April 17, 2003

Protecting Personal Health Information in Research: Understanding the HIPAA Privacy Rule

This booklet contains information about the "Privacy Rule," a Federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that protects certain health information. The Privacy Rule was issued to protect the privacy of health information that identifies individuals who are living or deceased.

The Rule balances an individual's interest in keeping his or her health information confidential with other social benefits, including health care research. This booklet provides researchers with a basic understanding of the Privacy Rule and how it may affect health research. It also addresses how researchers may be directly or indirectly affected by the Rule when their research requires the use of, or access to, an individual's identifiable health information. The Privacy Rule (also known as Standards for Privacy of Individually Identifiable Health Information) is in Title 45 of the Code of Federal Regulations, Part 160 and Subparts A and E of Part 164. The full text of the Privacy Rule can be found at the HIPAA Privacy Web site of the Office for Civil Rights (OCR): http://www.hhs.gov/ocr/hipaa.