blood, sperm, organs, or any other tissue; 
or 
(B) any sale or dispensing of a drug, de-
vice, equipment, or other health care-related 
item to an individual, or for the use of an indi-
vidual, pursuant to a prescription. 
(12) HEALTH
CARE
PROVIDER.—The term 
‘‘health care provider’’ means a person that, with re-
spect to a specific item of personal health informa-
tion, receives, accesses, maintains, retains, modifies, 
records, stores, destroys, or otherwise uses or dis-
closes the information while acting in whole or in 
part in the capacity of— 
(A) an entity that is, or holds itself out to 
be, licensed, certified, registered, or otherwise 
authorized by Federal or State law to provide 
an item or service that constitutes health care 
in the ordinary course of business, or practice 
of a profession; 
(B) a contractor or other health care pro-
vider or facility authorized to provide items or 
services related to diagnosis or treatment of a 
health concern, including a hospital, nursing fa-
cility, allied health professional, and a facility 
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used or maintained by allied health profes-
sionals; 
(C) a Federal or State program that di-
rectly provides items or services that constitute 
health care to beneficiaries; 
(D) an officer or employee or agent of a 
person described in subparagraph (A) or (C) 
who is engaged in the provision of health care 
or who uses personal health information; or 
(E) medical personnel in an emergency sit-
uation, including while communicating personal 
health information by radio transmission or 
other means. 
(13) HEALTH
INFORMATION
PERSON.—The 
term ‘‘health information person’’ means, in relation 
to personal health information, a person, including a 
health care provider, health researcher, health plan, 
health insurer, health care clearinghouse, health 
oversight agency, or public health authority, or such 
person’s agent, officer, employee, or affiliate, that 
accesses, maintains, retains, modifies, records, 
stores, or otherwise holds, uses, or discloses such in-
formation. 
(14) HEALTH PLAN.— 
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(A) IN GENERAL.—The term ‘‘health plan’’ 
means— 
(i) a group health plan (as defined in 
section 2791(a)(1) of the Public Health 
Service Act (42 U.S.C. 300gg–91(a)(1))); 
(ii) health insurance coverage (as such 
term is defined in section 2791(b)(1) of 
the Public Health Service Act (42 U.S.C. 
300gg–91(b)(1)); or 
(iii) a safety net health plan (as de-
fined in subparagraph (B)). 
(B) SAFETY
NET
HEALTH
PLAN.—For 
purposes of subparagraph (A)(iii), the term 
‘‘safety net health plan’’ means a managed care 
organization, 
as 
defined 
in 
section 
1932(a)(1)(B)(i) of the Social Security Act— 
(i) that is exempt from or not subject 
to Federal income tax, or that is owned by 
an entity or entities exempt from or not 
subject to Federal income tax; and 
(ii) for which not less than 75 percent 
of the enrolled population receives benefits 
under a Federal health care program (as 
defined in section 1128B(f)(1) of the So-
cial Security Act) or a health care plan or 
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program which is funded, in whole or in 
part, by a State (other than a program for 
government employees). 
(15) HEALTH
OR
LIFE
INSURER.—The term 
‘‘health or life insurer’’ means a health insurance 
issuer (as defined in section 9805(b)(2) of the Inter-
nal Revenue Code of 1986) or a life insurance com-
pany (as defined in section 816 of such Code) and 
includes the employees and agents of such a person. 
(16) HEALTH OVERSIGHT AGENCY.—The term 
‘‘health oversight agency’’— 
(A) means a person that— 
(i) performs or oversees the perform-
ance of an assessment, investigation, or 
prosecution relating to compliance with 
legal or fiscal standards relating to health 
care fraud or fraudulent claims regarding 
health care, health services or equipment, 
related activities and items, or the effec-
tiveness of health privacy and security 
measures; and 
(ii) is a public executive branch agen-
cy, acting on behalf of a public executive 
branch agency, acting pursuant to a re-
quirement of a public executive branch 
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agency, or carrying out activities under a 
Federal or State law governing an assess-
ment, evaluation, determination, investiga-
tion, or prosecution described in clause (i); 
and 
(B) includes the employees and agents of 
such a person. 
(17) HEALTH RECORD SET.—The term ‘‘health 
record set’’ means any item, collection, or grouping 
of information that includes personal health infor-
mation, such as a medical record, electronic health 
record, electronic medical record, personal health 
record, or account of disclosure, use or access, that 
is created, accessed, received, maintained, retained, 
modified, recorded, stored, destroyed, or otherwise 
used or disclosed by a health care provider, em-
ployer, insurer, health plan, health researcher, data 
partner, or other person that relates to the health or 
illness of the body, mind, or genome of an indi-
vidual. 
