[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4832 Introduced in House (IH)]







109th CONGRESS
  2d Session
                                H. R. 4832

   To amend the Social Security Act to establish an Office of Health 
     Information Technology for the purpose of creating a national 
 interoperable health information infrastructure, to provide loans to 
 health care entities seeking to implement such infrastructure, and to 
 provide exceptions to certain health anti-kickback laws to encourage 
          the dissemination of health information technology.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             March 1, 2006

 Mr. Clay (for himself and Mr. Porter) introduced the following bill; 
  which was referred to the Committee on Energy and Commerce, and in 
    addition to the Committee on Ways and Means, for a period to be 
subsequently determined by the Speaker, in each case for consideration 
  of such provisions as fall within the jurisdiction of the committee 
                               concerned

_______________________________________________________________________

                                 A BILL


 
   To amend the Social Security Act to establish an Office of Health 
     Information Technology for the purpose of creating a national 
 interoperable health information infrastructure, to provide loans to 
 health care entities seeking to implement such infrastructure, and to 
 provide exceptions to certain health anti-kickback laws to encourage 
          the dissemination of health information technology.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

    (a) Short Title.--This Act may be cited as the ``Electronic Health 
Information Technology Act of 2006''.
    (b) Table of Contents.--The table of contents of this Act is as 
follows:

Sec. 1. Short title; table of contents
Sec. 2. Office of Health Information Technology and standards 
                            development
Sec. 3. National Institute of Health demonstration program
Sec. 4. Health care provider HIT loan program
Sec. 5. Safe harbor from anti-kickback laws for health information 
                            technology
Sec. 6. Uniform Federal and State health information standards

SEC. 2. OFFICE OF HEALTH INFORMATION TECHNOLOGY AND STANDARDS 
              DEVELOPMENT.

    (a) In General.--Part A of title XI of the Social Security Act (42 
U.S.C. 1301 et seq.) is amended by adding at the end the following new 
section:

