110 HR 7038 IH: Independent Health Record Trust
U.S. House of Representatives
2008-09-24
text/xml
EN
Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.
1.Short Title; Table of
Contents
(a)This Act may be cited
as the Health Care Services Commission
Act
.
(b)
Sec. 1. Short Titlte; table of Contents.
Title I—ESTABLISHMENT AND GENERAL DUTIES
Sec. 101. Establishment.
Sec. 102. General authorities and duties.
Sec. 103. Dissemination.
Title II—FORUM FOR QUALITY AND EFFECTIVENESS IN HEALTH
CARE
Sec. 201. Establishment of office.
Sec. 202. Membership.
Sec. 203. Duties.
Sec. 204. Adoption and enforcement of guidelines and
standards.
Sec. 205. Additional requirements.
Title III—GENERAL PROVISIONS
Sec. 301. Certain administrative authorities.
Sec. 302. Funding.
Sec. 303. Definitions.
Title IV—TERMINATIONS AND TRANSITION
Sec. 401. Termination of Agency for Healthcare Research and
Quality.
Sec. 402. Transition.
Title V—INDEPENDENT HEALTH RECORD TRUST
Sec. 501. Title V short title.
Sec. 502. Purpose.
Sec. 503. Definitions.
Sec. 504. Establishment, certification, and membership of
independent health record trusts.
Sec. 505. Duties of IHRT to IHRT participants.
Sec. 506. Availability and use of information from records in
IHRT consistent with privacy protections and agreements.
Sec. 507. Voluntary nature of trust participation and
information sharing.
Sec. 508. Financing of activities.
Sec. 509. Regulatory oversight.
<enum>I</enum><header>ESTABLISHMENT AND
GENERAL DUTIES</header>
<section id="H711C3AFA08E94C02A9E5D0FB6FB17888"><enum>101.</enum><header>Establishment</header>
<subsection id="HD392F6EF5D8A40A1A45D87CBA7173F08"><enum>(a)</enum><header>In
general</header><text>There is hereby established a Health Care Services
Commission (in this Act, referred to as the <quote>Commission</quote>) to be
composed of five commissioners (in this Act referred to as the
<quote>Commissioners</quote>) to be appointed by the President by and with the
advice and consent of the Senate. Not more than three of such commissioners
shall be members of the same political party, and in making appointments
members of different political parties shall be appointed alternately as nearly
as may be practicable. No commissioner shall engage in any other business,
vocation, or employment than that of serving as commissioner. Each commissioner
shall hold office for a term of five years and until his successor is appointed
and has qualified, except that he shall not so continue to serve beyond the
expiration of the next session of Congress subsequent to the expiration of said
fixed term of office, and except (1) any commissioner appointed to fill a
vacancy occurring prior to the expiration of the term for which his predecessor
was appointed shall be appointed for the remainder of such term, and (2) the
terms of office of the commissioners first taking office after the enactment of
this Act shall expire as designated by the President at the time of nomination,
one at the end of one year, one at the end of two years, one at the end of
three years, one at the end of four years, and one at the end of five years,
after the date of the enactment of this Act.</text>
</subsection><subsection id="H3DD6A32EFE314D3ABA51BAD85977C778"><enum>(b)</enum><header>Purpose</header><text>The
purpose of the Commission is to enhance the quality, appropriateness, and
effectiveness of health care services, and access to such services, through the
establishment of a broad base of scientific research and through the promotion
of improvements in clinical practice and in the organization, financing, and
delivery of health care services.</text>
</subsection><subsection id="H8288066332E34B32A6DD4656A081766B"><enum>(c)</enum><header>Appointment of
chairman</header><text display-inline="yes-display-inline">The President shall,
from among the Commissioners appointed under subsection (a), designate an
individual to serve as the Chairman of the Commission.</text>
</subsection></section><section id="H0E614E0F2F114B3BA5B6C58681ED486F"><enum>102.</enum><header>General
authorities and duties</header>
<subsection id="H84887A96D4F143BA00341B4B82F7C4AC"><enum>(a)</enum><header>In
general</header><text>In carrying out section 101(b), the Commissioners shall
conduct and support research, demonstration projects, evaluations, training,
guideline development, and the dissemination of information, on health care
services and on systems for the delivery of such services, including activities
with respect to—</text>
<paragraph id="H50D166D2A5744462B08C93F7C78BAB6"><enum>(1)</enum><text>the effectiveness,
efficiency, and quality of health care services;</text>
</paragraph><paragraph id="HBF7512ABB73B4612A4DA65399DF36470"><enum>(2)</enum><text>the outcomes of
health care services and procedures;</text>
</paragraph><paragraph id="HFA0A8AFE454E4AD6A7FA77C2340943A6"><enum>(3)</enum><text>clinical practice,
including primary care and practice-oriented research;</text>
</paragraph><paragraph id="H86F5FCEA8D8746398E9C48FBE3ABCFE2"><enum>(4)</enum><text>health care
technologies, facilities, and equipment;</text>
</paragraph><paragraph id="H57BBEE7459404C0200C8FBE724F5F584"><enum>(5)</enum><text>health care costs,
productivity, and market forces;</text>
</paragraph><paragraph id="H3E4CC89833CA48CBB592846F00157597"><enum>(6)</enum><text>health promotion
and disease prevention;</text>
</paragraph><paragraph id="H0C90AAF32148471591DC00057665CF49"><enum>(7)</enum><text>health statistics
and epidemiology; and</text>
</paragraph><paragraph id="H99D641BADDF44E9380421DBE12328E10"><enum>(8)</enum><text>medical
liability.</text>
</paragraph></subsection><subsection id="HCEA0EBFC443B41288BB4F5C7BCB44B1C"><enum>(b)</enum><header>Requirements
with respect to rural areas and underserved populations</header><text>In
carrying out subsection (a), the Commissioners shall undertake and support
research, demonstration projects, and evaluations with respect to—</text>
<paragraph id="HA94024327D2443C1B0778B6FA47CE6C1"><enum>(1)</enum><text>the delivery of
health care services in rural areas (including frontier areas); and</text>
</paragraph><paragraph id="H52D2D68AB4804C85B8E4C458269004E3"><enum>(2)</enum><text>the health of
low-income groups, minority groups, and the elderly.</text>
</paragraph></subsection></section><section id="H1977C216BEB84362AC44E9B6DDE06288"><enum>103.</enum><header>Dissemination</header>
<subsection id="HEFC775458B374E5FA136A2D183D17118"><enum>(a)</enum><header>In
general</header><text>The Commissioners shall—</text>
<paragraph id="HF2763EF253394D38B1F32773385902FB"><enum>(1)</enum><text>promptly publish,
make available, and otherwise disseminate, in a form understandable and on as
broad a basis as practicable so as to maximize its use, the results of
research, demonstration projects, and evaluations conducted or supported under
this Act and the guidelines, standards, and review criteria developed under
this Act;</text>
</paragraph><paragraph id="H1F799F3D284E4D54B18B12876896E74B"><enum>(2)</enum><text>promptly make
available to the public data developed in such research, demonstration
projects, and evaluations; and</text>
</paragraph><paragraph id="H7B4A7B492B5148FDBBE9103900ABEF15"><enum>(3)</enum><text>as appropriate,
provide technical assistance to State and local government and health agencies
and conduct liaison activities to such agencies to foster dissemination.</text>
</paragraph></subsection><subsection id="HB8F8134FE5424FFF8F2005A1591BA27F"><enum>(b)</enum><header>Prohibition
against restrictions</header><text>Except as provided in subsection (c), the
Commissioners may not restrict the publication or dissemination of data from,
or the results of, projects conducted or supported under this Act.</text>
</subsection><subsection id="HFBF07FA91BE34DC7A98F4D3043ABA350"><enum>(c)</enum><header>Limitation on
use of certain information</header><text>No information, if an establishment or
person supplying the information or described in it is identifiable, obtained
in the course of activities undertaken or supported under this Act may be used
