Test Kit Privacy
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Test Kit Privacy
A. Summary
i. The Test Kit Privacy section specifically relates to the Privacy of any data acquired from your voluntary participation in Progene’s Test Kit program and as a donor, your contributed test samples. Other personal information you may provide is governed by the terms of our Privacy Statement (LINK TO PRIVACY STMT PAGE)
ii. Progene respects your privacy. Similar to our Website Privacy Statement, we do not sell, lease, or rent your individual-level Personal Information without explicit consent- this also applies to your contributed, donor test samples.
iii. We are committed to providing a secure, user-controlled environment for our Services.
iv. To help insure the privacy of your information, by default, Progene’s testosterone test kits are anonymous and only identifiable by the unique barcode provided with the test. For any subsequent information that you may volunteer or contribute as it relates to your test results, the following terms apply.
B. Definitions
i. "Progene" means Progene Healthcare, Inc., whose corporate mailing address at 1901 Dalton Ave. Cincinnati, OH 45214.
ii. "Progene Research" means research that Progene performs with the intent to publish findings. Progene Research only uses Self-Reported and Self-Contributed donor samples from volunteers.
C. Progene Respects Your Privacy
i. Progene recognizes the importance of privacy and respects your desire to store and access your information in a private and secure manner.
ii. This Privacy Statement is intended to make you aware of how we handle your Personal Information. We are committed to providing you a secure, user-controlled environment for the use of our Services. At the same time, you share responsibility for maintaining privacy and security - for example, by keeping your password secure.
iii. We encourage you to familiarize yourself with this Privacy Statement. Our Consent Form and Terms of Service explain that, by using our website and signing up for our service, you are allowing us to process your personal information according to the provisions set forth in those documents and this Privacy Statement.
D. Your Personal Information
In the course of your relationship with Progene, we collect several types of Personal Information. "Personal Information" is information that could be used to identify you, either alone or in combination with other information. We collect such information from you when you purchase our Products or Services, create a personal account, complete surveys and forms, and/or when you communicate with us or request information from us. Personal Information collected online can be combined with Personal Information collected offline. We collect 4 primary types of Personal Information through our Service and website.
- "Registration Information" is information that we collect from you when you purchase or sign up for our Services. Examples of such information include your name, credit card information, billing and shipping addresses, and contact information, such as email address and telephone number.
- "Sample Information" consists of the results from your Test. Sample Information is generated when you purchase Progene's Service and your saliva sample is analyzed and processed or you otherwise contribute or access your Sample Information through our Services. Our instructions for sample collection and shipment clearly require you to send only your saliva sample to our third-party laboratory labeled with the unique barcode and no other identifier. The unique barcode identifies you to us but not to the laboratory. We are also required to provide sex and date of birth or age to the laboratory pursuant to Clinical Laboratory Improvement Amendments (CLIA) requirements. No other Personal Information is required for the analysis. To protect your privacy, receiving personnel at the laboratory will remove and discard any identifying information (e.g. name, address) included with saliva samples before testing personnel receive the samples for testing. Receiving personnel do not perform testing, and testing personnel only handle samples labeled with the unique barcode. Saliva samples are destroyed after the laboratory completes its work, provided that laboratory legal and regulatory requirements no longer require the actual samples to be maintained. The laboratory securely sends the resulting Sample Information to us along with your unique barcode. Sample Information is stored securely on our servers. The laboratory conducting the analysis does not have access to your name, other Registration Information, or any other Personal Information except your sex and date of birth or age, as required by CLIA.
- "Self-Reported Information" includes information you provide to us, including but not limited to information about your lifestyle, health conditions (e.g. high blood pressure), other health-related information (e.g. pulse rate, cholesterol levels, visual acuity), ethnicity, and/or other qualitative personal observations about your body or experiences with Progene. We collect this information from you, if and when you enter the information into surveys, forms, or features while signed in to your account. Self-Reported Information is included in Progene Research only if you have given consent as described in the applicable Consent Document.
- "User Content" is all information other than Sample Information or Self-Reported Information generated by users of Progene Services and transmitted, whether publicly or privately, to Progene. User Content may include data, text, software, music, audio, photographs, graphics, video, messages, or other materials. For example, User Content includes posts made to the Progene community forums or emails to Customer Support. User Content does not include Sample Information or Self-Reported Information.
E. How We Use Personal Information
Progene collects Personal Information from you for all purposes necessary to ensure the regular operation of your account and/or availability of our Services. These include, among other things, providing you with our Services; improving our Services and/or offering new products or services to you; informing you about events; inviting you to participate in specific research projects, contacting you to obtain testimonials or for other promotional purposes; performing quality control activities; conducting other R&D; and, upon your authorization, conducting Progene Research. Below we will describe the additional ways in which we use subsets of Personal Information.
