Privacy & HIPAA Notice

Smart Medical Research ("we," "our," or "us") is committed to protecting the privacy and security of your personal health information (PHI). This Privacy & HIPAA Notice describes how we may use and disclose your health information in accordance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and its implementing regulations.

By participating in our clinical trials or receiving services from Smart Medical Research, you acknowledge that we may collect, use, and disclose your health information as described in this notice.

We may collect the following types of protected health information:

• Demographic information (name, date of birth, address, contact details)
• Medical history and current health conditions
• Laboratory results and diagnostic test results
• Clinical trial participation records and study data
• Medication and treatment information
• Insurance and billing information
• Emergency contact information

We may use and disclose your protected health information for the following purposes:

• Treatment: To provide, coordinate, and manage your medical care and clinical trial participation.
• Payment: To bill and receive payment for services rendered, as applicable.
• Healthcare Operations: For quality assessment, compliance, and operational improvement activities.
• Research: To conduct, monitor, and report on clinical trials and medical research studies.
• As Required by Law: When disclosure is mandated by federal, state, or local law.
• Public Health: To public health authorities for disease control, reporting, and prevention purposes.
• Regulatory Authorities: To the FDA, IRBs, and other regulatory bodies overseeing clinical research.

Under HIPAA, you have the following rights regarding your protected health information:

• Right to Access: You may request to inspect and obtain copies of your health records.
• Right to Amend: You may request corrections to inaccurate or incomplete health information.
• Right to an Accounting of Disclosures: You may request a list of certain disclosures we have made of your health information.
• Right to Request Restrictions: You may request restrictions on certain uses and disclosures of your information.
• Right to Confidential Communications: You may request that we communicate with you in a specific manner or location.
• Right to a Paper Copy of This Notice: You may request a printed copy of this notice at any time.

We implement comprehensive administrative, physical, and technical safeguards to protect your protected health information against unauthorized access, use, disclosure, or destruction. These safeguards include:

• Encrypted storage and transmission of electronic health records
• Access controls and authentication requirements for all systems containing PHI
• Regular security risk assessments and audits
• Staff training on HIPAA compliance and privacy practices
• Physical security measures at our research facilities
• Signed Business Associate Agreements (BAAs) with all third-party service providers who handle PHI

When you participate in a clinical trial at Smart Medical Research, your health information is collected, used, and disclosed for research purposes as described in the study's Informed Consent Form (ICF). Key aspects of research privacy include:

• Your data is de-identified or coded wherever possible to protect your identity.
• Study sponsors, monitors, and regulatory agencies may access your records to verify study data and ensure participant safety.
• Your identity will not be disclosed in any published research results.
• You may withdraw from a clinical trial at any time without affecting your right to standard medical care.
• All research activities are reviewed and approved by an Institutional Review Board (IRB).

In the event of a breach of unsecured protected health information, we will notify affected individuals in accordance with HIPAA breach notification requirements. Notifications will be provided without unreasonable delay and no later than 60 days following the discovery of the breach. The notification will include a description of what happened, the types of information involved, steps you can take to protect yourself, and what we are doing in response to the breach.

We reserve the right to update or change this Privacy & HIPAA Notice at any time. Any revised notice will be effective immediately upon posting on our website and will apply to all protected health information we maintain. We will update the "Last Updated" date at the top of this notice to reflect the date of the most recent revision. We encourage you to review this notice periodically to stay informed about how we protect your health information.

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. We will not retaliate against you for filing a complaint.

To file a complaint or for more information about our privacy practices, please contact us: