sage to a patient about a product or serv-
ice unless that product or service has al-
ready been prescribed or recommended to 
the patient by a health care provider. 
(iv) PATIENT OPT-IN.— 
(I) IN
GENERAL.—Subject to 
subclause (II), the QPHR service pro-
vider shall not allow messages to be 
sent to a patient unless the provider 
has requested and received the per-
mission of the patient (or patient’s 
authorized representative). 
(II) OPT-OUT.—A patient may at 
any time opt out of receiving mes-
sages entirely or from a particular 
source. 
(v) LIMITATION ON COMMERCIAL SO-
LICITATION.—The QPHR service provider 
shall not allow messages to be sent to a 
patient unless— 
(I) the patient is a patient or 
beneficiary of the sender or source of 
the message, uses the sender’s or 
source’s product with a prescription 
or recommendation of a provider, or 
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has some other health-related pre-ex-
isting relationship (as defined by the 
Secretary) with the sender or source, 
or the sender or source is a public 
health agency; 
(II) the message contains infor-
mation directly related to the patient’s 
health or health care and does not in-
clude marketing or commercial solici-
tations; 
(III) the message complies with 
standards adopted under subsection 
(h)(4); and 
(IV) the message clearly identi-
fies the source of the content and the 
sender of the message. 
(vi) HEALTH PLAN NOTIFICATION.— 
The QPHR service provider shall notify, 
no less frequently than quarterly, each 
Fund partner that operates a health ben-
efit plan of the individuals who have re-
ceived messages sent on behalf of the Fund 
partner under this section. 
(B) ALTERNATIVE
REQUIREMENTS.—For 
purposes of paragraph (1)(F), the Secretary 
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may develop and specify requirements that a 
QPHR service provider may meet instead of the 
requirements described in subparagraph (A) so 
long as such requirements provide for a method 
and incentives for private entities to contribute 
to the PHR Incentive Fund. 
(3) DISCLOSURE
REQUIREMENT.—The disclo-
sure requirement described in this paragraph with 
respect to a QPHR service provider is that at the 
time of entering into an arrangement with an indi-
vidual to operate or administer a QPHR (or part of 
a QPHR) of the individual, the QPHR service pro-
vider shall provide to the individual a notice of the 
privacy policies of the QPHR service provider, which 
shall be presented in a clear and understandable 
manner, meet such standards as specified by the 
Secretary of Health and Human Services and the 
Secretary of Commerce, and include the following: 
(A) ASSURANCES NOT TO SELL INDIVID-
UALLY
IDENTIFIABLE
INFORMATION.—Assur-
ances, in a form and manner specified by the 
Secretaries, that— 
(i) the QPHR service provider will not 
sell any individually identifiable health in-
formation of such individual and the 
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QPHR service provider will not sell or 
share any such information of such indi-
vidual for the purposes of marketing or de-
cisions related to employment or financial 
services; and 
(ii) the QPHR service provider will 
disclose to the individual any possible sec-
ondary users of the individually identifiable 
health information of such individual, in-
cluding business associates of the service 
provider who may have access to such in-
formation, and the purpose for such use or 
access. 
(B) FUND
PARTNER
INFORMATION.—In-
formation identifying the Fund partners on be-
half of which the QPHR service provider sends 
messages under paragraph (2)(C) and the types 
of information that would potentially be avail-
able to such Fund partners. 
