A Standard Document for research subjects to authorize an organization conducting a clinical trial regulated by the Food and Drug Administration (FDA) to use and disclose protected health information (PHI) under the Health Insurance Portability and Accountability Act (HIPAA). HIPAA and its regulations protect patient information and privacy during research conducted by an organization that is a covered entity. HIPAA also covers health plans and clearinghouses as covered entities. Researchers often use a stand-alone HIPAA Authorization as shown in this form as an attachment to a subject's informed consent form. This Standard Document contains integrated notes with important explanations and drafting tips and is based on federal law with references to applicable state laws and regulations.