# Implementing Ethical, Legal, and Societal Considerations in Wearable Robot Design
## 1 Introduction
### EISI Design Tools That Identify Substantive Principles  
Generally, design tools that include a set of substantive principles tend to be less focused on the specifics of the design process. Yet, procedural elements can merge to some extent with substantive principles, when certain procedural elements (such as stakeholder engagement) also embody substantive values (such as equality and fairness). In recent years, various high-level publications have provided guidance that focuses specifically on establishing a set of fundamental normative principles for the field of information technology, especially with regard to robots and AI.  
In 2019, an expert group convened by the European Commission published their _Guidance on Trustworthy AI_, requiring compliance with laws and regulations, adherence to ethical principles and values, and system robustness to avoid unintentional harm. They identified a list of seven essential principles: (1) human agency and oversight, (2) technical robustness and safety, (3) privacy and data governance, (4) transparency, (5) diversity, non-discrimination, and fairness, (6) environmental and societal well-being, and (7) accountability [17]. These principles were further specified and operationalised, to facilitate their application in diverse contexts. While these principles were developed with regard to AI, many of them appear applicable to data-intensive information technologies in general.  
The IEEE Global Initiative on Ethics of Autonomous and Intelligent Systems published a guidance document on _Ethically Aligned Design_[23] outlining core principles. The document is based on three \"pillars\", including an anthropological dimension by focusing on universal human values, a political dimension by focusing on political self-determination and data agency, and a technical dimension by focusing on technical dependability. These are complemented by the identification of a set of eight general principles that are partly cutting across the three pillars. These principles include (i) ensuring human rights, (ii) fostering human well-being, (iii) empowering human data agency, (iv) effectiveness and fitness for purpose, (v) transparency, (vi) accountability, (vii) awareness of risks of misuse, and (viii) specification of operators' competence requirements. The discussion of the realisation of these principles in practice operationalises these principles further, including extensive reference to relevant standards in the field.  
ELSI have also found their way into standards for robotics in recent years to mitigate the ELSI posed by robotics [34]. The British Standard Institute (BSI) has developed the British Standard (BS) 8611:2016 \"Robots and Robotic Devices. Guide to the ethical design and application of robots and robotic systems\" [35] which identifies 20 moral hazards and risks grouped on societal, application, commercial/financial, and environmental categories. It provides guidelines to mitigate or reduce risks associated with these categories. The standard builds on existing safety requirements for industrial, personal care, and medical robots and provides engineers with the tools to conduct an ethical risk assessment.