Periodic Reporting for period 1 - SAFEandSOUND (Towards Evidence-based Policies for Safe and Sound Robots: Harnessing experimentation to optimize the regulatory framing of healthcare robot technologies)
Periodo di rendicontazione: 2023-06-01 al 2025-11-30
GOAL.- This project aims to make service robots safe and sound for society. 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.
PROBLEM STATEMENT.- There is an increasing gap between the policy cycle's speed and technological change. This gap is very noticeable in service 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.- SAFEandSOUND has the ambition to connect the policy cycle with data generated in robot testing zones to support evidence-based policymaking for robot technologies. The project examines regulatory gaps for robots from different sources (literature, policy, and patient engagement), tests these issues in experimental zones, investigates how to generate policy-relevant data from such experimentation, and uses it for policy change, design requirements, and a charter for user rights.
RO1: Identify regulatory gaps for service robots
RO2: Test uncovered legal challenges for service robots
RO3: Leverage robot testing zones data to support evidence-based policy change
RO4: Investigate science for robot policy conception, effectiveness and sustainability
METHODS.- The project is pioneering the use of inter-disciplinary methodologies to develop new legal analyses and formulate evidence-based policymaking recommendations in the field of service robotics. By integrating legal scholarship, social science research methods, robotics studies, and policy analysis, the project contributes both conceptually and methodologically to the advancement of regulatory thinking in emerging technologies.
SCIENTIFIC CONTRIBUTION.- SAFEandSOUND 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. SAFEandSOUND 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.
PROBLEM STATEMENT.- There is an increasing gap between the policy cycle's speed and technological change. This gap is very noticeable in service 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.- SAFEandSOUND has the ambition to connect the policy cycle with data generated in robot testing zones to support evidence-based policymaking for robot technologies. The project examines regulatory gaps for robots from different sources (literature, policy, and patient engagement), tests these issues in experimental zones, investigates how to generate policy-relevant data from such experimentation, and uses it for policy change, design requirements, and a charter for user rights.
RO1: Identify regulatory gaps for service robots
RO2: Test uncovered legal challenges for service robots
RO3: Leverage robot testing zones data to support evidence-based policy change
RO4: Investigate science for robot policy conception, effectiveness and sustainability
METHODS.- The project is pioneering the use of inter-disciplinary methodologies to develop new legal analyses and formulate evidence-based policymaking recommendations in the field of service robotics. By integrating legal scholarship, social science research methods, robotics studies, and policy analysis, the project contributes both conceptually and methodologically to the advancement of regulatory thinking in emerging technologies.
SCIENTIFIC CONTRIBUTION.- SAFEandSOUND 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. SAFEandSOUND 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.
Since its launch in June 2023, the ERC project SAFE & SOUND has pioneered innovative approaches to regulation in service robotics, aiming to bridge the gap between scientific knowledge, technological innovation, and policymaking. At its core is the “Science for Robot Policy” model—a dynamic, interdisciplinary framework designed to integrate empirical evidence into regulatory governance. This model rethinks regulation as an adaptive, inclusive, and evidence-based process, moving beyond static legal rules to keep pace with technological change and societal needs.
Key achievements so far:
- Aligning science and policy – developed a structured approach that connects empirical research directly to regulatory design, closing long-standing gaps between robotics innovation and legal governance.
- Clarifying regulatory definitions – systematic reviews exposed ambiguities in standards like ISO 13482, proposing refined definitions for Mobile Servant Robots and Physical Assistant Robots to strengthen legal certainty for developers, regulators, and users.
- Identifying gaps and dissonances in regulation – mapping and prioritizing regulatory gaps through engagement with diverse stakeholders, including developers, policymakers, and user communities, to address the complexity of aligning robotics innovation with legal and ethical safeguards.
- Unpacking the concept of safety – SAFE & SOUND broadens the notion of safety in robotics beyond physical harm to include psychological and social risks. Using a four-dimensional model of gender (sex, attraction, expression, identity), the project exposed how current systems can obscure discrimination and create unsafe conditions for women and other groups historically excluded from design considerations. It also explores how emotion-recognition technologies in service robots present new challenges to user well-being, highlighting the need for more inclusive and resilient safety standards.
- Positioning for international impact – as members of ISO/TC 299/WG 2 (Safety Requirements for Service Robots), the team’s findings are positioned to inform the future revision of global safety standards, ensuring that issues of diversity, inclusivity, and human factors are embedded in technical requirements.
- Preparing robot testing to generate policy-relevant data – laying the foundations for experimental studies in real-world robotics environments. These tests will reveal how service robots interact with humans and society, providing evidence to inform smarter, safer, and fairer regulation.
Through these innovations, SAFE & SOUND is not only tackling regulatory uncertainty but also pioneering inclusive, anticipatory governance for robotics—ensuring that the technologies shaping our future are safe, fair, and aligned with societal values.
