on {ai}r | POWERWORKSHOP I: AI Reality Check – HealthTech Use & Misuse | Regulatory Thinking

​POWERWORKSHOP I: AI Reality Check – HealthTech Use & Misuse
Not What It Seemed – The Misleading Purpose Trap Motto: Decode the Black Box – Before It Decides for You
Driven by Regulatory Thinking®

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

​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
Dr. Dietmar Schaffarczyk

​📅 Date & Time: 26.09.2025, 12:15–13:00
⏱️ Duration: 45 Min
🌐 Language: English
🗣️ Format: Workshop
📍 Location: Live on Zoom

Part II and Part III are scheduled for 29.09. and 2.10. at 12:15.

​This session is intended for Founders, developers, clinicians, regulators, students, and all HealthTech professionals

​🔗 Part of the on {ai}r series by Swiss {ai} Weeks in cooperation with Wildcard Media.

Curious for more? Check out other sessions at swiss-ai-weeks.ch/onair