THE LEARNING HEALTH SYSTEM SERIES

ROUNDTABLE ON VALUE and amp; SCIENCE-DRIVEN HEALTH CARE

CLINICAL DATA AS THE BASIC STAPLE OF HEALTH LEARNING

Creating and Protecting a Public Good

Workshop Summary

Claudia Grossmann, W. Alexander Goolsby, LeighAnne Olsen, and J. Michael McGinnis

INSTITUTE OF MEDICINE
OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS

Washington, D.C.
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THE LEARNING HEALTH SYSTEM SERIES ROUNDTABLE ON VALUE & SCIENCE-DRIVEN HEALTH CARE CLINICAL DA AS THE BASIC TA STAPLE OF HEALTH LEARNING Creating and Protecting a Public Good Workshop Summary Claudia Grossmann, W. Alexander Goolsby, LeighAnne Olsen, and J. Michael McGinnis

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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 Agency for Healthcare Research and Quality, America’s Health Insurance Plans, AstraZeneca, Blue Shield of California Founda- tion, Burroughs Wellcome Fund, California Health Care Foundation, Centers for Medicare & Medicaid Services, Charina Endowment Fund, Department of Veterans Affairs, Food and Drug Administration, Johnson & Johnson, Moore Foundation, National Institutes of Health, The Peter G. Peterson Foundation, sanofi-aventis, and Stryker. 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: 978-0-309-12060-9 International Standard Book Number-10: 0-309-12060-8 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 2010 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). 2010. Clinical data as the basic staple of health learning: Creating and protecting a public good: Workshop Sum- mary. 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 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 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 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. www.national-academies.org

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ROUNDTABLE ON VALUE & SCIENCE-DRIVEN HEALTH CARE1 Denis A. Cortese (Chair), Emeritus President and Chief Executive Officer, Mayo Clinic; Foundation Professor, ASU Donald Berwick, Administrator, Centers for Medicare & Medicaid Services (ex officio) David Blumenthal, National Coordinator, Office of the National Coordinator for Health IT (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, Former Executive Chairman, Pitney Bowes, Inc. Helen Darling, President, National Business Group on Health Thomas R. Frieden, Director, Centers for Disease Control and Prevention (designee: Chesley Richards) (ex officio) 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) Carmen Hooker Odom, President, Milbank Memorial Fund Ardis Hoven, Professor of Medicine, University of Kentucky; Chair-elect, 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, Vice President for Health Affairs, Dean of the School of Medicine, University of Connecticut Stephen P. MacMillan, President and Chief Executive Officer, Stryker Mark B. McClellan, Director, Engelberg Center for Healthcare Reform, The Brookings Institution Sheri S. McCoy, Worldwide Chairman, Johnson & Johnson Pharmaceuticals Group Elizabeth G. Nabel, President, Brigham and Women’s Hospital 1 Formerly the Roundtable on Evidence-Based Medicine. IOM forums and roundtables do not issue, review, or approve individual documents. The responsibility for the published workshop summary rests with the workshop rapporteurs and the institution. 

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Mary D. Naylor, Professor and Director of Center for Transitions in Health, University of Pennsylvania Peter Neupert, Corporate Vice President, Health Solutions Group, Microsoft Corporation Nancy H. Nielsen, Past President, American Medical Association William D. Novelli, Former CEO, AARP; Professor, Georgetown University Jonathan B. Perlin, Chief Medical Officer and President, Clinical Services, HCA, Inc. Robert A. Petzel, Under Secretary, Veterans Health Administration (ex officio) Richard Platt, Professor and Chair, Harvard Medical School and Harvard Pilgrim Health Care 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 George P. Taylor, Assistant Secretary for Health Affairs (Acting), Department of Defense (designee: Michael Dinneen) (ex officio) Reed D. Tuckson, Executive VP and Chief of Medical Affairs, UnitedHealth Group Frances M. Visco, President, National Breast Cancer Coalition Workshop Planning Committee David Blumenthal, Office of the National Coordinator for Health IT (formerly Massachusetts General Hospital, Harvard University) Marc Boutin, National Health Council Mary Durham, Kaiser Foundation Hospitals Lynn Etheredge, George Washington University George Isham, HealthPartners Inc. Peter Juhn, Johnson & Johnson Alexander Walker, Harvard School of Public Health, Harvard University Roundtable Staff Christie Bell, Financial Associate Katharine Bothner, Senior Program Assistant (through July 2008) Patrick Burke, Financial Associate (until December 2009) Andrea Cohen, Financial Associate (until December 2008) W. Alexander Goolsby, Program Officer (through August 2008) Claudia Grossmann, Program Officer i

