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Leveraging the health information technology infrastructure to advance federal research priorities

Leveraging the health information technology infrastructure to advance federal research priorities Downloaded from https://academic.oup.com/jamia/article/27/4/647/5748149 by DeepDyve user on 16 July 2022 Journal of the American Medical Informatics Association, 27(4), 2020, 647–651 doi: 10.1093/jamia/ocaa011 Advance Access Publication Date: 24 February 2020 Perspective Perspective Leveraging the health information technology infrastructure to advance federal research priorities 1 2 3 Teresa Zayas-Caban, Amy P. Abernethy, Patricia Flatley Brennan, 4 5 6 7 Stephanie Devaney, Anthony R. Kerlavage, Rachel Ramoni, and P. Jon White Office of the National Coordinator for Health Information Technology, U.S. Department of Health and Human Services, Washing- 2 3 ton, DC, USA, Food and Drug Administration, Silver Spring, Maryland, USA, National Library of Medicine, National Institutes of 4 5 Health, Bethesda, Maryland, USA, All of Us Research Program, National Institutes of Health, Rockville, Maryland, USA, National Cancer Institute, National Institutes of Health, Rockville, Maryland, USA, Office of Research and Development, Veterans Health Administration, Washington, DC, USA, and Veterans Affairs Salt Lake City Health Care System, Salt Lake City, Utah, USA Corresponding Author: Teresa Zayas-Cab an, PhD, Office of the National Coordinator for Health Information Technology, U.S. Department of Health and Human Services, 330 C Street SW, Floor 7, Washington, DC 20201, USA; Teresa.ZayasCaban@hhs.gov Received 27 November 2019; Revised 10 January 2020; Editorial Decision 15 January 2020; Accepted 18 January 2020 ABSTRACT Ensuring that federally funded health research keeps pace with the explosion of health data depends on better information technology (IT), access to high-quality electronic health data, and supportive policies. Because it prominently funds and conducts health research, the U.S. federal government needs health IT to rapidly evolve and has the ability to drive that evolution. The Office of the National Coordinator for Health Information Tech- nology developed the National Health IT Priorities for Research: A Policy and Development Agenda (the Agenda) that identifies health IT priorities for research in consultation with relevant federal agencies. This article describes support for the Agenda from the Food and Drug Administration, the National Institutes of Health, and the Veterans Health Administration. Advancing the Agenda will benefit these agencies and support their mis- sions as well as the entire ecosystem leveraging the health IT infrastructure or using data from health IT sys- tems for research. Key words: health information technology, research, policy, federal government, goals 16–18 19 discovery. In addition, novel security approaches, new models INTRODUCTION 20 21 of consent, and open science initiatives are facilitating appropri- Use of health information technology (IT) by U.S. healthcare pro- ate data sharing and enabling discovery. These efforts highlight the viders and patient access to electronic health data have increased sig- value of a robust research data infrastructure, while also revealing 1–5 nificantly in the past decade. This has been facilitated by challenges. U.S. federal scientific policy has an essential role in technological changes in information system capabilities and infra- addressing barriers and accelerating data-driven discoveries. 6–9 structure, as well as legislation, governmental programs, and poli- 5,10–14 cies. In parallel, new health research information systems and capabilities are creating accelerated potential for research, discov- ADVANCING DISCOVERY THROUGH HEALTH IT ery, and clinical translation. Large-scale efforts across the research POLICY AND DEVELOPMENT enterprise are standardizing and increasing access to research data. New approaches, such as machine learning and advanced The Office of the National Coordinator for Health Information analytic techniques, have recently demonstrated possibilities for new Technology (ONC) is responsible for regulating the certification of Published by Oxford University Press on behalf of the American Medical Informatics Association 2020. This work is written by US Government employees and is in the public domain in the US. 647 Downloaded from https://academic.oup.com/jamia/article/27/4/647/5748149 by DeepDyve user on 16 July 2022 648 Journal of the American Medical Informatics Association, 2020, Vol. 27, No. 4 Table 1. Health IT priorities for research policy and development infrastructure, which receives and manages large quantities of data from application submissions, surveillance, research, and other sour- 1. Improve data quality at the point of capture. ces. To be successful, FDA requires access to timely, detailed data, 2. Increase data harmonization to enable research uses. which would be advanced by Agenda priorities 1, 3, and 4. In partic- 3. Improve access to interoperable electronic health data. ular, previous FDA experience with clinical data and claims data— 4. Improve services for efficient data storage and discovery. such as the development of the Sentinel System—has highlighted 5. Integrate emerging health and health-related data sources. limitations that can affect current data sources, including limited de- 6. Improve methods and tools to support data aggregation. 