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

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 View

Books/Policy Documents

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