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Kiran Gupta, Research Assistant (until May 2009) Katie Jakubs, NIH detailee J. Michael McGinnis, Senior Scholar and Executive Director LeighAnne Olsen, Program Officer Daniel O’Neill, Research Associate (until December 2008) Stephen Pelletier, Consultant Brian Powers, Program Assistant Ruth Strommen, Intern Kate Vasconi, Senior Program Assistant Pierre Yong, Program Officer Catherine Zweig, Senior Program Assistant ii

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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: Simon Cohn, Kaiser Permanente John Lumpkin, Robert Wood Johnson Foundation Douglas Peddicord, Oldaker, Belair, & Wittie, LLC Alan Westin, Columbia University 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 Daniel Masys, Vanderbilt University School of Medicine. Appointed by the National Research Council and the Institute of Medicine, Dr. Masys 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 authoring committee and the institution. ix

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Institute of Medicine Roundtable on Value & Science-Driven Health Care1 Charter and Vision Statement The Institute of Medicine’s Roundtable on Value & Science-Drien Health Care has been conened to help transform the way eidence on clinical effec- tieness is generated and used to improe health and health care. Participants hae 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 aailable eidence. 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-priate 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 evi- dence to provide the care most appropriate to each patient, emphasizes preven- tion 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- tives, and misplaced patient expectations. Increasingly, it is also a result of our 1 Formerly the Roundtable on Evidence-Based Medicine. xi

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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 evi- dence 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 activi- ties, we define science-driven health care broadly to mean that, to the great- est extent possible, the decisions that shape the health and health care of Americans—by patients, providers, payers, and policymakers alike—will be grounded on a reliable evidence base, will account appropriately for individ- ual 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 estab- lishment of healthcare data as a public good; shared responsibility distrib- uted 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. xii

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Foreword The Institute of Medicine (IOM) was established in 1970 as part of the National Academies to serve as the foremost adviser to the nation on issues related to medicine, health, and the biomedical sciences. Essential to fulfill- ing this role is a commitment to drawing upon the best evidence to guide policy development. Indeed, the capacity to excel, innovate, and advance in any field of inquiry is predicated upon the quality and availability of infor- mation—whether to guide decision making, suggest new areas of research, or confirm hypotheses. Clinical data represent an enormous opportunity to improve the quality and efficiency of the nation’s healthcare system. Whether captured as part of research, through delivery processes, or at the point of care, these data will be central to advance our understanding of which medical practices and treatments work best for different patients, and drive continual improvements in the delivery of health care. This potential will only be enhanced as health information technology enables the capture and analysis of vastly larger quantities of data. While important data are currently collected by a number of healthcare organizations and sectors, their capture and use reflect the fragmentation of the healthcare system, with much of this information siloed in different databases and repositories. In addition, broader sharing, aggregation, and use of these data are often restricted due to proprietary or privacy concerns. Taking better advantage of these resources, while maintaining appropriate privacy protections, requires the engagement of all healthcare sectors in dis- cussions of key challenges and opportunities in a neutral and trusted forum, such as that provided by the IOM Roundtable on Value & Science-Driven Health Care. Established in 2006 as the Roundtable on Evidence-Based xiii

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xi FOREWORD Medicine, the IOM Roundtable is composed of the nation’s top leaders in the public and private sectors who have a keen interest in transforming our nation’s healthcare system. Roundtable members have established a com- mon vision for a learning health system and 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. Since its inception, the Roundtable has convened a series of workshops and publications, as well as initiated a variety of projects and activities to help accelerate progress toward a learning health system. This publication represents the sixth in the Learning Health System series and summarizes the discussions at the Roundtable’s 2-day workshop titled Clinical Data as the Basic Staple of Health Learning: Creating and Protecting a Public Good. The workshop explored the range of activities that constitute the system of healthcare data in the United States, as well as the challenges and opportunities associated with efficiently leveraging data. Discussion identified many challenges, barriers, and policy issues that must be engaged to move to the next generation of data utility. As reflected by participants’ comments, broader use of health information technology for knowledge development, particularly electronic health records, holds significant potential for healthcare advancement through collaborative data mining and improving transparency of and access to data. Also evident is the central importance of stakeholder leadership, such as that provided by the Roundtable, for maximizing the use of clinical data for continuous learning and improvement in health care. I would like to offer my personal thanks to the Roundtable members for the leadership that they bring to these important issues, to the Round- table staff for their skill and dedication in coordinating and facilitating the activities, and importantly, to the sponsors who make this work pos- sible: Agency for Healthcare Research and Quality, America’s Health Insur- ance Plans, AstraZeneca, Blue Shield of California Foundation, Burroughs Wellcome Fund, California Health Care Foundation, Centers for Medicare & Medicaid Services, Charina Endowment Fund, Department of Veterans Affairs, Food and Drug Administration, Johnson & Johnson, Moore Foun- dation, National Institutes of Health, The Peter G. Peterson Foundation, sanofi-aventis, and Stryker. Harvey V. Fineberg, M.D., Ph.D. President, Institute of Medicine