(g) HEALTH INFORMATION EXCHANGE NETWORK 
DEFINED.—For purposes of this section, the term ‘‘health 
information exchange network’’ means any State-based or 
local entity— 
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(1) the governance of which formally involves 
health care consumers, employers, health plans, hos-
pitals, and practicing clinicians; 
(2) which facilitates private and secure access 
to and retrieval of clinical data, including laboratory 
test results and medication-related information, to 
provide safer, more timely, efficient, effective, and 
equitable patient-centered care; 
(3) which meets data standards for interoper-
ability, as specified by the Secretary; 
(4) which meets applicable requirements for pri-
vacy, confidentiality, and security as specified by the 
Secretary, including requirements and standards de-
scribed in subsection (h); and 
(5) that provides to each patient participating 
in such network (at the initiation of such participa-
tion) a notice of the privacy policies and other con-
sumer protection policies of the network, which shall 
be presented in a clear and understandable manner 
and meet such standards as specified by the Sec-
retary of Health and Human Services and the Sec-
retary of Commerce and include assurances, in a 
form and manner specified by the Secretaries, 
that— 
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(A) the entity will not sell any individually 
identifiable health information of such indi-
vidual and the entity will not sell or share any 
such information of such individual for the pur-
poses of marketing or decisions related to em-
ployment or financial services; and 
(B) the entity will disclose to the individual 
any possible secondary users of the individually 
identifiable health information of such indi-
vidual, including business associates of the serv-
ice provider who may have access to such infor-
mation, and the purpose for such use or access. 
(h) PRIVACY AND CONSUMER PROTECTION STAND-
ARDS.— 
(1) SECURITY AND PRIVACY STANDARDS, POLI-
CIES, AND PRACTICES.—For purposes of the dem-
onstration program, the security and privacy stand-
ards, policies, and practices described in this para-
graph include— 
(A) the standards required under regula-
tions promulgated under section 264(c) of the 
Health Insurance Portability and Accountability 
Act of 1996 (HIPAA); 
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(B) standards to require plain language 
notice of patients’ rights with respect to per-
sonal health records; and 
(C) any additional standards specified by 
the Secretary to optimally protect and safe-
guard patient health care information, as long 
as such standards are consistent with the 
standards described in subparagraph (A). 
(2) NOTIFICATION OF BREACH.— 
(A) IN GENERAL.—In accordance with the 
minimum criteria established under subpara-
graph (B), a QPHR service provider must dis-
close any breach of the security of individually 
identifiable health information contained in a 
QPHR to any individual whose individually 
identifiable health information was, or is rea-
sonably believed to have been, acquired by an 
unauthorized person and to the Secretary in a 
manner specified by the Secretary. 
(B) MINIMUM CRITERIA.—The Secretary, 
in consultation with relevant agencies and ap-
propriate entities in the private sector, shall es-
tablish minimum criteria for which notifications 
of wrongful disclosures are required under sub-
paragraph (A). 
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(3) AVAILABILITY OF INDIVIDUAL HEALTH IN-
FORMATION IN ELECTRONIC FORM.—Effective begin-
ning on January 1, 2010, an individual who requests 
a copy of the individual’s individually identifiable 
health information pursuant to the HIPAA regula-
tions referred to in paragraph (1) shall be entitled 
to receive that information in electronic form capa-
ble of being imported into a QPHR, if such informa-
tion is maintained in electronic form by the entity 
from which the information is requested. 
(4) 
MESSAGE
STANDARDS.—The 
Secretary 
shall establish minimum standards to ensure the ob-
jectivity, accuracy, and relevance of messages sent to 
individual patients under subsection (f)(2) from a 
QPHR and to protect against the use of such mes-
sages by Fund partners for commercial solicitations 
or marketing. Such standards shall incorporate ex-
isting standards governing communications to con-
sumers established by the Food and Drug Adminis-
tration, the Federal Trade Commission, or other 
Federal agencies. 
(i) PHR INCENTIVE FUND.— 
(1) IN GENERAL.—The Secretary shall establish 
a PHR Incentive Fund (in this section referred to 
as the ‘‘PHR Incentive Fund’’ or ‘‘Fund’’). The 
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Fund may receive contributions from Fund partners 
for the sole purpose of paying PHR incentives under 
the demonstration program, conducting the study 
under subsection (j), and otherwise carrying out the 
demonstration program. 
(2) FUND PARTNERS.— 
(A) IN
GENERAL.—The Secretary may 
enter into contracts with public or private pay-
ers, drug manufacturers, device manufacturers, 
or other public or private entities (in this sec-
tion referred to as ‘‘Fund partners’’) to allow 
the Fund to receive contributions in accordance 
with this subsection and other terms deter-
mined by the Secretary. 
