Accessibility settings

This paper is in the following e-collection/theme issue:

Viewpoints and Perspectives in AI (132) General Original Articles (3291) Epublishing and Open Access (154) Journal Club CATCH-IT Reports* (11)

Published on in Vol 4 (2025)

Preprints (earlier versions) of this paper are available at https://preprints.jmir.org/preprint/76854, first published .
Doctor uses tablet to display 3D holographic heart model in a modern medical lab.

Predetermined Change Control Plans: Guiding Principles for Advancing Safe, Effective, and High-Quality AI-ML Technologies

Predetermined Change Control Plans: Guiding Principles for Advancing Safe, Effective, and High-Quality AI-ML Technologies

Authors of this article:

Eduardo Carvalho1 Author Orcid Image ;   Miguel Mascarenhas2, 3, 4 Author Orcid Image ;   Francisca Pinheiro5 Author Orcid Image ;   Ricardo Correia5 Author Orcid Image ;   Sandra Balseiro6 Author Orcid Image ;   Guilherme Barbosa1 Author Orcid Image ;   Ana Guerra1 Author Orcid Image ;   Dulce Oliveira1 Author Orcid Image ;   Rita Moura1 Author Orcid Image ;   André Martins dos Santos2, 5 Author Orcid Image ;   Nilza Ramião1 Author Orcid Image
Article Authors Cited by (18) Tweetations Metrics

Journals

  1. Almarie B, Gonzalez-Gonzalez L, dos Santos Barbosa L, Lutz A, Grosse U, Fregni F. Machine Learning-Enabled Medical Devices Authorized by the US Food and Drug Administration in 2024: Regulatory Characteristics, Predicate Lineage, and Transparency Reporting. Biomedicines 2025;13(12):3005 View
  2. Naseer F, Naseer U, Yousaf M, Wei J, Gao Y, Li D, Tian X, Liu Y, Li X, Wang F, Luo P. AI-Integrated biosensors: A paradigm shift in multi-cancer detection with enhanced sensitivity and specificity. Sensors and Actuators Reports 2026;11:100439 View
  3. Bailo P, Nittari G, Pesel G, Basello E, Spasari T, Ricci G. Governing Healthcare AI in the Real World: How Fairness, Transparency, and Human Oversight Can Coexist: A Narrative Review. Sci 2026;8(2):36 View
  4. Xu Q, Li Y, Zhu M, Cai Y, Cheng X, Wang W, Ju J, Xu Y, Liu Y, Liu Y. Precision cardiovascular medicine with big data and AI. npj Digital Medicine 2026;9(1) View
  5. Varzideh F, Mone P, Kansakar U, Pande S, Jankauskas S, Santulli G. Artificial Intelligence in Cardiovascular Medicine: Focus on Hypertension. Hypertension 2026;83(6) View
  6. Ebrahimi Warkiani M, Safari B, Moattar M, Hosseinzadeh M. A systematic review of multimodal large language models for medical decision support: Architectures, fusion methods, and real-world applications. Applied Soft Computing 2026;196:115051 View
  7. Hong J. Artificial intelligence for optimizing medical laser procedure parameters: a data pipeline, performance metrics, and safety-first framework. Medical Lasers 2026;15(1):20 View
  8. Dinc R, Ardic N. Immunologically Adaptive Endovascular Devices: Integrating Thrombo-Inflammation, Biomaterials Design, and Artificial Intelligence for Precision Cardiovascular Intervention. International Journal of Molecular Sciences 2026;27(8):3493 View
  9. Nandagopal S. Safety Envelopes and Continuous Assurance for Updates and Postmarket Surveillance in Digital Mental Health Technologies. Journal of Medical Systems 2026;50(1) View
  10. Yang X, Ding S, Ren M, Zhang H, Tao X, Zhang N, Zhang Y, Jiange H, Pan Y, Yao S, Wang L, Ma Y, He Y, Yu S, Yu Y, Lyu A, Zhang B, Zhang G. From selection to design: Reshaping aptamer discovery with artificial intelligence. Chemical Engineering Journal 2026;538:176731 View
  11. Dabek P, Bourgeois F, Stern A, Zhu Y, Everhart A. Use and Public Reporting of Predetermined Change Control Plans for AI-Enabled Medical Devices. JAMA Health Forum 2026;7(5):e261204 View
  12. Lee H, Handler R, Mungle T, Hernandez-Boussard T. Building safer artificial intelligence mental health chatbots: a framework for transparency, evaluation, and shared accountability. Journal of the American Medical Informatics Association 2026 View
  13. Oloko-Oba M, Esenogho E, Aruleba K. From Biosignals to Bedside: A Review of Real-Time Edge Machine Learning for Wearable Health Monitoring. Bioengineering 2026;13(5):559 View
  14. Liu J, Zhang X. Artificial Intelligence-Driven Quantitative HER2 Scoring and Spatial Bystander Effect Modeling for ADC Response Stratification in HER2-Low Breast Cancer. Breast Cancer: Targets and Therapy 2026;Volume 18:1 View
  15. Zhang A, Cecchini M, Bashashati A, Gilks C, Kinloch M, Schaeffer D. Recommendations for Pathologist-Led Deployment of Artificial Intelligence Tools as Laboratory-Developed Tests. Laboratory Investigation 2026;106(7):106131 View
  16. Gumede S, Venter W, Mndebele N, Lalla-Edward S. Harnessing Artificial Intelligence in Health Research in Low- and Middle-income Countries: Potential and Caution. Mayo Clinic Proceedings: Digital Health 2026:100380 View
  17. Liebes-Peer Y, Czeisler S, Broderick R, Vecsler M, Heller Y, Linhart C, Mossel J, Lennerz J. Regulatory science for AI-based software as a medical device in computational pathology and oncology biomarker and drug development. Journal of Pathology Informatics 2026:100681 View
  18. Prabha S, Collaco B, Gomez-Cabello C, Haider S, Genovese A, Fang Z, Wood N, Bagaria S, Tao C, Forte A. Fine-Tuning, Retrieval-Augmented Generation, and Hybrid Large Language Models for Postoperative Decision Support: A Comparative Analysis (Preprint). Journal of Medical Internet Research 2026 View