Byonyks Pvt. Ltd and its U.S. affiliate, Byonyks Medical Devices, Inc. (collectively, “Byonyks,” “us,” “we,” or “our”), are committed to protecting your privacy. This Privacy Policy describes how we may use and collect information about you (“you,” “user”) when you use the Byonyks mobile application (the “App”).” 

Scope of This Privacy Policy

This Privacy Policy applies to:

•  The Byonyks mobile application, and any features or digital product experiences within it that link to or reference this Privacy Policy.

This Privacy Policy does not apply to:

• Byonyks medical devices, connected product features, or in-clinic systems, unless they specifically link to this Privacy Policy,
• Product support, customer service, or other business communications outside the App
• Information that constitutes Protected Health Information (“PHI”) under the U.S. Health Insurance Portability and Accountability Act (“HIPAA”).

Byonyks has other privacy notices which may supplement or supersede this Privacy Policy, including but not limited to:

• Our HIPAA Notice of Privacy Practices: Currently in preparation. The link will be added here once published, for Protected Health Information PHI.

Personal Information

For purposes of this Privacy Policy, “Personal Information” means information that may identify you that we collect or generate when you use the App. Depending on where you live, Personal Information may have a different definition under local privacy laws, this Privacy Policy applies to all types of Personal Information as defined by the laws that apply to you.

Types of Personal Information We Collect

We collect and generate different types of Personal Information depending on how you use the App. The following describes the categories of Personal Information we may collect through the App.

Demographic and Contact Information. Information you provide to us, such as your name, alias, postal address, phone number, email address, and account name.

Online or Other Account Information. Your username or email address and corresponding password, and other authentication details needed to create and access your account. We treat account login credentials as sensitive personal information, alongside the health-related information described below.

Profile Information. Profile details you choose to provide.

Mobile App and Device Information. Information needed to operate, support, and improve the App, which may include limited device permissions you approve in your settings, device identifiers, device type, and operating system version.

Health Information. If you use the App in connection with a Byonyks device or your treatment, we may process health data related to your use of the App, with your consent or as otherwise permitted by applicable law. Additional privacy laws apply to this type of sensitive information. Where it qualifies as Protected Health Information under HIPAA, it is governed by our separate HIPAA Notice of Privacy Practices, not this Privacy Policy.

Information From Other Sources. Where appropriate and permitted by law, we may receive information about you from your clinic, care team, or an authorized distributor connected to the App, to set up product support, keep records accurate, or meet quality and regulatory obligations.

How We Use Your Personal Information

Depending on how you use the App, we may use your Personal Information in the following ways:

To administer and provide you with the App. For example, to create and administer your account, authenticate your credentials, and allow you to access and use the App.

To support your care and product use. To help you with product information and support related to the App.

To respond to your inquiries. If you contact us with a question, request, or concern, we use your Personal Information to respond to you.

To send you administrative information. To share important product notices, safety information, and changes to our terms or policies.

To support product quality and safety. To monitor, investigate, and improve the quality and safety of the App and connected products, including as required for FDA medical device reporting and adverse event reporting under 21 CFR Part 803 (MedWatch), and equivalent obligations in other jurisdictions where applicable.

To protect the App. To keep our systems safe and secure, including fraud monitoring and prevention.

To comply with applicable laws. To meet legal and regulatory requirements, respond to lawful requests, and establish or defend our legal rights.

Legal Basis for Processing Your Personal Information

Byonyks will only use or process your Personal Information where permitted by applicable privacy laws. The legal basis we may rely on includes:

Consent. For example, where you provide consent for us to process health-related information collected through the App. You may withdraw your consent at any time by contacting us.

Legal Obligations. For example, requirements to report adverse events or medical device incidents to regulators such as the FDA.

Legitimate Interests. For example, operating, maintaining, and securing the App, and communicating with you about your account or our products.

How We Interact with Third Parties

Service Providers. We may share your Personal Information with third-party service providers that help us operate and support the App. These providers are required to protect your Personal Information under contractual and legal obligations.

