Harnessing Openness to Transform American Health Care

94 Pages·2008·1.55 MB·English

Harnessing Openness to
Transform American Health Care
Committee for
Economic Development
2000 L Street N.W.
Suite 700
Washington, D.C. 20036
202-296-5860 Main Number
202-223-0776 Fax
1-800-676-7353
www.ced.org
A Report by the Digital Connections Council of
the Committee for Economic Development
Harnessing Openness to
Transform American Health Care
A Report by the Digital Connections Council of
the Committee for Economic Development
Harnessing Openness to Transform American Health Care
Includes bibliographic references
ISBN #087186-188-7

First printing in bound-book form: 2008
Printed in the United States of America

COMMITTEE FOR ECONOMIC DEVELOPMENT
2000 L Street, N.W., Suite 700
Washington, D.C., 20036
202-296-5860

www.ced.org
Contents
PREFACE BY THE CED RESEARCH AND POLICY COMMITTEE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ix
EXECUTIVE SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
I. THE STATE OF U.S. HEALTH CARE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
II. THE GENOME ERA—OPENNESS IN BIOMEDICAL RESEARCH. . . . . . . . . . . . . . . . . . . . . . . . . . 9
T e Human Genome Project’s Open Model. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Some Limits on Openness . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Recommendations Regarding Openness in Biomedical Research . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
III. OPENNESS REGARDING CLINICAL TRIALS AND POST-APPROVAL
SURVEILLANCE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
T e Societal Bargain Underlying Clinical Trials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Registration of Clinical Trials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Data Integrity in Clinical Trials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Confl icts of Interest in Clinical Trials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Access to Data Produced in Clinical Trials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
T e Need for Usable Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Informed Consent for Participation in Clinical Trials. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Informed Consent for the Use of Tissue Samples in Clinical Trials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Privacy and Clinical Trials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Post-Approval Surveillance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Comparative Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Recommendations Regarding Clinical Trials and Post Approval Surveillance . . . . . . . . . . . . . . . . . . . . . . . 18
IV. ENCOURAGING OPENNESS IN PUBLISHING/DISCLOSURE OF
RESEARCH RESULTS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Scientifi c and Technical Publishing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Limits on Openness in the Present Model. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
New Open Alternatives Emerge . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
T e Advantages of Openness. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Openness and Government-Funded Research . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Diff ering Models for Openness . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Openness and Academic Advancement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Traditional Publishers Respond to New Open Models. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
T e Future of Open Publishing and Disclosure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Recommendations Regarding Openness and Publishing and Disclosure of Research Results . . . . . . . . . . 26
iii
V. OPENNESS REGARDING ELECTRONIC HEALTH RECORDS AND
EVIDENCE-BASED MEDICINE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
T e Vision of Electronic Health Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
T e Reality of Electronic Health Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Privacy and Security . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Today’s National Healthcare Privacy Law—HIPAA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Recent Privacy Initiatives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Electronic Health Records and the Development of Evidence-Based Medicine . . . . . . . . . . . . . . . . . . . . . . 34
Recommendations Regarding Electronic Health Records and the Development of
Evidence-Based Medicine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
