THE LEARNING HEALTH SYSTEM SERIES

ROUNDTABLE ON VALUE & SCIENCE-DRIVEN HEALTH CARE

DIGITAL INFRASTRUCTURE FOR
THE LEARNING HEALTH SYSTEM

The Foundation for Continuous
Improvement in Health and Health Care

Workshop Series Summary

Claudia Grossmann, Brian Powers, and J. Michael McGinnis,
Rapporteurs and Editors

INSTITUTE OF MEDICINE
              OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS

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THE LEARNING HEALTH SYSTEM SERIES ROUNDTABLE ON VALUE & SCIENCE-DRIVEN HEALTH CARE DIGITAL INFRASTRUCTURE FOR THE LEARNING HEALTH SYSTEM The Foundation for Continuous Improvement in Health and Health Care Workshop Series Summary Claudia Grossmann, Brian Powers, and J. Michael McGinnis, Rapporteurs and Editors

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THE NATIONAL ACADEMIES PRESS 500 Fifth Street, N.W. Washington, DC 20001 NOTICE: The project that is the subject of this report was approved by the Govern- ing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineer- ing, and the Institute of Medicine. This project was supported by the Office of the National Coordinator for Health Information Technology. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the author(s) and do not necessarily reflect the view of the organizations or agencies that provided support for this project. International Standard Book Number-13: 978-0-309-15416-1 International Standard Book Number-10: 0-309-15416-2 Additional copies of this report are available from the National Academies Press, 500 Fifth Street, N.W., Lockbox 285, Washington, DC 20055; (800) 624-6242 or (202) 334-3313 (in the Washington metropolitan area); Internet, http://www.nap. edu. For more information about the Institute of Medicine, visit the IOM home page at: www.iom.edu. Copyright 2011 by the National Academy of Sciences. All rights reserved. Printed in the United States of America The serpent has been a symbol of long life, healing, and knowledge among almost all cultures and religions since the beginning of recorded history. The serpent adopted as a logotype by the Institute of Medicine is a relief carving from ancient Greece, now held by the Staatliche Museen in Berlin. Suggested citation: IOM (Institute of Medicine). 2011. Digital Infrastructure for the Learning Health System: The Foundation for Continuous Improvement in Health and Health Care: Workshop Series Summary. Washington, DC: The National Academies Press.

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“Knowing is not enough; we must apply. Willing is not enough; we must do.” — Goethe Advising the Nation. Improving Health.

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The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Upon the authority of the charter granted to it by the Congress in 1863, the Acad- emy has a mandate that requires it to advise the federal government on scientific and technical matters. Dr. Ralph J. Cicerone is president of the National Academy of Sciences. The National Academy of Engineering was established in 1964, under the charter of the National Academy of Sciences, as a parallel organization of outstanding en- gineers. It is autonomous in its administration and in the selection of its members, sharing with the National Academy of Sciences the responsibility for advising the federal government. The National Academy of Engineering also sponsors engineer- ing programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. Charles M. Vest is presi- dent of the National Academy of Engineering. The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate professions in the examination of policy matters pertaining to the health of the public. The Insti- tute acts under the responsibility given to the National Academy of Sciences by its congressional charter to be an adviser to the federal government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Harvey V. Fineberg is president of the Institute of Medicine. The National Research Council was organized by the National Academy of Sci- ences in 1916 to associate the broad community of science and technology with the Academy’s purposes of furthering knowledge and advising the federal government. Functioning in accordance with general policies determined by the Academy, the Council has become the principal operating agency of both the National Academy of Sciences and the National Academy of Engineering in providing services to the government, the public, and the scientific and engineering communities. The Coun- cil is administered jointly by both Academies and the Institute of Medicine. Dr. Ralph J. Cicerone and Dr. Charles M. Vest are chair and vice chair, respectively, of the National Research Council. www.national-academies.org

