FDA, CISA advise on genomic device software vulnerabilities

The US Food and Drug Administration (FDA) has issued a statement to healthcare providers and labs over cybersecurity concerns with the universal copy service in several Illumina sequencing instruments, including MiSeqDx, NextSeq 550Dx, iSeq 100, MiniSeq and NextSeq 500. Although Illumina has not reported any exploits, the FDA stated bad actors could potentially alter software and patient test results, or compromise and exfiltrate protected data.