How does HIPAA apply to research involving blood or tissue samples?
Under HIPAA, neither blood nor tissue, in and of itself, is considered individually identifiable health information; therefore, research involving only the collection of blood or tissue would not be subject to HIPAAs requirements. Remember, however, blood and tissue are often labeled with information (e.g., admission date or medical record number) that HIPAA considers individually identifiable and thus, PHI. A covered entitys use or disclosure of this information for research is subject to HIPAA. In addition, the results from an analysis of blood and tissue, if containing or associated with individually identifiable information, would be PHI. 6. Q: What is the difference between a waiver of authorization and an altered authorization? A: A waiver of authorization refers to an IRB allowing the investigator to forgo obtaining permission from subjects to use their PHI for research purposes. An alteration of authorization refers to an IRB allowing the investigator to alter one of more of th