7. Develop tools and functions to support research. tail and lagging data updates, further emphasizing the need to ad- 31,32 8. Leverage health IT systems to increase education and participation. vance relevant priorities outlined in the Agenda. 9. Accelerate integration of knowledge at the point of care. A modern IT infrastructure capable of consuming, aggregating, and analyzing large and diverse datasets is needed to achieve FDA’s IT: information technology. broad goals and highlighted by priorities 6 and 7 of the Agenda. In September 2019, FDA published its Technology Modernization Ac- health IT, including electronic health records (EHRs); promulgating tion Plan, which is focused on modernizing its technical infrastruc- health IT data standards; and coordinating nationwide efforts to im- ture, enhancing its capabilities to develop relevant technology plement and use health IT for clinical care and research in the United products, and collaborating with key stakeholders to achieve inter- States. ONC has established a strategic goal to foster research, sci- operability. To be successful, FDA will require improved data entific knowledge, and innovation. Related projects, including data storage and services, along with new tools for aggregation and re- 23,24 standard development, interoperability functionality develop- search, which are highlighted by priorities 4, 6, and 7 in the Agenda. 25 26 ment, and future-oriented policy development, have been indi- As data collected in the health system are increasingly used to in- vidually successful and have been conducted in partnership with the form FDA’s regulatory decision making, interoperability and har- National Institutes of Health (NIH), Food and Drug Administration monization efforts outlined in the Agenda are needed for the (FDA), Agency for Healthcare Research and Quality (AHRQ), and efficient collection and use of high-quality data. The 21st Century others, but the broader mission requires increased strategic coordi- Cures Act of 2016 underscored the promise of real-world data, nation among all federal science agencies and initiatives. which can be derived from EHRs, mobile devices, claims and bil- Accordingly, ONC led the development of the National Health lings activities, product and disease registries, and other sources, and IT Priorities for Research: A Policy and Development Agenda (the evidence to support FDA’s regulatory decision making. In particu- 27,28 Agenda), which identifies priorities for policy and technological lar, FDA recently published a framework for the Real-World Evi- development in the United States, which are listed in Table 1. The dence Program and related use cases to evaluate the use of new types Agenda has 2 overarching goals: (1) leverage high-quality electronic of data and the subsequent analyses in regulatory decisions for drugs health data for research and (2) advance a health IT infrastructure and biologics and understand practical application. FDA also pro- to support research. vided guidance for the use of real-world data in the evaluation of The Agenda was developed in consultation with leading U.S. fe- medical devices and has used real-world data as part of medical de- 36,37 deral agencies that are using electronic health data and the health IT vice regulatory decisions. However, interoperability, standardi- infrastructure to advance health research. Several federal agencies zation, and harmonization are needed for the efficient collection and have a role to play in advancing the health IT infrastructure and use use of high-quality real-world data for these purposes, consistent of electronic health data for research. For example, while it does not with the need to advance priorities 2, 3, and 4 of the Agenda. have a direct role in advancing scientific policy, the Centers for The increasing complexity of data that inform the regulatory Medicare & Medicaid Services plays a role in the development and process has led the FDA to develop novel IT tools for those pur- adoption of health IT. The Centers for Disease Control and Preven- poses. For example, precisionFDA is a next-generation DNA se- tion (CDC) funds an extensive research portfolio and requires a ro- quencing platform that allows researchers to compare their genomic bust IT infrastructure to advance public health science. FDA, NIH, sequencing data against reference datasets and analyze their data us- 38,39 and the Veterans Health Administration (VHA) are leading efforts ing online genomic information libraries. This initiative