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Regulatory Insights From 27 Years of Artificial Intelligence/Machine Learning–Enabled Medical Device Recalls in the United States: Implications for Future Governance

Regulatory Insights From 27 Years of Artificial Intelligence/Machine Learning–Enabled Medical Device Recalls in the United States: Implications for Future Governance

The Guidance of Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C mentions referencing 21 CFR 820.100(a)(2), which requires procedures for implementing corrections or preventive actions to include an investigation of the causes for nonconformities related to the product, processes, and quality systems.

Wei-Pin Chen, Wei-Guang Teng, C Benson Kuo, Yu-Jui Yen, Jian-Yu Lian, Matthew Sing, Peng-Ting Chen

JMIR Med Inform 2025;13:e67552

Developing and Integrating Digital Sources in an Accessible and Sustainable Online Platform for Adolescents and Young Adult Cancer Survivors: Collaborative Design Approach

Developing and Integrating Digital Sources in an Accessible and Sustainable Online Platform for Adolescents and Young Adult Cancer Survivors: Collaborative Design Approach

These personas represent adolescent and young adult cancer survivors and their relatives, including different sexes (male and female), tumor types (Hodgkin lymphoma, lung cancer, leukemia, and breast cancer), different ages (eg, 21, 23, 30, and 36 y), different times since diagnosis (currently under treatment, diagnosed 2 y ago), and varying needs on the platform (such as reading blogs, connecting with peers, accessing information files, using health applications).

Carla Vlooswijk, Sophia HE Sleeman, Jonas Pluis, Daphne Bakker, Lisanne de Groot, Eveliene Manten, Peter Heine, Olga Husson, Mies C van Eenbergen, Pieter Vandekerckhove

JMIR Form Res 2025;9:e60897

Networked Behaviors Associated With a Large-Scale Secure Messaging Network: Cross-Sectional Secondary Data Analysis

Networked Behaviors Associated With a Large-Scale Secure Messaging Network: Cross-Sectional Secondary Data Analysis

Significance levels for pairwise comparisons with Bonferroni adjustment are indicated by letters a through c, as detailed in the footnote. a Indicates significant difference (adjusted P b Indicates significant difference (adjusted P c Indicates significant difference (adjusted P Heatmap for hierarchical clustering of health care professionals based on node-level metrics. The color bar depicts the magnitude of standardized values of the dataset, and the color range is computed with robust quantiles.

Laura Rosa Baratta, Linlin Xia, Daphne Lew, Elise Eiden, Y Jasmine Wu, Noshir Contractor, Bruce L Lambert, Sunny S Lou, Thomas Kannampallil

JMIR Med Inform 2025;13:e66544

Association Between COVID-19 During Pregnancy and Preterm Birth by Trimester of Infection: Retrospective Cohort Study Using Large-Scale Social Media Data

Association Between COVID-19 During Pregnancy and Preterm Birth by Trimester of Infection: Retrospective Cohort Study Using Large-Scale Social Media Data

To assess the association between COVID-19 infection during pregnancy and preterm birth, we used the frequencies of these 2 categorical variables in a 2 × 2 contingency table to calculate the odds ratio (OR) with a 95% CI, where OR = (A/B) / (C/D) (Table 2).

Ari Z Klein, Shriya Kunatharaju, Su Golder, Lisa D Levine, Jane C Figueiredo, Graciela Gonzalez-Hernandez

J Med Internet Res 2025;27:e66097