Evidence map›Paper›PMID 39191937›Full record

ArticleNPJ digital medicine2024

Mapping the regulatory landscape for artificial intelligence in health within the European Union.

Jelena Schmidt, Nienke M Schutte, Stefan Buttigieg, David Novillo-Ortiz, Eric Sutherland, Michael Anderson, Bart de Witte, Michael Peolsson, Brigid Unim, Milena Pavlova and 3 more

Abstract read
In one paragraph

Article in NPJ digital medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 57 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
57citing papers in PubMed, 2 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

57 citing papers in PubMed, 2 syntheses or guidelines pooled it.

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  8. Regulatory science for AI-basedJournal of pathology informatics · 2026
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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

13 authors.

Jelena SchmidtDepartment of International Health, Care and Public Health Research Institute (CAPHRI), Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, Netherlands.
Nienke M SchutteInnovation in Health Information Systems Unit, SD Data Governance, Sciensano, Brussels, Belgium.
Stefan ButtigiegMinistry for Health and Active Ageing, Valletta, Malta.ORCID http://orcid.org/0000-0002-9969-6874
David Novillo-OrtizDivision of Country Health Policies and Systems, World Health Organization Regional Office for Europe, Copenhagen, Denmark.ORCID http://orcid.org/0000-0001-9756-0984
Eric SutherlandIndependent Researcher, Paris, France.
Michael AndersonLSE Health, Department of Health Policy, London School of Economics and Political Science, London, United Kingdom.
Bart de WitteHippo AI Foundation, Berlin, Germany.
Michael PeolssonSwedish eHealth Agency, Stockholm, Sweden.
Brigid UnimDepartment of Cardiovascular, Endocrine-Metabolic Diseases and Aging, National Institute of Health, Rome, Italy.ORCID http://orcid.org/0000-0002-6522-9098
Milena PavlovaDepartment of Health Services Research, Care and Public Health Research Institute (CAPHRI), Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, Netherlands.
Ariel Dora SternHarvard Business School Technology and Operations Management, Boston, MS, USA.ORCID http://orcid.org/0000-0002-3586-1041
Elias MossialosLSE Health, Department of Health Policy, London School of Economics and Political Science, London, United Kingdom.ORCID http://orcid.org/0000-0001-8664-9297
Robin van KesselDepartment of International Health, Care and Public Health Research Institute (CAPHRI), Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, Netherlands. r.van-kessel@lse.ac.uk.ORCID http://orcid.org/0000-0001-6309-6343

Funding

World Health Organization 001
6 · The paper itself

Abstract

Regulatory frameworks for artificial intelligence (AI) are needed to mitigate risks while ensuring the ethical, secure, and effective implementation of AI technology in healthcare and population health. In this article, we present a synthesis of 141 binding policies applicable to AI in healthcare and population health in the EU and 10 European countries. The EU AI Act sets the overall regulatory framework for AI, while other legislations set social, health, and human rights standards, address the safety of technologies and the implementation of innovation, and ensure the protection and safe use of data. Regulation specifically pertaining to AI is still nascent and scarce, though a combination of data, technology, innovation, and health and human rights policy has already formed a baseline regulatory framework for AI in health. Future work should explore specific regulatory challenges, especially with respect to AI medical devices, data protection, and data enablement.

Identifiers

PMID39191937
PMCPMC11350181

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.