ExosCE: A legal-based computational system for compliance with exoskeletons’ CE marking

Abstract

Wearable robots are devices intended to improve the quality of users’ life by augmenting, assisting, or substituting human functions. Exoskeletons are one of the most widespread types of wearable robots, currently used extensively in medical applications (and also for industrial, assistive, or military purposes), thus governed by regulations for medical devices and their conformity assessment. On top of that, manufacturers must also specify if their exoskeletons can be categorized as machines and, therefore, additionally apply a number of requirements mandated from machinery regulations. This work focuses on capturing both the abovementioned requirements enacted by the Medical Devices Directive 2017/745 and the Machinery Directive 2006/42 into a single framework. It formalizes into Rules the Conformity Assessment procedures regarding the marketability of exoskeletons indicated by the CE marking (“Conformité Européene”). These Rules, expressed in the Positional-Slotted Object-Applicative (PSOA) RuleML code, were complemented by representative Facts based on real-life cases of commercialized exoskeletons. Additional Exoskeletons Facts can be included by users from other forms (such as MS Excel) and translated into the PSOA RuleML code through the provided Python script. The open-source Exoskeletons’ CE mark (ExosCE) Rules KB was tested by querying in the open-source PSOATransRun system. The ExosCE Rules prototype can assist in the compliance process of stakeholders and in the registration of exoskeletons with a CE mark.

Formalization of Ethical Decision Making

“…To create a computational prototype of this use case, ethical reasoning was integrated into the logic-based PSOA RuleML programming language (Boley, 2015) to illustrate how this ethical thinking can be formalized. PSOA RuleML has also been used for the formalization of legal procedures in similar cases, such as Exoskeletons (i.e., a type of WR) (Almpani et al, 2020) and Medical Devices (Almpani et al, 2019(Almpani et al, , 2018b(Almpani et al, , 2018a providing evidence that PSOA RuleML is well-suited to express robotic-related decision-making procedures.…”

Implementing Ethical, Legal, and Societal Considerations in Wearable Robot Design

“…Integrating legal and ethical considerations into WR design may not only ease market entrance, but also facilitate the building of trust and ultimately user acceptance of the device. Such acceptance is paramount because it leads to faster adoption of WRs in daily practice [7][8][9], making WRs more commercially successful. Considering ELSI also helps researchers think through their projects with a broader lens, which may also facilitate faster ethical approvals for testing and consecutive prototyping [10]).…”