search to be conducted by such department, pro-
gram, or administration, respectively, and the 
intended purpose of the research is related to a 
function committed to such department, pro-
gram, or administration by law that is not in-
vestigative in nature; or 
‘‘(E) an agent of the State agency or entity 
of another State that is responsible for the estab-
lishment and maintenance of that State’s con-
trolled substance monitoring program, who cer-
tifies that— 
‘‘(i) the State has an application ap-
proved under this section; and 
‘‘(ii) the requested information is for 
the purpose of implementing the State’s 
controlled substance monitoring program 
under this section. 
‘‘(2) DRUG
DIVERSION.—In consultation with 
practitioners, dispensers, and other relevant and in-
terested stakeholders, a State receiving a grant under 
subsection (a)— 
‘‘(A) shall establish a program to notify 
practitioners and dispensers of information that 
will help identify and prevent the unlawful di-
version or misuse of controlled substances; and
‘‘(B) may, to the extent permitted under 
State law, notify the appropriate authorities re-
sponsible for carrying out drug diversion inves-
tigations if the State determines that informa-
tion in the database maintained by the State 
under subsection (e) indicates an unlawful diver-
sion or abuse of a controlled substance. 
‘‘(g) LIMITATIONS.—In implementing or improving a 
controlled substance monitoring program under this section, 
a State— 
‘‘(1) shall limit the information provided pursu-
ant to a valid request under subsection (f)(1) to the 
minimum necessary to accomplish the intended pur-
pose of the request; and 
‘‘(2) shall limit information provided in response 
to a request under subsection (f)(1)(D) to nonidentifi-
able information. 
‘‘(h) ELECTRONIC
FORMAT.—The Secretary shall 
specify a uniform electronic format for the reporting, shar-
ing, and disclosure of information under this section. 
‘‘(i) RULES OF CONSTRUCTION.— 
‘‘(1) FUNCTIONS
OTHERWISE
AUTHORIZED
BY 
LAW.—Nothing in this section shall be construed to 
restrict the ability of any authority, including any 
local, State, or Federal law enforcement, narcotics
control, licensure, disciplinary, or program authority, 
to perform functions otherwise authorized by law. 
‘‘(2) NO PREEMPTION.—Nothing in this section 
shall be construed as preempting any State law, ex-
cept that no such law may relieve any person of a re-
quirement otherwise applicable under this Act. 
‘‘(3) ADDITIONAL PRIVACY PROTECTIONS.—Noth-
ing in this section shall be construed as preempting 
any State from imposing any additional privacy pro-
tections. 
‘‘(4) FEDERAL PRIVACY REQUIREMENTS.—Noth-
ing in this section shall be construed to supersede any 
Federal privacy or confidentiality requirement, in-
cluding the regulations promulgated under section 
264(c) of the Health Insurance Portability and Ac-
countability Act of 1996 (Public Law 104–191; 110 
Stat. 2033) and section 543 of the Public Health 
Service Act. 
‘‘(5) NO FEDERAL PRIVATE CAUSE OF ACTION.— 
Nothing in this section shall be construed to create a 
Federal private cause of action. 
‘‘(j) STUDIES AND REPORTS.— 
‘‘(1) IMPLEMENTATION REPORT.— 
‘‘(A) IN
GENERAL.—Not later than 180 
days after the date of enactment of this section,
the Secretary, based on a review of existing State 
controlled substance monitoring programs and 
other relevant information, shall determine 
whether the implementation of such programs 
has had a substantial negative impact on— 
‘‘(i) patient access to treatment, in-
cluding therapy for pain or controlled sub-
stance abuse; 
‘‘(ii) pediatric patient access to treat-
ment; or 
‘‘(iii) patient enrollment in research or 
clinical trials in which, following the pro-
tocol that has been approved by the relevant 
institutional review board for the research 
or clinical trial, the patient has obtained a 
controlled substance from either the sci-
entific investigator conducting such research 
or clinical trial or the agent thereof. 
‘‘(B) ADDITIONAL CATEGORIES OF EXCLU-
SION.—If the Secretary determines under sub-
paragraph (A) that a substantial negative im-
pact has been demonstrated with regard to one 
or more of the categories of patients described in 
such subparagraph, the Secretary shall identify 
additional appropriate categories of exclusion