I 

116TH CONGRESS 

2D SESSION H. R. 8080 

To amend the Public Health Service Act to encourage the development of 

certain public health data standards, authorize epidemiological surveillance grants, and authorize a data linkage demonstration project, and 

for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

AUGUST 21, 2020 

Mr. PETERS (for himself, Ms. ESHOO, Mrs. MCBATH, and Mr. FITZPATRICK) 

introduced the following bill; which was referred to the Committee on Energy and Commerce 

A BILL 

To amend the Public Health Service Act to encourage the 

development of certain public health data standards, authorize epidemiological surveillance grants, and authorize 

a data linkage demonstration project, and for other purposes. 

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

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Health Standards To 

5 Advance Transparency, Integrity, Science, Technology In6 frastructure, and Confidential Statistics Act of 2020’’ or 

7 the ‘‘Health STATISTICS Act of 2020’’. 

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1 SEC. 2. IMPROVING PUBLIC HEALTH DATA. 

2 Title XXXI of the Public Health Service Act (42 

3 U.S.C. 300kk) is amended— 

4 (1) by inserting before section 3101 the fol5 lowing subtitle designation and heading: 

6 ‘‘Subtitle A—In General’’; 

7 and 

8 (2) by adding at the end the following new sub9 title: 

10 ‘‘Subtitle B—Public Health 

11 Common Data Standards 

12 ‘‘SEC. 3111. TREATMENT OF PUBLIC HEALTH DATA. 

13 ‘‘(a) STANDARDIZED REPORTING.— 

14 ‘‘(1) IN GENERAL.—The Secretary, acting 

15 through the Director of the Centers for Disease 

16 Control and Prevention, shall— 

17 ‘‘(A) adopt and update as necessary uni18 form standards for State and local health de19 partments to report data to the Centers; and 

20 ‘‘(B) in adopting and updating standards 

21 under this subsection, give deference to— 

22 ‘‘(i) corresponding standards devel23 oped by standards development organiza24 tions and voluntary consensus-based stand25 ards bodies; and 

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1 ‘‘(ii) the recommendations of the 

2 working group established under para3 graph (3). 

4 ‘‘(2) REQUIREMENTS.—The standards under 

5 paragraph (1) shall— 

6 ‘‘(A) be consistent with— 

7 ‘‘(i) standards for the interoperability 

8 of health information technology under 

9 subtitle A; 

10 ‘‘(ii) Office of Management and Budg11 et Circular A–119 (or any successor there12 to); 

13 ‘‘(iii) Office of Management and 

14 Budget standards for race and ethnicity 

15 and other relevant measures; and 

16 ‘‘(B) provide for the use of interoperable 

17 systems, consistent with the application pro18 gramming interface standards and associated 

19 implementation specifications under section 

20 170.215 of title 45 (or any successor regula21 tions). 

22 ‘‘(3) WORKING GROUP.— 

23 ‘‘(A) ESTABLISHMENT.—The Secretary 

24 shall establish a permanent technical working 

25 group (in this paragraph referred to as the 

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1 ‘working group’) to make recommendations on 

2 an ongoing basis and as needed to establish 

3 more comprehensive common standards across 

4 appropriate health care, public health, environ5 mental, and public assistance data systems. 

6 ‘‘(B) DUTIES.—In making the recommen7 dations required by subparagraph (A), the 

8 working group shall— 

9 ‘‘(i) coordinate, and consult with the 

10 Interagency Council on Statistical Policy 

11 established under section 3504 of title 44, 

12 United States Code, and any other relevant 

13 interagency or intra-agency committee; 

14 ‘‘(ii) include recommendations for— 

15 ‘‘(I) efficiencies to reduce redun16 dancy and the public reporting burden 

17 in Federal health data reporting re18 quirements and data collections; and 

19 ‘‘(II) methods to facilitate evi20 dence-building through standardized 

21 local and State reporting and cross22 agency, linkable data sharing between 

23 and among local, State, and Federal 

24 agencies to collect, acquire, and com25 pile complete statistics; and 

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1 ‘‘(iii) build on existing efforts of pub2 lic multistakeholder initiatives seeking to 

3 standardize key data elements necessary 

4 for documenting clinical and other activi5 ties related to the social determinants of 

6 health in order to improve interoperability, 

7 exchange, and use of social determinants 

8 of health data across the health and 

9 human services sectors. 