                    ``health information technology

    ``Sec. 1150A. (a) Office of Health Information Technology.--
            ``(1) Establishment.--There is established within the 
        Department of Health and Human Services an Office of Health 
        Information Technology (referred to in this section as the 
        `Office') that shall be headed by the Chief Health Informatics 
        Officer of Health Information Technology (referred to in this 
        section as the `Chief Health Informatics Officer'). The Chief 
        Health Informatics Officer shall be appointed by the Secretary 
        and shall report directly to the Secretary. The Chief Health 
        Informatics Officer shall be paid at a rate equal to the rate 
        of basic pay for level IV of the Executive Schedule.
            ``(2) Objectives of office.--In fulfilling the duties under 
        paragraph (3), the work of the Chief Health Informatics Officer 
        shall be consistent with the following objectives:
                    ``(A) Convenient availability of health 
                information.--Ensuring that appropriate information to 
                guide medical decisions is available on the date on 
                which and at the location in which health care is 
                provided to an individual.
                    ``(B) Improved health care.--
                            ``(i) Improving health care quality.
                            ``(ii) Advancing the delivery of 
                        appropriate evidence-based health care.
                            ``(iii) Reducing the occurrence of medical 
                        errors, inefficiency, inappropriate health 
                        care, and incomplete information.
                            ``(iv) Reducing health costs that result 
                        from the occurrences referred to in clause 
                        (iii).
                    ``(C) Promotion of effective health care 
                marketplace.--Promoting an effective marketplace for 
                health care consumption, greater competition, and 
                increased choice through the wider availability of 
                accurate information about the costs, quality, and 
                outcomes (based on measurable public health 
                improvements) of health care.
                    ``(D) Improved coordination of health care 
                information.--Improving the coordination of health 
                information among hospitals, laboratories, physician 
                offices, and ambulatory care providers through an 
                effective infrastructure for the secure and authorized 
                exchange of health information.
                    ``(E) Secure and protected health information.--
                Ensuring that the individually identifiable health 
                information (as defined in section 1171(6)) of an 
                individual is secure and protected.
            ``(3) Duties of chief health informatics officer.--The 
        Chief Health Informatics Officer shall perform the following 
        duties:
                    ``(A) Development, implementation, and modification 
                of uniform hit standards.--Develop, implement, and 
                modify HIT standards, in accordance with subsections 
                (c), (d), and (e), respectively.
                    ``(B) Development, maintenance, and implementation 
                of interoperable hit strategic plan.--Develop, 
                maintain, and direct the implementation of an 
                interoperable HIT strategic plan (described in 
                paragraph (4)) to guide the nationwide implementation 
                of interoperable health information technology in the 
                public and private health care sectors.
                    ``(C) Principal advisor to secretary.--Serve as the 
                principal advisor to the Secretary on the development 
                and use of health information technology.
                    ``(D) Director of hhs health information technology 
                programs.--Direct any programs related to health 
                information technology that are conducted by the 
                Secretary.
                    ``(E) Coordinator of federal health information 
                policy and activities.--Coordinate health information 
                technology policies of the Department of Health and 
                Human Services and activities related to the 
                transmission, integrity, and security of health 
                information conducted by the Secretary with such 
                policies and activities of Federal agencies to avoid 
                duplication of effort and to ensure that each such 
                agency performs activities within the area of the 
                greatest expertise and technical capability of such 
                agency.
                    ``(F) Coordinator of outreach and consultation.--
                Coordinate programs of Federal agencies that are 
                related to health information technology outreach and 
                consultation by such agencies with public and private 
                entities, including consumers, providers, payers, and 
                administrators.
                    ``(G) Coordinator for plans for private sector 
                health information technology.--Coordinate plans for 
                Federal efforts to develop and implement interoperable 
                HIT standards for private sector physicians and other 
                health professionals who use electronic health records, 
                electronic prescribing systems, evidence-based clinical 
                support tools, patient registries, or other health 
                information technology.
                    ``(H) Advisor to omb.--Provide to the Director of 
                the Office of Management and Budget comments and advice 
                with respect to specific health information technology 
                programs.
                    ``(I) Administrator of grants program.--Administer 
                the HIT standards grants program under subsection (j).
            ``(4) Interoperable hit strategic plan.--
                    ``(A) Description.--For purposes of paragraph 
                (3)(B), an interoperable HIT strategic plan is a plan 
                that is consistent with the following:
                            ``(i) Advancement of hit standards.--
                        Advances the development and national 
                        implementation of HIT standards through the 
                        collaboration of public and private interests, 
                        and consistent with efforts in existence before 
                        the date of the enactment of this section.
                            ``(ii) Acknowledgement of certain issues 
                        involved in adoption of standards.--Ensures 
                        that the main technical, scientific, economic, 
                        and other issues affecting the adoption of HIT 
                        standards (in the public and private sectors) 
                        are addressed.
                            ``(iii) Evaluation of benefits and costs of 
                        interoperable health information technology.--
                        Evaluates the benefits and costs of 
                        interoperable health information technology and 
                        identifies the persons affected by such 
                        benefits and costs.
                            ``(iv) Acknowledgement of privacy and 
                        security issues.--Addresses the issues of 
                        privacy and security related to interoperable 
                        health information technology and recommends 
                        methods to ensure appropriate authorization, 
                        authentication, and encryption of data 
                        transmission over the Internet.
                            ``(v) Self-sufficient plan.--Does not 
                        assume or depend upon Federal resources or 
                        spending that is in addition to resources and 
                        spending authorized under the Electronic Health 
                        Information Technology Act of 2006 to 
                        accomplish the adoption of HIT standards and an 
                        interoperable health information technology 
                        infrastructure.
                            ``(vi) Measurable outcome goals.--Includes 
                        measurable outcome goals, such as for 
                        determining error reductions in patient care 
                        and economic benefits derived from the use of 
                        interoperable health information technology.
                    ``(B) Reports.--Not later than 180 days after the 
                date of the appointment of the Chief Health Informatics 
                Officer, and periodically thereafter, the Chief Health 
                Informatics Officer shall submit to the Secretary a 
                report on the progress of the development and 
                implementation of the interoperable HIT strategic plan.
    ``(b) Limitation on Use of Federal Funds to Purchase Health 
Information Technology Products.--
            ``(1) In general.--Effective as provided in paragraphs 
        (1)(B) and (2)(C) of subsection (d), no Federal funds 
        (including grants provided under subsection (j)) may be used 
        for the purchase (or update) of a health information technology 
        product unless the product (or update) is certified by the 
        entity selected under paragraph (2) as complying with HIT 
        standards in effect on the date of certification.
            ``(2) Selection of certification entity.--For purposes of 
        paragraph (1) and subject to paragraph (3), the Secretary shall 
        enter into a contract with an entity to certify that a health 
        information technology product (or update) meets HIT standards 
        implemented under subsection (d). For purposes of the preceding 
        sentence, the Secretary may enter into a contract with a 
        private entity, including the Certification Commission for 
        Healthcare Information Technology.
            ``(3) Contracting exception.--For purposes of paragraph (2) 
        and subsection (c)(3), the Secretary may enter into a contract 
        with the Certification Commission for Healthcare Information 
        Technology for purposes of such paragraph or such subsection, 
        but not for both.
    ``(c) Development of HIT Standards.--
            ``(1) Requirements.--The Chief Health Informatics Officer 
        shall provide for the development of HIT standards. Such 
        standards shall comply with the following:
                    ``(A) Interoperability.--The standards shall 
                provide for interoperability among health information 
                systems.
                    ``(B) Application to electronic transactions and 
                transmissions.--The standards shall apply to electronic 
                transactions and transmissions of health information, 
                to the content of such transactions and transmissions, 
                and to the data elements of such transactions and 
                transmissions, including standards for security and 
                coding of electronic health information created for the 
                purpose of establishing an interoperable health 
                information infrastructure.
                    ``(C) Proprietary neutrality.--The standards shall 
                not restrict, sponsor, promote, or prejudice in any 
                other way the certification of health information 
