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Cited by 231Artificial Intelligence in Healthcare and EducationMedical Malpractice and Liability IssuesDigitalization, Law, and Regulation

The DOI matches its Crossref record; 40 of the 40 references it cites were found in a registry or an index.

Defining medical liability when artificial intelligence is applied on diagnostic algorithms: a systematic review

Open access
Cestonaro, Clara, Delicati, Arianna, Marcante, Beatrice, Caenazzo, Luciana, Tozzo, Pamela·2023·Frontiers in Medicine
DOI 10.3389/fmed.2023.1305756PMC PMC10711067
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Abstract

Artificial intelligence (AI) in medicine is an increasingly studied and widespread phenomenon, applied in multiple clinical settings. Alongside its many potential advantages, such as easing clinicians’ workload and improving diagnostic accuracy, the use of AI raises ethical and legal concerns, to which there is still no unanimous response. A systematic literature review on medical professional liability related to the use of AI-based diagnostic algorithms was conducted using the public electronic database PubMed selecting studies published from 2020 to 2023. The systematic review was performed according to 2020 PRISMA guidelines. The literature review highlights how the issue of liability in case of AI-related error and patient’s damage has received growing attention in recent years. The application of AI and diagnostic algorithm moreover raises questions about the risks of using unrepresentative populations during the development and about the completeness of information given to the patient. Concerns about the impact on the fiduciary relationship between physician and patient and on the subject of empathy have also been raised. The use of AI in medical field and the application of diagnostic algorithms introduced a revolution in the doctor–patient relationship resulting in multiple possible medico-legal consequences. The regulatory framework on medical liability when AI is applied is therefore inadequate and requires urgent intervention, as there is no single and specific regulation governing the liability of various parties involved in the AI supply chain, nor on end-users. Greater attention should be paid to inherent risk in AI and the consequent need for regulations regarding product safety as well as the maintenance of minimum safety standards through appropriate updates.

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FIGURE 1 PRISMA flow-chart adapted from Page et al. (45).
FIGURE 1 PRISMA flow-chart adapted from Page et al. (45).CC BY · PubMed Central
FIGURE 2 Graphical representation of the pros and cons of using artificial intelligence in diagnostic pathways (created with BioRender.com).
FIGURE 2 Graphical representation of the pros and cons of using artificial intelligence in diagnostic pathways (created with BioRender.com).CC BY · PubMed Central
FIGURE 3 Possible approaches to liability issue (created with BioRender.com).
FIGURE 3 Possible approaches to liability issue (created with BioRender.com).CC BY · PubMed Central

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Research works printed but not linked: 5

  1. 2022, I Sistemi di Intelligenza Artificiale per la Diagnosi Medica.
  2. 2020, Intelligenza Artificiale e Medicina. Aspetti Etici
  3. 2021, The impact of artificial intelligence on the doctor-patient relationship.
  4. 2023, EU Legislation in Progress. New Product Liability Directive.
  5. 2023, EU Legislation in Progress. Artificial Intelligence Liability Directive.

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Metadata

Authors
Cestonaro, C., Delicati, A., Marcante, B., Caenazzo, L., & Tozzo, P.
Affiliations
University of Padua (IT)
Corresponding author
Tozzo, Pamela
ORCID
Venue
Frontiers in Medicine
Publisher
Frontiers Media SA
Published
2023-11-27
Volume
10
Pages
1305756-1305756
ISSN
2296-858X (ISSN-L)
DOI
10.3389/fmed.2023.1305756
PMC
PMC10711067
OpenAlex
W4389055737
Cited by
231
References
40
Citations by year
2026: 118 · 2025: 81 · 2024: 32
FWCI
2.69
Type
journal article
Language
en
Open access
Licence
Locations
  • Frontiers in Medicine (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • Padua Research Archive (University of Padova) (submittedVersion, cc-by)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
Topics
  • Health Sciences › Medicine › Health Informatics › Artificial Intelligence in Healthcare and Education
  • Social Sciences › Law › Medical Malpractice and Liability Issues
  • Social Sciences › Law › Digitalization, Law, and Regulation
Keywords
medical liability, artificial intelligence in healthcare, patient harm, physician-patient relationship, fiduciary relationship, empathy, product safety standards, algorithmic bias, informed consent, AI ethics

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