Intrinsically Secure, Open, and Safe Control of Essential LayErS (ISOSCELES)

Intrinsically Secure, Open, and Safe Control of Essential LayErS (ISOSCELES) will provide a safe and secure medical device reference architecture that is compliant with FDA approval guidelines and security requirements. The project will develop a reference design including FDA-required documentation as well as an exemplar device to demonstrate the use of the reference design. These will be available to medical device firms for use in their proprietary designs. By using ISOSCELES, these firms will be able to reduce device approval costs while meeting safety and cyber-security requirements. The project’s goal is to maintain a balance between security and safety across a wide range of networked medical devices.

ISOSCELES is part of the Department of Homeland Security Science and Technology Directorate’s (DHS S&T) initiative to enhance cyber physical systems