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 incentives. 

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 subsequently determined by the Speaker, in each case for consideration of such 

provisions as fall within the jurisdiction of the committee concerned 

A BILL 

To amend the 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 incentives. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 


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1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Personal Health 

3 Record Act of 2009’’. 

4 SEC. 2. ENHANCING MEANINGFUL USE OF ELECTRONIC 

5 HEALTH RECORDS THROUGH INTEROPER6 ABILITY. 

7 (a) DEFINITIONS.— 

8 (1) IN GENERAL.—Section 3000 of the Public 

9 Health Service Act (42 U.S.C. 300jj) is amended by 

10 adding at the end the following: 

11 ‘‘(15) ELECTRONIC EXCHANGE.—The term 

12 ‘electronic exchange’ shall include the automated 

13 transfer of individual health information between 

14 electronic medical records and personal health 

15 records, and between electronic medical records, per16 sonal health records, and other electronic systems. 

17 ‘‘(16) PERSONAL HEALTH RECORD.—The term 

18 ‘personal health record’ means an electronic record 

19 of PHR identifiable health information (as defined 

20 in section 13407(f)(2) of the HITECH Act) of an 

21 individual that— 

22 ‘‘(A) complies with appropriate data con23 tent standards; 

24 ‘‘(B) enables the individual, an authorized 

25 representative, vendor of personal health 

26 records (as defined in section 318.2(j) of title 


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1 16, Code of Federal Regulations, as in effect as 

2 of November 1, 2009), any covered entity (as 

3 defined for purposes of HIPAA privacy and se4 curity law, as defined in section 3009(a)(2)), or 

5 an entity to the extent that it engages in activi6 ties as a business associate (as defined for such 

7 purposes) of such a covered entity, to retrieve 

8 data from or input data into the electronic 

9 record; and 

10 ‘‘(C) is portable and capable of electronic 

11 communication between such individual and the 

12 relevant covered entity, business associate de13 scribed in subparagraph (B), or vendor of per14 sonal health records of such individual that is 

15 managed, shared, and controlled by or primarily 

16 for the individual.’’. 

17 (2) CONFORMING AMENDMENT.—Section 

18 13400(11) of the HITECH Act (42 U.S.C. 

19 17921(11)) is amended to read as follows: 

20 ‘‘(11) PERSONAL HEALTH RECORD.—The term 

21 ‘personal health record’ has the meaning given such 

22 term in section 3000(16) of the Public Health Serv23 ice Act.’’. 


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1 (b) ACCESS TO INDIVIDUALLY IDENTIFIABLE

2 HEALTH INFORMATION.—Section 3001(b) of the Public 

3 Health Service Act (42 U.S.C. 300jj–11(b)) is amended— 

4 (1) in the matter preceding paragraph (1), by 

5 inserting ‘‘electronic’’ before ‘‘exchange’’; 

6 (2) in paragraph (6)— 

7 (A) by inserting ‘‘individuals,’’ after ‘‘phy8 sician offices,’’; and 

9 (B) by inserting ‘‘electronic’’ before ‘‘ex10 change of health care information’’; 

11 (3) in paragraph (10), by striking at the end 

12 ‘‘and’’; 

13 (4) in paragraph (11), by striking the period 

14 and inserting ‘‘; and’’; and 

15 (5) by adding at the end the following new 

16 paragraph: 

17 ‘‘(12) allows for an individual to have access to 

18 their individually identifiable health information.’’. 

19 (c) STRATEGIC PLAN RELATING TO PERSONAL

20 HEALTH RECORDS.—Section 3001(c)(3)(A) of the Public 

21 Health Service Act (42 U.S.C. 300jj–11(c)(3)(A)) is 

22 amended by adding at the end the following new clause: 

23 ‘‘(ix) The interoperability of a per24 sonal health record with an electronic 

25 health record.’’. 


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1 (d) GUIDELINES RELATING TO PERSONAL HEALTH

2 RECORDS.—Section 3001(c) of the Public Health Service 

3 Act (42 U.S.C. 300jj–11(c)) is amended by adding at the 

4 end the following new paragraph: 

5 ‘‘(9) GUIDELINES FOR PERSONAL HEALTH

6 RECORDS.—Not later than the date that is 12 

7 months after the date of the enactment of the Per8 sonal Health Record Act of 2009, the National Co9 ordinator shall develop guidelines for making elec10 tronic health records interoperable with personal 

11 health records for the purpose of improving health 

12 care quality, reducing medical errors, and advancing 

13 the delivery of patient-centered medical care and 

14 health management. Such guidelines shall include— 

15 ‘‘(A) standards based on the recommenda16 tions provided in section 3002(b)(2)(B)(ix), in17 cluding for purposes of requiring electronic 

18 health records to be made available through 

19 electronic exchange and interoperable with per20 sonal health records for purposes of dem21 onstrating meaningful use of an electronic 

22 health record under sections 1848(o)(2)(A)(i), 

23 1886(n)(3)(A)(i), and 1903(t)(6)(C)(i)(II) of 

24 the Social Security Act; 


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1 ‘‘(B) recommendations for applying such a 

2 requirement of making electronic health records 

3 available, with respect to community and behav4 ioral health programs, in the form of personal 

5 health records to improve the effective and effi6 cient electronic exchange and management of 

7 information between the individual (or author8 ized representative of the individual), including 

9 those in medically underserved communities (as 

10 defined in section 799B(6)), and community 

11 health centers and behavioral health service 

12 providers; 

13 ‘‘(C) required components of a personal 

14 health record, which shall include— 

15 ‘‘(i) information on medical history, 

16 including diagnoses and procedures, includ17 ing updates if diagnosis or procedures 

18 change after each provider encounter; 

19 ‘‘(ii) information on recent laboratory 

20 results, diagnostic examinations, and 

21 radiologic procedures, if available in elec22 tronic format; 

23 ‘‘(iii) information on medications and 

24 prescriptions, both current and historical, 


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1 including updates if medications change 

2 after each provider encounter; 

3 ‘‘(iv) information on allergies, both 

4 medication and environmental, including 

5 the specific reaction; 

6 ‘‘(v) privacy, security, and electronic 

7 informed consents for disclosing individ8 ually identifiable health information; 

9 ‘‘(vi) computer programming stand10 ards determined by the National Coordi11 nator that allow interoperability of individ12 ually identifiable health information and 

13 communications between covered entities 

14 (as defined for purposes of HIPAA privacy 

15 and security law, as defined in section 

16 3009(a)(2)), entities to the extent that 

17 they engage in activities as business associ18 ates of such covered entities, individuals, 

19 and vendors of personal health records; 

20 ‘‘(vii) portability of the personal 

21 health record by the individual between 

22 covered entities, business associates de23 scribed in clause (vi), or vendors of per24 sonal health records; 


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1 ‘‘(viii) ability to use such record as 

2 part of the patient intake process; 

3 ‘‘(ix) accurate attribution of the 

4 source of all data in the personal health 

5 record, including the source of the infor6 mation, the date that such information was 

7 entered into the personal health record, 

8 and standards-based protection of data 

9 provided by the health care provider (such 

10 as health care provider clinic notes, labora11 tory results, diagnostic examinations, and 

12 radiologic procedures) from changes; 

13 ‘‘(x) notification of the individual in14 volved or the authorized representative of 

15 such individual of the risks of withholding 

16 medical information from a medical pro17 vider; and 

18 ‘‘(xi) health services communication 

19 tools, including those which offer online se20 cure communication with covered entities 

21 (as defined for purposes of HIPAA privacy 

22 and security law, as defined in section 

23 3009(a)(2)) and entities to the extent that 

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1 ates (as defined for such purposes) of such 

2 a covered entity; 

3 ‘‘(D) other possible components for consid4 eration of a personal health record, including— 

5 ‘‘(i) an audit trail to monitor who has 

6 accessed the personal health record of the 

7 individual; 

8 ‘‘(ii) automated appointment, care re9 minders, and health self-management tools; 

10 ‘‘(iii) the ability to provide education 

11 tools; 

12 ‘‘(iv) the ability of the individual or 

13 authorized representative involved to anno14 tate (without changing) health care pro15 vider records, such as to provide feedback 

16 to health care providers of the individual; 

17 ‘‘(v) protection of clinical records in 

18 the personal health record which are im19 ported from or exported to a covered enti20 ty, business associate described in clause 

21 (i), or vendor of personal health records 

22 from being changed by the individual, au23 thorized representative of the individual, 

24 vendor of personal health records, the cov25 ered entity, or business associate; 


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1 ‘‘(vi) the ability to allow comments by 

2 the individual, authorized representative, 

3 and covered entity within an area of the 

4 personal health record that is separate 

5 from the clinical record imported from or 

6 exported to a covered entity; and 

7 ‘‘(vii) emergency access procedures for 

8 medical personnel, with respect to the 

9 record, for clinical care in cases that the 

10 individual or authorized representative is 

11 not able to give consent; and 

12 ‘‘(E) security, privacy, and electronic in13 formed consents for disclosing individually iden14 tifiable health information for personal health 

15 records, including the recommendations de16 scribed in paragraph (6)(F). 

17 In the case that the Secretary determines that any 

18 standard or component for personal health records 

19 included under the guidance under this paragraph is 

20 not adequate pursuant to the report submitted 

21 under paragraph (6)(F), the Secretary shall notify 

22 the National Coordinator and the HIT Standards 

23 Committee in accordance with section 3004(a)(2)(B) 

24 and the National Coordinator may revise such stand25 ard or component, respectively.’’. 


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1 (e) REPORTS.—Section 3001(c)(6) of such Act (42 

2 U.S.C. 300jj–11(c)(6)) is amended by adding at the end 

3 the following new subparagraphs: 

4 ‘‘(F) MONITORING PERSONAL HEALTH

5 RECORDS.—Not later than the date that is 24 

6 months after the date of the enactment of the 

7 Personal Health Record Act of 2009 and annu8 ally thereafter, the National Coordinator, in 

9 consultation with the Administrator of the Cen10 ters for Medicare & Medicaid Services, shall 

11 submit to the appropriate committees of juris12 diction of Congress an annual report on— 

13 ‘‘(i) the extent to which personal 

14 health records have been integrated into 

15 the meaningful use of electronic health 

16 records for purposes of sections 

17 1848(o)(2), 1886(n)(3), and 1903(t)(6) of 

18 the Social Security Act; 

19 ‘‘(ii) the extent to which the use of 

20 personal health records improve commu21 nication between individuals and covered 

22 entities (as defined for purposes of HIPAA 

23 privacy and security law, as defined in sec24 tion 3009(a)(2)) and improve patient 

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1 tion of the extent to which there are cost 

2 savings; 

3 ‘‘(iii) the extent to which the use of 

4 personal health records, with respect to 

5 community health centers and behavioral 

6 health services, improve the effective and 

7 efficient exchange and management of in8 formation between the individual involved 

9 (or authorized representative of the indi10 vidual), including those in medically under11 served communities, and community health 

12 centers and behavioral health service pro13 viders; 

14 ‘‘(iv) status of the standards imple15 mented in paragraph (9)(A) and the need 

16 to revise or include new standards; 

17 ‘‘(v) the adequacy of the components 

18 of a personal health record described in 

19 paragraph (9)(C); and 

20 ‘‘(vi) the affect of having an individual 

21 with full access to the medical records of 

22 such individual through use of a personal 

23 health record, including— 

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1 ing the impact of personal health 

2 records on health care provider effi3 ciency, health care provider reim4 bursement for time spent interacting 

5 with individuals as a result of per6 sonal health records, and defensive 

7 medicine practices); 

8 ‘‘(II) the extent that such access 

9 affects communications by means of 

10 such records between various health 

11 care providers of the individual (in12 cluding the use of provider notations); 

13 ‘‘(III) a prospective study ana14 lyzing the affect of such access on the 

15 patient-health care provider relation16 ship; and 

17 ‘‘(IV) the risks and benefits of an 

18 individual having full access to med19 ical records of the individual through 

20 the use of personal health records. 