10 ‘‘(C) ADDITIONAL CONSULTATION.—The 

11 working group may consult with outside ex12 perts, including State, local, Tribal, and terri13 torial public health officials, public health re14 searchers, and health care providers rep15 resenting communities most affected by health 

16 disparities. 

17 ‘‘(D) TIMING.—Not later than 6 months 

18 after the date of enactment of this subtitle, the 

19 working group shall provide initial recommenda20 tions under subsection (a) to the Secretary and 

21 the Director of the Centers for Disease Control 

22 and Prevention. 

23 ‘‘(E) COMPOSITION.— 

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1 ‘‘(i) IN GENERAL.—The working 

2 group shall, at a minimum, include rep3 resentation from— 

4 ‘‘(I) all relevant Department of 

5 Health and Human Services units, in6 cluding— 

7 ‘‘(aa) the National Center 

8 for Health Statistics; 

9 ‘‘(bb) the Centers for Dis10 ease Control and Prevention; 

11 ‘‘(cc) the Office of the Chief 

12 Technology Officer in the Office 

13 of the Secretary; 

14 ‘‘(dd) the Office of the Na15 tional Coordinator for Health In16 formation Technology; and 

17 ‘‘(ee) the Health and 

18 Human Services Data Council; 

19 ‘‘(II) the Office of Information 

20 and Regulatory Affairs of the Office 

21 of Management and Budget; 

22 ‘‘(III) the National Institute of 

23 Standards and Technology; 

24 ‘‘(IV) the Veterans Health Ad25 ministration; 

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1 ‘‘(V) the Military Health System; 

2 and 

3 ‘‘(VI) the Indian Health Service. 

4 ‘‘(ii) CHAIR.—The chair of the work5 ing group shall be the Director of the Na6 tional Center for Health Statistics (or the 

7 Director’s designee). 

8 ‘‘(b) INCREASING EFFICIENCY AND ADVANCING EVI9 DENCE BUILDING.—Consistent with the standards in ef10 fect under subsection (a), the Chief Statistician of the 

11 United States in the Office of Management and Budget, 

12 in accordance with section 3504(e) of title 44, United 

13 States Code, shall issue and update on an ongoing basis 

14 as needed, directives guiding Federal health data informa15 tion collection to reduce public reporting burden, ensure 

16 information quality, improve use of determinants of health 

17 data, and enhance access to health data for evidence-build18 ing activities. 

19 ‘‘(c) COVID–19 HIGH-PRIORITY STANDARDS.—Not 

20 later than 30 days after the date of enactment of this sub21 title, the Secretary, acting through the Director of the 

22 Centers for Disease Control and Prevention, and in con23 sultation with the Director of the National Institutes of 

24 Health, shall— 

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1 ‘‘(1) establish standards under subsection (a) 

2 with respect to COVID–19, including for therapeutic 

3 interventions, treatment settings, and associated out4 comes; and 

5 ‘‘(2) in carrying out paragraph (1), adopt or 

6 build upon existing standards. 

7 ‘‘(d) SHARING DATA RELATED TO COVID–19.— 

8 Subject to applicable law on the privacy and confiden9 tiality of individually identifiable information, the Sec10 retary shall— 

11 ‘‘(1) share up-to-date data related to COVID– 

12 19 data collected by the Department of Health and 

13 Human Services with— 

14 ‘‘(A) the Centers for Disease Control and 

15 Prevention; and 

16 ‘‘(B) Federal, State, and local public 

17 health agencies outside of the Department of 

18 Health and Human Services; and 

19 ‘‘(2) make such data (including metadata as de20 fined in section 3502 of title 44, United States 

21 Code) publicly available using standardized, ma22 chine-readable formats— 

23 ‘‘(A) on the website of the Department of 

24 Health and Human Services; and 

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1 ‘‘(B) in the Federal data catalogue main2 tained under section 3511(c) of title 44, United 

3 States Code. 

4 ‘‘SEC. 3112. EPIDEMIOLOGICAL SURVEILLANCE GRANTS. 