(B) FEDERAL PARTNERS.—The Secretary 
shall seek the involvement and contributions of 
the Food and Drug Administration, the Centers 
for Disease Control and Prevention, the Agency 
for Healthcare Research and Quality, and the 
Department of Homeland Security to maximize 
the effectiveness of the QPHRs in meeting the 
health, national security, emergency response, 
biosurveillance, and research goals of the Fed-
eral government in a manner consistent with 
this section. A Federal agency described in the 
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previous sentence is authorized to make a con-
tribution to the Fund to the extent provided in 
appropriation Acts. 
(C) PARTNER ACCOUNTS.— 
(i) IN GENERAL.—The Fund shall in-
clude an account for each Fund partner, 
including the Medicare program, separately 
accounting for each Fund partner’s con-
tributions to the Fund. Contribution levels 
under subparagraph (D) shall be made to 
each account at the beginning of each fis-
cal year of the demonstration program for 
incentive payments under this section for 
services furnished during such fiscal year. 
Incentive payments shall be debited from 
each account in accordance with this sub-
section. 
(ii) REMAINING AMOUNTS.—Amounts 
in the account of a Fund partner that are 
not paid in a fiscal year (before the last 
fiscal year of the demonstration program) 
shall remain available for payment from 
such account in the subsequent fiscal year. 
Amounts in the account of a Fund partner 
that are not paid in the last fiscal year of 
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the demonstration program shall be re-
funded to the Fund partner. 
(D) CONTRIBUTION
LEVELS.—Contribu-
tion levels to the Fund by Fund partners shall 
be set annually, by the Secretary, except that 
the contribution level for the first year shall be 
as follows: 
(i) MEDICARE
CONTRIBUTION.—The 
Secretary shall contribute— 
(I) $3 for each qualifying patient 
described in subsection (b)(3)(A)(i)(I), 
with respect to a qualifying provider, 
who is a Medicare beneficiary for 
whom any PHR incentive payment 
may be made under subsection (b)(1) 
during such fiscal year to such pro-
vider; 
(II) $5 for each qualifying pa-
tient 
described 
in 
subsection 
(b)(3)(A)(i)(II), with respect to a 
qualifying provider, who is a Medicare 
beneficiary for whom any PHR incen-
tive payment may be made under sub-
section (b)(1) during such fiscal year 
to such provider; and 
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(III) $3 for each qualifying pa-
tient who is a Medicare beneficiary for 
whom an incentive payment may be 
made under subsection (b)(1) during 
such fiscal year to a health informa-
tion exchange network. 
The contribution amounts described in this 
clause shall be transferred from the Fed-
eral Hospital Insurance Trust Fund (es-
tablished under section 1817 of the Social 
Security Act) and from the Federal Sup-
plementary Medical Insurance Trust Fund 
(established under section 1841 of such 
Act) in such proportion as the Secretary 
may specify. 
(ii) OTHER PAYER CONTRIBUTIONS.— 
Any Fund partner that is a health care 
payer other than the Medicare program 
(and is not an agency described in sub-
paragraph (B)) shall contribute— 
(I) at least $3 for each qualifying 
patient 
described 
in 
subsection 
(b)(3)(A)(i)(I), with respect to a 
qualifying provider, who is covered 
under a health benefits or other plan 
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the sponsor of which is the Fund 
partner and for whom a PHR incen-
tive payment may be made under sub-
section (b)(1) during the fiscal year to 
such provider; 
(II) at least $5 for each quali-
fying patient described in subsection 
(b)(3)(A)(i)(II), with respect to a 
qualifying provider, who is covered 
under a health benefits or other plan 
the sponsor of which is the Fund 
partner and for whom a PHR incen-
tive payment may be made under sub-
section (b)(1) during the fiscal year to 
such provider; and 
(III) at least $3 for each quali-
fying patient who is covered under a 
health benefits or other plan the spon-
sor of which is the Fund partner and 
for whom an incentive payment may 
be made under subsection (b)(1) dur-
ing such fiscal year to a health infor-
mation exchange network. 