has pro- to leverage electronic health data and infrastructure advancements vided researchers with access to comparative data on genomic for research across the full spectrum of health and disease. The datasets and powerful analytic tools, which demonstrates the need Agenda represents the shared vision of these leading U.S. federal for advanced aggregation functions and tools to support data analy- health research funding agencies for future federal science policies, sis and research as noted under priorities 6 and 7 of the Agenda. In as well as for technological development of health IT systems that addition, other federal agencies such as the National Cancer Insti- support biomedical research and translation. tute (NCI) and CDC are participating in precisionFDA, highlighting the fact that several agencies have similar research-related needs and creating an example of the type of cross-agency collaboration that is needed to advance Agenda priorities. AGENCY INITIATIVES The Agenda priorities are critical to achieve the missions of these fe- deral agencies. In fact, several U.S. federal agencies already sponsor National Institutes of Health existing initiatives, described subsequently, which highlight how the NIH is the nation’s medical research agency. To achieve its mission Agenda priorities underpin meaningful improvement of research. “to enhance health, lengthen life, and reduce illness and disability,” NIH-funded researchers need access to high-quality electronic health Food and Drug Administration data and research data infrastructure and tools. Advancing the 29,30 FDA has broad responsibilities to protect the public health. Agenda priorities would help meet these needs. NIH is already ad- FDA’s regulatory responsibilities are supported by a significant IT vancing some of these priorities through several initiatives. In particu- Downloaded from https://academic.oup.com/jamia/article/27/4/647/5748149 by DeepDyve user on 16 July 2022 Journal of the American Medical Informatics Association, 2020, Vol. 27, No. 4 649 lar, in 2018 NIH launched the Science and Technology Research In- vancement of key informatics issues outlined under priorities 3, 4, 5, frastructure for Discovery, Experimentation, and Sustainability Initia- 6, and 7 of the Agenda for improved interoperability, data access, tive, which provides commercial cloud storage and computer support storage, aggregation, and analysis of both traditional and emerging for high-value datasets resulting from NIH-funded research, address- health and health-related data. ing Agenda priority 4, promoting efficient data storage and discov- ery. In 2018, NIH also published its Strategic Plan for Data Science Veterans Health Administration (the Plan), which aims to connect NIH data systems, support storage VHA, which provides care for more than 9 million veterans at 170 and sharing of data, increase data management and analytic capabili- medical centers around the nation, is also a major biomedical re- ties, enhance the relevant workforce, and implement good steward- search funder and uses health information systems for care delivery ship policies. The Plan is aligned with Agenda priorities 3, 4, 6, and and research. VHA’s strategic research priorities require access to 7 in highlighting the need for data to be findable, accessible, interoper- high-quality electronic health data and would be accelerated by im- able, and reusable, which can be achieved, in part, through more con- plementation of the Agenda. The ability to make discoveries from sistent use of data standards. these data depends on efficient storage and would benefit from ad- Most recently, to improve interoperability of research data, NIH vancing priority 4 in the Agenda. In addition, as veterans’ health released a notice encouraging researchers to make use of the Health care increasingly includes care outside of VHA facilities, interopera- V R Level Seven International Fast Healthcare Interoperability bility with private sector health information systems is essential, V R Resources standard to accelerate the use of clinical data for re- making it critical to address priorities 2 and 3 in the Agenda. search purposes and the exchange of research data. Not only will The Million Veteran Program (MVP) is a massive cohort pro- 59,60 this advance priority 3 in the Agenda, but also for NIH to reach gram, with more than 800 000 veteran volunteers to date. MVP goals outlined in the notice, it will require coordinated collaboration includes electronic health data, genomic information, and survey with ONC, researchers, and developers to continue to advance data, some of which is drawn from the VA Informatics and Comput- standards development as outlined under priority 2 of the Agenda. ing Infrastructure, which also supports thousands of other VA re- The National Library of Medicine, the world’s largest biomedi- search projects. MVP recently expanded to include veterans who cal library and a leading funder of informatics research, provides do not