Privacy Notice

Notice of Privacy Practices

ActagenCT, Inc., PBC (“ActagenCT,” “we,” “us,” or “our”) is committed to protecting the privacy and security of your personal information, including your protected health information (PHI) as defined under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and its implementing regulations.

Information We Collect

In the course of providing clinical research services, we may collect and maintain the following types of information:

• Name, date of birth, contact information, and demographic details
• Medical history, diagnoses, medications, and treatment records
• Clinical trial data, including lab results, imaging, and study assessments
• Insurance and billing information, if applicable
• Information provided through our website contact forms

How We Use Your Information

We use your information for the following purposes:

• Treatment: To provide, coordinate, and manage your participation in clinical research studies
• Research: To conduct clinical trials in accordance with FDA regulations, institutional review board (IRB) approvals, and informed consent
• Operations: To support our business functions, including quality assurance, auditing, and compliance
• Communication: To contact you regarding trial participation, appointments, and relevant research opportunities
• Legal Obligations: To comply with applicable federal and state laws, including FDA reporting requirements and adverse event reporting

Your Rights

Under HIPAA and applicable California law, you have the right to:

• Request access to your protected health information
• Request corrections to inaccurate or incomplete records
• Request restrictions on certain uses and disclosures of your PHI
• Request confidential communications (e.g., contact at an alternative address)
• Receive an accounting of disclosures of your PHI
• Receive a paper copy of this notice upon request
• Withdraw from a clinical study at any time without penalty

Information Security

We implement administrative, physical, and technical safeguards to protect your personal and health information. These include encrypted data storage, role-based access controls, secure document management systems, and staff training on HIPAA compliance. All clinical research data is maintained in accordance with FDA 21 CFR Part 11 requirements for electronic records.

Disclosures

We may disclose your information in the following circumstances:

• As required by law or regulation
• To the FDA, IRBs, Data Safety Monitoring Boards, or study sponsors as part of clinical trial oversight
• For public health activities, including adverse event reporting
• To avert a serious threat to health or safety
• For specialized government functions, including military and veterans’ activities

All other uses and disclosures of your PHI require your written authorization. You may revoke any authorization at any time by submitting a written request to our Privacy Officer.

Website Privacy

When you visit our website or submit a contact form:

• We collect only the information you voluntarily provide (name, email, phone, message content)
• We do not sell, rent, or share your personal information with third parties for marketing purposes
• We may use analytics tools to understand website usage patterns; these tools do not collect personally identifiable health information
• Contact form submissions are transmitted securely and stored in encrypted systems

Changes to This Notice

We reserve the right to change the terms of this notice at any time. Any revised notice will be posted on our website and will apply to all information we maintain. The effective date of the most recent revision will be noted at the top of the notice.

Contact Us

If you have questions about this privacy notice, wish to exercise your rights, or would like to report a concern, please contact us at: