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HIPAA Compliance and Privacy Statement
HIPAA Statement

As a manager of clinical study data for the CONTESSA clinical study for our client, Odonate Therapeutics, Inc. (“Odonate”), Lippe Taylor, Inc. (“Lippe Taylor”) understands the need to treat patient information in a manner that protects the privacy and security of protected health information (“PHI”). Because your privacy is important to us, we will safeguard your personal information and ensure that it is used only for the purposes you intend.

  1. In order to protect PHI, Lippe Taylor does not use, access or disclose PHI unless it is necessary to provide services to its client in a manner consistent with its contractual commitments or as required or allowed by law. However, your data will not be shared with the clinical study sponsor, Odonate.
  2. Lippe Taylor has adopted corporate policies that protect the privacy and security of PHI. These policies detail the appropriate access, handling and security measures that Lippe Taylor has set for the protection of collected and stored PHI when delivering services to its clients.
  3. Lippe Taylor has implemented reasonable and appropriate safeguards intended to maintain the security and integrity of electronic PHI under its control via its third-party data management partners. These safeguards at a minimum meet the required implementation specifications contained in the HIPAA (Health Insurance Portability and Accountability Act of 1996) Security Rule.
  4. Lippe Taylor (via its third-party data management partners) encrypts PHI when possible in those circumstances where such encryption will not materially affect the performance or use of its services.
  5. Lippe Taylor requires all subcontractors that may access PHI to provide written assurances that they will handle PHI in compliance with the HIPAA requirements applicable to subcontractors.
  6. Lippe Taylor does not sell PHI to outside parties.
  7. Lippe Taylor has established processes to identify and respond to potential security incidents affecting PHI.

Lippe Taylor is committed to maintaining its compliance with HIPAA and will adjust the policies and procedures listed above as laws affecting PHI evolve.

Privacy Policy


This Privacy Policy describes the ways in which Lippe Taylor, Inc. (together with its affiliates, “we” or “Lippe Taylor”) collects, holds and uses information about individual persons who visit and use this website. BY USING THIS WEBSITE, YOU CONSENT TO THE COLLECTION AND USE OF INFORMATION AS SET FORTH IN THIS PRIVACY POLICY, AND YOU AGREE TO THIS WEBSITE’S TERMS OF USE AVAILABLE AT www.CONTESSASTUDY.com

Via this website and any devices that you permit, we may collect, hold and use two forms of personal data:

  • Personal Identifiable Information is information that can be traced back to an individual, including your name, birth date, e-mail address, telephone number, address and/or any other information that is linked to this identifying information. Personal Identifiable Information (“PII”) may be collected via a clinical study survey in order for our client to determine if there are clinical studies or health information that may be of interest to you.
  • Personal Health Information is a combination of your PII and your known health characteristics and includes “protected health information,” as defined under the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”). For example, if you indicated that you have a certain disease or condition, when that information is combined with your name, it becomes Personal Health Information (“PHI”).

Your privacy will be protected, and the PHI you voluntarily provide will only be shared with those involved with the clinical study if it is determined that you may be eligible to participate (except as required by law or unless you specifically permit us to do otherwise). Your PII and PHI will not be shared with the study sponsor. Only the minimal amount of information necessary will be collected and only after you accept this Privacy Policy (with acceptance as described in the Website Terms of Use that can be obtained at www.CONTESSASTUDY.com).

The personal information that may be collected includes, but is not limited to, your first and last name, email address, telephone number, address, birth date, gender and health information.

We will use the PII and PHI that you provide to determine if you may be eligible for study participation. You are responsible for ensuring the accuracy of the PII and PHI that you submit to Lippe Taylor. Inaccurate information will affect our ability to properly determine if you may qualify to participate in a study. While you may view some of our study website without providing PII or PHI, you will need to provide this information to determine if you may be eligible to participate in the study.

Our Use and Disclosure of Personal Data

We use and disclose PII and PHI obtained from users in the following ways:

  • Communication with Regard to Study Referral Pre-qualification and/or Other Study-related Purposes: PII and PHI will be used by third parties to follow-up with the clinical study site about your pre-qualification for, and participation in, the study.
  • Agents and Service Providers: We sometimes employ other companies and individuals to perform functions on our behalf. They may need access to your PII and PHI to perform their functions. With respect to those companies and individuals with whom we share your PII and PHI, we use reasonable efforts to ensure that those companies and individuals adhere to this Privacy Policy or privacy practices similar to those indicated in this Privacy Policy.

We may be required to disclose PII and PHI to comply with a law or regulation, in response to a search warrant, subpoena, court order or other valid legal process, or in response to lawful requests by public authorities, including to meet national security or law enforcement requirements. In the event that we are legally compelled to disclose your PII or PHI to a third party, we will take reasonable steps under the particular circumstances to notify you, unless doing so would violate the law or be inconsistent with our legal obligations.

We may also disclose PII or PHI to third parties in any of the following circumstances: (a) to enforce or protect our legal rights or the rights of users of our website; (b) to protect the security or integrity of our website; (c) to take precautions against liability; (d) if Lippe Taylor undergoes any change in control, including by means of merger, acquisition or purchase of all or substantially all of its assets; (e) to detect, prevent or otherwise address fraud; (f) pursuant to your explicit approval; or (g) during emergencies if physical safety is believed to be at risk.

We will not use or disclose PII or PHI of users of our clinical study website for any purpose other than those described in this Privacy Policy or to comply with our legal obligations, without your written authorization. If these uses change at any time, we will update this Privacy Policy on our website. If you do authorize us to use or disclose your PII or PHI for another purpose, you may revoke your authorization in writing at any time.