for any purpose other than the purpose for which it was supplied unless such
establishment or person has consented (as determined under regulations of the
Secretary) to its use for such other purpose. Such information may not be
published or released in other form if the person who supplied the information
or who is described in it is identifiable unless such person has consented (as
determined under regulations of the Secretary) to its publication or release in
other form.</text>
</subsection><subsection id="H356369E3409F437486CFE6BB81BE63BF"><enum>(d)</enum><header>Certain
interagency agreement</header><text>The Commissioners and the Director of the
National Library of Medicine shall enter into an agreement providing for the
implementation of subsection (a)(1).</text>
</subsection></section><enum>II</enum><header>FORUM
FOR QUALITY AND EFFECTIVENESS IN HEALTH CARE</header>
<section display-inline="no-display-inline" id="H710B06F0842745F99B09B8208DAC99EE" section-type="subsequent-section"><enum>201.</enum><header>Establishment of
office</header><text display-inline="no-display-inline">There is established
within the Commission an office to be known as the Office of the Forum for
Quality and Effectiveness in Health Care. The office shall be headed by a
director (referred to in this Act as the <quote>Director</quote>) who shall be
appointed by the Commissioners.</text>
</section><section commented="no" id="HAA6F60A3A69F4B3D807C2C4B20DDAB9C"><enum>202.</enum><header>Membership</header>
<subsection commented="no" id="H8BC2AB1E54874D82B268E4AC7674ACA9"><enum>(a)</enum><header>In
general</header><text display-inline="yes-display-inline">The Office of the
Forum for Quality and Effectiveness in Health Care shall be composed of 15
individuals nominated by private sector health care organizations and appointed
by the Commission and shall include representation from at least the
following:</text>
<paragraph commented="no" id="H40B03E38CE62417AA6DC29EFF837F14"><enum>(1)</enum><text>Health insurance
industry.</text>
</paragraph><paragraph commented="no" id="H21FCA739D95248E2AA7974BCB00A8DE"><enum>(2)</enum><text>Health care
provider groups.</text>
</paragraph><paragraph commented="no" id="H9A935AD0F5CA42EC957D6F8EE6B6B7B4"><enum>(3)</enum><text>Non-profit
organizations.</text>
</paragraph><paragraph commented="no" id="H455DC48C106F4896987FEE10176132F5"><enum>(4)</enum><text>Rural health
organizations.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H45B3DAF1A020424BAB68E3DD4F4DD262"><enum>(b)</enum><header>Terms</header>
<paragraph commented="no" id="HB264A1543F724E0C8D00D6B3E5E9E154"><enum>(1)</enum><header>In
general</header><text display-inline="yes-display-inline">Except as provided in
paragraph (2), members of the Office of the Forum for Quality and Effectiveness
in Health Care shall serve for a term of 5 years.</text>
</paragraph><paragraph commented="no" id="H5C9DE79E8C5541A1A000EABE58F925A9"><enum>(2)</enum><header>Staggered
rotation</header><text display-inline="yes-display-inline">Of the members first
appointed to the Office of the Forum for Quality and Effectiveness in Health
Care, the Commission shall appoint 5 members to serve for a term of 2 years, 5
members to serve for a term of 3 years, and 5 members to serve for a term of 4
years.</text>
</paragraph></subsection><subsection commented="no" id="H6F5A73951A00479B824CA125EDAC7B37"><enum>(c)</enum><header>Treatment of
other employment</header><text display-inline="yes-display-inline">Each member
of the Office of the Forum for Quality and Effectiveness in Health Care shall
serve the Office independently from any other position of employment.</text>
</subsection></section><section commented="no" id="H23F975BC161B4D789067C1F945E0526"><enum>203.</enum><header>Duties</header>
<subsection commented="no" id="H2A0A98A60F704EC994BA4D6B6FABA845"><enum>(a)</enum><header>Establishment of
forum program</header><text>The Commissioners, acting through the Director,
shall establish a program to be known as the Forum for Quality and
Effectiveness in Health Care. For the purpose of promoting transparency in
price, quality, appropriateness, and effectiveness of health care, the
Director, using the process set forth in section 204, shall arrange for the
development and periodic review and updating of standards of quality,
performance measures, and medical review criteria through which health care
providers and other appropriate entities may assess or review the provision of
health care and assure the quality of such care.</text>
</subsection><subsection commented="no" id="H289DB19BFFA44FD4A8C133A843970063"><enum>(b)</enum><header>Certain
requirements</header><text>Guidelines, standards, performance measures, and
review criteria under subsection (a) shall—</text>
<paragraph commented="no" id="HCE1F59C2D5514CAC871494CB7684F1E2"><enum>(1)</enum><text>be based on the
best available research and professional judgment regarding the effectiveness
and appropriateness of health care services and procedures; and</text>
</paragraph><paragraph commented="no" id="H4071CC54B546419B82EB69A79480AB27"><enum>(2)</enum><text>be presented in
formats appropriate for use by physicians, health care practitioners,
providers, medical educators, and medical review organizations and in formats
appropriate for use by consumers of health care.</text>
</paragraph></subsection><subsection commented="no" id="HF0435CB19A3E446A850002E090CC721"><enum>(c)</enum><header>Authority for
contracts</header><text>In carrying out this title, the Director may enter into
contracts with public or nonprofit private entities.</text>
</subsection><subsection id="H231F17CBDA4E488D898591B02FF7DADB"><enum>(d)</enum><header>Public
disclosure of recommendations</header><text display-inline="yes-display-inline">For each fiscal year beginning with 2010,
the Director shall make publicly available the following:</text>
<paragraph id="H823BA72D03884B63BD68A07CA6001DF0"><enum>(1)</enum><text>quarterly reports
for public comment that include proposed recommendations for guidelines,
standards, performance measures, and review criteria under subsection (a) and
any updates to such guidelines, standards, performance measures, and review
criteria; and</text>
</paragraph><paragraph id="H06881DAB2F6747120056DD8DE8690062"><enum>(2)</enum><text>after
consideration of such comments, a final report that contains final
recommendations for such guidelines, standards, performance measures, review
criteria, and updates.</text>
</paragraph></subsection><subsection commented="no" id="HE9539B2C3A3342D99F2F9F8014706410"><enum>(e)</enum><header>Date certain for
initial guidelines and standards</header><text>The Commissioners, by not later
than January 1, 2012, shall assure the development of an initial set of
guidelines, standards, performance measures, and review criteria under
subsection (a).</text>
</subsection></section><section commented="no" id="H9127D8487D7F4194B0CA2034AA6A7DF"><enum>204.</enum><header>Adoption and
enforcement of guidelines and standards</header>
<subsection commented="no" id="H6FD4B987A6EE45A09099A0F8AF91996"><enum>(a)</enum><header>Adoption of
recommendations of Forum for Quality and Effectiveness in Health
Care</header><text display-inline="yes-display-inline">For each fiscal year,
the Commissioners shall adopt the recommendations made for such year in the
final report under subsection (d)(2) of section 203 for guidelines, standards,
performance measures, and review criteria described in subsection (a) of such
section.</text>
</subsection><subsection commented="no" id="HDDAB4E79D5CF4E2A00EB18BB9240FB74"><enum>(b)</enum><header>Enforcement
authority</header><text>The Commissioners, in consultation with the Secretary
of Health and Human Services, have the authority to make recommendations to the
Secretary to enforce compliance of health care providers with the guidelines,
standards, performance measures, and review criteria adopted under subsection
(a). Such recommendations may include the following, with respect to a health
care provider who is not in compliance with such guidelines, standards,