VI. EXPANDING OPENNESS FOR PATIENTS AND CAREGIVERS . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Changing Ideas About the Role of the Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Patient Access to Healthcare Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Personal Health Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Other Sources of Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Patients as Research Assistants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Other Patient Contributions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
More Informed Health Consumers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Greater Openness and Incentives for Improving Healthcare . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Openness and Caregivers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Caregivers and New Sources of Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
T e Attentive Caregiver . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Openness and Information Provided by Caregivers. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Caregiver Confl icts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Recommendations Regarding Expanding Openness for Patients and Caregivers . . . . . . . . . . . . . . . . . . . . 44
VII. OPENNESS AND PUBLIC HEALTH. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Lessons of the SARS Outbreak. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Openness and Contributions from Less Obvious Sources . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Recommendations Regarding Openness and Public Health . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
VIII. OPENNESS AND MEDICAL DEVICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Changes in Medical Devices. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
T e FDA’s Responsibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Recommendations Regarding the Openness of Medical Devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
IX. OPEN BUSINESS MODELS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
Not Invented Here . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
Not Sold Here . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
X. CONCLUSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
ENDNOTES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
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CED Research and Policy Committee
Chairmen KATHLEEN COOPER CONO R. FUSCO
Senior Fellow Managing Partner - Strategic Relationships
PATRICK W. GROSS
Southern Methodist University Grant T ornton
Chairman
T e Lovell Group
W. BOWMAN CUTTER GERALD GREENWALD
Managing Director Chairman
WILLIAM W. LEWIS
Warburg Pincus LLC Greenbriar Equity Group
Director Emeritus
McKinsey Global Institute
KENNETH W. DAM BARBARA B. GROGAN
McKinsey & Company, Inc.
Max Pam Professor Emeritus of American Founder
and Foreign Law and Senior Lecturer, Western Industrial Contractors
University of Chicago Law School
RICHARD W. HANSELMAN
Members T e University of Chicago
Former Chairman
IAN ARNOF RONALD R. DAVENPORT Health Net Inc.
Chairman Chairman of the Board
Arnof Family Foundation Sheridan Broadcasting Corporation RODERICK M. HILLS
Chairman
ALAN BELZER RICHARD H. DAVIS Hills Stern & Morley LLP
President & Chief Operating Offi cer Partner
(Retired) Davis Manafort, Inc. EDWARD A. KANGAS
Allied Signal Global Chairman & CEO (Retired)
RICHARD J. DAVIS Deloitte Touche Tohmatsu
LEE C. BOLLINGER Senior Partner
President Weil, Gotshal & Manges LLP JOSEPH E. KASPUTYS
Columbia University Chairman, President & Chief Executive
WILLIAM DONALDSON Offi cer
ROY J. BOSTOCK Chairman Global Insight, Inc.
Chairman Donaldson Enterprises
Sealedge Investments, LLC CHARLES E.M. KOLB
FRANK P. DOYLE President
JOHN BRADEMAS Executive Vice President (Retired) Committee for Economic Development
President Emeritus General Electric Company
New York University BRUCE K. MACLAURY
W. D. EBERLE President Emeritus
BETH BROOKE Chairman T e Brookings Institution
Global Vice Chair, Strategy, Manchester Associates, Ltd.
Communications and Regulatory Aff airs WILLIAM J. MCDONOUGH
Ernst & Young LLP ALLEN FAGIN Vice Chairman and Special Advisor to the
Chairman Chairman
DONALD R. CALDWELL Proskauer Rose LLP Merrill Lynch & Co., Inc.
Chairman & Chief Executive Offi cer
Cross Atlantic Capital Partners MATTHEW FINK LENNY MENDONCA
President (Retired) Chairman
DAVID A. CAPUTO Investment Company Institute McKinsey Global Institute
President Emeritus McKinsey & Company, Inc.
Pace University EDMUND B. FITZGERALD
Managing Director ALFRED T. MOCKETT
GERHARD CASPER Woodmont Associates Chairman & CEO
President Emeritus Motive, Inc.
Stanford University HARRY FREEMAN
Chairman NICHOLAS G. MOORE
MICHAEL CHESSER T e Mark Twain Institute Senior Counsel and Director
