THE LEARNING HEALTH SYSTEM SERIES

Sharing Health Data:
The Why, the Will,
and the Way Forward

National Academy of Medicine
NAM Leadership Consortium: Collaboration for
a Learning Health System

THE NATIONAL ACADEMIES PRESS
Washington, DC
www.nap.edu

THE NATIONAL ACADEMIES PRESS 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. This publication is sponsored by the Patient-Centered Outcomes Research Institute (PCORI). The 11 case studies featured in this manuscript were selected based on input from PCORI and the editors and contributors to the NAM Special Publication Health Data Sharing to Support Better Health Outcomes: Building a Foundation of Stakeholder Trust, the progenitor of this publication. Opinions and advice presented within each case study are those of the interviewees. The case studies are solely an educational exercise and views presented in this publication are those of individual contributors and do not represent formal consensus positions of the editors’ organizations; the NAM; or the National Academies of Sciences, Engineering, and Medicine.

Library of Congress Catalog Number: 20222933551

Copyright 2022 by the National Academy of Sciences. All rights reserved.

Printed in the United States of America

Suggested citation: National Academy of Medicine. 2022. Sharing Health Data: The Why, the Will, and the Way Forward. S. M. Greene, M. Ahmed, P. S. Chua, and C. Grossmann, editors. NAM Special Publication. Washington, DC: National Academies Press.

“Knowing is not enough; we must apply.
Willing is not enough; we must do.”
-GOETHE

ABOUT THE NATIONAL ACADEMY OF MEDICINE

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Learn more about the National Academy of Medicine at NAM.edu.

SHARING HEALTH DATA: THE WHY, THE WILL, AND THE WAY FORWARD

Steering Committee and Working Group Participants

ERIN MACKAY(Co-Chair), National Partnership for Women & Families

PETER MARGOLIS(Co-Chair), Cincinnati Children’s Hospital Medical Center

KRISTIN CARMAN, Patient-Centered Outcomes Research Institute

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 Leadership Consortium for a Value & Science-Driven Health System:

SARAH M. GREENE, Senior Advisor

MAHNOOR AHMED, Associate Program Officer

PEAK SEN CHUA, Consultant

JENNA L. OGILVIE, Deputy Director of Communications

Patient-Centered Outcomes Research Institute Staff

NAKELA COOK, Executive Director

CLAUDIA GROSSMANN, Associate Director, Research Infrastructure

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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.

We wish to thank the following individuals for their contributions:

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 SARAH M. GREENE, Senior Advisor; MAHNOOR AHMED, Associate Program Officer, and J. MICHAEL MCGINNIS, Leonard D. Schaeffer Executive Officer, NAM. Responsibility for the final content of this publication rests with the editors and the NAM.

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CONTENTS

Foreword

1 Introduction

2 Case Study: OpenNotes

3 Case Study: The University of Michigan (U-M)

4 Case Study: Luna

5 Case Study: COVID-19 Evidence Accelerator (EA)

6 Case Study: The National COVID Cohort Collaborative (N3C)

7 Case Study: The Yale Open Data Access (YODA) Project

8 Case Study: Vivli

9 Case Study: The Louisiana Public Health Institute (LPHI) and the Greater New Orleans Health Information Exchange (GNOHIE)

10 Case Study: The Sanford Health System and Sanford Data Collaborative (SDC)

11 Case Study: Blue Cross Blue Shield of North Carolina

12 Case Study: Mayo-Google Partnership

13 Conclusion

References

Appendix A: Key Informant Interview Questions

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BOXES AND FIGURES

Boxes

1 Defining Real-World Data and Real-World Evidence

2 Common Data Models: Definition and Applied Example

Figures

1 Priority Barriers to Health Data Sharing

2 Funding Sources for the Data-Sharing Initiatives

3 Real-World Data for COVID-19 Ecosystem

4 COVID-19 Evidence Accelerator Work Streams

5 COVID-19 Evidence Accelerator Principles

6 Diagram of a Federated Learning Model

7 Mapping of Case Studies to Priority Barriers

Tables

1 Case Study Characteristics

2 List of Vivli’s Data Contributors by Sector

3 Role of Vivli’s Data-Sharing Platform in the Data-Sharing Ecosystem

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ACRONYMS AND ABBREVIATIONS

FOREWORD

Health data has proven its centrality in guiding action to change the course of individual and population health, if properly stewarded and used. Consequently, we are obliged to use it to its fullest, most beneficent potential. Too often barriers, such as disagreements about data ownership and misaligned incentives, have impeded research or practice, further hindering this potential. Evolving from a mindset of data guarding to data sharing is essential to meet society’s potential: it is imperative for effectiveness, efficiency, and equity in health system performance. In the context of the COVID-19 pandemic, both data and a lack of data illuminated profound shortcomings that affected health care and health equity. Yet a silver lining of the pandemic was a surge in collaboration among data holders in public health, health care, and technology firms, suggesting that an evolution in health data sharing is visible and tangible. This publication features some of these novel data-sharing collaborations born out of the pandemic.

