Evidence map›Paper›PMID 38161692›Full record

ReviewFrontiers in pharmacology2023

Liability for harm caused by AI in healthcare: an overview of the core legal concepts.

Dane Bottomley, Donrich Thaldar

Erratum issuedAbstract readReview
In one paragraph

Review in Frontiers in pharmacology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 26 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing 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

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

  1. AI in Medical Questionnaires: Scoping ReviewJournal of medical Internet research · 2025
    Pooled it
  2. Article
  3. Article
  4. Article
  5. Article
  6. Artificial intelligence in orthopaedics: Enhanced examinations, ambient intelligence and the future of clinical practice.Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA · 2026
    Review
  7. Consensus statement on the application of artificial intelligence in osteoporosis screening and management: perspectives from the Asia-Pacific region.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2026
    Article
  8. AI-powered tools in family medicine: Bridging technology and practice.Journal of family medicine and primary care · 2026
    Article
  9. Article
  10. CostWorld journal of gastrointestinal oncology · 2025
    Article
  11. Review
  12. Review
  13. The Next Frontiers in Preventive and Personalized Healthcare: Artificial Intelligent-powered Solutions.Journal of preventive medicine and public health = Yebang Uihakhoe chi · 2025
    Review
  14. Article
  15. Article
  16. Review
  17. Artificial Intelligence in Dentistry: A Narrative Review of Diagnostic and Therapeutic Applications.Medical science monitor : international medical journal of experimental and clinical research · 2025
    Review
  18. Article
  19. Article
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

2 authors.

Dane BottomleySchool of Law, University of KwaZulu-Natal, Durban, South Africa.
Donrich ThaldarSchool of Law, University of KwaZulu-Natal, Durban, South Africa.

Funding

DS-I Africa - LAWU01MH127690 · NIMH · UNIVERSITY OF KWAZULU-NATAL · PI THALDAR, DONRICH WILLEM · 2021 to 2023
$1.2M
NIMH NIH HHS U01 MH127690
6 · The paper itself

Abstract

The integration of artificial intelligence (AI) into healthcare in Africa presents transformative opportunities but also raises profound legal challenges, especially concerning liability. As AI becomes more autonomous, determining who or what is responsible when things go wrong becomes ambiguous. This article aims to review the legal concepts relevant to the issue of liability for harm caused by AI in healthcare. While some suggest attributing legal personhood to AI as a potential solution, the feasibility of this remains controversial. The principal-agent relationship, where the physician is held responsible for AI decisions, risks reducing the adoption of AI tools due to potential liabilities. Similarly, using product law to establish liability is problematic because of the dynamic learning nature of AI, which deviates from static products. This fluidity complicates traditional definitions of product defects and, by extension, where responsibility lies. Exploring alternatives, risk-based determinations of liability, which focus on potential hazards rather than on specific fault assignments, emerges as a potential pathway. However, these, too, present challenges in assigning accountability. Strict liability has been proposed as another avenue. It can simplify the compensation process for victims by focusing on the harm rather than on the fault. Yet, concerns arise over the economic impact on stakeholders, the potential for unjust reputational damage, and the feasibility of a global application. Instead of approaches based on liability, reconciliation holds much promise to facilitate regulatory sandboxes. In conclusion, while the integration of AI systems into healthcare holds vast potential, it necessitates a re-evaluation of our legal frameworks. The central challenge is how to adapt traditional concepts of liability to the novel and unpredictable nature of AI-or to move away from liability towards reconciliation. Future discussions and research must navigate these complex waters and seek solutions that ensure both progress and protection.

Indexed as

Africaartificial intelligenceharmhealthcareliability

Identifiers

PMID38161692
PMCPMC10755877

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.