I 
111TH CONGRESS 
1ST SESSION H. R. 4216 
To amend the Public Health Service Act and titles XVIII and XIX of 
the Social Security Act to establish guidelines to enhance the meaningful 
use and interoperability of electronic medical records with personal health 
records, including for purposes of Medicare and Medicaid payment incen-
tives. 
IN THE HOUSE OF REPRESENTATIVES 
DECEMBER 7, 2009 
Mr. KENNEDY (for himself and Mr. REICHERT) introduced the following bill; 
which was referred to the Committee on Energy and Commerce, and in 
addition to the Committee on Ways and Means, for a period to be subse-
quently determined by the Speaker, in each case for consideration of such 
provisions as fall within the jurisdiction of the committee concerned 
A BILL 
To amend the Public Health Service Act and titles XVIII 
and XIX of the Social Security Act to establish guide-
lines to enhance the meaningful use and interoperability 
of electronic medical records with personal health 
records, including for purposes of Medicare and Medicaid 
payment incentives. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
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SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Personal Health 
Record Act of 2009’’. 
SEC. 2. ENHANCING MEANINGFUL USE OF ELECTRONIC 
HEALTH RECORDS THROUGH INTEROPER-
ABILITY. 
(a) DEFINITIONS.— 
(1) IN GENERAL.—Section 3000 of the Public 
Health Service Act (42 U.S.C. 300jj) is amended by 
adding at the end the following: 
‘‘(15) ELECTRONIC
EXCHANGE.—The term 
‘electronic exchange’ shall include the automated 
transfer of individual health information between 
electronic medical records and personal health 
records, and between electronic medical records, per-
sonal health records, and other electronic systems. 
‘‘(16) PERSONAL HEALTH RECORD.—The term 
‘personal health record’ means an electronic record 
of PHR identifiable health information (as defined 
in section 13407(f)(2) of the HITECH Act) of an 
individual that— 
‘‘(A) complies with appropriate data con-
tent standards; 
‘‘(B) enables the individual, an authorized 
representative, 
vendor 
of 
personal 
health 
records (as defined in section 318.2(j) of title 
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16, Code of Federal Regulations, as in effect as 
of November 1, 2009), any covered entity (as 
defined for purposes of HIPAA privacy and se-
curity law, as defined in section 3009(a)(2)), or 
an entity to the extent that it engages in activi-
ties as a business associate (as defined for such 
purposes) of such a covered entity, to retrieve 
data from or input data into the electronic 
record; and 
‘‘(C) is portable and capable of electronic 
communication between such individual and the 
relevant covered entity, business associate de-
scribed in subparagraph (B), or vendor of per-
sonal health records of such individual that is 
managed, shared, and controlled by or primarily 
for the individual.’’. 
(2) 
CONFORMING
AMENDMENT.—Section 
13400(11) of the HITECH Act (42 U.S.C. 
17921(11)) is amended to read as follows: 
‘‘(11) PERSONAL HEALTH RECORD.—The term 
‘personal health record’ has the meaning given such 
term in section 3000(16) of the Public Health Serv-
ice Act.’’. 
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(b) 
ACCESS
TO
INDIVIDUALLY
IDENTIFIABLE 
HEALTH INFORMATION.—Section 3001(b) of the Public 
Health Service Act (42 U.S.C. 300jj–11(b)) is amended— 
(1) in the matter preceding paragraph (1), by 
inserting ‘‘electronic’’ before ‘‘exchange’’; 
(2) in paragraph (6)— 
(A) by inserting ‘‘individuals,’’ after ‘‘phy-
sician offices,’’; and 
(B) by inserting ‘‘electronic’’ before ‘‘ex-
change of health care information’’; 
(3) in paragraph (10), by striking at the end 
‘‘and’’; 
(4) in paragraph (11), by striking the period 
and inserting ‘‘; and’’; and 
(5) by adding at the end the following new 
paragraph: 
‘‘(12) allows for an individual to have access to 
their individually identifiable health information.’’. 
(c) STRATEGIC
PLAN
RELATING
TO
PERSONAL 
HEALTH RECORDS.—Section 3001(c)(3)(A) of the Public 
Health Service Act (42 U.S.C. 300jj–11(c)(3)(A)) is 
amended by adding at the end the following new clause: 
‘‘(ix) The interoperability of a per-
sonal health record with an electronic 
health record.’’. 
