Diagnosing the impact of the EU AI Act on market access and pace of innovation of AI-enabled healthcare devices in the EU

Abstract This study examined if the announcement of the EU AI Act was associated with changes in market access and the pace of innovation for AI-enabled healthcare devices within the European Union. The analysis compared pre- and post-announcement periods to determine whether challenges and criticisms identified in prior research corresponded with significant changes in market access or pace of innovation. Specifically, the study investigated market access by analyzing the number of regulatory approvals for AI-enabled medical devices and the rate of innovation, measured by the number of new patent filings for AI-enabled healthcare products. The analysis also considered the volume of venture capital funding directed toward AI healthcare startups and small and medium-sized enterprises in the EU. Data were collected from publicly available sources, including the FDA, OECD Policy Observatory, Health AI Register, and WIPO Patentscope, over a 6-year period. The findings reveal no sustained, statistically significant change in the post-intervention period across all data sources except the OECD data, where descriptive statistics indicated a difference in mean values between EU and non-EU countries. Overall, the study found that the announcement of the EU AI Act did not lead to significant changes in the number of approved devices in the EU, contrary to what previous research had suggested. These results provide policymakers, economic operators in the AI medical device/healthcare sector, and global regulators with insights into the relationship between AI-specific regulations and economic outcomes.