Zyliant™ Release, Disclaimer, and Assumption of Risk

Zyliant™, a product of Wyoming Health Innovation Living Laboratory (“WHILL”), is a digital screening tool which can be used, in conjunction with the services of a health care provider, to give participants insight into their neurohealth through a series of assessments surrounding cognition and mobility. 

IMPORTANT NOTICE 
Zyliant™ is not a “medical device” under section 201(h)(1) of the federal Food, Drug and Cosmetic Act and is not regulated or approved for use by the U.S. Food and Drug Administration or any other federal or state agency. Zyliant™ does not provide medical advice, nor does it identify, diagnose, or treat any disease or medical condition, and it should not be used or relied upon to do so. Zyliant™ provides data relating to an individual’s neurohealth that may be used by a health care provider as part of a broader clinical evaluation. 

No part of the assessments, scores, results, or communications generated by use of Zyliant™ should be interpreted as medical advice or as a substitute for a comprehensive clinical evaluation by a licensed provider. Your use of Zyliant™ does not create a health care provider-patient relationship with WHILL. If you have concerns about the results or recommendations provided through Zyliant™, consult your health care provider directly. 

By continuing with the use of Zyliant™, you acknowledge and agree to the following: 

Use of Zyliant™ and Assumption of Risk 

  • Your use of Zyliant™ and any data it provides is entirely at your own risk. 

  • You assume all risks of use, including but not limited to illness or injury, emotional distress, property damage, or death. 

  • WHILL makes no warranty as to the accuracy, completeness, or clinical validity of any information provided. 

  • You specifically accept the risk of false positives or false negatives and understand these may affect your clinical care or personal decisions. 

Release of Liability 

You agree to release, discharge, and hold harmless WHILL and its affiliates, owners, employees, contractors, and agents from any and all claims or liability, of any nature, arising from your use of Zyliant™, to the maximum extent permitted by law. 

Use and Sharing of Personal and Health Information 

Using Zyliant™ will result in the collection and transmission of personal and health-related information (“Personal Data”). WHILL may store, use, or share this data as outlined in its Privacy Policy, which is subject to change. By using Zyliant™, you grant WHILL the right to use your Personal Data, including Protected Health Information (“PHI”), as permitted under applicable law and in accordance with WHILL’s obligations under HIPAA when acting as a Business Associate to a covered entity. 

When Zyliant™ is offered through a health care provider who has entered into a Business Associate Agreement (BAA) with WHILL, your data may be disclosed to that provider and used in accordance with HIPAA. WHILL also works with subcontractors who may receive and process PHI to support Zyliant™ operations. These subcontractors are required to sign subcontractor BAAs and follow HIPAA-compliant safeguards. 

Email Transmission of Results – Risks and Opt-In 

Your Zyliant™ results may be sent to you and/or to a third party (e.g., your health care provider) by email. Please be aware of the following: 

  • Email communications may not be encrypted during transmission, especially if the recipient’s email server does not support encryption protocols (such as TLS). 

  • There is a risk that unencrypted email may be intercepted or accessed by unauthorized parties. 

  • WHILL cannot guarantee the security of email once it leaves its systems. 

By proceeding, you: 

  • Acknowledge and accept the risks associated with receiving PHI via unencrypted email. 

  • Authorize WHILL to send your Zyliant™ results and any related health information to (1) the email address you provided, and/or (2) third-party providers or vendors who have signed a HIPAA-compliant Business Associate Agreement (BAA) or subcontractor BAA with WHILL. 

  • Consent to receive your results via email, including through unsecured channels if encryption is not available. 

  • Acknowledge that you may revoke this consent at any time by contacting WHILL before your results are transmitted. 

If you do not wish to accept these risks or do not consent to email delivery, please do not proceed with Zyliant™ at this time.

Updated Date: 4/11/25