; and (vi) has a relationship with the covered entity such that the covered entity creates and maintains auditable health care records which demonstrate that— (I) the covered entity has a provider-to-patient relationship with the individual; and (II) responsibility for the individual’s health care service that resulted in the prescription or order for the drug described in clause (iii) is with the covered entity. (B) Exclusions For purposes of this section, an individual shall not be considered a patient of a covered entity described in subparagraph (L) or (M) of subsection (a)(4) if— (i) the individual is an inmate of a correctional facility; (ii) the health care service described in clause (ii) of subparagraph (A) received by the individual from the covered entity consists only of the administration or infusion of a drug or drugs, or the dispensing of a drug or drugs for subsequent self-administration or administration in the home setting, without a covered entity provider-to-patient encounter; (iii) the health care service described in clause (ii) of subparagraph (A) received by the individual from the covered entity is provided by a health care organization that has only an affiliation arrangement with the covered entity, even if the covered entity has access to the affiliated organization’s records