POWERWORKSHOP I: AI Reality Check – HealthTech Use & Misuse Not What It Seemed – The Misleading Purpose Trap
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 1: Not What It Seemed – The Misleading Purpose Trap
Focus: When intended use is poorly written, it leads to legal exposure and clinical misunderstanding.
Case: A fertility app was promoted as contraception. After multiple pregnancies, regulators intervened.
Task: Participants rewrite a flawed intended purpose statement into a legally and clinically safe version.
Certificate: Digital Certificate of Completion
Target Group: Founders, developers, clinicians, regulators, students, and all HealthTech professionals
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