; and (B) include those associated with providing timely situational awareness and priority setting during the course of a threat to the public health (including natural or man-made disasters and deliberate attacks on the United States). (3) Exclusion An in vitro clinical test is not excluded from the provisions of this subchapter if such test is intended for use in making clinical decisions for individual patients. (j) Law enforcement or employer testing An in vitro clinical test that is intended solely for use in forensic analysis, law enforcement activity, or employment purposes is exempt from the requirements of this Act. An in vitro clinical test that is intended for use in making clinical decisions for individual patients, or whose individually identifiable results may be reported back to an individual patient or the patient’s health care provider, even if also intended for law enforcement or employment testing purposes, is not intended solely for use in law enforcement or employment testing for purposes of this subsection. (k) In vitro clinical tests under a technology certification order An in vitro clinical test that is within the scope of a technology certification order, as described in section 587D(a)(2), is exempt from premarket review under section 587B. (l) Modified tests (1) In general An in vitro clinical test that is modified, by the initial developer of the test or a different person, is a new in vitro clinical test subject to the requirements of this subchapter if the modification— (A) affects the analytical or clinical validity of such test; (B) causes the test to no longer comply with applicable mitigating measures under section 587E or restrictions under section 587N