5 ‘‘(a) GRANT AUTHORITY.—The Secretary, in con6 sultation with the Director of the National Center for 

7 Health Statistics, may award grants or cooperative agree8 ments to public health reporting entities— 

9 ‘‘(1) to establish protocols and acquire tech10 nologies to implement the standards under section 

11 3111 for reporting, directly or indirectly, to the Fed12 eral Government, including by— 

13 ‘‘(A) supporting expansion and moderniza14 tion of electronic case reporting, laboratory re15 porting, and mortality reporting; 

16 ‘‘(B) making data sharing with the Na17 tional Center for Health Statistics bidirectional; 

18 ‘‘(C) improving interoperability standards 

19 and implementation specifications for industry 

20 use to fulfill specific clinical health information 

21 technology interoperability needs; 

22 ‘‘(D) developing and implementing protec23 tions required by subsection (b); and 

24 ‘‘(E) conducting real-world testing of data 

25 sharing to ensure viability, scalability, and 

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1 adaptability of data collection and reporting ac2 tivities; and 

3 ‘‘(2) to carry out such reporting using such pro4 tocols and technologies. 

5 ‘‘(b) ADOPTION OF STANDARDS AND DATA PROTEC6 TIONS.—The Secretary may not award a grant or coopera7 tive agreement under subsection (a) unless the applicant 

8 develops an implementation plan to develop and implement 

9 policies, practices, procedures, and controls related to— 

10 ‘‘(1) improving data quality and reporting time11 liness; 

12 ‘‘(2) data security, in accordance with the most 

13 recent versions of the Cybersecurity Framework and 

14 Privacy Framework (or successor frameworks) of the 

15 National Institute of Standards and Technology; and 

16 ‘‘(3) confidentiality and privacy of any informa17 tion that pertains to an individual and from which, 

18 either alone or in combination with other reasonably 

19 available information, the individual’s identity can be 

20 determined, including policies, practices, procedures, 

21 and controls for— 

22 ‘‘(A) minimizing collection, processing, 

23 maintenance, retention, and disclosure of such 

24 information to what is necessary, proportionate, 

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1 pose that is clearly described and limited in an 

2 agreement between the Federal Government 

3 and the recipient; 

4 ‘‘(B) prohibiting disclosure of such infor5 mation to persons, including government enti6 ties, absent legal safeguards included in Federal 

7 or State laws or regulations, for protecting the 

8 security and privacy of such information; and 

9 ‘‘(C) making the data available to the Na10 tional Center for Health Statistics for statistical 

11 purposes under subchapter III of chapter 35 of 

12 title 44, United States Code. 

13 ‘‘(c) COVID–19 REPORTING.—The Secretary may 

14 not award a grant or cooperative agreement under sub15 section (a) unless the applicant agrees— 

16 ‘‘(1) to use the grant for activities under sub17 section (a) with respect to COVID–19, including 

18 with respect to— 

19 ‘‘(A) testing results data; 

20 ‘‘(B) testing results turnaround time; 

21 ‘‘(C) hospitalization and intensive care unit 

22 data; 

23 ‘‘(D) new infections among health care 

24 workers; 

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1 ‘‘(E) new cases among quarantined con2 tacts; and 

3 ‘‘(F) long-term care facilities, prisons, and 

4 other congregate settings; and 

5 ‘‘(2) in carrying out such activities, to 

6 disaggregate data by age, sex, race, ethnicity, and 

7 ZIP Code, as appropriate and to the extent possible. 

8 ‘‘(d) APPLICATION.—A public health reporting entity 

9 applying for a grant or cooperative agreement under this 

10 section shall submit an application to the Secretary at 

11 such time and in such manner as the Secretary may re12 quire. 

13 ‘‘(e) DEFINITION.—In this section, the term ‘public 

14 health reporting entity’ means any entity that reports data 

15 to the Centers for Disease Control and Prevention or an16 other public health authority, including a State or local 

17 public health department, a public health laboratory, and 

18 a health care provider. 

19 ‘‘SEC. 3113. EVIDENCE-BUILDING DEMONSTRATION PRO20 GRAM. 