(18) HEALTH RESEARCHER.—The term ‘‘health 
researcher’’ means a person that is engaged in ac-
tivities conducted for the purpose of advancing pub-
lic knowledge and, with respect to a specific item of 
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personal health information, receives the informa-
tion— 
(A) pursuant to section 142 (relating to 
health research); or 
(B) while acting in whole or in part in the 
capacity of an officer, employee, or agent of a 
person that receives the information pursuant 
to such section. 
(19) INFORMED CONSENT.— 
(A) IN
GENERAL.—Subject to subpara-
graph (B), the term ‘‘informed consent’’ means 
the written authorization for use or disclosure 
of personal health information by the individual 
who is the subject of such information, condi-
tioned upon— 
(i) that individual’s having been in-
formed of the nature and probability of 
harm to the individual resulting from such 
authorization; and 
(ii) the authorization meeting the re-
quirements of section 122(b). 
(B) 
THROUGH
INFERENCE.—Informed 
consent may be inferred, in the absence of a 
contrary indication by the individual— 
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(i) to the extent necessary to provide 
treatment and obtain payment for health 
care in emergency situations; 
(ii) to the extent necessary to provide 
treatment and payment where a health 
care provider is required by law to treat 
the individual; 
(iii) if the health care provider is un-
able to obtain informed consent due to 
substantial barriers to communicating with 
the individual and the provider reasonably 
infers from the circumstances, based upon 
the exercise of professional judgment, that 
the individual does not object to the disclo-
sure or the disclosure is in the best inter-
est of the individual; and 
(iv) to the extent the information is 
necessary to carry out or otherwise imple-
ment a medical or mental health practi-
tioner’s order or prescription for health 
services, medical devices or supplies, or 
pharmaceuticals. 
(C) MULTIPLE USES AND DISCLOSURES.— 
Informed consent may authorize multiple uses 
or disclosures. 
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(20) OFFICE
OF
HEALTH
INFORMATION
PRI-
VACY.—The term ‘‘Office of Health Information Pri-
vacy’’ means the Office of Health Information Pri-
vacy designated under section 161. 
(21) PERSON.—The term ‘‘person’’ means an 
entity that is a government, governmental subdivi-
sion of an executive branch agency or authority, cor-
poration, company, association, firm, partnership, 
society, estate, trust, joint venture, individual, indi-
vidual representative, tribal government, or any 
other legal entity. Such term also includes the em-
ployees, contractors, agents, and affiliates of all legal 
entities described in the preceding sentence, whether 
or not they are acting in the capacity of their em-
ployment, contract, agency, or affiliation. 
(22) PRIVACY.—The term ‘‘privacy’’ means an 
individual’s right to control the acquisition, uses, or 
disclosures of his or her identifiable health data. 
(23) PERSONAL HEALTH INFORMATION.— 
(A) IN
GENERAL.—The term ‘‘personal 
health information’’ means any information, in-
cluding genetic information, biometric informa-
tion, demographic information, and tissue sam-
ples collected from an individual, whether oral 
or recorded in any form or medium, that— 
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(i) is created or received by a health 
care provider, health researcher, health 
plan, health or life insurer, medical or 
health savings plan administrator, health 
care clearinghouse, health oversight agen-
cy, public health authority, employer, data 
partner, or other person or such person’s 
agent, officer, or employee; and 
(ii)(I) relates to the past, present, or 
future physical or mental health or condi-
tion of an individual (including individual 
cells and their components), the provision 
of health care to an individual, or the past, 
present, or future payment for the provi-
sion of health care to an individual; and 
(II)(aa) identifies an individual; or 
(bb) with respect to which there is a 
reasonable basis to believe that the infor-
mation can be used to identify an indi-
vidual. 
(B) INCLUSION
OF
DECRYPTION
KEY.— 
The term ‘‘personal health information’’ in-
cludes any decryption key used for the 
encryption or decryption of information de-
scribed in subparagraph (A). 
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100 
(24) PUBLIC HEALTH AUTHORITY.—The term 
‘‘public health authority’’ means an authority or in-
strumentality of the United States, a tribal govern-
ment, a State, or a political subdivision of a State 
that is— 
(A) primarily responsible for public health 
matters; and 
(B) primarily engaged in activities such as 
injury reporting, public health surveillance, and 
public health investigation or intervention. 
