Cybersecurity features of digital medical devices: an analysis of FDA product summaries.

ABSTRACT:

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 medical devices.

Design

We analysed data from publicly available FDA product summaries to understand the frequency and recent time trends of inclusion of software and cybersecurity content in publicly available product information.

Setting

The full set of regulated medical devices, approved over the years 2002-2016 included in the FDA's 510(k) and premarket approval databases.

Primary and secondary outcome measures

The primary outcome was the share of devices containing sof

SUBMITTER: Stern AD 

PROVIDER: S-EPMC6609083 | biostudies-literature | 2019 Jun

REPOSITORIES: biostudies-literature