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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...
Autores principales: | , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
JMIR Publications
2023
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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 |