What cyber insurance do CROs handling PHI need?

CROs handling patient PHI from clinical sites need cyber insurance with structurally distinct elements from generic professional services cyber.

Explicit HIPAA Business Associate coverage: the cyber form should cover defense costs, settlements, and HHS civil monetary penalties under HITECH arising from Business Associate Agreement obligations.

Dependent business interruption: loss of revenue arising from a sponsor or site cyber event, not just the CRO's own systems. This is increasingly demanded by CTA cyber wording.

Regulatory defense for state privacy laws: multi-state trial activity requires coverage for the strictest applicable state regime - WA MHMDA, Connecticut, Maryland MOPDPA, California CMIA/CCPA, Texas TDPSA.

Voluntary notification: coverage for proactive customer notification when no statutory notice is required. The reputational cost of withheld notification often exceeds the cost of overnotification.

Forensic IR retainer: pre-selected incident response firm on retainer with hours included. Reduces incident-to-investigation time from days to hours.

Tower sizing for mid-market CROs at $5M-$20M revenue: $3M-$10M tower. Larger CROs scale to $10M-$25M.