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. Author manuscript; available in PMC: 2021 Jul 23.
Published in final edited form as: Fla Law Rev. 2019 Sep;71(5):1281–1345.

Table 2.

Parroted language in the CLIA research exception

Source Jurisdictional conditions: an act + scienter
CLIA Statute and Regulations
42 U.S.C. § 263a(a); 42 C.F.R. §§ 493.1, 493.2		 A facility triggers CLIA jurisdiction by:
 “providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings.”233
CLIA Research Exception
42 C.F.R. § 493.3(b)(2)		 A facility escapes CLIA jurisdiction if it:
 “do[es] not report patient specific results for the diagnosis, prevention or treatment of any disease or impairment of, or the assessment of the health of … individual patients.”234