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
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 Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, 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
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Copyright 2011 by the National Academy of Sciences. All rights reserved.
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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.
THE NATIONAL ACADEMIES
Advisers to the Nation on Science, Engineering, and Medicine
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 Academy 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 engineers. 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 engineering programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. Charles M. Vest is president 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 Institute 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 Sciences 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 Council 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.
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.
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.
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
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
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 responsible 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.
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 effectiveness 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 effectiveness 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 performance, 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-
tives, and misplaced patient expectations. Increasingly, it is also a result of our limited capacity for timely generation of evidence on the relative effectiveness, efficiency, and safety of available and emerging interventions. Improving the value of the return on our healthcare investment is a vital imperative that will require much greater capacity to evaluate high-priority clinical interventions, stronger links between clinical research and practice, and reorientation of the incentives to apply new insights. We must quicken our efforts to position evidence development and application as natural outgrowths of clinical care—to foster health care that learns.
Approach: The IOM Roundtable on Value & Science-Driven Health Care serves as a forum to facilitate the collaborative assessment and action around issues central to achieving the vision and goal stated. The challenges are myriad and include issues that must be addressed to improve evidence development, evidence application, and the capacity to advance progress on both dimensions. To address these challenges, as leaders in their fields, 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.
Activities include collaborative exploration of new and expedited approaches to assessing the effectiveness of diagnostic and treatment interventions, better use of the patient care experience to generate evidence on effectiveness, identification of assessment priorities, and communication strategies to enhance provider and patient understanding and support for interventions proven to work best and deliver value in health care.
Core concepts and principles: For the purpose of the Roundtable activities, we define evidence-based medicine broadly to mean that, to the greatest extent possible, the decisions that shape the health and health care of Americans—by patients, providers, payers, and policy makers alike—will be grounded on a reliable evidence base, will account appropriately for individual variation in patient needs, and will support the generation of new insights on clinical effectiveness. Evidence is generally considered to be information from clinical experience that has met some established test of validity, and the appropriate standard is determined according to the requirements of the intervention and clinical circumstance. Processes that involve the development and use of evidence should be accessible and transparent to all stakeholders.
A common commitment to certain principles and priorities guides the activities of the Roundtable and its members, including the commitment to the right health care for each person; putting the best evidence into practice; establishing the effectiveness, efficiency, and safety of medical care delivered; building constant measurement into our healthcare investments; the establishment of healthcare data as a public good; shared responsibility distributed equitably across stakeholders, both public and private; collaborative stakeholder involvement in priority setting; transparency in the execution of activities and reporting of results; and subjugation of individual political or stakeholder perspectives in favor of the common good.
Marshaling the best information has always been fundamental to the success of all aspects of health and health care—medical diagnosis and treatment, quality improvement, public health and health research. What is different today—and what makes this field so exciting—is the possibility, through digital data systems, to have information that is not only relevant to actions and decisions for the delivery of care, but is available, accessible, transferable, usable, and manipulatable in a way that integrates information from a number of sources and provides unprecedented opportunity for learning and improvement.
Improvement is clearly vital. In 2001, the Institute of Medicine issued its landmark report, Crossing the Quality Chasm, which drew the nation’s attention sharply to the fact that health care in the United States was falling far short of its potential. The central lesson in that report was, in effect, that the nation needed a continuously improving learning health system that reliably delivered the best outcome. In 2006, the Institute of Medicine chartered the Roundtable on Evidence-Based Medicine, now the Roundtable on Value & Science-Driven Health Care, to engage key stakeholders in a discussion of ways to ensure that better information is available and used to transform healthcare delivery in this country. The Roundtable brings together patients, consumers, providers, researchers, health product manufacturers, payers, employees, and policy makers to discuss health reform priorities in a neutral venue and identify key impediments to progress toward a patient-centered learning health system. The Roundtable’s vision of a learning health system describes a health infrastructure characterized by evidence-based care that ensures proper decision making for each patient
and provider, and generates scientific evidence as a natural by-product of the care process.
Building on previous efforts to characterize, develop, and implement the infrastructure for a learning health system, and with generous support from the Office of the National Coordinator for Health Information Technology, the Roundtable convened stakeholders from across the healthcare and information technology fields in a series of workshops whose discussions are summarized in this volume, Digital Infrastructure for the Learning Health System: The Foundation for Continuous Improvement in Health and Health Care.
This compilation summarizes the presentations and discussions from the series, which look at the role of the digital health data systems and how they can be used to provide the information backbone for a learning health system. Participants worked to identify the opportunities, challenges, and priorities represented by the application of new information systems to health care and to consider strategy options that could further the development of a learning health system.
I would like to extend my personal thanks especially to David Blumenthal and his Office of the National Coordinator for Health Information Technology, its Chief Scientist, Charles Friedman, to the Planning Committee assembled for the series, to the Roundtable membership for their continued leadership and commitment to advancing health care in this nation, and to the Roundtable staff for their contributions in coordinating and supporting the meeting series and ongoing Roundtable activities.
Harvey V. Fineberg, M.D., Ph.D.
