Methodology for Assessment of Medical IT-based Systems

Methodology for Assessment of Medical IT-based Systems

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The present study has a broader scope than qjustq knowledge-based systems' development: to provide a user-oriented assessment methodology for the development of medical IT-based solutions in general and with the following qualities: 1) It covers the entire system life-cycle; 2) the target users of the assessment methodology are users from the application domain of the future systems; 3) it enables formative assessment during the development and implementation of IT-based systems; 4) it is applicable independently of the system development approach and; 5) it provides users of IT-based solution with information enabling them to decide whether or not to take the system into real-life clinical usage. The study is formulated in a sequence of steps attempting a falsification based on pre-defined criteria, followed by a refinement of the recognised failure aspects and a renewed attempt, ending with a final conclusion. The four steps applied and their respective outcomes are as follows. First, - as a pilot application - a methodology for assessment of knowledge-based systems was developed and experimented with. Second, this methodology was refined and extended for application at the development of other types of IT-based systems. Third, a full-scale prospective casestudy was applied by independent users to gain experience with the methodology. At last, the lessons learned were incorporated and synthesised into the final version of the dynamic assessment methodology.8.2 Assessment Methods Applied in ISAR 8.2.1 Method for Technical Verification Major problems were revealed for the Technical Verification, although the ... of reference? b) The approach used for Technical Verification (and Ergonomic Assessment) may be ideal for in-house developments or other situations, ... This requirement is not always realistic, or may be achievable only in terms of a user manual.

Title:Methodology for Assessment of Medical IT-based Systems
Author: Jytte Brender
Publisher:IOS Press - 1997-01-01

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