Pelvital 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.

Pelvital USA, Inc. ("Pelvital"), maker of the Flyte® device and provider of the websites, mobile applications, customer support, and related services that make up the optional components of the Flyte System (“Services”), is committed to protecting the privacy and security of your data. To that end, we operate in compliance with all applicable privacy and data protection laws including the Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 ("HITECH") and applicable regulations (“HIPAA”).

This Notice of Privacy Practices describes the practices Pelvital will follow with respect to the privacy of your health information.

Health Information We Collect

Pelvital takes the confidentiality of your health information seriously. In providing our Services, some of the information we collect may constitute protected health information (“PHI”) under HIPAA. PHI is individually identifiable information that may relate to (a) your past, present or future physical or mental health or condition, (b) the provision of health care to you, or (c) your past, present, or future payment for the provision of health care, which is created, received, transmitted or maintained by Pelvital. This Notice of Privacy Practices describes how we protect the privacy of your protected health information as a person using our Services. Pelvital has certain obligations under HIPAA for maintaining the privacy and security of your PHI collected while providing our Services.

Information We Disclose

Pelvital may use and disclose your PHI for the purposes described below. These uses and disclosures do not require your prior authorization. You may request restrictions on Pelvital’s use and disclosure of your PHI at any time, except for uses or disclosures we have already made. Pelvital may use and disclose your health information for the following purposes:

Treatment

Pelvital can use your health information in the delivery of Pelvital’s Services. For example, your PHI can be used by Pelvital to personalize your experience.

Payment

We may use and share your PHI to obtain payment for our Services. For example, we may disclose your PHI to your health plan to determine whether you are enrolled with the payer or eligible for health benefits or to get payment for our Services.

Health Care Operations

We may use and disclose your PHI for health care operations purposes. These uses and disclosures are necessary to make sure that you receive quality care and to operate and manage our operations. For example, we may use and disclose your PHI for purposes of reviewing the quality of services you receive. We also may share PHI with other entities that have a relationship with you (for example, your health plan) for their health care operation activities.

Associated Health Care

We may use and share your PHI for activities related to your health care. For example, the Pelvital Customer Care team, your healthcare provider, or your health plan may access your PHI to verify your progress and provide recommendations to improve your experience.

Family Members

We may use and share your PHI with family members and others involved in your healthcare or payment for care including disclosures of information after your death.

Business Associates

For some aspects of the Services, we work with other companies, including other “Covered Entities” and “Business Associates” (as those terms are defined by HIPAA), who help deliver the Services you enjoy. These entities are required to keep any PHI confidential and store it securely. As an example, we use Amazon Web Services (AWS) as a subcontractor business associate to help securely store and back up the data we collect.

De-identified and Aggregated Data

We may use and disclose your PHI in a de-identified and aggregated manner to conduct certain analytical research, for performance and/or outcomes tracking, for improving the Services, for marketing, and to assist in troubleshooting and technical support. In this case, all references that could be used to identify you would be removed from the data prior to use.

Research

We are allowed to use or share your PHI for health research as authorized by law. However, if this situation arises, Pelvital would not release information without de-identifying the data in advance.

As Required by Law

We may use or disclose your PHI if required by state or federal law.

Public Health and Safety

We may use and disclose your PHI to prevent or minimize a serious threat to your health and safety or that of another person. We may also disclose PHI to those assisting in disaster relief efforts, so that others can be notified about your condition, status and location.

Law Enforcement Activities

We may also provide PHI to law enforcement officials, for example, in response to a warrant, investigative demand or similar legal process, or for officials to identify or locate a suspect, fugitive, material witness, or missing person. We may also disclose PHI to appropriate agencies if we reasonably believe an individual to be a victim of abuse, neglect or domestic violence.

Legal Proceedings

We may disclose PHI to respond to a court or administrative order, or in response to a warrant, investigation demand or other legal process.

We may also use and disclose your PHI for other purposes as permitted by HIPAA.

State Law

Where state law is applicable and more restrictive of disclosure than federal law, we are required to follow the more restrictive state law.

Your Rights

As a user of Pelvital’s Services, you have rights with respect to your health information:

• Right to Inspect and Obtain a copy of PHI: You have a right to inspect and obtain a copy of your protected health information we maintain. We may charge you a reasonable, cost-based fee for the labor associated with compiling the copy.
• Right to Request Restrictions: You may request that we limit what information we use or share. We will notify you within 60 days whether we can agree to your request.
• Right to Request Alternative Means of Confidential Communication: You have the right to request that copies of your medical information be provided by alternative means.
• Right to Request Amendment: You have a right to request that we amend your protected health information that you think is incorrect or incomplete. We will notify you within 60 days whether we can agree to your request and/or to confirm completion of your request.
• Right to Receive an Accounting of Disclosures: You can ask for a list (accounting) of the times we’ve shared your health information for six years prior to the date you ask. The accounting will outline who we shared it with and why. We will include all the disclosures except for those about treatment, payment, and health care operations, and certain other disclosures (i.e. any you asked us to make). We’ll provide one accounting a year for free but may charge a reasonable, cost-based fee if you ask for another one within 12 months.
• Right to Obtain a Paper Copy of this Notice: You have the right to obtain a paper copy of this notice upon request at the address below.
• Right to File a Complaint: You may file a complaint with Pelvital if you believe your Privacy Rights have been violated. To file a complaint or ask any questions about this Notice of Privacy Practices, send an email to us at privacy@pelvital.com, or write to us at the following address: 860 Blue Gentian Rd. Suite 200, Eagan MN 55121.
• You also have the right to file a complaint with the Secretary of the U.S. Department of Health and Human Services, Office for Civil Rights. We will not retaliate against any individual for filing a complaint.

Our Responsibilities

• We are required by law to maintain the privacy and security of your protected health information.
• We will not use or disclose your PHI for marketing purposes or sell your PHI, unless you have agreed to this use or disclosure.
• We must follow the duties and privacy practices described in this notice and provide a copy of it.
• We will not use or share your information other than as described here unless you tell us in writing that we can. If you tell us we can, you may change your mind at any time. Let us know in writing if you change your mind.
• We will inform you, without unreasonable delay, if a breach occurs that may have compromised the privacy or security of your information and we may use or disclose your PHI to provide legally required notices of unauthorized access to or disclosure of your PHI.

Changes to the Terms of this Notice

From time to time, Pelvital may change this privacy statement, which is applicable to all PHI we maintain about you regardless of when such PHI was collected. For example, as we update and improve our Services, new features may require modifications to the privacy statement. The new notice will be posted and available on our website. As a result, please check back periodically.

Revised: November 28, 2023