have read in the imaware™ Report. Reliance on any information in the imaware™ Report, or any other information provided by Elo Health or Microdrop or by other users of imaware™ services, is solely at your own risk.
Scientific developments occur at a rapid pace, and it is possible that new biomarkers will be identified, or new information about the biomarkers we examine will be discovered, after we prepare your imaware™ Report, which could affect the accuracy and completeness of the health and wellness information we provide. Elo Health and Microdrop do not warrant the accuracy, completeness, timeliness or usefulness of your imaware™ Report and its content or other information or services provided through Elo Health or Microdrop’s websites or referenced on the Internet generally. Elo Health and Microdrop do not warrant the accuracy or completeness of the information and conclusions in the scientific journals and other resources referenced in the imaware™ Report.
Microdrop will ensure the Test Laboratory implements several safeguards to avoid technical errors, but there are general risks and limitations of laboratory testing and, as with all laboratory testing, there is a chance of a false positive or a false negative result. Other sources of error include sample mix-up, poor sample quality or contamination, 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 imaware™ services from being completed. If testing results are inconclusive, you may be asked for an additional specimen(s). You hereby acknowledge and agree that Elo Health and Microdrop do not warrant and are not liable for the accuracy or completeness of the laboratory testing performed by the Test Laboratory.
Early detection of the health conditions can lead to significant health benefits. All tests offered by Elo Health and Microdrop can generate information that, when shared with your Health Professional, may have a beneficial impact on your health. Elo Health’s service and Microdrop’s imaware™ Report will provide insights about your risk level associated with having the condition(s) discussed in your report, which can spark and inform further conversations with your Health Professional. These insights may also be helpful in informing your choices about nutrition, diet, and lifestyle upon consultation with your Health Professional. More information about the specific benefits of imaware™ are available on Microdrop’s website.
There are risks presented by using Elo Health’s service and imaware™ including, without limitation, the receipt of information about health that you may prefer not to know, and which may suggest conditions or problems that may be upsetting or even incurable, and you assume those risks by your consent.
Elo Health and Microdrop encourage you to have a follow-up visit with a Health Professional after reviewing results in the Elo Health service and in the imaware™ Report. As a result, you may learn about health conditions and problems or potential health risks that you were not aware of before you utilized Elo Health’s service or imaware™. You may experience stress, anxiety, or emotional or physical discomfort upon learning about potential health problems. There may also be additional risks of utilizing Elo Health’s service and imaware™ that are currently not known or foreseeable.
The laboratory tests require the collection of a small volume of sample blood or appropriate sample. While the risks and discomfort associated with a sample collection 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 a subscriber has a history of excessive bleeding or fainting while having blood work done, we advise avoiding self-blood collection.
By signing this consent form, you acknowledge that your sample and any data received or created in connection with the Elo Health and imaware™ services will be stored by Elo Health, Microdrop, or third-party vendors and may be retained after testing for internal research, test validation, quality assurance, product improvement and/or educational purposes by Elo Health and Microdrop. Your consent allows us to share your data with third-party vendors or publish the results from your data, but any use or disclosure of the sample and any data will be done in an anonymized manner by either encrypting or removing personally identifiable information. You can withdraw your permission at any time hereafter. If you do so, your samples and your information in the possession of Elo Health and Microdrop will be deleted or destroyed.
By signing this consent form, you acknowledge that Elo Health and Microdrop may decide to share your stored sample in an anonymized manner for various research purposes approved by an Institutional Review Board (“IRB”). Elo Health and Microdrop will do so only if you give us your separate consent which we will ask for through our research consent process.
If you have questions about the information included in this Informed Consent, or have questions or concerns after receiving your Elo Health services or imaware™ Report, please contact us at email@example.com or firstname.lastname@example.org, or call Microdrop at 1.855.502.9273 for further information.
By signing below, I consent and agree to the following:
I am 18 years of age or older.
I have read this Informed Consent or have had the form read to me.
I understand and voluntarily agree to the purpose, risks, benefits, and limitations of the Elo Health services and the imaware™ services provided by Microdrop.
I have had the opportunity to have my questions about Elo Health’s services and imaware™ answered.
I acknowledge that my employer may administer health testing and view the results in accordance with EEOC guidance. I voluntarily consent and authorize Elo Health and/or imaware™ to release my test results directly to my employer if requested.
The Test Laboratory has my permission to release to Elo Health and Microdrop, and Elo Health and Microdrop have my permission to use the test report and biomarker data for the purpose of providing the Elo Health services and reports and the imaware™ services and reports.