Evolving artificial intelligence and robotics in medicine, evolving European law. Comparative remarks based on the surgery litigation
| DOI | 10.1177/1023263X211042470 |
| Date | 01 December 2021 |
| Author | Giorgia Guerra |
| Published date | 01 December 2021 |
| Subject Matter | Articles |
Evolving artificial intelligence
and robotics in medicine,
evolving European law.
Comparative remarks based on
the surgery litigation
Giorgia Guerra
Abstract
This article discusses key and critical tort law issues that have arisen from artificial intelligence
and robotic medical applications. It aims at addressing the most recent European regulatory
trajectories –ultimately traced by the Proposal for the Artificial Intelligence Act April 21 2021
–starting from the study of the legal issues that stemmed from the instructive experience of
the US litigation on robotic surgery, which was foregoing on account of its cutting-edge and
accelerated enhancement of the field. The recognition and analysis of the criticalities about
products’malfunctioning as well as the focus on other producers’duties will lead the reader to
reflect on the suitability of the legal rules planned by the European Authorities on the ground
of the empirical features of the new step of technological progress in the field in question.
Keywords
Comparative tort law, empirical research, European regulation, law and technology, medical law,
US litigation
1. Introduction
In the ‘dynamic’European legal landscape concerning product regulation and liability for artificial
intelligence applications in medicine –which this introduction will describe –this article aims at
pointing out which insights and lessons have been illustrated by the US case-law on robotic
surgery, given its prominent meaning.
Assistant Professor in Comparative Private Law, Department of Legal Sciences, University of Verona, Verona, Italy
Corresponding author:
Giorgia Guerra, Assistant Professor in Comparative Private Law, University of Verona, Department of Legal Sciences, Italy.
Email: giorgia.guerra@univr.it
Article
Maastricht Journal of European and
Comparative Law
2021, Vol. 28(6) 805–833
© The Author(s) 2021
Article reuse guidelines:
sagepub.com/journals-permissions
DOI: 10.1177/1023263X211042470
maastrichtjournal.sagepub.com
As alluded to above, during the last two years the European Regulatory framework in the field of
AI has provided a set of benchmarks for addressing the complex enabling ecosystem and the fea-
tures of autonomous decision-making. They have been shown to be particularly keen on reflecting
on the suitability of current safety and liability regimes, as highly sophisticated AI technologies may
present new safety risks for users when embedded.
1
Besides all the crucial domains for AI developments, legal issues are particularly debated with
regard to near-future applications in medicine and healthcare, even in the perspective of fostering
personalized medicine. In this perspective, a study report in April 2021 prepared for the European
Commission has noted that ‘AI cannot be deployed in healthcare without sufficient infrastructure
and risk mitigation. Failures in the medicine industry may cause harm to individuals by, for
example, failed robotic surgeries or incorrect treatment’.
2
Thus, current socio-economic challenges affecting healthcare in Europe may justify the use of AI
and robotics in healthcare, even if unleashing the potential of AI and robotics would require good
integration with the existing and future ‘technological stack’–from high-performance computing to
5G connectivity, nanotech and IoT, not to contribute either to address inequalities or to exacerbate
them.
3
Today’s medical context, characterized by the pervasive impact of digital progress, requires,
in fact, a reconsideration of the traditional civil law categories, in order to identify, from time to
time, the necessary adaptations to preserve the protection of the health and safety of the patient/
user.
4
However, it is necessary to warn against the risk of generalizations since, just as for
medical technologies, as in other fields, their degree of complexity ranges considerably depending
on the specific equipment considered. The legal impact of these is thus not always such that legal
adaptations are required by default.
5
1. E.g. Communication from the Commission to the European Parliament, the European Council, the Council, the
European Economic and Social Committee and the Committee of the Regions, Artificial Intelligence for Europe,
Brussels, COM(2018) 237 final; EU Commission, Report from the Expert Group on Liability and New Technologies
–New Technologies Formation, 2019, p. 3. EU Commission, Report on the Safety and Liability Implications of
Artificial Intelligence, the Internet of Things and Robotics, COM(2020), 64 final.
2. A. Renda et al., Study to Support an Impact Assessment of the Regulatory Requirements for Artificial Intelligence in
Europe (Final Report) (Publications Office of the European Union, 2021).
3. See the report: Z. Dolic et al., Robots in Healthcare: A Solution or a Problem? (Committee on Environment, Public
Health, and Food Safety, Policy Department for Economic, Scientific and Quality of Life Policies, European
Parliament, 2019) (specifically Dr Renda’s contribution).
4. This finding can be extended to other private law domains. See G. Guerra, La sicurezza degli artefatti robotici in pros-
pettiva comparatistica. Dal cambiamento tecnologico all’adattamento giuridico (il Mulino, 2018), p. 142; G. Resta, La
successione nei rapporti digitali e la tutela post-mortale dei dati personali, in D. Poletti and A. Mantelero (eds),
Regolare la tecnologia: il Reg. UE 2016/679 e la protezione dei dati personali. Un dialogo fra Italia e Spagna (Pisa
University Press, 2018), p. 396. Big Data analytics can change legal practice, see C. Busch and A. De Franceschi,
‘Granular Legal Norms: Big Data and the Personalization of Private Law’, in V. Mask et al., Research Handbook in
Data Science and Law (Edward Elgar, 2018), p. 408. The authors affirmed: ‘the rise of Big Data could fundamentally
change the design and structure of legal norms and thus the legal system itself […] Big Data and algorithm-based reg-
ulation could lead to a shift from impersonal law based on the widespread use of typification to a more personalized law
based on “granular legal norms”that are tailored to the individual addresses. As a consequence, the balance between
individual fairness and legal certainty could be readjusted’(p. 409).
5. This is the position of the most influential Italian literature, see R. Leenes et al., ‘Regulatory challenges of robotics: Some
guidelines for addressing legal and ethical issues’,1Law, Innovation and Technology (2017), p. 44. Contra see R. Calo,
‘Robotics and the Lessons of Cyberlaw’, 103 Cal. L. Rev. (2015), p. 513; A. Sandberg, ‘Law-abiding Robots?’,Oxford
Martin Opinion (2016), www.oxfordmartin.ox.ac.uk/opinion/view/340; G. Miller, ‘A Brief History of Robot Law’,
Atlantic (2016), www.theatlantic.com/technology/archive/2016/03/a-brief-history-of-robot-law/474156/. This debate
806 Maastricht Journal of European and Comparative Law 28(6)
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