Nick Mankovich, Philips Healthcare

Brian Fitzgerald, FDA Center for Devices and Radiological Health

Full Article 

This paper discusses the nature and use of security risk disclosures under IEC 80001-1 with an emphasis on the use of common terminology to group together and discuss the security capabilities and/or requirements for medical devices that are risk managed during the entire life cycle of connection to the medical IT network.

This article was originally published in the fall 2011 issue of Horizons, a series of special-topic magazines from the Association for the Advancement of Medical Instrumentation, www.aami.org. Posted with permission from AAMI. Any other distribution of AAMI-copyrighted material requires written permission from AAMI.