Evidence map›Paper›PMID 40085197›Full record

ReviewInnere Medizin (Heidelberg, Germany)2025

[Focus: artificial intelligence in medicine-Legal aspects of using large language models in clinical practice].

Eva Weicken, Mirja Mittermaier, Thomas Hoeren, Juliana Kliesch, Thomas Wiegand, Martin Witzenrath, Miriam Ballhausen, Christian Karagiannidis, Leif Erik Sander, Matthias I Gröschel

Abstract readEnglish AbstractReview
In one paragraph

Review in Innere Medizin (Heidelberg, Germany), 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. 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

10 authors.

Eva WeickenFraunhofer-Institut für Nachrichtentechnik, Heinrich-Hertz-Institut, Einsteinufer 37, 10587, Berlin, Deutschland.
Mirja MittermaierFächerverbund für Infektiologie, Pneumologie, und Intensivmedizin, Charité - Universitätsmedizin Berlin, Südring 9, 13353, Berlin, Deutschland.
Thomas HoerenInstitut für Informations‑, Telekommunikations- und Medienrecht (ITM), Universität Münster, Leonardo-Campus 9, 48149, Münster, Deutschland.
Juliana KlieschBird & Bird LLP, Am Sandtorkai 50, 20457, Hamburg, Deutschland.
Thomas WiegandFraunhofer-Institut für Nachrichtentechnik, Heinrich-Hertz-Institut, Einsteinufer 37, 10587, Berlin, Deutschland.
Martin WitzenrathFächerverbund für Infektiologie, Pneumologie, und Intensivmedizin, Charité - Universitätsmedizin Berlin, Südring 9, 13353, Berlin, Deutschland.
Miriam BallhausenBird & Bird LLP, Am Sandtorkai 50, 20457, Hamburg, Deutschland.
Christian KaragiannidisLungenklinik Köln-Merheim, Abteilung für Pneumologie und Intensivmedizin, ARDS and ECMO Zentrum, Ostmerheimer Str. 200, 51109, Köln, Deutschland.
Leif Erik SanderFächerverbund für Infektiologie, Pneumologie, und Intensivmedizin, Charité - Universitätsmedizin Berlin, Südring 9, 13353, Berlin, Deutschland.
Matthias I GröschelFächerverbund für Infektiologie, Pneumologie, und Intensivmedizin, Charité - Universitätsmedizin Berlin, Südring 9, 13353, Berlin, Deutschland. matthias.groeschel@charite.de.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe use of artificial intelligence (AI) and natural language processing (NLP) methods in medicine, particularly large language models (LLMs), offers opportunities to advance the healthcare system and patient care in Germany. LLMs have recently gained importance, but their practical application in hospitals and practices has so far been limited. Research and implementation are hampered by a complex legal situation. It is essential to research LLMs in clinical studies in Germany and to develop guidelines for users.

objectiveHow can foundations for the data protection-compliant use of LLMs, particularly cloud-based LLMs, be established in the German healthcare system? The aim of this work is to present the data protection aspects of using cloud-based LLMs in clinical research and patient care in Germany and the European Union (EU); to this end, key statements of a legal opinion on this matter are considered. Insofar as the requirements for use are regulated by state laws (vs. federal laws), the legal situation in Berlin is used as a basis. MATERIALS AND

methodsAs part of a research project, a legal opinion was commissioned to clarify the data protection aspects of the use of LLMs with cloud-based solutions at the Charité - University Hospital Berlin, Germany. Specific questions regarding the processing of personal data were examined.

resultsThe legal framework varies depending on the type of data processing and the relevant federal state (Bundesland). For anonymous data, data protection requirements need not apply. Where personal data is processed, it should be pseudonymized if possible. In the research context, patient consent is usually required to process their personal data, and data processing agreements must be concluded with the providers. Recommendations originating from LLMs must always be reviewed by medical doctors.

conclusionsThe use of cloud-based LLMs is possible as long as data protection requirements are observed. The legal framework is complex and requires transparency from providers. Future developments could increase the potential of AI and particularly LLMs in everyday clinical practice; however, clear legal and ethical guidelines are necessary.

Indexed as

Artificial IntelligenceNatural Language ProcessingComputer SecurityGermanyHumansLarge Language ModelsArtificial intelligence/legal opinionCloud computingData protectionLarge language models/clinical implementationNatural language processing

Identifiers

PMID40085197
PMCPMC11965224

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.