What does the HIPAA Privacy Rule say about a research participants right of access to research records or results?
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. One of the permitted exceptions applies to protected health information created or obtained by a covered health care provider/researcher for a clinical trial
Related Questions
- What does the HIPAA Privacy Rule say about a research participant’s right of access to research records or results?
- What does the HIPAA Privacy Rule say about a research participants right of access to research records or results?
- What does the HIPAA Privacy Rule say about a research participants right of access to research records or results?