,i #aafth ,,congress #b;d ,session ,h4 ,r4 #hjhj ,,in ,,the ,,house ,,of ,,representatives ,august #ba1 #bjbj,mr4 ,peters 7for himself1 ,ms4 ,eshoo1 ,mrs4 ,mc,bath1 and ,mr4 ,fitzpatrick7 introduced the following bill2 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 standards1 authorize epidemiological surveillance grants1 and authorize a data linkage demonstration project1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,health ,standards ,to ,advance ,transparency1 ,integrity1 ,science1 ,technology ,infrastructure1 and ,confidential ,statistics ,act of #bjbj or the ,health ,,statistics ,act of #bjbj4 #b4 ,improving public health data ,title ,,xxxi of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjjkk7 is amended-- 7#a7 by inserting before section #caja the following subtitle designation and heading3 ,a ,in general 2 and 7#b7 by adding at the end the following new subtitle3 ,b ,public health common data standards #caaa4 ,treatment of public health data 7a7 ,standardized reporting 7#a7 ,in general ,the ,secretary1 acting through the ,director of the ,centers for ,disease ,control and ,prevention1 shall-- 7,a7 adopt and update as necessary uniform standards for ,state and local health departments to report data to the ,centers2 and 7,b7 in adopting and updating standards under this subsection1 give deference to-- 7i7 corresponding standards developed by standards development organizations and voluntary consensus-based standards bodies2 and 7ii7 the recommendations of the working group established under paragraph 7#c74 7#b7 ,requirements ,the standards under paragraph 7#a7 shall-- 7,a7 be consistent with-- 7i7 standards for the interoperability of health information technology under subtitle ,a2 7ii7 ,office of ,management and ,budget ,circular ,a-#aai 7or any successor thereto72 7iii7 ,office of ,management and ,budget standards for race and ethnicity and other relevant measures2 and 7,b7 provide for the use of interoperable systems1 consistent with the application programming interface standards and associated implementation specifications under section #agj4bae of title #de 7or any successor regulations74 7#c7 ,working group 7,a7 ,establishment ,the ,secretary shall establish a permanent technical working group 7in this paragraph referred to as the working group7 to make recommendations on an ongoing basis and as needed to establish more comprehensive common standards across appropriate health care1 public health1 environmental1 and public assistance data systems4 7,b7 ,duties ,in making the recommendations required by subparagraph 7,a71 the working group shall-- 7i7 coordinate1 and consult with the ,interagency ,council on ,statistical ,policy established under section #cejd of title #dd1 ,united ,states ,code1 and any other relevant interagency or intra-agency committee2 7ii7 include recommendations for-- 7,i7 efficiencies to reduce redundancy and the public reporting burden in ,federal health data reporting requirements and data collections2 and 7,,ii7 methods to facilitate evidence-building through standardized local and ,state reporting and cross-agency1 linkable data sharing between and among local1 ,state1 and ,federal agencies to collect1 acquire1 and compile complete statistics2 and 7iii7 build on existing efforts of public multistakeholder initiatives seeking to standardize key data elements necessary for documenting clinical and other activities related to the social determinants of health in order to improve interoperability1 exchange1 and use of social determinants of health data across the health and human services sectors4 7,c7 ,additional consultation ,the working group may consult with outside experts1 including ,state1 local1 ,tribal1 and territorial public health officials1 public health researchers1 and health care providers representing communities most affected by health disparities4 7,d7 ,timing ,not later than #f months after the date of enactment of this subtitle1 the working group shall provide initial recommendations under subsection 7a7 to the ,secretary and the ,director of the ,centers for ,disease ,control and ,prevention4 7,e7 ,composition 7i7 ,in general ,the working group shall1 at a minimum1 include representation from-- 7,i7 all relevant ,department of ,health and ,human ,services units1 including-- 7aa7 the ,national ,center for ,health ,statistics2 7bb7 the ,centers for ,disease ,control and ,prevention2 7cc7 the ,office of the ,chief ,technology ,officer in the ,office of the ,secretary2 7dd7 the ,office of the ,national ,coordinator for ,health ,information ,technology2 and 7ee7 the ,health and ,human ,services ,data ,council2 7,,ii7 the ,office of ,information and ,regulatory ,affairs of the ,office of ,management and ,budget2 7,,iii7 the ,national ,institute of ,standards and ,technology2 7,,iv7 the ,veterans ,health ,administration2 7,v7 the ,military ,health ,system2 and 7,,vi7 the ,indian ,health ,service4 7ii7 ,chair ,the chair of the working group shall be the ,director of the ,national ,center for ,health ,statistics 7or the ,director's designee74 7b7 ,increasing efficiency and advancing evidence building ,consistent with the standards in effect under subsection 7a71 the ,chief ,statistician of the ,united ,states in the ,office of ,management and ,budget1 in accordance with section #cejd7;e7 of title #dd1 ,united ,states ,code1 shall issue and update on an ongoing basis as needed1 directives guiding ,federal health data information collection to reduce public reporting burden1 ensure information quality1 improve use of determinants of health data1 and enhance access to health data for evidence-building activities4 7c7 ,,covid-#ai high-,priority standards ,not later than #cj days after the date of enactment of this subtitle1 the ,secretary1 acting through the ,director of the ,centers for ,disease ,control and ,prevention1 and in consultation with the ,director of the ,national ,institutes of ,health1 shall-- 7#a7 establish standards under subsection 7a7 with respect to ,,covid-#ai1 including for therapeutic interventions1 treatment settings1 and associated outcomes2 and 7#b7 in carrying out paragraph 7#a71 adopt or build upon existing standards4 7d7 ,sharing data related to ,,covid-#ai ,subject to applicable law on the privacy and confidentiality of individually identifiable information1 the ,secretary shall-- 7#a7 share up-to-date data related to ,,covid-#ai data collected by the ,department of ,health and ,human ,services with-- 7,a7 the ,centers for ,disease ,control and ,prevention2 and 7,b7 ,federal1 ,state1 and local public health agencies outside of the ,department of ,health and ,human ,services2 and 7#b7 make such data 7including metadata as defined in section #cejb of title #dd1 ,united ,states ,code7 publicly available using standardized1 machine-readable formats-- 7,a7 on the website of the ,department of ,health and ,human ,services2 and 7,b7 in the ,federal data catalogue maintained under section #ceaa7;c7 of title #dd1 ,united ,states ,code4 #caab4 ,epidemiological surveillance grants 7a7 ,grant authority ,the ,secretary1 in consultation with the ,director of the ,national ,center for ,health ,statistics1 may award grants or cooperative agreements to public health reporting entities-- 7#a7 to establish protocols and acquire technologies to implement the standards under section #caaa for reporting1 directly or indirectly1 to the ,federal ,government1 including by-- 7,a7 supporting expansion and modernization of electronic case reporting1 laboratory reporting1 and mortality reporting2 7,b7 making data sharing with the ,national ,center for ,health ,statistics bidirectional2 7,c7 improving interoperability standards and implementation specifications for industry use to fulfill specific clinical health information technology interoperability needs2 7,d7 developing and implementing protections required by subsection 7b72 and 7,e7 conducting real-world testing of data sharing to ensure viability1 scalability1 and adaptability of data collection and reporting activities2 and 7#b7 to carry out such reporting using such protocols and technologies4 7b7 ,adoption of standards and data protections ,the ,secretary may not award a grant or cooperative agreement under subsection 7a7 unless the applicant develops an implementation plan to develop and implement policies1 practices1 procedures1 and controls related to-- 7#a7 improving data quality and reporting timeliness2 7#b7 data security1 in accordance with the most recent versions of the ,cybersecurity ,framework and ,privacy ,framework 7or successor frameworks7 of the ,national ,institute of ,standards and ,technology2 and 7#c7 confidentiality and privacy of any information that pertains to an individual and from which1 either alone or in combination with other reasonably available information1 the individual's identity can be determined1 including policies1 practices1 procedures1 and controls for-- 7,a7 minimizing collection1 processing1 maintenance1 retention1 and disclosure of such information to what is necessary1 proportionate1 and limited for a good faith public