(25) RE-IDENTIFY.—The term ‘‘re-identify’’, 
when used with respect to de-identified health infor-
mation, means an attempt, successful or otherwise, 
to ascertain— 
(A) the identity of the individual who is 
the subject of such information; or 
(B) the decryption key with respect to the 
information (when undertaken with knowledge 
that such key would allow for the identification 
of the individual who is the subject of such in-
formation). 
(26) 
SECRETARY.—The 
term 
‘‘Secretary’’ 
means the Secretary of Health and Human Services. 
(27) SECURITY.—The term ‘‘security’’ means 
physical, technological, or administrative safeguards 
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101 
or tools used to protect identifiable health data from 
unwarranted access or disclosure. 
(28) SECURITY BREACH.—The term ‘‘security 
breach’’ means the physical, structural, or sub-
stantive compromise of the security of personal 
health information, through unauthorized disclosure, 
use, or access, whether actual or attempted, result-
ing in the acquisition, access, or use of such infor-
mation by an unauthorized person. Such term does 
not apply to good faith or accidental acquisition, or 
disclosure of personal health information by an un-
authorized person, so long as no further use or dis-
closure is made by such person. 
(29) 
SEGREGATE.—The 
term 
‘‘segregate’’ 
means to hide, mask, or mark separate a designated 
subset of an individual’s personal health informa-
tion, or to place such a subset in a location that is 
securely separated from the location used to store 
other personal health information, such that access 
to or use of any information so segregated may be 
effectively limited to those persons that are author-
ized by the individual to access or use that seg-
regated information. 
(30) SIGNED.—The term ‘‘signed’’ refers both 
to signatures in ink and to electronic signatures that 
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102 
are authenticated by the individual using an authen-
tication method approved by the Secretary. 
(31) STATE.—The term ‘‘State’’ means each of 
the several States, the District of Columbia, Puerto 
Rico, the Virgin Islands, Guam, American Samoa, 
and the Northern Mariana Islands. 
(32) 
TO
THE
MAXIMUM
EXTENT
PRAC-
TICABLE.—The term ‘‘to the maximum extent prac-
ticable’’ means the level of compliance that a reason-
able person would deem technologically feasible so 
long as such feasibility is periodically evaluated in 
light of scientific advances. 
(33) USE.—The term ‘‘use’’ means to create, 
record, collect, access, obtain, store, maintain, 
amend, correct, restore, modify, supplement, iden-
tify, re-identify, employ, apply, utilize, examine, ana-
lyze, detect, remove, destroy, dispose of, account for, 
or monitor the flow of personal health information. 
(34) WRITING; WRITTEN.—The terms ‘‘writing’’ 
and ‘‘written’’ mean writing or written, respectively, 
in either a paper-based or computer-based form, in-
cluding electronic and digital signatures. 
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103 
TITLE 
II—PROMOTION 
OF 
HEALTH INFORMATION TECH-
NOLOGY 
Subtitle A—Improving the Inter-
operability of Health Informa-
tion Technology 
SEC. 201. OFFICE OF THE NATIONAL COORDINATOR OF 
HEALTH INFORMATION TECHNOLOGY. 
(a) ESTABLISHMENT.—There is established within 
the office of the Secretary, the Office of the National Co-
ordinator of Health Information Technology. The Na-
tional Coordinator shall be appointed by the Secretary in 
consultation with the President, and shall report directly 
to the Secretary. 
(b) PURPOSE.—The Office of the National Coordi-
nator shall be responsible for— 
(1) ensuring that key health information tech-
nology initiatives are coordinated across programs of 
the Department of Health and Human Services; 
(2) ensuring that health information technology 
policies and programs of the Department of Health 
and Human Services are coordinated with such poli-
cies and programs of other relevant Federal agencies 
(including Federal commissions and advisory com-
mittees) with a goal of avoiding duplication of ef-
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104 
forts and of helping to ensure that each agency un-
dertakes activities primarily within the areas of its 
greatest expertise and technical capability; 
(3) reviewing Federal health information tech-
nology investments to ensure that Federal health in-
formation technology programs are meeting the ob-
jectives of the strategic plan published by the Office 
of the National Coordinator of Health Information 
Technology to establish a nationwide interoperable 
health information technology infrastructure; 
(4) providing comments and advice regarding 
specific Federal health information technology pro-
grams, at the request of Office of Management and 
Budget; 
(5) enhancing the use of health information 
technology to improve the quality of health care in 
the prevention and management of chronic disease 
and to address population health; and 
(6) consulting with the Office of Health Infor-
mation Privacy to ensure that key health informa-
tion technology initiatives of the Department of 
Health and Human Services and other Federal 
agencies are consistent with the privacy, confiden-
tiality, and security requirements in title I. 