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Preface The Institute of Medicine convened the Roundtable on Value & Science-Driven Health Care (formerly the Roundtable on Evidence-Based Medicine) in 2006 to provide a trusted forum in which multiple healthcare sectors—including patients, health providers, payers, employees, health product manufacturers, information technology companies, policy mak- ers, and researchers—could share perspectives on key opportunities to help transform how evidence is generated and applied to drive improve- ments in the efficiency and effectiveness of health care, to guide healthcare decisions, and to improve the nation’s health. An early outcome of the Roundtable activities is a shared vision of a healthcare system that draws on the best available evidence to appropriately tailor care to individual patients and to continuously add to the healthcare knowledge base. Salient topics, addressed through public workshops and collaborative groups, engage critical aspects of concepts essential to achieving this vision and the Roundtable’s goal that by 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. The perspectives, themes, and insights from each workshop are dis- seminated through the Learning Health System series of publications. The Clinical Data as a Basic Staple of Health Learning: Creating and Protecting a Public Good publication is a summary of the proceedings of the sixth workshop in the Learning Health System series. Held on February 12–13, 2008, this workshop was designed to explore leading perspectives on clini- cal data as a transformative agent in health care, as well as possible strate- gies for their implementation in the delivery of evidence-based care. Issues motivating the discussion include: x

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xi PREFACE 1. Discovering what works best in medical care—including for whom and under what circumstances—requires that clinical data be care- fully nurtured as a resource for continuous learning. 2. Transformational opportunities are presented by evolving large and potentially interoperable clinical and administrative datasets. 3. Clinical data are recorded and held in multiple activities and many institutions, including medical records, administrative and claims records, and research studies. 4. Public policy and public awareness lag behind the technical, orga- nizational, and legal capacity for reliable safeguarding of indi- vidual privacy and data security in mining clinical data for new knowledge. 5. A significant challenge to progress resides in the barriers and restrictions that derive from the treatment of medical care data as a proprietary commodity by the organizations involved. 6. Even clinical research and medical care data developed with public funds are often not available for broader analysis and insights. 7. Broader access and use of healthcare data for new insights require not only fostering data system reliability and interoperability but also addressing the matter of individual data ownership and the extent to which data central to progress in health and health care should constitute a public good. During the 2-day workshop, participants explored a variety of relevant technical, economic, legal, and policy issues important to addressing these issues. Invited speakers and panelists highlighted opportunities to advance elements of clinical data and identified areas in need of greater attention and focus. The following pages summarize the workshop discussion, includ- ing the review of characteristics of clinical data, the marketplace for health- care data, legal issues related to data access and use, and the role of privacy and security concerns. Throughout the workshop, participants identified specific policy issues in need of engagement to move to the next generation of data utility. The need for broader public engagement was also discussed, as participants noted that public policy and awareness often lag behind the technical, organizational, and legal capacity for reliable safeguarding of individual privacy and data security. Key opportunities identified included realigning incentives to promote real-time use of clinical data in evidence development, correcting the market failure for expanding electronic health records, and greater engagement of the public in shaping evidence develop- ment strategies. We wish to acknowledge the individuals and organizations who offered their time and guidance in the development and execution of the work- shop and summary. Individuals presenting at the workshop and authoring