receive care through VHA, underscoring the centrality of in- valuable data and information resources for researchers, healthcare teroperability. The VA Informatics and Computing Infrastructure professionals, and the public. The National Library of Medicine and MVP rely on interoperable health and health-related data and Strategic Plan 2017-2027 identifies 3 goals, which focus on provid- advanced storage and analytics, which will be well served by ing the tools for data-driven research, enhanced dissemination and addressing Agenda priorities 2, 3, 4, 5, 6, and 7. engagement pathways, and building the needed research work- 45,46 force. To reach these goals, it is critical to create an ecosystem CONCLUSION that addresses Agenda priorities 7, 8, and 9. In addition, molecular and genomic databases provided by the National Center for Biotech- ONC, FDA, NIH, and VHA individually have missions, goals, and nology Information support next-generation sequence alignment programs that require the advanced use of electronic health data for and clinical variation discovery and documentation, highlighting the research and public benefit. Federal health research funding agencies need to address Agenda priority 5 regarding emerging health data. face common barriers and would benefit from collective action on The All of Us Research Program at NIH intends to “collect and electronic health data policies and technological development. They study data” longitudinally “from one million or more people,” lead- also have significant roles in improving the health IT infrastructure ing to precision medicine treatments and prevention strategies based through their funding priorities and related policies so that that in- on individual differences. All of Us is both generating primary data frastructure can be more effectively leveraged for research use of (eg, individual genetic sequences) and collecting data from healthcare health data. While several separate efforts currently underway are providers. This initiative has required new policy and IT to address addressing some Agenda priorities, these agencies support the challenges in data acquisition, curation, and analysis, identified across Agenda and recognize the need for comprehensive and coordinated 48–50 Agenda priorities. All of Us will require ongoing advances in data action. Other agencies such as Centers for Medicare & Medicaid aggregation and analysis, as noted under priorities 6 and 7 of the Services and the CDC also have aligned authority or interests and Agenda, as well as increasing access to interoperable health data, as are exploring supportive collaborations. Several agencies are already outlined under priorities 3 and 4 of the Agenda. advancing cross-agency collaboration such as through NCI and NCI is also gaining new insights from large datasets and leverag- CDC participation in precisionFDA, and relevant consultation re- ing health IT for research. NCI’s efforts under the Precision Medi- garding implementation of pertinent 21st Century Cures Act provi- 51 52,53 cine Initiative and the Cancer Moonshot have funded the sions. Successful implementation of the Agenda will include collection of tumor genomic information, relevant clinical trials, strategic coordinated action by federal health research funding agen- and related cloud data sharing and computing capabilities. The Cen- cies, yielding a variety of benefits for the agencies and beyond, in- ter for Biomedical Informatics and Information Technology sup- cluding efficient use of financial and technical resources, shared 54,55 ports the needed advanced data infrastructure and capabilities. policies across research initiatives, increased impact through com- In addition, the Surveillance, Epidemiology, and End Results Pro- mon policies, and—most importantly—improved health through gram is creating linkages between state registries, EHRs, pharma- scientific discovery. cies, and Medicare data. To be successful, these and other NCI programs must have access to a robust health data infrastructure FUNDING that aggregates and harmonizes health data from diverse and novel sources for advanced analysis, such as environmental sensor data or This work was partially funded through U.S. Department of Health wearable technology, which will be achieved via implementation of and Human Services Contract Number HHSP233201600021I, Task the Agenda. Specifically, NCI’s programmatic goals require ad- Order Number HHSP23337008T, with RTI International. Downloaded from https://academic.oup.com/jamia/article/27/4/647/5748149 by DeepDyve user on 16 July 2022 650 Journal of the American Medical Informatics Association, 2020, Vol. 27, No. 4 9. Payne TH, Corley S, Cullen TA, et al. Report of the AMIA EHR-2020 AUTHOR CONTRIBUTIONS Task Force on the status and future direction of EHRs. 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Leveraging the health information technology infrastructure to advance federal research priorities

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Oxford University Press