21 ‘‘(G) RECOMMENDATION RELATING TO SE22 CURITY AND PRIVACY OF PERSONAL HEALTH

23 RECORDS.—Not later than 6 months after the 

24 date of the enactment of the Personal Health 

25 Record Act of 2009, the National Coordinator 


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1 shall submit to the appropriate committees of 

2 jurisdiction of Congress a report, including rec3 ommendations, on the technological, 

4 medicolegal, medical safety, and other pertinent 

5 issues related to an individual’s control of the 

6 personal health record of such individual and 

7 shall establish guidelines for such control. The 

8 National Coordinator shall ensure the participa9 tion in such a report of health care consumers, 

10 vendors of personal health records, and covered 

11 entities (as defined for purposes of HIPAA pri12 vacy and security law, as defined in section 

13 3009(a)(2)), along with other health care stake14 holders. The report shall encompass at least the 

15 following issues: 

16 ‘‘(i) the rights of an individual uti17 lizing a personal health record with respect 

18 to the individual’s own individually identifi19 able health information contained in such; 

20 and 

21 ‘‘(ii) the security and privacy of an in22 dividual utilizing a personal health record, 

23 including— 

24 ‘‘(I) defining who has right of ac25 cess to an individual’s personal health 


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1 record in the case of a personal health 

2 record provided by a covered entity; 

3 ‘‘(II) security and privacy issues 

4 following medical emergency access of 

5 information in a personal health 

6 record by health care providers; 

7 ‘‘(III) the impact of an individual 

8 restricting medical information access 

9 in a personal health record of such in10 dividual to health care providers on 

11 patient care and safety; 

12 ‘‘(IV) the risks and benefits of 

13 health care provider notification if the 

14 personal health record of an individual 

15 is restricted by the individual; 

16 ‘‘(V) the uses and disclosures of 

17 the information of an individual con18 tained in a personal health record that 

19 should be authorized or required by a 

20 vendor of personal health records pro21 viding and maintaining such record; 

22 ‘‘(VI) electronic informed con23 sents for disclosing individually identi24 fiable health information; 


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1 ‘‘(VII) the use of an audit trail of 

2 who has entered, removed, and 

3 changed data within a personal health 

4 record; and 

5 ‘‘(VIII) the dissemination of ab6 normal laboratory results, diagnostic 

7 examinations, and radiological proce8 dures into personal health records 

9 prior to notification of the abnor10 mality by the health care provider.’’. 

11 (f) PERSONAL HEALTH RECORD STANDARDS IN12 CLUDED IN HIT POLICY COMMITTEE RECOMMENDA13 TIONS.— 

14 (1) IN GENERAL.—Section 3002(b)(2)(B) of 

15 the Public Health Service Act (42 U.S.C. 300jj– 

16 12(b)(2)(B)) is amended by adding at the end the 

17 following new clause: 

18 ‘‘(ix) Standards and implementation 

19 specifications for the interoperability of 

20 personal health records and electronic 

21 health records.’’. 

22 (2) CONFORMING CHANGES RELATING TO HIT

23 STANDARDS COMMITTEE RECOMMENDATIONS.— 

24 (A) DEADLINE FOR SUBMISSION OF REC25 OMMENDATIONS TO NATIONAL COORDINATOR.— 


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1 Section 3003(b)(1)(A) of such Act (42 U.S.C. 

2 300jj–13(b)(1)(A)) is amended by adding at the 

3 end the following: ‘‘Not later than the date that 

4 is 6 months after the date of the enactment of 

5 the Personal Health Record Act of 2009, the 

6 HIT Standards Committee shall recommend to 

7 the National Coordinator standards and imple8 mentation specifications described in section 

9 3002(b)(2)(B)(ix). The HIT Standards Com10 mittee shall update such recommendations and 

11 make new recommendations as appropriate, in12 cluding in response to notification sent under 

13 section 3004(a)(2)(B).’’. 

