Privacy Policy — iUFlow Voiding Diary App and Uroflow at Home

Last Revised: March 09, 2021

Introduction

Kesem Health Pty Ltd, also doing business as Kesem Health Corporation. (“us”, “we” or the “Company”) respect your privacy and are committed to protect the privacy of our users (“user” or “you”).

This Privacy Policy outlines our practices with respect to collecting, using and sharing your information through the use of our website (“Site”), mobile applications (“App”) , iUFlow Device (“Device”) and other services made available by us (collectively, the “Services”). Our Services are designed to give our users a complete solution for personal bladder management solution.

HIPAA Privacy Notice: We are committed to protect the privacy of our users’ personal health information. Part of that commitment is complying with the privacy and security rules of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), which requires us to take additional measures to maintain the privacy and security of our users’ protected health information (“PHI”) and to inform our users about those measures. We will let you know promptly if a breach occurs that may have compromised the privacy or security of your PHI. This Privacy Policy describes how we may use and share your PHI which is collected by our Site, App and by all of our Services and how our users can get access to this information. We must follow the duties and privacy practices described in this Privacy Policy and give you a copy of it. We will not use or share your PHI other than as described in this Privacy Policy, as amended and in effect from time to time, unless authorize us to do so in writing. For more information see www.hhs.gov/ocr/privacy/hipaa/understanding/consumers/noticepp.html.

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.

GDPR Privacy Notice: As part of our commitment to protect the confidentiality, data privacy and security of our users, we have drafted this Privacy Policy to comply with the requirements of the EU General Data Protection Regulation (“GDPR”), including providing the contact information of our Data Protection Officer and an explanation on our users’ rights regarding their personal information. However, depending on your region of residency, different regulations may apply, and we are committed to protect your privacy in accordance with such applicable regulations.

The Privacy Policy is a part of our Terms of Use and is incorporated therein by reference.

We encourage you to read the Privacy Policy carefully and use it to make informed decisions. By using our Services, you agree to the terms of this Privacy Policy and your continued use of the Services constitutes your ongoing agreement to this Privacy Policy.

In this Privacy Policy you will read about:

What types of information we collect and how we collect it
How we use Cookies
How we use the information we collect
With whom we share the information, and for what purpose
What rights users have with regard to their information
For how long we retain the information we collect
How do we safeguard your information
How we use the information for marketing purposes
How to contact us

What type of information we collect

We collect two types of data and information from our users.

The first type of information is un-identified and non-identifiable information pertaining to a user(s), which may be made available or gathered via the user’s use of the Services (“Non-personal Information”). We are not aware of the identity of the user from which the Non-personal Information was collected. Non-personal Information which is being collected may include your aggregated usage information and technical information transmitted by your device, including certain software and hardware information (e.g. the type of browser and operating system your device uses, language preference, access time and the domain name of the website from which you linked to the Services; etc.), in order to enhance the functionality of our Services.

The second type of information is individually identifiable information, namely information that identifies an individual or may with reasonable effort identify an individual (“Personal Information”). This includes:

Registration information: In order to use our Services, you will be required to register to the Services. As part of the registration process, we may collect your full name, gender, e-mail address and birth date.

When you register to our Services with your social network account (e.g. Facebook account) we may have access to basic information about you from such account, such as your name, email address, photo, as well as any other information you made publicly available on such account or agreed to share with us. At all times, we will abide by the terms, conditions and restrictions of such social network.

Financial information: In order to make purchases through our Site and carry out transactions, you may be required to share with us relevant payment information, including your PayPal account, Credit card number, etc.
Health information: As part of the registration process, you will be required to share with us your Lower Urinary Tract Symptoms (LUTS). Additionally, as part of our Services, you may provide us with additional sensitive Personal Information which is related to your health. Such information may include LUTS (i.e. urge levels), medicines (e.g. Desmopressin), nutrition, liquid input events (drinking), weight, sleep times, as well as exercise activity and motion (e.g. steps, cardio activity). You may manually upload your health information to our Site or App, or allow us to collect such information automatically by performing synchronization to the results of our “iUFlow Device”. Some of this information may constitute PHI under HIPAA. We will take all necessary steps to protect your PHI as required under HIPAA.
Voluntary information: We also collect information which you provide us voluntarily. For example, when you respond to communications from us, contact our support, communicate with us via email or the Services or share additional information about yourself or about others through your use of the Services.
Device Information: We may also collect Personal Information from your device (e.g. geolocation data, IP address) and information on your activity on the Services (e.g. pages viewed, online browsing, clicks, actions, etc.).
Third parties’ SDKs: Within our App, we may use Software Development Kits (SDK) provided by third parties. If you grant us your explicit consent to such use and integration (through the App), we may gather additional Personal Information about your activities, location and behavior, such as Wi-Fi, Bluetooth, accelerometer, gyroscope, GPS, etc. For additional information about SDKs we advise you to visit the third parties’ website(s) to learn more.