measures, and criteria:</text>
<paragraph commented="no" id="H505E0A2E40EE4BD09FA894900300E88C"><enum>(1)</enum><text display-inline="yes-display-inline">Exclusion from participation in Federal
health care programs (as defined in section 1128B(f) of the Social Security Act
(42 U.S.C. 1320a–7b(f))).</text>
</paragraph><paragraph commented="no" id="H73F7B711FECA403C00AF6D7E96F8117E"><enum>(2)</enum><text>Imposition of a
civil money penalty on such provider.</text>
</paragraph></subsection></section><section id="H6A267321EEA341A6A6696351E559B66D"><enum>205.</enum><header>Additional
requirements</header>
<subsection id="H4FF03191822E4D028747E9EE06D29A3"><enum>(a)</enum><header>Program
agenda</header><text display-inline="yes-display-inline">The Commissioners
shall provide for an agenda for the development of the guidelines, standards,
performance measures, and review criteria described in section 203(a),
including with respect to the standards, performance measures, and review
criteria, identifying specific aspects of health care for which the standards,
performance measures, and review criteria are to be developed and those that
are to be given priority in the development of the standards, performance
measures, and review criteria.</text>
</subsection></section><enum>III</enum><header>GENERAL
PROVISIONS</header>
<section display-inline="no-display-inline" id="H84C9264F55F64634A575BD45004DD830" section-type="subsequent-section"><enum>301.</enum><header>Certain
administrative authorities</header><text display-inline="no-display-inline">The
Commissioners, in carrying out this Act, may accept voluntary and uncompensated
services.</text>
</section><section id="HB9E57BDA1A2A47D585A33D4907A65700"><enum>302.</enum><header>Funding</header><text display-inline="no-display-inline">For the purpose of carrying out this Act,
there are authorized to be appropriated such sums as may be necessary for
fiscal years 2010 through 2014.</text>
</section><section id="HD1076F64E6FF4F6C93033600B12B561E"><enum>303.</enum><header>Definitions</header><text display-inline="no-display-inline">For purposes of this Act:</text>
<paragraph id="HEDC1A9A08E524BAB9FA9B4B205679DEF"><enum>(1)</enum><text>The term
<term>Commissioners</term> means the Commissioners of the Health Care Services
Commission.</text>
</paragraph><paragraph id="HA757ED92221143188D32CE2EBF9C1CCE"><enum>(2)</enum><text>The term
<term>Commission</term> means the Health Care Services Commission.</text>
</paragraph><paragraph id="H68E13A84EB54438DB0642E531EEB91D1"><enum>(3)</enum><text>The term
<term>Director</term> means the Director of the Office of the Forum for Quality
and Effectiveness in Health Care.</text>
</paragraph><paragraph id="H0C307FB480454A1E831081FD5DCFD85E"><enum>(4)</enum><text>The term
<term>Secretary</term> means the Secretary of Health and Human Services.</text>
</paragraph></section><enum>IV</enum><header>TERMINATIONS AND
TRANSITION</header>
<section display-inline="no-display-inline" id="HF30831B3BC3D44048B55B34060785218" section-type="subsequent-section"><enum>401.</enum><header>Termination of
Agency for Healthcare Research and Quality</header><text display-inline="no-display-inline">As of the date of the enactment of this Act,
the Agency for Healthcare Research and Quality is terminated, and title IX of
the Public Health Service Act is repealed.</text>
</section><section id="HFA196A6B991342E993B29D77BD441ECF"><enum>402.</enum><header>Transition</header><text display-inline="no-display-inline">All orders, grants, contracts, privileges,
and other determinations or actions of the Agency for Healthcare Research and
Quality that are effective as of the date before the date of the enactment of
this Act, shall be transferred to the Secretary and shall continue in effect
according to their terms unless changed pursuant to law.</text>
</section><enum>V</enum><header>INDEPENDENT HEALTH
RECORD TRUST</header>
<section display-inline="no-display-inline" id="H8AED7E71E8564B1583E2F5E14938BEF9" section-type="subsequent-section"><enum>501.</enum><header>Title V short
title</header><text display-inline="no-display-inline">This title may be cited
as the <quote><short-title>Independent Health Record Trust
Act of 2008</short-title></quote>.</text>
</section><section id="H58C5EF96974F4D70BCAEAF7341EDA14E" section-type="subsequent-section"><enum>502.</enum><header>Purpose</header><text display-inline="no-display-inline">It is the purpose of this title to provide
for the establishment of a nationwide health information technology network
that—</text>
<paragraph id="H251795893D5542E79D008BC7A06BFA64"><enum>(1)</enum><text>improves health
care quality, reduces medical errors, increases the efficiency of care, and
advances the delivery of appropriate, evidence-based health care
services;</text>
</paragraph><paragraph id="H56A997A158124697878D434537B263AD"><enum>(2)</enum><text>promotes wellness,
disease prevention, and the management of chronic illnesses by increasing the
availability and transparency of information related to the health care needs
of an individual;</text>
</paragraph><paragraph id="H6E87432496534234BBA17D2801007EB9"><enum>(3)</enum><text>ensures that
appropriate information necessary to make medical decisions is available in a
usable form at the time and in the location that the medical service involved
is provided;</text>
</paragraph><paragraph id="HAA6B733B64C9481D8509BCFE78DDFFA5"><enum>(4)</enum><text>produces greater
value for health care expenditures by reducing health care costs that result
from inefficiency, medical errors, inappropriate care, and incomplete
information;</text>
</paragraph><paragraph id="HDA79AF9AEE254077A9BEB1ACBB4619F"><enum>(5)</enum><text>promotes a more
effective marketplace, greater competition, greater systems analysis, increased
choice, enhanced quality, and improved outcomes in health care services;</text>
</paragraph><paragraph id="H9018EA7E1215405781ABD4B73513B23B"><enum>(6)</enum><text>improves the
coordination of information and the provision of such services through an
effective infrastructure for the secure and authorized exchange and use of
health information; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HFF5A5D261B7F4562B2A05ED7A61E3899"><enum>(7)</enum><text display-inline="yes-display-inline">ensures that the health information
privacy, security, and confidentiality of individually identifiable health
information is protected.</text>
</paragraph></section><section id="H30BB8151713149AD8E3EFD8E114E2335" section-type="subsequent-section"><enum>503.</enum><header>Definitions</header><text display-inline="no-display-inline">In this title:</text>
<paragraph commented="no" display-inline="no-display-inline" id="H1F4620912F454741AA19A79C8F20A8D5"><enum>(1)</enum><header>Access</header><text>The
term <term>access</term> means, with respect to an electronic health record,
entering information into such account as well as retrieving information from
such account.</text>
</paragraph><paragraph id="HBABDFB4CFE6642D5AE618BD6BE2313F3"><enum>(2)</enum><header>Account</header><text>The
term <term>account</term> means an electronic health record of an individual
contained in an independent health record trust.</text>
</paragraph><paragraph id="H30883AFD459E47F381BB862175A3AF16"><enum>(3)</enum><header>Affirmative
consent</header><text>The term <term>affirmative consent</term> means, with
respect to an electronic health record of an individual contained in an IHRT,
express consent given by the individual for the use of such record in response
to a clear and conspicuous request for such consent or at the individual’s own
initiative.</text>
</paragraph><paragraph id="H6C9E534A8AFB438398BC7545EE4EE540"><enum>(4)</enum><header>Authorized EHR
data user</header><text display-inline="yes-display-inline">The term
<term>authorized EHR data user</term> means, with respect to an electronic
health record of an IHRT participant contained as part of an IHRT, any entity
(other than the participant) authorized (in the form of affirmative consent) by
