AI and Liability in Medicine: The Case of Assistive-Diagnostic AI

Rimkutė, Deimantė

doi:10.2478/bjlp-2023-0013

Abstract

As the prevalence of assistive-diagnostic artificial intelligence (AI) grows, so too will the legal controversies surrounding its use continue to grow. Consequently, determining liability in cases where patients experience harm due to the use of assistive-diagnostic AI in personal healthcare services requires a re-evaluation of existing civil liability regulations. This article proposes a framework for addressing liability in these situations by exploring medical malpractice, organisational negligence by healthcare institutions, and producer liability.

References

Abràmoff, M. D. et al. “Pivotal Trial of an Autonomous AI-Based Diagnostic System for Detection of Diabetic Retinopathy in Primary Care Offices.” npj Digital Medicine 1 (2018).
Search in Google Scholar Back to article
Aftergood. S. “Jason: Artificial Intelligence for Health Care.” Federation of American Scientists (1 January 2018) (accessed 2 February, 2023) // https://fas.org/blogs/secrecy/2018/02/ai-health-care/.
Search in Google Scholar Back to article
Ahuja, A. S. “The Impact of Artificial Intelligence in Medicine on the Future Role of the Physician.” PeerJ. 7 (2019).
Search in Google Scholar Back to article
Bal, S. B. “An Introduction to Medical Malpractice in the United States.” Clinical Orthopaedics & Related Research 467 (2009).
Search in Google Scholar Back to article
Behrendt, P. and Moelle, H. “Product Liability – 5 Particularities in Germany.” Taylor Wessing (28 January 2020) (accessed February, 2023) // https://www.taylor-wessing.com/de/insights-and-events/insights/2018/10/product-liability-5-particularities-in-germany; “Country Comparative Guides: France: Product Liability.” Country Comparative Guides | The Legal 500 (accessed 3 February, 2023) // https://www.legal500.com/guides/chapter/france-product-liability/.
Search in Google Scholar Back to article
Challen, R. et al. “Artificial Intelligence, Bias and Clinical Safety.” BMJ Quality & Safety 28 (2019).
Search in Google Scholar Back to article
Esteva, A. et al. “Dermatologist-Level Classification of Skin Cancer with Deep Neural Networks.” Nature 542 (2017).
Search in Google Scholar Back to article
Fairgrieve, D. Product Liability in Comparative Perspective (Cambridge University Press, 2005).
Search in Google Scholar Back to article
Ferrara, S. D., Boscolo-Berto, R. and Viel, G. Malpractice and Medical Liability European State of the Art and Guidelines (Springer Berlin, 2015).
Search in Google Scholar Back to article
Greenfield, D. “Artificial Intelligence in Medicine: Applications, Implications, and Limitations.” (Accessed 2 January, 2023) // https://sitn.hms.harvard.edu/flash/2019/artificial-intelligence-in-medicine-applications-implications-and-limitations/.
Search in Google Scholar Back to article
Griffin, F. “Artificial Intelligence and Liability.” Health Care Health Matrix 31 (2021).
Search in Google Scholar Back to article
Hacker, P. “Review of The European AI Liability Directives – Critique of a Half-Hearted Approach and Lessons for the Future.” Working document (2022).
Search in Google Scholar Back to article
Herring, J. Medical Law (Oxford University Press, 2011).
Search in Google Scholar Back to article
Hoffman, Sharona anf Podgurski, Andy. “E-Health Hazards: Provider Liability and Electronic Health Record Systems.” Berkeley Tech. LJ 24 (2009): 1523, 1528.
Search in Google Scholar Back to article
Hurwitz, B. Clinical Guidelines, and the Law: Negligence, Discretion, and Judgment (Radcliffe Medical Press, 1998).
Search in Google Scholar Back to article
Ipsos Belgium (research for European Commission). “European enterprise survey on the use of technologies based on artificial intelligence.” Ipsos (28 September 2020) (accessed 2 February, 2023) // https://www.ipsos.com/en/european-enterprises-and-ai-technologies.
Search in Google Scholar Back to article
MacHnikowski, P. “Austria” in Koch BA, European product liability analysis of the state of the art in the era of New Technologies (Intersentia, 2016).
Search in Google Scholar Back to article
Maliha, G. et al. “Artificial Intelligence and Liability in Medicine: Balancing Safety and Innovation.” The Milbank Quarterly 99 (2021): 629.
Search in Google Scholar Back to article
Mehlman, M. J. “Medical Practice Guidelines as Malpractice Safe Harbors: Illusion or Deceit?” Journal of Law, Medicine & Ethics 40 (2012).
