Healthcare Robots 

Healthcare, Robots & the Law

The line of research Healthcare, Robots, and the Law explores the legal and regulatory implications of the deployment of robotic and artificial intelligence technologies in healthcare settings. It explores systems like physical and social assistive robots, surgery robots, AI in biomedical research, and robots for sex care.

On Healthcare Robots

Concepts, definitions, and considerations for healthcare robot governance

Fosch-Villaronga, E. & Drukarch, H. (2021) On Healthcare Robots: Concepts, definitions, and considerations for healthcare robot governance. ArXiv pre-print, 1-87, https://arxiv.org/abs/2106.03468


Although healthcare is a remarkably sensitive domain of application, and systems that exert direct control over the world can cause harm in a way that humans cannot necessarily correct or oversee, it is still unclear whether and how healthcare robots are currently regulated or should be regulated. Existing regulations are primarily unprepared to provide guidance for such a rapidly evolving field and accommodate devices that rely on machine learning and AI. Moreover, the field of healthcare robotics is very rich and extensive, but it is still very much scattered and unclear in terms of definitions, medical and technical classifications, product characteristics, purpose, and intended use. As a result, these devices often navigate between the medical device regulation or other non-medical norms, such as the ISO personal care standard. Before regulating the field of healthcare robots, it is therefore essential to map the major state-of-the-art developments in healthcare robotics, their capabilities and applications, and the challenges we face as a result of their integration within the healthcare environment. This contribution fills in this gap and lack of clarity currently experienced within healthcare robotics and its governance by providing a structured overview of and further elaboration on the main categories now established, their intended purpose, use, and main characteristics. We explicitly focus on surgical, assistive, and service robots to rightfully match the definition of healthcare as the organized provision of medical care to individuals, including efforts to maintain, treat, or restore physical, mental, or emotional well-being. We complement these findings with policy recommendations to help policymakers unravel an optimal regulatory framing for healthcare robot technologies

On Healthcare Robots_ Concepts, definitions, and considerations for healthcare robot governance (1).pdf

Fosch-Villaronga, E. (2019) Robots, Healthcare and the Law: Regulating Automation in Personal Care. Routledge, New York.

The integration of robotic systems and artificial intelligence into healthcare settings is accelerating. As these technological developments interact socially with children, the elderly, or the disabled, they may raise concerns besides mere physical safety; concerns that include data protection, inappropriate use of emotions, invasion of privacy, autonomy suppression, decrease in human interaction, and cognitive safety. Given the novelty of these technologies and the uncertainties surrounding the impact of care automation, it is unclear how the law should respond.

This book investigates the legal and regulatory implications of the growing use of personal care robots for healthcare purposes. It explores the interplay between various aspects of the law, including safety, data protection, responsibility, transparency, autonomy, and dignity; and it examines different robotic and AI systems, such as social therapy robots, physical assistant robots for rehabilitation, and wheeled passenger carriers. Highlighting specific problems and challenges in regulating complex cyber-physical systems in concrete healthcare applications, it critically assesses the adequacy of current industry standards and emerging regulatory initiatives for robots and AI. After analyzing the potential legal and ethical issues associated with personal care robots, it concludes that the primarily principle-based approach of recent law and robotics studies is too abstract to be as effective as required by the personal care context. Instead, it recommends bridging the gap between general legal principles and their applicability in concrete robotic and AI technologies with a risk-based approach using impact assessments.

As the first book to compile both legal and regulatory aspects of personal care robots, this book will be a valuable addition to the literature on robotics, artificial intelligence, human–robot interaction, law, and philosophy of technology.

Pierce, R. L & Fosch-Villaronga, E. (2020) Medical robotics and the right to health care: A progressive realisation. Ienca, M. et al. (2020) Cambridge Handbook of Life Science, Information Technology and Human Rights, forthcoming

Robotic technologies have shown to have clear potential for providing innovation in treatments and treatment modalities for various diseases and disorders that cover unmet needs and are cost-efficient. However, the emergence of technology that promises to improve health outcomes raises the question regarding the extent to which it should be incorporated, how, made available to whom, and on what basis. Since countries usually have limited resources to favour access to state-of-the-art technologies and develop strategies to realize the right to health progressively, in this article, we investigate whether the right to health, particularly the core obligations specified under this right, helps implement medical robots.

