Are current clinical studies on artificial intelligence-based medical devices comprehensive enough to support a full health technology assessment? A systematic review.

Journal: Artificial intelligence in medicine
Published Date:

Abstract

INTRODUCTION: Artificial Intelligence-based Medical Devices (AI-based MDs) are experiencing exponential growth in healthcare. This study aimed to investigate whether current studies assessing AI contain the information required for health technology assessment (HTA) by HTA bodies.

Authors

  • Line Farah
    Groupe de Recherche et d'accueil en Droit et Economie de la Santé (GRADES) Department, University Paris-Saclay, Orsay, France; Innovation Center for Medical Devices, Foch Hospital, 40 Rue Worth, 92150 Suresnes, France. Electronic address: line.farah1@gmail.com.
  • Julie Davaze-Schneider
    Pharmacy Department, Georges Pompidou European Hospital, AP-HP, 20 Rue Leblanc, 75015 Paris, France.
  • Tess Martin
    Groupe de Recherche et d'accueil en Droit et Economie de la Santé (GRADES) Department, University Paris-Saclay, Orsay, France; Pharmacy Department, Georges Pompidou European Hospital, AP-HP, 20 Rue Leblanc, 75015 Paris, France.
  • Pierre Nguyen
    Pharmacy Department, Georges Pompidou European Hospital, AP-HP, 20 Rue Leblanc, 75015 Paris, France.
  • Isabelle Borget
    Gustave Roussy Cancer Campus, Villejuif, France.
  • Nicolas Martelli
    Groupe de Recherche et d'accueil en Droit et Economie de la Santé (GRADES) Department, University Paris-Saclay, Orsay, France; Pharmacy Department, Georges Pompidou European Hospital, AP-HP, 20 Rue Leblanc, 75015 Paris, France.