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

GOAL

This project aims to make healthcare robots safe and sound for society.

PROBLEM STATEMENT

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 entail unevenly.

This disconnect results in:

• Robot developers failing to integrate essential legal considerations into their designs.
• User safety not always being ensured.
• 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:

1. Regulatory gaps for robots from different sources (literature, policy, and patient engagement).
2. Tests these issues in experimental zones.
3. Investigates how to generate policy-relevant data from such experimentation.
4. Uses it for policy change, design requirements, and a charter for user rights.

METHODS

SAFEandSOUND'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.
• Active patient engagement.

These elements support regulators' proactive, engaged role in the healthcare robot innovation process.

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.