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HIPAA Forms
HIPAA and The Privacy Rule
The Health Insurance Portability and Accountability Act (HIPAA) was designed to improve the efficiency and effectiveness of the healthcare system. In response to the original HIPAA law, Health and Human Services (HHS) published an additional regulation referred to as the Privacy Rule that relates directly to organizations involved in healthcare operations that transmit health information electronically.
The Privacy Rule establishes Federal protections for the privacy of protected health information (PHI), which is defined as individually identifiable health information transmitted or maintained in any form or medium including paper records. Explicitly, PHI:
- Relates to the past, present or future physical or mental health condition.
- Relates to the provision of health care or the past, present, or future payment for the provision of health care.
- Identifies individual or could reasonably be used to identify individual.
AND - Has been transmitted or maintained in any form or medium (electronic, paper, oral).
Forms
Investigators who utilize PHI in their research may need to complete one or more of the following forms:
- Authorization to Use & Disclose Protected Health Information for Research Purposes (RTF) | (DOC)
- Waiver of Individual Authorization for Disclosure of Protected Health Information (RTF) | (DOC)
- Letter to Revoke Authorization (RTF) | (DOC)
- Data Use Agreement for Research 45 CFR 164.514(e) (RTF) | (DOC)
- Data Collection for Reviews Preparatory to Research 45 CFR 164.512 (RTF) | (DOC)
- HIPAA De-Identification Certification (RTF) | (DOC)
- HIPAA Disclosure Tracking Form (RTF) | (DOC)
- Research on Decedent's Information (RTF) | (DOC)
- HIPAA Consent Form Wording (RTF)
For additional information about protected health information , please see our Protected Health Information (HIPAA) and Pathways for Data Access pages.
Getting Started → Preparing a New eSubmission Application → The Review Process → Ongoing Actions Post Approval → Closing the Study
