Standards Committee: EMB Standards Committee, Engineering in Medicine and Biology Society

Standards Committee Chair: Carole C. Carey


Title: Standard for Wireless Diabetes Device Security Assurance

Scope: This standard specifies the security assurance requirements for wireless diabetes devices. These requirements are codified by the use of Protection Profiles and Security Targets in this standard for the following:
* To establish the general requirements for connected diabetes devices that meet the balanced needs for security and clinical application.
* To identify possible and potential threats related to the various components and interfaces of the connected diabetes devices, such as network, storage, software, connected peer devices, and cryptography.
* To define a set of generalized requirements that apply to families of similar devices
* To define a set of specific mandatory requirements, derived from the generalized requirements, corresponding to specific connected diabetes device products and components.
* To outline additional optional functional requirements for manufacturers to consider adding to their products for future development.

In addition to the creation and approval of security requirements documents, this standard also defines the assurance program for evaluating and certifying products against those requirements.


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