Journal articles

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.

This paper analyzes and classifies regulatory gaps and inconsistencies in ISO 13482:2014 (‘Safety Requirements for Personal Care Robots'), specifically regarding robotic lower-limb exoskeletons, being personal care robots, for everyday activities. Following a systematic literature review, our findings support the conclusion that, even though ISO 13482:2014 has proven to be a substantial step towards regulating that type of wearable robot, it fails to address safety sufficiently and comprehensively.

That failure results in a general overlook of critical legal, ethical, and social considerations when designing robots, with the consequence that seemingly safe systems might nonetheless harm end-users. Notwithstanding those limitations and impediments to the development of safe technologies, to date, there has been no thorough assessment of how the standard regulates the development of exoskeletons and whether it requires any improvement in light of ethical, legal, and societal considerations.

To bridge this gap, we compile relevant areas for improvement concerning ISO 13482:2014 fueled by these considerations. We do so in an accessible manner and provide concrete recommendations to help decision-makers overcome the standard's drawbacks.

The rapid advancement of service robotics has outpaced regulatory frameworks, leading to gaps and inconsistencies that hinder effective governance. While evidence-based policymaking is well-established in health and consumer protection fields, robotics regulation remains fragmented and reactive. This paper proposes Science for Robot Policy, a structured, evidence-driven model that bridges the disconnect between robotics innovation and regulatory adaptation.

Using a Constructive Research Approach, the model integrates scientific experimentation, stakeholder engagement, and knowledge brokering to generate policy-relevant data and transform it into actionable regulatory insights. The model follows a five-step process, beginning with risk identification and prioritization, followed by controlled experimentation in simulators, testing zones, living labs, and real-world markets. 

The ambition is that insights generated are then translated into policy-relevant information and further refined into knowledge for policymakers, ensuring that empirical evidence informs that robotics regulation is dynamic, anticipatory, and informed. This approach contributes to ongoing discussions on science-for-policy methodologies and fosters iterative regulatory refinement in service robotics. If successful, such a model could allow policymakers to address emerging risks proactively, reduce regulatory uncertainty, enhance user safety, and promote responsible robotics innovation by embedding scientific insights into the policy cycle.