Healthcare and Care Partners. We may share your Personal Information with your clinic, healthcare provider, or other authorized parties involved in your care or in supporting Byonyks products, where appropriate and permitted by law.

Legal and Regulatory Recipients. We may share your Personal Information when required to comply with law, respond to a lawful request, or meet medical device reporting and safety obligations.

We do not sell your Personal Information. In the past twelve (12) months, we have disclosed Personal Information to the categories of recipients above for the business purposes described in this Policy, this is a disclosure for a business purpose, not a sale.

International Transfers of Personal Information

Byonyks operates clinics and business relationships in both Pakistan and the United States. As a result, your Personal Information may be transferred to, stored in, or accessed from a country other than the one in which you reside, which may have different data protection laws than your own. We take steps required by applicable law to protect your Personal Information in connection with such transfers.

Your Personal Information Rights

Depending on where you live, you may have rights with respect to your Personal Information, including the right to:

• Know and access the Personal Information we hold about you,
• Correct inaccuracies in your Personal Information,
• Delete your Personal Information, and obtain a copy of Personal Information you’ve provided to us,
• Withdraw consent where we rely on your consent to process your Personal Information; withdrawal does not affect processing that occurred before you withdrew consent,
• Opt out of the sale of Personal Information, targeted advertising, or certain profiling (Byonyks does not currently engage in these activities, but this right is described here for completeness),
• Limit the use of your sensitive Personal Information, and
• Non-discrimination for exercising any of these rights.

These rights are available under the laws of California, Colorado, Connecticut, Delaware, Florida, Indiana, Iowa, Kentucky, Maryland, Minnesota, Montana, Nebraska, New Hampshire, New Jersey, Oregon, Rhode Island, Tennessee, Texas, Utah, and Virginia, and may vary by state. You may exercise your rights by contacting us using the details below. We will verify your identity before fulfilling a request. If you use an authorized agent, we may require proof of their written authorization. If we deny your request, you may appeal by contacting us. If your appeal is denied, you may lodge a complaint with your state attorney general.

Minors

The App may be used by individuals of any age, including patients whose care is supervised by a parent, guardian, or clinician. We do not knowingly collect Personal Information directly from a child under 13 without verifiable parental or guardian consent, consistent with the U.S. Children’s Online Privacy Protection Act (“COPPA”) and other applicable law. Where a parent, guardian, or caregiver uses the App on behalf of a minor patient in connection with the minor’s treatment or care, information about that minor necessary for their care may be processed through the adult’s account. If you believe we have collected Personal Information from a child in a manner inconsistent with this section, contact us and we will take steps to address it.

Security

We use administrative, technical, and organizational security measures appropriate for a medical device company to protect your Personal Information. No method of electronic transmission or storage is 100% secure, and we cannot guarantee that unauthorized parties will never defeat our security. If we become aware of a breach affecting your Personal Information, we will notify you as required under HIPAA, the FTC Health Breach Notification Rule (16 CFR Part 318, where applicable), and other applicable laws.

Data Retention

We retain your Personal Information only as long as reasonably necessary for the purposes described in this Privacy Policy, or as required by applicable law, including FDA device recordkeeping requirements (21 CFR 820.180) where relevant. If you have questions about a specific retention period, please contact us.

How to Submit a Complaint

Byonyks is committed to ensuring that complaints and concerns about our privacy practices are investigated and resolved. If you submit a privacy-related concern, the Byonyks Privacy Office will investigate and work to resolve it. Privacy questions or complaints may be submitted using the contact details below. If your concern relates to Protected Health Information, you may also file a complaint with the U.S. Department of Health and Human Services, Office for Civil Rights, without retaliation, as described in our HIPAA Notice of Privacy Practices.

Changes to This Privacy Policy

We may periodically update this Privacy Policy to reflect changes to the App or applicable law. If we make material changes, we will post a notice of those changes or notify you directly. We encourage you to review this Policy periodically.

Contact Us

If you have questions or concerns about this Privacy Policy, please contact us:

Email: [email protected]

Mail: 
Byonyks Pvt. Ltd / Byonyks Medical Devices
550 E. Devon Avenue, Unit 140
Itasca, IL 60143
United States