                technology products according to brand, product line, 
                or vendor.
                    ``(D) Patient safety and quality of care.--The 
                standards shall be consistent with the objectives of 
                improving patient safety and the quality of care 
                provided to patients.
                    ``(E) No undue burden.--The standards shall not, to 
                the extent practicable, impose an undue administrative 
                or financial burden on the practice of medicine, or any 
                other health care profession, particularly on small 
                physician practices and practices located in rural 
                areas.
                    ``(F) Compatibility with hipaa privacy laws.--The 
                standards shall be consistent with the standards under 
                section 264(c) of the Health Insurance Portability and 
                Accountability Act of 1996 (42 U.S.C. 1320d-2 note) 
                (concerning the privacy of individually identifiable 
                health information).
            ``(2) Access restriction standards.--The Chief Health 
        Informatics Officer shall establish standards to restrict 
        access of public and private entities to health information 
        transferred, used, or stored by health information technology.
            ``(3) Contracting authority.--Subject to subsection (b)(3), 
        the Chief Health Informatics Officer may enter into a contract 
        with the Certification Commission for Healthcare Information 
        Technology, or any other appropriate certification entity, to 
        develop HIT standards, access restriction standards described 
        in paragraph (2), or both.
            ``(4) HIT standards defined.--For purposes of this section, 
        the term `HIT standards' means standards related to the 
        transmission, integrity, and security of health information.
    ``(d) Implementation of HIT Standards.--
            ``(1) Consolidated health informatics council standards in 
        existence before date of enactment.--
                    ``(A) In general.--Not later than one year after 
                the date of the enactment of this section, the Chief 
                Health Informatics Officer shall implement all 
                standards that were developed, implemented, or modified 
                by the Consolidated Health Informatics Council before 
                such date of enactment.
                    ``(B) Effective dates.--
                            ``(i) Federal agencies.--For purposes of 
                        subsection (b) and not later than the date that 
                        is 30 days after the date on which HIT 
                        standards are implemented under subparagraph 
                        (A), such standards shall apply to a Federal 
                        agency.
                            ``(ii) Non-federal agencies.--For purposes 
                        of subsection (b) and not later than 18 months 
                        after the date of the enactment of the 
                        Electronic Health Information Technology Act of 
                        2006, the HIT standards implemented under 
                        subparagraph (A) shall apply to an entity that 
                        is not a Federal agency.
            ``(2) Standards developed after date of enactment.--
                    ``(A) In general.--The Chief Health Informatics 
                Officer shall implement, in accordance with 
                subparagraph (B), each HIT standard developed under 
                subsection (c) or modified under subsection (e) unless 
                the Chief Health Informatics Officer determines that 
                the standard would not be effective in promoting an 
                interoperable health information technology 
                infrastructure.
                    ``(B) Regulations.--For purposes of subparagraph 
                (A), the Secretary shall establish guidelines for 
                determining if a standard would not be effective in 
                promoting an interoperable health information 
                technology infrastructure and for specifying dates by 
                which the Chief Health Informatics Officer is required 
                to make a determination under such subparagraph before 
                standards developed under subsection (c) or modified 
                under subsection (e) shall be implemented.
                    ``(C) Effective dates.--
                            ``(i) Federal agencies.--For purposes of 
                        subsection (b) and not later than 18 months 
                        after the date on which a HIT standard is 
                        implemented under subparagraph (A), such 
                        standard shall apply to a Federal agency.
                            ``(ii) Non-federal agencies.--For purposes 
                        of subsection (b) and not later than 24 months 
                        after the date on which a HIT standard is 
                        implemented under subparagraph (A), such 
                        standard shall apply to an entity that is not a 
                        Federal agency.
            ``(3) Documentation of compliance.--On the date of the 
        implementation of a HIT standard under this subsection, the 
        Chief Health Informatics Officer shall provide documentation to 
        the Secretary showing that the standard complies with each 
        requirement under subsection (c)(1).
    ``(e) Modification of Standards.--The Chief Health Informatics 
Officer may modify, according to a procedure established by the Chief 
Health Informatics Officer, a HIT standard implemented under subsection 
(d). A standard modified under this subsection shall be implemented in 
accordance with such subsection.
    ``(f) Authority to Waive Compliance.--
            ``(1) In general.--The Chief Health Informatics Officer may 
        waive the application of HIT standards implemented under 
        subsection (d) for not more than a one-year period, on a case-
        by-case basis, in unusual or extreme circumstances.
            ``(2) Reports.--Not later than 60 days after the date on 
        which the Chief Health Informatics Officer makes such a waiver, 
        the Chief Health Informatics Officer shall submit to Congress a 
        report stating the purpose and circumstances justifying the 
        waiver.
    ``(g) Penalties.--
            ``(1) Federal agencies.--The Director of the Office of 
        Management and Budget shall develop and implement a system to 
        enforce compliance with HIT standards implemented under 
        subsection (d). Such system shall include appropriate budgetary 
        penalties--
                    ``(A) for a Federal agency that is not in 
                compliance with such standards and has not received a 
                waiver under subsection (f)(1); and
                    ``(B) for a Federal agency that has received a 
                waiver under subsection (f)(1) but, starting on a date 
                that is after the date on which the waiver terminates, 
                is not in compliance with such standards.
            ``(2) Non-federal entities.--An entity that is not a 
        Federal agency shall no longer receive Federal funds for 
        purposes of purchasing a health information technology product 
        if--
                    ``(A) such entity is in violation of subsection (b) 
                and has not received a waiver under subsection (f)(1); 
                or
                    ``(B) such entity has received a waiver under 
                subsection (f)(1) but starting on a date that is after 
                the date on which the waiver terminates the entity is 
                not in compliance with HIT standards implemented under 
                subsection (d).
    ``(h) Consultation and Recommendations.--For purposes of developing 
HIT standards under subsection (c) and modifying such standards under 
subsection (e), the following applies:
            ``(1) Stakeholder consultation.--The Chief Health 
        Informatics Officer, in accordance with subchapter II of 
        chapter 5 and chapter 7 of title 5, United States Code 
        (popularly known as the Administrative Procedure Act), shall 
        consult with Federal agencies and private entities that are 
        involved in the transfer or collection of health information, 
        including agencies of the Federal Health Architecture, members 
        of the Consolidated Health Informatics Council, physicians, 
        hospitals, health care delivery systems, health insurance 
        providers, pharmaceutical and biologics manufacturers, medical 
        device manufacturers, information technology vendors, patient 
        groups, private standards-setting organizations, public health 
        interest groups, and other health care professionals determined 
        by the Chief Health Informatics Officer necessary to the 
        process of developing and modifying such standards.
            ``(2) National committee on vital and health statistics 
        recommendations.--Not later than the date that is one year 
        after the date of the enactment of this section, and each year 
        thereafter, the National Committee on Vital and Health 
        Statistics shall submit to the Chief Health Informatics Officer 
        recommendations for activities to advance the development and 
        modification of HIT standards.
    ``(i) Treatment of State HIT Standards.--A standard implemented 
under subsection (d) for application to electronic transfers or 
transactions described in subsection (c)(1)(B) shall supersede any 
standard prescribed by a State or local government for a similar 
application.
    ``(j) HIT Grants Program.--
            ``(1) Establishment of program.--In accordance with this 
        subsection and subject to paragraph (3) and subsection (m), the 
        Chief Health Informatics Officer shall award one-year grants to 
        eligible health information technology entities whose 
        applications under paragraph (2) demonstrate a proposal that 
        will benefit an interoperable health information technology 
        infrastructure and is consistent with the mission of such an 
        entity.
            ``(2) Application.--To be eligible for an award of a grant 
        under this section, an eligible health information technology 
        entity shall submit to the Secretary an application that 
        contains a description of how the applicant proposes to use the 
        grant funds. The application shall be submitted in such form, 
        at such time, and containing such other information as the 
        Chief Health Informatics Officer may require.
            ``(3) Set-asides for dsh qualifying facilities.--
                    ``(A) In general.--The Secretary shall use at least 
                20 percent of the funds authorized under subsection (m) 
                for purposes of this section to award grants under 
                paragraph (1) to eligible health information technology 
                entities, which are DSH qualifying facilities.
                    ``(B) DSH qualifying facility defined.--For 
                purposes of subparagraph (A), the term `DSH qualifying 
                facility' means any of the following:
                            ``(i) Medicare disproportionate share 
                        hospital.--A hospital that qualifies for an 
                        additional payment under section 1886(d)(4)(F).
                            ``(ii) Medicaid disproportionate share 
                        hospital.--A hospital that qualifies for an 
                        increase in the rate or amount of payment for 
