Biotech FAQ
Does a biotech company need cyber insurance?
Yes. Biotech operators need cyber insurance to address several distinct exposures that standard cyber forms typically underweight or do not address at all.
IND data protection: unauthorized disclosure of unpublished trial data is a material exposure for any operator with an active IND. Standard cyber forms cover PHI but not necessarily the broader IND data category - specific endorsement wording is required.
Clinical PHI handling under HIPAA: any operator handling PHI from clinical sites or CROs needs explicit Business Associate coverage. Civil monetary penalties under HITECH are insurable but require specific endorsement.
Drug master file (DMF) trade secret coverage: theft or unauthorized disclosure of DMF content is a material biotech exposure that standard cyber forms typically do not address. Trade secret extension wording is required.
Multi-state privacy regime defense: any operator running multi-state clinical trials needs coverage for the strictest applicable state privacy regime (WA MHMDA, Connecticut, Maryland MOPDPA, California CMIA/CCPA, Texas TDPSA).
Tower sizing follows stage: pre-IND $1M-$3M, Phase 1-2 $3M-$5M, IPO-readiness $5M-$15M, commercial $15M-$50M plus.
Related
Biotech coverage review
A specialist will reach out by end of business day.
Request a coverage review