the participant to access the electronic health record.</text>
</paragraph><paragraph id="HFE0A952D41B446819ED013C350CFE11E"><enum>(5)</enum><header>Confidentiality</header><text display-inline="yes-display-inline">The term <term>confidentiality</term>
means, with respect to individually identifiable health information of an
individual, the obligation of those who receive such information to respect the
health information privacy of the individual.</text>
</paragraph><paragraph id="H7377F46909D14D67A8AD08D4A8DB96DB"><enum>(6)</enum><header>Electronic
health record</header><text>The term <term>electronic health record</term>
means a longitudinal collection of information concerning a single individual,
including medical records and personal health information, that is stored
electronically.</text>
</paragraph><paragraph id="HBEFC2C90FB6B4D0A93532FD9767E97B0"><enum>(7)</enum><header>Health
information privacy</header><text display-inline="yes-display-inline">The term
<term>health information privacy</term> means, with respect to individually
identifiable health information of an individual, the right of such individual
to control the acquisition, uses, or disclosures of such information.</text>
</paragraph><paragraph commented="no" id="H141BAE9724FB44CEAEC3314F47D03F85"><enum>(8)</enum><header>Health
plan</header><text display-inline="yes-display-inline">The term <term>health
plan</term> means a group health plan (as defined in section 2208(1) of the
Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300bb-8">42 U.S.C. 300bb–8(1)</external-xref>)) as well as a plan that offers
health insurance coverage in the individual market.</text>
</paragraph><paragraph id="HD19B57C49D644A15A4405B97D96BBCF6"><enum>(9)</enum><header>HIPAA privacy
regulations</header><text>The term <term>HIPAA privacy regulations</term> means
the regulations promulgated under section 264(c) of the Health Insurance
Portability and Accountability Act of 1996 (<external-xref legal-doc="usc" parsable-cite="usc/42/1320d-2">42 U.S.C. 1320d–2</external-xref> note).</text>
</paragraph><paragraph id="H7A3D2BF47A7B4BA5004F078E2B4B4BB"><enum>(10)</enum><header>Independent
health record trust; IHRT</header><text>The terms <term>independent health
record trust</term> and <term>IHRT</term> mean a legal arrangement under the
administration of an IHRT operator that meets the requirements of this title
with respect to electronic health records of individuals participating in the
trust or IHRT.</text>
</paragraph><paragraph id="H07199C74A9194E0988FB00DCFF6B24BA"><enum>(11)</enum><header>IHRT
operator</header><text>The term <term>IHRT operator</term> means, with respect
to an IHRT, the organization that is responsible for the administration and
operation of the IHRT in accordance with this title.</text>
</paragraph><paragraph id="H60582542BC8144738214FC7786CF08C0"><enum>(12)</enum><header>IHRT
participant</header><text>The term <term>IHRT participant</term> means, with
respect to an IHRT, an individual who has a participation agreement in effect
with respect to the maintenance of the individual’s electronic health record by
the IHRT.</text>
</paragraph><paragraph id="H1AF28588BD6749AA887C22C18FED85AC"><enum>(13)</enum><header>Individually
identifiable health information</header><text>The term <term>individually
identifiable health information</term> has the meaning given such term in
section 1171(6) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1320d">42 U.S.C. 1320d(6)</external-xref>).</text>
</paragraph><paragraph id="H34B45D7D139548E4958CEC2695E6A5"><enum>(14)</enum><header>Security</header><text>The
term <term>security</term> means, with respect to individually identifiable
health information of an individual, the physical, technological, or
administrative safeguards or tools used to protect such information from
unwarranted access or disclosure.</text>
</paragraph></section><section commented="no" display-inline="no-display-inline" id="H37A865088F4B42B0AA92EBB9A4899DF7"><enum>504.</enum><header>Establishment,
certification, and membership of independent health record trusts</header>
<subsection id="H4A6E86454633444D8C967093C9561201"><enum>(a)</enum><header>Establishment</header><text>Not
later than one year after the date of the enactment of this Act, the Federal
Trade Commission, in consultation with the National Committee on Vital and
Health Statistics, shall prescribe standards for the establishment,
certification, operation, and interoperability of IHRTs to carry out the
purposes described in section 502 in accordance with the provisions of this
title.</text>
</subsection><subsection id="HD4EA906ED4D84759B9BEEC00895D7898"><enum>(b)</enum><header>Certification</header>
<paragraph id="H1070EB4518A141AC9F77BA3800BDB24F"><enum>(1)</enum><header>Certification by
FTC</header><text display-inline="yes-display-inline">The Federal Trade
Commission shall provide for the certification of IHRTs. No IHRT may be
certified unless the IHRT is determined to meet the standards for certification
established under subsection (a).</text>
</paragraph><paragraph id="H206D8751FC424F38BF2F47D600E3EFC2"><enum>(2)</enum><header>Decertification</header><text>The
Federal Trade Commission shall establish a process for the revocation of
certification of an IHRT under this section in the case that the IHRT violates
the standards established under subsection (a).</text>
</paragraph></subsection><subsection display-inline="no-display-inline" id="H6C6EF863F7484F619FBF24E087ADF78F"><enum>(c)</enum><header>Membership</header>
<paragraph id="H0FEBC826AF814661ADFC61C85901F93D"><enum>(1)</enum><header>In
general</header><text>To be eligible to be a participant in an IHRT, an
individual shall—</text>
<subparagraph id="H706A3B89F3774D6CBEF87CD530A190A9"><enum>(A)</enum><text>submit to the IHRT
information as required by the IHRT to establish an electronic health record
with the IHRT; and</text>
</subparagraph><subparagraph id="HBA28A7A0B38A463F92A3675050DBE34F"><enum>(B)</enum><text>enter into a
privacy protection agreement described in section 506(b)(1) with the
IHRT.</text>
</subparagraph><continuation-text continuation-text-level="paragraph">The process
to determine eligibility of an individual under this subsection shall allow for
the establishment by such individual of an electronic health record as
expeditiously as possible if such individual is determined so eligible.</continuation-text></paragraph><paragraph id="H97D809DF663B48A48F7C468051A1EB2"><enum>(2)</enum><header>No limitation on
membership</header><text>Nothing in this subsection shall be construed to
permit an IHRT to restrict membership, including on the basis of health
condition.</text>
</paragraph></subsection></section><section id="HDED7A51E4997452DA005F396BEEDA05C"><enum>505.</enum><header>Duties of IHRT
to IHRT participants</header>
<subsection display-inline="no-display-inline" id="HB705AA737E43418C822B5CEF709BB111"><enum>(a)</enum><header>Fiduciary duty
of IHRT; penalties for violations of fiduciary duty</header>
<paragraph id="H4EA45B77C29D40F8BCD48ED008264205"><enum>(1)</enum><header>Fiduciary
duty</header><text display-inline="yes-display-inline">With respect to the
electronic health record of an IHRT participant maintained by an IHRT, the IHRT
shall have a fiduciary duty to act for the benefit and in the interests of such
participant and of the IHRT as a whole. Such duty shall include obtaining the
affirmative consent of such participant prior to the release of information in
such participant’s electronic health record in accordance with the requirements
of this title.</text>
</paragraph><paragraph id="HA5B5935C8E8D4B289664AC12AE14F15"><enum>(2)</enum><header>Penalties</header><text display-inline="yes-display-inline">If the IHRT knowingly or recklessly
breaches the fiduciary duty described in paragraph (1), the IHRT shall be
subject to the following penalties:</text>
<subparagraph id="H829B7879B3BA4C6D9EE41297FBC401EC"><enum>(A)</enum><text>Loss of
certification of the IHRT.</text>
</subparagraph><subparagraph id="H09A7A8E4F1674D6896C4F487F4540682"><enum>(B)</enum><text>A fine that is not
