Researchers propose standards and community oversight to improve interoperability, accountability and public trust
The U.S. healthcare system runs on fractured data. Even with widespread adoption of electronic health records and digital technologies, real-world health information is locked in incompatible systems, governed unevenly and shared inconsistently. This fragmentation hampers the nation’s ability to generate evidence quickly, detect safety concerns, respond to emerging threats, drive precision medicine and reduce inequities in care.
In a perspective article researchers from several organizations, including the UNC School of Medicine, Regenstrief Institute, Indiana University School of Medicine and Datavant propose a new framework that would treat real-world health data as a public utility, like how water, electricity and internet are structured.
“We cannot afford to keep treating health data as the digital exhaust from care,” said Shaun Grannis, M.D., M.S., vice president for data and analytics at the Regenstrief Institute. “If we want a true learning health system, one that continuously improves based on real-world experience, we need coordinated, sustainable infrastructure that enables a pace of innovation that address the challenges facing patients and communities in a more timely fashion.”
The researchers argue the challenge is not a lack of data but a lack of coordinated governance and aligned incentives. The public utility framework refers to essential infrastructure guided by required standards and oversight, not a centralized government database or a system that charges patients for their own data.
“If you look at the history of infrastructure systems like electricity, water and internet, they were once fragmented and incompatible,” said lead author of the study Melissa Haendel, PhD, of the UNC School of Medicine. “What transformed them into reliable, interoperable services was the combination of required standards, transparent community-driven governance and accountability. We believe real-world health data require the same kind of coordinated oversight in order to realize precision medicine as a public service available to everyone.”
The proposed framework emphasizes sustainable economic models that support long-term investment while maintaining strong privacy safeguards. Importantly, ownership of data would remain with the organizations and individuals who generate and steward it, with oversight designed to ensure responsible use, transparency and public benefit.
“Patients generate real-world health data every time they interact with the health system, yet too often these data disappear into silos,” said Regenstrief Chief Data Scientist Jiang Bian, PhD. “By establishing a regulated, utility-like framework for data governance, we can ensure that every patient’s experience contributes safely and securely to better care, faster discoveries and a stronger public health system.”
Existing efforts to improve access and usability of real-world data through distributed networks, research enclaves and private platforms have shown promise but remain constrained by uneven incentives and voluntary compliance. The proposed public utility framework is intended to complement these initiatives by replacing fragmented, voluntary arrangements with clearer, consistent standards.
By treating real-world health data as essential infrastructure, the framework aims to unlock its full potential to improve interoperability, ensure sustainable access, strengthen patient protections and enhance the nation’s ability to respond to emerging health challenges.
The paper, “Governing real-world health data as a public utility” is published in the journal Science.
Shaun Grannis, M.D., M.S.
In addition to his role as vice president for data and analytics and research scientist with the Clem McDonald Center for Biomedical Informatics, at Regenstrief Institute, Shaun Grannis, M.D., M.S., is the Regenstrief Professor of Medical Informatics and a professor of family medicine at Indiana University School of Medicine. He is also an adjunct professor with the Indiana University Richard M. Fairbanks School of Public Health at IU Indianapolis and at the Indiana University School of Informatics and Computing at IU Indianapolis.
Jiang Bian, PhD
In addition to his role as a research scientist, Jiang Bian, PhD, holds several leadership positions across Indiana University and its health system. He serves as Chief Data Scientist for both Regenstrief Institute and IU Health and is the Walther and Regenstrief Endowed Chair in Cancer Informatics at the IU Melvin and Bren Simon Comprehensive Cancer Center and Regenstrief Institute. He also serves as Chief Research Information Officer at the cancer center, associate dean for data science at the IU School of Medicine, and Regenstrief Deputy Director of the Indiana Clinical and Translational Sciences Institute. In addition, he is professor and vice chair for translational informatics in the department of biostatistics and health data science at the IU School of Medicine.
Authors and affiliations
Melissa A. Haendel1, Ryan Ahern2, Kasie B. Bailey2, Spyridon Bakas20 1,Daniel C. Barth-Jones3, Alex Bohl4, Jiang Bian20 22, Philip E. Bourne5, Rebecca R. Boyles1, Christopher G. Chute6, James J. Cimino14 3 , Shaun Grannis 22 4, Terry S. Hartman1, Michelle Holko7, Nathan A. Hotaling8, Dan J. Housman9, Lawrence E. Hunter10, Eric Hurwitz1, Jasmin Phua3 5, Michael G. Kahn13, Dario Kuzmanovic11 6, Josh Lemieux1, Johanna Loomba1, Charisse R. Madlock-Brown14 7, Kenneth D. Mandl15, Raja Mazumder16, Julie A. McMurry1, Andrew J. McMurry15 8, Zubin J. Modi17, Richard A. Moffitt18, Abu S. M. Mosa14, Messina Nicholas2 9, Shawn T. O’Neil1, Josh F Peterson23, Emily R. Pfaff1, Jimmy Phuong19 10, Rachel Presskreischer1, Lee Sanders25, Abeed Sarker18 11, Alastair Thomson21, Kim M. Unertl23, Anita Walden1, Jim Weinstein12 24
1University of North Carolina at Chapel Hill, Chapel Hill, NC USA.
2Truveta, Bellevue, WA, USA.
3Datavant Inc., Phoenix, AZ, USA.
4Mathematica Inc., Princeton, NJ, USA.
5University of Virginia, Charlottesville, VA, USA.
6Johns Hopkins University, Baltimore, MD, USA.
7Defensive BioTech LLC; Bethesda, MD, USA.
8Axle Informatics, Rockville, MD USA.
9Graticule, Dedham, MA, USA.
10University of Chicago, Chicago, IL USA.
11University of Southern California, Los Angeles, CA, USA.
12University of Iowa, Iowa City, IA, USA.
13University of Colorado Anschutz Medical Campus, Aurora, CO, USA.
14Department of Biomedical Informatics and Data Science, University of Alabama at Birmingham, Birmingham, AL, USA.
15Computational Health Informatics Program, Boston Children’s Hospital, Boston, MA, USA.
16George Washington University, Washington, DC USA.
17University of Michigan, Ann Arbor, MI, USA.
18Emory University, Atlanta, GA USA.
19University of Washington, Seattle, WA USA.
20Indiana University School of Medicine, Indianapolis, IN, USA.
21AI Strategy LLC, Haymarket, VA, USA.
22Regenstrief Institute, Indianapolis, IN, USA.
23Vanderbilt University Medical Center, Nashville, TN, USA
24Microsoft Research, Redmond, WA, USA,
25Stanford University, Stanford, CA USA.
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