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Copyright © 2022 American Medical Informatics Association
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1067-5027
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1527-974X
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10.1093/jamia/ocaa011
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Abstract

Downloaded from https://academic.oup.com/jamia/article/27/4/647/5748149 by DeepDyve user on 16 July 2022 Journal of the American Medical Informatics Association, 27(4), 2020, 647–651 doi: 10.1093/jamia/ocaa011 Advance Access Publication Date: 24 February 2020 Perspective Perspective Leveraging the health information technology infrastructure to advance federal research priorities 1 2 3 Teresa Zayas-Caban, Amy P. Abernethy, Patricia Flatley Brennan, 4 5 6 7 Stephanie Devaney, Anthony R. Kerlavage, Rachel Ramoni, and P. Jon White Office of the National Coordinator for Health Information Technology, U.S. Department of Health and Human Services, Washing- 2 3 ton, DC, USA, Food and Drug Administration, Silver Spring, Maryland, USA, National Library of Medicine, National Institutes of 4 5 Health, Bethesda, Maryland, USA, All of Us Research Program, National Institutes of Health, Rockville, Maryland, USA, National Cancer Institute, National Institutes of Health, Rockville, Maryland, USA, Office of Research and Development, Veterans Health Administration, Washington, DC, USA, and Veterans Affairs Salt Lake City Health Care System, Salt Lake City, Utah, USA Corresponding Author: Teresa Zayas-Cab an, PhD, Office of the National Coordinator for Health Information Technology, U.S. Department of Health and Human Services, 330 C Street SW, Floor 7, Washington, DC 20201, USA; Teresa.ZayasCaban@hhs.gov Received 27 November 2019; Revised 10 January 2020; Editorial Decision 15 January 2020; Accepted 18 January 2020 ABSTRACT Ensuring that federally funded health research keeps pace with the explosion of health data depends on better information technology (IT), access to high-quality electronic health data, and supportive policies. Because it prominently funds and conducts health research, the U.S. federal government needs health IT to rapidly evolve and has the ability to drive that evolution. The Office of the National Coordinator for Health Information Tech- nology developed the National Health IT Priorities for Research: A Policy and Development Agenda (the Agenda) that identifies health IT priorities for research in consultation with relevant federal agencies. This article describes support for the Agenda from the Food and Drug Administration, the National Institutes of Health, and the Veterans Health Administration. Advancing the Agenda will benefit these agencies and support their mis- sions as well as the entire ecosystem leveraging the health IT infrastructure or using data from health IT sys- tems for research. Key words: health information technology, research, policy, federal government, goals 16–18 19 discovery. In addition, novel security approaches, new models INTRODUCTION 20 21 of consent, and open science initiatives are facilitating appropri- Use of health information technology (IT) by U.S. healthcare pro- ate data sharing and enabling discovery. These efforts highlight the viders and patient access to electronic health data have increased sig- value of a robust research data infrastructure, while also revealing 1–5 nificantly in the past decade. This has been facilitated by challenges. U.S. federal scientific policy has an essential role in technological changes in information system capabilities and infra- addressing barriers and accelerating data-driven discoveries. 6–9 structure, as well as legislation, governmental programs, and poli- 5,10–14 cies. In parallel, new health research information systems and capabilities are creating accelerated potential for research, discov- ADVANCING DISCOVERY THROUGH HEALTH IT ery, and clinical translation. Large-scale efforts across the research POLICY AND DEVELOPMENT enterprise are standardizing and increasing access to research data. New approaches, such as machine learning and advanced The Office of the National Coordinator for Health Information analytic techniques, have recently demonstrated possibilities for new Technology (ONC) is responsible for regulating the certification of Published by Oxford University Press on behalf of the American Medical Informatics Association 2020. This work is written by US Government employees and is in the public domain in the US. 647 Downloaded from https://academic.oup.com/jamia/article/27/4/647/5748149 by DeepDyve user on 16 July 2022 648 Journal of the American Medical Informatics Association, 2020, Vol. 27, No. 4 Table 1. Health IT priorities for research policy and development infrastructure, which receives and manages large quantities of data from application submissions, surveillance, research, and other sour- 1. Improve data quality at the point of capture. ces. To be successful, FDA requires access to timely, detailed data, 2. Increase data harmonization to enable research uses. which would be advanced by Agenda priorities 1, 3, and 4. In partic- 3. Improve access to interoperable electronic health data. ular, previous FDA experience with clinical data and claims data— 4. Improve services for efficient data storage and discovery. such as the development of the Sentinel System—has highlighted 5. Integrate emerging health and health-related data sources. limitations that can affect current data sources, including limited de- 6. Improve methods and tools to support data aggregation. 