Towards Evidence-based Policies for Safe and Sound Robots: Harnessing experimentation to optimize the regulatory framing of healthcare robot technologies

GOALThis project aims to make healthcare robots safe and sound for society.PROBLEM STATEMENTThere 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 OBJECTIVESSAFEandSOUND 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. METHODSSAFEandSOUND's overarching methodology is anticipatory regulation, an emerging, proactive, iterative legal approach for empirically framing fast-evolving technological changes. SAFEandSOUND 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 CONTRIBUTIONSAFEandSOUND 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.