Mobile Application and OrthoPulse® Privacy Policy

This Privacy Policy describes the ways in which Biolux Technology GmbH (“Biolux,” “we,” “our,” or “us”) collects, uses, and discloses information about you through the OrthoPulse® device and the associated OrthoPulse® mobile application (the “OrthoPulse® App”), and through OrthoPulse Connect (Dr. Portal). We refer to the OrthoPulse® device, the OrthoPulse® App, and Dr. Portal collectively as the “OrthoPulse® System.” By using the OrthoPulse® device, the OrthoPulse® App, or Dr. Portal, you consent to the processing of your information as set forth in this Privacy Policy, now and as amended by us. This Privacy Policy applies specifically to the OrthoPulse® System; general use of www.orthopulse.com outside of the OrthoPulse® System is instead governed by our separate Privacy Policy.

Consent for Patients

Before a patient’s information is collected through the OrthoPulse® System, or a patient account is created, the patient (or the patient’s legal guardian, if the patient has not reached the age of majority) must agree to the then-current Biolux Patient Consent Form. Where a patient is under the age of eighteen (18), the patient’s parent or legal guardian must additionally agree to the then-current Biolux Parent Acknowledgment Form before the patient uses the OrthoPulse® App. These consent mechanisms are described further in our Terms and Conditions.

What Information Do We Collect?

Information You or Your Dental Provider Share with Us

We and our service providers collect and store information that you provide to us, as well as information provided to us by your dentist, orthodontist, or other treatment provider. If you, your dentist, orthodontist, or other treatment provider create a provider or patient account linked to your name or contact information (an “Account”), we collect the registration information shared with us. We collect information when you contact us via the OrthoPulse® App with a request, question, or comment. We collect information about patients when dental providers create patient Accounts, when patients access their Accounts via the OrthoPulse® App, and when an OrthoPulse® device syncs with the OrthoPulse® App. This information may include: (a) your name, contact information, e-mail address, mobile phone number, password, OrthoPulse® device serial number, and other registration information; (b) personal details such as your age and gender; (c) orthodontic treatment details, such as your treatment start date; (d) information regarding your usage of the OrthoPulse® device, such as the date, time, and duration of use; and (e) information you provide when you contact us with a request, question, or comment. Even if you, as a patient, do not use the OrthoPulse® App yourself, your dental treatment provider may send us information regarding your usage of your OrthoPulse® device by syncing it with his or her OrthoPulse® App or Dr. Portal account.

Information Automatically Collected

We and our service providers collect and store certain technical information from your mobile device over time whenever you interact with us through the OrthoPulse® App, such as: your Internet Protocol address; your general geographic location (for example, for purposes of determining your time zone); your mobile device’s model, software version, and network status; and information about how and when you use the OrthoPulse® App or your mobile device.

Health Information

Information about your orthodontic treatment and your use of the OrthoPulse® device — such as treatment start date, usage duration, and treatment progress — may constitute health information under applicable law. We treat this information with heightened care, and access to it is limited to those who need it to provide, support, or improve the OrthoPulse® System, comply with legal obligations, or as otherwise described in this Privacy Policy.

How Do We Use This Information?

We may use the information we collect for a number of purposes, including to:

  • Provide you and your dental provider with information about your use of the OrthoPulse® device;

  • Operate the OrthoPulse® System, including providing the features and services available through the OrthoPulse® App and Dr. Portal;

  • Provide information, services, or products you request, and respond to your inquiries;

  • Customize your experience using the OrthoPulse® System, such as by supporting personalized treatment options;

  • Monitor the safety and efficacy of the OrthoPulse® System, including for post-market surveillance and quality/regulatory obligations applicable to a medical device;

  • Generate and analyze statistics about use of the OrthoPulse® System;

  • Provide required notices about the OrthoPulse® System;

  • Improve the OrthoPulse® System and the services we provide; and

  • Detect, prevent, and respond to fraud, intellectual property infringement, violations of our Terms and Conditions, violations of law, or other misuse of the OrthoPulse® System.

Legal Bases for Processing (EEA/UK)

Where the GDPR or UK GDPR applies, we process information through the OrthoPulse® System on the following legal bases: your explicit consent (in particular for health-related information, obtained through the Patient Consent Form and, where applicable, the Parent Acknowledgment Form); performance of a contract with you or your treatment provider; our legitimate interests in operating and improving the OrthoPulse® System and monitoring device safety; and compliance with our legal and regulatory obligations as a medical device manufacturer. You may withdraw consent at any time, without affecting the lawfulness of processing before withdrawal, though this may limit your ability to use the OrthoPulse® System.

