Study to support an impact assessment of regulatory requirements for Artificial Intelligence in Europe : final report

This Study, completed for the European Commission, DG CONNECT, supports the Impact Assessment of the European Commission's proposed Regulation on a European approach to Artificial Intelligence (AI). The study is divided into four main sections. Section 1 of the Study is dedicated to a comprehensive overview of existing evidence and prospective assessments of the risks and harms generated by AI for fundamental rights as well as for safety/security. Section 2 provides a comparative overview of emerging national experiences in developing strategies and regulatory frameworks in this domain, with specific emphasis on risk governance. Section 3 contains a detailed analysis of the results of the public consultation on the European Commission White Paper on Artificial Intelligence. It includes the analysis of 18 free-text questions from the consultation on the White Paper (6,667 free-text responses); and the screening of 408 position papers submitted to the public consultation. Section 4 is dedicated to an assessment of the compliance costs generated by the proposed Regulation on Artificial Intelligence, including both administrative burdens and substantive compliance costs. The cost estimation is built on time expenditures of activities induced by the new requirements under the proposed Regulation. Below, we describe our main findings in each of the sections.