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ROUNDTABLE ON VALUE & SCIENCE-DRIVEN HEALTH CARE1 Mark B. McClellan (Chair, 2011-Present), Director, Engelberg Center for Healthcare Reform, The Brookings Institution Denis A. Cortese (Chair, 2006-2011), Emeritus President and Chief Executive Officer, Mayo Clinic; Foundation Professor, ASU Donald Berwick, Administrator, Centers for Medicare & Medicaid Services (ex officio) Bruce G. Bodaken, Chairman, President, and Chief Executive Officer, Blue Shield of California David R. Brennan, Chief Executive Officer, AstraZeneca PLC Paul Chew, Chief Science Officer and CMO, sanofi-aventis U.S., Inc. Carolyn M. Clancy, Director, Agency for Healthcare Research and Quality (ex officio) Michael J. Critelli, Chief Executive Officer, Dossia Helen Darling, President, National Business Group on Health Thomas R. Frieden, Director, Centers for Disease Control and Prevention (designee: Chesley Richards) (ex officio) Patricia A. Gabow, Chief Executive Officer, Denver Health & Hospital Authority Atul Gawande, General and Endocrine Surgeon, Brigham and Women’s Hospital Gary L. Gottlieb, President and CEO, Partners HealthCare System James A. Guest, President, Consumers Union George C. Halvorson, Chairman and Chief Executive Officer, Kaiser Permanente Margaret A. Hamburg, Commissioner, Food and Drug Administration (ex officio) James Heywood, Chairman, PatientsLikeMe Carmen Hooker Odom, President, Milbank Memorial Fund Ardis Hoven, Immediate Past Board Chair, American Medical Association Brent James, Chief Quality Officer and Executive Director, Institute for Health Care Delivery Research, Intermountain Healthcare Michael M. E. Johns, Chancellor, Emory University Craig Jones, Director, Vermont Blueprint for Health Cato T. Laurencin, Director, Regenerative Engineering, University of Connecticut Stephen P. MacMillan, President and Chief Executive Officer, Stryker 1 Formerly the Roundtable on Evidence-Based Medicine. Institute of Medicine forums and roundtables do not issue, review, or approve individual documents. The responsibility for the published workshop summary rests with the workshop rapporteur and the institution. v

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Sheri S. McCoy, Vice Chair, Executive Committee, Johnson & Johnson Farzad Mostashari, National Coordinator, Office of the National Coordinator for Health IT (ex officio) Elizabeth G. Nabel, President, Brigham and Women’s Hospital Mary D. Naylor, Professor and Director, NewCourtland Center, University of Pennsylvania Peter Neupert, Corporate Vice President, Health Solutions Group, Microsoft Corporation William D. Novelli, Former CEO, AARP; Professor, Georgetown University Jonathan B. Perlin, President, Clinical and Physician Services (Health), HCA, Inc. Robert A. Petzel, Under Secretary (Health), Department of Veterans Affairs (ex officio) Richard Platt, Professor and Chair, Population Medicine, Harvard Medical School John C. Rother, Group Executive Officer, AARP John W. Rowe, Professor, Mailman School of Public Health, Columbia University Susan Shurin, Acting Director, National Heart, Lung, and Blood Institute (ex officio) Mark D. Smith, President and CEO, California HealthCare Foundation Glenn D. Steele, President and Chief Executive Officer, Geisinger Health System Reed D. Tuckson, Executive VP and Chief of Medical Affairs, UnitedHealth Group Frances M. Visco, President, National Breast Cancer Coalition Jonathan Woodson, Assistant Secretary for Health Affairs (Acting), Department of Defense (designee: Michael Dinneen) (ex officio) Workshop Planning Committee2 Laura L. Adams (Chair), Rhode Island Quality Institute Kenneth Buetow, National Institutes of Health Janet Corrigan, National Quality Forum Gregory Downing, Health and Human Services Christopher Greer, Office of Science and Technology Policy John Halamka, Beth Israel Deaconness Medical Center Rebecca Kush, Clinical Data Interchange Standards Consortium Martin LaVenture, Minnesota Department of Health 2 Institute of Medicine planning committees are solely responsible for organizing the workshop, identifying topics, and choosing speakers. The responsibility for the published workshop summary rests with the workshop rapporteurs and the institution. vi

