THE LEARNING HEALTH SYSTEM SERIES
HEALTH DATA SHARING TO SUPPORT
BETTER OUTCOMES
BUILDING A FOUNDATION OF STAKEHOLDER TRUST
DANIELLE WHICHER, MAHNOOR AHMED, SAMEER SIDDIQI, INEZ ADAMS,
MARYAN ZIRKLE, CLAUDIA GROSSMANN, AND KRISTIN L. CARMAN,
EDITORS
WASHINGTON, DC
NAM.EDU
NATIONAL ACADEMY OF MEDICINE 500 Fifth Street, NW Washington, DC 20001
This publication has undergone peer review according to procedures established by the National Academy of Medicine (NAM). Publication by the NAM signifies that it is the product of a carefully considered process and is a contribution worthy of public attention, but does not constitute endorsement of conclusions and recommendations by the NAM. The views presented in this publication are those of individual contributors and do not represent formal consensus positions of the authors’ organizations; the NAM; or the National Academies of Sciences, Engineering, and Medicine.
This activity was supported by a contract between the National Academy of Medicine and the Patient-Centered Outcomes Research Institute.
Library of Congress Control Number: 2020948195
Copyright 2021 by the National Academy of Sciences. All rights reserved.
Printed in the United States of America
Suggested citation: Whicher, D., M. Ahmed, S. Siddiqi, I. Adams, M. Zirkle, C. Grossmann, and K. L. Carman, Editors. 2021. Health Data Sharing to Support Better Outcomes: Building a Foundation of Stakeholder Trust. NAM Special Publication. Washington, DC: National Academy of Medicine.
“Knowing is not enough; we must apply.
Willing is not enough; we must do”
—GOETHE
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ABOUT THE NATIONAL ACADEMY OF MEDICINE
The National Academy of Medicine is one of three Academies constituting the National Academies of Sciences, Engineering, and Medicine (the National Academies). The National Academies provide independent, objective analysis and advice to the nation and conduct other activities to solve complex problems and inform public policy decisions. The National Academies also encourage education and research, recognize outstanding contributions to knowledge, and increase public understanding in matters of science, engineering, and medicine.
The National Academy of Sciences was established in 1863 by an Act of Congress, signed by President Lincoln, as a private, nongovernmental institution to advise the nation on issues related to science and technology. Members are elected by their peers for outstanding contributions to research. Dr. Marcia McNutt is president.
The National Academy of Engineering was established in 1964 under the charter of the National Academy of Sciences to bring the practices of engineering to advising the nation. Members are elected by their peers for extraordinary contributions to engineering. Dr. John L. Anderson is president.
The National Academy of Medicine (formerly the Institute of Medicine) was established in 1970 under the charter of the National Academy of Sciences to advise the nation on issues of health, health care, and biomedical science and technology. Members are elected by their peers for distinguished contributions to medicine and health. Dr. Victor J. Dzau is president.
Learn more about the National Academy of Medicine at NAM.edu.
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STEERING COMMITTEE AND WORKING GROUP PARTICIPANTS
Steering Committee
ERIN MACKAY (Co-Chair), National Partnership for Women & Families
PETER MARGOLIS (Co-Chair), Cincinnati Children’s Hospital Medical Center
HELEN BURSTIN, Council of Medical Specialty Societies
HUGO CAMPOS, California Precision Medicine Consortium
KRISTIN CARMAN, Patient-Centered Outcomes Research Institute
CHRISTINE GRADY, National Institutes of Health
ADRIAN HERNANDEZ, Duke University Medical Center and Duke Clinical Research Institute
KATHY HUDSON, Hudson Works LLC
RAINU KAUSHAL, NewYork-Presbyterian Hospital/Weill Cornell Medical Center
BRADLEY MALIN, Vanderbilt University
DEVEN MCGRAW, Ciitizen Corporation
C. DANIEL MULLINS, University of Maryland School of Pharmacy
ADNAN MUNKARAH, Henry Ford Health System
HAROLD PAZ, Aetna Inc.