health purpose that is clearly described and limited in an agreement between the ,federal ,government and the recipient2 7,b7 prohibiting disclosure of such information to persons1 including government entities1 absent legal safeguards included in ,federal or ,state laws or regulations1 for protecting the security and privacy of such information2 and 7,c7 making the data available to the ,national ,center for ,health ,statistics for statistical purposes under subchapter ,,iii of chapter #ce of title #dd1 ,united ,states ,code4 7c7 ,,covid-#ai reporting ,the ,secretary may not award a grant or cooperative agreement under subsection 7a7 unless the applicant agrees-- 7#a7 to use the grant for activities under subsection 7a7 with respect to ,,covid-#ai1 including with respect to-- 7,a7 testing results data2 7,b7 testing results turnaround time2 7,c7 hospitalization and intensive care unit data2 7,d7 new infections among health care workers2 7,e7 new cases among quarantined contacts2 and 7,f7 long-term care facilities1 prisons1 and other congregate settings2 and 7#b7 in carrying out such activities1 to disaggregate data by age1 sex1 race1 ethnicity1 and ,,zip ,code1 as appropriate and to the extent possible4 7d7 ,application ,a public health reporting entity applying for a grant or cooperative agreement under this section shall submit an application to the ,secretary at such time and in such manner as the ,secretary may require4 7e7 ,definition ,in this section1 the term public health reporting entity means any entity that reports data to the ,centers for ,disease ,control and ,prevention or another public health authority1 including a ,state or local public health department1 a public health laboratory1 and a health care provider4 #caac4 ,evidence-building demonstration program 7a7 ,in general ,the ,secretary acting through the ,director of the ,national ,center for ,health ,statistics 7in this section referred to as the ,secretary7 shall expand the data linkage program of the ,department of ,health and ,human ,services consisting of ,federal statistical and programmatic datasets from specified ,federal entities1 as authorized by subchapter ,,iii of chapter #ce of title #dd1 ,united ,states ,code1 for the purpose of facilitating statistical public health research on trends and patterns across specifically defined1 statistically relevant populations1 with a particular focus on linking social determinants of health data1 including with respect to-- 7#a7 food insecurity2 7#b7 housing instability2 7#c7 transportation access2 7#d7 safety2 7#e7 social connection and isolation2 7#f7 financial resource strain2 and 7#g7 stress4 7b7 ,activities ,the activities of the demonstration program under this section shall include3 7#a7 ,assessing the availability of identified and deidentified data sets held by ,federal1 ,state1 local1 and non-,federal entities that may be useful for research described in subsection 7a74 7#b7 ,using existing authorities and linkages of data in accordance with subchapter ,,iii of chapter #ce of title #dd1 ,united ,states ,code1 when relevant to request the submission of datasets to the ,national ,center for ,health ,statistics for linking4 7c7 ,limitation ,the ,secretary shall limit access to data under the demonstration program under this section-- 7#a7 to ,federal statistical agencies and qualified public and private researchers1 as determined by the ,director of the ,national ,center for ,health ,statistics2 7#b7 for a period to be specified by the ,secretary2 and 7#c7 exclusively for the purpose described in subsection 7a74 7d7 ,process for making data available 7#a7 ,in general ,consistent with paragraph 7#b71 the ,secretary shall establish a rigorous process for making data available and usable pursuant to the demonstration program under this section4 7#b7 ,requirements ,before any data is made available pursuant to the demonstration program under this section by an entity described in subsection 7b77#a7 to another entity described in subsection 7b77#a7-- 7,a7 the receiving entity shall submit to the ,director of the ,national ,center for ,health ,statistics an application for data for the purpose described in subsection 7a72 and 7,b7 the ,director shall approve or deny such request in writing1 including in the case of a denial an explanation of the reasons for the denial4 7e7 ,rulemaking 7#a7 ,no delay on implementation ,the ,secretary-- 7,a7 shall begin implementation of the demonstration program under this section upon the date of enactment of this subtitle2 and 7,b7 shall not delay