POWERWORKSHOP III: AI Reality Check – HealthTech Use & Misuse Sandboxed but Exposed – The Myth of Safe Testing
Event
About the event
Why Attend
This is not an AI hype session. It is a reality check. Learn how AI in HealthTech can fail silently, mislead users, and create regulatory risks—before it harms patients or reputations.
Participants will:
- Understand real-world failure cases
- Work hands-on in co-creation tasks
- Take home actionable strategies and a certificate
Program Overview – 3 Sessions
Session 3: Sandboxed but Exposed – The Myth of Safe Testing
Focus: Regulatory sandboxes are misunderstood. Testing in “beta” does not protect you from liability or regulatory scrutiny.
Case: A digital health chatbot marketed for wellness was perceived by users as clinical advice, triggering ethical and legal issues.
Task: Participants design a sandbox strategy that meets regulatory, clinical, and investor expectations.
Certificate
Participants who attend all three sessions and complete at least one breakout task receive a Digital Certificate of Completion.
This certificate can be used as documentation for:
- QMS training requirements under ISO 13485
- MDR compliance evidence (Annex I and Chapter VI)
- Continuing education and investor communication
Organized and delivered by:
Regulatory Thinking® – The Home of Regulation – www.homeofregulation.com