in excess of $50,000.</text>
</subparagraph><subparagraph id="HCE606EB0ED7C4FE89B3EE0086B349E8"><enum>(C)</enum><text>A term of
imprisonment for the individuals involved of not more than 5 years.</text>
</subparagraph></paragraph></subsection><subsection id="HE10E4A653755485A9981A31B5809FCC8"><enum>(b)</enum><header>Electronic
health record deemed To be held in trust by IHRT</header><text>With respect to
an individual, an electronic health record maintained by an IHRT shall be
deemed to be held in trust by the IHRT for the benefit of the individual and
the IHRT shall have no legal or equitable interest in such electronic health
record.</text>
</subsection></section><section id="H92300CE9A5F64F86A9EBC2D40938FF11"><enum>506.</enum><header>Availability
and use of information from records in IHRT consistent with privacy protections
and agreements</header>
<subsection commented="no" display-inline="no-display-inline" id="H65CF598D161B44A7906565ABB71EA65E"><enum>(a)</enum><header>Protected
electronic health records use and access</header>
<paragraph id="H5D91BF4ABF7F4BE596B66EAC4C5522BB"><enum>(1)</enum><header>General rights
regarding uses of information</header>
<subparagraph id="H73D7B22BE5464790A39CCD1000003F23"><enum>(A)</enum><header>In
general</header><text>With respect to the electronic health record of an IHRT
participant maintained by an IHRT, subject to paragraph (2)(C), primary uses
and secondary uses (described in subparagraphs (B) and (C), respectively) of
information within such record (other than by such participant) shall be
permitted only upon the authorization of such use, prior to such use, by such
participant.</text>
</subparagraph><subparagraph id="HED622E32A8DD48C6B8C73C6B62BB70F8"><enum>(B)</enum><header>Primary
uses</header><text>For purposes of subparagraph (A) and with respect to an
electronic health record of an individual, a primary use is a use for purposes
of the individual’s self-care or care by health care professionals.</text>
</subparagraph><subparagraph id="H275378F5975F43078624D406A7E0B1B1"><enum>(C)</enum><header>Secondary
uses</header><text display-inline="yes-display-inline">For purposes of
subparagraph (B) and with respect to an electronic health record of an
individual, a secondary use is any use not described in subparagraph (B) and
includes a use for purposes of public health research or other related
activities. Additional authorization is required for a secondary use extending
beyond the original purpose of the secondary use authorized by the IHRT
participant involved. Nothing in this paragraph shall be construed as requiring
authorization for every secondary use that is within the authorized original
purpose.</text>
</subparagraph></paragraph><paragraph id="HED9ACD8A3FB24E7C93DBD08E8FEFF0E8"><enum>(2)</enum><header>Rules for
primary use of records for health care purposes</header><text>With respect to
the electronic health record of an IHRT participant (or specified parts of such
electronic health record) maintained by an IHRT standards for access to such
record shall provide for the following:</text>
<subparagraph id="HE4C8DA97C37A40B600FF8E34D29C95E8"><enum>(A)</enum><header>Access by IHRT
participants to their electronic health records</header>
<clause id="HC5961A2E441E4F6882B2AC0696035672"><enum>(i)</enum><header>Ownership</header><text>The
participant maintains ownership over the entire electronic health record (and
all portions of such record) and shall have the right to electronically access
and review the contents of the entire record (and any portion of such record)
at any time, in accordance with this subparagraph.</text>
</clause><clause id="H64D721570AEE489D94EE9EFDAD8222E"><enum>(ii)</enum><header>Addition of
personal information</header><text display-inline="yes-display-inline">The
participant may add personal health information to the health record of that
participant, except that such participant shall not alter information that is
entered into the electronic health record by any authorized EHR data user. Such
participant shall have the right to propose an amendment to information that is
entered by an authorized EHR data user pursuant to standards prescribed by the
Federal Trade Commission for purposes of amending such information.</text>
</clause><clause id="HC7B25544D03045CD87F2E6B98266876F"><enum>(iii)</enum><header>Identification
of information entered by participant</header><text display-inline="yes-display-inline">Any additions or amendments made by the
participant to the health record shall be identified and disclosed within such
record as being made by such participant.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H52EC920451684BBBB8C7C000B3DC7EEC"><enum>(B)</enum><header>Access by
entities other than IHRT participant</header>
<clause id="H9F3289C8B6D14E559633E74449417532"><enum>(i)</enum><header>Authorized
access only</header><text>Except as provided under subparagraph (C) and
paragraph (4), access to the electronic health record (or any portion of the
record)—</text>
<subclause id="HC1CF7E72666B4E998FBA6EDD4097B2A"><enum>(I)</enum><text>may be made only by
authorized EHR data users and only to such portions of the record as specified
by the participant; and</text>
</subclause><subclause id="H1FA3ABA5D308424082DB8F3F7DFAA518"><enum>(II)</enum><text>may be limited by
the participant for purposes of entering information into such record,
retrieving information from such record, or both.</text>
</subclause></clause><clause id="HB3EEB887D91C49C28033C0E4519F8B60"><enum>(ii)</enum><header>Identification
of entity that enters information</header><text>Any information that is added
by an authorized EHR data user to the health record shall be identified and
disclosed within such record as being made by such user.</text>
</clause><clause commented="no" id="HBC9B0E25DD21417D9EE449026D1F3C1D"><enum>(iii)</enum><header>Satisfaction
of HIPAA privacy regulations</header><text display-inline="yes-display-inline">In the case of a record of a covered entity
(as defined for purposes of HIPAA privacy regulations), with respect to an
individual, if such individual is an IHRT participant with an independent
health record trust and such covered entity is an authorized EHR data user, the
requirement under the HIPAA privacy regulations for such entity to provide the
record to the participant shall be deemed met if such entity, without charge to
the IHRT or the participant—</text>
<subclause commented="no" id="H70F09CCCD99F439FA5FF16C44FC82C5"><enum>(I)</enum><text>forwards to the
trust an appropriately formatted electronic copy of the record (and updates to
such records) for inclusion in the electronic health record of the participant
maintained by the trust;</text>
</subclause><subclause commented="no" id="H2D78FD7EE0D640ACA977F5DB14292BCF"><enum>(II)</enum><text>enters such
record into the electronic health record of the participant so maintained;
or</text>
</subclause><subclause id="H74FAC9C9078A472994EA965055C1DBAB"><enum>(III)</enum><text>otherwise makes
such record available for electronic access by the IHRT or the individual in a
manner that permits such record to be included in the account of the individual
contained in the IHRT.</text>
</subclause></clause><clause id="H8CC9E7C58A0C4960B4C441A0AF44B3F"><enum>(iv)</enum><header>Notification of
sensitive information</header><text>Any information, with respect to the
participant, that is sensitive information, as specified by the Federal Trade
Commission, shall not be forwarded or entered by an authorized EHR data user
into the electronic health record of the participant maintained by the trust
unless the user certifies that the participant has been notified of such
information.</text>
</clause></subparagraph><subparagraph id="H844C61D75AF64A1C98F48064CEA55F15"><enum>(C)</enum><header>Deemed
authorization for access for emergency health care</header>
<clause id="H894B29B1E4CA4E338C2E844D7344A5C9"><enum>(i)</enum><header>Findings</header><text>Congress
finds that—</text>
<subclause id="H334A760C85954A84872F35DB160059E2"><enum>(I)</enum><text>given the size and
