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Research is defined in the Privacy Rule as, “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.” See 45 CFR 164.501.
What is HIPAA Waiver of Authorization. A legal document that allows an individual’s health information to be used or disclosed to a third party. The waiver is part of a series of patient-privacy measures set forth in the Health Insurance Portability and Accountability Act (HIPAA) of 1996.
The Privacy Rule allows three methods for accounting for research-related disclosures that are made without the individual’s Authorization or other than a limited data set: (1) A standard approach, (2) a multiple-disclosures approach, and (3) an alternative for disclosures involving 50 or more individuals.
Under HIPAA, PHI can be used and disclosed, without patient authorization, for essential healthcare operations, such as administrative, financial, legal, and quality improvement activities. Examples include: quality assessments for patient safety or general health/healthcare costs. in support of compliance.
Covered entities may disclose protected health information that they believe is necessary to prevent or lessen a serious and imminent threat to a person or the public, when such disclosure is made to someone they believe can prevent or lessen the threat (including the target of the threat).
The combination of two or more pieces of PHI can be more valuable than a single piece. The more PHI a criminal has access to, the more thorough the criminal can create a complete identity of a person. The criminal can sell this identity to multiple buyers. A cybercriminal can sell PHI on the dark web.
With limited exceptions, the HIPAA Privacy Rule (the Privacy Rule) provides individuals with a legal, enforceable right to see and receive copies upon request of the information in their medical and other health records maintained by their health care providers and health plans.
Examples of PHI Dates — Including birth, discharge, admittance, and death dates. Biometric identifiers — including finger and voice prints. Full face photographic images and any comparable images.