such implementation for purposes of promulgating the regulations required by paragraph 7#b74 7#b7 ,promulgation ,the ,secretary shall-- 7,a7 issue regulations for carrying out this section2 and 7,b7 specify in such regulations the allowed and disallowed purposes for sharing and linking data through the program1 including areas of potential research4 7f7 ,website ,the ,secretary shall maintain a publicly accessible website-- 7#a7 providing information about demonstration program under this section2 7#b7 facilitating stakeholder participation in such demonstration program2 7#c7 facilitating oversight of such demonstration program2 7#d7 providing lists of datasets from ,federal and nonfederal entities2 7#e7 providing lists of identified and deidentified datasets2 7#f7 identifying linked datasets2 7#g7 delineating a process to protect privacy and confidentiality2 7#h7 identifying sources of the datasets2 and 7#i7 delineating categories of personal data4 7g7 ,program requirements ,the demonstration program under this section shall be designed to-- 7#a7 support data matching services for agencies and researchers using the ,national ,death ,index2 and 7#b7 facilitate collaboration with ,states and private entities to examine1 update1 and modernize the fee structure of the ,national ,death ,index to support a broad range of data queries4 7h7 ,contracted entities 7#a7 ,in general ,subject to the availability of appropriations1 the ,secretary may enter into contracts with eligible entities1 as appropriate1 for infrastructure and support services in carrying out the demonstration program under this section4 7#b7 ,eligibility ,to be eligible for a contract under paragraph 7#a71 an entity shall-- 7,a7 demonstrate core capabilities for data sharing1 data linkage1 and compliance with subchapter ,,iii of chapter #ce of title #dd1 ,united ,states ,code2 and 7,b7 adhere to security standards in accordance with the ,federal ,risk and ,authorization ,management ,program 7or any successor program74 7i7 ,rule of construction ,nothing in this section shall be construed to authorize the availability or use of data for-- 7#a7 law enforcement2 or 7#b7 any determination of the eligibility of an individual for any direct or indirect payment1 benefit1 or service4 7j7 ,report to ,congress ,not later than #a year after the date of enactment of this ,act1 and annually thereafter1 the ,secretary shall submit a report to the ,congress on the implementation of this section1 including-- 7#a7 identification of best ,states practices for-- 7,a7 sharing data with1 and reporting data to1 the ,national ,death ,index2 and 7,b7 ensuring the quality of such data2 and 7#b7 recommendations to improve-- 7,a7 such sharing and reporting2 and 7,b7 access to the ,national ,death ,index by researchers4 #caad4 ,building statistical public health research capacity 7a7 ,in general ,the ,secretary1 acting through the ,director of the ,centers for ,disease ,control and ,prevention1 shall provide financial assistance to research entities and public health departments to establish1 expand1 or enhance capacity for conducting statistical public health research-- 7#a7 in connection with the programs and activities under this subtitle2 and 7#b7 in accordance with subchapter ,,iii of chapter #ce of title #dd1 ,united ,states ,code4 7b7 ,capacity for sharing and linking ,the capacity referred to in subsection 7a7 may include sharing and linking information and accessing and utilizing linked health data files in accordance with established data use agreements with data holders 7including electronic case reporting1 electronic health records1 and electronic test orders and results7 with public health agencies and related systems1 including the ,national ,death ,index1 immunization information systems1 syndromic surveillance systems1 laboratory information management systems1 electronic case reporting systems1 medical examiner case management systems1 and ,patient ,unified ,look-up ,systems for ,emergencies4 #caae4 ,rule of construction ,nothing in this subtitle shall be construed to supersede the authority of the ,director of the ,office of ,management and ,budget under title #dd1 ,united ,states ,code1 to determine and issue relevant standards for information management4 #caaf4 ,authorization of appropriations ,there are authorized to be appropriated-- 7#a7 to carry out this subtitle 7other than section #caac71 #dej1jjj1jjj1 to remain available until expended2 and 7#b7 to carry out section #caac1 #ajj1jjj1jjj for the period of fiscal years #bjbj through #bjbe4 4