Medical Device Cybersecurity Lifecycle Management

Abstract —

This document provides an overview of a lifecycle-based approach to managing medical device cybersecurity from the perspective of Medical Device Manufacturers and Healthcare Delivery Organizations. It provides a high-level overview of the four main lifecycle phases and the relationship between them. Further, it provides references to key regulations and standards as well as other leading practices provided in the literature.

In light of the importance of medical device cybersecurity, and in consideration of the growing complexity of our medical device ecosystem on one hand and the increase in the number and sophistication of cyber threats, following a programmatic and repeatable set of security processes is a requirement for any medical device manufacturer and healthcare delivery organization. We hope that this whitepaper lies the foundation for a better understanding of such approach.


Contributors —

This document was developed in cooperation of Healthcare Delivery Organizations (HDOs) and Medical Device Manufacturer (MDMs). Contributors include members of the H-ISAC Medical Device Security Information Sharing Council (MDSISC) as well as IHE PCD working groups.

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