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Health Insurance Portability and Accountability Act (HIPAA) and the Privacy Rule
The Health Insurance Portability and Accountability Act (HIPAA) and the Privacy Rule (45 CFR 160 and 45 CFR 164) will have a significant impact on the conduct and oversight of human subject research and Protected Healthcare Information (PHI).
The eMedicus Institutional Review Board will assist investigators in meeting the privacy requirements of the Health Insurance Portability and Accountability Act (HIPAA) and the Privacy Rule of 1996.
To ensure that investigators meet the requirements for research, which utilizes Protected Healthcare Information (PHI), the eMedicus Institutional Review Board will also function as a Privacy Board.
The HIPAA Privacy Rule covers any use or disclosure of protected health information by a covered entity, including the conduct of research, recruitment of research subjects and the review of medical records for research purposes.
The HIPAA Privacy Rule became effective on April 14, 2001 and was implemented on April 14, 2003.
HIPAA is "enforced" by the Office of Civil Rights, within the Department of Health and Human Services.
The eMedicus Institutional Review Board provides Sample HIPAA Forms that are downloadable for use by its customers.
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