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Kenneth Mandl, Children’s Hospital Boston Daniel Masys, Vanderbilt University David McCallie, Cerner Corporation Anthony Rodgers, Centers for Medicare & Medicaid Services David Ross, Public Health Informatics Institute Edward Shortliffe, American Medical Informatics Association Jonathan Silverstein, University of Chicago (former, now NorthShore University Health System) James Walker, Geisinger Health System Jon White, Agency for Healthcare Research and Quality Roundtable Staff Neha Agarwal, Intern (through August 2010) Christie Bell, Financial Associate Malcolm Biles, Program Assistant (through October 2010) Greta Gorman, Editorial Projects Manager Claudia Grossmann, Program Officer J. Michael McGinnis, Senior Scholar and Executive Director Brian Powers, Senior Program Assistant Elizabeth Rach, Research Assistant (through November 2010) Valerie Rohrbach, Program Assistant Julia Sanders, Program Assistant Robert Saunders, Program Officer Leigh Stuckhardt, Program Associate Kate Vasconi, Senior Program Assistant (through January 2011) Isabelle Von Kohorn, Program Officer vii

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Reviewers This report has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, in accordance with procedures approved by the National Research Council’s Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its published report as sound as possible and to ensure that the report meets institutional standards for objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process. We wish to thank the following individuals for their review of this report: Robert Califf, Duke University Art Davidson, Denver Public Health Shelley A. Hearne, The Pew Charitable Trusts Carl Kesselman, University of Southern California Kristen Rosati, Coppersmith Schermer & Brockelman PLC Although the reviewers listed above have provided many constructive comments and suggestions, they were not asked to endorse the final draft of the report before its release. The review of this report was overseen by Christopher Forrest, Children’s Hospital of Philadelphia. Appointed by the National Research Council and the Institute of Medicine, he was respon- sible for making certain that an independent examination of this report was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this report rests entirely with the editors and the institution. ix

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Institute of Medicine Roundtable on Value & Science-Driven Health Care Charter and Vision Statement The Institute of Medicine’s Roundtable on Value & Science-Driven Health Care has been convened to help transform the way evidence on clinical effec- tiveness is generated and used to improve health and health care. Participants have set a goal that, by the year 2020, 90 percent of clinical decisions will be supported by accurate, timely, and up-to-date clinical information, and will reflect the best available evidence. Roundtable members will work with their colleagues to identify the issues not being adequately addressed, the nature of the barriers and possible solutions, and the priorities for action, and will marshal the resources of the sectors represented on the Roundtable to work for sustained public–private cooperation for change. ****************************************** The Institute of Medicine’s Roundtable on Value & Science-Driven Health Care has been convened to help transform the way evidence on clinical effec- tiveness is generated and used to improve health and health care. We seek the development of a learning health system that is designed to generate and apply the best evidence for the collaborative healthcare choices of each patient and provider; to drive the process of discovery as a natural outgrowth of patient care; and to ensure innovation, quality, safety, and value in health care. Vision: Our vision is for a healthcare system that draws on the best evidence to provide the care most appropriate to each patient, emphasizes prevention and health promotion, delivers the most value, adds to learning throughout the delivery of care, and leads to improvements in the nation’s health. Goal: By the year 2020, 90 percent of clinical decisions will be supported by accurate, timely, and up-to-date clinical information, and will reflect the best available evidence. We feel that this presents a tangible focus for progress toward our vision, that Americans ought to expect at least this level of perfor- mance, that it should be feasible with existing resources and emerging tools, and that measures can be developed to track and stimulate progress. Context: As unprecedented developments in the diagnosis, treatment, and long-term management of disease bring Americans closer than ever to the promise of personalized health care, we are faced with similarly unprecedented challenges to identify and deliver the care most appropriate for individual needs and conditions. Care that is important is often not delivered. Care that is delivered is often not important. In part, this is due to our failure to apply the evidence we have about the medical care that is most effective—a failure related to shortfalls in provider knowledge and accountability, inadequate care coordination and support, lack of insurance, poorly aligned payment incen- xi

