FDA, CISA advise on genomic device software vulnerabilities

The U.S. Food and Drug Administration (FDA) has warned healthcare providers about a cybersecurity vulnerability in Illumina’s sequencing instruments. The vulnerability could allow bad actors to compromise the devices, alter software and patient test results, or access protected data. The FDA is urging device owners to review recall notices, install patches, and contact Illumina for support. Genomic data breaches are a significant concern due to the potential risks to patient safety, data confidentiality, and care delivery. The FBI is also urging healthcare organizations to address medical device cybersecurity.