Sharing Your Information

We may disclose information collected through the OrthoPulse® System in the following circumstances:

  • Treatment Purposes: information collected from patients, such as usage of the OrthoPulse® System, may be disclosed to your dental treatment provider;

  • Third-Party Service Providers: we may engage other companies and individuals to perform functions on our behalf, such as data hosting, application development, and customer service support, under confidentiality and data protection obligations;

  • As Required by Law: we may disclose information to comply with legal obligations or requests, such as a subpoena, court order, or government reporting obligation, including obligations applicable to medical devices;

  • Protection of Rights: we may disclose information to enforce our Terms and Conditions and other agreements, or to protect the rights, property, or safety of the OrthoPulse® System, our users, or others; this does not include selling, renting, or otherwise disclosing information that reasonably identifies users for purposes other than those addressed in this Privacy Policy;

  • Corporate Transactions: we may disclose information to service providers, advisors, potential transactional partners, or other third parties in connection with a corporate transaction in which we are acquired by or merged with another company, or in which we sell, liquidate, or transfer all or a portion of our assets.

We do not sell information that reasonably identifies you.

Where Is This Information Processed?

We process information collected via the OrthoPulse® System in and subject to the laws of the European Union. We may also transfer your information outside the European Union to our affiliates, business partners, and service providers located in other countries, using appropriate safeguards such as the European Commission’s Standard Contractual Clauses where required. By using the OrthoPulse® System, you consent to such transfer and processing.

Data Retention

We retain information collected through the OrthoPulse® System for as long as necessary to provide the OrthoPulse® System, support your treatment, comply with our legal, regulatory, and quality-system obligations as a medical device manufacturer, resolve disputes, and enforce our agreements.

Your Privacy Rights

European Economic Area, United Kingdom, and Switzerland

Subject to certain conditions and exceptions, you have the right to access the information we hold about you, request correction of inaccurate information, request deletion, object to or restrict certain processing, request portability of information you provided to us, and lodge a complaint with your local data protection authority. The Data Protection Authority is the responsible supervisory authority in Austria.

California

If you reside in California and have provided us with information that identifies you, you may be entitled to request information, once per calendar year, about our disclosures of certain categories of information to third parties for their direct marketing purposes. Such requests must be submitted in writing to support@orthopulse.com.

To exercise any of the rights described in this section, please contact us at support@orthopulse.com. We may need to verify your identity, or the identity of your legal guardian, before responding to your request.

Other U.S. States

Depending on your state of residence, you may have similar rights under other applicable state privacy or consumer health data laws, which may include the right to know, delete, correct, and withdraw consent to certain processing of health-related information. To exercise these rights, please contact us using the details below.

Canada

If you are located in Canada, PIPEDA or applicable provincial privacy or health-information legislation may give you the right to access and request correction of the information we hold about you, and to withdraw consent to certain processing, subject to legal and contractual restrictions.

Australia and New Zealand

If you are located in Australia, we handle personal information, including health information, in accordance with the Australian Privacy Principles under the Privacy Act 1988 (Cth) and, where applicable, state or territory health records legislation. If you are located in New Zealand, we handle personal information in accordance with the Privacy Act 2020 and the Health Information Privacy Code. In both cases, you may have the right to access and request correction of the information we hold about you.

Information Security

We maintain administrative, technical, and physical safeguards designed to protect the information collected by the OrthoPulse® System. However, no information system can be 100% secure, and we cannot guarantee the absolute security of your information. We are not responsible for the security of information transmitted over networks that we do not control, including the internet and wireless networks.

Your Choices

The OrthoPulse® App allows you to access information about your Account for the limited purpose of viewing, and in certain cases updating, that information.

Children’s Information

If you are a parent or legal guardian of a child who uses the OrthoPulse® App, you may be able to review or delete certain information we have collected in connection with your child’s use of the OrthoPulse® App. To do so, please contact us at support@orthopulse.com. See also the Consent for Patients section above regarding the Parent Acknowledgment Form.

Changes To This Privacy Policy

If we update this Privacy Policy, we will notify you by posting the updated Privacy Policy on this page. If we make revisions that materially change how we use or share information previously collected from you through the OrthoPulse® System, we may give you the opportunity to consent to those changes before they apply to that information.

Contact Us

If you have questions about this Privacy Policy or our use of information collected through the OrthoPulse® System, please contact us at support@orthopulse.com.

Biolux Technology GmbH

Neubaugasse 31

3462 Absdorf

Austria

This Privacy Policy was last updated on DATE SET ON PUBLICATION.