nature of visits to emergency departments in the United States, readily
available health information could make the difference between life and death;
and</text>
</subclause><subclause id="H2F446B8FD6164B80852201EA994C9546"><enum>(II)</enum><text>because of the
case mix and volume of patients treated, emergency departments are well
positioned to provide information for public health surveillance, community
risk assessment, research, education, training, quality improvement, and other
uses.</text>
</subclause></clause><clause id="H8B9D68CA0E894643BE7F798CB3E1A865"><enum>(ii)</enum><header>Use of
information</header><text>With respect to the electronic health record of an
IHRT participant (or specified parts of such electronic health record)
maintained by an IHRT, the participant shall be deemed as providing
authorization (in the form of affirmative consent) for health care providers to
access, in connection with providing emergency care services to the
participant, a limited, authenticated information set concerning the
participant for emergency response purposes, unless the participant specifies
that such information set (or any portion of such information set) may not be
so accessed. Such limited information set may include information—</text>
<subclause id="HBD090E1CF3924F76AB57F8CF0783C864"><enum>(I)</enum><text>patient
identification data, as determined appropriate by the participant;</text>
</subclause><subclause id="HB00ECCFF0B7E4D81B594D5ECF9B55159"><enum>(II)</enum><text>provider
identification that includes the use of unique provider identifiers;</text>
</subclause><subclause id="HEF056D063A7A4A71B1E4D7F576B1D427"><enum>(III)</enum><text>payment
information;</text>
</subclause><subclause id="H6E36178D112D4CDC86C8BC46C9CDDCDF"><enum>(IV)</enum><text>information
related to the individual’s vitals, allergies, and medication history;</text>
</subclause><subclause id="H84415D4AA8F04E4B86E55EBA15C9BB84"><enum>(V)</enum><text>information
related to existing chronic problems and active clinical conditions of the
participant; and</text>
</subclause><subclause id="HD6F74AC2533F4081AD9C7709E0002B36"><enum>(VI)</enum><text>information
concerning physical examinations, procedures, results, and diagnosis
data.</text>
</subclause></clause></subparagraph></paragraph><paragraph commented="no" id="HBE766F77202F4276BB29DAF85865F2B"><enum>(3)</enum><header>Rules for
secondary uses of records for research and other purposes</header>
<subparagraph id="H12D9D77231AD40E1AB14CB4C0030E4C4"><enum>(A)</enum><header>In
general</header><text>With respect to the electronic health record of an IHRT
participant (or specified parts of such electronic health record) maintained by
an IHRT, the IHRT may sell such record (or specified parts of such record) only
if—</text>
<clause commented="no" id="HD5E2609954474D4EB605F27C7283B87C"><enum>(i)</enum><text>the transfer is
authorized by the participant pursuant to an agreement between the participant
and the IHRT and is in accordance with the privacy protection agreement
described in subsection (b)(1) entered into between such participant and such
IHRT;</text>
</clause><clause commented="no" id="H2961AAA3A35147FCB41EAA8929D6D3CA"><enum>(ii)</enum><text>such agreement
includes parameters with respect to the disclosure of information involved and
a process for the authorization of the further disclosure of information in
such record;</text>
</clause><clause id="HDCADACCF91D44180A1E287C73C85E61B"><enum>(iii)</enum><text>the information
involved is to be used for research or other activities only as provided for in
the agreement;</text>
</clause><clause id="HD87552782A8B4A4BB7B19CB867E53CA5"><enum>(iv)</enum><text>the
recipient of the information provides assurances that the information will not
be further transferred or reused in violation of such agreement; and</text>
</clause><clause commented="no" id="HCA3AD943AC7E48239DBF554E9537BA00"><enum>(v)</enum><text>the transfer
otherwise meets the requirements and standards prescribed by the Federal Trade
Commission.</text>
</clause></subparagraph><subparagraph id="H8C786BCB19B3487293837D6DBD2CCB55"><enum>(B)</enum><header>Treatment of
public health reporting</header><text>Nothing in this paragraph shall be
construed as prohibiting or limiting the use of health care information of an
individual, including an individual who is an IHRT participant, for public
health reporting (or other research) purposes prior to the inclusion of such
information in an electronic health record maintained by an IHRT.</text>
</subparagraph></paragraph><paragraph id="H91B48664B9954D0081260081578EE5E9"><enum>(4)</enum><header>Law enforcement
clarification</header><text display-inline="yes-display-inline">Nothing in this
title shall prevent an IHRT from disclosing information contained in an
electronic health record maintained by the IHRT when required for purposes of a
lawful investigation or official proceeding inquiring into a violation of, or
failure to comply with, any criminal or civil statute or any regulation, rule,
or order issued pursuant to such a statute.</text>
</paragraph><paragraph id="H8CF3C1B9310F42B9811320704875FD36"><enum>(5)</enum><header>Rule of
construction</header><text>Nothing in this section shall be construed to
require a health care provider that does not utilize electronic methods or
appropriate levels of health information technology on the date of the
enactment of this Act to adopt such electronic methods or technology as a
requirement for participation or compliance under this title.</text>
</paragraph></subsection><subsection id="HAA0541CD3CFA4B3C8C61F46C4E92ACB9"><enum>(b)</enum><header>Privacy
protection agreement; treatment of State privacy and security laws</header>
<paragraph id="H2B201798DF394EB1A2C80DC89CD1BD5"><enum>(1)</enum><header>Privacy
protection agreement</header><text>A privacy protection agreement described in
this subsection is an agreement, with respect to an electronic health record of
an IHRT participant to be maintained by an independent health record trust,
between the participant and the trust—</text>
<subparagraph id="HEBA68533FC4C4A858042BE120904F1EC"><enum>(A)</enum><text>that is consistent
with the standards described in subsection (a)(2);</text>
</subparagraph><subparagraph id="H51D15CFF4B6845C78746A5FD6204D317"><enum>(B)</enum><text display-inline="yes-display-inline">under which the participant specifies the
portions of the record that may be accessed, under what circumstances such
portions may be accessed, any authorizations for indicated authorized EHR data
users to access information contained in the record, and the purposes for which
the information (or portions of the information) in the record may be
used;</text>
</subparagraph><subparagraph id="HBA1831D7824642D089D6795D008CC433"><enum>(C)</enum><text display-inline="yes-display-inline">which provides a process for the
authorization of the transfer of information contained in the record to a third
party, including for the sale of such information for purposes of research, by
an authorized EHR data user and reuse of such information by such third party,
including a provision requiring that such transfer and reuse is not in
violation of any privacy or transfer restrictions placed by the participant on
the independent health record of such participant; and</text>
</subparagraph><subparagraph id="H30F8585E358145E3A65CCFCAD2BA789"><enum>(D)</enum><text>under which the
trust provides assurances that the trust will not transfer, disclose, or
provide access to the record (or any portion of the record) in violation of the
parameters established in the agreement or to any person or entity who has not
agreed to use and transfer such record (or portion of such record) in
accordance with such agreement.</text>
</subparagraph></paragraph><paragraph id="H51BA9EEF4E784DEAA881A3FDC7FB17E1"><enum>(2)</enum><header>Treatment of
State laws</header>
<subparagraph id="H67E58EF085F940EF9076A13EE1E7B644"><enum>(A)</enum><header>In
general</header><text>Except as provided under subparagraph (B), the provisions