RICHARD PLATT, Harvard University and Harvard Pilgrim Health Care Institute
MICHELLE SCHREIBER, Centers for Medicare & Medicaid Services
JOE SELBY, Patient-Centered Outcomes Research Institute (until December 2019)
RACHEL SHERMAN, Food and Drug Administration (until January 2019)
MONA SIDDIQUI, Department of Health and Human Services (until February 2020)
FRANGISCOS SIFAKIS, AstraZeneca
PAUL WALLACE, AcademyHealth
Patient and Family Leaders Working Group
STACEY LIHN (Co-Chair), National Pediatric Cardiology Quality Improvement Collaborative
SUSAN WOODS (Co-Chair), Society for Participatory Medicine
CHRISTINE BECHTEL, X4 Health
JANET FREEMAN-DAILY, Patient Advocate and Gray Connections
KAMERON MATTHEWS, Veterans Health Administration
SALLY OKUN, PatientsLikeMe (until December 2019)
CASEY QUINLAN, Mighty Casey Media
JOHN SANTA, OpenNotes
ANDREW SPERLING, National Alliance on Mental Illness
SHARON TERRY, Genetic Alliance
VERONICA TODARO, Parkinson’s Foundation
DANNY VAN LEEUWEN, Health Hats
Research and Research Oversight Leaders Working Group
SARAH GREENE (Co-Chair), Health Care Systems Research Network (until May 2020)
RUSSEL ROTHMAN (Co-Chair), Vanderbilt University
TANISHA CARINO, Alexion Pharmaceuticals, Inc.
JODI DANIEL, Crowell & Moring LLP
BOB HARRINGTON, Stanford University
JOHN LANTOS, Children’s Mercy Kansas City
EMILY LARGENT, University of Pennsylvania Perelman School of Medicine
MICHELLE MEYER, Geisinger’s Center for Translational Bioethics and Health Care Policy
PEARL O’ROURKE, Partners HealthCare International
MARK SCHREINER, Children’s Hospital of Philadelphia
JEREMY SUGARMAN, Berman Institute of Bioethics, Johns Hopkins University
Health Care Executives Working Group
RAINU KAUSHAL (Co-Chair), NewYork-Presbyterian Hospital/Weill Cornell Medical Center
GREGG S. MEYER (Co-Chair), Partners HealthCare International
KEVIN BAN, athenahealth, Inc.
RICKY BLOOMFIELD, Apple Inc.
ADRIENNE BOISSY, Cleveland Clinic
JOHN BULGER, Geisinger
RAJ DAVDA, Cigna
ROBERT EMERSON, BlueCross BlueShield of North Carolina
JULIE GERBERDING, Merck & Co., Inc.
JOHN HALAMKA, Mayo Clinic
LEWIS SANDY, UnitedHealth Group
DARSHAK SANGHAVI, OptumLabs
MARIANN YEAGER, The Sequoia Project
NAM Staff
Development of this publication was facilitated by contributions of the following NAM staff, under the guidance of J. Michael McGinnis, Leonard D. Schaeffer Executive Officer and Executive Director of the NAM Leadership Consortium: Collaboration for a Value & Science-Driven Health System:
DANIELLE WHICHER, Senior Program Officer (until September 2019)
MAHNOOR AHMED, Associate Program Officer
SAMEER SIDDIQI, Technical Consultant (temporary)
INEZ ADAMS, Senior Program Officer (temporary)
JENNA OGILVIE, Deputy Director of Communications
Patient-Centered Outcomes Research Institute Staff
NAKELA COOK, Executive Director
CLAUDIA GROSSMANN, Senior Program Officer
MARYAN ZIRKLE, Associate Director (until December 2019)
KRISTIN CARMAN, Director
JOE SELBY, Executive Director (until December 2019)
Consultant
STEVE OLSON, Science Writer
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REVIEWERS
This Special Publication was reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, in accordance with review procedures established by the National Academy of Medicine (NAM).
We wish to thank the following individuals for their contributions:
ANEESH CHOPRA, CareJourney
PATRICK O. GEE, SR., Health Care Consultant and Consumer Advocate
WILLIAM (BILL) GREGG, HCA Healthcare
SUSAN KIRSH, Department of Veterans Affairs
ARTI K. RAI, Duke University School of Law
TERESA ZAYAS-CABÁN, The Office of the National Coordinator for Health Information Technology
The reviewers listed above provided many constructive comments and suggestions, but they were not asked to endorse the content of the publication, and did not see the final draft before it was published. Review of this publication was overseen by MAHNOOR AHMED, Associate Program Officer, and J. MICHAEL MCGINNIS, Leonard D. Schaeffer Executive Officer. Responsibility for the final content of this publication rests entirely with the editors and the NAM.
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FOREWORD
The effective use of data is foundational to the concept of a learning health system—one that leverages and shares data to learn from every patient experience, and feeds the results back to clinicians, patients and families, and health care executives to transform health, health care, and health equity. More than ever, the American health care system is in a position to harness new technologies and new data sources to improve individual and population health. Wisely stewarded, data can inform decision making about prevention and care for a wide variety of health conditions and result in health care services tailored to the needs of individuals, populations, and communities. The range of data sources relevant to this task is vast and continuously growing. Achieving this potential depends on overcoming substantial friction and inertia that exist today between this ideal state and current reality.
Learning health systems are driven by multiple stakeholders—patients, clinicians and clinical teams, health care organizations, academic institutions, government, industry, and payers. Each stakeholder group has its own sources of data, its own priorities, and its own goals and needs with respect to sharing that data. However, in America’s current health system, these stakeholders operate in silos without a clear understanding of the motivations and priorities of other groups. To foster dialogue, the National Academy of Medicine and Patient-Centered Outcomes Research Institute convened a multi-stakeholder steering committee of patients and families, health system executives, representatives from biopharmaceutical and technology companies, clinicians, and research and research oversight leaders with the goal of generating wider awareness and discussion about the barriers to effective, efficient, and ethical data sharing. The committee’s charge was to bring together these groups to identify actions that could stimulate more demand for this ideal state of data sharing.
The three stakeholder working groups that served as the authors of this Special Publication identified many cultural, ethical, regulatory, and financial barriers to greater data sharing, linkage, and use. What emerged was the foundational role of trust in achieving the full vision of a learning health system. Numerous examples detailed in this Special Publication reflect the broader environment of health care, in which factors like market competition, the potential to treat data as monetized commodities, and reluctance to share override the moral and ethical imperatives of exchanging and using data to improve the health of patients and populations. Historic and current misuses of data have only further diminished public trust in institutions that rely on data for advancing progress.
Understanding and addressing the challenges of data sharing and trust are especially noteworthy at the time of publication. The COVID-19 pandemic exemplifies the need for data sharing to drive rapid learning and meaningful actions. The U.S. response to the COVID-19 pandemic is characterized by a patchwork of data sources barriers to sharing data across health care, public health, and other sectors: antiquated methods of data capture, including a reliance on manual data entry and faxed surveillance reports; inadequate use of electronic health records; and gaps and variation in public reporting of data related to race and ethnicity. Together, these factors have thwarted a unified response by public health and policy makers, business leaders, health care practitioners, and the general public. Moreover, the absence of a connected system for exchanging data has reduced the ability of communities to understand and respond to local context and has compromised real-time learning. The COVID-19 pandemic also highlights the structural inequities that have resulted in worse outcomes for communities of color and underscores the need to improve data sharing and use in ways that advance health equity.
This Special Publication outlines a number of potentially valuable policy changes and actions that will help drive toward effective, efficient, and ethical data sharing, including more compelling and widespread communication efforts to improve awareness, understanding, and participation in data sharing. However, there is tension between the role of national policy organizations’ top-down recommendations and the bottom-up actions and relationships required to facilitate and build participation and trust among the individuals who will be sharing their personal data. For example, some health data are produced out of relationships between patients and clinicians as part of health care services and in the pursuit of better health. In any relationship, trust grows as a result of thoughtful, respectful, and transparent interactions. Thus, decision makers should prioritize collaborations and activities that are likely to generate trust among stakeholder groups. One of the action steps this Special Publication
proposes is the establishment of a consortium of organizations committed to progress by testing new approaches to data sharing. The authors of this publication believe that this is an important action-oriented proposal that could build the knowledge and momentum to realize this ideal state of data sharing. The proposed consortium of organizations committed to progress by testing new approaches to data sharing is an important action-oriented approach that could build the knowledge, expertise, and momentum to realize the goals of the report.
