Industry guide
HIPAA for Laboratories
Guidance for specimen, result, interface, referral, and vendor data flows in laboratory environments.
Reviewed August 2026
Key considerations
- Interfaces and result delivery can create ePHI outside the primary laboratory system.
- Instrument, middleware, support, and cloud dependencies belong in risk analysis.
- Access and integrity controls are important where results affect care decisions.
Starting points
- Inventory interfaces, result destinations, instruments, and support access.
- Review integrity, audit, authentication, and downtime procedures.
- Coordinate vendor incident reporting with covered-entity responsibilities.