of a privacy protection agreement entered into between an IHRT and an IHRT
participant shall preempt any provision of State law (or any State regulation)
relating to the privacy and confidentiality of individually identifiable health
information or to the security of such health information.</text>
</subparagraph><subparagraph id="H733FF39545254B81AF4D517100889BD4"><enum>(B)</enum><header>Exception for
privileged information</header><text>The provisions of a privacy protection
agreement shall not preempt any provision of State law (or any State
regulation) that recognizes privileged communications between physicians,
health care practitioners, and patients of such physicians or health care
practitioners, respectively.</text>
</subparagraph><subparagraph id="H4BB03B6EB73B4653ABE2B0D11AAB87F"><enum>(C)</enum><header>State
defined</header><text>For purposes of this section, the term <term>State</term>
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 (<external-xref legal-doc="usc" parsable-cite="usc/42/1301">42 U.S.C. 1301(a)</external-xref>).</text>
</subparagraph></paragraph></subsection></section><section id="H84CEE2A454634B07BE8E211BEB4124E2"><enum>507.</enum><header>Voluntary
nature of trust participation and information sharing</header>
<subsection id="H7408F4F085674B7CA9F1E096F8A0C79"><enum>(a)</enum><header>In
general</header><text>Participation in an independent health record trust, or
authorizing access to information from such a trust, is voluntary. No employer,
health insurance issuer, group health plan, health care provider, or other
person may require, as a condition of employment, issuance of a health
insurance policy, coverage under a group health plan, the provision of health
care services, payment for such services, or otherwise, that an individual
participate in, or authorize access to information from, an independent health
record trust.</text>
</subsection><subsection id="H3AC2309E69094B258FA704F8736075F0"><enum>(b)</enum><header>Enforcement</header><text>The
penalties provided for in subsection (a) of section 1177 of the Social Security
Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1320d-6">42 U.S.C. 1320d–6</external-xref>) shall apply to a violation of subsection (a) in the
same manner as such penalties apply to a person in violation of subsection (a)
of such section.</text>
</subsection></section><section id="HD6D925B61F864968A58DD3ACF9685BA0"><enum>508.</enum><header>Financing of
activities</header>
<subsection id="H218FBCC6B8F34B21BB61DB0550EBC02E"><enum>(a)</enum><header>In
general</header><text>Except as provided in subsection (b), an IHRT may
generate revenue to pay for the operations of the IHRT through—</text>
<paragraph id="H7BA4EF3CBC804A4B8B16787CF6FF071D"><enum>(1)</enum><text>charging IHRT
participants account fees for use of the trust;</text>
</paragraph><paragraph id="H8DE878198B4947E4AE17A9C4E37E751"><enum>(2)</enum><text>charging authorized
EHR data users for accessing electronic health records maintained in the
trust;</text>
</paragraph><paragraph id="H06FDBC7714F140F29019A5C1EB30905F"><enum>(3)</enum><text>the sale of
information contained in the trust (as provided for in section 506(a)(3)(A));
and</text>
</paragraph><paragraph id="H96ECEEF3FA6F49119EAD4DFADAEED7"><enum>(4)</enum><text>any
other activity determined appropriate by the Federal Trade Commission.</text>
</paragraph></subsection><subsection id="HACBAA72822D14B11A2E033AE0018E570"><enum>(b)</enum><header>Prohibition
against access fees for health care providers</header><text display-inline="yes-display-inline">For purposes of providing incentives to
health care providers to access information maintained in an IHRT, as
authorized by the IHRT participants involved, the IHRT may not charge a fee for
services specified by the IHRT. Such services shall include the transmittal of
information from a health care provider to be included in an independent
electronic health record maintained by the IHRT (or permitting such provider to
input such information into the record), including the transmission of or
access to information described in section 506(a)(2)(C)(ii) by appropriate
emergency responders.</text>
</subsection><subsection id="H75378AD2ED294465B02C27B68CC85800"><enum>(c)</enum><header>Required
disclosures</header><text>The sources and amounts of revenue derived under
subsection (a) for the operations of an IHRT shall be fully disclosed to each
IHRT participant of such IHRT and to the public.</text>
</subsection><subsection commented="no" id="H70F8E15B1C694EA995568BFCA2098025"><enum>(d)</enum><header>Treatment of
income</header><text>For purposes of the Internal Revenue Code of 1986, any
revenue described in subsection (a) shall not be included in gross income of
any IHRT, IHRT participant, or authorized EHR data user.</text>
</subsection></section><section commented="no" display-inline="no-display-inline" id="H44A7B824AC7E48F2AA2000879DC7D9BA" section-type="subsequent-section"><enum>509.</enum><header>Regulatory
oversight</header>
<subsection id="H827B90AFE8C24322B1C23D734F4E1F1F"><enum>(a)</enum><header>In
general</header><text>In carrying out this title, the Federal Trade Commission
shall promulgate regulations for independent health record trusts.</text>
</subsection><subsection id="HC5F8C088B6D843FB9F00ACF793287BCC"><enum>(b)</enum><header>Establishment of
Interagency Steering Committee</header>
<paragraph id="H1E677C8C0FAF427C8654E2DE1F8F5567"><enum>(1)</enum><header>In
general</header><text>The Secretary of Health and Human Services shall
establish an Interagency Steering Committee in accordance with this
subsection.</text>
</paragraph><paragraph id="H40652D4C17BB482500FCF14F3E156C5F"><enum>(2)</enum><header>Chairperson</header><text>The
Secretary of Health and Human Services shall serve as the chairperson of the
Interagency Steering Committee.</text>
</paragraph><paragraph id="HB72F3C9488414EF49E0072CA75CC67FB"><enum>(3)</enum><header>Membership</header><text>The
members of the Interagency Steering Committee shall consist of the Attorney
General, the Chairperson of the Federal Trade Commission, the Chairperson for
the National Committee for Vital and Health Statistics, a representative of the
Federal Reserve, and other Federal officials determined appropriate by the
Secretary of Health and Human Services.</text>
</paragraph><paragraph id="HFB5AD3B2FB4049E087BA2CE7F5149CFB"><enum>(4)</enum><header>Duties</header><text>The
Interagency Steering Committee shall coordinate the implementation of this
title, including the implementation of policies described in subsection (d)
based upon the recommendations provided under such subsection, and regulations
promulgated under this title.</text>
</paragraph></subsection><subsection id="H0BEA6126D2694DB39298538CB488CA83"><enum>(c)</enum><header>Federal advisory
committee</header>
<paragraph id="H32F3EC59962A4A80BABAD56CDAE0C6A4"><enum>(1)</enum><header>In
general</header><text>The National Committee for Vital and Health Statistics
shall serve as an advisory committee for the IHRTs. The membership of such
advisory committee shall include a representative from the Federal Trade
Commission and the chairperson of the Interagency Steering Committee. Not less
than 60 percent of such membership shall consist of representatives of
nongovernment entities, at least one of whom shall be a representative from an
organization representing health care consumers.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HD7B69B8BF7DA4F8E9F75FEF8421567FC"><enum>(2)</enum><header>Duties</header><text>The
National Committee for Vital and Health Statistics shall issue periodic reports
and review policies concerning IHRTs based on each of the following
factors:</text>
<subparagraph id="H1180D133CACF46EEA8D81F8BD7EDCC6D"><enum>(A)</enum><text>Privacy and
security policies.</text>
</subparagraph><subparagraph id="H02A311983B4445F2A825C2F47CD5E503"><enum>(B)</enum><text>Economic
progress.</text>
</subparagraph><subparagraph id="H99504FE5275C46BDA5A4293FABE7005F"><enum>(C)</enum><text>Interoperability
standards.</text>
