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HIPAA Privacy Regulations Exempt Donation Agencies

The latest regulations regarding privacy of medical records and other health information, known collectively as HIPAA, do not affect the release of such documents to tissue and organ donation agencies. On Dec. 28, 2000, the Department of Health and Human Services (DHHS) published in the Federal Register a final rule creating new federal privacy rights for personal health information. These “Standards for Privacy of Individually Identifiable Health Information” are intended to ensure patients that the privacy of their medical records is secure, and that the information is used appropriately.

The regulation specifically exempts tissue, eye and organ donation agencies because they are not considered “health care providers” within the meaning of the regulation. In the description of the rules provisions, DHHS notes that the proposed definition of “health care” was changed in the final regulation to: “… care, services or supplies related to the health of an individual…. Therefore the procurement or banking of organ, blood (including autologus blood), sperm, eyes or any other tissue or human product is not considered to be health care under this rule and the organizations that perform such activities would not be considered health care providers when conducting these functions. As described in 164.512 (h), covered entities are permitted to disclose protected health information without individual authorization, consent, or agreement…as necessary to facilitate cadaveric donation.” (65 Federal Register 82477)

All information provided to the donation agencies is confidential. In addition, consent for release of medical information is included in the Consent for Organ and Tissue Donation, the informed consent document families sign when their loved one becomes a donor. For more information regarding the regulations, you may consult the following Web sites http://www.hhs.gov/ocr, http://aspe.hhs.gov/admnsimp/index.htm. or contact the Northwest Tissue Services at 1 (800) 858-2282.

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