                        inpatient hospital services under section 
                        1923(a).
                            ``(iii) Provider serving a medically 
                        underserved population.--A health care provider 
                        that serves a medically underserved population, 
                        as defined in section 330(a)(3) of the Public 
                        Health Service Act.
                            ``(iv) Critical access hospital.--A 
                        facility designated as a critical access 
                        hospital in accordance with section 1820(c)(2).
            ``(4) Permissible use of grants.--A grant awarded under 
        paragraph (1) may be used by an eligible health information 
        technology entity only for purposes of the proposal submitted 
        by such entity under paragraph (2).
            ``(5) Extension of grants.--Upon the expiration of a grant 
        awarded to an eligible health information technology entity 
        under paragraph (1) and the request of such entity, the Chief 
        Health Informatics Officer, in accordance with procedures 
        established by the Chief Health Informatics Officer, may extend 
        the duration of the grant once by one year if the Chief Health 
        Informatics Officer determines that the programs established 
        and implemented by such group with the grant resulted in (or 
        are likely to result in) significant progress in benefiting an 
        interoperable health information technology infrastructure.
            ``(6) Definition of eligible health information technology 
        entity.--For purposes of this subsection, the term `eligible 
        health information technology entity' means an entity of a 
        State or local government or a private entity that seeks (and 
        has the capacity) to participate in the research, development, 
        or implementation of HIT standards. Such term includes a health 
        care provider, whether or not the provider participates under 
        title XVIII or XIX, a health insurance issuer, and a group 
        health plan.
    ``(k) Progress and Compliance Reports.--
            ``(1) Biennial progress reports.--The Chief Health 
        Informatics Officer shall submit to Congress biennial reports 
        on the progress of the development and implementation of HIT 
        standards.
            ``(2) Annual compliance reports.--The Chief Health 
        Informatics Officer shall submit to Congress an annual report 
        that assesses the compliance of all Federal Health Architecture 
        agencies with HIT standards.
            ``(3) Administrative provisions.--For purposes of 
        paragraphs (1) and (2), the Chief Health Informatics Officer 
        shall specify dates on which such reports shall be submitted 
        under such paragraphs, the periods during which progress or 
        compliance shall be assessed under such paragraphs, and a 
        method for assessing such progress or compliance, respectively.
            ``(4) Bi-annual gap assessment.--
                    ``(A) In general.--Starting on the date that is one 
                year after the date of the enactment of this section, 
                the Chief Health Informatics Officer shall request the 
                Institute of Medicine to enter into an agreement with 
                the Officer under which such Institute conducts a bi-
                annual assessment that identifies problems that present 
                barriers to adaptation of HIT standards implemented 
                during the period of such assessment. Such assessment 
                shall--
                            ``(i) analyze the impact and effectiveness 
                        of such standards;
                            ``(ii) identify the costs and long-term 
                        savings to Federal agencies of complying with 
                        such standards during the period of the 
                        assessment;
                            ``(iii) identify the impact of such 
                        standards on patient safety, on the quality of 
                        medical care provided to patients, and on 
                        mortality rates;
                            ``(iv) identify significant administrative 
                        or business practice efficiencies and 
                        inefficiencies that result from the 
                        implementation of such standards;
                            ``(v) identify ways to improve methods of 
                        developing and implementing such standards in 
                        public and private sectors; and
                            ``(vi) recommend requirements and 
                        guidelines for future research and development 
                        of such standards.
                    ``(B) Report.--Not later than 60 days after the 
                last day of each period of semi-annual assessment 
                conducted under subparagraph (A), the Secretary shall 
                submit to Congress a report on the findings of such 
                assessment.
    ``(l) Definitions.--For purposes of this section:
            ``(1) Health information.--The term `health information' 
        has the meaning given such term in section 1171(4).
            ``(2) Health information technology.--The term `health 
        information technology' means products, devices, or systems 
        that allow for the electronic collection, storage, exchange, or 
        management of health information.
            ``(3) Health care provider.--The term `health care 
        provider' means--
                    ``(A) a health care provider defined in section 
                1171(3), including a critical access hospital; and
                    ``(B) a federally qualified health center defined 
                in section 1861(aa)(4).
            ``(4) Interoperability.--The term `interoperability' means 
        the ability of different information systems and software 
        applications to communicate and to exchange information 
        accurately, effectively, and consistently.
            ``(5) Federal agency.--The term `Federal agency' means a 
        department or agency of the Federal Government that possesses, 
        uses, or transfers health information.
            ``(6) Federal health architecture.--The term `Federal 
        Health Architecture' means the entity overseen by the Secretary 
        and the Director of the Office of Management and Budget and 
        administered by the National Coordinator for Health Information 
        Technology pursuant to Executive Order 13335 to provide the 
        structure for collaboration and interoperability among Federal 
        health efforts.
            ``(7) Consolidated health informatics council.--The term 
        `Consolidated Health Informatics Council' means the initiative 
        overseen by the Secretary and the Director of the Office of 
        Management and Budget and administered by the National 
        Coordinator for Health Information Technology pursuant to 
        Executive Order 13335 to adopt existing health information 
        interoperability standards.
    ``(m) Authorization of Appropriations.--There is authorized to be 
appropriated such funds as are necessary, but not more than 
$750,000,000, for each of fiscal years 2007 through 2011 to carry out 
this section. Of such amounts made available for a fiscal year, the 
Secretary shall allocate--
            ``(1) not less than 60 percent for the HIT grants program 
        under subsection (j); and
            ``(2) not less than 10 percent for research and development 
        activities and demonstration programs carried out by the 
        Office.''.
    (b) Appointment of Chief Health Informatics Officer of the Office 
of Health Information Technology.--Not later than 60 days after the 
date of the enactment of this Act, the Secretary of Health and Human 
Services shall appoint a Chief Health Informatics Officer of the Office 
of Health Information Technology under section 1150A(a) of the Social 
Security Act, as added by subsection (a).
    (c) Transition From Office of the National Coordinator for Health 
Information Technology.--
            (1) Functions, personnel, assets, and liabilities.--
                    (A) In general.--There shall be transferred to the 
                Chief Health Informatics Officer the functions, 
                personnel, assets, and liabilities of the National 
                Coordinator. For purposes of the previous sentence, the 
                term ``assets'' includes contracts, facilities, 
                property, records, unobligated or unexpended balances 
                of appropriations, and other funds or resources (other 
                than personnel).
                    (B) Employment provisions.--The transfer pursuant 
                to subparagraph (A) of personnel shall not alter the 
                terms and conditions of employment, including 
                compensation, of any employee so transferred.
                    (C) Chief health informatics officer and national 
                coordinator defined.--For purposes of this subsection:
                            (i) Chief health informatics officer.--The 
                        term ``Chief Health Informatics Officer'' means 
                        the Chief Health Informatics Officer of Health 
                        Information Technology appointed under section 
                        1150A of the Social Security Act, as added by 
                        subsection (a).
                            (ii) National coordinator.--The term 
                        ``National Coordinator'' means the National 
                        Coordinator for Health Information Technology 
                        appointed under Executive Order 13335.
            (2) Acting chief health informatics officer.--Before the 
        appointment of the Chief Health Informatics Officer, the 
        National Coordinator shall act as the Chief Health Informatics 
        Officer until the office is filled as provided in section 
        1150A(a) of the Social Security Act. The Secretary may appoint 
        the National Coordinator as the Chief Health Informatics 
        Officer.
            (3) Completed administrative actions.--
                    (A) In general.--Completed administrative actions 
                of the Office of the National Coordinator shall 
                continue in effect according to their terms until 
                amended, modified, superseded, terminated, set aside, 
                or revoked by the Office of the Chief Health 
                Informatics Officer.
                    (B) Completed administrative action described.--For 
                purposes of subparagraph (A), the term ``completed 
                administrative action'' includes orders, 
                determinations, rules, regulations, personnel actions, 
                permits, agreements, grants, contracts, certificates, 
                licenses, registrations, and privileges.
            (4) References.--References relating to the Office of the 
        National Coordinator that precede the effective date of this 
        Act shall be deemed to refer, as appropriate, to the Office of 
        the Chief Health Informatics Officer.
            (5) Statutory reporting requirements.--Any statutory 
        reporting requirement that applied to the Office of the 
        National Coordinator immediately before the effective date of 
        this Act shall apply to the Office of the Chief Health 
        Informatics Officer following such date.
            (6) Treatment of executive order 13335.--Executive Order 
        13335 shall not have any force or effect after the date of the 
        appointment of the first Chief Health Informatics Officer.

