Business Brunch Mobile health

Category: data protection, product liability, compliance Industry: healthcare, consumer goods Location: Augsburg Date:

Focus on mHealth: medical apps, the Medical Device Directive and data protection

Business Brunch with Miriam Schuh and Dr. Carlo Piltz on 3 November 2017 in Augsburg

Manufacturers of medical software and health apps are asking themselves whether or not their product qualifies as a medical device. The border between a ‘mere’ lifestyle app and a medical app – and thus also a medical device – is often unclear. If it is a medical device, it has been necessary to pay heed to the new Medical Device Regulation (MDR) since May 2017. If the product is manufactured, classified or labelled in a way that does not conform to the MDR, the manufacturer may be exposed to major liability risks. 

At our business brunch on 3 November 2017 in Augsburg we would like to discuss this topic with you and look into questions such as

  • What kinds of software qualify as medical devices?
  • How do lifestyle apps differ from medical apps? 
  • What impacts does the new MDR have on medical software?
  • What risks do medical software and medical apps entail in terms of data protection law?
  • What liability risks does the new DSGVO entail?

We look forward to discussing these topics with you at our Business Brunch.