FAQ 20111 Are tissue repositories covered entities?
This is a FAQ regarding tissue repositories.
Final
Issued by: Office for Civil Rights (OCR)
Are tissue repositories covered entities?
Answer:
Not unless the organization maintaining the tissue repository conducts some other activity that makes it a covered entity. For example, tissue repositories that conduct testing of specimens for the benefit of transplant recipients based on another health care provider's orders would be covered providers under HIPAA if they conduct electronic transactions for which the HHS has adopted standards.
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