The Progressive Intertwinement Between Design, Human Needs and the Regulation of Care Technology: The Case of Lower-Limb Exoskeletons

Abstract

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.

Digi-HTA: Health technology assessment framework for digital healthcare services

“…Although the possibilities of applying robots in healthcare are broad, HTA studies are still focused mainly on surgical robots and their cost effectiveness [52,53]. Service robot studies have highlighted that the aspects of usability, data protection, and security should be taken into account when assessing robot applications [55,56]. Due to the special nature of AI solutions, HTA and guideline-producing agencies should be adapting their methods and processes for AI solutions.…”

“…The evaluated studies highlighted that, in addition to traditional HTA domains (e.g. effectiveness and safety), usability and accessibility issues should be taken into account in all applications, from mHealth to robotics [42,43,55,56]. A well-designed user experience improves product acceptance and increases people's confidence in the product.…”

“…Even personal healthcare data from multiple sources could also be used as input for AI solutions, and therefore, the access rights and data protection issues should be in order in every use case, including the retraining of the AI system [64]. In robotics, it must be ensured that the system cannot be hacked, which enables avoiding the possible safety risks to end users [56].…”

“…Evaluated HTA reports related to robotic surgery have mostly covered the cost effectiveness, but some of the reports also included the following HTA domains: clinical effectiveness, safety, organizational issues, and technology [51][52][53][54]. In addition, Fosch-Villaronga et al's articles related to service robots also highlighted the aspects of usability, data protection, and security [55,56]. From a regulatory point of view, the field of robotics is broad so at the moment that there is no specific robot regulation in which clear procedures, boundaries, and requirements are explained [57,58].…”

“…For this reason, we left them out, as our aim is to create a tool to provide fast assessments in a rapidly developing technology sector. The Digi-HTA domains and criteria are presented in Table 1.The detailed criteria in our framework are based on aspects of the mini-HTA questionnaire, ideas from NHS DAQ as well as information from literature, interviews, and workshops [9,29,31,[39][40][41][42][43]46,[55][56][57][58][59][60][61][62][63][64][67][68][69][70][71].…”