Lawmakers Question FDA On Medical Device Cybersecurity Concerns
Top lawmakers on the House Energy and Commerce Committee wrote to US FDA asking what the agency is doing to ensure devices are protected against malicious hackers.
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As the medical device industry enters a brave new world of connected products, cybersecurity vulnerabilities and hacking threats have surfaced, raising many questions. Among them: what protections are available to employees who raise the alarm about cybersecurity problems with a device sold by their company. Attorney Alexis Ronickher addresses this question in this article and in a Medtech Insight podcast interview.
Following months of bickering between St. Jude and Muddy Waters Research, US FDA issued a safety alert for the device-maker's wireless cardiac devices. The agency says there's a risk for malicious cyber-attacks and recommends a software patch to minimize risk.