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Human Subjects Research - Institutional Review Boards - IRBs

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Health Insurance and Portability and Accountability Act

The Health Insurance and Portability and Accountability Act of 1996 (HIPAA) is federal legislation that has an impact on how we conduct research involving specific health information.


It is a broad federal law, only part of which is intended to protect the privacy of healthcare information. It is divided into three parts: portability, accountability, and administrative simplification. There are several sets of HIPAA regulations. The most important regulation under HIPAA for research are the privacy regulations, often referred to as the Privacy Rule. The intent of the Privacy Rule is to protect the private individual’s health care information. It defines the means by which individuals/human research subjects can be informed of how their health information will be used or disclosed and it gives individuals a number of rights with regard to their health information. This information is contained in what is referred to as a HIPAA authorization. The authorization must be signed by the subject prior to beginning research activities.

Fletcher Allen Health Care, as the covered entity, has developed a HIPAA authorization template. Use of the FAHC authorization template is mandatory.

Links to HIPAA Resources:
Local Guidance
• FAHC HIPAA policy
HIPAA Glossary
HIPAA Authorization Template
Frequently Asked Questions


Regulations
US Office for Civil Rights (OCR) HIPAA website
8/9/02 Final Rule (Full Regulation Text of Modified Final Rule)

Last modified December 13 2012 12:49 PM

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