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Collection and Analysis of Adherence Information for Software as a Medical Device Clinical Trials: Systematic Review

BACKGROUND: The rapid growth of digital health apps has necessitated new regulatory approaches to ensure compliance with safety and effectiveness standards. Nonadherence and heterogeneous user engagement with digital health apps can lead to trial estimates that overestimate or underestimate an app’s...

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Detalles Bibliográficos
Autores principales: Grayek, Emily, Krishnamurti, Tamar, Hu, Lydia, Babich, Olivia, Warren, Katherine, Fischhoff, Baruch
Formato: Online Artículo Texto
Lenguaje:English
Publicado: JMIR Publications 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10687688/
https://www.ncbi.nlm.nih.gov/pubmed/37966871
http://dx.doi.org/10.2196/46237