Minimizing regulatory friction when designing Health AI solutions

Designing digital health AI solutions means navigating one of the most complex regulatory landscapes in tech. Between privacy laws, medical regulation frameworks, information security obligations and the EU's AI Act, even early design decisions can create regulatory roadblocks - or pave the way for compliant innovation.

In this interactive workshop, participants will explore how to minimize regulatory friction from the earliest stages of product development. Led by InfoSec expert Aengus O'Donoghue and tech attorney Thomas Kuster, we will work through real-life use cases to identify how design choices impact classification under the EU AI Act, trigger medical device obligations, or require health data safeguards under GDPR and national laws. Using practical exercises, we will highlight how security-by-design thinking helps avoid costly surprises down the line. Whether you’re building a clinical decision support tool, a wellness app with diagnostic features, or a generative AI chatbot for healthcare settings, this is the workshop for you.

Key takeaways:

• How to identify which health AI use cases fall under the AI Act’s high-risk categories
• The overlap (and friction) between AI, medical device, information security and privacy regulations
• Tactical design strategies to reduce compliance complexity
• How to future-proof your product for regulatory audits and market entry

This session is ideal for product managers, engineers, compliance leads, and legal professionals working in or with Health AI startups. Come ready to discuss, debate, and co-create smart solutions.