FDA lays out device cybersecurity efforts as feds look to implement Biden executive order

Healthcare DIVE

Greg Slabodkin

Dive Brief:

FDA has warned the Biden administration that recent ransomware attacks on hospitals and health systems “highlight the ungraceful failure” of perimeter-based firewalls and the safety consequences of not separating operational technology (OT) from information technology (IT).

The agency voiced its concerns for the healthcare sector and specifically medical device cybersecurity in a response to a National Institute of Standards and Technology call for position papers to fulfill President Joe Biden’s executive order signed last month, which seeks to bolster U.S. cyber posture amid growing hacker threats.

FDA’s document provides its current OT cybersecurity practices and efforts while laying out its support for NIST’s goal of developing software-related standards and guidelines especially for a Software Bill of Materials, an electronically...

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