Continued involvement of patients and communities is essential to achieving this ideal state of data sharing. If patients are to take on a more robust and informed role in guiding decision making about the collection, use, and sharing of their data, substantial commitment and openness on the part of all stakeholders is integral. This includes a commitment to authentic engagement and participation of patients and families; extensive education about the use of data; changes in technology to make data sharing easier; necessary privacy and civil rights protections; and novel governance models that recognize, define, and support the rights and responsibilities of a wide variety of patients as data contributors and users. Only then will all patients and other stakeholders feel empowered to exert a stronger voice in governing shared data resources.
Achieving the vision of a learning health system will require eliminating the artificial boundaries that exist today among patient care, health system improvement, and research. Breaking down these barriers will require an unrelenting commitment across multiple stakeholders toward a shared goal of better, more equitable health. We can improve together by sharing and using data in ways that produce trust and respect. Patients and families deserve nothing less.
Erin Mackay, M.P.H.
Peter Margolis, M.D., Ph.D.
Co-Chairs of the Special Publication Steering Committee
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PREFACE
This Special Publication was first conceived out of the firm belief that health data sharing is a moral imperative. It is an obligation that requires the equal engagement of all health care stakeholders—patients, consumers, providers, researchers, health system leaders, technology and pharmaceutical partners—to facilitate greater data sharing for advancing health, health care, and health equity.
Throughout this Special Publication, the authors cite the numerous benefits of data sharing and present compelling reasons from a variety of viewpoints that underscore the importance of this mission. However, nothing has made a more urgent case for data sharing than the coronavirus disease 2019 (COVID-19) pandemic.
Due to COVID-19, health data sharing is no longer just a moral imperative but a vital component in overcoming this crisis. The novelty of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and the variable and mysterious manner in which the ensuing disease manifests in different people highlight the need for rapid, timely, and accurate data exchange from a myriad of sources. COVID-19 has demonstrated the value of and raised our reliance on patient- and consumer-reported data in tracking transmissions and understanding risk factors for the disease. The pandemic necessitates the sharing of results, broadening the potential for new insights and accelerating the pace of developing a cure.
The authors of this Special Publication have seen an encouraging coming together of stakeholders across borders and sectors of the health care system to share new discoveries and experiences with COVID-19. Several public initiatives such as the National Institutes of Health’s National COVID Cohort Collaborative, the Food and Drug Administration’s Evidence Accelerator, and the National Patient-Centered Clinical Research Network’s COVID-19 Common Data Model have emerged to coordinate data resources across groups.
Private entities and academic institutions have put aside competition to form new data partnerships for surveillance, predictive modeling, comparative effectiveness, addressing health disparities, quality improvement, and innovation. Additionally, waivers and modifications of the Health Insurance Portability and Accountability Act (HIPAA) privacy rules have eased the sharing of patient medical data across hospitals, vendors, and public health authorities.
The data collaborations and policy adjustments promoted by COVID-19 are a testament to the rapid dismantling of decades-old barriers—many of them mentioned in this Special Publication—to solve a public health crisis. These rapid pivots reveal a remarkable commitment among stakeholder groups to sideline concerns over market competition, the burden of managing data, and data control and ownership in pursuit of a common cause. Above all, it reflects the ability of stakeholders to develop trust in each other for the sake of progress.
