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Code · STATUTE-COMPILATIONS · Food and Drug Administration Safety and Innovation Act · Sec. 1141

Sec. 1141. RECOMMENDATIONS ON INTEROPERABILITY STANDARDS

466 words·~2 min read·/statute-compilations/comps-9932/sec-1141

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

## SEC. 1141 RECOMMENDATIONS 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; ####
(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, and abuse 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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  • Pub. L. 107-77
  • 115 Stat. 748
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Sec. 1141
RECOMMENDATIONS ON INTEROPERABILITY STANDARDS
Pub. L.Pub. L. 107-77
Stat.115 Stat. 748
Cites 3Cited by 0 across 0 sources
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