Health Insurance Portability and Accountability Act (HIPAA)
HIPAA Administrative Simplification
Administrative Simplification provisions of the Health Insurance Portability and Accountability Act of 1996 (HIPAA, Title II) addresses the security and privacy of health data. This Privacy Rule establishes, for the first time, a foundation of Federal protections for the privacy of protected health information. The Privacy Rule permits research physicians and investigators to use or disclose protected health information for research purposes when a research participant authorizes the use or disclosure of information about him or herself. To use or disclose protected health information with authorization by the research participant, the investigator must obtain an authorization that satisfies the requirements of 45 CFR 164.508. The Privacy Rule has a general set of authorization requirements that apply to all uses and disclosures, including those for research purposes. The Privacy Rule also specifies circumstances wherein an IRB may review and approve an investigator's request for a waiver of subject's authorization. The recommended approach is to obtain permission from the human subject for the use and disclosure of private health information. This can be included as a component in the written Informed Consent Document or a separate Patient Authorization sheet. Specifically, the document should have authorization language for release of private health information and signature block for the subject.