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xvi PREFACE workshop considered the transformational power of digital technology in health and health care. Workshop participants focused their discussion on four important cross-cutting dimensions of the opportunities and challenges: promoting technical advances and innovation, knowledge generation and use, engag- ing patients and the public, and fostering stewardship and governance. Initial discussions focused on mapping the current state of play with respect to these areas and on the ways in which a developed digital infrastructure presents challenges and opportunities within each realm. Next, participants worked together to envision innovative approaches to the way in which a learning health system would be supported by a powerful, nimble, and secure digital infrastructure. The final stages of the series were centered on developing concrete strategy options whereby specific actors could work to accelerate the effective implementation of advances in building this learning health system. Numerous organizations and individuals devoted their time and efforts in developing this workshop summary. We, of course, also wish to acknowl- edge and offer strong appreciation for the contributors to this volume for their insightful perspectives and observations. In this respect, we should emphasize that this workshop summary is intended to convey only the views and opinions of individuals participating in this workshop. As such, it is not intended to express or reflect the opinions of the Roundtable on Value & Science-Driven Health Care, its sponsors, or IOM. In particular, we are indebted to the members of the expert IOM Planning Committee, who worked to guide and shape a series of pro- ductive and insightful workshop discussions. We were privileged to have the following individuals represented on the committee: Laura Adams (Chair) (Rhode Island Quality Institute), Ken Buetow (National Institutes of Health), Janet Corrigan (National Quality Forum), Greg Downing (U.S. Department of Health and Human Services), Chris Greer (Office of Science and Technology Policy), John Halamka (Beth Israel Deaconness Medi- cal Center), Rebecca Kush (Clinical Data Interchange Standards Consor- tium), Martin LaVenture (Minnesota Department of Health), Ken Mandl (Children’s Hospital Boston), Dan Masys (Vanderbilt University), David McCallie (Cerner Corporation), Anthony Rodgers (Centers for Medicare & Medicaid Services), David Ross (Public Health Informatics Institute), Edward Shortliffe (American Medical Informatics Association), Jonathan Silverstein (University of Chicago), James Walker (Geisinger Health Sys- tem), and Jon White (Agency for Healthcare Research and Quality). Under the leadership of IOM Program Officer Claudia Grossmann, a number of Roundtable staff played instrumental roles in coordinating the workshops and translating the workshop proceedings into this sum- mary, including Neha Agarwal, Christie Bell, Malcolm Biles, Brian Powers,

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xvii PREFACE Elizabeth Rach, Robert Saunders, and Kate Vasconi. We would also like to acknowledge National Academy of Sciences colleagues Jon Eisenberg and Herb Lin who participated in the meetings and provided valuable counsel on the technical components of these issues. Finally, we would also like to thank Greta Gorman, Christine Stencel, Vilija Teel, and Jordan Wyndelts for helping to coordinate the various aspects of review, production, and publication. Successfully developing and implementing the next generation of the digital infrastructure for the learning health system will require consider- able additional effort and collaboration. We believe the perspectives sum- marized in Digital Infrastructure for the Learning Health System: The Foundation for Continuous Improvement in Health and Health Care will be a very important resource not only with respect to the vision of the pos- sible, but to the practical near-term decisions and actions of leaders and stakeholders in many quarters. Laura L. Adams Planning Committee Chair Denis A. Cortese Chair, Roundtable on Value & Science-Driven Health Care (2006-2011) Mark B. McClellan Chair, Roundtable on Value & Science-Driven Health Care (2011-Present) J. Michael McGinnis Executive Director, Roundtable on Value & Science-Driven Health Care