SEC. 3. NATIONAL INSTITUTE OF HEALTH DEMONSTRATION PROGRAM.

    (a) In General.--The Secretary of Health and Human Services, acting 
through the Director of the National Institute of Health, shall carry 
out a demonstration program to determine methods by which contextual 
access criteria and analysis technologies for specific diseases and 
health criteria may be used to search patient electronic health records 
and aggregated health information without using personal identifying 
information of patients. Participants in the program shall include 
representatives of Federal health agencies, State health agencies, 
research facilities approved for clinical trials of the National 
Institute of Health, health insurance organizations, self-insured 
corporations, and private sector health care providers.
    (b) Report.--Not later than two years after the date of the 
enactment of this Act, the Secretary of Health and Human Services shall 
submit to Congress a report on the findings of the demonstration 
program under subsection (a).

SEC. 4. HEALTH CARE PROVIDER HIT LOAN PROGRAM.

    (a) Program Established.--Part A of title XI of the Social Security 
Act (42 U.S.C. 1301 et seq.), as amended by section 2, is further 
amended by adding at the end the following new section:

``SEC. 1150B HEALTH CARE PROVIDER HIT LOAN PROGRAM.

    ``(a) Program Established.--
            ``(1) In general.--There is established a program to be 
        known as the `Health Care Provider HIT Loan Program' (referred 
        to in this section as the `Loan Program'.
            ``(2) Entitlement.--There are hereby made available, in 
        accordance with the provisions of this section, such sums as 
        may be necessary to make loans under the Loan Program to all 
        eligible health care providers, including critical access 
        hospitals and federally qualified health centers, to enable the 
        implementation and adoption by such providers of health 
        information technology systems that promote interoperability 
        among health care settings.
    ``(b) Eligibility.--
            ``(1) Application.--To be eligible to participate in the 
        Loan Program, a health care provider shall submit to a loan 
        originator center an application that demonstrates the 
        following:
                    ``(A) State licensed.--The provider is licensed by 
                an appropriate State agency to perform the duties of 
                the provider.
                    ``(B) Participant in the medicare program.--The 
                provider participates under title XVIII.
                    ``(C) Use of loan funds for interoperable hit 
                project.--The loan will be used to purchase, implement, 
                or improve health information technology and such 
                health information technology is interoperable with a 
                shared health facility, hospital, or health system in 
                the community of the provider.
                    ``(D) No default on existing loans.--The provider 
                is not in default on an existing Federal loan.
            ``(2) Administration of application.--The application shall 
        be submitted in such form, at such time, and containing such 
        additional information as the Secretary may require.
    ``(c) Duties of the Secretary.--The Secretary, through the Chief 
Health Informatics Officer of Health Information Technology, shall 
carry out the Loan Program. In carrying out the Loan Program, the 
Secretary shall, with respect to loans made under subsection (a)--
            ``(1) enter into contracts under subsections (d) and (e) 
        for purposes of originating and servicing, respectively, such 
        loans;
            ``(2) review requests submitted by a loan originator center 
        for such loans;
            ``(3) transfer loans funds to loan originator centers;
            ``(4) monitor activities performed by loan originator 
        centers under subsection (d) and loan service centers under 
        subsection (e); and
            ``(5) monitor the rate at which eligible health care 
        providers default on such loans made to such providers.
    ``(d) Origination of Loans.--
            ``(1) Funds for origination of loans.--The Secretary shall 
        provide funds, out of funds available pursuant to subsection 
        (a), for loans under this section through a loan originator 
        center to an eligible health care provider.
            ``(2) Contracts with loan originator centers.--The 
        Secretary of Health and Human Services shall enter into 
        contracts with loan originator centers under which the loan 
        originator centers shall, with respect to loans under 
        subsection (a)--
                    ``(A) assess applications submitted under 
                subsection (b);
                    ``(B) originate such loans to eligible providers in 
                accordance with this section, including request loan 
                funds from the Secretary for an eligible provider, 
                disburse loan funds to an eligible provider, and notify 
                the Secretary that such funds have been disbursed;
                    ``(C) obtain from an eligible provider a note or 
                evidence of obligation on such a loan and provide that 
                such note or evidence shall be the property of the 
                Secretary;
                    ``(D) set forth a schedule for disbursement of the 
                proceeds of the loan in installments; and
                    ``(E) perform administrative functions, as 
                determined by the Secretary necessary to the 
                origination of loan funds, including monthly account 
                reconciliation.
    ``(e) Contracts With Loan Service Centers for Servicing Loans.--The 
Secretary of Health and Human Services shall enter into contracts with 
loan service centers under which the loans service centers shall, with 
respect to loan funds disbursed to an eligible health care provider--
            ``(1) monitor the eligibility status of such providers to 
        receive such loan funds;
            ``(2) submit to such providers bills and collect from such 
        providers payments for such loan funds in accordance with the 
        applicable repayment plan of the provider under subsection 
        (g)(1);
            ``(3) conduct initial collection services on delinquent 
        payments by such providers for loans under this section; and
            ``(4) transfer loans in default to a debt collection 
        system.
    ``(f) Terms and Conditions of Loans.--
            ``(1) Amounts of loans.--
                    ``(A) Determination of amounts.--The determination 
                of the amount of a loan made under subsection (a) to an 
                eligible health care provider shall be calculated, in 
                accordance with a methodology specified by the 
                Secretary, based on the projected health IT cost and 
                the size of the provider (as determined by a method 
                specified by the Secretary.
                    ``(B) Definition of projected health it cost.--For 
                purposes of this paragraph and paragraph (2), the term 
                `projected health IT cost' means the cost to the 
                eligible health care provider to purchase, implement, 
                or improve the health information technology involved 
                in the application under subsection (b)(1).
            ``(2) Loan limits.--
                    ``(A) Establishment of limits.--The Secretary shall 
                establish limits on loans under the Loan Program, based 
                on categories under subparagraph (B).
                    ``(B) Creation of loan limit categories.--For 
                purposes of subparagraph (A), the Secretary shall 
                create categories of eligible health care providers 
                that represent various ranges of health IT costs to 
                such providers and sizes of such providers. The 
                Secretary shall assign to each category a value that 
                shall be the maximum amount for a loan made under the 
                Loan Program to an eligible health care provider whose 
                projected health IT cost and whose size correspond with 
                the range of costs and sizes represented by such 
                category.
            ``(3) Interest rates.--
                    ``(A) Determination of interest rate.--Subject to 
                subparagraph (B), the applicable rate of interest for a 
                loan under this section, during any 12-month period 
                beginning on July 1 and ending on June 30 shall be 
                determined on the preceeding June 1 and be equal to--
                            ``(i) the bond equivalent rate of 91-day 
                        Treasury bills auctioned at the first auction 
                        held prior to such June 1; plus
                            ``(ii) 3.1 percent.
                    ``(B) Maximum interest rate.--A rate of interest 
                determined under subparagraph (A) shall not exceed 8.25 
                percent.
                    ``(C) Interest rate discounts.--The Secretary may 
                prescribe by regulation such reductions in the interest 
                rate paid by an eligible health care provider for a 
                loan under subsection (a) as the Secretary determines 
                appropriate to encourage on-time repayment of the loan. 
                Such reductions may be offered only if the Secretary 
                determines the reductions are cost neutral and in the 
                best financial interest of the Federal Government.
            ``(4) Origination fees.--The Secretary shall charge an 
        eligible health care provider who receives a loan under 
        subsection (a) an origination fee of 4 percent of the principal 
        amount of loan and, if applicable, a fee for loan insurance.
    ``(g) Repayment of Loans.--
            ``(1) Repayment plans.--
                    ``(A) Design and selection.--
                            ``(i) In general.--Consistent with criteria 
                        established by the Secretary, the Secretary 
                        shall offer an eligible health care provider 
                        who receives a loan under the Loan Program (and 
                        the provider may choose one of) the plans for 
                        repayment of such loan, including repayment of 
                        principal and interest on such loan, described 
                        in clause (ii). Such criteria shall be 
                        different for eligible health care providers 
                        that are physicians or medical groups, or that 
                        are DSH qualifying facilities described in 
