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‘‘(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 re-
sponse to a request under subsection (f)(1)(D) to 
nonidentifiable 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 
requirement otherwise applicable under this Act. 
‘‘(3) ADDITIONAL
PRIVACY
PROTECTIONS.—
Nothing in this section shall be construed as pre-
empting any State from imposing any additional pri-
vacy protections.
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‘‘(4) FEDERAL
PRIVACY
REQUIREMENTS.—
Nothing in this section shall be construed to super-
sede any Federal privacy or confidentiality require-
ment, including the regulations promulgated under 
section 264(c) of the Health Insurance Portability 
and Accountability 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
AC-
TION.—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
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‘‘(iii) patient enrollment in research or 
clinical trials in which, following the pro-
tocol that has been approved by the rel-
evant institutional review board for the re-
search or clinical trial, the patient has ob-
tained a controlled substance from either 
the scientific investigator conducting such 
research or clinical trial or the agent there-
of. 
‘‘(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 iden-
tify additional appropriate categories of exclu-
sion from reporting as authorized under sub-
section (d)(2)(C). 
‘‘(2) PROGRESS
REPORT.—Not later than 3 
years after the date on which funds are first appro-
priated under this section, the Secretary shall—
‘‘(A) complete a study that—
‘‘(i) determines the progress of States 
in establishing and implementing con-
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trolled substance monitoring programs 
under this section; 
‘‘(ii) provides an analysis of the extent 
to which the operation of controlled sub-
stance monitoring programs have reduced 
inappropriate use, abuse, or diversion of 
controlled substances or affected patient 
access to appropriate pain care in States 
operating such programs; 
‘‘(iii) determines the progress of 
States in achieving interoperability between 
controlled substance monitoring programs, 
including an assessment of technical and 
legal barriers to such activities and rec-
ommendations for addressing these bar-
riers; 
‘‘(iv) determines the feasibility of im-
plementing a real-time electronic controlled 
substance monitoring program, including 
the costs associated with establishing such 
a program; 
‘‘(v) provides an analysis of the pri-
vacy protections in place for the informa-
tion reported to the controlled substance 
monitoring program in each State receiv-