SEC. 1121. Guidance
Document Regarding Production Using The Internet
Not later than 2 years
after the date of enactment of this Act, the Secretary of Health and Human
Services shall issue guidance that describes Food and Drug Administration
policy regarding the promotion, using the Internet (including social media), of
medical products that are regulated by such Administration.
SEC. 1122. COMBATING
PRESCRIPTION DRUG ABUSE.
(a) IN GENERAL.—To
combat the significant rise in prescription drug abuse and the consequences of
such abuse, the Secretary of Health and Human Services (referred to in this
section as the‘‘Secretary’’), in coordination with other Federal agencies, as
appropriate,shall review current Federal initiatives and identify gaps
and opportunities with
respect to—
(1) ensuring the safe use of prescription
drugs with the potential for abuse; and
(2) the treatment of prescription drug dependance.
(b) REPORT.—Not later
than 1 year after the date of enactment
of this Act, the
Secretary shall post on the Department of Health
and Human Service’s
Internet Web site a report on the findings
S. 3187—121 of the
review under subsection (a). Such report shall include findings
and recommendations on—
(1) how best to leverage and build upon
existing Federal and federally funded data sources, such as prescription drug monitoring
program data and the sentinel initiative of the Food and Drug Administration
under section 505(k)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
351(k)(3)), as it relates to collection of information relevant to adverse events,
patient safety, and patient outcomes, to create a centralized
data clearinghouse and
early warning tool;
(2) how best to develop and disseminate
widely best practices models and suggested standard requirements to States for
achieving greater interoperability and effectiveness of prescription drug
monitoring programs, especially with respect to provider participation,
producing standardized data on adverse events, patient safety, and patient
outcomes; and
(3) how best to develop provider, pharmacist,
and patient education tools and a strategy to widely disseminate such tools and
assess the efficacy of such tools.
(c) GUIDANCE ON
ABUSE-DETERRENT PRODUCTS.—Not later than
6 months after the date
of enactment of this Act, the Secretary
shall promulgate
guidance on the development of abuse-deterrent
drug products.
SEC 1141 Recommendation on Interoperability
Standards
(a) IN GENERAL.—The Secretary of Health and
Human Services may facilitate, and, as appropriate, may consult with the
Attorney General to facilitate, the development of recommendations on interoperability
standards to inform and facilitate the exchange of prescription drug
information across State lines by States receiving grant funds under—
(1) the
Harold Rogers Prescription Drug Monitoring Program established under the
Departments of Commerce, Justice, and State, the Judiciary, and Related
Agencies Appropriations Act, 2002 (Public Law 107–77; 115 Stat. 748); and
(2) the
Controlled Substance Monitoring Program established under section 399O of the
Public Health Service Act (42 U.S.C. 280g–3).
(b) REQUIREMENTS.—The Secretary of Health and
Human Services shall consider the
following in facilitating the development of recommendations on
interoperability of prescription drug monitoring programs under subsection (a)—
(1) open
standards that are freely available, without cost and without restriction, in
order to promote broad implementation; S. 3187—135
(2) the
use of exchange intermediaries, or hubs, as necessary to facilitate interstate
interoperability by accommodating State-to-hub, hub-to-hub, and direct
State-to-State communication;
(3) the
support of transmissions that are fully secured as required, using industry
standard methods of encryption, to ensure that protected health information and
personally identifiable information are not compromised at any point during
such transmission;
(4)
access control methodologies to share protected information solely in
accordance with State laws and regulations; and
(5)
consider model interoperability standards developed by the Alliance of States
with Prescription Monitoring Programs.
(c)
REPORT.—
(1) IN GENERAL.—Not later than 1 year after
the date of enactment of this Act, the Secretary of Health and Human Services
shall submit to the Committee on Health, Education, Labor, and Pensions of the
Senate and the Committee on Energy and Commerce of the House of Representatives
a report on enhancing the interoperability of State prescription drug monitoring
programs with other technologies and databases used for detecting and reducing
fraud, diversion, and abuse of prescription drugs.
(2) CONTENTS.—The report required under
paragraph (1) shall include—
(A) an assessment of legal, technical,
fiscal, privacy, or security challenges that have an impact on
interoperability;
(B) a discussion of how State prescription drug
monitoring programs could increase the production and distribution of
unsolicited reports to prescribers and dispensers of prescription drugs, law
enforcement officials, and health professional licensing agencies, including
the enhancement of such reporting through interoperability with other States
and relevant technology and databases;
(C) any recommendations for addressing
challenges that impact interoperability of State prescription drug monitoring
programs in order to reduce fraud, diversion, andabuse of prescription drugs;
and
(D) an assessment of the extent to which
providers use prescription drug management programs in delivering care and
preventing prescription drug abuse.
No comments:
Post a Comment