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(d) GUIDELINES RELATING TO PERSONAL HEALTH 
RECORDS.—Section 3001(c) of the Public Health Service 
Act (42 U.S.C. 300jj–11(c)) is amended by adding at the 
end the following new paragraph: 
‘‘(9) GUIDELINES
FOR
PERSONAL
HEALTH 
RECORDS.—Not later than the date that is 12 
months after the date of the enactment of the Per-
sonal Health Record Act of 2009, the National Co-
ordinator shall develop guidelines for making elec-
tronic health records interoperable with personal 
health records for the purpose of improving health 
care quality, reducing medical errors, and advancing 
the delivery of patient-centered medical care and 
health management. Such guidelines shall include— 
‘‘(A) standards based on the recommenda-
tions provided in section 3002(b)(2)(B)(ix), in-
cluding for purposes of requiring electronic 
health records to be made available through 
electronic exchange and interoperable with per-
sonal health records for purposes of dem-
onstrating meaningful use of an electronic 
health record under sections 1848(o)(2)(A)(i), 
1886(n)(3)(A)(i), and 1903(t)(6)(C)(i)(II) of 
the Social Security Act; 
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‘‘(B) recommendations for applying such a 
requirement of making electronic health records 
available, with respect to community and behav-
ioral health programs, in the form of personal 
health records to improve the effective and effi-
cient electronic exchange and management of 
information between the individual (or author-
ized representative of the individual), including 
those in medically underserved communities (as 
defined in section 799B(6)), and community 
health centers and behavioral health service 
providers; 
‘‘(C) required components of a personal 
health record, which shall include— 
‘‘(i) information on medical history, 
including diagnoses and procedures, includ-
ing updates if diagnosis or procedures 
change after each provider encounter; 
‘‘(ii) information on recent laboratory 
results, 
diagnostic 
examinations, 
and 
radiologic procedures, if available in elec-
tronic format; 
‘‘(iii) information on medications and 
prescriptions, both current and historical, 
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including updates if medications change 
after each provider encounter; 
‘‘(iv) information on allergies, both 
medication and environmental, including 
the specific reaction; 
‘‘(v) privacy, security, and electronic 
informed consents for disclosing individ-
ually identifiable health information; 
‘‘(vi) computer programming stand-
ards determined by the National Coordi-
nator that allow interoperability of individ-
ually identifiable health information and 
communications between covered entities 
(as defined for purposes of HIPAA privacy 
and security law, as defined in section 
3009(a)(2)), entities to the extent that 
they engage in activities as business associ-
ates of such covered entities, individuals, 
and vendors of personal health records; 
‘‘(vii) portability of the personal 
health record by the individual between 
covered entities, business associates de-
scribed in clause (vi), or vendors of per-
sonal health records; 
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‘‘(viii) ability to use such record as 
part of the patient intake process; 
‘‘(ix) accurate attribution of the 
source of all data in the personal health 
record, including the source of the infor-
mation, the date that such information was 
entered into the personal health record, 
and standards-based protection of data 
provided by the health care provider (such 
as health care provider clinic notes, labora-
tory results, diagnostic examinations, and 
radiologic procedures) from changes; 
‘‘(x) notification of the individual in-
volved or the authorized representative of 
such individual of the risks of withholding 
medical information from a medical pro-
vider; and 
‘‘(xi) health services communication 
tools, including those which offer online se-
cure communication with covered entities 
(as defined for purposes of HIPAA privacy 
and security law, as defined in section 
3009(a)(2)) and entities to the extent that 
they engage in activities as business associ-
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ates (as defined for such purposes) of such 
a covered entity; 
‘‘(D) other possible components for consid-
eration of a personal health record, including— 
‘‘(i) an audit trail to monitor who has 
accessed the personal health record of the 
individual; 
‘‘(ii) automated appointment, care re-
minders, and health self-management tools; 
‘‘(iii) the ability to provide education 
tools; 
‘‘(iv) the ability of the individual or 
authorized representative involved to anno-
tate (without changing) health care pro-
vider records, such as to provide feedback 
to health care providers of the individual; 
‘‘(v) protection of clinical records in 
the personal health record which are im-
ported from or exported to a covered enti-
ty, business associate described in clause 
(i), or vendor of personal health records 
from being changed by the individual, au-
thorized representative of the individual, 
vendor of personal health records, the cov-
ered entity, or business associate; 
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‘‘(vi) the ability to allow comments by 
the individual, authorized representative, 
and covered entity within an area of the 
personal health record that is separate 
from the clinical record imported from or 
exported to a covered entity; and 
‘‘(vii) emergency access procedures for 
medical personnel, with respect to the 
record, for clinical care in cases that the 
individual or authorized representative is 
not able to give consent; and 
‘‘(E) security, privacy, and electronic in-
formed consents for disclosing individually iden-
tifiable health information for personal health 
records, including the recommendations de-
scribed in paragraph (6)(F). 
In the case that the Secretary determines that any 
standard or component for personal health records 
included under the guidance under this paragraph is 
not adequate pursuant to the report submitted 
under paragraph (6)(F), the Secretary shall notify 
the National Coordinator and the HIT Standards 
Committee in accordance with section 3004(a)(2)(B) 
and the National Coordinator may revise such stand-
ard or component, respectively.’’. 