Schauer, T., Fosch-Villaronga, E., and Moreno, J. C. (2023) Fusing Electrical Stimulation and Wearable Robots with Humans to Restore and Enhance Mobility. In: Annaswamy, A., Khargonekar, P., Lamnabhi-Lagarrigue, F. and Spurgeon, S. (2023) Cyber-Physical-Human Systems: Fundamentals and Applications, Wiley-IEEE Press.


Participation in everyday life and life satisfaction are greatly affected by disabilities. Motor impairments caused by neurological disorders, like spinal cord injury, stroke, traumatic brain injury, and multiple sclerosis, represent a significant burden for those affected and society. Wearable robotics and neuro-prostheses are two emerging technologies to recover mobility by generating lost movements or amplifying residual weak functions. The suppression of pain, elimination of spasticity, and movement restoration by spinal cord stimulation (i.e., neuromodulation) represent other indirect means for the mobilization of the impaired. This chapter introduces the underlying basics of neuro-prostheses, spinal cord stimulation, and wearable robotics and highlights recent technological developments with application examples and open challenges. These include using various sensor technologies to recognize the user’s intention, generalized movement, muscular fatigue, and environmental disturbances. The authors discussed feedback and learning control as essential solutions for user-individual support and assist-as-needed behavior and outlined hybrid approaches in evolving multi-modal actuation principles to combine the advantages and compensate for the disadvantages of the individual support modalities. They also provided examples of hybrid systems connecting wearable robots and electrical stimulation illustrate the current state of the art and research before discussing applicability and transfer to daily practice, which, Fosch-Villaronga remarks, does not come without drawbacks.

Wanna read more? You can access the article by following this link (https://ieeexplore.ieee.org/abstract/document/10154097). If you want to read the book, you can access it here (https://ieeexplore.ieee.org/book/10154022). 

Poulsen, A., Song, Y. J. C., Fosch-Villaronga, E., LaMonica, H. M.; Iannelli, O.;  Alam, M., and Hickie, I. B. (2023). Digital Rights and mHealth in Low- and Middle-Income Countries: Protocol for a Scoping Review. JMIR Research Protocols, 12:e49150, doi: 10.2196/49150.


Background: Digital technology is a means to uphold or violate human rights in various domains, including business, military, and health. Given the pervasiveness of mobile technology in low- and middle-income countries (LMICs), mobile health (mHealth) interventions present an opportunity to reach remote populations and enable them to exercise civil and political rights and economic, social, and cultural rights, such as the right to health and education. Simultaneously, the ubiquity of mobile phones involves processing sensitive data which can threaten rights, including the right to privacy and nondiscrimination. Digital health is often promoted as advancing human rights and health equity; however, digital rights are underexplored in the literature on mHealth in LMICs. As such, creating an understanding of the digital rights topics covered in the 2022 literature is important to avoid exacerbating existing inequities relating to digital health design, use, implementation, and access.

Objective: This scoping review aims to identify digital rights topics in the 2022 peer-reviewed literature on mHealth in LMICs.

Methods: The Arksey and O’Malley framework for scoping reviews guides this review. Searches were performed across 7 electronic databases (Web of Science, Scopus, Ovid, ACM Digital Library, IEEE Xplore, ProQuest, and PubMed). The screening processes were guided by the research question “What digital rights topics have been explored in the 2022 literature on mHealth in LMICs?” Only papers addressing mHealth in LMICs and digital rights topics were included. Data extraction will include publication title, year, and type; first author’s affiliation country; LMICs implicated; infrastructure challenges; study aims, design, limitations, and future work; health area; mHealth technology, functions, purpose or application, and target end users; human or digital right terms used; explicit rights topics cited; and implied rights topics. The results will be reported using the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews) checklist.

Results: This scoping review was registered in Open Science Framework (December 22, 2022). Title and abstract screening and full-text paper screening were completed in 2023. This resulted in 56 papers being included in the study. The target date for completing data extraction and publishing a case study of the initial findings is the end of 2023. The full scoping review findings are expected to be disseminated through various pathways benefiting academia, practice, and policy making by the end of 2024. These include journal papers, conference presentations, publicly available toolkits for research and practice, public webinars, and policy briefs with evidence-based policy recommendations emerging from this review.