This Special Publication by the National Academy of Medicine, featuring case studies, has been developed to provide practical context and implementation guidance important to advancing the lessons identified in its progenitor Special Publication, entitled Health Data Sharing: Building a Foundation of Stakeholder Trust. Developed in light of the realization that progress in data sharing and collaboration required the direct involvement of data stewards and stakeholders, the former publication was the culmination of a two-year partnership between Patient-Centered Outcomes Research Institute and the National Academy of Medicine to understand barriers and facilitators to health data sharing across a number of key stakeholder groups. With the goal of charting a collaborative path forward, that Special Publication identified several cultural, operational, financial, and ethical barriers meriting concerted attention and prioritized several action steps that could be accomplished in

a one-to-three-year time horizon. One of those important action steps is the focus of this publication: to identify and describe exemplar groups to dispel the myth that sharing health data more broadly is impossible and illuminate the innovative approaches that are being taken to make progress in the current environment. It also serves as a resource for those waiting in the wings, showing how barriers can be addressed and harvesting lessons and insights from those on the front lines.

Common to all of the case studies included in this report is the fundamental importance of strong partnerships built on common ground. The foundation of trust that enables collaborative data sharing activities is only attained through trustworthy and transparent behaviors and actions by all partners. As has been seen in numerous historic examples, misuse of health data has spawned a long legacy of mistrust. Hence, even when a data sharing compact has been established, ongoing, diligent attention to a shared commitment and shared values is imperative.

The profiled organizations were selected based on notable data-sharing interactions, dynamics, and barriers identified in the progenitor Special Publication. Given the dynamic state of partnerships, new exemplars are emerging with growing frequency. Interviews with representatives from these case studies not only describe how they overcame the specific barriers that drove their inclusion in this report, but also identify additional pertinent considerations that others should note as they engage in similar data-sharing eff orts.

These profiles illustrate how a small but committed group of vanguard entities is willing to push for a diff e rent way. Grounded in shared values, a common purpose, and clearly defined processes, these organizations have shown how barriers, once thought to be intractable, can be surmounted. Fifteen years ago, the idea of patients having free and seamless access to the clinical notes in their medical records was progressive and exceptional. Today, legislation obligates health systems to provide patient access to records as the norm rather than the exception. Ten years ago, compensation strategies for people who contribute genomic data to a repository was inconceivable. However, numerous private companies are reevaluating the value proposition for patients who are willing to

share data to further the research enterprise.

This compilation of case studies is one of many tools to drive action and progress toward broader health data sharing. We are hopeful that examining the partnership approaches described in these case studies can motivate new thinking and new action. A potentially valuable next step articulated in the previous publication is a national conversation about the importance and benefit of sharing health data. Particularly in this circumstance, it is important to underscore the very real risks and consequences of not sharing data. Nonetheless, the approach to such a dialogue must be supported by a foundation of meaningful engagement and partnership with patients, families, and community members who often have been sidelined in these conversations, the keystone for genuine, sustained trust building.

Refining and updating the regulatory context is a logically important element on the path forward. Many regulations were developed well before the expansion of data sources, modalities for data exchange, and attendant security considerations for these new mechanisms. However, these outmoded regulations are now drawing attention to themselves and the facilitative advances needed. The enactment of information-blocking regulations by the Office of the National Coordinator for Health IT, the October 2020 release of the NIH Policy for Data Management and Sharing, and the potential changes to the Health Information Portability and Accountability Act indicate that modernization of data-sharing regulations may be realized in the decade ahead.

In the meantime, knowledge is already available to foster better health care and health outcomes, and the examples of new partnerships and new technologies described in this volume suggest how intentional and assiduous attention to health data sharing can enable unparalleled advances, securing a healthier and more equitable future for all.

Nakela L. Cook, MD, MPH
Executive Director, PPCORI

J. Michael McGinnis, MD, MPP
Executive Officer, National Academy of Medicine

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