ERC Starting Grant

SAFE & SOUND Towards Evidence-based Policies for Safe and Sound Robots 

ERC StG SAFE & SOUND has the ambition to connect the policy cycle with data generated in robot testing zones to support evidence-based policymaking for robot technologies. 


There is an increasing gap between the policy cycle's speed and technological change. This gap is very noticeable in healthcare robotics, where policies are scattered and cover the issues robots entailed unevenly. This disconnect results in robot developers failing to integrate essential legal considerations into their designs, user safety not always being ensured, and the development of systems that may cause harm to patients. While other sectors enjoy evidence-based policies that translate policy goals into practical guidance, these frameworks have yet to emerge for robotic technology. 

Research objectives

SAFE&SOUND ushers in a new knowledge-policy relationship model for robots to facilitate the integration of legal requirements into the design of robotic technology in simulators, testing zones, and living labs, and reuse the data generated from this process for evidence-based policies on robots.

To turn this conceptual model into practice, this project focuses on healthcare robots; in particular, on two specific case studies: lower-limb exoskeletons and socially assistive robots. The testing zones developed by H2020 EUROBENCH and ISO 13482:2014 on safety requirements for personal care robots are used for this project.


SAFE & SOUND's overarching methodology is anticipatory regulation, an emerging, proactive, iterative legal approach for empirically framing fast-evolving technological changes. This novel method is inclusive and collaborative, future-facing, proactively engages with innovation, has an iterative mindset and is outcomes-based. Moreover, it counts with decentralized experimentation to enable diverse responses to the regulation of early-stage opportunities and risks where national or global policies and standards are still to be established. SAFE & SOUND uses robot testbeds, open data, interaction between regulators and developers, and active patient engagement to support regulators' proactive, engaged role in the healthcare robot innovation process.

Scientific contribution

SAFE & SOUND advances research toward an evidence-based regulatory model for robots that guides rather than catches up with robot (r)evolution and is more attuned to societal needs and fundamental rights. SAFE & SOUND opens new avenues for using evidence-based mechanisms to regulate robots in the EU and serves as an example for such activities across the globe. 

Team configuration (TBD)

Eduard Fosch-Villaronga

Principal Investigator


Postdoctoral Researcher


Ph.D. Candidate


Ph.D. Candidate

Job openings!

Slide vacancies

Background reading

You can read more about the foundations on which this project is based by reading the following articles:

Research outputs

Prifti, K., & Fosch-Villaronga, E. (2024). Towards experimental standardization for AI governance in the EU. Computer Law & Security Review, 52, 105959. 

The EU has adopted a hybrid governance approach to address the challenges posed by Artificial Intelligence (AI), emphasizing the role of harmonized European standards (HES). Despite advantages in expertise and flexibility, HES processes face legitimacy problems and struggle with epistemic gaps in the context of AI. This article addresses the problems that characterize HES processes by outlining the conceptual need, theoretical basis, and practical application of experimental standardization, which is defined as an ex-ante evaluation method that can be used to test standards for their effects and effectiveness. Experimental standardization is based on theoretical and practical developments in experimental governance, legislation, and innovation. Aligned with ideas and frameworks like Science for Policy and evidence-based policymaking, it enables co-creation between science and policymaking. We apply the proposed concept in the context of HES processes, where we submit that experimental standardization contributes to increasing throughput and output legitimacy, addressing epistemic gaps, and generating new regulatory knowledge. 

1-s2.0-S0160791X23001926-main (1).pdf

Fosch-Villaronga, E., Calleja, C., Drukarch, H., Torricelli, D. (2023) How can ISO 13482:2014 account for the ethical and social considerations of robotic exoskeletons? Technology in Society, 102387, 1-21. 

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 Safe and Sound project has received funding from the European Union's Horizon-ERC program,  Grant Agreement No. 101076929. Views and opinions expressed are, however, those of the author(s) only and do not necessarily reflect those of the European Union or the European Research Council. Neither the European Union nor the granting authority can be held responsible for them.