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Viewpoints on and Experiences with Digital Technologies in Health (295) E-Health Policy and Health Systems Innovation (540) Adoption and Change Management of eHealth Systems (1134) Machine Learning (3272) Artificial Intelligence (4894) Regulatory Issues and Medical Device Certification (13)

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 .
Medical technology: Stethoscope, tablet with vital signs, laptop, and medical history form.

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 (17) 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
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  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
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  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
  10. Tabassum A, Fatima M, Fathima S, Ameer S, Fatima Z, Fatima N, Angelina P, Battula A, Rezvani M, Das P, Bhattacharya D, Atanase L. Beyond the Lab: Ethical, Legal and Social Implications in Health Biotechnology. BIO Web of Conferences 2025;204:01003 View
  11. Alves R, Nascimento O, Tavares F, Seixas J, Trajman A. Incremental Continual Learning for Tuberculosis Detection Based on Chest X-Ray Images and Synthetic Data Generated by Adversarial Networks. IEEE Access 2026;14:79960 View
  12. Xilong Z. From pulse to pixel: artificial intelligence-enhanced pulse diagnosis for cardiovascular diseases. Digital Chinese Medicine 2026;9(2):161 View
  13. Kandala A, Rai A, Penumaka R, Wilcox N, Lefebvre B, Bravo P, Fradley M. Radiomics for the Detection and Prediction of Cancer Therapy-Related Cardiotoxicity. JACC: Advances 2026;5(8):102942 View
  14. Yu J, Zhang J, Miyashita S, Sengoku S. Innovation trajectory of Software as a Medical Device: Evidence from the US FDA-approved products. DIGITAL HEALTH 2026;12 View
  15. Dong Y, Jiang P, Zhou X. Artificial intelligence-based software as a medical device: regulatory evolution toward continuous oversight. Medical Review 2026 View
  16. Danilczuk D, Półchłopek S, Szpanelewski K, Kołodziej R, Kołodziej A, Lulek S, Klecha J, Kucab E, Dziki K, Kula I, Ciemięga J, Adamiec W. THE POCKET LABORATORY IN PRACTICE: A SOCIO-TECHNICAL REVIEW OF SMARTPHONE-BASED POINT-OF-CARE DIAGNOSTICS IN LMICs. International Journal of Innovative Technologies in Social Science 2026;5(2(50)) View

Books/Policy Documents

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