Evidence map›Paper›PMID 42370110›Full record

ReviewEULAR rheumatology open2026

Artificial intelligence in healthcare faces regulatory challenges: balancing innovation with human oversight.

Herve Servy, Ben Braithwaite, Uta Kiltz, Astrid van Tubergen, Paul Studenic, Marieke Voshaar, Dieter Wiek, Sonia Tropé, Gerd Burmester, Vincenzo Venerito and 1 more

Abstract readReview
In one paragraph

Review in EULAR rheumatology open, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

11 authors.

Herve ServySanoïa e-Health Services, Aubagne, France.
Ben BraithwaiteSanoïa e-Health Services, Aubagne, France.
Uta KiltzRheumazentrum Ruhrgebiet, Herne, Ruhr-University Bochum, Bochum, Germany.
Astrid van TubergenDepartment of Rheumatology, Maastricht University Medical Centre, Maastricht, The Netherlands.
Paul StudenicDivision of Rheumatology, Department of Internal Medicine 3, Medical University of Vienna, Vienna, Austria.
Marieke VoshaarDepartment of Pharmacy and Department of Research & Innovation, Sint Maartenskliniek, The Netherlands.
Dieter WiekEULAR PARE Patient Research Partner, Zurich, Switzerland.
Sonia TropéAssociation Nationale de Défense contre la polyArthrite Rhumatoïde, Paris, France.
Gerd BurmesterDepartment of Rheumatology and Clinical Immunology, Charité - University Medicine Berlin, Berlin, Germany.
Vincenzo VeneritoRheumatology Unit - Department of Precision and Regenerative Medicine and Ionian Area, University of Bari "Aldo Moro", Bari, Italy.
Laure GossecSorbonne Université, INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique, Team Pepites, Paris, France.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Artificial intelligence (AI) has experienced unprecedented growth in the healthcare sector, promising to revolutionise diagnosis, care, treatment, and biomedical research. This viewpoint article discusses the challenges in this sector and highlights the evolution of the regulatory framework surrounding AI in healthcare and its concrete consequences on innovation. Layered regulatory developments, notably the Medical Device Regulation of 2021 and the AI Act of 2024, have introduced stricter requirements for traceability, clinical performance, risk management, transparency, and human oversight. Although these changes are expected to foster greater trust and accountability among healthcare stakeholders, they also increase the complexity and cost of compliance. These regulatory and organisational challenges represent a turning point for innovative projects in healthcare. Many projects are moving from complex systems toward simpler human-centred tools, whereas others are pushing for collaboration between stakeholders to harmonise existing regulatory frameworks. These combined efforts could lead to more compliant, understandable, and user-friendly solutions for routine care.

Identifiers

PMID42370110
PMCPMC13292489

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.