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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.

Author information

1
Office of Science and Engineering Laboratories, FDA/CDRH Silver Spring MD 20993 USA.
2
MDPnP Program Department of Anesthesia Massachusetts General Hospital Boston MA 02114 USA.
3
Anakena Solutions, Inc. Woodland Hills CA 91367 USA.
4
DocBox, Inc. Newton MA 02460 USA.

Abstract

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.

KEYWORDS:

Safety; context; interoperability; state

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