F. How We Use Registration Information
We use your Registration Information to authenticate your website visits and usage; to enable your purchase; to communicate with you about information, services, and products that you have requested; and to manage and improve our website, software, and Services. We give you the opportunity to opt out of optional communications, either through our Service or by contacting our Privacy Administrator at privacy@Progene.com.
G. How We Use Sample and Self-Reported Information
i. We use your Sample and Self-Reported Information to provide you with Progene Services, customize the user experience, and enhance our features. IF you allow sharing, Sample and Self-Reported Information may be displayed in other users' accounts. Self-Reported Information is used to customize your user experience - for example, by adjusting reports of Sample risk to account for your reported behaviors or environmental exposures.
ii. If, and only if, you have given consent to participate in Progene Research as described in the applicable Consent Document, we may include your Sample Information and Self-Reported Information in Aggregated Sample and Self-Reported Information disclosed to third parties for the purpose of publication in a peer-reviewed scientific journal. Progene Research is intended to advance knowledge surrounding testosterone performance and to create, commercialize, or undertake activities toward the practical applications of this learning to the improvement of our aging population. Towards the same goals, if you have given consent to participate in Progene Research, we may allow research contractors to access your individual-level Sample and/or Self-Reported Information onsite at Progene’s offices for the purpose of conducting scientific research, provided that all such research contractors will be supervised by Progene and subject to Progene’s access rules and guidelines.
iii. If you do not give your consent to participate in Progene Research, Progene may still use your Sample and Self-Reported Information for purposes such as quality control or other R&D activities. Sample and Self-Reported Information used for such purposes may be included in Aggregated Sample and Self-Reported Information disclosed to third-party research partners who will not publish the information in a peer-reviewed scientific journal. Research partners may include commercial or non-profit organizations that conduct or support scientific/medical research or conduct or support the development of drugs or devices to diagnose, predict, or treat health conditions.
H. How We Use User Content and Web Behavior Information
i. Progene uses User Content to provide our Services and improve the overall user experience. For example, posts made to the Progene community forums are publicly displayed to other users. By submitting, posting, or displaying User Content, you give Progene a non-exclusive license to use any User Content that you submit, post, or display on or through the Services, as further described in the Website Privacy, the Testimonial Terms & Conditions and the Website Terms of Use.
ii. Progene may make such User Content available to other companies, organizations, or individuals with whom Progene has relationships, and to use such User Content in connection with the provision of those services. Progene, in performing the required technical steps to provide the Services to our users, may also (a) transmit or distribute your User Content over various public networks and in various media; and (b) make such changes to your content as are necessary to conform and adapt that content to the technical requirements of connecting networks, devices, services, or media.
I. Information Sharing
i. Progene gives you the ability to connect with other individuals who have Progene accounts through our community forums, relative finding features, and other sharing features. For some features, opt-out is required to avoid notifications. In addition, you may choose to disclose, through other means not associated with Progene, any part of your Personal Information to friends and/or family members, groups of individuals, third-party service providers, doctors or other health care professionals, and/or other individuals. We recommend that you make such choices carefully.
ii. Personal Information, once released or shared, can be difficult to contain. Progene will have no responsibility or liability for any consequences that may result because you have released or shared Personal Information with a third party. Likewise, if you are reading this because you have access to the Personal Information of a Progene customer through a multi-profile account, we urge you to recognize your responsibility to protect the privacy of that person. It is incumbent upon customers to share Personal Information only with people they know and trust. Users with multi-profile accounts should use caution in setting profile-level privacy settings.
J. Ordering Progene Services as a Gift
If you provide us personal information about others, or if others give us your information for purposes of ordering the Test Kit Service as a gift, we will only use that information for the specific reason for which it was provided to us, provided that once a gift recipient registers for his or her Services and agrees to our Website Terms of Use, Privacy Statement, Test TOS and if applicable, Consent Form, his or her information will be used consistent with this Privacy Statement and those agreements.