7. Develop tools and functions to support research. tail and lagging data updates, further emphasizing the need to ad- 31,32 8. Leverage health IT systems to increase education and participation. vance relevant priorities outlined in the Agenda. 9. Accelerate integration of knowledge at the point of care. A modern IT infrastructure capable of consuming, aggregating, and analyzing large and diverse datasets is needed to achieve FDA’s IT: information technology. broad goals and highlighted by priorities 6 and 7 of the Agenda. In September 2019, FDA published its Technology Modernization Ac- health IT, including electronic health records (EHRs); promulgating tion Plan, which is focused on modernizing its technical infrastruc- health IT data standards; and coordinating nationwide efforts to im- ture, enhancing its capabilities to develop relevant technology plement and use health IT for clinical care and research in the United products, and collaborating with key stakeholders to achieve inter- States. ONC has established a strategic goal to foster research, sci- operability. To be successful, FDA will require improved data entific knowledge, and innovation. Related projects, including data storage and services, along with new tools for aggregation and re- 23,24 standard development, interoperability functionality develop- search, which are highlighted by priorities 4, 6, and 7 in the Agenda. 25 26 ment, and future-oriented policy development, have been indi- As data collected in the health system are increasingly used to in- vidually successful and have been conducted in partnership with the form FDA’s regulatory decision making, interoperability and har- National Institutes of Health (NIH), Food and Drug Administration monization efforts outlined in the Agenda are needed for the (FDA), Agency for Healthcare Research and Quality (AHRQ), and efficient collection and use of high-quality data. The 21st Century others, but the broader mission requires increased strategic coordi- Cures Act of 2016 underscored the promise of real-world data, nation among all federal science agencies and initiatives. which can be derived from EHRs, mobile devices, claims and bil- Accordingly, ONC led the development of the National Health lings activities, product and disease registries, and other sources, and IT Priorities for Research: A Policy and Development Agenda (the evidence to support FDA’s regulatory decision making. In particu- 27,28 Agenda), which identifies priorities for policy and technological lar, FDA recently published a framework for the Real-World Evi- development in the United States, which are listed in Table 1. The dence Program and related use cases to evaluate the use of new types Agenda has 2 overarching goals: (1) leverage high-quality electronic of data and the subsequent analyses in regulatory decisions for drugs health data for research and (2) advance a health IT infrastructure and biologics and understand practical application. FDA also pro- to support research. vided guidance for the use of real-world data in the evaluation of The Agenda was developed in consultation with leading U.S. fe- medical devices and has used real-world data as part of medical de- 36,37 deral agencies that are using electronic health data and the health IT vice regulatory decisions. However, interoperability, standardi- infrastructure to advance health research. Several federal agencies zation, and harmonization are needed for the efficient collection and have a role to play in advancing the health IT infrastructure and use use of high-quality real-world data for these purposes, consistent of electronic health data for research. For example, while it does not with the need to advance priorities 2, 3, and 4 of the Agenda. have a direct role in advancing scientific policy, the Centers for The increasing complexity of data that inform the regulatory Medicare & Medicaid Services plays a role in the development and process has led the FDA to develop novel IT tools for those pur- adoption of health IT. The Centers for Disease Control and Preven- poses. For example, precisionFDA is a next-generation DNA se- tion (CDC) funds an extensive research portfolio and requires a ro- quencing platform that allows researchers to compare their genomic bust IT infrastructure to advance public health science. FDA, NIH, sequencing data against reference datasets and