Work

Use and Public Reporting of Predetermined Change Control Plans for AI-Enabled Medical Devices

Year: 2026

Type: article

Abstract: 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.

Source: JAMA Health Forum

DOI: 10.1001/jamahealthforum.2026.1204

Authors: Patryk A. Dabek, Florence T. Bourgeois, Ariel D. Stern, Yi Zhu, Alexander O. Everhart

Institutions: Washington University in St. Louis, Boston Children's Hospital, Harvard University, Harvard-MIT Center for Regulatory Science, Hasso Plattner Institute, University of Potsdam, Icahn School of Medicine at Mount Sinai, The University of Texas at Dallas

Language: English

Topic: Healthcare Regulation

Subfield: Health Information Management

Field: Health Professions

Domain: Health Sciences

SDG: Good health and well-being

Open Access status: gold

Estimated APC paid: $5,000

OpenAlex ID: W7162101487

FWCI: 22.16

Cites: 3

Cited by: 3

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