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.