Evidence map›Paper›PMID 36267404›Full record

ArticleFrontiers in genetics2022

The future regulation of artificial intelligence systems in healthcare services and medical research in the European Union.

Janos Meszaros, Jusaku Minari, Isabelle Huys

Abstract read
In one paragraph

Article in Frontiers in genetics, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 31 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed, 1 pooled it
–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

31 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Review
  4. Article
  5. Article
  6. Catching pancreatic cancer early: Are we there yet?Journal of the National Cancer Center · 2026
    Review
  7. Review
  8. The Right to Explanation in AI: In a Lonely Place.Journal of medical Internet research · 2025
    Article
  9. Review
  10. Review
  11. Review
  12. Review
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  14. Article
  15. Review
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  17. Article
  18. Review
  19. AI in Radiology: Navigating Medical Responsibility.Diagnostics (Basel, Switzerland) · 2024
    Review
  20. 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

3 authors.

Janos MeszarosDivision of Clinical Pharmacology and Pharmacotherapy, Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium.
Jusaku MinariUehiro Research Division for iPS Cell Ethics, Center for iPS Cell Research and Application (CiRA), Kyoto University, Kyoto, Japan.
Isabelle HuysDivision of Clinical Pharmacology and Pharmacotherapy, Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Despite its promising future, the application of artificial intelligence (AI) and automated decision-making in healthcare services and medical research faces several legal and ethical hurdles. The European Union (EU) is tackling these issues with the existing legal framework and drafting new regulations, such as the proposed AI Act. The EU General Data Protection Regulation (GDPR) partly regulates AI systems, with rules on processing personal data and protecting data subjects against solely automated decision-making. In healthcare services, (automated) decisions are made more frequently and rapidly. However, medical research focuses on innovation and efficacy, with less direct decisions on individuals. Therefore, the GDPR's restrictions on solely automated decision-making apply mainly to healthcare services, and the rights of patients and research participants may significantly differ. The proposed AI Act introduced a risk-based approach to AI systems based on the principles of ethical AI. We analysed the complex connection between the GDPR and AI Act, highlighting the main issues and finding ways to harmonise the principles of data protection and ethical AI. The proposed AI Act may complement the GDPR in healthcare services and medical research. Although several years may pass before the AI Act comes into force, many of its goals will be realised before that.

Indexed as

AI Actartificial intelligenceautomated decision-makingdata protectionEuropean UnionGDPR–General Data Protection Regulationhealthcaremedical research

Identifiers

PMID36267404
PMCPMC9576843

What OpenQuestion holds

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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.