Conclusions: The planned scoping review will identify digital rights topics in the 2022 literature at the intersection of mHealth and LMICs. Furthermore, it will highlight the importance of patient empowerment, data protection, and inclusion in mHealth research and related policies in LMICs.

Zardiashvili, L. & Fosch-Villaronga, E. (2020) AI in Healthcare Through the Lens of Human Dignity In: Motahareh Fathisalout-Bollon, M. and Berti Suman, A. (2020) Legal, social and ethical perspectives on Health & Technology, Savoie Mont Blanc University Press and LEXTENSO Editions, 45-64.

Embodied and non-embodied applications of Artificial Intelligence (AI) are increasingly used in the healthcare domain. Their development, adoption and implementation promises safer, more personalised and more efficient care, oftentimes portrayed as the only available solution for individuals to live a ‘dignified’ life. However, these technologies also raise the concern they might cause the very same problem they intend to solve, for instance, by increasing loneliness, inciting unhealthy attachments, preventing users from accessing care and objectifying individuals. The multifaceted nature of AI technology also raises unprecedented regulatory issues that current legislation struggles to solve. Hard laws such as data protection legislation are often limited, scoping out various harmful impacts of technology. Technology ethics is also considered to be a good instrument to steer discussions but ethics lack enforceability. In this chapter, we explore the concept of ‘human dignity’, an axiomatic notion that acknowledges primacy of human beings and entitles them with human rights, as a lens through which the development of AI for healthcare should be analysed to reap the potential benefits of this technology without harming the individuals, or society at large, directly or indirectly.

Fosch-Villaronga, E., Chokoshvili, D., Pierce, R. L., Ienca, M., & Binz, V. V. (2020) Implementing AI in Healthcare: An Ethical and Legal Analysis Based on Case Studies. In: Leenes, R., van Brakel, R., Gutwirth, S., and de Hert, P. (2020) Computers, Privacy, and Data Protection 2020 – Artificial Intelligence. Hart Publishing.

The integration of artificial intelligence (AI) technologies in healthcare promises safer, more efficient, and more personalised care. Typical applications of such systems include personalised diagnosis, early disease detection, hospitalisation risk prediction, and drug discovery. These technologies process vast amounts of data, can learn from experience, and are capable of autonomously improving their performance. This also challenges the applicability of existing regulations that were not designed for progressive and adaptive aspects of AI. The automated processing of data that will evaluate, analyse, and predict health-related outcomes may also affect not only data protection regulations but also safety and other aspects of the individual’s environment. This chapter explores the challenges to existing legal frameworks brought about by the potential uptake and integration of several AI-based technologies in healthcare. Specifically, we look at AI-driven analytic tools for precision medicine, assistive technologies that adapt and facilitate rehabilitation and recovery, and various types of decision aids that may assist in critical processes such as diagnosis and screening. Although, in reality, the use of these technologies may not be limited to a single context, this approach allows us to focus the legal and ethical analysis on particular types of issues that may be based on function, usage, and implications. This analysis then examines both the practical and theoretical challenges and their possible impact on the use of AI in healthcare. The chapter concludes with a forward look at how these issues could be addressed proactively.

Surgery Automation

Fosch-Villaronga, E., Khanna, P., Drukarch, H., Custers, B.H.M. (2021) A human in the loop in surgery automation. Nature Machine Intelligence. https://doi.org/10.1038/s42256-021-00349-4. 

This research focuses on how the complex interplay between increasingly autonomous surgical robots, medical practitioners and support staff will soon complicate the understanding of how to allocate responsibility if something goes wrong. For the automotive industry, the Society of Automotive Engineers established different automation levels to clarify the progressive development of automotive technology. However, no universal standards have been defined for medical robots. Guang-Zhong Yang et al. established a 6-layered model for medical robots’ autonomy levels in. Our work complements this work by providing more detailing on how it applies to one specific type of medical robots: surgery robots. We argue that while the increasing autonomy of surgical robots brings up the worry that human oversight will decrease, we have found that with progressive robot autonomy, the human surgeons’ active performance decreases while in parallel their oversight increases.

