Do the HIPAA requirements allow for participants to request a copy of any structured interviews they completed/responded to as part of the study? What about the results of research laboratory tests?
Individuals have a right to a copy of their “designated record set”. This is defined as Designated record set means:(1) A group of records maintained by or for a covered entity that is:(i) The medical records and billing records about individuals maintained by or for a covered health care provider;(ii) The enrollment, payment, claims adjudication, and case or medical management record systems maintained by or for a health plan; or(iii) Used, in whole or in part, by or for the covered entity to make decisions about individuals(2) For purposes of this paragraph, the term record means any item, collection, or grouping of information that includes protected health information and is maintained, collected, used, or disseminated by or for a covered entity.We are taking the position that a research record is not part of the “designated record set” and that only information that is entered into an individual’s medical record during the course of the research would be part of the “designated re
