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

Covered entities may also use statistical methods to establish de-identification instead of removing all 18 identifiers. The covered entity may obtain certification by “a person with appropriate knowledge of and experience with generally accepted statistical and scientific principles and methods for rendering information not individually identifiable” that there is a “very small” risk that the information could be used by the recipient to identify the individual who is the subject of the information, alone or in combination with other reasonably available information. The person certifying statistical de-identification must document the methods used as well as the result of the analysis. | o EAL Protecting Personal Health Information in Research Understanding the HIPAA Privacy Rule and its companion documents explain the Privacy Rule in the research context. They are not intended to be legal doCuments and shOuld not be construed to be legal advice. The specific Privacy Rule requirements are contained in the relevant laws and regulations. Protecting Personal Health Information in Research Understanding the HIPAA Privacy Rule Preface 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 ofIndividually 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 ocr hipaa. The Department of Health and Human Services HHS issued the Privacy Rule HHS s OCR has been given the authority to implement and enforce it. To increase researchers understanding of the Privacy Rule OCR has developed guidance and technical assistance materials which can be found at the HIPAA Privacy Web site noted above. In working with OCR HHS s Office for Human Research Protections OHRP and HHS s research agencies .

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