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Contents Abbreviations and Acronyms xxiii Synopsis and Highlights 1 1 Introduction 53 The Learning Health System, 54 The Digital Health Infrastructure, 55 About the Digital Infrastructure Meetings, 67 2 Visioning Perspectives on the Digital Health Utility 71 Introduction, 71 Informed and Empowered Patients: Moving Beyond a Bystander in Care, 73 Adam M. Clark Building a Learning Health System Clinicians Will Use, 78 James Walker Improving Quality and Safety, 81 Janet M. Corrigan Clinical Research in the Information Age, 85 Christopher G. Chute Integrating the Public Health Perspective, 90 Martin LaVenture, Sripriya Rajamani, and Jennifer Fritz xix

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xx CONTENTS 3 Technical Issues for the Digital Health Infrastructure 99 Introduction, 99 Building a Standards and Interoperability Framework, 101 Douglas Fridsma Interoperability for the Learning Health System, 108 Rebecca D. Kush Promoting Secure Data Liquidity, 114 Jonathan C. Silverstein Innovative Approaches to Information Diversity, 119 Shaun Grannis 4 Engaging Patient and Population Needs 125 Introduction, 125 Electronic Health Data for High-Value Health Care, 127 Mark McClellan Engaging Individuals in Population Health Monitoring, 134 Kenneth D. Mandl Optimizing Chronic Disease Care and Control, 138 Sophia W. Chang Targeting Population Health Disparities, 141 M. Christopher Gibbons 5 Weaving a Strong Trust Fabric 149 Introduction, 149 Demonstrating Value to Secure Trust, 151 Edward H. Shortliffe Policies and Practices to Build Public Trust, 155 Deven McGraw HIPAA and a Learning Healthcare System, 157 Bradley Malin Building a Secure Learning Health System, 161 Ian Foster 6 Stewardship and Governance in the Learning Health System 167 Introduction, 167 Governance Coordination, Needs, and Options, 169 Laura Adams Consistency and Reliability in Reporting for Regulators, 172 Theresa Mullin Complying with Patient Expectations for Data De-Identification, 176 Shawn N. Murphy Information Governance in the National Health Service (UK), 180 Harry Cayton

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xxi CONTENTS 7 Perspectives on Innovation 185 Introduction, 185 Conceptualizing a U.S. Population Health Record, 186 Daniel J. Friedman Accelerating Innovation Outside the Private Sector, 190 Molly J. Coye Combinatorial Innovation in Health Information Technology, 193 Michael Liebhold 8 Fostering the Global Dimension of the Health Data Trust 197 Introduction, 197 TRANSFoRm: Translational Medicine and Patient Safety in Europe, 198 Brendan Delaney Healthgrids, the SHARE Project, and Beyond, 202 Tony Solomonides A Global Perspective on the Importance of Systematic Data to Drive Improvements in Care, 211 Ashish K. Jha Informatics and the Future of Infectious Disease Surveillance, 216 David L. Buckeridge and John S. Brownstein 9 Growing the Digital Health Infrastructure 223 Introduction, 223 Technical Progress, 225 Knowledge Generation and Use, 227 Patient and Population Engagement, 230 Governance, 231 Common Themes and Principles, 233 10 Accelerating Progress 239 Introduction, 239 Stakeholder Engagement, 241 Technical Progress, 241 Infrastructure Use, 243 Governance, 244 Opportunities in the Next Stages of Meaningful Use, 245 Stakeholder Responsibilities and Opportunities, 247

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xxii CONTENTS Appendixes A The Learning Health System and the Digital Health Utility 251 B Case Studies for the Digital Health Infrastructure 255 C Example Stakeholder Responsibilities and Opportunities 277 D Summary Overview of Meaningful Use Objectives 279 E PCAST Report Recommendations 281 F Workshop Agendas 285 G Workshop Participants 297

