Kill Bill: Does the EU AI Act actually kill innovation?

Sammanfattning

As a solution to the problem of AI systems failing to detect critical health issues, the “Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised rules on artificial intelligence and amending Regulations”, later referred as “the AI Act”, was enacted. This study aims to gain a better understanding of the impact of the EU AI Act on medical companies utilising AI systems classified as high-risk under the Act. Specifically, it investigates anticipated changes in workload and work environment, organisational structures, and how these factors together affect innovation processes. In addition, the potential gaps of the Act are researched and discussed. Employing a qualitative research design with semi-structured interviews and thematic analysis of document data, the study examines three companies that deploy high-risk AI medical technologies. For each firm, interviews are conducted with an employee with the expertise needed to bring valuable information to the study. In addition, company reports are used to compare with the case study, improving the reliability of the findings and expanding the scope. The findings reveal that MedTech companies are positive about the Act; however, they are concerned about the future. The resources that the Act will demand and the uncertainty of classifications are mostly their concerns. These obstacles represent the most significant impediments and areas for potential improvement in the Act. Implications of our research include challenges such as scope, time constraints, and the novelty of the topic, which made data collection through interviews difficult. However, our research contributes to international business research on legal frameworks and opens avenues for future research on the impacts of the EU AI Act in other sectors, as well as the MedTech industry.