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

Development and Evaluation of Research Methods, Instruments and Tools (796) Adoption and Change Management of eHealth Systems (947) Formative Evaluation of Digital Health Interventions (3421) Artificial Intelligence (2323) Clinical Informatics (1426) Clinical Information and Decision Making (2054) Digital Health, Telehealth and e-Innovation in Clinical Settings (577) AI Applications in Biomedical Engineering (20)

Published on in Vol 8 (2024)

This is a member publication of Imperial College London (Jisc)

Preprints (earlier versions) of this paper are available at https://preprints.jmir.org/preprint/56241, first published .
Clinical Simulation in the Regulation of Software as a Medical Device: An eDelphi Study

Clinical Simulation in the Regulation of Software as a Medical Device: An eDelphi Study

Clinical Simulation in the Regulation of Software as a Medical Device: An eDelphi Study

Authors of this article:

Fiona O'Driscoll1 Author Orcid Image ;   Niki O'Brien1 Author Orcid Image ;   Chaohui Guo2 Author Orcid Image ;   Matthew Prime2 Author Orcid Image ;   Ara Darzi1 Author Orcid Image ;   Saira Ghafur1 Author Orcid Image
Article Authors Cited by (5) Tweetations (5) Metrics

Journals

  1. Ebad S, Alhashmi A, Amara M, Miled A, Saqib M. Artificial Intelligence-Based Software as a Medical Device (AI-SaMD): A Systematic Review. Healthcare 2025;13(7):817 View
  2. Scott I, Shaw T, Slade C, Wan T, Barmanray R, Coorey C, Johnson S, Bell L, Herd M, Sullivan C. Proposing core competencies for physicians in using artificial intelligence tools in clinical practice. Internal Medicine Journal 2025;55(8):1403 View
  3. Ebad S, Zaghdoud R, Ben Miled A. Metrics and Quality Attributes of AI-Based Software as a Medical Device. Engineering, Technology & Applied Science Research 2025;15(4):24644 View
  4. Panzavolta A, Sternini F, Caffarra P, De Vita D, Dodich A, Fonti C, L’Abbate F, Lavorgna L, Laganà V, Marra C, Papagno C, Ferrari Pellegrini F, Stracciari A, Trojano L, Iaquinta T, Pandolfi R, Calore M, Sanzone S, Ravizza A, Cappa S, Cerami C. Accelerating digital innovation in clinical neuropsychology: simulation approach to support medical device certification. Frontiers in Digital Health 2026;7 View
  5. Waldock W, Gilchrist M, Ashrafian H, Darzi A, Franklin B. Enhancing quality of antimicrobial prescribing through ‘Ask Eolas’ (language model): a user-testing and simulation evaluation. npj Antimicrobials and Resistance 2026;4(1) View