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105 
(c) ROLE WITH AMERICAN HEALTH INFORMATION 
COMMUNITY AND THE PARTNERSHIP FOR HEALTH CARE 
IMPROVEMENT.—The Office of the National Coordinator 
shall— 
(1) serve as an ex officio member of the Amer-
ican Health Information Community established 
under section 203, and act as a liaison between the 
Federal Government and the Community; 
(2) serve as an ex officio member of the Part-
nership and act as a liaison between the Federal 
Government and the Partnership for Health Care 
Improvement (established under section 202); and 
(3) serve as a liaison between the Partnership 
and the Community. 
(d) REPORTS AND WEBSITE.—The Office of the Na-
tional Coordinator shall— 
(1) develop and publish a strategic plan for im-
plementing a nationwide interoperable health infor-
mation technology infrastructure; 
(2) maintain and frequently update an Internet 
website that— 
(A) publishes the schedule for the assess-
ment of standards for significant use cases; 
(B) publishes the recommendations of the 
American Health Information Community; 
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106 
(C) publishes the recommendations of the 
Partnership for Health Care Improvement; 
(D) publishes quality measures; 
(E) identifies sources of funds that will be 
made available to facilitate the purchase of, or 
enhance the utilization of, health information 
technology systems, either through grants or 
technical assistance; and 
(F) publishes a plan for a transition of any 
functions of the Office of the National Coordi-
nator that should be continued after September 
30, 2014; 
(3) prepare a report on the lessons learned 
from major public and private health care systems 
that have implemented health information tech-
nology systems, including an explanation of whether 
the systems and practices developed by such systems 
may be applicable to and usable in whole or in part 
by other health care providers; and 
(4) assess the impact of health information 
technology in communities with health disparities 
and identify practices to increase the adoption of 
such technology by health care providers in such 
communities. 
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107 
(e) RULE OF CONSTRUCTION.—Nothing in this sec-
tion shall be construed as requiring the duplication of Fed-
eral efforts with respect to the establishment of the Office 
of the National Coordinator of Health Information Tech-
nology, regardless of whether such efforts are carried out 
before or after the date of the enactment of this title. 
(f) AUTHORIZATION OF APPROPRIATIONS.—There is 
authorized to be appropriated to carry out this section, 
$5,000,000 for each of fiscal years 2009 and 2010. 
(g) SUNSET.—The provisions of this section shall not 
apply after September 30, 2014. 
SEC. 202. PARTNERSHIP FOR HEALTH CARE IMPROVE-
MENT. 
(a) ESTABLISHMENT.— 
(1) IN GENERAL.—There is established a pub-
lic-private Partnership for Health Care Improvement 
(in this title referred to as the ‘‘Partnership’’) to— 
(A) provide advice to the Secretary and the 
Nation and recommend specific actions to 
achieve a nationwide interoperable health infor-
mation technology infrastructure; 
(B) make recommendations concerning 
standards, including privacy, security, and con-
fidentiality standards, implementation specifica-
tions, and certification criteria for the electronic 
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108 
exchange of personal health information (in-
cluding for the reporting of quality data under 
section 221) for adoption by the Federal Gov-
ernment and voluntary adoption by private enti-
ties that are consistent with the requirements of 
title I; 
(C) serve as a forum for the participation 
of a broad range of stakeholders with specific 
technical expertise in the development of stand-
ards, implementation specifications, and certifi-
cation criteria and protection of privacy and 
data security to provide input on the effective 
implementation of health information tech-
nology systems; and 
(D) develop and maintain an Internet 
website that— 
(i) publishes established governance 
rules (including a subsequent appointment 
process); 
(ii) publishes a business plan; 
(iii) publishes meeting notices at least 
14 days prior to each meeting; 
(iv) publishes meeting agendas at 
least 7 days prior to each meeting; and 
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109 
(v) publishes meeting materials at 
least 3 days prior to each meeting. 
(2) LIMITATION.—The Partnership shall not 
meet or take any action until an advisory committee 
charter has been filed with the Secretary and with 
the appropriate committees of the Senate and House 
of Representatives for the American Health Infor-
mation Community described in section 203. 
