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

Our grand vision is to enable the deployment of patient-centric and context-aware networked medical systems in all care environments, ranging from homes and general hospital floors to the operating rooms and intensive care units. These systems would securely connect to a local or remote healthcare network enabling real-time continuous monitoring.  Devices such as injection pumps can also be connected, and securely controlled.  Heterogeneous devices in each care environment would interoperate efficiently, safely, and securely to minimize preventable errors that are often induced unknowingly by human operators. As medical devices move between different care environments or from patient to patient, they would securely discover other devices that they need to interoperate with and verify and run safe, authorized, and compliant operational profiles. Our grand vision also includes the ability to incorporate continuing degrees of autonomous healthcare as part of the virtual healthcare network. The key to realizing this vision is to come up with standardized architectures and interfaces that balance utility, reliability, and safety requirements with those of security and privacy. The ICE standard [3] is definitely a step in the right direction, however, it does not yet explicitly address scalability and security concerns. Security considerations for interconnected and dynamically composable medical systems are critical not only because laws such as the Health Insurance Portability and Accountability Act (HIPAA) [4] mandate it, but also because security attacks can have serious safety consequences for patients. Since interoperable medical systems are dynamically composed, there is an additional need for security mechanisms that allow for automatic verification that system components are being used as intended in the clinical context, and that they have been cleared for safety and effectiveness.  In order to enable the kind of scalability that will be required, advances will be required to ensure that these systems based upon the ICE protocol and built on RTI’s technology foundation can securely and reliably connect to the virtual healthcare network.