21 ‘‘(a) IN GENERAL.—The Secretary acting through 

22 the Director of the National Center for Health Statistics 

23 (in this section referred to as the ‘Secretary’) shall expand 

24 the data linkage program of the Department of Health 

25 and Human Services consisting of Federal statistical and 

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1 programmatic datasets from specified Federal entities, as 

2 authorized by subchapter III of chapter 35 of title 44, 

3 United States Code, for the purpose of facilitating statis4 tical public health research on trends and patterns across 

5 specifically defined, statistically relevant populations, with 

6 a particular focus on linking social determinants of health 

7 data, including with respect to— 

8 ‘‘(1) food insecurity; 

9 ‘‘(2) housing instability; 

10 ‘‘(3) transportation access; 

11 ‘‘(4) safety; 

12 ‘‘(5) social connection and isolation; 

13 ‘‘(6) financial resource strain; and 

14 ‘‘(7) stress. 

15 ‘‘(b) ACTIVITIES.—The activities of the demonstra16 tion program under this section shall include: 

17 ‘‘(1) Assessing the availability of identified and 

18 deidentified data sets held by Federal, State, local, 

19 and non-Federal entities that may be useful for re20 search described in subsection (a). 

21 ‘‘(2) Using existing authorities and linkages of 

22 data in accordance with subchapter III of chapter 35 

23 of title 44, United States Code, when relevant to re24 quest the submission of datasets to the National 

25 Center for Health Statistics for linking. 

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1 ‘‘(c) LIMITATION.—The Secretary shall limit access 

2 to data under the demonstration program under this sec3 tion— 

4 ‘‘(1) to Federal statistical agencies and quali5 fied public and private researchers, as determined by 

6 the Director of the National Center for Health Sta7 tistics; 

8 ‘‘(2) for a period to be specified by the Sec9 retary; and 

10 ‘‘(3) exclusively for the purpose described in 

11 subsection (a). 

12 ‘‘(d) PROCESS FOR MAKING DATA AVAILABLE.— 

13 ‘‘(1) IN GENERAL.—Consistent with paragraph 

14 (2), the Secretary shall establish a rigorous process 

15 for making data available and usable pursuant to 

16 the demonstration program under this section. 

17 ‘‘(2) REQUIREMENTS.—Before any data is 

18 made available pursuant to the demonstration pro19 gram under this section by an entity described in 

20 subsection (b)(1) to another entity described in sub21 section (b)(1)— 

22 ‘‘(A) the receiving entity shall submit to 

23 the Director of the National Center for Health 

24 Statistics an application for data for the pur25 pose described in subsection (a); and 

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1 ‘‘(B) the Director shall approve or deny 

2 such request in writing, including in the case of 

3 a denial an explanation of the reasons for the 

4 denial. 

5 ‘‘(e) RULEMAKING.— 

6 ‘‘(1) NO DELAY ON IMPLEMENTATION.—The 

7 Secretary— 

8 ‘‘(A) shall begin implementation of the 

9 demonstration program under this section upon 

10 the date of enactment of this subtitle; and 

11 ‘‘(B) shall not delay such implementation 

12 for purposes of promulgating the regulations re13 quired by paragraph (2). 

14 ‘‘(2) PROMULGATION.—The Secretary shall— 

15 ‘‘(A) issue regulations for carrying out this 

16 section; and 

17 ‘‘(B) specify in such regulations the al18 lowed and disallowed purposes for sharing and 

19 linking data through the program, including 

20 areas of potential research. 

21 ‘‘(f) WEBSITE.—The Secretary shall maintain a pub22 licly accessible website— 

23 ‘‘(1) providing information about demonstration 

24 program under this section; 

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1 ‘‘(2) facilitating stakeholder participation in 

2 such demonstration program; 

3 ‘‘(3) facilitating oversight of such demonstra4 tion program; 

5 ‘‘(4) providing lists of datasets from Federal 

6 and nonfederal entities; 

7 ‘‘(5) providing lists of identified and deidenti8 fied datasets; 

9 ‘‘(6) identifying linked datasets; 

10 ‘‘(7) delineating a process to protect privacy 

11 and confidentiality; 

12 ‘‘(8) identifying sources of the datasets; and 

13 ‘‘(9) delineating categories of personal data. 

