Use and Public Reporting of Predetermined Change Control Plans for AI-Enabled Medical Devices
This cross-sectional study describes predetermined change control plan use among artificial intelligence (AI)–enabled medical devices and the comprehensiveness of public reporting documenting predetermined change control plans.
Authors
- Yi Zhu (ORCID: https://orcid.org/0000-0003-2625-9953)
- Alexander Everhart (ORCID: https://orcid.org/0000-0001-5192-6557)
- A. Stern
- Florence T. Bourgeois
- Patryk A. Dabek
Institutions
- Boston Children's Hospital (US)
- Harvard University (US)
- Hasso Plattner Institute (DE)
- The University of Texas at Dallas (US)
- University of Potsdam (DE)
- Washington University in St. Louis (US)
- Center for Advancing Health (US)
- Icahn School of Medicine at Mount Sinai (US)
Publication Details
- Journal
- JAMA Health Forum
- Published
- 2026-05-22
- DOI
- https://doi.org/10.1001/jamahealthforum.2026.1204
- Primary Topic
- Artificial Intelligence in Healthcare and Education
- Type
- article
- Field-Weighted Citation Impact
- 0.00