Wednesday, July 11, 2012

Excerpts - S, 3187 Internet and Interoperability


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.


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