"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).
"Covered entity." As defined in 45 CFR § 160.103.
"Diagnostic laboratory testing." The term includes genetic
testing or procedures for the purpose of screening, diagnosing,
managing or treating a physical or mental condition or disease.
THE USE OF SPECIALIZED APPARATUS, EQUIPMENT AND METHODS, FOR THE
PURPOSE OF SCREENING AND OBTAINING DIAGNOSTIC INFORMATION FROM
ANY MATERIAL ORIGINATING FROM THE HUMAN BODY TO AID OR ASCERTAIN
A PERSON'S STATE OF HEALTH. THE TERM DOES NOT APPLY TO GERMLINE
GENETIC OR GENOMIC TESTING DONE IN CONNECTION WITH THE ANALYSIS,
DIAGNOSIS OR PREDICTION OF HUMAN DISEASES.
Section 2. Section 14(b) of the act is amended to read:
Section 14. Penalty.--* * *
(b) In addition to any other penalty that may be imposed by
the department, the department [may] shall assess a civil
penalty of up to [five hundred dollars ($500)] five thousand
dollars ($5,000) per day on a person or clinical laboratory that
engages in any of the following:
(1) Violates the provisions of this act or the department's
regulations.
(2) Operates a clinical laboratory within this Commonwealth
without a permit from the department.
(3) Performs testing without a permit from the department on
any specimen accepted or collected within this Commonwealth.
* * *
Section 2 3. All regulations and parts of regulations are
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