AI is transforming how biotech and longevity companies interpret biomarkers, blood panels, and genomics — but the moment your AI starts informing diagnosis or clinical decisions, it becomes a regulated medical device. This guide breaks down the regulatory line, FDA/MDR implications, PCCP, cybersecurity requirements, and how to build compliant AI systems without slowing innovation.

Generative AI is transforming biotechnology — from drug discovery to genomics — but it is also creating a new class of cyberbiosecurity risks. As biological data, AI models, and laboratory systems converge, the attack surface expands beyond databases to the algorithms designing the next generation of medicine.

As biology becomes increasingly digital, the line between cybersecurity and biosecurity is disappearing. From genomic databases and lab automation to AI-designed proteins, the digital infrastructure of biology is under threat. This guide explains what cyberbiosecurity is, why it matters for biotech and healthtech, and how organizations can secure genomic data, lab systems, and AI pipelines against emerging cyber risks.