By providing sensitive Personal Information to us (including health information and PHI), you explicitly consent to the collection, use and sharing of your sensitive Personal Information in accordance with this Privacy Policy.

If we combine Personal Information with Non-personal Information, the combined information will be treated as Personal Information for as long as it remains combined.

We may anonymize, aggregate or de-identify the information collected by the Services or via other means so that the information cannot, on its own, personally identify you. Our use and sharing of such aggregated or de-identified information is not subject to any restrictions under this Privacy Policy, and we may share it with others without limitation and for any purpose. Generally, however, we and third parties may share aggregated or de-identified information with third parties (whether by sale or free of charge) for research and statistical analysis. Unless we de-identify PHI in accordance with HIPAA requirements, it will continue to be PHI subject to HIPAA’s privacy and security requirements, as described in this Privacy Policy.

You may refuse to disclose certain information, but please bear in mind this may result in preventing you from using the Site and Services to some extent, and in some cases may result in your inability to use the Site and Services.

Cookies

A cookie is a small data file that is sent to your device when you first visit a website. Cookies usually include an identification number that is unique to the device you are using. Such identifier can help us better understand our users and how they are using the Site and the Services. Cookies also enable recognition of a user when they re-visit the Site, keeping their settings and preferences and ability to offer customized features.

The Services may implement the following types of cookies: (i) cookies implemented by us for the purposes described above (“First Party Cookie”); and (ii) third party cookies which are set by other online services who run content on the page you are viewing, for example by third party analytics companies who monitor and analyze our web access or online advertisers on our Services. Ads appearing on our Site and/or through the Services may be delivered to users by advertising partners, who may set cookies. These cookies allow the ad server to recognize your computer each time they send you an online advertisement to compile information about you or others who use your computer. Among other things, this information allows ad networks to deliver targeted advertisements that they believe will be of most interest to you. This Privacy Policy covers the use of cookies by us alone, and does not cover the use of cookies by any advertisers.

You may remove the cookies by following the instructions of your device preferences; however, if you choose to disable cookies, some features of our Services may not operate properly and your online experience may be limited.

We may from time to time contract with third parties for the purpose of analyzing user’s data, optimizing the Services and communications, etc. To do this, we may use web beacons, pixels etc. provided by such third parties. The information collected will also allow us to learn how to improve the Services for the benefit of our users.

How we use the information we collect

We use and share Personal Information, including PHI, in the manners described in this Privacy Policy. In addition to the purposes listed above, the Personal Information we collect is used for the following purposes:

To set up your account and to provide our Services;
To optimize the Site, our Services and your experience;
To allow you to obtain relevant information about your health and provide the tools to manage it;
To personalize our recommendations for better management of your urological conditions, nutrition, medicines, etc.;
To send you reminders based on your location and activity (including through SDKs);
To allow you to make purchases through the Services and carry out transactions which you request;
To identify and authenticate your access to certain features of the Services;
To communicate with you in order to keep you informed of our latest updates and features;
To perform research or to conduct analytics in order to improve and customize our Services to our users’ needs and interests;
To market our products and services to you (to the extent permitted under HIPAA);
To detect and prevent illegal activity or any other type of activity that may jeopardize or negatively affect the integrity of the Services;
To support and troubleshoot our Services, to respond to your queries and communicate with you;
To comply with our obligations under HIPAA;
To investigate violations and enforce our policies, and as required by law, regulation or other governmental authority, or to comply with a subpoena or similar legal process or respond to a government request; and
To transfer or share, against payment or free of charge, aggregated information, un-identifiable Personal Information and/or anonymized information to or with third parties for their legitimate purposes.

If you are a registered user on our Services and have supplied your email address or phone number, we may occasionally send you an e-mail or contact you via your phone number, including by SMS, telephone call or push notifications in order to provide you the Service (for example, for the purpose of sending you a verification code to confirm user login, tracking info on shipping a package, and a link to download the App). You hereby consent and authorize us to contact you in accordance with the above.