(b) MEMBERSHIP.— 
(1) MEMBERS.—The members of the Partner-
ship shall consist of the following: 
(A) 
APPOINTED
MEMBERS.—The 
ap-
pointed members of the Partnership shall be 
appointed as follows: 
(i) 2 members shall be appointed by 
the Secretary. 
(ii) 1 member shall be appointed by 
the majority leader of the Senate. 
(iii) 1 member shall be appointed by 
the minority leader of the Senate. 
(iv) 1 member shall be appointed by 
the Speaker of the House of Representa-
tives. 
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110 
(v) 1 member shall be appointed by 
the minority leader of the House of Rep-
resentatives. 
(vi) Seven members shall be appointed 
by the Comptroller General of whom— 
(I) one member shall be a rep-
resentative of consumer or patient or-
ganizations; 
(II) one member shall be a rep-
resentative of organizations with ex-
pertise in the protection of privacy; 
(III) one member shall be a rep-
resentative of organizations with ex-
pertise in security; 
(IV) one member shall be a rep-
resentative of health care providers; 
(V) one member shall be a rep-
resentative of health plans or other 
third party payers; 
(VI) one member shall be a rep-
resentative of information technology 
vendors; and 
(VII) one member shall be a rep-
resentative of purchasers or employ-
ers. 
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111 
(B) NATIONAL
COORDINATOR.—The Na-
tional Coordinator shall be a member of the 
Partnership and act as a liaison among the 
Partnership, the community, and the Federal 
Government. 
(2) CHAIRPERSON AND VICE CHAIRPERSON.— 
The Partnership shall designate one member to 
serve as the chairperson and one member to serve as 
the vice chairperson of the Partnership. 
(3) PARTICIPATION.—Members shall be ap-
pointed under paragraph (1)(A), and the Partner-
ship shall develop procedures for conducting its ac-
tivities, so as to ensure a balance among various sec-
tors of the health care system so that no single sec-
tor unduly influences the recommendations of the 
Partnership. 
(4) TERMS.—Members appointed under para-
graph (1)(A) shall serve for 3 year terms, except 
that any member appointed to fill a vacancy for an 
unexpired term shall be appointed for the remainder 
of such term. A member may serve for not to exceed 
180 days after the expiration of such member’s term 
or until a successor has been appointed. 
(5) OUTSIDE INVOLVEMENT.—The Partnership 
shall ensure an adequate opportunity for the partici-
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112 
pation of outside advisors, including individuals with 
expertise in— 
(A) the protection of personal health infor-
mation privacy; 
(B) personal health information security; 
(C) health care quality and patient safety, 
including individuals with expertise in utilizing 
health information technology to improve health 
care quality and patient safety; 
(D) medical and clinical research data ex-
change; and 
(E) developing health information tech-
nology standards and new health information 
technology. 
(6) QUORUM.—Two-thirds of the members of 
the Partnership shall constitute a quorum for the 
purpose of conducting votes. 
(c) STANDARDS AND IMPLEMENTATION SPECIFICA-
TIONS.— 
(1) SCHEDULE.—Not later than 90 days after 
the date of enactment of this title, the Partnership 
shall develop a schedule for the assessment of stand-
ards and implementation specifications under this 
section. The Partnership shall update such schedule 
annually. The Secretary shall publish such schedule 
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113 
in the Federal Register and on the Internet website 
of the Department of Health and Human Services. 
(2) FIRST
YEAR
RECOMMENDATIONS.—Con-
sistent with the schedule published under paragraph 
(1) and not later than 1 year after date of enact-
ment of this title, the Partnership shall recommend, 
and the Secretary shall review, such standards and 
implementation specifications. 
(3) ONGOING RECOMMENDATIONS.—The Part-
nership shall review and modify, as appropriate but 
at least annually, adopted standards and implemen-
tation specifications and continue to recommend ad-
ditional standards and implementation specifications, 
consistent with the schedule published pursuant to 
paragraph (1). The Secretary shall review such 
modifications and recommendations. 
(4) RECOGNITION OF PRIVATE ENTITIES.—The 
Partnership, in consultation with the Secretary, may 
recognize a private entity or entities for the purpose 
of developing and updating standards and implemen-
tation specifications to achieve uniform and con-
sistent implementation of the standards adopted by 
the President under this title. Such entity or entities 
shall make recommendations to the Partnership con-
sistent with this section. 
VerDate Aug 31 2005 
20:42 Feb 21, 2008
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hsrobinson on PROD1PC76 with BILLS