“This Standard is an important step in the collaborative efforts between health delivery organizations and manufacturers to mitigate cybersecurity risk,” added Tim Walsh, Principal Information Security Analyst – CIS Operations, Mayo Clinic, and member of the MDS2 Canvass Group. “Transparent information and speed of getting that information from manufacturers to health delivery organizations are crucial, and this Standard helps foster both.”

The shared responsibility recognized by this Standard is aligned with the position of the U.S. Food and Drug Administration (FDA), which released a preparedness and response “ playbook ” last October to help healthcare delivery organizations address threats to medical device cybersecurity. Recognizing that manufacturers, hospitals, health care providers, cybersecurity researchers and government entities all have roles to play in addressing threats to medical device cybersecurity, the playbook serves as a resource to healthcare delivery organizations as they develop their individual emergency response plans.