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What does the HIPAA Privacy Rule say about a research participants right of access to research records or results?

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What does the HIPAA Privacy Rule say about a research participants right of access to research records or results?

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With few exceptions, the Privacy Rule gives patients the right to inspect and obtain a copy of health information about themselves that is maintained by a covered entity or its business associate in a designated record set. A designated record set is basically a group of records which a covered entity uses to make decisions about individuals, and includes a health care providers medical records and billing records, and a health plans enrollment, payment, claims adjudication, and case or medical management record systems. While it may be unlikely that a researcher would be maintaining a designated record set, any research records or results that are actually maintained by the covered entity as part of a designated record set would be accessible to research participants unless one of the Privacy Rules permitted exceptions applies.

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