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What medical device manufacturers need to know about the Cyberspace Solarium Commission’s Final Report and the reference to Software Bill Of Materials (SBOM)

Are you prepared for US cybersecurity legislation that could result in lawsuits and fines if not implemented according to prescription? Did you know that the 2019 National Defense Authorization Act chartered the US Cyberspace Solarium Commission (CSC) to define such cybersecurity policies and legislation? As a stakeholder in the healthcare industry, you should be aware of the CSC final report and the possible implications. This overview provides a brief summary of the report’s discussion …

Vigilant Ops Announces Availability of InSight Platform V1

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On May 11 2020, Vigilant Ops, an innovator in medical device cybersecurity, announced the immediate availability of InSight Platform V1, enabling medical device manufacturers to begin automatically generating, updating, and monitoring device software bills of materials (SBOMs). FDA’s draft version of their premarket guidance refers to these as CBOMs (Cybersecurity Bill of Materials)​1​, given the original desire to include hardware components in device bills of materials. Since the original d…

Incident Response Plan Cyber Simulation Exercise

Executing effective simulation exercises and rigorously testing the organization’s incident response capability has been proven to positively impact the organization’s ability to recover. There is sufficient evidence to show that organizations can reduce the cost of a breach by more than 30%​1​ simply by having an Incident Response (IR) team following a thoroughly tested IR plan. In this document, we will explore the fundamentals of testing an organization’s IR plan using cyber simulation exe…

Three Reasons You Need to Use AI Software for Generating and Maintaining Medical Device SBOMs/CBOMs

What if you found out there was a way to interrogate medical devices and automatically generate cybersecurity bill of materials (CBOM)? Although you may initially miss the manual effort, you and fellow MDMs can now use artificial intelligence to begin automatically generating, maintaining, and monitoring medical device SBOMs/CBOMs. The Solution Utilizing the cloud, the Vigilant Ops InSight platform introduces a solution for generating, updating, and monitoring device software bills of …

The Impact of COVID-19 on Medical Device Cybersecurity

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Hackers are opportunists. Not long after the first case of COVID-19, possibly as early as November 17, 2019, hackers, bad actors and cyberpunks sensed an opportunity. They could be heard echoing the battle cry to never let a crisis go to waste! Long before you heard of Coronavirus, there were plans being formulated to leverage the FUD (Fear, Uncertainty and Doubt) that would inevitably follow. Since the initial outbreaks of COVID-19 in January 2020 over 16,000 new coronavirus-related domains …

The Importance of an Incident Response Plan

Medical device manufacturers must follow various regulations for their fielded devices, generally referred to as postmarket requirements, which include tracking and reporting malfunctions and injuries. Most have formal procedures and processes in place to satisfy these requirements. However, security incidents impact medical device manufacturers, and their customers, in ways that go beyond the requirements satisfied by existing procedures. Effective response to security incidents requires …