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An individual's right to receive an accounting of disclosures (unless an exception applies) starts with the covered entity's compliance date and goes back 6 years from the date of the request, not including periods prior to the compliance date. A covered entity must therefore keep records of such PHI disclosures for 6 years.
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With few exceptions, the Privacy Rule guarantees individuals access to their medical records and other types of health information to the extent the information is maintained by the covered entity or its business associate within a designated record set. Research records maintained by a covered entity may be part of a designated record set if, for example, the records are medically related or are used to make decisions about research participants.
In addition to establishing conditions for the use and disclosure of PHI, the Privacy Rule establishes certain rights of individuals with respect to their health information. Covered entities must provide individuals with written notice of the entity's privacy practices and the individual's privacy rights. In addition, the Rule permits individuals to gain access to, request amendment of, request restrictions on, and request confidential communication of certain records related to their health care. Individuals are also given the right to request and receive a written account from a covered entity of when and why their PHI has been disclosed without their Authorization, except under limited circumstances. Individuals also have the right to complain to the covered entity and to the Secretary of Health and Human Services if they believe a violation of the Privacy Rule has occurred. This document discusses an individual's rights to access PHI and receive an accounting of PHI disclosures.
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An Authorization for research uses and disclosures need not have a fixed expiration date or state a specific expiration event; the form can list "none" or "the end of the research project." However, although an Authorization for research uses and disclosure need not expire, a research subject has the right to revoke, in writing, his/her Authorization at any time. The individual's revocation is effective, except to the extent that the covered entity has taken action in reliance upon the Authorization prior to revocation. For example, a covered entity is not required to retrieve information that it disclosed under a valid Authorization before learning of the revocation. And the preamble to the Privacy Rule states that, for research uses and disclosures, the reliance exception would permit the continued use and disclosure of PHI already obtained with an Authorization to the extent necessary to protect the integrity of the research—for example, to account for a subject's withdrawal from the research study, to conduct investigations of scientific misconduct, or to report adverse events.
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NOTE: If an Authorization permits disclosure of the individual's PHI to a person or organization that is not a covered entity or a business associate acting on behalf of a covered entity (such as a sponsor or funding source of the research), the Privacy Rule does not continue to protect the PHI disclosed to such entity. However, other applicable Federal and State laws between the disclosing covered entity and the PHI recipient may establish continuing protections for the disclosed information. Under the HHS Protection of Human Subjects Regulations or the FDA Protection of Human Subjects Regulations, an IRB may impose further restrictions on the use or disclosure of research information to protect subjects.
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The Privacy Rule does not specify who may draft the Authorization, so a researcher could draft it regardless of whether the researcher is a covered entity. However, in order to have a Privacy Rule-compliant Authorization, it must be written in plain language and contain the core elements and required statements, and a signed copy must be provided to the individual signing it if the covered entity itself is seeking the Authorization. The companion piece contains language that illustrates the inclusion of core elements and required statements.
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A valid Privacy Rule Authorization is an individual's signed permission that allows a covered entity to use or disclose the individual's PHI for the purposes, and to the recipient or recipients, as stated in the Authorization. When an Authorization is obtained for research purposes, the Privacy Rule requires that it pertain only to a specific research study, not to nonspecific research or to future, unspecified projects. The Privacy Rule considers the creation and maintenance of a research repository or database as a specific research activity, but the subsequent use or disclosure by a covered entity of information from the database for a specific research study will require separate Authorization unless the PHI use or disclosure is permitted without Authorization (discussed later in this section). If an Authorization for research is obtained, the actual uses and disclosures made must be consistent with what is stated in the Authorization. The signed Authorization must be retained by the covered entity for 6 years from the date of creation or the date it was last in effect, whichever is later.