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Cybersecurity features of digital medical devices: an analysis of FDA product summaries
OBJECTIVES: To more clearly define the landscape of digital medical devices subject to US Food and Drug Administration (FDA) oversight, this analysis leverages publicly available regulatory documents to characterise the prevalence and trends of software and cybersecurity features in regulated medica...
Autores principales: | Stern, Ariel Dora, Gordon, William J, Landman, Adam B, Kramer, Daniel B |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BMJ Publishing Group
2019
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6609083/ https://www.ncbi.nlm.nih.gov/pubmed/31256020 http://dx.doi.org/10.1136/bmjopen-2018-025374 |
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