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

Viewpoints on and Experiences with Digital Technologies in Health (96) Regulatory Issues and Medical Device Certification (8) Artificial Intelligence (2055) E-Health Policy and Health Systems Innovation (330) Adoption and Change Management of eHealth Systems (877) Machine Learning (2029)

Published on in Vol 10, No 1 (2022): January

Preprints (earlier versions) of this paper are available at https://preprints.jmir.org/preprint/34038, first published .
Technology-Enabled, Evidence-Driven, and Patient-Centered: The Way Forward for Regulating Software as a Medical Device

Technology-Enabled, Evidence-Driven, and Patient-Centered: The Way Forward for Regulating Software as a Medical Device

Technology-Enabled, Evidence-Driven, and Patient-Centered: The Way Forward for Regulating Software as a Medical Device

Authors of this article:

Jane Elizabeth Carolan1, 2, 3 Author Orcid Image ;   John McGonigle3 Author Orcid Image ;   Andrea Dennis3 Author Orcid Image ;   Paula Lorgelly2 Author Orcid Image ;   Amitava Banerjee1, 4, 5 Author Orcid Image
Article Authors Cited by (10) Tweetations (4) Metrics

Journals

  1. Locke D, Hoyt C. Companion diagnostic requirements for spatial biology using multiplex immunofluorescence and multispectral imaging. Frontiers in Molecular Biosciences 2023;10 View
  2. 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
  3. O'Driscoll F, O'Brien N, Guo C, Prime M, Darzi A, Ghafur S. Clinical Simulation in the Regulation of Software as a Medical Device: An eDelphi Study. JMIR Formative Research 2024;8:e56241 View
  4. Malik S, Das R, Thongtan T, Thompson K, Dbouk N. AI in Hepatology: Revolutionizing the Diagnosis and Management of Liver Disease. Journal of Clinical Medicine 2024;13(24):7833 View
  5. Faheem F, Haq M, Derhab M, Saeed R, Ahmad U, Kalia J. Integrating Ethical Principles Into the Regulation of AI-Driven Medical Software. Cureus 2025 View
  6. Arima H, Kano S. International Comparative Research of Governance against “unwanted bias” of AI-based Medical Devices. Transactions of the Japanese Society for Artificial Intelligence 2025;40(2):D-O96_1 View
  7. 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
  8. 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
  9. Penteado B, Fornazin M, Castro L, Rachid R, Gonçalves L, Falcão M. The implications of artificial intelligence in clinical healthcare: a scoping review on regulatory challenges up to 2023. Health and Technology 2025;15(6):995 View

Books/Policy Documents

  1. Cesario A, Gorini M, D’Amario D. Digital Medicine Starter Guide. View