AI Article Synopsis
- The study highlights that current frameworks for evaluating computerized clinical decision support software (CDSS) are not effectively suited for assessing their value and safety, indicating a need for new approaches.
- Researchers interviewed professionals in Australia to understand the challenges of evaluating CDSS, revealing that existing evaluations mainly overlook the broader social and technical influences on these technologies.
- The authors call for a "living health technology assessment" approach that utilizes real-world evidence to continuously monitor the effects of software changes and their impact on patient safety.
Article 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 current CDSS evaluations have an overly narrow perspective on the risks and benefits of CDSS due to an inability to capture the impact of the technology on the sociotechnical environment. By adopting a static view of the CDSS, these evaluation frameworks are unable to discern how rapidly evolving technologies and a dynamic clinical environment can impact CDSS performance. After software upgrades, CDSS can transition from providing information to specifying diagnoses and treatments. Therefore, it is not clear how CDSS can be monitored continuously when changes in the software can directly affect patient safety.
Conclusion: Our findings emphasize the importance of taking a living health technology assessment approach to the evaluation of digital health technologies that evolve rapidly. There is a role for observational (real-world) evidence to understand the impact of changes to the technology and the sociotechnical environment on CDSS performance.
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| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC11570080 | PMC |
| http://dx.doi.org/10.1017/S0266462324000059 | DOI Listing |
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