Notwithstanding any of the above, with respect to PHI, we might use or share PHI for research and improvement purposes. This includes providing our Services, allowing you to obtain relevant information about your health and providing tools to manage it, personalizing our recommendations for better management of your LUTS, nutrition, medicines, etc. (including through our community learning tools, etc.) or sending you reminders based on your location and activity (including through SDKs). We may also use or share your PHI to run our organization. This includes setting up your account, identifying and authenticating your access to certain features of the Services, communicating with you in order to keep you informed of our latest updates and features and performing research or conducting analytics in order to improve and customize our Services to our users’ needs and interests. We can also use and share your PHI to bill for your services.

With whom we share the information we collect

We do not rent, sell or share your Personal Information with third parties except as described in this Privacy Policy.

We may transfer or share Personal Information, including PHI, to our subsidiaries, affiliated companies, subcontractors, SDKs or such other trusted third parties and/or service providers or partners who are located in different jurisdictions across the world for the purpose of: (a) storing or processing such information on our behalf (e.g. on cloud computing services) or to assist us with our business operations, to authenticate your access and to provide and improve our Services; (b) performing research, technical diagnostics, analytics, research or statistical purposes; or (c) marketing, in accordance with our marketing policy and (with respect to PHI) to the extent you have given us written permission and in accordance with HIPAA.

In addition, under your specific acknowledgment and consent, we may share your Personal Information and PHI with third party service providers in the healthcare ecosystem, such as hospitals, physicians, insurance companies, coaching services providers and others to allow them to obtain a holistic view of your needs and interests. Please note that under such consent, we may disclose to third party service providers in the healthcare ecosystem all relevant Personal Information and PHI that you share with us on an ongoing basis through the Services.

Please note: When we share information with third parties, such information is either anonymized or encrypted (as required by applicable laws) in order to effectively protect personal and/or health related information of users. To the extent PHI is shared with third parties, the third parties must first agree to be bound by HIPAA privacy and security protections.

We may also share Personal Information, including PHI, or any information you submitted via the Services if we have a good faith belief that the sharing of such information is helpful or reasonably necessary to: (i) comply with any applicable law, regulation, legal process or governmental request; (ii) enforce our policies (including our Agreement), including investigations of potential violations thereof; (iii) investigate, detect, prevent, or take action regarding illegal activities or other wrongdoing, suspected fraud or security issues; (iv) establish or exercise our rights to defend against legal claims; (v) prevent harm to the rights, property or safety of us, our users, yourself or any third party; or (vi) collaborate with law enforcement agencies or in case we find it necessary in order to enforce intellectual property or other legal rights.

With respect to PHI, you have both the right and choice to tell us to share information with your family, close friends or others involved in your care and to share information in a disaster relief situation. If you are unable to tell us your preference (for example, if you are unconscious), we may go ahead and share your PHI if we believe it is in your best interest. We may also share your PHI when needed to lessen a serious and imminent threat to health or safety. We will never share your PHI for marketing purposes or sell your PHI, unless you give us written permission.

We are allowed or required to share your PHI in other ways that contribute to the public good (such as public health and research), provided we meet many conditions under HIPAA before doing so. These disclosures include those that help with public health and safety issues (such as preventing disease, helping with recalls, reporting adverse reactions, suspected abuse, neglect or domestic violence or preventing or reducing a serious threat to anyone‘s health or safety). We can also share your PHI for health research or if state or federal laws require it, to respond to court or administrative orders or to address workers’ compensation, law enforcement and other government requests.

Information shared through HealthKit

You may instruct us to share information (including Personal Information and PHI) with systems such as Apple Inc.’s HealthKit and to access and collect information from those systems, for the purpose of improving the Services which we provide to you. If you grant our App access to HealthKit, our App can add information such as bladder activity measures and drinking events, amongst other data, to HealthKit. Kesem is in no way responsible for the protection of data and information stored within the Apple HealthKit database. It is strongly recommended that you review Apple’s applicable policies and procedures before synching and backup your Apple HealthKit data (e.g. Apple’s privacy policy can be found here). You can remove this access at any time either from our App or from the Apple Health app.

We do not use or share with third parties any information gained through the use of the HealthKit for advertising or similar services, other than for purposes of improving health or for purposes of health or medical research and, with respect to PHI, only to the extent permitted under HIPAA.

