Evaluating clinical decision support software (CDSS): challenges for robust evidence generation.

ABSTRACT:

Objectives

Computerized clinical decision support software (CDSS) are digital health technologies that have been traditionally categorized as medical devices. However, the evaluation frameworks for traditional medical devices are not well adapted to assess the value and safety of CDSS. In this study, we identified a range of challenges associated with CDSS evaluation as a medical device and investigated whether and how CDSS are evaluated in Australia.

Methods

Using a qualitative approach, we interviewed 11 professionals involved in the implementation and evaluation of digital health technologies at national and regional levels. Data were thematically analyzed using both data-driven (inductive) and theory-based (deductive) approaches.

Results

Our results suggest that c

SUBMITTER: Laka M 

PROVIDER: S-EPMC11570080 | biostudies-literature | 2024 Feb

REPOSITORIES: biostudies-literature