International – IMDRF New Guidance : Principles and Practices for Medical Device Cybersecurity

The need for effective cybersecurity to ensure medical device functionality and safety has become more important with the increasing use of wireless, Internet, and network-connected devices. Cybersecurity incidents have rendered medical devices and hospital networks inoperable, disrupting the delivery of patient care across healthcare facilities. Such incidents may lead to patient harm because of delays in diagnoses and/or treatment, errors in diagnoses and/or treatment, etc.

Stakeholders within the healthcare sector have a shared responsibility regarding medical device cybersecurity. This guidance assists all these stakeholders in gaining a better understanding of their role in support of proactive cybersecurity that helps protect and secure medical devices in anticipation of future attacks, problems, or events.

Convergence of global healthcare cybersecurity principles and practices is necessary to ensure that patient safety and medical device performance is maintained. To date, however, current disparate regulations across governments lack the global alignment needed to ensure medical device cybersecurity…