K. Information Disclosure
We do not sell, lease, or rent your individual-level Personal Information without your explicit consent. As a general rule, Progene will not disclose your individual-level Personal Information to any third party, except under the following circumstances:
a) Partners or service providers (e.g. credit card processors or our contracted Sample Testing laboratory) process and/or store the information in order to provide you with Progene's Services.
b) If you have consented for research, research contractors may access your individual-level Sample and Self-Reported Information onsite at Progene's offices for the purpose of scientific research, provided that all such research contractors will be supervised by Progene and subject to Progene's access rules and guidelines.
p c) We are required to do so by law (see the section below titled "Information Disclosure Required By Law").
d) You have provided explicit consent for us to do so.
e) Progene may disclose Personal Information for the following reasons:
- Progene Research. Progene may disclose Aggregated Sample and Self-Reported Information intended to be published in a peer-reviewed scientific journal to research collaborators or as a result of publication. You may give/withhold consent for your data to be used in Progene Research when viewing the applicable Consent Document during the process of activating your test kit. You may also give consent or change your global consent status by notifying us directly in writing or via email and/or through your Account Settings at any subsequent time which will be effective thirty (30) days thereafter; however, we cannot withdraw information that has previously been used for published research or shared with external collaborators prior to your request to withdraw consent. Progene will not use your Sample Information in new research that starts thirty (30) days or more after your withdrawal of consent.
- Contact information. Progene will ask for and require your explicit consent to allow partner organizations direct access to your Registration Information.
- Commercial partnerships. Progene may enter into commercial arrangements to enable partners to provide our Service to their customers and/or to provide you access to their products and services. We will not provide any individual-level Personal Information to these commercial partners without your explicit consent. Progene may include your Sample and/or Self-Reported Information in Aggregated Sample and Self-Reported Information disclosed to these commercial partners even if you have not given consent for your data to be used in Progene Research.
- Information Disclosure Required By Law. Under certain circumstances Personal Information may be subject to disclosure pursuant to judicial or other government subpoenas, warrants, or orders. You acknowledge and agree that Progene is free to preserve and disclose any and all Personal Information to law enforcement agencies or others if required to do so by law or in the good faith belief that such preservation or disclosure is reasonably necessary to: (a) comply with legal process (such as a judicial proceeding, court order, or government inquiry) or obligations that Progene may owe pursuant to ethical and other professional rules, laws, and regulations; (b) enforce the Progene TOS; (c) respond to claims that any content violates the rights of third parties; or (d) protect the rights, property, or personal safety of Progene, its employees, its users, its clients, and the public. In such event we will notify you through the contact information you have provided to us in advance, unless doing so would violate the law or a court order.
- Linked Websites: Progene provides links to third-party websites operated by organizations not affiliated with Progene. Progene does not disclose your Personal Information to organizations operating linked third-party websites. Progene does not review or endorse, and is not responsible for, the privacy practices of these organizations. We encourage you to read the privacy statements of each and every website that you visit. This Privacy Statement applies solely to information collected by Progene.
- Customer Testimonials: We post customer testimonials on our web site, and may use testimonials in other formats consistent with consent received. Customer testimonials may contain personally identifiable information. We may use your Personal Information to contact you to obtain a testimonial and obtain your consent via email or agreement sent via fax, pdf or mail prior to using such testimonial and/or using your name along with your testimonial.
L. Account Closure and Correction of Personal Information:
i. If you no longer wish to participate in our Services, you may close your account by sending a request to Customer Support at customerservice@Progene.com. When closing an account, we remove all Sample Information within your account (or profile) within thirty (30) days of our receipt of your request. As stated in the applicable Consent Document, however, Sample Information and/or Self-Reported Information that you have previously provided and for which you have given consent to use in Progene Research will not be removed from ongoing or completed studies that use the information. Our contracted laboratory may also retain your Sample Information as required by local law and we may retain backup copies for a limited period of time pursuant to data protection policies. In addition, we retain limited Registration Information related to your order history (e.g., name, contact, and transaction data) for accounting and compliance purposes.
ii. If your Personal Information changes, you may correct or update your Registration Information via your Account Settings page. You may also correct or reset Self-Reported Information entered into a survey, form, or feature by emailing a request to Customer Support at customerservice@Progene.com and including the name of the specific survey, form, or feature.
M. Newsletter and Email Communications:
You may choose to stop or start receiving our newsletter or marketing emails by changing your notifications settings in your account (go to Account, Settings, Notifications) or you can contact us at privacy@Progene.com.
N. Children's Privacy
Progene is committed to protecting the privacy of children as well as adults. Neither Progene nor any of its Services are designed or intended for anyone under the age of 18.
O. Security
i. Progene takes seriously the trust you place in us. To prevent unauthorized access or disclosure, to maintain data accuracy, and to ensure the appropriate use of information, Progene uses a range of reasonable physical, technical, and administrative measures to safeguard your Personal Information, in accordance with current technological and industry standards. In particular, all connections to and from our website are encrypted using Secure Socket Layer (SSL) technology.
ii. Please recognize that protecting your Personal Information is also your responsibility. We ask you to be responsible for safeguarding your password, secret questions and answers, and other authentication information you use to access our Services. You should not disclose your authentication information to any third party and should immediately notify Progene of any unauthorized use of your password. Progene cannot secure Personal Information that you release on your own or that you request us to release. Finally, as you are also critical to your own data security, your use of any public wireless access or use of a virally infected machine may compromise your data security. Choosing to do so is at your own risk and may cause the release or disclosure of your information.
