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Human Subjects Division (HSD)

Questions and Answers

| Clear Filter: "PHI"
  • What are the requirements for authorization when researchers wish to access patient information?

    The HIPAA regulations use the term \"authorization\" to describe the process through which a patient allows researchers to access protected health information (PHI). The information must include:

    • a description of the information to be used for research purposes;
    • who may use or disclose the information;
    • who may receive the information;
    • purpose of the use or disclosure;
    • expiration date or event (if the information will be kept indefinitely, the authorization states that there is no expiration date);
    • individual\'s signature and date;
    • right to revoke authorization;
    • right to refuse to sign authorization (if this happens, the individual may be excluded from the research and any treatment associated with the research);
    • if relevant, that the research subject\'s access rights are to be suspended while the clinical trial is in progress, and that the right to access PHI will be reinstated at the conclusion of the clinical trial.

    Blanket authorizations for research to be conducted in the future are not permitted. Each new use requires a specific authorization.

  • What is HIPAA?

    HIPAA is an acronym for the Health Insurance Portability and Accountability Act, passed by Congress in 1996. The purpose of the Act was to increase the ease with which people could transfer their health care information from one insurer or provider to the next. Congress, as part of HIPAA, required the development of privacy regulations to protect the confidentiality of individually identifiable health care information. The final (HIPAA) privacy rule was issued on August 14, 2002. As of April 14, 2003, The University of Washington is in compliance with the Privacy Rule.

  • What is PHI?

    Protected Health Information is any information pertaining to:

    • the past, present, or future physical or mental health or condition of an individual;
    • the provision of health care to an individual; or
    • the past, present, or future payment for the provision of health care to an individual.

    PHI may be information that is recorded electronically, on paper, or orally. PHI may concern living people or dead people (referred to in the law as "decedents"). PHI does NOT include de-identified information or biological tissue with no accompanying information, such as an accession number or code number that may be linked to an identifier.

  • What kind of research and researchers are affected by the HIPAA regulations?

    Any kind of research conducted under the auspices of the UW and UW Medicine that creates or uses protected health information is subject to the HIPAA regulations. This includes such research activities as clinical trials, chart reviews, epidemiological studies, behavioral, and social science studies, as well as basic science research activities. It includes research that involves the provision of treatment as well as research that provides neither treatment nor diagnosis.

    All researchers, whether or not they are directly connected with UW Medicine, who wish to conduct research involving protected health information must complete HIPAA training before they will be allowed to have access to individually identifiable health information in any form.

  • Who is affected by HIPAA?

    All researchers (faculty, staff, or students) at the UW who access or create Protected Health Information (PHI) preceding or during the conduct of their research must comply with the HIPAA regulations.