Evidence map›Paper›PMID 40702036›Full record

ArticleScientific reports2025

Data-driven FMEA approach for hazard identification and risk evaluation in digital health.

Hafiz Muhammad Waseem, Saif Ul Islam, Stuart Harrison, Gregory Epiphaniou, Nikolaos Matragkas, Theodoros N Arvanitis, Carsten Maple

Abstract read
In one paragraph

Article in Scientific reports, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Hafiz Muhammad WaseemWarwick Manufacturing Group, University of Warwick, Coventry, CV4 7AL, UK. hm.waseem@warwick.ac.uk.
Saif Ul IslamWarwick Manufacturing Group, University of Warwick, Coventry, CV4 7AL, UK.
Stuart HarrisonETHOS Digital Health Ltd, Exeter, EX4 3SR, UK.
Gregory EpiphaniouWarwick Manufacturing Group, University of Warwick, Coventry, CV4 7AL, UK.
Nikolaos MatragkasCEA List, Université Paris-Saclay, 2 Bd Thomas Gobert, 91120, Palaiseau, France.
Theodoros N ArvanitisDepartment of Electronic, Electrical and Systems Engineering, School of Engineering, University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK.
Carsten MapleWarwick Manufacturing Group, University of Warwick, Coventry, CV4 7AL, UK.

Funding

Health Programme of the European Commission 101095661
6 · The paper itself

Abstract

The increasing digitization of healthcare data systems presents substantial opportunities for enhancing patient care and operational efficiency, while simultaneously introducing critical vulnerabilities such as unauthorized access, inconsistent data formats, and privacy breaches. To systematically address these risks, this study employs Failure Modes and Effects Analysis (FMEA) to identify, evaluate, and prioritize potential hazards within digital healthcare systems. It is among the first to apply the FMEA approach in a comprehensive manner to assess risks across diverse healthcare data categories and modalities, offering a novel perspective on the vulnerabilities inherent in digital health systems. Through a structured methodology, this research investigates risks across three key healthcare data categories, such as clinical, operational, and patient-reported, as well as across five major data modalities including text, image, tabular, audio, and video. Each identified failure mode was assessed through expert consultation and comprehensive literature review, considering its severity, occurrence, and detectability, and subsequently assigned a Risk Priority Number for quantitative prioritization. Key findings highlighted significant risks, including unauthorized access, data corruption, transmission errors, and privacy breaches, that threaten patient safety and system reliability. This study provides actionable recommendations to strengthen data integrity, security, and interoperability, supporting the safe adoption of AI, blockchain, and other emerging technologies in developing secure and resilient digital healthcare systems.

Indexed as

Computer SecurityHealthcare Failure Mode and Effect AnalysisConfidentialityDelivery of Health CareDigital HealthHumansRisk AssessmentCybersecurityDigital healthHealthcare data categoriesHealthcare data modalitiesPatient safetyRisk assessment

Identifiers

PMID40702036
PMCPMC12287468

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.