                        clause (iii) or (iv) of section 1150A(j)(3)(B), 
                        in order to take into account the different 
                        financial ability of such providers to repay 
                        loans made. The Secretary shall allow the 
                        provider to accelerate, without penalty, 
                        repayment on the loans involved.
                            ``(ii) Repayment plans.--The plans 
                        described in this clause are the following:
                                    ``(I) Standard repayment plan.--A 
                                standard repayment plan, with annual 
                                payment amount paid over a fixed period 
                                of time.
                                    ``(II) Income contingent repayment 
                                plan.--An income contingent repayment 
                                plan, with varying monthly payment 
                                amounts based on the income of the 
                                eligible health care provider involved, 
                                paid over an extended period of time 
                                prescribed by the Secretary, not to 
                                exceed 25 years.
                    ``(B) Selection by secretary.--If an eligible 
                health care provider that receives a loan under the 
                Loan Program does not select a repayment plan for such 
                loan described in subparagraph (A)(ii), the Secretary 
                shall select the repayment plan described in subclause 
                (I) of such subsection.
                    ``(C) Changes in selection.--An eligible health 
                care provider that receives a loan under the Loan 
                Program may change the selection of such provider of a 
                repayment plan under subparagraph (A)(ii), or the 
                Secretary's selection of a plan for the provider under 
                subparagraph (B), as the case may be, under such terms 
                and conditions as may be established by the Secretary.
                    ``(D) Alternative repayment plans.--The Secretary 
                may provide, on a case by case basis, an alternative 
                repayment plan to an eligible health care provider that 
                receives a loan under the Loan Program who demonstrates 
                to the satisfaction of the Secretary that the terms and 
                conditions of the repayment plans available under 
                subparagraph (A)(ii) are not adequate to accommodate an 
                exceptional circumstance of the provider. In designing 
                such an alternative repayment plan, the Secretary shall 
                ensure that such plan does not exceed the cost to the 
                Federal Government, as determined on the basis of the 
                present value of future payments by such providers, of 
                loans made using the plans available under subparagraph 
                (A)(ii).
            ``(2) Repayment relief.--
                    ``(A) Required program for loan forgiveness.--The 
                Secretary shall, in accordance with guidelines 
                specified by the Secretary, establish a program for the 
                forgiveness of a loan provided under the Loan Program 
                to an eligible health care provider that is--
                            ``(i) a physician or medical group that 
                        serves a medically underserved population, as 
                        defined in section 330(a)(3) of the Public 
                        Health Service Act; or
                            ``(ii) a participant in the National Health 
                        Service Corps Loan Repayment Program under 
                        section 338B of such Act.
                    ``(B) Authority for additional relief.--The 
                Secretary may, in accordance with guidelines specified 
                by the Secretary, provide for the deferment, 
                forbearance, consolidation, discharge, or forgiveness 
                of another loan provided under the Loan Program.
            ``(3) Loan default.--
                    ``(A) Terms of default.--An eligible health care 
                provider that receives a loan under subsection (a) has 
                defaulted on such loan if--
                            ``(i) the provider fails to make a payment 
                        amount for the loan by the date required by the 
                        repayment plan of the provider and has failed 
                        to make such repayment for at least 180 
                        consecutive days; or
                            ``(ii) the provider otherwise violates the 
                        terms of the promissory note for the loan made 
                        to the provider and continues to violate such 
                        terms for 180 days.
                    ``(B) Consequences of default.--If, under 
                subparagraph (A), an eligible health care provider 
                defaults on a loan made under subsection (a), the 
                Secretary may--
                            ``(i) report such default to a major credit 
                        bureau;
                            ``(ii) offset a tax refund for which the 
                        provider is eligible by the amount of the loan 
                        in default;
                            ``(iii) garnish wages or profits of the 
                        provider;
                            ``(iv) except for a provider that makes 
                        payment amounts for at least six consecutive 
                        months for such loan in default, disqualify the 
                        provider from any further loans under 
                        subsection (a); and
                            ``(v) pursue litigation against the 
                        provider for purposes of recovering the amount 
                        of the loan in default.
    ``(h) Administrative Provisions.--The Secretary shall issue 
regulations for purposes of carrying out the Loans Program. The 
regulations shall include measures to ensure compliance of loan 
originator centers, loan service centers, and eligible health care 
providers with the Loan Program.
    ``(i) Definitions.--For purposes of this section:
            ``(1) Loan originator centers.--The term `loan originator 
        center' means an entity with the capacity to perform the duties 
        under subsection (d)(2) and with which the Secretary of Health 
        and Human Services enters into a contract under such 
        subsection.
            ``(2) Loan service centers.--The term `loan service center' 
        means an entity with the capacity to perform the duties under 
        subsection (e) and with which the Secretary of Health and Human 
        Services enters into a contract under such subsection.
            ``(3) Health care provider.--The term `health care 
        provider' means--
                    ``(A) a health care provider defined in section 
                1171(3), including a critical access hospital; and
                    ``(B) a federally qualified health center defined 
                in section 1861(aa)(4).
            ``(4) Eligible health care provider.--The term `eligible 
        health care provider' means a health care provider that is 
        eligible under subsection (b) to receive a loan under 
        subsection (a).
    ``(j) Effective Date.--Loans under this section shall be available 
to eligible health care providers starting on the date that is one year 
after the date of the enactment of this section.''.
    (b) Study on Health Care Provider HIT Loan Program Savings; HIT 
Implementation Incentives.--
            (1) Study on health care provider hit loan program 
        savings.--
                    (A) Study.--Each Federal entity officer described 
                in subparagraph (C) shall conduct a study to determine 
                any savings realized or costs incurred by Federal 
                health care programs (as defined in section 1128B(f) of 
                the Social Security Act (42 U.S.C. 1320a-7b(f))) 
                because of the implementation or adoption of health 
                information technology financed through loans made 
                under the Health Care Provider HIT Loan Program under 
                section 1150B of the Social Security Act, as added by 
                subsection (a).
                    (B) Report.--Not later than the date that is one 
                year after the date of the enactment of this Act, each 
                Federal entity officer described in subparagraph (C) 
                shall submit a report to Congress on the results of the 
                study conducted under subparagraph (A).
                    (C) Federal entity officer described.--For purposes 
                of this paragraph, a Federal entity officer is each of 
                the following:
                            (i) The Comptroller General of the 
                        Government Accountability Office.
                            (ii) The Commissioner of the Medicare 
                        Payment Advisory Commission (MedPAC), 
                        established by the Balanced Budget Act of 1997 
                        (Public Law 105-33).
                            (iii) The Administrator of the Centers for 
                        Medicare and Medicaid Services (CMS).
                            (iv) The Director of the Congressional 
                        Budget Office.
            (2) HIT implementation incentives.--
                    (A) Study.--The Secretary of Health and Human 
                Services, through the Administrator of the Centers for 
                Medicare and Medicaid Services and after consultation 
                with the Agency for Healthcare Research and Quality, 
                health care providers, and other interested parties, 
                shall specify methods to incentivize the purchase and 
                implementation of health information technology 
                systems. Such incentives may include certain payment 
                incentives made by the Federal Government to entities, 
                such as prompt claims payments, payment differentials, 
                cost differentials, direct payments for services 
                provided through health information technology, and 
                bonus payments for meeting quality outcomes.
                    (B) Implementation.--Not later than 18 months after 
                the date of the enactment of this Act, the Secretary of 
                Health and Human Services shall implement the methods 
                specified in subparagraph (A).

