Evidence map›Paper›PMID 40657527›Full record

ArticleIEEE journal of translational engineering in health and medicine2025

Letter to the Editor on "From Concept to Clinic: Living Labs and Regulatory Sandboxes for Health System Digitalization and the Integration of Innovative Devices Into Clinical Workflows".

Rebecca Mathias, Anett Schonfelder, Cindy Welzel, Stephen Gilbert

Abstract readLetter
In one paragraph

Article in IEEE journal of translational engineering in health and medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Review
  2. Article
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

4 authors.

Rebecca MathiasElse Kröner Fresenius Center for Digital HealthTUD Dresden University of Technology Dresden 01307 Germany.ORCID 0000-0002-3906-2415
Anett SchonfelderElse Kröner Fresenius Center for Digital HealthTUD Dresden University of Technology Dresden 01307 Germany.ORCID 0009-0007-7064-1611
Cindy WelzelElse Kröner Fresenius Center for Digital HealthTUD Dresden University of Technology Dresden 01307 Germany.ORCID 0000-0002-5710-1975
Stephen GilbertElse Kröner Fresenius Center for Digital HealthTUD Dresden University of Technology Dresden 01307 Germany.ORCID 0000-0002-1997-1689

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Digital health and AI-enabled technologies hold the promise of addressing gaps in healthcare, but balancing rapid market access with the need for safe, functional, and user-centered solutions remains a challenge [1], [2]. Regulatory requirements for device development and market approval demand detailed documentation and predetermined protocols, which can limit the adaptability developers require for iterative improvement and real-world testing with patients and healthcare professionals [1], [3], [4]-an approach that would be highly beneficial for digital and AI-enabled technologies. As a result, key factors like clinical workflow integration, interoperability, and usability with the real range of in-use devices are often overlooked or addressed in a cursory fashion [5].

Indexed as

TelemedicineWorkflowArtificial IntelligenceHumans

Identifiers

PMID40657527
PMCPMC12251058

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.