Effective Date: April 7, 2026

HIPAA Disclosure

Envoy Clinical Research, LLC (“Envoy,” “we,” “our,” or “us”) is committed to protecting the privacy and security of health information. This HIPAA Disclosure explains how Envoy handles Protected Health Information (“PHI”) when performing services that fall under the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) and the Texas Medical Records Privacy Act (Texas Health & Safety Code §181).

Envoy Clinical Research is not a healthcare provider and does not collect PHI through this website. However, when we support clinical research sites, sponsors, or healthcare organizations, we may act as a Business Associate under HIPAA.

When HIPAA Applies

Envoy handles PHI only when:

• A clinical research sponsor, CRO, or healthcare provider shares PHI with us for study‑related services

• A Business Associate Agreement (BAA) is in place

• The PHI is necessary to perform contracted research, operational, or documentation services

Outside of these circumstances, Envoy does not access, store, or process PHI.

How Envoy Protects PHI

When acting as a Business Associate, Envoy:

• Uses and discloses PHI only as permitted by the BAA

• Implements administrative, technical, and physical safeguards

• Maintains HIPAA‑compliant workforce training

• Restricts access to authorized personnel only

• Encrypts PHI during transmission when required

• Reports any unauthorized use or disclosure as required by law

Envoy does not use PHI for marketing, data monetization, or any purpose not expressly permitted by the BAA or applicable law.

PHI and This Website

Any information submitted through contact forms (such as name, email, gender, address or phone number) is not considered PHI unless provided by a covered entity under a BAA.

Your Rights Under HIPAA

If Envoy receives PHI as part of contracted services, your rights regarding that information are governed by the covered entity (such as your healthcare provider or research site). Requests to access, amend, or restrict PHI must be directed to that organization.

Envoy will support the covered entity in fulfilling HIPAA‑related requests as required by law.

Questions About HIPAA or PHI

If you have questions about how Envoy handles PHI or wish to request a Business Associate Agreement, please contact:

Envoy Clinical Research, LLC 10601 Clarence Dr., Suite 250 Frisco, Texas 75033, US +1 (430) 373‑3541 info@envoyclinical.com

Legal Disclaimer: Envoy Clinical Research is required by law to maintain the privacy of your Protected Health Information (PHI) and to provide you with this notice of our legal duties and privacy practices with respect to PHI.

1. How We May Use and Disclose Your PHI

We may use and disclose your PHI for the following purposes:

• Treatment: To provide, coordinate, or manage your health care and related services. For example, we may share PHI with your primary care physician to coordinate your care.

• Payment: For billing and payment activities, such as submitting claims to insurance companies (though many trial-related costs are covered by the sponsor).

• Health Care Operations: For our day-to-day operations, such as quality assessment, training, and compliance reviews.

• Clinical Research: We may use and disclose your PHI for research purposes, such as determining your eligibility for a clinical trial. This will only be done with your written authorization or as permitted by law.

• As Required By Law: We will disclose PHI about you when required to do so by federal, state, or local law.

• To Avert a Serious Threat to Health or Safety: We may use and disclose PHI to prevent a serious threat to your health and safety or the health and safety of the public or another person.

2. Other Uses and Disclosures Require Your Authorization

All other uses and disclosures of your PHI not described in this notice will be made only with your written authorization. You may revoke this authorization at any time, in writing, except to the extent that we have already acted in reliance on it.

3. Your Rights Regarding Your PHI

You have the following rights with respect to your PHI:

• Right to Inspect and Copy: You have the right to inspect and receive a copy of your PHI that we maintain.

• Right to Amend: If you believe that your PHI is incorrect or incomplete, you may request that we amend the information.

• Right to an Accounting of Disclosures: You have the right to request a list of certain disclosures we have made of your PHI.

• Right to Request Restrictions: You have the right to request a restriction on how we use or disclose your PHI. We are not required to agree to all requests.

• Right to Request Confidential Communications: You have the right to request that we communicate with you about medical matters in a certain way or at a certain location.

• Right to a Paper Copy of This Notice: You have the right to receive a paper copy of this notice upon request, even if you have agreed to receive it electronically.

4. Breach Notification

We are required by law to notify you following a breach of your unsecured PHI. We will provide such notification in accordance with applicable federal and state law.

5. Complaint Procedures

If you believe your privacy rights have been violated, you may file a complaint with us or with the Secretary of the Department of Health and Human Services.

To file a complaint with us, please contact our Privacy Officer. You will not be penalized for filing a complaint.

6. Contact Information

For questions about this notice or to file a complaint, please contact our designated Privacy Officer:

Privacy Officer
Envoy Clinical Research
10601 Clarence Dr.
Ste 250
Frisco, TX 75033
+1 (430)- 373-3541
info@envoyclinical.com

7. Changes to This Notice

We reserve the right to change this notice and to make the revised or changed notice effective for PHI we already have as well as any information we receive in the future. We will post a copy of the current notice on our website.