President, Institute of Medicine
Spurred by the growing potential of the availability of large amounts of digital health information to improve the quality of health care in this country, the Roundtable on Value & Science-Driven Health Care, with the support of the Office of the National Coordinator for Health Information Technology, convened the three-part workshop series summarized in this volume, Digital Infrastructure for the Learning Health System: The Foundation for Continuous Improvement in Health and Health Care. Stakeholders from across the health system—including patient advocates, providers, researchers, privacy experts, computer scientists, and policy makers—met to discuss the opportunities and challenges presented by the application of advanced information technology systems to health and health care. This summary of the workshop presentations and discussions conveys the thoughts of field leaders, and the views they shared on important strategy elements and next steps to transform the information infrastructure of the American health system into one characterized by patient engagement and continuous improvement.
The vision of the Institute of Medicine (IOM) Roundtable on Value & Science-Driven Health Care is to help advance the development of a learning health system in which evidence is generated in a timely manner by capturing results of the care process, and applied effectively and efficiently to ensure best care practices. Since its inception in 2006, the Roundtable has set out to advance this vision through collaborative initiatives, public workshops, and published proceedings that involve senior leadership from key healthcare stakeholders. Building on previous work of the Roundtable to identify the structural components of a learning health system, this
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, engaging 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 acknowledge 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 productive 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 Medical Center), Rebecca Kush (Clinical Data Interchange Standards Consortium), 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 System), 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 summary, including Neha Agarwal, Christie Bell, Malcolm Biles, Brian Powers,
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 considerable additional effort and collaboration. We believe the perspectives summarized 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 possible, 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
Mark B. McClellan
Chair, Roundtable on Value & Science-Driven Health Care
J. Michael McGinnis
Roundtable on Value & Science-Driven Health Care
Adam M. Clark
Janet M. Corrigan
Christopher G. Chute
Martin LaVenture, Sripriya Rajamani, and Jennifer Fritz
Rebecca D. Kush
Jonathan C. Silverstein
Kenneth D. Mandl
Sophia W. Chang
M. Christopher Gibbons
Edward H. Shortliffe
Shawn N. Murphy
Daniel J. Friedman
Molly J. Coye
Ashish K. Jha
David L. Buckeridge and John S. Brownstein
adverse drug event
Agency for Healthcare Research and Quality
acute myocardial infarction
Application Programming Interface
antinogensin receptor blocker
American Reinvestment and Recovery Act (2009)
Adverse Drug Event Spontaneous Triggered Events Recording
automated teller machine
Biomedical Informatics Research Network
Biomedical Research Integrated Domain Group
cancer Biomedical Informatics Grid
Coalition Against Major Diseases
Continuity of Care Document
Clinical Data Acquisition Standards Harmonization
Centers for Disease Control and Prevention
Clinical Data Standards Interchange Consortium
comparative effectiveness research
California HealthCare Foundation
Center for Medicare & Medicaid Innovation
Centers for Medicare & Medicaid Services
Clinical and Translational Science Award
Clinical and Translational Science Award
CardioVascular Research Grid
disability-adjusted life year
Department of Defense
electronic health record
Energy Independence and Security Act
ethical, legal, social, and economic issues
European Medicines Agency
Enterprise Vocabulary Services
Federal Communications Commission
Food and Drug Administration
Food and Drug Administration Amendments Act
Federal Energy Regulatory Commission
Federal Health Architecture
Federal Partners’ Collaboration
genome-wide association study
U.S. Department of Health and Human Services
health information exchange
American National Standards Institute’s Healthcare Informatics Standards Board
Health Information Standards Planning Panel
Health Information Technology for Economic and Clinical Health Act
Healthcare Information Technology Standards Committee
Healthcare Information Technology Standards Panel
health maintenance organization
HMO Research Network
Health Resources and Services Administration
International Classification of Diseases
information and communications technology
Institute of Electrical and Electronics Engineers
Information Exchange Package Documentation
Internet Engineering Task Force
Integrating the Healthcare Enterprise
Indiana Network for Patient Care
Institute of Medicine
institutional review board
independent system operator
Logical Observation Identifiers Names and Codes
Mini-Sentinel Coordinating Center
National Cancer Institute
National Committee on Vital and Health Statistics
new drug application
National Health Service (UK)
National Information Exchange Model
National Information Governance Board for Health and Social Care (UK)
National Institutes of Health
National Institute of Standards and Technology
National Library of Medicine
National Quality Forum
Nationwide Health Information Network
Office of Management and Budget
Office of the National Coordinator for Health Information Technology
President’s Council on Science and Technology
personally controlled health record
Patient-Centered Outcomes Research Institute
protected health information
Public Health Information Network Notifiable Condition Mapping Table
personal health record
Population Health Record
Resource Description Framework
Retrieve Form for Data Capture
regional transmission organization
Robert Wood Johnson Foundation
Software Development Kit
Study Data Tab Model
Strategic Health Information Technology Advanced Research Projects
Systematized Nomenclature of Medicine
Semantic Web Rule Language
Telemedicine and Advanced Technology Research Center
Department of Veterans’ Affairs
Veterans Health Administration
Veterans Health Information Systems and Technology Architecture
Virtual Lifetime Electronic Record
virtual private network
World Health Organization
eXtensible Access Control Markup Language