The US Food and Drug Administration has released draft guidance for internet- and network-connected medical devices in response to cybersecurity concerns, updating previous guidance published in 2014.
Data aggregated from electronic health record (EHRs), social media platforms, and other sources could hasten the medical device development process and help regulators monitor safety, according to an assembly of bipartisan experts.
Patient information is increasingly being stored on networked devices, and hackers, likewise, are more intent than ever on getting their hands on that information. The FDA has responded with non-binding guidance for developers.
Concerns about potential security flaws in medical devices and hospital equipment are significant enough to warrant investigation by the US Department of Homeland Security.
The US Food and Drug Administration (FDA) will only exert its considerable oversight powers over mobile health applications and technologies that are likely to pose an adverse effect if used incorrectly, according to final guidance released by the agency on Monday, Sept. 23.