Methodologies and Tools for Securing Medical Device Systems in Integrated Clinical Environments (ICE)

Period of Performance: 09/29/2016 - 02/28/2019

$1000K

Phase 2 SBIR

Recipient Firm

Real-time Innovations
232 East Java Drive Array
Sunnyvale, CA 94089
Firm POC
Principal Investigator

Abstract

The focus of this effort is to enable the deployment of patient-centric and context-aware networked medical systems. Securing medical device communications is a foundational requirement before the Medical Internet of Things can become a reality. Devices and applications need to be provisioned with certified credentials; they need to discover each other through a secure discovery process; and mechanisms should be in place to protect and enforce security policies that specify device and application authorizations for a given setting. Add to these, interoperability, performance, and usability requirements that would have to be met regardless of security. If awarded, we will continue addressing these serious requirements by designing and implementing: a reference implementation of a secured Integrated Clinical Environment (ICE) Network Controller, advanced clinical-level security policies, and advanced execution-time tools. At Harvards MD PnP Lab, our technologies will be evaluated by clinical end-users including clinical caregivers such as doctors and nurses as well as hospital IT, biomedical and clinical engineers, and cyber-medical systems experts. Moreover, we will work with DocBox, a commercial vendor using ICE, and the FDA, to assess vendor and regulatory issues.