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(e) REPORTS.—Section 3001(c)(6) of such Act (42 
U.S.C. 300jj–11(c)(6)) is amended by adding at the end 
the following new subparagraphs: 
‘‘(F) MONITORING
PERSONAL
HEALTH 
RECORDS.—Not later than the date that is 24 
months after the date of the enactment of the 
Personal Health Record Act of 2009 and annu-
ally thereafter, the National Coordinator, in 
consultation with the Administrator of the Cen-
ters for Medicare & Medicaid Services, shall 
submit to the appropriate committees of juris-
diction of Congress an annual report on— 
‘‘(i) the extent to which personal 
health records have been integrated into 
the
meaningful
use of electronic health 
records 
for 
purposes 
of 
sections 
1848(o)(2), 1886(n)(3), and 1903(t)(6) of 
the Social Security Act; 
‘‘(ii) the extent to which the use of 
personal health records improve commu-
nication between individuals and covered 
entities (as defined for purposes of HIPAA 
privacy and security law, as defined in sec-
tion 3009(a)(2)) and improve patient 
health management, including documenta-
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tion of the extent to which there are cost 
savings; 
‘‘(iii) the extent to which the use of 
personal health records, with respect to 
community health centers and behavioral 
health services, improve the effective and 
efficient exchange and management of in-
formation between the individual involved 
(or authorized representative of the indi-
vidual), including those in medically under-
served communities, and community health 
centers and behavioral health service pro-
viders; 
‘‘(iv) status of the standards imple-
mented in paragraph (9)(A) and the need 
to revise or include new standards; 
‘‘(v) the adequacy of the components 
of a personal health record described in 
paragraph (9)(C); and 
‘‘(vi) the affect of having an individual 
with full access to the medical records of 
such individual through use of a personal 
health record, including— 
‘‘(I) a prospective study ana-
lyzing health care utilization (includ-
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ing the impact of personal health 
records on health care provider effi-
ciency, health care provider reim-
bursement for time spent interacting 
with individuals as a result of per-
sonal health records, and defensive 
medicine practices); 
‘‘(II) the extent that such access 
affects communications by means of 
such records between various health 
care providers of the individual (in-
cluding the use of provider notations); 
‘‘(III) a prospective study ana-
lyzing the affect of such access on the 
patient-health care provider relation-
ship; and 
‘‘(IV) the risks and benefits of an 
individual having full access to med-
ical records of the individual through 
the use of personal health records. 
‘‘(G) RECOMMENDATION RELATING TO SE-
CURITY AND PRIVACY OF PERSONAL HEALTH 
RECORDS.—Not later than 6 months after the 
date of the enactment of the Personal Health 
Record Act of 2009, the National Coordinator 
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shall submit to the appropriate committees of 
jurisdiction of Congress a report, including rec-
ommendations, 
on 
the 
technological, 
medicolegal, medical safety, and other pertinent 
issues related to an individual’s control of the 
personal health record of such individual and 
shall establish guidelines for such control. The 
National Coordinator shall ensure the participa-
tion in such a report of health care consumers, 
vendors of personal health records, and covered 
entities (as defined for purposes of HIPAA pri-
vacy and security law, as defined in section 
3009(a)(2)), along with other health care stake-
holders. The report shall encompass at least the 
following issues: 
‘‘(i) the rights of an individual uti-
lizing a personal health record with respect 
to the individual’s own individually identifi-
able health information contained in such; 
and 
‘‘(ii) the security and privacy of an in-
dividual utilizing a personal health record, 
including— 
‘‘(I) defining who has right of ac-
cess to an individual’s personal health 
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record in the case of a personal health 
record provided by a covered entity; 
‘‘(II) security and privacy issues 
following medical emergency access of 
information in a personal health 
record by health care providers; 
‘‘(III) the impact of an individual 
restricting medical information access 
in a personal health record of such in-
dividual to health care providers on 
patient care and safety; 
‘‘(IV) the risks and benefits of 
health care provider notification if the 
personal health record of an individual 
is restricted by the individual; 
‘‘(V) the uses and disclosures of 
the information of an individual con-
tained in a personal health record that 
should be authorized or required by a 
vendor of personal health records pro-
viding and maintaining such record; 
‘‘(VI) electronic informed con-
sents for disclosing individually identi-
fiable health information; 
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‘‘(VII) the use of an audit trail of 
who 
has 
entered, 
removed, 
and 
changed data within a personal health 
record; and 
‘‘(VIII) the dissemination of ab-
normal laboratory results, diagnostic 
examinations, and radiological proce-
dures into personal health records 
prior to notification of the abnor-
mality by the health care provider.’’. 
