Evidence map›Paper›PMID 41519775›Full record

SynthesisBMC medical ethics2026

"First, do no harm" in the digital era: examining the practicality of the European Health Data Space proposal and ethical implications of artificial intelligence: A systematic literature review.

Margarida Mateus, Irina Alho, Ana Luísa Neves, Henrique Lopes, Mónica Correia

Abstract readSystematic Review
In one paragraph

Synthesis in BMC medical ethics, 2026. 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. Article
  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

5 authors.

Margarida MateusFaculty of Medicine, University of Porto, Alameda Prof. Hernâni Monteiro, Porto, 4200-319, Portugal. margaridamateus@icloud.com.
Irina AlhoFaculdade de Medicina, Universidade de Lisboa, Edifício Egas Moniz, Av. Prof. Egas Moniz, Lisboa, 1649-028, Portugal.
Ana Luísa NevesDepartment of Community Medicine, Information and Health Decision Sciences, Faculty of Medicine, RISE-Health, University of Porto, Alameda Prof. Hernâni Monteiro, Porto, 4200-319, Portugal.
Henrique LopesNOVA Center for Global Health, NOVA-IMS, NOVA University Lisbon, Campus de Campolide, Lisboa, 1070-312, Portugal.
Mónica CorreiaDepartment of Community Medicine, Information and Health Decision Sciences, Faculty of Medicine, RISE-Health, University of Porto, Alameda Prof. Hernâni Monteiro, Porto, 4200-319, Portugal.

Funding

National Institute for Health and Care Research (NIHR)
6 · The paper itself

Abstract

backgroundThis systematic review aims to synthesize the current knowledge about the applications and challenges of Artificial Intelligence (AI) technologies in healthcare, while evaluating the extent to which the European Union (EU) AI Act and the European Health Data Space (EHDS) contribute to ensuring responsible, secure, and ethically sound adoption of AI in clinical practice.

methodsThis review adheres to the guidelines set by the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) and has also been registered in PROSPERO. The PubMed®, Web of Science™, Scopus and ScienceDirect® databases were used as scientific search strategy. In addition, records identified through other sources (grey literature) were also assessed for eligibility and included. All studies published between 2020 and 2024 about the application of AI and its regulation and ethical implications, particularly in healthcare, were included. Eligible studies were assessed for potential risk of bias during data extraction and quality evaluation screening.

resultsA total of 76 studies were included. Although AI technologies have several applications in the healthcare sector such as disease diagnosis, treatment, clinical data management, automated surgery, remote health monitoring, elderly patient care and/ or biomedical research, important ethical issues are raised when using AI, namely data privacy, safety, lack of transparency, explainability, trust and potential biases.

conclusionsA proper application and compliance with established ethical principles, and legal regulations such as the EU AI Act and the EHDS are fundamental to ensure a responsible, safe, sustainable and trustworthy use of AI in healthcare.

Indexed as

Artificial IntelligenceDelivery of Health CareConfidentialityDigital HealthEuropean UnionHumansArtificial intelligenceEHDSEthicsEU AI actHealthcareRegulation

Identifiers

PMID41519775
PMCPMC12927267

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
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 Socratic graph.