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Abbreviations and Acronyms ADE adverse drug event AHRQ Agency for Healthcare Research and Quality AMI acute myocardial infarction API Application Programming Interface ARB antinogensin receptor blocker ARRA American Reinvestment and Recovery Act (2009) ASTER Adverse Drug Event Spontaneous Triggered Events Recording ATM automated teller machine BIRN Biomedical Informatics Research Network BRIDG Biomedical Research Integrated Domain Group caBIG cancer Biomedical Informatics Grid CAMD Coalition Against Major Diseases CC Coordinating Committee CCD Continuity of Care Document CDASH Clinical Data Acquisition Standards Harmonization CDC Centers for Disease Control and Prevention CDISC Clinical Data Standards Interchange Consortium CER comparative effectiveness research CHCF California HealthCare Foundation CMMI Center for Medicare & Medicaid Innovation CMS Centers for Medicare & Medicaid Services CTSA Clinical and Translational Science Award xxiii

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xxiv ABBREVIATIONS AND ACRONYMS CVRG CardioVascular Research Grid DALY disability-adjusted life year DOD Department of Defense ED emergency department EHR electronic health record EISA Energy Independence and Security Act ELSE ethical, legal, social, and economic issues EMA European Medicines Agency EU European Union EVS Enterprise Vocabulary Services FCC Federal Communications Commission FDA Food and Drug Administration FDAAA Food and Drug Administration Amendments Act FERC Federal Energy Regulatory Commission FHA Federal Health Architecture FPC Federal Partners’ Collaboration GE General Electric GWAS genome-wide association study HHS U.S. Department of Health and Human Services HIE health information exchange American National Standards Institute’s Healthcare HISB Informatics Standards Board HISPP Health Information Standards Planning Panel HITECH Health Information Technology for Economic and Clinical Health Act HITSC Healthcare Information Technology Standards Committee HITSP Healthcare Information Technology Standards Panel HMO health maintenance organization HMORN HMO Research Network HRSA Health Resources and Services Administration ICD International Classification of Diseases ICT information and communications technology IEEE Institute of Electrical and Electronics Engineers IEPD Information Exchange Package Documentation IETF Internet Engineering Task Force

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xxv ABBREVIATIONS AND ACRONYMS IHE Integrating the Healthcare Enterprise INPC Indiana Network for Patient Care IOM Institute of Medicine IRB institutional review board ISO independent system operator IT information technology KP Kaiser Permanente LOINC Logical Observation Identifiers Names and Codes MSCC Mini-Sentinel Coordinating Center NCI National Cancer Institute NCVHS National Committee on Vital and Health Statistics NDA new drug application NHS National Health Service (UK) NIEM National Information Exchange Model NIGB National Information Governance Board for Health and Social Care (UK) NIH National Institutes of Health NIST National Institute of Standards and Technology NLM National Library of Medicine NQF National Quality Forum NWHIN Nationwide Health Information Network OMB Office of Management and Budget ONC Office of the National Coordinator for Health Information Technology PCAST President’s Council on Science and Technology PCHR personally controlled health record PCORI Patient-Centered Outcomes Research Institute PHI protected health information PHIN-NCMT Public Health Information Network Notifiable Condition Mapping Table PHR personal health record PopHR Population Health Record RDF Resource Description Framework RFD Retrieve Form for Data Capture RTO regional transmission organization RWJF Robert Wood Johnson Foundation

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xxvi ABBREVIATIONS AND ACRONYMS SDK Software Development Kit SDTM Study Data Tab Model SHARP Strategic Health Information Technology Advanced Research Projects SNOMED Systematized Nomenclature of Medicine SWRL Semantic Web Rule Language TATRC Telemedicine and Advanced Technology Research Center TC Technical Committee UK United Kingdom ULS ultra-large-scale VA Department of Veterans’ Affairs VHA Veterans Health Administration VistA Veterans Health Information Systems and Technology Architecture VLER Virtual Lifetime Electronic Record VPN virtual private network WHO World Health Organization XACML eXtensible Access Control Markup Language