P. Business Transitions
In the event that Progene goes through a business transition such as a merger, acquisition by another company, or sale of all or a portion of its assets, your Personal Information will likely be among the assets transferred. In such a case, your information would remain subject to the promises made in any pre-existing Privacy Statement.
Q. Contact Information
i. If you have questions about this statement, please email Progene's Privacy Administrator at privacy@Progene.com. You can also contact us at this address if you have a question about Progene's handling of your information:
ii. Privacy Administrator, Progene: 544 W Liberty St Suite 200 Cincinnati, OH 45214.
HIPAA Notice of Privacy Practices for Personal Health Information
Effective Date: March 1, 2012
THIS NOTICE DESCRIBES HOW MEDICAL INFORMATION ABOUT YOU MAY BE USED AND DISCLOSED AND HOW YOU CAN ACCESS TO THIS INFORMATION.
PLEASE REVIEW IT CAREFULLY
Dear Progene Customer,
While all parties agree that the information collected for Test Kit purposes are not considered “Medical Specimen” nor are the procedures considered “Medical”, “Clinical” or for “Diagnostic Purposes” and that you are not participating as a “Patient” nor is there a “doctor-patient” relationship, we have an interest in ensuring compliance with laws that may or may not apply.
In addition to our:
- Privacy Statements (both for the website and for TestKits) as well as our
- TestKit Consent Form (as it relates to research and aggregated, non-individual data) along with our
- TestKit Terms of Service
Progene is interested in taking privacy and security precautions to protect your personal confidential information. As a result,by default, all tests are not personally identifiable and are anonymous with only a barcode ID associated with the test. Progene seeks compliance beyond what may be expected with Federal and State laws and related Rules and Regulations to protect your confidential personal health information ("PHI") as defined by the Health Insurance Portability and Accountability Act of 1996 ("HIPAA") and the American Recovery and Reinvestment Act of 2009 (the "Stimulus Package")- as it is understood today. In particular, because the Stimulus Package is new and untested, all resulting implications of such are not yet known. As a result, all parties recognize that changes may have to take place to comply.
In that same spirit, we want to provide you with this Notice of Privacy Practices to further explain our legal duties as it may apply under HIPAA.
Should the Sample Information we provide you from the participation in the Testosterone TestKit program be considered “Personal Health Information” (PHI) then by law, we are required to:
- Maintain the privacy of your Personal Health Information (PHI)
- Provide you this notice of our legal duties and privacy practices with respect to your PHI; and
- Follow the terms of this notice.
- Please note that the following are terms we abide by but we cannot control what you chose to do with your information any disclosure by you invalidates what may be considered PHI under HIPAA- including but not limited to your choice in posting results on our testimonials page.
How We Collect Information: We obtain most PHI directly from you, the “Individual”. The Information that an Individual gives us when registering for a services generally provides the information we need. An individual’s information is accessible only by the individual and some form of record is either retained in secure hard copy file or with a laboratory’s archival record for 3 years. Information collected may relate to an individual’s demographics, employment, health, avocations or other personal characteristics which may assist us in evaluating the individual’s status. In most cases we do not retain the dates and locations where service was provided or for that matter, any individually identifiable information as it may relate to PHI.
We will strive to protect your PHI from inappropriate use or disclosure. Our employees, and those of companies that help us service your tests, are required to comply with our requirements that protect the confidentiality of your PHI. They may look at your PHI (if any) only when you have given clear authorization or there is appropriate reason to do so, such as to administer the process of returning your health test results back to you.
We will not knowingly disclose or sell your PHI to any other individual or organization for their use in marketing products to your without your prior consent.
We will not forward by mail, fax or electronically your PHI to any healthcare provider without your prior written consent.
We will not make available your test results to your employer or 3rd party carrier without your prior written consent.
We May Use and Disclose PHI about You without Your Authorization unless you Object as described below, together with some examples.
- Appointments and Other Health Information. We may send you reminders for appointments or checkups. We may send you information about future health services that may be of interest to you as a health conscious individual. For example, we may make mailings to you as a prior customer
- Research: We may use PHI about you for studies and to develop reports. These reports do not identify specific people. For example, we may want to determine how many individuals of a sex in an age range from a defined population have a testosterone value over 200 pg/ml
- Future Business: PHI may be disclosed as part of a potential merger or acquisition involving our business in order to make an informed decision regarding any such prospective transaction. Should a merger or acquisition take place, our database of names and addresses may be part of the process.