(iii) MESSAGING CONTRIBUTIONS.— 
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(I) IN
GENERAL.—Subject to 
subclause (II), the Secretary may es-
tablish contribution levels for Fund 
partners that employ messages sent 
under subsection (f)(2)(C) in the fis-
cal year. 
(II) FDA-MESSAGING CONTRIBU-
TIONS.—The amount of the contribu-
tion of a drug manufacturer that is a 
Fund partner is equal to at least $3 
for each qualifying patient for each 
medication adherence program for 
which one or more messages are sent 
under subsection (f)(2)(C) in the fis-
cal year. 
(E) DEBITING
FUND
PARTNERS’ 
AC-
COUNTS.—The Medicare program’s account 
shall be debited for each incentive payment 
made under subsection (b)(1), with respect to a 
qualifying patient who is a Medicare bene-
ficiary. Each other Fund partner’s account 
shall be debited for each incentive payment 
made under subsection (b)(1), with respect to a 
qualifying patient who is covered under a health 
benefits or other plan the sponsor of which is 
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such Fund partner. Each Fund partner’s ac-
count shall be debited for messages sent under 
subsection (f)(2)(C) for such partner in accord-
ance with a methodology specified by the Sec-
retary. In the event that a Fund partner’s ac-
count does not have a sufficient balance to 
cover the Fund partner’s liability, the Fund 
partner shall make a supplemental contribution 
to the Fund to cover the shortfall. 
(F) LIMITATION ON BENEFITS.—Contribu-
tions by a Fund partner to the Fund shall con-
fer no preferential access to data or information 
or any other benefit to the partner other than 
public acknowledgment under paragraph (3) 
and the ability to have messages sent to quali-
fying patients under subsection (f)(2)(C). 
(3) PUBLICATION OF FUND CONTRIBUTORS.— 
The Secretary shall publish on the official public 
website of the Centers for Medicare & Medicaid 
Services a list of Fund partners that have contrib-
uted to the Fund. 
(j) STUDY AND REPORTS.— 
(1) INTERIM REPORT.—Not later than 3 years 
after the initiation of the demonstration program, 
the Secretary shall submit to Congress a report on 
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the following, with respect to the demonstration pro-
gram: 
(A) The extent to which privacy protec-
tions are sufficient under the demonstration 
program and recommendations for any addi-
tional privacy protections that may be nec-
essary. 
(B) The extent to which use of data in 
QPHRs by qualifying providers varies based on 
the size of the practice of the qualifying pro-
viders and based on whether the qualifying pro-
viders are located in a rural or urban area. 
(C) The effectiveness of patient and pro-
vider outreach and education efforts to increase 
the utilization and utility of QPHRs. 
(D) The measurable benefits and concerns 
of qualifying providers, with respect to use of 
QPHRs and potential adoption of personal 
health record technology. 
(2) STUDY AND FINAL REPORT.— 
(A) STUDY.—At the conclusion of the 
demonstration program, the Secretary shall 
provide for a study to assess the level of pa-
tients’ use of their QPHR, the type of data 
transmitted by health information exchange 
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networks, the impact of the standards used in 
transmitting the data, the utility of such data 
to health care providers in delivering patient 
care and to patients in managing their health 
(including adherence to prescribed medications 
and recommended preventive care), any changes 
in health outcomes, and any cost savings result-
ing from implementation of the program. The 
study shall include collection of aggregate data 
documenting the number of qualifying patients, 
the number of providers using the QPHR, the 
number of patients using the QPHR, the type 
of data presented in the QPHR, and other 
measures of the program’s effectiveness. 
(B) FINAL
REPORT.—Not later than 2 
years after the last day of the demonstration 
program, the Secretary shall submit to Con-
gress a report on the results of the study under 
paragraph (1). 
Æ 
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