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The Health Insurance Portability and Accountability Act (HIPAA) is a law that was passed in 1996, designed primarily to modernize the flow of health information.
HIPAA’s “Privacy Rule” sets standards for the use and disclosure of all individually identifiable health information obtained from a covered entity.
Some were concerned that HIPAA wouldn’t provide meaningful privacy protection.
Others worried that HIPAA would be redundant with state health privacy laws and would not add much value.
All forms of health information that are associated with any of the 18 identifiers specifically defined by HIPAA are considered to be protected health information (PHI) subject to HIPAA regulations.
To access this information, all research studies must either 1) obtain an individual’s HIPAA authorization (on the covered entity’s Authorization form) or 2) request a waiver of HIPAA authorization (through a protocol application in e Protocol).