(xiii) Hospital confinement or other supplemental
limited benefit insurance coverage.
(xiv) Automobile medical payment insurance.
"Institution." A hospital or organization that is involved
in administering clinical trials.
"Institutional review board." A board, committee or other
group that is:
(1) formally designated by an institution to approve the
initiation of and to conduct periodic review of biomedical
research involving human subjects and in which the primary
purpose of the review is to assure the protection of the
rights and welfare of the human subjects and not to review a
clinical trial for scientific merit; and
(2) approved by the National Institutes of Health Office
for Protection from Research Risks.
"Multiple project assurance contract." A contract between an
institution and the United States Department of Health and Human
Services that defines the relationship of the institution to the
United States Department of Health and Human Services and that
sets out the responsibilities of the institution and the
procedures that will be used by the institution to protect human
subjects.
"Patient." The subscriber, insured or enrollee or the
covered dependent of the subscriber, insured or enrollee.
"Routine care costs." Physician fees, laboratory expenses
and expenses associated with the hospitalization, administering
of treatment and evaluation of the patient during the course of
treatment that:
(1) are consistent with usual and customary patterns and
standards of care incurred whenever an enrollee, subscriber
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