Exploring the Influence of Automation on Human–Robot Interaction and Responsibility in Surgery Innovation

Fosch-Villaronga, E., Khanna, P., Drukarch, H., Custers, B.H.M. (2022) The role of humans in surgery automation. Exploring the influence of automation on human-robot interaction and responsibility in surgery innovation. International Journal of Social Robotics, https://link.springer.com/article/10.1007/s12369-022-00875-0.  

The role of humans in surgery automation.pdf

Social Robots

Interactions between older adults, caregivers, and robots in the home

Søraa, R. A., Nyvoll, P., Tøndel, G., Fosch-Villaronga, E., & Serrano, A. (2021) The social dimension of domesticating technology: Interactions between older adults, caregivers, and robots in the home. Technological Forecasting and Social Change, 167, 120678, 1-13.

1-s2.0-S0040162521001104-main.pdf

Fosch-Villaronga, E. and Albo-Canals, J. (2019) “I’ll take care of you,” said the robot. Reflecting upon the Legal and Ethical Aspects of the Use and Development of Social Robots for Therapy, Paladyn, Journal of Behavioral Robotics, 10(1), 77-93

The insertion of robotic and artificial intelligent (AI) systems in therapeutic settings is accelerating. In this paper, we investigate the legal and ethical challenges of the growing inclusion of social robots in therapy. Typical examples of such systems are Kaspar, Hookie, Pleo, Tito, Robota,Nao, Leka or Keepon. Although recent studies support the adoption of robotic technologies for therapy and education, these technological developments interact socially with children, elderly or disabled, and may raise concerns that range from physical to cognitive safety, including data protection. Research in other fields also suggests that technology has a profound and alerting impact on us and our human nature. This article brings all these findings into the debate on whether the adoption of therapeutic AI and robot technologies are adequate, not only to raise awareness of the possible impacts of this technology but also to help steer the development and use of AI and robot technologies in therapeutic settings in the appropriate direction. Our contribution seeks to provide a thoughtful analysis of some issues concerning the use and development of social robots in therapy, in the hope that this can inform the policy debate and set the scene for further research.

Wearable Robots

Kapeller, A., Felzmann, H., Fosch-Villaronga, E., Hughes, A. M. (2020) A taxonomy of ethical, legal and social implications of wearable robots: an expert perspective. Science Engineering Ethics, 1-19

Wearable robots and exoskeletons are relatively new technologies designed for assisting and augmenting human motor functions. Due to their different possible design applications and their intimate connection to the human body, they come with specific ethical, legal, and social issues (ELS), which have not been much explored in the recent ELS literature. This paper draws on expert consultations and a literature review to provide a taxonomy of the most important ethical, legal, and social issues of wearable robots. These issues are categorized in (1) wearable robots and the self, (2) wearable robots and the other, and (3) wearable robots in society.

Fosch-Villaronga, E. and Özcan, B. (2019) The progressive intertwinement between design, human needs and the regulation of care technology: the case of lower-limb exoskeletons. International Journal of Social Robotics, 1-14.

The adoption of robot technology is accelerating in healthcare settings. Care robots can support and extend the work of caregivers in assisting patients, elderly or children. Typical examples of such systems are ‘cognitive therapeutic robots,’ ‘physical rehabilitation robots,’ ‘assistive and lifting robots.’ Although these robots might reduce the workload of care workers, and be a cost-efficient solution against healthcare system cuts, the insertion of such technologies may also raise ethical, legal and societal concerns concerning users. In this article, we describe some of these concerns, including cognitive safety, prospective liability, and privacy. We argue that the current regulatory framework for care robot technology is ill-prepared to address such multidisciplinary concerns because it only focuses on physical safety requirements, whereas it disregards other issues arising from the human–robot interaction. We support the idea that design plays a significant role in shaping the technology to meet the needs of the users and the goals set by the regulation. To illustrate practical challenges, in this article we consider as an example the case of lower-limb exoskeletons. This example helps illuminate the overarching idea of the article, that is, that regulation, design, and human needs need to intertwine and mutually shape each other to serve the solutions these technologies proclaim.

Kapeller, A., Felzmann, H., Fosch-Villaronga, E., Nizamis, K. Hughes, A. M. (2021) Implementing Ethical, Legal, and Societal Considerations in Wearable Robot Design. Applied Sciences.