</subparagraph></paragraph></subsection><subsection id="HC92B4600C25046CF9688E6B4923CC2A9"><enum>(d)</enum><header>Policies
recommended by Federal Trade Commission</header><text>The Federal Trade
Commission, in consultation with the National Committee for Vital and Health
Statistics, shall recommend policies to—</text>
<paragraph id="HBAFCE7E835644E46A132A473D50139CF"><enum>(1)</enum><text>provide assistance
to encourage the growth of independent health record trusts;</text>
</paragraph><paragraph id="H404A71613CAB43E3A4E6008678533563"><enum>(2)</enum><text>track economic
progress as it pertains to operators of independent health records trusts and
individuals receiving nontaxable income with respect to accounts;</text>
</paragraph><paragraph id="HFE06EF887E834AA4A3627B5CB2A1850"><enum>(3)</enum><text>conduct public
education activities regarding the creation and usage of the independent health
records trusts;</text>
</paragraph><paragraph id="HF80EBB3EE7CE49949E43309B5D3BCEC7"><enum>(4)</enum><text display-inline="yes-display-inline">establish standards for the
interoperability of health information technology to ensure that information
contained in such record may be shared between the trust involved, the
participant, and authorized EHR data users, including for the standardized
collection and transmission of individual health records (or portions of such
records) to authorized EHR data users through a common interface and for the
portability of such records among independent health record trusts; and</text>
</paragraph><paragraph id="H5372028B963D4484942C6F3B7B0005CD"><enum>(5)</enum><text>carry out any
other activities determined appropriate by the Federal Trade Commission.</text>
</paragraph></subsection><subsection id="H336652AB4B8E4D489591944E23C3E4EB"><enum>(e)</enum><header>Regulations
promulgated by Federal Trade Commission</header><text>The Federal Trade
Commission shall promulgate regulations based on, at a minimum, the following
factors:</text>
<paragraph id="H8C01BA5C7B634C039C4C9827C78BB094"><enum>(1)</enum><text>Requiring that an
IHRT participant, who has an electronic health record that is maintained by an
IHRT, be notified of a security breech with respect to such record, and any
corrective action taken on behalf of the participant.</text>
</paragraph><paragraph id="H76F907DB90C748B089BA407116BB9B4C"><enum>(2)</enum><text>Requiring that
information sent to, or received from, an IHRT that has been designated as
high-risk should be authenticated through the use of methods such as the
periodic changing of passwords, the use of biometrics, the use of tokens or
other technology as determined appropriate by the council.</text>
</paragraph><paragraph id="H9E3B2016AA594598BF501423B87E5680"><enum>(3)</enum><text>Requiring a delay
in releasing sensitive health care test results and other similar information
to patients directly in order to give physicians time to contact the
patient.</text>
</paragraph><paragraph id="H1EFE3E751CAB4A1DA52071CB443F5618"><enum>(4)</enum><text>Recommendations
for entities operating IHRTs, including requiring analysis of the potential
risk of health transaction security breeches based on set criteria.</text>
</paragraph><paragraph id="HE9B627CB177148C889BFD0095FFAC63"><enum>(5)</enum><text>The conduct of
audits of IHRTs to ensure that they are in compliance with the requirements and
standards established under this title.</text>
</paragraph><paragraph id="H39F9F87CC0A64E43BF520882DE422453"><enum>(6)</enum><text>Disclosure to IHRT
participants of the means by which such trusts are financed, including revenue
from the sale of patient data.</text>
</paragraph><paragraph id="H030876A259414D328DB0E9A5065C5308"><enum>(7)</enum><text>Prevention of
certification of an entity seeking independent heath record trust certification
based on—</text>
<subparagraph id="HF544963649134E4883E1B4AADAA76CFF"><enum>(A)</enum><text>the potential for
conflicts between the interests of such entity and the security of the health
information involved; and</text>
</subparagraph><subparagraph id="H7428B81CD5604E1887C4DF5700ABE046"><enum>(B)</enum><text>the involvement of
the entity in any activity that is contrary to the best interests of a
patient.</text>
</subparagraph></paragraph><paragraph id="HCA668CBFBA38448CA09DEECEA899D6E8"><enum>(8)</enum><text>Prevention of the
use of revenue sources that are contrary to a patient’s interests.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H39E8AD427C9B4617A157D6D995E8A89B"><enum>(9)</enum><text>Public disclosure
of audits in a manner similar to financial audits required for publicly traded
stock companies.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H94C3BAC654D0491689FB79DF86E8CC68"><enum>(10)</enum><text>Requiring
notification to a participating entity that the information contained in such
record may not be representative of the complete or accurate electronic health
record of such account holder.</text>
</paragraph></subsection><subsection id="HFBC2FABC91E245D0BED1EF126F4CA88"><enum>(f)</enum><header>Compliance
report</header><text>Not later than 1 year after the date of the enactment of
this Act, and annually thereafter, the Commission shall submit to the Committee
on Health, Education, Labor, and Pensions and the Committee on Finance of the
Senate and the Committee on Energy and Commerce and the Committee on Ways and
Means of the House of Representatives, a report on compliance by and progress
of independent health record trusts with this title. Such report shall describe
the following:</text>
<paragraph id="H88374564BFB0487C8EF789AEE08DD0D1"><enum>(1)</enum><text>The number of
complaints submitted about independent health record trusts, which shall be
divided by complaints related to security breaches, and complaints not related
to security breaches, and may include other categories as the Interagency
Steering Committee established under subsection (b) determines
appropriate.</text>
</paragraph><paragraph id="H5D244D905ECE48A10019B0E94C43BBE"><enum>(2)</enum><text>The number of
enforcement actions undertaken by the Commission against independent health
record trusts in response to complaints under paragraph (1), which shall be
divided by enforcement actions related to security breaches and enforcement
actions not related to security breaches and may include other categories as
the Interagency Steering Committee established under subsection (b) determines
appropriate.</text>
</paragraph><paragraph id="H1695ABA581A9481A9199489BF85CEF80"><enum>(3)</enum><text>The economic
progress of the individual owner or institution operator as achieved through
independent health record trust usage and existing barriers to such
usage.</text>
</paragraph><paragraph id="HC4F369EE50AD40DB919672E04E1F8155"><enum>(4)</enum><text>The progress in
security auditing as provided for by the Interagency Steering Committee council
under subsection (b).</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HE47A50AAD6DE413C006BD2FF17F083AA"><enum>(5)</enum><text>The other core
responsibilities of the Commission as described in subsection (a).</text>
</paragraph></subsection><subsection id="HE6751EC3953E47BCBE897647006D72FE"><enum>(g)</enum><header>Interagency
memorandum of understanding</header><text>The Interagency Steering Committee
shall ensure, through the execution of an interagency memorandum of
understanding, that—</text>
<paragraph id="H89A40E3377874D2282A25CD74B53D5AD"><enum>(1)</enum><text>regulations,
rulings, and interpretations issued by Federal officials relating to the same
matter over which 2 or more such officials have responsibility under this title
are administered so as to have the same effect at all times; and</text>
</paragraph><paragraph id="HAA6AFF1D1128443CB534F021EECA85FE"><enum>(2)</enum><text>the memorandum
provides for the coordination of policies related to enforcing the same
requirements through such officials in order to have coordinated enforcement
strategy that avoids duplication of enforcement efforts and assigns priorities
in enforcement.</text>
</paragraph></subsection></section>