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 Th 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 Th 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 Th 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 Th 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 Th 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 Th e Vision of Electronic Health Records . 29 Th 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 Th 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. ..