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xii PREFACE manuscripts for the summary are acknowledged in particular. Also vital to the success of the workshop were the planning committee members, repre- senting a cross-section of stakeholders and thought leaders in clinical data issues: David Blumenthal (Massachusetts General Hospital), Mary Durham (Kaiser Permanente), Lynn Etheredge (George Washington University), George Isham (HealthPartners, Inc.), Peter Juhn (Johnson & Johnson), and Alexander Walker (Harvard University). Roundtable staff members, includ- ing Katharine Bothner, Alexander Goolsby, Claudia Grossmann, Kiran Gupta, LeighAnne Olsen, Daniel O’Neill, Kate Vasconi, Pierre Yong, and Catherine Zweig, were instrumental to workshop coordination and sum- mary production. We also wish to acknowledge the Roundtable members for their guidance and the sponsors of Roundtable activities: Agency for Healthcare Research and Quality, America’s Health Insurance Plans, Astra- Zeneca, Blue Shield of California Foundation, Burroughs Wellcome Fund, California Health Care Foundation, Centers for Medicare & Medicaid Ser- vices, Charina Endowment Fund, Department of Veterans Affairs, Food and Drug Administration, Johnson & Johnson, Moore Foundation, National Institutes of Health, The Peter G. Peterson Foundation, sanofi-aventis, and Stryker. Denis A. Cortese, M.D. Chair, Roundtable on Value & Science-Drien Health Care J. Michael McGinnis, M.D., M.P.P. Executie Director, Roundtable on Value & Science-Drien Health Care

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Contents SUMMARY 1 1 CLINICAL DATA AS THE BASIC STAPLE OF THE LEARNING HEALTH SYSTEM 43 Introduction, 43 Clinical Data as the Basic Staple of the Health Learning System, 50 Daid Brailer Vision for the Future: Creating a Public Good for the Public’s Health, 56 Carol C. Diamond 2 U.S. HEALTHCARE DATA TODAY: CURRENT STATE OF PLAY 69 Introduction, 69 Current Healthcare Data Profile, 71 Simon P. Cohn Data Used as Indicators for Assessing, Managing, and Improving Health Care, 82 Barbra G. Rabson Data Primarily Collected for New Insights, 90 Michael S. Lauer Health Product Marketing Data, 100 William D. Marder xix

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xx CONTENTS 3 CHANGING THE TERMS: DATA SYSTEM TRANSFORMATION IN PROGRESS 109 Introduction, 109 Emerging Large-Scale Linked Data Systems and Tools, 111 Peter Coitz Networked Data-Sharing and Standardized Reporting Initiatives, 117 Pierre-Andre LaChance Large Health Database Aggregation, 122 Steen Waldren Registries and Care with Evidence Development, 125 Peter Smith 4 HEALTHCARE DATA: PUBLIC GOOD OR PRIVATE PROPERTY? 137 Introduction, 137 Characteristics of a Public Good and How They Are Applied to Healthcare Data, 139 Daid Blumenthal Characteristics of the Marketplace for Medical Care Data, 143 William Crown Legal Issues Related to Data Access, Pooling, and Use, 151 Nicolas P. Terry 5 HEALTHCARE DATA AS A PUBLIC GOOD: PRIVACY AND SECURITY 171 Introduction, 171 Public Views, 173 Alan Westin HIPAA Implications and Issues, 179 Marcy Wilder Examples from Other Sectors, 183 Elliot E. Maxwell Institutional and Technical Approaches to Ensuring Privacy and Security of Clinical Data, 191 Alexander D. Eremia 6 CREATING A NExT-GENERATION DATA UTILITY: BUILDING BLOCKS AND THE ACTION AGENDA 203 Introduction, 203 Building on Collaborative Models, 205 Christopher Forrest

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xxi CONTENTS Technical and Operational Challenges, 212 Brian Kelly Economic Incentives and Legal Issues, 217 Eugene Steuerle The Action Agenda, 221 Policies on Data Sharing and Research, 226 Translation for Engaging the Public, 227 Areas for Follow-Up, 228 7 ENGAGING THE PUBLIC 231 Introduction, 231 Generating Public Interest in a Public Good, 233 Alison Rein Implications of “Patients Like Me” Databases, 238 Courtney Hudson Implications of Personal Health Records, 243 Jim Karkanias 8 CLINICAL DATA AS THE BASIC STAPLE OF HEALTH LEARNING: IDEAS FOR ACTION 249 Introduction, 249 Common Themes, 250 Issues and Opportunities, 253 Areas for Innovation and Collaborative Action, 266 APPENDIxES A Workshop Agenda 271 B Biographical Sketches of Workshop Participants 277 C Workshop Attendee List 299 D IOM HIPAA Report Recommendations 311

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