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

Jane Elizabeth Carolan   1, 2, 3 , BMedSc, MPH ;   John McGonigle   3 , PhD ;   Andrea Dennis   3 , PhD ;   Paula Lorgelly   2 , PhD ;   Amitava Banerjee   1, 4, 5 , MA, MPH, DPhil

1 Institute of Health Informatics, University College London, London, United Kingdom

2 Institute of Epidemiology and Health Care, University College London, London, United Kingdom

3 Perspectum Ltd, Oxford, United Kingdom

4 University College London Hospitals NHS Foundation Trust, London, United Kingdom

5 Barts Health NHS Trust, London, United Kingdom

Corresponding Author:

  • Jane Elizabeth Carolan, BMedSc, MPH
  • Institute of Health Informatics
  • University College London
  • Gower Street
  • London, WC1E 6BT
  • United Kingdom
  • Phone: 44 07464345635
  • Email: j.carolan@ucl.ac.uk