D.7.6 BRIEF Report on policy design and advice

This report contains a set of policy recommendations for European policymakers and best practices for researchers working in the biorobotics field, often with biomedical applications, within the BRIEF project. The previous cross-field regulatory analysis (published in deliverable D7.3) has identified the relevant regulatory frameworks that govern such a multidisciplinary area where technological advancements outpace the development of regulations. Such rapidly evolving frameworks concern personal and non-personal data management (i.e., the General Data Protection Regulation, the Data Governance Act, the Regulation on the Free Flow of Data, the European Health Data Space proposal, the Data Act proposal, and their national implementations), health law (e.g., the Clinical Trials Regulation, the Medical Devices Regulation and their national implementations), artificial intelligence (i.e., the AI Act proposal and the AI liability Directive proposal), liability (e.g., the Product Liability Directive Update), cybersecurity (i.e., the NIS Directive, NIS2 and the Cyber resilience Act, and their national implementations) and machinery (e.g., the Machinery Directive and the General Product Safety Regulation). Even in the absence of enforceable regulations, three main principles underpin the trustworthy-by-design development of technologies, namely fairness, accountability, and transparency. Based on this analysis, the report provides an initial set of guidelines that are meant to equip researchers with hands-on best practices to be implemented in their R&I activities; and policy recommendations that identify regulatory gaps that need to be overcome to ensure legal certainty and support technological advancements. These are two of the possible interventions that we propose to facilitate the compliant design of new biorobotic technologies. Additional ones include e.g. educational and training interventions such as workshops, awareness panels and policy briefs. All these interventions are illustrated in this report throughout the coherent framework of behavior change. Future work will complement the present policy recommendations and best practices, based on the ongoing cross-field regulatory analysis (for instance, concerning intellectual property aspects) and on the close collaboration with the researchers and technologists of the project that will elicit the challenges they encounter in the other working packages of BRIEF. The results will be published at the end of the project in an updated version of this deliverable.