Articles with tag: «clinical validation»
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2020 № 1 Life cycle of decision support systems as medical technologies
Decision support systems (DSS) in medicine can be classified into reference and intellectual, and the latter, in turn, into
modeling and imitating human reasoning. Modeling systems are based on formalized expert knowledge, and imitating ones are
based on models built by various multidimensional data analysis methods. DSS should be considered as medical technologies,
therefore, after their development, assessing of analytical (technical) and clinical validity should follow, regardless of current
national regulatory documents. Clinical validation have to be based on principles of evidence based medicine and demonstrate
superiority, non-inferiority or equivalence to routine practice. Then a clinical and economic analysis can be carried out in order
to justify the economic feasibility of DSS, and later health technology assessment can be performed.