This Special Publication repeatedly identifies trust as the cornerstone of building successful data-sharing partnerships. It is no different under the current circumstances. Trust must remain a priority in all efforts to address the pandemic. Trust begins with health care leaders being transparent about their intentions and plans for health data and using clear, understandable language to communicate data-sharing plans with patients and caregivers. Particular attention must be given to engaging underrepresented minorities, who have disproportionately borne the burden of COVID-19 and, yet, are underrepresented in demographic and social data.
The research community can instill trust by ensuring that data and information used in COVID-19 studies are credible, verified, and sourced appropriately. While scientific integrity is sometimes compromised by the urgency to publish, it behooves researchers and research oversight leaders to develop and adhere to agreed-upon standards in the use of electronic data and data analysis transparency. Without these standards, public trust in institutions that rely on data, as fragile as it is, will erode further.
An area in which trust plays a crucial role is the protection of privacy. As shown in this Special Publication, privacy is an enduring concern of health care stakeholders, further accentuated by COVID-19. Understandably, in times of crisis, the relaxation of privacy regulations may be warranted in service to public health and safety. However, in doing so, trust and transparency must maintain a central presence. It is here that the opportunity presents itself once again for implementing many of the approaches proposed in this Special Publication—a sweeping educational campaign for consumers on the implications of changing policies, the use of anonymized and de-identified datasets, and the development of novel data governance and stewardship models to ensure that data shared
for the purposes of COVID-19 are used responsibly and according to the preferences of their providers during and well after the pandemic.
Although COVID-19 has been a horrific and unwelcome disruption in our lives, it serves as a much needed catalyst for change. The pandemic has provided a window of opportunity to reassess and re-design interactions in health care for the better and shown that barriers long-assumed immovable can be overcome, including many of the barriers identified in this Special Publication. However, sustaining progress requires upholding the central tenet of trust. Without trust, not only will health care and data sharing struggle to move forward, but the gains achieved during this pandemic may be reversed.
Stacey Lihn
Susan Woods
Co-Chairs, Patient and Family Leaders Working Group
Sarah M. Greene
Russell Rothman
Co-Chairs, Research and Research Oversight Leaders Working Group
Rainu Kaushal
Gregg S. Meyer
Co-Chairs, Health Care Executives Working Group
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CONTENTS
Steering Committee and Vision Statement
Stakeholder Working Group Statements
2 Vision and Strategy Background
A Vision for a Learning Health System Sharing Data for Continuous Improvement
3 Statement of the Patient and Family Leaders
Solutions Impacting Multiple Priority Barriers
BOXES AND FIGURES
BOXES
1-1 List of Steering Committee Members
3-1 Members of the Patient and Family Leaders Workgroup
4-1 Members of the Research and Research Oversight Leaders Workgroup
5-1 Members of the Health Care Executives Workgroup
FIGURES
ES-1 Cultural, ethical, regulatory, and financial barriers to data sharing, linkage, and use
1-1 Generating stakeholder engagement and demand for sharing data for continuous learning
6-1 Cultural, ethical, regulatory, and financial barriers to data sharing, linkage, and use
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ACRONYMS AND ABBREVIATIONS
| AAN | American Academy of Neurology |
| API | application programming interface |
| CDC | Centers for Disease Control and Prevention |
| CHIP | Children’s Health Insurance Program |
| CMS | Centers for Medicare & Medicaid Services |
| EHR | electronic health record |
| HHS | Department of Health and Human Services |
| HIPAA | Health Insurance Portability and Accountability Act |
| HL7 | Health Level Seven International |
| IRB | institutional review board |
| IT | information technology |
| MACRA | Medicare Access and CHIP (Children’s Health Insurance Program) Reauthorization Act of 2015 |
| NAM | National Academy of Medicine |
| NGA | National Governors Association |
| NIH | National Institutes of Health |
| OCR | Office for Civil Rights |
| OHRP | Office for Human Research Protections |
| ONC | The Office of the National Coordinator for Health Information Technology |
| OSTP | Office of Science and Technology Policy |
| PCORI | Patient-Centered Outcomes Research Institute |
| ResDAC | Research Data Assistance Center (CMS) |
| TEFCA | Trusted Exchange Framework and Common Agreement |
| VHA | Veterans Health Administration |
