HIPAA Privacy Policy

Last Updated: 03/20/2025

Your Privacy Under HIPAA

Helios Clinical Research (“Helios,” “we,” “us,” or “our”) is committed to protecting the privacy and security of your protected health information (PHI) in accordance with the Health Insurance Portability and Accountability Act (HIPAA) and applicable state laws.

This HIPAA Privacy Policy explains how we collect, use, disclose, and protect your PHI when you participate in clinical research studies.

1. What is Protected Health Information (PHI)?

Under HIPAA, PHI includes any health-related information that can identify you, such as:

  • Name, address, phone number, email
  • Medical history, conditions, medications
  • Test results, lab reports, imaging
  • Health insurance details
  • Any other health-related data tied to your identity

2. How We Use & Disclose Your Health Information

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

A. Clinical Research & Healthcare Operations

✔ Determining your eligibility for clinical trials
✔ Conducting research activities and study coordination
✔ Reporting results to regulatory agencies (e.g., FDA, IRBs)
✔ Improving research processes and data security

B. Legal & Regulatory Compliance

✔ Complying with federal, state, and local laws
✔ Reporting adverse events or safety concerns to oversight bodies
✔ Responding to audits, inspections, or subpoenas

C. With Your Written Authorization

✔ Sharing PHI beyond research (e.g., with your doctor or other providers)
✔ Using your data for purposes not listed here (only with your consent)

🚨 We will NOT use or disclose your PHI for marketing, sales, or non-research purposes without your explicit written authorization.

3. Your HIPAA Privacy Rights

As a research participant, you have the right to:

✔ Access Your Records – Request copies of your health information.
✔ Request Corrections – Ask us to amend inaccurate PHI.
✔ Restrict Data Use – Request limits on how your PHI is used or shared.
✔ Receive an Accounting of Disclosures – Know who has accessed your PHI.
✔ File a Complaint – If you believe your rights have been violated, you can file a complaint with:
📌 Helios Clinical Research Privacy Officer at info@heliosclinical.com
📌 U.S. Department of Health & Human Services (HHS) at www.hhs.gov/ocr

4. How We Protect Your Information

🔒 Encryption: PHI is encrypted in transit and at rest.
🛡️ Access Controls: Only authorized research staff can access your data.
📜 Regulatory Compliance: We follow HIPAA, FDA, and state regulations.

We do not store or share PHI beyond the necessary study duration, unless legally required.

5. Changes to This HIPAA Privacy Policy

We may update this notice as needed to comply with regulatory changes. The latest version will always be available at www.heliosclinical.com