analyze their data us- 38,39 and the Veterans Health Administration (VHA) are leading efforts ing online genomic information libraries. This initiative has pro- to leverage electronic health data and infrastructure advancements vided researchers with access to comparative data on genomic for research across the full spectrum of health and disease. The datasets and powerful analytic tools, which demonstrates the need Agenda represents the shared vision of these leading U.S. federal for advanced aggregation functions and tools to support data analy- health research funding agencies for future federal science policies, sis and research as noted under priorities 6 and 7 of the Agenda. In as well as for technological development of health IT systems that addition, other federal agencies such as the National Cancer Insti- support biomedical research and translation. tute (NCI) and CDC are participating in precisionFDA, highlighting the fact that several agencies have similar research-related needs and creating an example of the type of cross-agency collaboration that is needed to advance Agenda priorities. AGENCY INITIATIVES The Agenda priorities are critical to achieve the missions of these fe- deral agencies. In fact, several U.S. federal agencies already sponsor National Institutes of Health existing initiatives, described subsequently, which highlight how the NIH is the nation’s medical research agency. To achieve its mission Agenda priorities underpin meaningful improvement of research. “to enhance health, lengthen life, and reduce illness and disability,” NIH-funded researchers need access to high-quality electronic health Food and Drug Administration data and research data infrastructure and tools. Advancing the 29,30 FDA has broad responsibilities to protect the public health. Agenda priorities would help meet these needs. NIH is already ad- FDA’s regulatory responsibilities are supported by a significant IT vancing some of these priorities through several initiatives. In particu- Downloaded from https://academic.oup.com/jamia/article/27/4/647/5748149 by DeepDyve user on 16 July 2022 Journal of the American Medical Informatics Association, 2020, Vol. 27, No. 4 649 lar, in 2018 NIH launched the Science and Technology Research In- vancement of key informatics issues outlined under priorities 3, 4, 5, frastructure for Discovery, Experimentation, and Sustainability Initia- 6, and 7 of the Agenda for improved interoperability, data access, tive, which provides commercial cloud storage and computer support storage, aggregation, and analysis of both traditional and emerging for high-value datasets resulting from NIH-funded research, address- health and health-related data. ing Agenda priority 4, promoting efficient data storage and discov- ery. In 2018, NIH also published its Strategic Plan for Data Science Veterans Health Administration (the Plan), which aims to connect NIH data systems, support storage VHA, which provides care for more than 9 million veterans at 170 and sharing of data, increase data management and analytic capabili- medical centers around the nation, is also a major biomedical re- ties, enhance the relevant workforce, and implement good steward- search funder and uses health information systems for care delivery ship policies. The Plan is aligned with Agenda priorities 3, 4, 6, and and research. VHA’s strategic research priorities require access to 7 in highlighting the need for data to be findable, accessible, interoper- high-quality electronic health data and would be accelerated by im- able, and reusable, which can be achieved, in part, through more con- plementation of the Agenda. The ability to make discoveries from sistent use of data standards. these data depends on efficient storage and would benefit from ad- Most recently, to improve interoperability of research data, NIH vancing priority 4 in the Agenda. In addition, as veterans’ health released a notice encouraging researchers to make use of the Health care increasingly includes care outside of VHA facilities, interopera- V R Level Seven International Fast Healthcare Interoperability bility with private sector health information systems is essential, V R Resources standard to accelerate the use of clinical data for re- making it critical to address priorities 2 and 3 in the Agenda. search purposes and the exchange of research data. Not only will The Million Veteran Program (MVP) is a massive cohort pro- 59,60 this advance priority 3 in the Agenda, but also for NIH to reach gram, with more than 800 000 veteran volunteers to date. MVP goals outlined in the notice, it will require coordinated collaboration includes electronic health data, genomic information, and survey with ONC, researchers, and developers to continue to advance data, some of which is drawn from the VA Informatics and Comput- standards development as outlined under priority 2 of the Agenda. ing Infrastructure, which also supports thousands of other VA re- The National Library of Medicine, the world’s largest