From exoskeletons to lightweight robotic suits, wearable robots are changing dynamically and rapidly, challenging the timeliness of laws and regulatory standards that were not prepared for robots that would help wheelchair users walk again. In this context, equipping regulators with technical knowledge on technologies could solve information asymmetries among developers and policymakers and avoid the problem of regulatory disconnection. This article introduces pushing robot development for lawmaking (PROPELLING), an financial support to third parties from the Horizon 2020 EUROBENCH project that explores how robot testing facilities could generate policy-relevant knowledge and support optimized regulations for robot technologies. With ISO 13482:2014 as a case study, PROPELLING investigates how robot testbeds could be used as data generators to improve the regulation for lower-limb exoskeletons. Specifically, the article discusses how robot testbeds could help regulators tackle hazards like fear of falling, instability in collisions, or define the safe scenarios for avoiding any adverse consequences generated by abrupt protective stops. The article’s central point is that testbeds offer a promising setting to bring policymakers closer to research and development to make policies more attuned to societal needs. In this way, these approximations can be harnessed to unravel an optimal regulatory framework for emerging technologies, such as robots and artificial intelligence, based on science and evidence.
Innovation in healthcare promises unparalleled potential in optimizing the production, distribution, and use of the health workforce and infrastructure, allocating system resources more efficiently, and streamline care pathways and supply chains. A recent innovation contributing to this is robot-assisted surgeries (RAS). RAS causes less damage to the patient's body, less pain and discomfort, shorter hospital stays, quicker recovery times, smaller scars, and less risk of complications. However, introducing a robot in traditional surgeries is not straightforward and brings about new risks that conventional medical instruments did not pose before. For instance, since robots are sophisticated machines capable of acting autonomously, the surgical procedure's outcome is no longer limited to the surgeon but may also extend to the robot manufacturer and the hospital. This article explores the influence of automation on stakeholder responsibility in surgery robotization. To this end, we map how the role of different stakeholders in highly autonomous robotic surgeries is transforming, explore some of the challenges that robot manufacturers and hospital management will increasingly face as surgical procedures become more and more automated, and bring forward potential solutions to ascertain clarity in the role of stakeholders before, during, and after robot-enabled surgeries (i.e. a Robot Impact Assessment (ROBIA), a Robo-Terms framework inspired by the international trade system 'Incoterms', and a standardized adverse event reporting mechanism). In particular, we argue that with progressive robot autonomy, performance, oversight, and support will increasingly be shared between the human surgeon, the support staff, and the robot (and, by extent, the robot manufacturer), blurring the lines of who is responsible if something goes wrong. Understanding the exact role of humans in highly autonomous robotic surgeries is essential to map liability and bring certainty concerning the ascription of responsibility. We conclude that the full benefits the use of robotic innovations and solutions in surgery could bring to healthcare providers and receivers cannot be realized until there is more clarity on the division of responsibilities channeling robot autonomy and human performance, support, and oversight; a transformation on the education and training of medical staff, and betterment on the complex interplay between manufacturers, healthcare providers, and patients.
Science has started highlighting the importance of integrating diversity considerations in medicine and healthcare. However, there is little research into how these considerations apply, affect, and should be integrated into concrete healthcare innovations such as rehabilitation robotics. Robot policy ecosystems are also oblivious to the vast landscape of gender identity understanding, often ignoring these considerations and failing to guide developers in integrating them to ensure they meet user needs. While this ignorance may be for the traditional heteronormative configuration of the medical, technical, and legal world, the ending result is the failure of roboticists to consider them in robot development. However, missing diversity, equity, and inclusion considerations can result in robotic systems that can compromise user safety, be discriminatory, and not respect their fundamental rights. This paper explores the impact of overlooking gender and sex considerations in robot design on users. We focus on the safety standard for personal care robots ISO 13482:2014 and zoom in on lower-limb exoskeletons. Our findings signal that ISO 13482:2014 has significant gaps concerning intersectional aspects like sex, gender, age, or health conditions and, because of that, developers are creating robot systems that, despite adherence to the standard, can still cause harm to users. In short, our observations show that robotic exoskeletons operate intimately with users’ bodies, thus exemplifying how gender and medical conditions might introduce dissimilarities in human–robot interaction that, as long as they remain ignored in regulations, may compromise user safety. We conclude the article by putting forward particular recommendations to update ISO 13482:2014 to reflect better the broad diversity of users of personal care robots.
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