Chairman, President & CEO Bechtel Group, Inc.
Great Plains Energy Services PATRICK FORD
President & CEO, U.S. DONNA S. MOREA
CAROLYN CHIN Burson-Marsteller President, U.S. Operations and India
Chairman & Chief Executive Offi cer CGI
Cebiz
v
CED Research and Policy Committee
M. MICHEL ORBAN JAMES Q. RIORDAN SARAH G. SMITH
Partner Chairman Chief Accounting Offi cer
RRE Ventures Quentin Partners Co. Goldman Sachs Group Inc.
STEFFEN E. PALKO DANIEL ROSE MATTHEW J. STOVER
Vice Chairman & President (Retired) Chairman Chairman
XTO Energy Inc. Rose Associates, Inc. LKM Ventures, LLC
CAROL J. PARRY LANDON H. ROWLAND VAUGHN O. VENNERBERG
President Chairman Senior Vice President and Chief of Staff
Corporate Social Responsibility EverGlades Financial XTO Energy Inc.
Associates
GEORGE E. RUPP JOSH S. WESTON
PETER G. PETERSON President Honorary Chairman
Senior Chairman International Rescue Committee Automatic Data Processing, Inc.
T e Blackstone Group
JOHN C. SICILIANO JOHN P. WHITE
NED REGAN Partner Lecturer in Public Policy
University Professor Grail Partners LLC Harvard University
T e City University of New York
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Digital Connections Council
Council Chair: JONATHAN FOX
Senior Manager, Privacy Governance
Committee for Economic Development:
PAUL M. HORN Sun Microsystems
Senior Vice President, Research (Retired) CHARLES E.M. KOLB
IBM Corporation DANIEL J. GREENWOOD President
Distinguished Scientist in Residence Founder
Stern School of Business, Courant CIVICS.com – T e Information Age JOSEPH MINARIK
Institute of Mathematical Sciences Consultancy Senior Vice President and
and the Graduate School of Arts & Director of Research
PATRICK W. GROSS
Sciences
Chairman ELLIOT SCHWARTZ
New York University
T e Lovell Group Vice President and Director,
Economic Studies
RICHARD HOWARD
Project Director: Program Manager (Retired) CHARLES JOHNSON
Lucent Technologies Inc. Research Associate
ELLIOT E. MAXWELL
Chief Strategist LARRY JACKEL
eMaxwell & Associates North-C Technologies, Inc.
Fellow, Communications Program
JOHN KOLB
Johns Hopkins University
Vice President and Chief Information Offi cer
Rensselaer Polytechnic Institute
Members: BOB OBEE
Chief Information Offi cer
CAROLYN CHIN YRC Regional Transportation
Chairman & Chief Executive Offi cer
Cebiz LARS RABBE
Senior Vice President and Chief
MICHELLE DENNEDY Information Offi cer
Chief Privacy Offi cer Intuit
Sun Microsystems
MATTHEW J. STOVER
IRWIN DORROS Chairman
President LKM Ventures, LLC
Dorros Associates
CHRIS WU
REGINALD FOSTER Open Educational Resource Fellow
Managing Director Institute for the Study of Knowledge
Beacon Equity Partners Management in Education
vii
viii
Committee for Economic Development
Digital Connections Council
Harnessing Openness to Transform American Health Care
Preface by the CED Research and Policy Committee
CED’s Digital Connections Council (DCC), a group of information technology experts from CED trustee-
affi liated companies, was established to advise CED on the policy issues associated with cutting-edge technologies.
T is report, concerning “openness” in healthcare, is the third of its products. CED appreciates greatly the eff orts
of the members of the Council, and in particular, the work of DCC Chair Paul Horn, Senior Vice President,
Research (retired), IBM Corporation, and Distinguished Scientist in Residence, Stern School of Business, Cou-
rant Institute of Mathematical Sciences and the Graduate School of Arts and Science, New York University, for
his leadership in bringing this report to completion. Special thanks are also due to Elliot Maxwell, CED’s project
director and consultant, to Charles Johnson and Daphne McCurdy, CED Research Associates, for assistance
with research, editing, and publication, and to Elliot Schwartz, CED’s Vice President and Director of Economic
Studies.
T is report is the work of the Digital Connections Council. We welcome this report and recommend it to readers
as an excellent analysis of how the system of healthcare in the United States, and importantly health outcomes,
can benefi t from the application of greater openness through digital technologies. T e recommendations of this
report, along with those of CED’s policy statement, Quality, Aff ordable Health Care for All: Moving Beyond the
Employer-Based Health-Insurance System, can transform healthcare in the United States by making it signifi cantly
more effi cient, accessible, and responsive.
Patrick W. Gross, Co-Chair
Research and Policy Committee
Chairman, T e Lovell Group
William W. Lewis, Co-Chair
Research and Policy Committee
Director Emeritus, McKinsey Global Institute
McKinsey & Company, Inc.
ix