Ethical, legal and societal implications (ELSI) in the development of wearable robots (WRs) are currently not explicitly addressed in most guidelines for WR developers. Previous work has identified ELSI related to WRs, e.g., impacts on body and identity, ableism, data protection, control and responsibilities, but translation of these concerns into actionable recommendations remains outstanding. This paper provides practical guidance for the implementation of ELSI in WR design, development and use. First, we identify the need for domain-specific recommendations against the context of current ELSI guidance. We then demonstrate the feasibility and usefulness of taking a domain-specific approach by successively transforming currently identified ELSI into an action-guiding flowchart for integration of ELSI specific to the different stages of WR development. This flowchart identifies specific questions to be considered by WR development teams and suggests actions to be taken in response. By tailoring ELSI guidance to WR developers, centring it on user needs, their relation to others and wider society, and being cognizant of existing legislation and values, we hope to help the community develop better WRs that are safer, have greater usability, and which impact positively on society.


Schauer, T., Fosch-Villaronga, E., and Moreno, J. C. (2023) Fusing Electrical Stimulation and Wearable Robots with Humans to Restore and Enhance Mobility. In: Annaswamy, A., Khargonekar, P., Lamnabhi-Lagarrigue, F. and Spurgeon, S. (2023) Cyber-Physical-Human Systems: Fundamentals and Applications, Wiley-IEEE Press. 

Participation in everyday life and life satisfaction are greatly affected by disabilities. Motor impairments caused by neurological disorders, like spinal cord injury, stroke, traumatic brain injury, and multiple sclerosis, represent a significant burden for those affected and society. Wearable robotics and neuro-prostheses are two emerging technologies to recover mobility by generating lost movements or amplifying residual weak functions. The suppression of pain, elimination of spasticity, and movement restoration by spinal cord stimulation (i.e., neuromodulation) represent other indirect means for the mobilization of the impaired. This book section introduces the underlying basics of neuro-prostheses, spinal cord stimulation, and wearable robotics and highlights recent technological developments with application examples and open challenges. These include using various sensor technologies to recognize the user’s intention, generalized movement, muscular fatigue, and environmental disturbances. We dis- cuss feedback and learning control as essential solutions for user-individual support and assist-as-needed behavior and outline hybrid approaches in evolving multi-modal actuation principles to combine the advantages and compensate for the disadvantages of the individual support modalities. Examples of hybrid systems connecting wearable robots and electrical stimulation will illustrate the current state of the art and research before discussing applicability and transfer to daily practice, which does not come without drawbacks.

Felzmann, H., Kapeller, A. Hughes, A. M., and Fosch-Villaronga, E. (2020) Ethical, legal and social issues in wearable robotics: Perspectives from the work of the COST Action on Wearable Robots. In: Pons-Rovira, J.L. (2020) Inclusive Robotics for a Better Society. INBOTS 2018. Biosystems & Biorobotics, Springer, Cham, 25, 92-97.

The COST Action on Wearable Robots (CA16116) brings together a multidisciplinary, cross-European consortium of experts in Wearable Robotics. Ethical, legal and social (ELS) issues in Wearable Robotics have so far been comparatively underexplored. The ELS Working Group of CA16116 aims to develop a comprehensive understanding of ELS issues in Wearable Robotics, identifying relevant values and ethical, philosophical, legal and social concerns related to the design, deployment and practical use of wearable robots. Here, we present a brief overview of the preliminary findings of a literature search and a series of three expert consultation workshops on ELS issues in Wearable Robotics conducted as part of the work of the Action between October 2017 and October 2018.

Fosch-Villaronga, E.,  Čartolovni, A., & Pierce, R. L. (2020) Promoting inclusiveness in exoskeleton robotics: Addressing challenges for pediatric access. Paladyn Journal of Behavioral Robotics 11(1)

Pediatric access to exoskeletons lags far behind that of adults. In this article, we promote inclusiveness in exoskeleton robotics by identifying and addressing challenges and barriers to pediatric access to this potentially life-changing technology. We first present available exoskeleton solutions for upper and lower limbs and note the variability in the absence of these. Next, we query the possible reasons for this variability in access, explicitly focusing on children, who constitute a categorically vulnerable population, and also stand to benefit significantly from the use of this technology at this critical point in their physical and emotional growth. We propose the use of a life-based design approach as a way to address some of the design challenges and offer insights toward a resolution regarding market viability and implementation challenges. We conclude that the development of pediatric exoskeletons that allow for and ensure access to health-enhancing technology is a crucial aspect of the responsible provision of health care to all members of society. For children, the stakes are particularly high, given that this technology, when used at a critical phase of a child’s development, not only holds out the possibility of improving the quality of life but also can improve the long-term health prospects.