biomedi- search projects. MVP recently expanded to include veterans who cal library and a leading funder of informatics research, provides do not receive care through VHA, underscoring the centrality of in- valuable data and information resources for researchers, healthcare teroperability. The VA Informatics and Computing Infrastructure professionals, and the public. The National Library of Medicine and MVP rely on interoperable health and health-related data and Strategic Plan 2017-2027 identifies 3 goals, which focus on provid- advanced storage and analytics, which will be well served by ing the tools for data-driven research, enhanced dissemination and addressing Agenda priorities 2, 3, 4, 5, 6, and 7. engagement pathways, and building the needed research work- 45,46 force. To reach these goals, it is critical to create an ecosystem CONCLUSION that addresses Agenda priorities 7, 8, and 9. In addition, molecular and genomic databases provided by the National Center for Biotech- ONC, FDA, NIH, and VHA individually have missions, goals, and nology Information support next-generation sequence alignment programs that require the advanced use of electronic health data for and clinical variation discovery and documentation, highlighting the research and public benefit. Federal health research funding agencies need to address Agenda priority 5 regarding emerging health data. face common barriers and would benefit from collective action on The All of Us Research Program at NIH intends to “collect and electronic health data policies and technological development. They study data” longitudinally “from one million or more people,” lead- also have significant roles in improving the health IT infrastructure ing to precision medicine treatments and prevention strategies based through their funding priorities and related policies so that that in- on individual differences. All of Us is both generating primary data frastructure can be more effectively leveraged for research use of (eg, individual genetic sequences) and collecting data from healthcare health data. While several separate efforts currently underway are providers. This initiative has required new policy and IT to address addressing some Agenda priorities, these agencies support the challenges in data acquisition, curation, and analysis, identified across Agenda and recognize the need for comprehensive and coordinated 48–50 Agenda priorities. All of Us will require ongoing advances in data action. Other agencies such as Centers for Medicare & Medicaid aggregation and analysis, as noted under priorities 6 and 7 of the Services and the CDC also have aligned authority or interests and Agenda, as well as increasing access to interoperable health data, as are exploring supportive collaborations. Several agencies are already outlined under priorities 3 and 4 of the Agenda. advancing cross-agency collaboration such as through NCI and NCI is also gaining new insights from large datasets and leverag- CDC participation in precisionFDA, and relevant consultation re- ing health IT for research. NCI’s efforts under the Precision Medi- garding implementation of pertinent 21st Century Cures Act provi- 51 52,53 cine Initiative and the Cancer Moonshot have funded the sions. Successful implementation of the Agenda will include collection of tumor genomic information, relevant clinical trials, strategic coordinated action by federal health research funding agen- and related cloud data sharing and computing capabilities. The Cen- cies, yielding a variety of benefits for the agencies and beyond, in- ter for Biomedical Informatics and Information Technology sup- cluding efficient use of financial and technical resources, shared 54,55 ports the needed advanced data infrastructure and capabilities. policies across research initiatives, increased impact through com- In addition, the Surveillance, Epidemiology, and End Results Pro- mon policies, and—most importantly—improved health through gram is creating linkages between state registries, EHRs, pharma- scientific discovery. cies, and Medicare data. To be successful, these and other NCI programs must have access to a robust health data infrastructure FUNDING that aggregates and harmonizes health data from diverse and novel sources for advanced analysis, such as environmental sensor data or This work was partially funded through U.S. Department of Health wearable technology, which will be achieved via implementation of and Human Services Contract Number HHSP233201600021I, Task the Agenda. Specifically, NCI’s programmatic goals require ad- Order Number HHSP23337008T, with RTI International. Downloaded from https://academic.oup.com/jamia/article/27/4/647/5748149 by DeepDyve user on 16 July 2022 650 Journal of the American Medical Informatics Association, 2020, Vol. 27, No. 4 9. Payne TH, Corley S, Cullen TA, et al. Report of the AMIA EHR-2020 AUTHOR CONTRIBUTIONS Task Force on the status and future direction of EHRs. 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