Search in Google Scholar Back to article
Miller, R. A. and Miller, S. M. “Legal and Regulatory Issues Related to the Use of Clinical Software in Health Care Delivery.” Clinical Decision Support (2007).
Search in Google Scholar Back to article
Morkunaite, M. Pacientų patirtos žalos atlyginimo problematika (Vilniaus universiteto leidykla, 2021).
Search in Google Scholar Back to article
Moore, M. “Causation in the Law.” Stanford Encyclopedia of Philosophy (accessed 2 February, 2023) // https://ramsey.stanford.edu/entries/causation-law/.
Search in Google Scholar Back to article
Muehlematter, U. J., Daniore, P., and Vokinger, K. N. “Approval of Artificial Intelligence and Machine Learning-Based Medical Devices in the USA and Europe (2015–20): A Comparative Analysis.” The Lancet Digital Health 3 (2021).
Search in Google Scholar Back to article
Nam, J. G. et al. “Development and Validation of Deep Learning–Based Automatic Detection Algorithm for Malignant Pulmonary Nodules on Chest Radiographs.” Radiology 290 (2019).
Search in Google Scholar Back to article
Policy Department C at the request of the Committee on Legal Affairs. “Artificial Intelligence and Civil Liability” (2020) (accessed 10 October, 2022) // https://www.europarl.europa.eu/thinktank/en/document/IPOL_STU(2020)621926.
Search in Google Scholar Back to article
Price, W. N., Gerke, S., and Cohen, I. G. “Potential Liability for Physicians Using Artificial Intelligence.” JAMA 322 (2019).
Search in Google Scholar Back to article
Ridgely, M. S. and Greenberg, M. D. “Too Many Alerts, Too Much Liability.” RAND Corporation (1 June 2012) (accessed 2 February, 2023) // https://www.rand.org/pubs/external_publications/EP201200144.html.
Search in Google Scholar Back to article
Rimkute, D. and Povylius, K. “Civil and Criminal Liability for Damage Caused by Self–Driving Cars.” Vilnius University Open Series (2021).
Search in Google Scholar Back to article
Stauch, M. The Law of Medical Negligence in England and Germany: A Comparative Analysis (Hart, 2008).
Search in Google Scholar Back to article
Synodinu, T. E, et al. “Product Liability and Digital Products.” In: Synodinu T-E and others EU internet law: Regulation and enforcement (Springer Nature, 2017).
Search in Google Scholar Back to article
Talby, D. “Council Post: The Current State of the Healthcare AI Revolution.” Forbes (28 April 2021) (accessed 2 February, 2023) // https://www.forbes.com/sites/forbestechcouncil/2021/04/28/the-current-state-of-the-healthcare-ai-revolution/.
Search in Google Scholar Back to article
Tilson, J. “Can You Have Software without Hardware?” AlphaFirst (13 October 2020) (accessed 2 February, 2023) // https://alphafirst.net/questions/can-you-have-software-without-hardware/.
Search in Google Scholar Back to article
Topol, E. J. “High-Performance Medicine: The Convergence of Human and Artificial Intelligence” Nature Medicine 25, (2019).
Search in Google Scholar Back to article
Turner, J. Robot Rules (Cham: Palgrave Macmillan, 2019).
Search in Google Scholar Back to article
Ulfbeck, V. “Autonomous Ships and Product Liability under the EU Directive.” Autonomous Ships and the Law (2020).
Search in Google Scholar Back to article
Van Dam, C. C. European Tort Law (Oxford University Press, 2013).
Search in Google Scholar Back to article
Van Gool, E. “Case C-65/20 Krone: Offering (Some) Clarity Relating to Product Liability, Information and Software.” European Law Blog (19 January 2022) // https://europeanlawblog.eu/2022/01/19/case-c-65-20-krone-offering-some-clarity-relating-to-product-liability-information-and-software/.
Search in Google Scholar Back to article
Council Directive 85/374/EEC of 25 July 1985 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products.
Search in Google Scholar Back to article
Supreme Court of UK. 1957, case No. 2 All ER 267, Bolam v. Friern HMC,
Search in Google Scholar Back to article
European Court of Justice. 2006, case No. C-127/04, Declan O’Byrne v. Sanofi Pasteur MSD Ltd.
Search in Google Scholar Back to article
European Court of Justice. 2020, case No. C-65/20, KRONE – Verlag.
Search in Google Scholar Back to article
European Court of Justice. 1995, case No. C-300/95, 1995, Commission v United Kingdom.
Search in Google Scholar Back to article
Supreme Court of Lithuania decision. 2014, case No. 3K-7-144/2014.
Search in Google Scholar Back to article

AI and Liability in Medicine: The Case of Assistive-Diagnostic AI

Abstract

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