We do not share any of your information with any third party without your express permission (other than in anonymized and/or aggregated format), and in the case of information gained through HealthKit, such sharing will only be for purposes of enabling the third party to provide health services or for medical research and, with respect to PHI, only to the extent permitted under HIPAA.

Third party collection of information

Our policy only addresses the use and sharing of information we collect from you. To the extent that you share your information with other parties via our Services (e.g. by clicking on a link to any other website or location) or via other sites throughout the internet, different rules may apply to their use or sharing of the information that you disclose to them. You agree that we shall have no liability whatsoever with respect to such third party sites and services and your usage of them.

Users’ rights

HIPAA:

We respect your privacy rights and strive to comply in all aspects with HIPAA. For example, you have the right under HIPAA to inspect or get copies of your PHI contained in a designated record set. Generally, a “designated record set” contains medical records we may have about you. Therefore you may contact us at any time and request the following:

You can ask us to access, delete, change or update PHI relating to you (for example, if you believe that your PHI is incorrect, you may ask to have it corrected or deleted). We may say “no” to your request, but we will tell you why within 60 days.
You can ask us to contact you in a specific way or to send mail or email to a different address. We will approve all reasonable requests.
You can ask to inspect or copy your PHI in electronic or paper form. We will provide a copy or summary of your PHI, usually within 30 days of your request. We may charge a reasonable fee for the information.
You can ask that we cease any further use or sharing of your PHI for treatment, payment or our operations. We are not required to agree to your request and we may not agree if it would affect your care.
If you pay for a service or health care item out-of-pocket in full, you can ask us not to share that information for purpose of payment or our operations with your health insurer or group health plan. We will agree unless a law requires us to share that information.
You may request a list (accounting) of disclosures of your PHI, including list of the times we have shared your PHI for six years prior to the date you ask, who we shared it with, and why. We reserve the right to charge a reasonable, cost-based fee if you ask for another list within 12 months of such request. We will include all disclosures except those about treatment, payment and health care operations, and certain other disclosures (such as those you asked us to make).
You can ask for a paper copy of this notice at any time, and will provide it to you promptly.

If you have given someone a medical power of attorney or if someone is your legal guardian, that person can exercise your rights and make choices about your PHI. We will make sure the person has this authority and can act for you before we take any action.

For EEA users:

If you are a resident of the European Union, Switzerland, Lichtenstein, Norway or Iceland, please note that you have the right to: (1) receive confirmation as to whether or not Personal Information concerning you is being processed, and access your stored Personal Information, together with supplementary information; (2) receive a copy of Personal Information you directly volunteer to us in a structured, commonly used and machine-readable format; (3) request rectification of your Personal Information that is in our control; (4) request erasure of your Personal Information; (5) object to the processing of Personal Information by us; (6) request to restrict processing of your Personal Information by us; or (7) lodge a complaint with a supervisory authority.

Complaints:

If you wish to exercise any of the abovementioned rights or raise a complaint on how we have handled your Personal Information or PHI, please contact us directly at [email protected].

If you are not satisfied with our response or believe we are collecting or processing your Personal Information not in accordance with the laws, you can complain to the applicable data protection authority. In addition, if you believe your privacy rights with respect to PHI have been violated, or if you are dissatisfied with our privacy practices or procedures regarding your PHI, you may file a complaint with the U.S. Department of Health and Human Services by sending a letter to U.S. Department of Health and Human Services Office for Civil Rights, 200 Independence Avenue, S.W., Washington, D.C. 20201, calling 1-877-696-6775 or visiting www.hhs.gov/ocr/privacy/hipaa/complaints/.We will not retaliate against you for filing a complaint.

Retention

We will retain your personal information for the duration required to provide our Services, and as necessary to comply with our legal obligations, resolve disputes and enforce our policies. Retention periods will be determined taking into account the type of information that is collected and the purpose for which it is collected, bearing in mind the requirements applicable to the situation and the need to destroy outdated, unused information at the earliest reasonable time. Under applicable regulations, we will keep records containing client personal data, account opening documents, communications and anything else as required by applicable laws and regulations.

We may rectify, replenish or remove incomplete or inaccurate information, at any time and at our own discretion.

How do we safeguard and transfer your information?