14 ‘‘(g) PROGRAM REQUIREMENTS.—The demonstration 

15 program under this section shall be designed to— 

16 ‘‘(1) support data matching services for agen17 cies and researchers using the National Death 

18 Index; and 

19 ‘‘(2) facilitate collaboration with States and pri20 vate entities to examine, update, and modernize the 

21 fee structure of the National Death Index to support 

22 a broad range of data queries. 

23 ‘‘(h) CONTRACTED ENTITIES.— 

24 ‘‘(1) IN GENERAL.—Subject to the availability 

25 of appropriations, the Secretary may enter into conVerDate Sep 11 2014 22:55 Sep 04, 2020 Jkt 099200 PO 00000 Frm 00016 Fmt 6652 Sfmt 6201 E:\BILLS\H8080.IH H8080
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1 tracts with eligible entities, as appropriate, for infra2 structure and support services in carrying out the 

3 demonstration program under this section. 

4 ‘‘(2) ELIGIBILITY.—To be eligible for a con5 tract under paragraph (1), an entity shall— 

6 ‘‘(A) demonstrate core capabilities for data 

7 sharing, data linkage, and compliance with sub8 chapter III of chapter 35 of title 44, United 

9 States Code; and 

10 ‘‘(B) adhere to security standards in ac11 cordance with the Federal Risk and Authoriza12 tion Management Program (or any successor 

13 program). 

14 ‘‘(i) RULE OF CONSTRUCTION.—Nothing in this sec15 tion shall be construed to authorize the availability or use 

16 of data for— 

17 ‘‘(1) law enforcement; or 

18 ‘‘(2) any determination of the eligibility of an 

19 individual for any direct or indirect payment, ben20 efit, or service. 

21 ‘‘(j) REPORT TO CONGRESS.—Not later than 1 year 

22 after the date of enactment of this Act, and annually 

23 thereafter, the Secretary shall submit a report to the Con24 gress on the implementation of this section, including— 

25 ‘‘(1) identification of best States practices for— 

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1 ‘‘(A) sharing data with, and reporting data 

2 to, the National Death Index; and 

3 ‘‘(B) ensuring the quality of such data; 

4 and 

5 ‘‘(2) recommendations to improve— 

6 ‘‘(A) such sharing and reporting; and 

7 ‘‘(B) access to the National Death Index 

8 by researchers. 

9 ‘‘SEC. 3114. BUILDING STATISTICAL PUBLIC HEALTH RE10 SEARCH CAPACITY. 

11 ‘‘(a) IN GENERAL.—The Secretary, acting through 

12 the Director of the Centers for Disease Control and Pre13 vention, shall provide financial assistance to research enti14 ties and public health departments to establish, expand, 

15 or enhance capacity for conducting statistical public health 

16 research— 

17 ‘‘(1) in connection with the programs and ac18 tivities under this subtitle; and 

19 ‘‘(2) in accordance with subchapter III of chap20 ter 35 of title 44, United States Code. 

21 ‘‘(b) CAPACITY FOR SHARING AND LINKING.—The 

22 capacity referred to in subsection (a) may include sharing 

23 and linking information and accessing and utilizing linked 

24 health data files in accordance with established data use 

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1 porting, electronic health records, and electronic test or2 ders and results) with public health agencies and related 

3 systems, including the National Death Index, immuniza4 tion information systems, syndromic surveillance systems, 

5 laboratory information management systems, electronic 

6 case reporting systems, medical examiner case manage7 ment systems, and Patient Unified Look-up Systems for 

8 Emergencies. 

9 ‘‘SEC. 3115. RULE OF CONSTRUCTION. 

10 ‘‘Nothing in this subtitle shall be construed to super11 sede the authority of the Director of the Office of Manage12 ment and Budget under title 44, United States Code, to 

13 determine and issue relevant standards for information 

14 management. 

15 ‘‘SEC. 3116. AUTHORIZATION OF APPROPRIATIONS. 

16 ‘‘There are authorized to be appropriated— 

17 ‘‘(1) to carry out this subtitle (other than sec18 tion 3113), $450,000,000, to remain available until 

19 expended; and 

20 ‘‘(2) to carry out section 3113, $100,000,000 

21 for the period of fiscal years 2020 through 2025.’’. 

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