SEC. 5. SAFE HARBOR FROM ANTI-KICKBACK LAWS FOR HEALTH INFORMATION 
              TECHNOLOGY.

    (a) For Civil Penalties.--Section 1128A(b) of the Social Security 
Act (42 U.S.C. 1320a-7a(b)) is amended by adding at the end the 
following new paragraph:
    ``(4)(A) For purposes of this subsection, a payment described in 
paragraph (1) does not include any nonmonetary remuneration (in the 
form of permitted support) made by a hospital or critical access 
hospital to a physician if--
            ``(i) such remuneration is made (or is believed in good 
        faith to be made) without regard to the amount or quality of 
        referrals made or business generated by the physician to the 
        critical access hospital or hospital; and
            ``(ii) in the case of such remuneration made on or after 
        the date that is four years after the date described in section 
        5(d)(2) of the Electronic Health Information Technology Act of 
        2006, such remuneration is made (or is believed in good faith 
        to be made) in accordance with the criteria (relating to 
        compliance with interoperability standards) established by the 
        Secretary under section 5(e) of such Act.
    ``(B) For purposes of subparagraph (A) and sections 1128B(b)(3)(J) 
and 1877(e)(9), the term `permitted support' means any equipment, item, 
information, right, license, intellectual property, software, or 
service (or funding used exclusively to provide or pay for such 
equipment, item, information, right, license, intellectual property, 
software, or service) that is used for at least the purpose of 
exchanging health information.''.
    (b) For Criminal Penalties.--Section 1128B(b)(3) of such Act (42 
U.S.C. 1320a-7b(b)(3)) is amended--
            (1) in subparagraph (G), by striking ``and'' at the end;
            (2) in the subparagraph (H) added by section 237(d) of the 
        Medicare Prescription Drug, Improvement, and Modernization Act 
        of 2003 (Public Law 108-173; 117 Stat. 2213)--
                    (A) by moving such subparagraph 2 ems to the left; 
                and
                    (B) by striking the period at the end and inserting 
                a semicolon;
            (3) in the subparagraph (H) added by section 431(a) of such 
        Act (117 Stat. 2287)--
                    (A) by redesignating such subparagraph as 
                subparagraph (I);
                    (B) by moving such subparagraph 2 ems to the left; 
                and
                    (C) by striking the period at the end and inserting 
                ``; and''; and
            (4) by adding at the end the following new subparagraph:
            ``(J) any nonmonetary remuneration (in the form of 
        permitted support, as defined in section 1128A(b)(4)(B)) made 
        to a person if--
                    ``(i) such remuneration is solicited or received 
                (or offered or paid) (or believed in good faith to be 
                solicited, received, offered, or paid) without regard 
                to the amount or quality of referrals made or business 
                generated by the person; and
                    ``(ii) in the case of such remuneration made on or 
                after the date that is four years after the date 
                described in section 5(d)(2) of the Electronic Health 
                Information Technology Act of 2006, such remuneration 
                is solicited or received (or offered or paid) (or 
                believed in good faith to be solicited, received, 
                offered, or paid) in accordance with the criteria 
                (relating to compliance with interoperability 
                standards) established by the Secretary under section 
                5(e) of such Act.''.
    (c) For Limitation on Certain Physician Referrals.--Section 1877(e) 
of such Act (42 U.S.C. 1395nn(e)) is amended by adding at the end the 
following new paragraph:
            ``(9) Information technology and training services.--Any 
        nonmonetary remuneration (in the form of permitted support, as 
        defined in section 1128A(b)(4)(B)) made by an entity to a 
        physician if--
                    ``(A) such remuneration is made (or believed in 
                good faith to be made) without regard to the amount or 
                quality of referrals made or business generated by the 
                physician to the entity; and
                    ``(B) in the case of such remuneration made on or 
                after the date that is four years after the date 
                described in section 5(d)(2) of the Electronic Health 
                Information Technology Act of 2006, such remuneration 
                is made (or believed in good faith to be made) in 
                accordance with the criteria (relating to compliance 
                with interoperability standards) established by the 
                Secretary under section 5(e) of such Act.''.
    (d) Regulations, Effective Date, and Effect on State Laws.--
            (1) Regulations.--
                    (A) In general.--Subject to subparagraph (B) and 
                not later than the date that is 180 days after the date 
                of the enactment of this Act, the Secretary of Health 
                and Human Services shall issue such regulations as may 
                be necessary to carry out the provisions of this 
                section.
                    (B) Notice and comment.--Not later than the date 
                that is 60 days after the date of the enactment of this 
                Act, the Secretary of Health and Human Services shall 
                issue a notice of proposed rulemaking, with respect to 
                the regulations issued under subparagraph (A).
                    (C) Subsequent regulations.--Any regulation issued 
                by the Secretary on a date after the date described in 
                subparagraph (A), with respect to the safe harbors 
                described in paragraph (4), shall be issued after 
                notice and comment.
            (2) Effective date.--The amendments made by this section 
        shall take effect on the date that is 180 days after the date 
        of the enactment of this Act.
            (3) Effect of state laws.--No State (as defined in section 
        1101(a)) shall have in effect a State law that imposes a 
        criminal or civil penalty for a transaction described in 
        section 1128A(b)(4); 1128B(b)(3)(J); or 1877(e)(9) of the 
        Social Security Act, as added by this section, if--
                    (A) the conditions described in the respective 
                section, with respect to such transaction, are met; or
                    (B) the person or entity involved in such 
                transaction acted in good faith under the belief that 
                such conditions are met.
            (4) Safe harbors described.--For purposes of paragraphs (1) 
        and subsection (e), the safe harbors described in this 
        paragraph are--
                    (A) the safe harbor under paragraph (4) of section 
                1128A(b) of the Social Security Act (42 U.S.C. 1320a-
                7a(b)), as added by subsection (a);
                    (B) the safe harbor under subparagraph (J) of 
                section 1128B(b)(3) of such Act (42 U.S.C. 1320a-
                7b(b)(3)), as added by subsection (b); and
                    (C) the safe harbor under paragraph (9) of section 
                1877(e) of such Act (42 U.S.C. 1395nn(e)), as added by 
                subsection (c).
    (e) Interoperability Criteria for Permissible Health Information 
Technology Remuneration Under Safe Harbors.--Starting on the date that 
is four years after the effective date described in subsection (d)(2) 
and every two years thereafter, the Secretary of Health and Human 
Services may issue regulations that establish criteria for nonmonetary 
remuneration (in the form of permitted support defined under section 
1128A(b)(4) of the Social Security Act, as added by subsection (a)) for 
purposes of the safe harbors described in subsection (d)(4). The 
Secretary shall base such criteria on the extent to which the permitted 
support conforms to a standard implemented under section 1150A(d) of 
the Social Security Act, as added by section 2, based on the following 
considerations:
            (1) Wide acceptance of standard.--The standard is widely 
        accepted within the health care industry and has been used 
        within the industry for a sufficient amount of time to ensure 
        successful implementation.
            (2) Necessity.--The standard is necessary to improve the 
        quality of health care or patient safety, or to provide greater 
        administrative efficiencies.
            (3) Cost benefit analysis.--The results of a cost benefit 
        test conducted to determine the effect of applying the standard 
        for purposes of the safe harbors described in subsection 
        (d)(4).

