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Legal challenges of healthcare robots and AI

2 March 2020

The insertion of robots and artificial intelligent (AI) systems in healthcare settings is accelerating. Healthcare robots offer the possibility of assisting patients in ways that seemed far-fetched time ago and freeing caregivers from doing tedious tasks. Typical healthcare robots include socially assistive robots for therapy, lower/upper-limb exoskeletons for rehabilitation, robots for the blind, feeding robots, companion robots, surgery robots, or delivery robots. Healthcare AI applications promise safer, more efficient, and personalized care. Typical applications of such systems include personalized diagnosis, early disease detection, hospitalization risk prediction, and drug discovery.

Although recent studies support the adoption of robotic technologies for care purposes, these technological developments interact with children, elderly or disabled, socially and physically, and may raise legal and regulatory concerns that range from physical to cognitive safety, including data protection, responsibility, discrimination, autonomy, access, or dignity. Research in other fields also suggests that technology may have a profound and alerting impact on us and our human nature in the long run, as the more time we spend with technology, the less time we spend on learning abilities and skills that real-life requires. Moreover, European Institutions worry that the insertion of robots could dehumanize caring practices as human contact is an essential aspect of personal care. 

These technologies also process vast amounts of data - often using cloud services, can learn from experience and self-improve their performance, which challenges the applicability of existing regulations that were not designed for progressive, adaptive, and evolutionary systems. Static regulations are not ready for the automated processing of data evaluating, analyzing, and predicting health-related outcomes, affecting not only data protection rights but, ultimately, the overall safety of the individual. Moreover, legislation establishing safety requirements was mostly designed for things working in isolation, mostly in industrial environments. However, robots represent an interface to the physical world, making security concerns particularly salient because, unlike traditional computers, they can have an immediate physical effect on their environment. Acknowledging such a link is essential in the healthcare domain, as ‘vulnerabilities could allow unauthorized users to remotely access, control, and issue commands to compromised devices, potentially leading to patient harm’ (FDA, 2019)

Find more about the legal and regulatory aspects of healthcare robots and AI in the book ‘Robots, Healthcare, and the Law. Regulating Automation in Personal Care’ edited by Routledge and written by Dr. Eduard Fosch-Villaronga.

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