Health AI Central
Peer-Reviewed Publication
J Am Med Inform Assoc2025;32(11):1746-1755.November 1, 2025Journal Article

Towards responsible artificial intelligence in healthcare-getting real about real-world data and evidence.

Eileen Koski1, Amar Das2, Pei-Yun Sabrina Hsueh3, Anthony Solomonides4, Amanda L Joseph5,6,7, Gyana Srivastava7, Carl Erwin Johnson8, Joseph Kannry9, Bilikis Oladimeji10, Amy Price11,12, Steven Labkoff7,13, Gnana Bharathy14, Baihan Lin15,16,17, Douglas Fridsma18, Lee A Fleisher19, Monica Lopez-Gonzalez20, Reva Singh21, Mark G Weiner22, Robert Stolper23, Russell Baris24, Suzanne Sincavage25,26, Tristan Naumann27, Tayler Williams21, Tien Thi Thuy Bui7,28, Yuri Quintana6,7,29
1IBM Research, Yorktown Heights, NY 10598, United States.
2Real World Evidence, Guardant Health, Palo Alto, CA 94304, United States.
3Department of Ethical AI and External Innovation, Pfizer Inc., New York, NY 10001, United States.
4Research Institute, Endeavor Health, Evanston, IL 60201, United States.
5School of Health Information Science, University of Victoria, Victoria, BC V8P 5C2, Canada.
6Homewood Research Institute, Guelph, ON N1E 6K9, Canada.
7Division of Clinical Informatics, Beth Israel Deaconess Medical Center, Boston, MA 02215, United States.
8Outcomes Research, Merck & Co., Inc., North Wales, PA 19454, United States.
9Division of General Internal Medicine, Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, NY 10029, United States.
10Clinical Technology Strategy, UnitedHealth Group, Eden Prairie, MN 55344, United States.
11The Dartmouth Institute for Health Policy and Clinical Practice, Geisel School of Medicine at Dartmouth, Hanover, NH 03755, United States.
12BMJ, London, WC1H 9JP, United Kingdom.
13Quantori, Cambridge, MA 02142, United States.
14Faculty of Engineering and IT, University of Technology Sydney, Sydney, NSW 2007, Australia.
15Department of AI, Hasso Plattner Institute for Digital Health, Icahn School of Medicine at Mount Sinai, New York, NY 10029-5674, United States.
16Department of Psychiatry, Mount Sinai, New York, NY 10029, United States.
17Department of Neuroscience, Icahn School of Medicine at Mount Sinai, New York, NY 10029, United States.
18Health Universe, San Francisco, CA 94114, United States.
19Anesthesiology and Critical Care, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA 19104, United States.
20Cognitive Insights for Artificial Intelligence, Baltimore, MD 21202, United States.
21Public Policy, American Medical Informatics Association, Washington, DC 20011, United States.
22Department of Population Health Sciences, Weill Cornell Medicine, New York, NY 10065, United States.
23Strategy Consulting, IQVIA, Boston, MA 02210, United States.
24eLumindata, Westport, CT, United States.
25Foundation for Biodefense Research, Fallbrook, CA, United States.
26IDIQ Inc., Fallbrook, CA 92028, United States.
27Microsoft New England Research and Development Center, Microsoft Research, Cambridge, MA 02142, United States.
28Massachusetts College of Pharmacy and Health Sciences, Boston, MA, United States.
29Department of Medicine, Harvard Medical School, Boston, MA 02115, United States.
PubMed PMC DOI PDF

Abstract

BACKGROUND: The use of real-world data (RWD) in artificial intelligence (AI) applications for healthcare offers unique opportunities but also poses complex challenges related to interpretability, transparency, safety, efficacy, bias, equity, privacy, ethics, accountability, and stakeholder engagement. METHODS: A multi-stakeholder expert panel comprising healthcare professionals, AI developers, po…

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