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

Artificial Intelligence (1371) Viewpoints and Perspectives (514) Machine Learning (1465) Development of Novel Medical Devices and Innovations for Existing Devices (80) E-Health Policy and Health Systems Innovation (230) Policy and Policy Proposals (121)

Published on in Vol 23, No 10 (2021): October

Preprints (earlier versions) of this paper are available at https://preprints.jmir.org/preprint/30545, first published .
Algorithm Change Protocols in the Regulation of Adaptive Machine Learning–Based Medical Devices

Algorithm Change Protocols in the Regulation of Adaptive Machine Learning–Based Medical Devices

Algorithm Change Protocols in the Regulation of Adaptive Machine Learning–Based Medical Devices

Authors of this article:

Stephen Gilbert1, 2 Author Orcid Image ;   Matthew Fenech1, 3 Author Orcid Image ;   Martin Hirsch1, 4 Author Orcid Image ;   Shubhanan Upadhyay1 Author Orcid Image ;   Andrea Biasiucci5, 6 Author Orcid Image ;   Johannes Starlinger7 Author Orcid Image
Article Authors Cited by (32) Tweetations (6) Metrics

Journals

  1. Wellnhofer E. Real-World and Regulatory Perspectives of Artificial Intelligence in Cardiovascular Imaging. Frontiers in Cardiovascular Medicine 2022;9 View
  2. Hughes J, Woo K, Keizer R, Goswami S. Clinical Decision Support for Precision Dosing: Opportunities for Enhanced Equity and Inclusion in Health Care. Clinical Pharmacology & Therapeutics 2023;113(3):565 View
  3. Gilbert S, Gabriel H, Pankow A, Biskup S, Wagner A. Was ist gesichert in der Diagnostik von autoinflammatorischen Fiebererkrankungen?. Der Internist 2021;62(12):1290 View
  4. Goergen S, Frazer H, Reddy S. Quality use of artificial intelligence in medical imaging: What do radiologists need to know?. Journal of Medical Imaging and Radiation Oncology 2022;66(2):225 View
  5. Carolan J, McGonigle J, Dennis A, Lorgelly P, Banerjee A. Technology-Enabled, Evidence-Driven, and Patient-Centered: The Way Forward for Regulating Software as a Medical Device. JMIR Medical Informatics 2022;10(1):e34038 View
  6. Rowan N, Kremer T, McDonnell G. A review of Spaulding's classification system for effective cleaning, disinfection and sterilization of reusable medical devices: Viewed through a modern-day lens that will inform and enable future sustainability. Science of The Total Environment 2023;878:162976 View
  7. Gilbert S, Anderson S, Daumer M, Li P, Melvin T, Williams R. Learning From Experience and Finding the Right Balance in the Governance of Artificial Intelligence and Digital Health Technologies. Journal of Medical Internet Research 2023;25:e43682 View
  8. Wardi G, Owens R, Josef C, Malhotra A, Longhurst C, Nemati S. Bringing the Promise of Artificial Intelligence to Critical Care: What the Experience With Sepsis Analytics Can Teach Us. Critical Care Medicine 2023;51(8):985 View
  9. Combi C, Facelli J, Haddawy P, Holmes J, Koch S, Liu H, Meyer J, Peleg M, Pozzi G, Stiglic G, Veltri P, Yang C. The IHI Rochester Report 2022 on Healthcare Informatics Research: Resuming After the CoViD-19. Journal of Healthcare Informatics Research 2023;7(2):169 View
  10. Raja M, Loughran R, Caffery F. A review of applications of artificial intelligence in cardiorespiratory rehabilitation. Informatics in Medicine Unlocked 2023;41:101327 View
  11. Gilbert S, Pimenta A, Stratton-Powell A, Welzel C, Melvin T. Continuous Improvement of Digital Health Applications Linked to Real-World Performance Monitoring: Safe Moving Targets?. Mayo Clinic Proceedings: Digital Health 2023;1(3):276 View
  12. Wall D, Liu-Mayo S, Salomon C, Shannon J, Taraman S. Optimizing a de novo artificial intelligence-based medical device under a predetermined change control plan: Improved ability to detect or rule out pediatric autism. Intelligence-Based Medicine 2023;8:100102 View
  13. Zhu J, Tan W, Zhan X, Lu Q, Liang T, JieJiang , Li H, Zhou C, Wu S, Chen T, Yao Y, Liao S, Yu C, Chen L, Liu C. Development and validation of a machine learning-based nomogram for predicting HLA-B27 expression. BMC Immunology 2023;24(1) View
  14. Musgrove D, Radtke A, Haddad T. Discordant pair analysis for sample efficient model evaluation. Scientific Reports 2023;13(1) View
  15. Welzel C, Cotte F, Wekenborg M, Vasey B, McCulloch P, Gilbert S. Holistic Human-Serving Digitization of Health Care Needs Integrated Automated System-Level Assessment Tools. Journal of Medical Internet Research 2023;25:e50158 View
  16. Derraz B, Breda G, Kaempf C, Baenke F, Cotte F, Reiche K, Köhl U, Kather J, Eskenazy D, Gilbert S. New regulatory thinking is needed for AI-based personalised drug and cell therapies in precision oncology. npj Precision Oncology 2024;8(1) View
  17. Lee B, Naftalovich R, Ali S, Chaudhry F, Tewfik G. Liability Exposure of Clinicians in Artificial Intelligence–Driven Healthcare. Biomedical Instrumentation & Technology 2024;58(2):39 View
  18. Muniappan S, Jeyaraman M, Yadav S, Jeyaraman N, Muthu S, Ramasubramanian S, Patro B. Applications of Blockchain-Based Technology for Healthcare Devices Post-market Surveillance. Cureus 2024 View
  19. Svempe L. Exploring Impediments Imposed by the Medical Device Regulation EU 2017/745 on Software as a Medical Device. JMIR Medical Informatics 2024;12:e58080 View
  20. DeCamp M, Kao D. Adaptive Machine Learning as Research: Does the Cure Fit the Disease?. The American Journal of Bioethics 2024;24(10):70 View
  21. Kaladharan S, Manayath D, Gopalakrishnan R. Regulatory Challenges in AI/ML-Enabled Medical Devices: A Scoping Review and Conceptual Framework. Journal of Medical Devices 2024;18(4) View
  22. Muralidharan V, Adewale B, Huang C, Nta M, Ademiju P, Pathmarajah P, Hang M, Adesanya O, Abdullateef R, Babatunde A, Ajibade A, Onyeka S, Cai Z, Daneshjou R, Olatunji T. A scoping review of reporting gaps in FDA-approved AI medical devices. npj Digital Medicine 2024;7(1) View
  23. Chuco Aguilar V. Avances y desafíos en la regulación del software basado en Inteligencia Artificial como Dispositivo Médico. Iberoamerican Business Journal 2024;7(2):62 View

Books/Policy Documents

  1. Manjula Devi C, Dharani I, Srinivasan A. Predicting Pregnancy Complications Through Artificial Intelligence and Machine Learning. View
  2. Aquino Y, Shih P, Bosward R. International Encyclopedia of Public Health. View
  3. Gilbert S. Digital Respiratory Healthcare. View
  4. Saran V, Chennappan R. Multidisciplinary Applications of AI Robotics and Autonomous Systems. View
  5. Ambiha A, S S, Kokilamani M. Smart Healthcare and Machine Learning. View
  6. Shobeiry S. Artificial Intelligence in the Operation and Control of Digitalized Power Systems. View