Authors:
Jan Sliwa
and
Emmanuel Benoist
Affiliation:
Bern University of Applied Sciences, Switzerland
Keyword(s):
Smart Medical Devices, Interoperability, Translational Medicine, Evidence Based Medicine, Cyber-Physical Systems, Research Roadmap.
Abstract:
The actual clinical use of smart wireless, software-based, mobile medical devices does not meet the recently raised expectations. First, current low level of interoperability calls for setting and enforcing open standards from the device level to the national/global collaboration structure. Second, heterogeneous and
frequently changing devices, operating in various natural, technical and human environments, do not match the classical approval model. In addition to a time-limited set of clinical trials, they need a system of continuous quality monitoring. Third, ad-hoc deployment, without dedicated staff with well defined, novel skill sets is not scalable.
A proper organizational structure is necessary. In this paper we present a modular software structure and a framework of a system supporting both the direct health care and the continuous quality evaluation. We expose the location of interfaces crucial
for assuring multivendor interoperability. We then define a roadmap giving
structure to the necessary development effort. The structure we propose should permit to coordinate the actions of independent teams tackling the immense number of multifaceted and interrelated tasks.
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