Your Personal Health Information Rights

Right to Request Special Privacy Protections. You have the right to request restrictions on certain uses and disclosures of your PHI by a written request specifying what information you want to limit, and what limitations on our use or disclosure of that information you wish to have imposed. We reserve the right to accept or reject any other request, and we will notify you of our decision.

Right to Request Confidential Communications. You have the right to request that you receive your health information in a specific way or at a specific location. For example, you may ask that we send information to a particular e-mail account or to your work address. We will comply with all reasonable requests submitted in writing that specify how or where you wish to receive these communications.

Right to Inspect and Copy. You have the right to inspect and copy your health information, with limited exceptions. To access your medical information, you must submit a written request detailing what information you want access to, whether you want to inspect it or get a copy of it and, if you want a copy, your preferred form and format. We will provide copies in your requested form and format if it is readily producible, or we will provide you with an alternative format you find acceptable, or, if we cannot agree and we maintain the record in an electronic format, your choice of a readable electronic or hardcopy format. We will also send a copy to any other person you designate in writing. We will charge a reasonable fee that covers our costs for labor, supplies, postage and, if requested and agreed to in advance, the cost of preparing an explanation or summary. We may deny your request under limited circumstances.

Right to Amend or Supplement. You have a right to request that we amend your health information that you believe is incorrect or incomplete. You must make a request to amend in writing and include the reasons you believe the information is inaccurate or incomplete. We are not required to change your health information and will provide you with information about our denial and how you can disagree with the denial. We may deny your request if we do not have the information, if we did not create the information (unless the person or entity that created the information is no longer available to make the amendment), if you would not be permitted to inspect or copy the information at issue or if the information is accurate and complete as is. If we deny your request, you may submit a written statement of your disagreement with that decision, and we may, in turn, prepare a written rebuttal. All information related to any request to amend will be maintained and disclosed in conjunction with any subsequent disclosure of the disputed information.

Right to an Accounting of Disclosures. You have a right to receive an accounting of disclosures of your health information made by us, except that we do not have to account for the disclosures provided to you or pursuant to your written authorization, or disclosures for purposes of research or public health that exclude direct patient identifiers or are incident to a use or disclosure otherwise permitted or authorized by law, or the disclosures to a health oversight agency or law enforcement official to the extent we have received notice from that agency or official that providing this accounting would be reasonably likely to impede their activities.

Right to a Paper or Electronic Copy of this Policy. You have a right to notice of our legal duties and privacy practices with respect to your health information, including a right to a paper copy of this Privacy Policy, even if you have previously requested its receipt by e-mail.

If you would like to exercise one or more of these rights, please email the Global Privacy Office at GlobalPrivacyOffice@lippetaylor.com. If you contact us, please note the name of the website where you provided the information, as well as the specific information you would like us to correct, update or delete, plus a proper identification of you.

Security and Confidentiality

To ensure the security and confidentiality of personal data that we collect online, we use data networks protected by, among other methods, industry-standard firewall and password protection. In the course of handling your PII and PHI, we take measures reasonably designed to protect that information from loss, misuse, unauthorized access, disclosure, alteration or destruction. We will retain PII and PHI for as long as we are required to do so by law, or for as long as necessary for the purposes for which it was collected; we will delete and/or destroy such information thereafter.

“Cookies" and Internet Tags

We may collect and process information about your visit to this website, such as the pages you visit, the website and/or advertisements you came from and some of the searches you perform. Such information is used by us to help improve the contents of the website and to compile aggregate statistics about individuals using our website for internal, market research purposes. In doing this, we may install "cookies" that collect your domain name, your internet service provider, your operating system and the date and time of access. A "cookie" is a small piece of information that is sent to your browser and stored on your computer’s hard drive. Cookies do not damage your computer. You can set your browser to notify you when you receive a "cookie;" this will enable you to decide if you want to accept it or not. If you do not accept cookies, you may not be able to use all functionality of your browser software. We may obtain the services of outside parties to assist us in collecting and processing the information described in this section. If you would like more information about website tags and cookies or to opt-out of third-party collection of this information, please visit the Network Advertising Initiative website at http://www.networkadvertising.org.

Links to Other Sites

This Privacy Policy applies only to this website and any of Lippe Taylor’s other websites. This Privacy Policy does not apply to websites owned by third parties. We may provide links to other websites that we believe may be of interest to our visitors. We aim to ensure that such websites are of the highest standard. However, due to the nature of the internet, we cannot guarantee the privacy standards of websites to which we link or be responsible for the contents of websites other than this one, and this Privacy Policy does not apply to any linked, non-Lippe Taylor website. In addition, it is your responsibility to ensure that the device you use is adequately secured and protected against malicious software and computer viruses. And, as noted above, there is always some risk that an unauthorized party could violate our security systems or that transmissions of your information over the internet could be intercepted.

Changes to this Privacy Policy

We reserve the right to amend this Privacy Policy at any time in the future. Until such amendment is made, we are required by law to comply with the terms of this Privacy Policy currently in effect. After an amendment is made, the revised Privacy Policy will apply to all protected health information that we maintain, regardless of when it was created or received. If you live in a country outside the United States, we will comply with applicable legal requirements to provide adequate protection of your PII and PHI, as well as the transfer of your information to recipients.

Requests for Information or Complaints

If you have questions or concerns about this Privacy Policy, or if you would like any further information, please email us at GlobalPrivacyOffice@lippetaylor.com or call us at + 212-598-4400. You can also write us at:
Lippe Taylor, Inc.
Global Privacy Office
215 Park Avenue South, 16th Floor
New York, NY 10003

If you are not satisfied with the manner in which we handle a complaint, you may submit a formal complaint to the U.S. Department of Health & Human Services Office for Civil Rights. The complaint form may be found at https://ocrportal.hhs.gov/ocr/smartscreen/main.jsf

You will not be penalized in any way for filing a complaint.

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