HealthTech Innovation Bottlenecks Identified: AIRegu TO Launch Solution Workshops This Autumn
Spring interviews with regulatory experts across Europe reveal the specific compliance challenges delaying AI and health technology products. Collaborative workshops starting in autumn will tackle these barriers head-on.
Text: Martti Asikainen, 8.5.2025 | Photo: Adobe Stock Photos
AI and health technology developers face a critical timing problem: regulations evolve slower than innovation, yet compliance demands immediate clarity. Companies developing new solutions need practical guidance now – not interpretations that arrive months after crucial development decisions have been made.
What the Research Revealed
This spring, AIRegu conducted comprehensive interviews with specialists spanning AI development, health technology, data protection, and regulatory compliance. The research specifically targeted practitioners dealing with the intersection of multiple regulatory frameworks: the EU AI Act, Medical Device Regulation (MDR), and GDPR requirements for health data.
The project team is currently analysing interview data to pinpoint the precise regulatory bottlenecks that most frequently delay product launches. Early analysis suggests several recurring themes: conflicting interpretations between different regulatory bodies, uncertainty about AI risk classification in medical contexts, and the challenge of maintaining compliance documentation as both products and regulations evolve.
What the Research Revealed
Starting this autumn, AIRegu will convene co-creation workshops with experts and developers to tackle these identified challenges. Each session will focus on specific regulatory pain points, developing practical operating models and compliance frameworks that companies can implement immediately.
The goal is to accelerate the innovation cycle for AI-enabled health technology by creating clearer pathways through regulatory complexity. Workshop schedules and participation details will be announced throughout the summer. Follow AIRegu for updates.
Contact Us
Elisa Laatikainen
Project Manager
Haaga-Helia University of Applied Sciences
elisa.laatikainen(at)haaga-helia.fi