14 (B) FORUM.—Section 3003(b)(2) of such 

15 Act (42 U.S.C. 300jj–13(b)(2)) is amended by 

16 inserting before the period the following: ‘‘, in17 cluding for the adoption of interoperability of 

18 personal health records and electronic health 

19 records’’. 

20 (3) CONFORMING CHANGES RELATING TO

21 ADOPTION OF INITIAL SET OF STANDARDS.—Section 

22 3004(b)(1) of such Act (42 U.S.C. 300jj–14(b)(1)) 

23 is amended by inserting ‘‘(other than clause (ix))’’ 

24 after ‘‘section 3002(b)(2)(B)’’. 


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1 (g) APPLICATION OF GUIDELINES TO MEANINGFUL

2 USE REQUIREMENTS OF ELECTRONIC MEDICAL RECORDS

3 UNDER MEDICARE.— 

4 (1) ELIGIBLE PROFESSIONAL PAYMENT INCEN5 TIVES.—Section 1848(o)(2)(A)(i) of the Social Secu6 rity Act (42 U.S.C. 1395w–4(o)(2)(A)(i)) is amend7 ed by inserting before the period at the end the fol8 lowing: ‘‘and shall include demonstrating the avail9 ability of such technology to and use of such tech10 nology by individuals furnished items and services by 

11 such professional in the form of electronic and per12 sonal health records consistent with guidelines estab13 lished by the National Coordinator under section 

14 3001(c)(9)(A) of the Public Health Service Act’’. 

15 (2) ELIGIBLE HOSPITAL PAYMENT INCEN16 TIVES.—Section 1886(n)(3)(A)(i) of such Act (42 

17 U.S.C. 1395ww(n)(3)(A)(i)) is amended by inserting 

18 before the period at the end the following: ‘‘, which 

19 shall include demonstrating the availability of such 

20 technology to and use of such technology by individ21 uals furnished items and services by such hospital in 

22 the form of electronic and personal health records 

23 consistent with guidelines established by the Na24 tional Coordinator under section 3001(c)(9)(A) of 

25 the Public Health Service Act’’. 


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1 (h) APPLICATION OF GUIDELINES TO MEANINGFUL

2 EHR USE REQUIREMENTS UNDER MEDICAID.—Section 

3 1903(t)(6)(C)(i)(II) of the Social Security Act (42 U.S.C. 

4 1396b(t)(6)(C)(i)(II)) is amended— 

5 (1) by striking ‘‘and’’ before ‘‘that may be 

6 based’’; and 

7 (2) by inserting before the period at the end the 

8 following: ‘‘, and which shall include demonstrating 

9 the availability of such technology to and use of such 

10 technology by individuals furnished items and serv11 ices by such Medicaid provider in the form of elec12 tronic and personal health records consistent with 

13 guidelines established by the National Coordinator 

14 under section 3001(c)(9)(A) of the Public Health 

15 Service Act’’. 

16 (i) RELATIONSHIP TO OTHER LAWS.—Section 13421 

17 of the HITECH Act (42 U.S.C. 17951) is amended by 

18 adding at the end the following new subsection: 

19 ‘‘(c) HEALTH INFORMATION PORTABILITY AND AC20 COUNTABILITY ACT, HEALTH CARE PROVIDERS, AND

21 PERSONAL HEALTH RECORDS.—Nothing in this subtitle 

22 or the provisions of or amendments made by the Personal 

23 Health Record Act of 2009 shall affect the ability of a 

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1 tory of such individual from another health care provider 

2 involved in the medical care of the individual, in accord3 ance with HIPAA privacy and security law (as defined in 

4 section 3009(a)(2) of the Public Health Service Act) as 

5 in effect before the date of the enactment of the Personal 

6 Health Record Act of 2009.’’. 

Æ 


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