HIPAA Privacy Regulations: Uses and Disclosures for Which an Authorization or Opportunity to Agree or Object is Not Required: Cadaveric Organ, Eye or Tissue Donation Purposes - § 164.512(h)
As Contained in the HHS HIPAA Privacy Rules
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HHS Regulations |
Standard: uses and disclosures for cadaveric organ, eye or tissue donation purposes. A covered entity may use or disclose protected health information to organ procurement organizations or other entities engaged in the procurement, banking, or transplantation of cadaveric organs, eyes, or tissue for the purpose of facilitating organ, eye or tissue donation and transplantation.
| HHS Description Uses and Disclosures for Which an Authorization or Opportunity to Agree or Object is Not Required: Uses and Disclosures for Cadaveric Organ, Eye or Tissue Donation Purposes |
In the NPRM we proposed to include the procurement or banking of blood, sperm, organs, or any other tissue for administration to patients in the definition of “health care” (described in proposed § 160.103). The NPRM's proposed approach did not differentiate between situations in which the donor was competent to consent to the donation – for example, when an individual is donating blood, sperm, a kidney, or a liver or lung lobe – and situations in which the donor was deceased, for example, when cadaveric organs and tissues were being donated. We also proposed to allow use and disclosure of protected health information for treatment without consent.
In the final rule, we take a different approach. In § 164.512(h), we permit covered entities to disclose protected health information without individual authorization to organ procurement organizations or other entities engaged in the procurement, banking, or transplantation of cadaveric organs, eyes, or tissue for donation and transplantation. This provision is intended to address situations in which an individual has not previously indicated whether he or she seeks to donate organs, eyes, or tissues (and therefore authorized release of protected health information for this purpose). In such situations, this provision is intended to allow covered entities to initiate contact with organ and tissue donation and transplantation organizations to facilitate transplantation of cadaveric organs, eyes, and tissues.
| HHS Response to Comments Received Uses and Disclosures for Which an Authorization or Opportunity to Agree or Object is Not Required: Uses and Disclosures for Cadaveric Organ, Eye or Tissue Donation Purposes |
Comment: Commenters noted that under the organ donation system, information about a patient is disclosed before seeking consent for donation from families. These commenters offered suggestions for ensuring that the system could continue to operate without consent for information sharing with organ procurement organizations and tissue banks. Commenters suggested that organ and tissue procurement organizations should be “covered entities” or that the procurement of organs and tissues be included in the definition of health care operations or treatment, or in the definition of emergency circumstances.
Response: We agree that organ and tissue donation is a special situation due to the need to protect potential donors' families from the stress of considering whether their loved one should be a donor before a determination has been made that donation would be medically suitable. Rather than list the entities that are “covered entities” or modify the definitions of health care operations and treatment or emergency circumstances to explicitly include organ procurement organizations and tissue banks, we have modified § 164.512 to permit covered entities to use or disclose protected health information to organ procurement organizations or other entities engaged in the procurement, banking, or transplantation of cadaveric organs, eyes, or tissues.
Comment: Commenters asked that the rule clarify that organ procurement organizations are health care providers but not business partners of the hospitals.
Response: We agree that organ procurement organizations and tissue banks are generally not business associates of hospitals.