Comment: A number of commenters asked that we include disease management activities and other similar health improvement programs, such as preventive medicine, health education services and maintenance, health and case management, and risk assessment, in the definition of "health care." Commenters maintained that the rule should avoid limiting technological advances and new health care trends intended to improve patient "health care."
Response: Review of these and other comments, and our fact-finding, indicate that there are multiple, different, understandings of the definition of these terms. Therefore, rather than create a blanket rule that includes such terms in or excludes such terms from the definition of "health care," we define health care based on the underlying activities that constitute health care. The activities described by these commenters are considered 'health care' under this rule to the extent that they meet this functional definition. Listing activities by label or title would create the risk that important activities would be left out and, given the lack of consensus on what these terms mean, could also create confusion.
Comment: Several commenters urged that the Department clarify that the activities necessary to procure and distribute eyes and eye tissue will not be hampered by the rule. Some of these commenters explicitly requested that we include "eyes and eye tissue" in the list of procurement biologicals as well as "eye procurement" in the definition of "health care." In addition, it was argued that "administration to patients" be excluded in the absence of a clear definition. Also, commenters recommended that the definition include other activities associated with the transplantation of organs, such as processing, screening, and distribution.
Response: We delete from the definition of "health care" activities related to the procurement or banking of blood, sperm, organs, or any other tissue for administration to patients. We do so because persons who make such donations are not seeking to be treated, diagnosed, or assessed or otherwise seeking health care for themselves, but are seeking to contribute to the health care of others. In addition, the nature of these activities entails a unique kind of information sharing and tracking necessary to safeguard the nation's organ and blood supply, and those seeking to donate are aware that this information sharing will occur. Consequently, such procurement or banking activities are not considered health care and the organizations that perform such activities are not considered health care providers for purposes of this rule.
With respect to disclosure of protected health information by covered entities to facilitate cadaveric organ and tissue donation, the final rule explicitly permits a covered entity to disclose protected health information without authorization, consent, or agreement 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 donation and transplantation. See § 164.512(h). We do not include blood or sperm banking in this provision because, for those activities, there is direct contact with the donor, and thus opportunity to obtain the individual's authorization.
Comment: A large number of commenters urged that the term "assessment" be included in the list of services in the definition, as "assessment" is used to determine the baseline health status of an individual. It was explained that assessments are conducted in the initial step of diagnosis and treatment of a patient. If assessment is not included in the list of services, they pointed out that the services provided by occupational health nurses and employee health information may not be covered.
Response: We agree and have added the term "assessment" to the definition to clarify that this activity is considered "health care" for the purposes of the rule.
Comment: One commenter asked that we revise the definition to explicitly exclude plasmapheresis from paragraph (3) of the definition. It was explained that plasmapheresis centers do not have direct access to health care recipients or their health information, and that the limited health information collected about plasma donors is not used to provide health care services as indicated by the definition of health care.
Response: We address the commenters' concerns by removing the provision related to procurement and banking of human products from the definition.