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Hydra, a Computer-Based Platform for Aiding Clinicians in Cardiovascular Analysis and Diagnosis
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Evaluating clinical decision support software (CDSS): challenges for robust evidence generation.

Mah Laka1, Drew Carter1, Tracy Merlin1

  • 1Adelaide Health Technology Assessment (AHTA), School of Public Health, University of Adelaide, Adelaide, SA, Australia.

International Journal of Technology Assessment in Health Care
|February 8, 2024
PubMed
Summary
This summary is machine-generated.

Current medical device frameworks inadequately assess computerized clinical decision support software (CDSS). A living health technology assessment approach is crucial for evaluating these evolving digital health technologies and ensuring patient safety.

Keywords:
CDSSClinical decision support systemsReal world evidenceassessmentdigital healthevaluationquality of health care

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Area of Science:

  • Digital Health Technologies
  • Health Informatics
  • Medical Device Regulation

Background:

  • Computerized clinical decision support software (CDSS) are digital health technologies often regulated as medical devices.
  • Existing medical device evaluation frameworks struggle to adequately assess the unique value and safety of CDSS.
  • Challenges exist in evaluating CDSS due to their dynamic nature and integration within complex healthcare systems.

Purpose of the Study:

  • To identify challenges in evaluating CDSS as medical devices.
  • To investigate current CDSS evaluation practices in Australia.
  • To explore the suitability of existing frameworks for assessing rapidly evolving digital health technologies.

Main Methods:

  • Qualitative research approach.
  • Interviews conducted with 11 professionals involved in digital health technology implementation and evaluation.
  • Thematic analysis of interview data using inductive and deductive approaches.

Main Results:

  • Current CDSS evaluations adopt a narrow perspective, failing to capture the impact on the sociotechnical environment.
  • Static evaluation frameworks cannot account for how evolving technologies and dynamic clinical settings affect CDSS performance.
  • Continuous monitoring of CDSS is challenging, especially after software updates that can alter functionality and patient safety implications.

Conclusions:

  • Emphasizes the need for a 'living health technology assessment' approach for rapidly evolving digital health technologies like CDSS.
  • Highlights the importance of observational (real-world) evidence to understand the impact of technological and environmental changes on CDSS performance.
  • Suggests a shift towards more adaptive and continuous evaluation methods to ensure the ongoing safety and effectiveness of CDSS.