We take great care in implementing and maintaining the security of the Services and your information in accordance with the requirements of all applicable laws (including with requirements under HIPAA). We employ industry standard procedures and policies to ensure the safety of our users’ information, and prevent unauthorized use of any such information. Although we take reasonable steps to safeguard information, we cannot be responsible for the acts of those who gain unauthorized access or abuse our Services, and we make no warranty, express, implied or otherwise, that we will prevent such access.

As an additional safeguard to your information, the Company employs a Data Protection Officer (“DPO”). The DPO has the power to insist on company resources for information protection matters and has a deep knowledge of information protection regulations and privacy law requirements. The DPO’s responsibility includes, among other things: providing privacy and security compliance advice, notifying users and applicable authorities of any data breach incident as required by law, conducting awareness and training programs, etc. The DPO serves as our HIPAA privacy official.

Since we operate globally, it may be required to transfer your Personal Information to countries outside the European Union. The data protection and other laws of these countries may not be as comprehensive as those in the European Union − in these instances we will take steps to ensure that a similar level of protection is given to your Personal Information. You hereby consent to transfer of your Personal Information to countries outside the European Union.

If you feel that your privacy was treated not in accordance with our policy, or if any person attempted to abuse our Services or acted in an inappropriate manner, please contact us directly at [email protected]

Affiliates and corporate transaction

We may share your information, including your Personal Information and PHI, with any subsidiaries, joint ventures, or other companies under our common control (collectively, “Affiliated Companies”). We may share Information, including Personal Information and PHI, in the event of a corporate transaction (e.g. sale of a substantial part of our business, merger, consolidation or asset sale). In the event of the above, our Affiliated Companies or acquiring company will assume the rights and obligations as described in this Privacy Policy and, with respect to PHI, under HIPAA.

Minors

The Services are not designed for the use of any children under 16 years of age. If you have reason to believe that a child under the age of 16 has provided Personal Information to us through the use of any of the Services without the consent of their parent or legal guardian, you should immediately contact us and we will endeavor to delete that information from our records.

Additionally, no information should be submitted to or posted to any of the Services by users under 18 years of age without the consent of their parent or legal guardian. We encourage parents and legal guardians to monitor their children’s Internet usage and to help enforce our Privacy Policy by instructing their children to never provide Personal Information and PHI on any of the Services without their permission.

Marketing

We may use your Personal Information, such as your email address and mobile phone number, ourselves or by using our third party subcontractors for the purpose of providing you with promotional material, which we believe may interest you. If we or our third party subcontractors wish to use PHI for marketing purposes, we will request that you provide a written authorization for us to do so. You hereby consent and authorize us to contact you in accordance with the above.

Out of respect to your right to privacy, at any time, you may request to unsubscribe and discontinue receiving marketing offers by contacting us by email or by using the unsubscribe link provided within any such communication.

If you unsubscribe we will remove your email address and phone number from our marketing distribution list. Please note that even if you unsubscribe from our marketing mailing list, we may continue to send you Service-related updates and notifications.

California “Do Not Track” Disclosure

In case you are using our Services in the state of California, United States we inform you that we do not respond to Do Not Track requests or signals at this time in accordance with the California Online Privacy Protection Act (“CalOPPA”) Amendment of 2013.

Updates or amendments to the Privacy Policy

We may revise this Privacy Policy from time to time, in our sole discretion, and the most current version will always be posted on our Site (as reflected in the “Last Revised” heading). Any changes will apply to all information we have about you and will be available upon request and on our Site. We encourage you to review this Privacy Policy regularly for any changes. In case of material changes we may notify you through our Services or by email. Should you object to any such modifications, you must cease using our Site and Services and request that we delete your account. Your continued use of the Services, following the notification of such amendments on our Site or the App, constitutes your acknowledgement and consent of such amendments to the Privacy Policy and your agreement to be bound by the terms of such amendments.

How to contact us

If you have any general questions about the Services or the information that we collect about you and how we use it, please contact us.

The iUFlow™ – Home Bladder Monitoring Solution. Including a home Uroflow and a connected App.

The iUFlow is a connected health solution providing accurate and objective monitoring of Lower Urinary Tract Symptoms. The iUFlow allows patients to capture voiding frequency, volume & flowrate, at home & then send a clinical report to their physician.

Kesem Health Pty Ltd Quality Policy Statement:
Achieve customer satisfaction for KH’s iUFlow uroflowmetry products, via establishment, implementation and maintenance of an effective and efficient quality management system that consistently complies with the applicable requirements