another person otherwise authorized by the laws of this
Commonwealth to order the test.
(2) The testing is performed by the clinical laboratory.
(3) The clinical laboratory is a covered entity or a
business associate of a covered entity for the purpose of
compliance with Health Insurance Portability and Accountability
Act of 1996 (Public Law 104-191, 110 Stat. 1936) and the Health
Information Technology for Economic and Clinical Health Act
(Public Law 111-5, 123 Stat. 226-279 and 467-496).
(4) The clinical laboratory does not make a claim about the
reliability and validity of the testing that is inconsistent
with the testing proficiency standards under section 353 of the
Public Health Service Act.
(b) The department may prohibit the use of a clinical
laboratory's advertisement or solicitation of business for
diagnostic laboratory testing or ancestry testing under
subsection (a) or impose a penalty authorized under section
14(b) if the department determines any of the following:
(1) The diagnostic laboratory testing or ancestry testing
poses a public threat.
(2) The diagnostic laboratory testing or ancestry testing is
not in compliance with this section.
(c) As used in this section, the following words and phrases
shall have the meanings given to them in this subsection unless
the context clearly indicates otherwise:
"Ancestry testing." Y-chromosome mitochondrial DNA or
autosomal DNA testing for the detection and reporting of genetic
evidence of parental lineage and generic ethnicity.
"Business associate." As defined in 45 CFR § 160.103
(relating to definitions).
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