Outset Medical Validates Tablo System to FIPS 140-3

Corsec would like to congratulate our partner, Outset Medical, Inc., on completing the Federal Information Processing Standard Publication 140-3 (FIPS 140-3) validation process on their Tablo Medical Informatics System solution.

To achieve this milestone, Outset partnered with Corsec, completing the validation at a Level 1 as seen in certificate #4812. For more information on the validation and to find additional details on the module’s security policy, visit NIST’s validated modules site.

To learn more about engineering your product to meet Federal and regulated industry security requirements, schedule time to speak to a Corsec engineer.

About FIPS 140

FIPS 140-2 / FIPS 140-3 are a joint effort by the National Institute of Standards and Technology (NIST) in the United States and the Communications Security Establishment Canada (CSEC), under the Canadian government. The Cryptographic Module Validation Program (CMVP), headed by NIST, provides module and algorithm testing for FIPS 140, which applies to Federal agencies using validated cryptographic modules to protect sensitive government data in computer and telecommunication systems. FIPS 140 provides stringent third-party assurance of security claims on any product containing cryptography that may be purchased by a government agency.

FIPS 140 is mandated by law in the U.S. and very strictly enforced in Canada. FIPS 140 has gained worldwide recognition as an important benchmark for third party validations of encryption products of all kinds. A FIPS 140 validation of a product provides end users with a high degree of product security, assurance, and dependability.

The Outset Tablo is a dialysis machine designed from the inside out to offer a better and easier experience for patients and providers. The Outset Tablo machine creates an all-in-one solution that reduces care and infrastructure costs, expands the variety of eligible users, and enables new care delivery models.

The Tablo Hemodialysis System is an automated machine designed to filtrate blood and offers multiple automated maintenance functions. It consists of a water purification system, Tablo cartridge, Non-invasive blood pressure cuff, and a two-way data communication. The Tablo Hemodialysis System is a mobile indoor unit that establishes a two-way data communication that automatically sends treatment data as well as machine performance to the Outset Tablo Cloud. The Tablo machine includes touchscreen guidance that contains animations and conversational instructions.

For two decades Corsec has assisted companies through the IT security certification process for FIPS 140-2 / FIPS 140-3, Common Criteria (CC), CSfC, and the DoD’s APL. We are a privately owned company focused on partnering with organizations worldwide to assist with the process of security certifications and validations. Our certification methodology helps open doors to new markets and increase revenue for clients with products ranging from mobile phones to satellites. Our broad knowledge safeguards against common pitfalls and thwarts delays, translating to a swift and seamless path to certification. Corsec has created the benchmark for providing business leaders with fast, flexible access to industry knowledge on security certifications and validations.

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