Use and public reporting of predetermined change control plans for AI-enabled medical devices

Authors

• Patryk A Dabek, Washington University School of Medicine in St. Louis
• Florence T Bourgeois, Harvard University
• Ariel D Stern, University of Potsdam
• Yi Zhu, University of Texas at Dallas
• Alexander O Everhart, Washington University School of Medicine in St. Louis

Journal

JAMA Health Forum

Publication Date

5-1-2026

Volume

7

Issue

5

First Page

e261204

Document Type

Open Access Publication

DOI

10.1001/jamahealthforum.2026.1204

Rights and Permissions

Dabek PA, Bourgeois FT, Stern AD, Zhu Y, Everhart AO. Use and Public Reporting of Predetermined Change Control Plans for AI-Enabled Medical Devices. JAMA Health Forum. 2026;7(5):e261204. doi:10.1001/jamahealthforum.2026.1204. This is an open access article distributed under the terms of the CC-BY-NC-ND License, which does not permit alteration or commercial use, including those for text and data mining, AI training, and similar technologies. © 2026 Dabek PA et al. JAMA Health Forum.

Recommended Citation

Dabek, Patryk A; Bourgeois, Florence T; Stern, Ariel D; Zhu, Yi; and Everhart, Alexander O, "Use and public reporting of predetermined change control plans for AI-enabled medical devices." JAMA Health Forum. 7, 5. e261204 (2026).
https://digitalcommons.wustl.edu/oa_4/6750

Department

ICTS (Institute of Clinical and Translational Sciences)

Additional Links

Supplemental material is available for this article at publisher site.