"FDA, CISA Advise on Genomic Device Software Vulnerabilities"

A software patch has been made available to prevent cybersecurity threats to patient care, genomic data, and provider networks posed by software vulnerabilities in benchtop and production-scale genomic sequencing instruments manufactured by Illumina. According to a letter to healthcare providers from the US Food and Drug Administration (FDA), malicious actors could take control of the devices, alter the software and patient test results, or compromise a provider's network and exfiltrate protected data. The FDA issued a statement to healthcare providers and laboratory personnel regarding the necessary steps to mitigate cybersecurity risks in Illumina's sequencing instruments. According to a medical advisory from the US Homeland Security Department's Cybersecurity and Infrastructure Security Agency (CISA), the vulnerability affects the universal copy service in various versions of device control and operating software. The FDA noted that some laboratories may be using Illumina genomic sequencing devices for clinical diagnostic applications. In addition to the FDA and CISA, the FBI urges healthcare organizations to remain vigilant regarding medical device cybersecurity. The agency reports that risks associated with out-of-date software and a lack of security features in older hardware in unpatched, active medical devices are being increasingly targeted. In the event of a data compromise, genomic data is especially concerning. This article continues to discuss genomic device software vulnerabilities. 

HealthITNews reports "FDA, CISA Advise on Genomic Device Software Vulnerabilities"