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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,
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Copyright 2011 by the National Academy of Sciences. All rights reserved.
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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
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of Sciences and the National Academy of Engineering in providing services to the
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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
