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IEEE J Transl Eng Health Med. 2016 Aug 8;4:2800110. eCollection 2016.

The Importance of State and Context in Safe Interoperable Medical Systems.

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Office of Science and Engineering Laboratories, FDA/CDRH Silver Spring MD 20993 USA.
MDPnP Program Department of Anesthesia Massachusetts General Hospital Boston MA 02114 USA.
Anakena Solutions, Inc. Woodland Hills CA 91367 USA.
DocBox, Inc. Newton MA 02460 USA.


This paper describes why "device state" and "patient context" information are necessary components of device models for safe interoperability. This paper includes a discussion of the importance of describing the roles of devices with respect to interactions (including human user workflows involving devices, and device to device communication) within a system, particularly those intended for use at the point-of-care, and how this role information is communicated. In addition, it describes the importance of clinical scenarios in creating device models for interoperable devices.


Safety; context; interoperability; state

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