What it changes

1 change to S. 3187 · shown in the bill's text

Adds a section
  1. Adds SEC. 11__. RECOMMENDATIONS ON INTEROPERABILITY STANDARDS at the end of title XI

    Adds a section

    In S. 3187 · Placed on Calendar Senate

    "(b) Financial Interest.--In this section, the term 'financial interest' means a financial interest under section 208(a) of title 18, United States Code.".

    Inserted: SEC. 11__. RECOMMENDATIONS ON INTEROPERABILITY STANDARDS.

    Inserted: (a) In General.--The Attorney General and the Secretary of Health and Human Services may collaborate to facilitate the development of recommendations on interoperability standards to inform and facilitate the exchange of prescription information across State lines by making grants to States under--

    Inserted: (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

    Inserted: (2) the Controlled Substance Monitoring Program established under section 399O of the Public Health Service Act (42 U.S.C. 280g 3).

    Inserted: (b) Requirements.--The Attorney General and 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)--

    Inserted: (1) open standards that are freely available, without cost and without restriction, in order to promote broad implementation;

    Inserted: (2) the use of exchange intermediaries, or hubs, as necessary to facilitate interstate interoperability by accommodating State-to-hub and direct State-to-State communication;

    Inserted: (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; and

    Inserted: (4) access control methodologies to share protected information solely in accordance with State laws and regulations.

    Original wording

    At the end of title XI, add the following:

Read automatically from the Congressional Record. Check the original before relying on it.

As printed

SA 2152. Mr. PORTMAN submitted an amendment intended to be proposed by him to the bill S. 3187, to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and medical devices, to establish user-fee programs for generic drugs and biosimilars, and for other purposes; which was ordered to lie on the table; as follows:

At the end of title XI, add the following:

SEC. 11__. RECOMMENDATIONS ON INTEROPERABILITY STANDARDS.

(a) In General.--The Attorney General and the Secretary of Health and Human Services may collaborate to facilitate the development of recommendations on interoperability standards to inform and facilitate the exchange of prescription information across State lines by making grants to States 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 Attorney General and 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 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; and

(4) access control methodologies to share protected information solely in accordance with State laws and regulations.

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Senate amendment submitted

May 23, 2012