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Peer-Reviewed Publication
Therapie2024;79(1):137-150.January 1, 2024Journal Article

Evaluation of digital medical devices: How to take into account the specificities of these solutions?

Anouk Trancart1, Valery-Pierre Riche2, Antoine Disset3, Dorothée Camus1, Anne Josseran4, Pascal Bécache5, Cécile Charle-Maachi6, Laure De Place7, Arthur Denninger8, Jérôme Fabiano9, Charlotte Gourio10, Vincent Vercamer11
1SNITEM, 92400 Courbevoie, France.
2CHU de Nantes, 44000 Nantes, France. Electronic address: valerypierre.riche@chu-nantes.fr.
3Median Technologies, 06080 Valbonne, France.
4Resmed, 94250 Gentilly, France.
5Digital Pharma Lab, 75017 Paris, France.
6MyDiabby Healthcare, 33000 Bordeaux, France.
7Medtronic, 75014 Paris, France.
8UniHA, 69003 Lyon, France.
9EIT Health France, 75013 Paris, France.
10CHU de Caen, 14000 Caen, France.
11Ministère de la Santé et de la Prévention (DNS), 75007 Paris, France.
PubMed DOI

Abstract

The beginning of the 21st century has seen an increasing number of digital medical devices (DMDs) arrive on the European market, bringing major benefits and changes for society. DMDs are unique in that they bring intelligence to the organisation of care, and generate and collect a wealth of real-life data with ultra-fast life cycles. They have specific requirements, particularly in terms of data s…

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