Sex Care Robots

Setting the Stage for a Discussion on the Potential Use of Sexual Robot Technologies for Persons with Disabilities

Fosch-Villaronga, E., & Poulsen, A. (2021, March). Sex Robots in Care: Setting the Stage for a Discussion on the Potential Use of Sexual Robot Technologies for Persons with Disabilities. In Companion of the 2021 ACM/IEEE International Conference on Human-Robot Interaction (pp. 1-9).

Although every human should enjoy physical touch, intimacy, and sexual pleasure, persons with disabilities are often not in the position to fully experience the joys of life in the same manner as abled people. The United Nations stated in 1993 that persons with disabilities should enjoy family life and personal integrity and should not be denied the opportunity to experience their sexuality, have sexual relationships, and experience parenthood. However, after nearly 30 years of discussion, universal access to sexual and reproductive health remains an unfinished agenda for the disabled, as if society failed in recognizing people with disabilities as sexual beings. In this respect, a growing body of scholars have started to explore the idea of using technology to help disabled people satisfy some of these needs, although not without controversy. In concrete, ideas surrounding the use of robots for sex care purposes have been put forward, as service robots performing actions contributing directly towards improvement in the satisfaction of a user's sexual needs. This paper continues to explore the potential use of these robots in disability care for sex care purposes, including for those with physical and mental health disabilities, which is currently underexplored. Our contribution seeks to understand whether sex robots could serve as a step forward in realizing the sexual rights of persons with disabilities. By building on a conceptual analysis of how sex robots could empower persons with disabilities to exercise their sexual rights, we hope to inform the policy debate around robots' regulation and governance and set the scene for further research

3434074.3446907.pdf

Exploring the potential use of sexual robot technologies for disabled and elder care

Fosch-Villaronga, E. and Poulsen, A. (2020) Sex Care Robots. Exploring the potential use of sexual robot technologies for disabled and eldercare. Paladyn Journal of Behavioral Robotics, 11, 1–18

The creation and deployment of sex robots are accelerating. Sex robots are service robots that perform actions contributing directly towards improvement in the satisfaction of the sexual needs of a user. In this paper, we explore the potential use of these robots for elder and disabled care purposes,which is currently underexplored. Indeed, although every human should be able to enjoy physical touch, intimacy, and sexual pleasure, persons with disabilities are often not in the position to fully experience the joys of life in the same manner as abled people. Similarly, older adults may have sexual needs that public healthcare tend to ignore as an essential part of their well-being. We develop a conceptual analysis of how sex robots could empower persons with disabilities and older adults to exercise their sexual rights, which are too often disregarded in society. Our contribution seeks to understand whether sex robots could serve as a step forward in enhancing the care of (mainly but not exclusively) persons with disabilities and older adults. By identifying the potential need to incorporate sex within the concept of care, and by exploring the use of robot technology to ease its materialization, we hope to inform the policy debate around the regulation of robots and set the scene for further research.

Person Carrier Robots

Fosch-Villaronga, E. and Roig, A. (2017) European Regulatory Framework for Person Carrier Robots. Computer Law & Security Review, 33(4), 502-520.

The aim of this paper is to establish the grounds for a future regulatory framework for Person Carrier Robots, which includes legal and ethical aspects. Current industrial standards focus on physical human–robot interaction, i.e. on the prevention of harm. Current robot technology nonetheless challenges other aspects in the legal domain. The main issues comprise privacy, data protection, liability, autonomy, dignity, and ethics. The paper first discusses the need to take into account other interdisciplinary aspects of robot technology to offer complete legal coverage to citizens. As the European Union starts using impact assessment methodology for completing new technologies regulations, a new methodology based on it to approach the insertion of personal care robots will be discussed. Then, after framing the discussion with a use case, analysis of the involved legal challenges will be conducted. Some concrete scenarios will contribute to easing the explanatory analysis.