FDA Cybersecurity Forum: Manufacturers Explain Coordinated Vulnerability Disclosures

02 Feb 2019

• By Sue Darcey

Device firms well-versed in carrying out coordinated vulnerability disclosures said it is important to secure company executive buy-in and to use the principles laid out in an evolving US FDA guidance on cybersecurity for assistance at a recent FDA cybersecurity meeting.

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Device-makerspointed to advice in draft FDA guidance and the need to obtain the support of key company executives as important steps for assuring successful coordinated vulnerability disclosures for their devices. That was one central theme during the second of a two-day cybersecurity meeting held this week at FDA headquarters in Silver Spring, Md. (Also see "FDA Cybersecurity Forum: Trustworthiness, Threat Modeling Central Issues" - Medtech Insight, 1 February, 2019.)

Coordinated vulnerability disclosure is a process where product-makers work with cybersecurity researchers to find vulnerabilities in any software-based product –...