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Peer-reviewedCC BY 4.0PLOS Digital Health

When the algorithm passes the test but fails the patient

  1. 1Makerere University, School of Public Health, Kampala, Uganda

Abstract

Tens of thousands of AI diagnostic tools have been authorised for clinical diagnosis worldwide, justified primarily by benchmark accuracy (performance on a fixed, curated test dataset), a number that says little about what the tool will do at the bedside. The field rests on three flawed foundations: datasets that do not reflect the populations served, development pipelines that exclude clinicians, and regulatory pathways that mistake on-paper accuracy for evidence of benefit. Closing the gap requires global coordination and the political will to treat clinical validation as a prerequisite rather than an afterthought.

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BibTeX
@article{mirugwe2026when,
  title = {{When the algorithm passes the test but fails the patient}},
  author = {Alex Mirugwe},
  journal = {PLOS Digital Health},
  year = {2026},
  month = oct,
  doi = {10.1371/journal.pdig.0001774},
  url = {https://journals.plos.org/digitalhealth/article?id=10.1371/journal.pdig.0001774},
  note = {CC BY 4.0},
}
RIS
TY  - JOUR
TI  - When the algorithm passes the test but fails the patient
AU  - Alex Mirugwe
PY  - 2026
DA  - 2026/10/06
JO  - PLOS Digital Health
DO  - 10.1371/journal.pdig.0001774
UR  - https://journals.plos.org/digitalhealth/article?id=10.1371/journal.pdig.0001774
AB  - Tens of thousands of AI diagnostic tools have been authorised for clinical diagnosis worldwide, justified primarily by benchmark accuracy (performance on a fixed, curated test dataset), a number that says little about what the tool will do at the bedside. The field rests on three flawed foundations: datasets that do not reflect the populations served, development pipelines that exclude clinicians, and regulatory pathways that mistake on-paper accuracy for evidence of benefit. Closing the gap requires global coordination and the political will to treat clinical validation as a prerequisite rather than an afterthought.
SN  - 2767-3170
ER  -