(f) PERSONAL HEALTH RECORD STANDARDS IN-
CLUDED
IN HIT POLICY COMMITTEE RECOMMENDA-
TIONS.— 
(1) IN
GENERAL.—Section 3002(b)(2)(B) of 
the Public Health Service Act (42 U.S.C. 300jj– 
12(b)(2)(B)) is amended by adding at the end the 
following new clause: 
‘‘(ix) Standards and implementation 
specifications for the interoperability of 
personal health records and electronic 
health records.’’. 
(2) CONFORMING CHANGES RELATING TO HIT 
STANDARDS COMMITTEE RECOMMENDATIONS.— 
(A) DEADLINE FOR SUBMISSION OF REC-
OMMENDATIONS TO NATIONAL COORDINATOR.— 
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Section 3003(b)(1)(A) of such Act (42 U.S.C. 
300jj–13(b)(1)(A)) is amended by adding at the 
end the following: ‘‘Not later than the date that 
is 6 months after the date of the enactment of 
the Personal Health Record Act of 2009, the 
HIT Standards Committee shall recommend to 
the National Coordinator standards and imple-
mentation specifications described in section 
3002(b)(2)(B)(ix). The HIT Standards Com-
mittee shall update such recommendations and 
make new recommendations as appropriate, in-
cluding in response to notification sent under 
section 3004(a)(2)(B).’’. 
(B) FORUM.—Section 3003(b)(2) of such 
Act (42 U.S.C. 300jj–13(b)(2)) is amended by 
inserting before the period the following: ‘‘, in-
cluding for the adoption of interoperability of 
personal health records and electronic health 
records’’. 
(3) CONFORMING
CHANGES
RELATING
TO 
ADOPTION OF INITIAL SET OF STANDARDS.—Section 
3004(b)(1) of such Act (42 U.S.C. 300jj–14(b)(1)) 
is amended by inserting ‘‘(other than clause (ix))’’ 
after ‘‘section 3002(b)(2)(B)’’. 
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(g) APPLICATION OF GUIDELINES TO MEANINGFUL 
USE REQUIREMENTS OF ELECTRONIC MEDICAL RECORDS 
UNDER MEDICARE.— 
(1) ELIGIBLE PROFESSIONAL PAYMENT INCEN-
TIVES.—Section 1848(o)(2)(A)(i) of the Social Secu-
rity Act (42 U.S.C. 1395w–4(o)(2)(A)(i)) is amend-
ed by inserting before the period at the end the fol-
lowing: ‘‘and shall include demonstrating the avail-
ability of such technology to and use of such tech-
nology by individuals furnished items and services by 
such professional in the form of electronic and per-
sonal health records consistent with guidelines estab-
lished by the National Coordinator under section 
3001(c)(9)(A) of the Public Health Service Act’’. 
(2) ELIGIBLE
HOSPITAL
PAYMENT
INCEN-
TIVES.—Section 1886(n)(3)(A)(i) of such Act (42 
U.S.C. 1395ww(n)(3)(A)(i)) is amended by inserting 
before the period at the end the following: ‘‘, which 
shall include demonstrating the availability of such 
technology to and use of such technology by individ-
uals furnished items and services by such hospital in 
the form of electronic and personal health records 
consistent with guidelines established by the Na-
tional Coordinator under section 3001(c)(9)(A) of 
the Public Health Service Act’’. 
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(h) APPLICATION OF GUIDELINES TO MEANINGFUL 
EHR USE REQUIREMENTS UNDER MEDICAID.—Section 
1903(t)(6)(C)(i)(II) of the Social Security Act (42 U.S.C. 
1396b(t)(6)(C)(i)(II)) is amended— 
(1) by striking ‘‘and’’ before ‘‘that may be 
based’’; and 
(2) by inserting before the period at the end the 
following: ‘‘, and which shall include demonstrating 
the availability of such technology to and use of such 
technology by individuals furnished items and serv-
ices by such Medicaid provider in the form of elec-
tronic and personal health records consistent with 
guidelines established by the National Coordinator 
under section 3001(c)(9)(A) of the Public Health 
Service Act’’. 
(i) RELATIONSHIP TO OTHER LAWS.—Section 13421 
of the HITECH Act (42 U.S.C. 17951) is amended by 
adding at the end the following new subsection: 
‘‘(c) HEALTH INFORMATION PORTABILITY AND AC-
COUNTABILITY ACT, HEALTH CARE PROVIDERS, AND 
PERSONAL HEALTH RECORDS.—Nothing in this subtitle 
or the provisions of or amendments made by the Personal 
Health Record Act of 2009 shall affect the ability of a 
health care provider involved in the direct care of an indi-
vidual to obtain pertinent information on the medical his-
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tory of such individual from another health care provider 
involved in the medical care of the individual, in accord-
ance with HIPAA privacy and security law (as defined in 
section 3009(a)(2) of the Public Health Service Act) as 
in effect before the date of the enactment of the Personal 
Health Record Act of 2009.’’. 
Æ 
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