SEC. 6. UNIFORM FEDERAL AND STATE HEALTH INFORMATION STANDARDS.

    (a) Study to Determine Extent of Variation in State Health 
Information Laws and Regulations.--
            (1) In general.--The Secretary of Health and Human Services 
        shall conduct a study of State laws and regulations relating to 
        the security and confidentiality of individually identifiable 
        health information to determine--
                    (A) the degree to which such laws and regulations 
                vary among States, and between the States and the 
                Federal privacy standards established pursuant to 
                section 264(c) of the Health Insurance Portability and 
                Accountability Act of 1996 (42 U.S.C. 1320d-2 note) and 
                security standards established under section 1173(d) of 
                the Social Security Act; and
                    (B) how any such variation may adversely impact the 
                electronic exchange of clinical health information 
                among States, the Federal Government, and private 
                entities.
            (2) Report.--Not later than 18 months after the date of the 
        enactment of this Act, the Secretary of Health and Human 
        Services shall submit to Congress a report on the study under 
        paragraph (1) and shall include in such report--
                    (A) a determination by the Secretary whether the 
                State laws and regulations described in such paragraph 
                should be conformed to a set of Federal standards to 
                protect the security and confidentiality of patient 
                health information and to improve health care quality 
                or efficiency; and
                    (B) recommendations for legislation to conform such 
                State laws and regulations to such a set of Federal 
                standards.
            (3) State defined.--For purposes of this subsection, the 
        term ``State'' has the meaning given such term when used in 
        title XI of the Social Security Act, as provided under section 
        1101(a) of such Act (42 U.S.C. 1301(a)).
    (b) Confidentiality and Security Regulations Preemption of State 
Laws If Congress Fails to Establish Uniform Standards.--
            (1) In general.--Section 1178(a) of the Social Security Act 
        (42 U.S.C. 1320d-7(a)) is amended--
                    (A) in paragraph (1) by inserting after ``Except as 
                provided in paragraph (2)'' the following: ``and 
                subject to paragraph (3)''; and
                    (B) by adding at the end the following new 
                paragraph:
            ``(3) Uniform standards.--
                    ``(A) In general.--If legislation to create uniform 
                Federal standards, and to preempt State laws, with 
                respect to the confidentiality and security of 
                individually identifiable health information is not 
                enacted by Congress on the date that is 36 months after 
                the date of the enactment of the Electronic Health 
                Information Technology Act of 2006, the regulation and 
                standards described in subparagraph (B) shall supersede 
                any contrary provision of State law.
                    ``(B) Application of uniform standards.--The 
                regulation and standards described in this subparagraph 
                are the regulation promulgated under section 264(c)(1) 
                of the Health Insurance Portability and Accountability 
                Act of 1996 and the standards under section 1173(d), as 
                modified by the Secretary to the extent the Secretary 
                determines, after consideration of the results of the 
                study conducted under section 6(a) of the Electronic 
                Health Information Technology Act of 2006, necessary to 
                promote uniform national standards.''.
            (2) HIPAA conforming amendment.--Section 264(c)(2) of the 
        Health Insurance Portability and Accountability Act of 1996 (42 
        U.S.C. 1320d-2 note) is amended by striking ``A regulation'' 
        and inserting ``(A) Subject to section 1178(a)(3) of the Social 
        Security Act, a regulation''.
                                 <all>