Key achievements so far:
- Aligning science and policy – developed a structured approach that connects empirical research directly to regulatory design, closing long-standing gaps between robotics innovation and legal governance.
- Clarifying regulatory definitions – systematic reviews exposed ambiguities in standards like ISO 13482, proposing refined definitions for Mobile Servant Robots and Physical Assistant Robots to strengthen legal certainty for developers, regulators, and users.
- Identifying gaps and dissonances in regulation – mapping and prioritizing regulatory gaps through engagement with diverse stakeholders, including developers, policymakers, and user communities, to address the complexity of aligning robotics innovation with legal and ethical safeguards.
- Unpacking the concept of safety – SAFE & SOUND broadens the notion of safety in robotics beyond physical harm to include psychological and social risks. Using a four-dimensional model of gender (sex, attraction, expression, identity), the project exposed how current systems can obscure discrimination and create unsafe conditions for women and other groups historically excluded from design considerations. It also explores how emotion-recognition technologies in service robots present new challenges to user well-being, highlighting the need for more inclusive and resilient safety standards.
- Positioning for international impact – as members of ISO/TC 299/WG 2 (Safety Requirements for Service Robots), the team’s findings are positioned to inform the future revision of global safety standards, ensuring that issues of diversity, inclusivity, and human factors are embedded in technical requirements.
- Preparing robot testing to generate policy-relevant data – laying the foundations for experimental studies in real-world robotics environments. These tests will reveal how service robots interact with humans and society, providing evidence to inform smarter, safer, and fairer regulation.
Through these innovations, SAFE & SOUND is not only tackling regulatory uncertainty but also pioneering inclusive, anticipatory governance for robotics—ensuring that the technologies shaping our future are safe, fair, and aligned with societal values.
The project is setting new benchmarks for regulating service robotics by addressing critical gaps at the intersection of law, technology, and society. Its Science for Robot Policy model represents a breakthrough in regulatory thinking—offering, for the first time, a structured framework that meaningfully integrates scientific evidence and interdisciplinary expertise into the governance of robotics.
This model advances the state of the art in several key ways:
- It challenges static, one-size-fits-all regulatory approaches by promoting adaptive, evidence-informed, and participatory processes that can keep pace with rapidly evolving technologies.
- It uncovers and addresses hidden risks in robotics systems, such as gender and diversity biases, that have historically been overlooked in safety standards. For example, SAFE & SOUND’s findings revealed how exoskeletons and other assistive systems often fail to accommodate women’s physiology or gender-diverse users—issues with direct implications for safety, accessibility, and trust.
- It expands the concept of “safety” in robotics beyond physical harm to encompass psychological and social dimensions, demonstrating how emotional interactions and algorithmic classifications impact user well-being and societal acceptance.
To maximize uptake and impact, the following enablers are key:
- Continued collaboration with international standardization bodies, including participation in ISO/TC 299/WG 2 (Safety Requirements for Service Robots), to embed inclusive, evidence-based practices in future safety standards.
- Exploration of a working relationship with the European Commission’s Joint Research Centre (JRC) to align methodologies with EU-level governance priorities.
- Demonstration and validation of the Science for Robot Policy model through real-world experiments in robot testing zones.
- Dissemination of results to industry, regulators, and civil society to foster the adoption of inclusive, fair design practices.
- Cross-sectoral engagement to apply the model’s principles in other high-stakes domains (e.g. healthcare, AI governance) where resilient regulation is urgently needed.
This model advances the state of the art in several key ways:
- It challenges static, one-size-fits-all regulatory approaches by promoting adaptive, evidence-informed, and participatory processes that can keep pace with rapidly evolving technologies.
- It uncovers and addresses hidden risks in robotics systems, such as gender and diversity biases, that have historically been overlooked in safety standards. For example, SAFE & SOUND’s findings revealed how exoskeletons and other assistive systems often fail to accommodate women’s physiology or gender-diverse users—issues with direct implications for safety, accessibility, and trust.
- It expands the concept of “safety” in robotics beyond physical harm to encompass psychological and social dimensions, demonstrating how emotional interactions and algorithmic classifications impact user well-being and societal acceptance.
To maximize uptake and impact, the following enablers are key:
- Continued collaboration with international standardization bodies, including participation in ISO/TC 299/WG 2 (Safety Requirements for Service Robots), to embed inclusive, evidence-based practices in future safety standards.
- Exploration of a working relationship with the European Commission’s Joint Research Centre (JRC) to align methodologies with EU-level governance priorities.
- Demonstration and validation of the Science for Robot Policy model through real-world experiments in robot testing zones.
- Dissemination of results to industry, regulators, and civil society to foster the adoption of inclusive, fair design practices.
- Cross-sectoral engagement to apply the model’s principles in other high-stakes domains (e.g. healthcare, AI governance) where resilient regulation is urgently needed.