- Where Required by Law or for Public Health Activities: We may disclose PHI when required by federal, state or local law. Examples of such mandatory disclosures include notifying state or local health authorities regarding particular communicable diseases, or providing PHI to a government agency or regulator with health care oversight responsibilities. We may also release PHI to a coroner or medical examiner to assist in identifying a diseased individual or to determine the cause of death.
- For Payment. We may use or disclose PHI about you to get payment or to pay for other services you receive. For example, we may provide PHI to bill your health plan for health care provided to you.
- To Avert a Serious Threat to Health or Safety: We may disclose PHI about you to law enforcement in order to avoid a serious threat to the health and safety of a person or the public.
- For Law Enforcement or Specific Government Functions: We may disclose PHI in response to a request by law enforcement official made through a court order, subpoena, warrant, summons or similar process. We may disclose PHI about you to federal officials for intelligence, counterintelligence, and other national security activities authorized by law.
- When Requested as Part of a Regulatory or Legal Proceeding: If you or your estate is involved in a lawsuit or a dispute, we may disclose PHI about you in response to a court or administrative order. We may also disclose PHI about you in response to a subpoena, discovery request, or other lawful process by someone else involved in the dispute, but only if efforts have been made to tell you about the request or to obtain an order protecting the PHI requested. We may also disclose PHI to any governmental agency or regulator with whom you have filed a complaint or as part of a regulatory agency examination.
- Other Uses of PHI: Other uses and disclosures of PHI not covered by this notice and permitted by the laws that apply to us will be made only with your written authorization or that of your legal representative. If we are authorized to use or disclose PHI about you, you or your legally authorized representative may revoke that authorization, in writing, at any time. We cannot take back any uses or disclosures already made with your authorization or those disclosed by you directly.
- Disclosure to Family, Friends, and Others. We may disclose PHI about you to your family or other persons who are involved in your medical care.
Your PHI Privacy Rights
- Right to See and Get Copies of Your PHI. In most cases, you have the right to look at or get copies of your PHI. You must make the request in writing and include dates and location(s) of service.. You may be charged a fee for the cost of copying and mailing the PHI to you.
- Right to Request to Correct or Update Your PHI. You may ask us to change or add missing PHI if you think there is a mistake. You must make the request in writing and provide a reason for your request. However, there are conditions under which we may deny this request.
- Right to Get a List of Disclosures. You have the right to ask us for a list of disclosures made after the effective date of this document listed above and up to two years prior to the date you made the request. You must make the request in writing.
- Right to Request Limits on Uses or Disclosures of Your PHI. You have the right to ask us to limit how PHI about you is used or disclosed. You must make the request in writing and tell us what PHI you want to limit and to whom you want the limits to apply. In your request, you must you must tell us (1) dates and location(s) of service (2) what information you want to limit; (3) whether you want to limit our use, disclosure , or both; and (4) to whom you want the limits to apply (for example , disclosure to your spouse or parent). To make a request, you must make your request in writing to Privacy Coordinator, Progene Healthcare, 544 W Liberty St Suite 200 Cincinnati, OH 45214. We will not agree to restrictions on PHI uses or disclosures that are legally required, or which are necessary to administer our business. While we will consider your request, we are not required to agree to it. If we do agree to it, we will comply with your request.
- Right to Revoke Permission. If you are asked to sign an authorization to use or disclose PHI about you, you can cancel that authorization at any time. You must make the request in writing. This will not affect PHI that has already been shared.
- Right To Choose How We Communicate With You. You have the right to ask us to share your PHI with you in a certain way or in a certain place. For example, you may ask us to send PHI about you to your work address instead of your home address. You must make this request in writing. You do not have to explain the basis for your request.
- Right to File a Complaint. You have the right to file a complaint if you do not agree with how we have used or disclosed PHI about you. All complaints must be submitted in writing. Your services will not be affected by any complaints you make. We cannot retaliate against you for filing a complaint or refusing to agree to something that you believe to be unlawful.
- Right to Get a Paper Copy of this Notice. You have the right to ask for a paper copy of this notice at any time.
ADDITIONAL INFORMATION
We reserve the right to change the terms of this Notice of Privacy Practices at any time. Any changes will apply to information we already have and any information we receive in the future. A copy of the new notice will be posted at www.Progene.com and provided to individuals upon request as required by law. You may request a copy of the current notice at anytime.