Use of Direct for the Secure Transmission of Laboratory Test Results
Direct: A simple, secure, scalable, standards based way to send authenticated, encrypted health information directly to known,
trusted recipients over the Internet.
• Clinical Laboratory Improvement Amendments of 1988 (CLIA) Requirements: The laboratory must have an adequate manual or electronic
system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point
of data entry (whether interfaced or entered manually) to final report destination, in a timely manner (42 CFR §493.1291(a)).
• CLIA guidance: The Centers for Medicare & Medicaid Services (CMS) considers that laboratories utilizing the Direct transport
protocols and fully supporting the Direct Implementation Guide for Delivery Notification requirements would meet the CLIA
regulations for an adequate electronic system for sending laboratory test results to the final report destination as specified
in 42 CFR §493.1291(a).