Operation security domain

MDCG 2019-16 uses ENISA's security domains to describe the scope of medical device cybersecurity. This domain covers attacks on how a device is operated and used, not only on its data.

ENISA defines Operation Security Domain as "Protection against the intended corruption of procedures or workflows which will have results that were unintended by its owners, designers or users".

MDCG 2019-16 Rev.1, Section 2.1, IT Security, Information Security, Operation Security (ENISA definition)