NOTICE OF PRIVACY PRACTICES
THIS NOTICE DESCRIBES HOW MEDICAL INFORMATION ABOUT YOU MAY BE USED AND DISCLOSED AND HOW YOU CAN GET ACCESS TO THIS INFORMATION. PLEASE REVIEW IT CAREFULLY.
Effective Date: August 20, 2026
Our Commitment to Your Privacy
Byonyks Medical Devices, Inc. (“Byonyks,” “we,” “us,” or “our”) is required by law to maintain the privacy of your Protected Health Information (“PHI”), to provide you with this Notice of Privacy Practices describing our legal duties and privacy practices with respect to PHI, and to notify affected individuals following a breach of unsecured PHI. We are required to abide by the terms of this Notice while it is in effect. This Notice applies to PHI we create or receive in connection with your use of a Byonyks device, the Byonyks mobile application, or your care. It does not apply to information governed by our general Privacy Policy, which covers information that is not PHI.
How We May Use and Disclose Your PHI
For Treatment. We may use or disclose your PHI to provide, coordinate, or manage your treatment and related services — for example, sharing device usage and therapy data with your clinic or care team so they can manage your care.
For Payment. We may use or disclose your PHI to obtain payment for services, or to support billing and reimbursement activities related to your device or treatment, where applicable.
For Health Care Operations. We may use or disclose your PHI to support quality assessment, safety monitoring, device improvement, staff training, compliance activities, and other operations necessary to run our business and support your care.
Other permitted or required uses and disclosures, without your authorization, include:
As required by law;
For public health and safety reporting activities, including reporting to applicable government health and safety regulators;
For health oversight activities (audits, inspections, licensure);
In response to judicial or administrative proceedings;
For law enforcement purposes, in limited circumstances;
To avert a serious threat to health or safety;
To business associates who perform services on our behalf and agree in writing to protect your PHI;
For research purposes, subject to institutional review board approval or your written authorization;
To coroners, medical examiners, or funeral directors, as applicable;
For workers’ compensation purposes, as authorized by law;
For specialized government functions (e.g., military, national security), if applicable; and
As required by state or federal breach notification laws.
Uses and disclosures requiring your written authorization. Uses of your PHI for marketing purposes, and any sale of your PHI, require your prior written authorization. Byonyks does not use PHI for marketing and does not sell PHI.
Your Rights Regarding Your PHI
You have the right to:
Request restrictions on certain uses and disclosures of your PHI (we are not required to agree, except in limited circumstances required by law);
Request confidential communications by an alternative means or at an alternative location;
Inspect and copy your PHI, with limited exceptions;
Request an amendment to your PHI if you believe it is incorrect or incomplete;
Receive an accounting of certain disclosures of your PHI made in the six years prior to your request;
Receive a paper copy of this Notice upon request, even if you agreed to receive it electronically; and
File a complaint if you believe your privacy rights have been violated, by contacting us using the details below or by filing a complaint with the U.S. Department of Health and Human Services, Office for Civil Rights. You will not be retaliated against for filing a complaint.
Our Duties
We are required by law to maintain the privacy of your PHI, provide you with this Notice of our legal duties and privacy practices, and notify you following a breach of unsecured PHI. We reserve the right to change the terms of this Notice and to make the revised Notice effective for all PHI we maintain. If we make a material revision, the updated Notice will be posted with a new effective date at the location where this Notice is made available, and provided to you upon request.
Contact Us
If you have questions about this Notice or wish to exercise any of the rights described above, contact:
Byonyks Privacy Team
Byonyks Medical Devices, Inc.
550 E. Devon Avenue, Unit 140
Itasca, IL 60143, United States
Email: [email protected]
You may also file a complaint with:
Office for Civil Rights, U.S. Department of Health and Human Services
200 Independence Avenue, S.W., Washington, D.C. 20201
1-877-696-6775 · https://www.hhs.gov/ocr/complaints